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Comparison of Member State Authorisation Processes

VIEWS: 7 PAGES: 103

									          Competent Authority Survey
                    A Comparison
                          of
          Member State Authorisation Processes




Brussels, 1 March 2010
Hans Mattaar
                                                               Contents
Contents.................................................................................................................................................. 1	
  
Preface..................................................................................................................................................... 3	
  
Introduction ........................................................................................................................................... 6	
  
Analysis of Competent Authority structures .................................................................................... 7	
  
   Bodies involved in the process ....................................................................................................... 8	
  
       Lead Ministry ................................................................................................................................ 8	
  
       Agencies......................................................................................................................................... 8	
  
       Pesticide Boards ........................................................................................................................... 9	
  
       Separation of powers ................................................................................................................... 9	
  
       Centralisation ................................................................................................................................ 9	
  
   Financing & Resources ..................................................................................................................10	
  
       Financing & budgets..................................................................................................................10	
  
       Resources.....................................................................................................................................14	
  
   Process Efficiency & Legal or Target timelines.........................................................................15	
  
   Transparency ...................................................................................................................................16	
  
   Mutual Recognition ........................................................................................................................17	
  
   Conclusions .....................................................................................................................................19	
  
Germany ...............................................................................................................................................20	
  
France....................................................................................................................................................24	
  
United Kingdom..................................................................................................................................28	
  
Italy ........................................................................................................................................................32	
  
Spain ......................................................................................................................................................36	
  
Poland ...................................................................................................................................................42	
  
Romania ................................................................................................................................................47	
  
Netherlands ..........................................................................................................................................52	
  
Greece ...................................................................................................................................................56	
  
Portugal.................................................................................................................................................60	
  
Belgium .................................................................................................................................................64	
  
Czech Republic ....................................................................................................................................68	
  
Hungary ................................................................................................................................................72	
  
Sweden ..................................................................................................................................................76	
  
Austria ...................................................................................................................................................80	
  
Denmark ...............................................................................................................................................83	
  
Slovakia .................................................................................................................................................86	
  
Ireland ...................................................................................................................................................90	
  
Lithuania ...............................................................................................................................................93	
  
Latvia.....................................................................................................................................................96	
  
Estonia ..................................................................................................................................................99	
  



Contents                                                                                                                                              Page 1
Page 2
Preface
This report was commissioned by the European Crop Protection Association. It was drafted
by Hans Mattaar of Pappas & Associates, attorneys at law in Brussels, and was based on
interviews with experienced Regulatory Affairs managers from member companies of the
national associations in each of the reported Member States, and further enhanced through
discussions with or comments from the national associations’ experts.

With the introduction of the new Regulation on the placing on the market of Plant
Protection Products, a new paradigm for cooperation and work sharing between Member
States will be inevitable. This study was conducted with the aim to better understand the
existing structures and working processes of the different Member State Competent
Authorities, and thus help to achieve that goal.

The figures in the report are as much as possible derived from publications by the
Competent Authorities, or from analyses carried out by the national associations. Where no
hard figures were available, the report mentions that the presented numbers are estimates.
These estimates are based on the many years of experience of the interviewed experts.

A total of 21 Member States are described in the report. The selection of Member States
was limited only by the available time and resources, and does in no way reflect the
importance or the quality of the selected or not selected Member States’ regulatory systems,
or their role in the European process.

This study does not make policy recommendations. Rather, its purpose is to enable
stakeholders to learn from the different processes and structures, and to make better-
informed choices when improving them. The study identifies the potential for important
improvements, and hopes to contribute to a new paradigm for cooperation and work sharing.



Brussels, 1 March 2010



Hans Mattaar,
Pappas & Associates




J.Th.A. Mattaar                Pappas & Associates, Attorneys at Law
mobile phone +31 611 929 009   49-51 Rue Stevin
email: Mattaar@pappaslaw.net   B-1000 Brussels
                               Belgium
                               phone: +32 2 231 57 05
                               http://www.pappaslaw.net




Preface                                                                               Page 3
Page 4   Executive Summary
Executive Summary
Directive 91/414, and soon Regulation 1107/2009, provides clear instructions and
harmonised requirements and criteria for the placing on the market of Plant Protection
Products. Nevertheless, the regulatory process varies greatly between the Member States,
with average registration times ranging from 10 months to 54 months, and costs ranging
from € 500 to € 40.000. Since the same criteria apply in all Member States, and applications
for authorisation in the different Member States are often prepared by the same
multinationally operating companies, these variations can only be explained by differences in
organisation, workflow and efficiency.

This study investigates the organisational structures and workflows of the authorisation
process in 21 Member States. The study does not attempt to rate the quality of the
Competent Authorities or of their decisions, but offers the possibility to identify possible
obstacles to efficiency, and key factors for success.

In spite of the broad variety in the organisation of the authorisation process, the number of
elements that can be distinguished in the organisational structures is limited. Centralisation
or decentralisation of the evaluation process, concentration or separation of legislative and
executive tasks, the involvement of a “Pesticide Board” or not, with a consultative or an
executive power, are the main common parameters observed.

In terms of organisation, it can be concluded that the most efficient Competent Authorities
are those who operate in a centralised fashion. This can be in the form of an Agency or a
dedicated Department within the responsible Ministry. Key is for the Competent Authority
to have a high level of autonomy in its executive task, and for this task to be fulfilled without
confusing it with legislative development. Although it may not be a prerequisite for
efficiency, it is repeatedly noted that Competent Authorities or evaluating bodies that are
disengaged from agriculture can be more cumbersome to communicate with. At the same
time Competent Authorities that are closely connected to agriculture are by no means less
responsible or strict in their approach to human and environmental protection.

The most efficient Member States thus appear to be those who see the role of their
Competent Authority as one supporting their national agriculture to become or remain both
competitive and sustainable, whilst protecting the safety of man and environment.

The introduction of the new Regulation 1107/2009 will require a new paradigm for
worksharing and cooperation between Member States, and the introduction of a new zonal
regulatory level demands a harmonisation of not only the regulatory requirements and
criteria, but also of the regulatory workflows and structures.




Executive Summary                                                                        Page 5
Introduction
Historically, plant protection products were regulated in all EU Member States by national
legislation covering all aspects of placing on the market, use, trade, health of operators and
consumers, the environment, monitoring and control. Although all national legislative
systems were designed with the same overall goal in mind -a high level of protection for man
and environment- they were elaborated at different times, and with different objectives
within the existing legislative frameworks. As a result, differences between national rules
occurred, which constituted barriers in the trade of plant protection products within the
European Community. It was therefore considered desirable to harmonise the provisions
laid down in the Member States, with the aim to eliminate those barriers. The resulting
Community legislation, Directive 91/4141, obliged the Member States to adapt their national
legislation with regard to the placing on the market of plant protection products. The
harmonisation of those legislative provisions however did not automatically lead to a
harmonisation of the legislative procedures, and even less of the structural organisation of
the Competent Authorities that were trusted with this task.

Participation in the evaluation and decision process for European approvals of active
substances led to an increase of the workload of the Competent Authorities of the Member
States, which was further increased by the obligatory re-evaluation of all existing authorised
products after Annex I inclusion2 of the active substances. This increasing workload, as well
as the first work-sharing projects3 between Member States, inspired some Member States to
adapt their national procedures, and sometimes also to reorganise the structure of their
Competent Authorities, or even to re-consider the role and responsibilities of the different
bodies in the process. Nevertheless, many Member States continue to work on the basis of
historical structures and workflows, with increasing difficulties in coping with their workload.

With the publication of the new Regulation4 for placing on the market of plant protection
products, further work sharing and ultimately an increasing reliance on forms of Mutual
Recognition will most likely drive Member States to reconsider their internal workflow and
consequently the structure and organisation of their Competent Authorities, in the light of
the increasing workload.


1
  Council Directive of 15 July 1991 concerning the placing of plant protection products on the market (91/414/EEC),
OJ L 230, 19 Aug. 1991.
2
  After entry into force of Directive 91/414, all products that were already on the market had to undergo a re-evaluation
under the provisions of the new Directive; active substances were subjected to a Review Programme, and were placed
in Annex I of the Directive if it was proven that use, compliant with the new criteria, was possible. Subsequently,
Member States had to re-evaluate ALL previously nationally authorised uses under the new EU criteria.
3
  Under the Directive, the principle of Mutual Recognition was introduced: a product, authorised by one Member State
under the conditions and criteria of the Directive, should be authorised by all other Member States, provided that the
conditions of use are comparable. The variation in environmental and climatic conditions between Member States made
this principle complicated to apply. As a result it has proven necessary for Member States to harmonise and synchronise
their national evaluations, and to cooperate and share the workload, in order to allow a legally correct, and efficient
application of this principle.
4
  Regulation No. 1107/2009 (EC) of the European Parliament and of the Council of 21 October 2009 concerning the
placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC, OJ
L309/1 of 24/11/2009


Page 6                                                                                           Introduction
This report provides an overview of the organisational structures and workflows of the
authorisation procedures of a majority of the European Member States. It is drafted so as to
allow a comparison between the different systems, and to identify elements that may
facilitate or impede the authorisation process. It should be noted however that in each
Member State, the Competent Authority has to function within an existing governmental
structure, and each structure has its own advantages and disadvantages, and will demand
different solutions for common problems. Nevertheless, the Member States have the same
responsibility towards their citizens and towards applicants, and the same standards to
comply with. Yet, the cost of an application varies from € 500 to € 40.000, and the time
necessary for an average decision process from 10 to 54 months. Moreover, these differences
are not correlated: a high cost is no guarantee for a fast and/or efficient process, and a low
cost is no sign of a poor evaluation.

Efficiency is not necessarily defined as “speed of authorisation decision”. It is a balanced
mix of speed, transparency of the process, solution oriented communication between
Competent Authorities and applicants, and a rational and commonly agreed interpretation
and implementation of the requirements and criteria laid down in the Community legislation.
Although efficiency and bureaucracy may appear to be mutually exclusive, a certain level of
bureaucracy is required in order to guarantee impartiality and neutrality of the Competent
Authority. The most efficient Member States appear to be those who see the role of their
Competent Authority as assisting their national agriculture to become or remain competitive
and sustainable, whilst protecting the safety of man and environment.

Lack of efficiency can in many cases be explained by a structure or workflow that struggles
to adapt to a constantly evolving environment. Several Member States have recently proven
that it is possible to overcome historical structures’ hindrances, and have made significant
changes e.g. to the distribution of responsibilities between the involved Ministries, or to the
separation of tasks between the different bodies, with consequent changes in efficiency in the
decision process. This report offers insight in the level of complexity in the different models,
and the consequences for efficiency and reliability of the process.

Analysis of Competent Authority structures
Although structures within Competent Authorities can be very different, a number of
common elements can be distinguished. The individual Member State chapters hereafter
describe the processes of administration, coordination, evaluation and decision, and the roles
and responsibilities of the involved Ministries and Institutions. Because undesirably long
delays in the authorisation process are often attributed to a high workload and lack of
resources, the report also looks into the financing of the Competent Authorities: the level of
the fees charged, the link between the funds collected and the Competent Authority budget,
and the resources available to deal with the workload. The report also pays attention to the
transparency of the national systems and the level of communication between applicants and
Competent Authority and evaluators. Finally, there is special attention for the Member
States’ national data requirements, and more specifically with regard to the biological section
of dossiers. A successful introduction of the zonal system, zonal evaluation and Mutual
Recognition will largely depend on the Member States’ ability to share responsibilities and to
trust and accept evaluations drafted by their peers.



Introduction                                                                            Page 7
The efficiency of the different Competent Authorities is clearly not dependent on a single
factor. Also, it can be safely assumed that the variation in speed of the evaluation and
decision process cannot be attributed to differences in quality of the submitted dossiers: the
data collected in this report are based on the joint experience of ECPA member companies,
the majority of whom operate on an international and European level, delivering the same
quality dossiers across the Community. If the perception of the dossier quality differs
between Member States, these differences cannot be explained by differences in standards,
because those should be similar between Member States. Differences in speed and cost of
evaluation and decision process therefore have to be found in the interpretation or
implementation of the EU standards and requirements in Member States’ working models.

Bodies involved in the process
Lead Ministry
In most Member States the responsibility for the authorisation process is with the Ministry
of Agriculture, in some cases this Ministry has a combined responsibility with Environment,
or includes also Public Health. Only in Italy the lead Ministry is the Ministry of Health, and
in Sweden and Denmark the Ministry of Environment. Although this could lead to the
conclusion that a “non-Agriculture” lead Ministry could negatively influence the efficiency of
the process, this would be contradicted by Spain, with the longest registration times but with
the Ministry of Agriculture as lead Ministry, and the UK with the shortest timelines but with
the Competent Authority now operating under the Department for Work and Pensions
(previously under the Department for the Environment, Food and Rural Affairs, Defra). In
Spain however decisive steps of the evaluation process are under control of other (non-
agricultural) Ministries, and in the UK the Competent Authority works in a very centralised
fashion, with strategic policy remaining with Defra, the UK no longer having a
Ministry/Department of Agriculture.

In general, a disengagement of any involved staff with the ultimate goal of the authorisation
process, i.e. to allow the (safe) use of crop protection solutions in order to support a
sustainable agricultural production, is often seen as a factor negatively influencing efficiency.

The responsible Ministry does not usually have full autonomy for regulatory decisions: in
many countries this responsibility is shared with other Ministries: either through their role in
the evaluation process, or through their membership of a Pesticide Board, where they can
have a vote or even a veto right.

Agencies
Several Member States have delegated the full responsibility for the authorisation process to
an Agency, or to an Agency-like body within the lead-Ministry (FR, UK, NL, CZ, AT, SE,
DK, SK). But even in these countries there is often some form of a Pesticide Board (see
below) involved in the evaluation and/or the decision process. In general the experience with
Agencies is favourable: the concentration of the entire process in one body usually enhances
transparency of the process and shortens the lines of communication. Also the centralisation
leads to more reliable and predictable process and decision-making. Especially when the
legislative and executive tasks are clearly separated, with the executive tasks assigned to the
Agency or Agency-like body, the process can become more efficient (see below).



Page 8                                                                        Introduction
Pesticide Boards
Roughly two thirds of Member States have established a Pesticide Board in one form or
another. A Pesticide Board is an inter-departmental body, also referred to as Expert
Committee, Consultative Pesticides Committee, Advisory Panel, Registration Committee,
etc.. The national pesticide law usually provides that the Minister (of the lead Ministry)
appoints the members of the Board, with the agreement of the members’ own Minister or
head of their Institution. Some Pesticide Boards include members from a wider range,
including not only co-responsible Ministries (Health, Environment, Labour..) but also from
other groups of stakeholders (Farmers’ organisations, Agricultural Chambers, Bee Research
Stations, and other research organisations, or agrochemical industry). The role of a Pesticide
Boards can be a consultative one (in case of complicated scientific issues), a decision role
(usually guided by the consolidated opinion of the Evaluation Bodies) or an oversight role. It
can be questioned whether the existence of a Pesticide Board is merely a formality, a
necessity to guarantee that human health and environment are sufficiently protected, or a
means to ensure a balanced risk-benefit assessment in the case of an uncertain outcome of an
evaluation, or parts thereof.

Separation of powers
In some Member States there is a clear separation of powers, especially where the
authorisation process is delegated to an Agency. Both at the national level and at
international level it has been repeatedly demonstrated that the authorisation process (or any
executive task, for that matter) can be seriously hampered if it gets mixed up with the
development of the legislative procedures or criteria. In those Member States where the
executive body can fulfil its tasks according to the rules of procedure and the criteria granted
by the European and the national legislator, the process can run uninterrupted, and without
individual dossiers turning into platforms of the development of new criteria, risk assessment
methodology, or political debate, and decisions being delayed for indeterminate periods. A
dedicated executive body, with sufficient resources, and provided with clear guidance, has all
the possibilities to operate smoothly. This is usually the case with Agencies and Agency-like
bodies. Such conditions also enhance the level of predictability and confidence for
applicants, and stimulate innovation, and the introduction of new crop protection solutions.
At the same time it allows full involvement of all Ministries and expert bodies in the
legislative task, but without interfering with the executive task of the Competent Authority.
Since the authorisation process is by definition a repetitive process, the separation of the
legislative and executive tasks can lead to a smooth and pragmatic authorisation process,
where changes in the rules or criteria are applied at a next evaluation and re-authorisation
round for all products in the market.

Pesticide Boards can be involved in both the legislative and the executive processes for
maximum cohesion.

Centralisation
One of the most conspicuous differences between the regulatory systems is the level of
centralisation, with the completely centralised Agency process on one end of the scale, and
on the other end systems where parts of the dossier are sent to multiple addresses
throughout the country, with the same section of the dossier sometimes evaluated



Introduction                                                                            Page 9
simultaneously by different bodies, and separate approvals being granted by different
Ministries.

The level of centralisation should be regarded for each of the phases in the authorisation
process.

   • The Coordination and administration is always concentrated in one Department of
     the lead Ministry (or in the Agency).

   • In the Evaluation phase there is a large range, from complete centralisation within an
     Agency (UK) or the responsible Department in the Ministry (Portugal, Lithuania,
     Austria), to the involvement of 1 to 4 other Ministries, and up to 6 or more Institutes,
     Research Stations, Universities, or other bodies or individuals, who can operate either
     independently or again under control of one (or more) Ministries. The involvement of
     multiple Evaluating Bodies is not always directly comparable: in some cases, e.g. in the
     Netherlands, external Evaluating Bodies are contracted by the Agency to deal with
     (temporary) overload, and they simply deliver an evaluation with an opinion, which is
     subsequently used by the Competent Authority; in other countries (e.g. Germany, Italy,
     Romania, Spain) the evaluating bodies have their own independent and decisive role in
     the process, and can operate in a very independent fashion, with the possible risk of
     disconnection with the overall task. These systems require not only a larger overhead
     for coordination; they also create uncertainty and unpredictability.

   • In the Decision phase, the Competent Authority can decide independently, on the
     basis of the opinions provided by the Evaluating Bodies, and finalises the authorisation
     process without any intervention (UK, Portugal, Hungary, Austria, Sweden, Estonia).
     Also operating in a centralised fashion, but with a Board overseeing the final decision,
     are Agencies such as the Netherlands. Finally there are models where all Ministries take
     part in the final stage of the process, usually in a Pesticide Board, sometimes after
     having been involved already at the evaluation phase through one of their
     Departments, or through Institutes operating under their responsibility.

In general it can be concluded that the most efficient model is the one where the Competent
Authority can decide independently, on the basis of the opinion of the Evaluating Bodies,
whether those are internal or external ones. It is often claimed that other Ministries than the
lead Ministry must have a say in the final decision to ensure that human health or
environmental safety is guaranteed. This claim is contradicted by countries like the UK or the
Netherlands, which are generally considered as very thorough in their regulatory decision-
process, but with one centralised Competent Authority. In general, it can be assumed that a
well-resourced, professional evaluation process, following procedures laid down under an
interdepartmental process, and possibly overlooked by a (interdepartmental) Pesticide Board
should work most efficiently.

Financing & Resources
Financing & budgets
In some Member States, the Competent Authority, under a cost recovery scheme, is
permitted to retain fees for evaluations carried out under the law (Netherlands, France, UK).


Page 10                                                                     Introduction
However, adoption of such a scheme may or may not be legally possible in other Member
States, since some countries require that all government-acquired fees be consigned to the
consolidated fund administered by the ministry responsible for finance, which then allocates
the funds to the various ministries and agencies through the normal budgetary process. This
is the case in the majority of Member States, with the result that, although the fee may reflect
the actual cost of the evaluation, the Competent Authority may not necessarily be able to
adjust its resources in proportion to its workload.




Figure 1


The new Regulation states that “Member States may recover the costs associated with any work they
carry out within the scope of this Regulation, by means of fees or charges, and (..) shall ensure that the fees or
charges and (..) correspond to the actual total cost of the work involved”. Figure 1 shows an overview of
the (average) fee for the evaluation of a new product5 set off against the average actual time
necessary for the authorisation process. The average time for the authorisation process is
derived from the estimates from industry for the time necessary for obtaining an
authorisation for a new product, with an active substance not yet registered in the Member
State, on the basis of a dossier, with only minor issues arising during the evaluation process.
These figures are subjective, but based on long-standing experience from applicants. The
figure shows clearly that there is no direct correlation between the level of the fee and the
efficiency of the process. It also shows that the range of fees is such (€ 500 - € 40.000) that it
cannot possibly be in all cases representative of the actual total cost of the work involved.
The Regulation states that Member States may recover the costs, which means that Member

5
    with a substance new for the Member State, already on Annex I, with a DAR available


Introduction                                                                                             Page 11
States may choose to charge a fee lower than the actual cost. This can be a political choice in
smaller Member States, where the agrochemical market for many crops/uses is so small that
a fee corresponding with the actual cost of the work involved would deter companies from
registering products, and farmers in such countries could be deprived of the necessary crop
protection solutions.

On the other hand, especially in the Member States with the longer evaluation periods, the
fees are consistently very low, which could suggest that there are insufficient resources
available. In all these countries (SP, IT, GR, PT, BE, SE) the fees go directly into the general
state budget, and are not directly utilised for the evaluation process. Sweden however, as well
as Denmark, has a system in place with a levy on the sales of plant protection products. In
Sweden the income from the annual charges used to cover ca. 90% of the income of the




Figure 2

Competent Authority, the remaining 10% comes from the fees This ratio is expected to
change to ca. 50/50, with an increase in the application fees introduced in 2010. In Denmark
there is no fee at all: the annual charges are used for the financing of the Competent
Authority, as well as for other purposes.

When a Member State acts as Rapporteur Member State, and is responsible for the
evaluation of an Annex II dossier, the fee could be expected to be more representative of the
actual cost of the evaluation, because there is no direct national interest involved, nor can
there be a compensation from national levies on sales. Figure 2 however shows that here too
the range (from € 23.000 in Estonia, to € 450.000 in Sweden) is more than can be explained


Page 12                                                                      Introduction
by resources invested in the process. Especially when the cost for a national evaluation is
compared with that for a European evaluation, the results are remarkable: in Poland the cost
is almost identical, in Spain or Belgium a national evaluation costs less than 1% of a
European one. In other countries this ranges between 3 and 20%. It should be noted that in
this comparison, the availability of a European evaluation (Annex I inclusion, Draft
Assessment Report) is assumed for the application of a national authorisation for a new
product.

Especially in Member States with strongly decentralised evaluation procedures, the fee-
system can become extremely complicated, with each evaluating body charging its own fee
directly to the applicant.
        country            time for authorisation   # staff    average fee for application
                                (in months)
                        average legal exceedance               EU         national    MR

          Germany           24   12       12         285      € 143,000    € 31,000   € 13,750
             France         16   12        4         108      € 200,000    € 40,000   € 15,000
                                     6
                  UK        10   7         3         250      € 166,000     € 9,000    € 4.500
                Italy       45   12       33          58       € 52,000     € 1,500    € 3,615
              Spain         54   12       42          28      € 150,000     € 2,000    € 1,350
             Poland         24   16        8          44       € 30,000    € 32,500
           Romania          18   12        6                   € 50,000    € 10,000
       Netherlands          26   11       15          65      € 250,000    € 28,000    € 8,000
             Greece         36    0        --         29       € 80,000     € 6,000    € 5,000
           Portugal         30    0        --         16      € 100,000     € 5,350      € 680
    Czech Republic          24   24        0          41       € 70,500    € 17,000    € 5,100
            Belgium         27    0        --         28      € 150,000     € 1,000    € 1,000
           Hungary          18   18        0          23       € 55,500    € 13,000      € 550
            Sweden          42   126      30          26      € 450,000    € 13,500    € 6,000
             Austria        12   15        -3         52      € 320,000    € 19,800    € 7,200
           Slovakia         24   18        6          25      € 135,000     € 3,000      € 200
          Denmark           30   246       6          20      € 223.000         €0
             Ireland        18    0        --         21      € 200.000     € 5.000    € 2.500
          Lithuania         12   12        0          9        € 78.000     € 5,800    € 2,900
              Latvia        12   15        -3         8        € 49,800     € 2,900    € 1.150
            Estonia         12   13        -1         6        € 23,100       € 500      € 320
Table 1


One small but remarkable difference between Member State approaches is that several
Competent Authorities will charge a fee upon application, and will not commence the
process until receipt of payment (Germany, Belgium, Czech Republic, Netherlands, Sweden)
has arrived on the desk of the administrator, or require even pre-payment with a receipt
added to the application (Spain, Poland, Greece, Lithuania). Other Member States are more
pragmatic and will commence processing regardless of payment (Portugal, Hungary, Austria).
The differences are notable because in the Member States where an invoice is sent upon
application, and work is not started until the confirmation of payment has been received, this
6
    target timeline, not legal


Introduction                                                                                 Page 13
simple administrative process can lead to delays of several weeks. In countries where the
process commences regardless of payment, it seems that applicants dutifully fulfil their
financial obligations. The approach of Portugal, Ireland and the UK seems to be the more
efficient and pragmatic: the process starts immediately, but confirmation of payment is a
prerequisite for issuing the authorisation certificate at the end of the process.




Figure 3


Obviously, from the different systems, the least desirable is the more bureaucratic one, where
payment of the fee can only be done after receipt of an invoice, and the process does not
start until the confirmation of payment is received, as visualised in Figure 3.

Resources
Member States that work with an Agency that can retain the fees for the evaluations carried
out, usually do not suffer from lack of resources (UK, France, Netherlands), although
temporary increase in workload can lead to delays here, too. The number of staff available
varies a great deal between Member States. Countries like Germany, UK and France work
with a total staff of 100-250 people, while Portugal or Lithuania have a total of 10-15 staff
employed for the entire process (administration, evaluation and decision). Of course, the
number of applications and/or evaluations treated on an annual basis may differ between
countries.

It is very difficult to make a direct comparison of the number of evaluators available for the
different scientific disciplines, because the Evaluating Bodies combine the responsibilities for
these sections in very different ways: Ecotox, Efate, PhysChem, Analytical Methods,
Efficacy, Toxicology (operators, consumers, general toxicology), Residues, can be treated by
separate teams or persons, or in any combination. Also, in many countries the evaluators
operate in different institutions and are often also responsible for evaluation work for
biocides, REACH, or the labelling and classification of dangerous substances. Alternatively,
many of them operate in Universities or Research Institutes, and have research or
educational tasks in addition to their evaluation work. Nevertheless, in Table 1 an attempt is
made to quantify the number of staff involved.

The staff-numbers from Table 1 are visualised in Figure 4. Again, these data should be
regarded as purely indicative, because the available data do not allow a detailed comparison.
In the first place, the figures for number of staff could not always be specified to fte’s (full
time equivalents) dedicated to the pesticide evaluation work; secondly, the figures are not



Page 14                                                                       Introduction
related to the total number of applications treated annually in each country: not only is the
total number of applications different between countries, there are also differences between
the total number of authorised products in each country and the frequency of authorisation
renewal, and the related workload.




Figure 4


What is clear however is that there appears to be little or no correlation between number of
staff and speed of authorisation, also between countries of comparable size.

Process Efficiency & Legal or Target timelines
The speed of the regulatory process is not necessarily a reflection of the quality of the
evaluation process, nor of the available resources. Obviously, when Competent Authorities
can dispose of sufficient resources this can positively influence the speed (and/or the quality)
of the evaluation, but bureaucratic procedures, a fragmentation of the evaluation process,
decentralisation of the decision process, and lack of communication between evaluators and
applicants can negatively influence efficiency. Also, as is shown in Figure 5, the definition of
legal or target timelines appears to make no difference in the actual time required for the
process. Although most authorities rigorously enforce the deadlines they impose on
applicants, there are usually no consequences if they exceed their own deadlines.

Most Member States that have established legal or target timelines, have set these at ca. 12
months. This should be an indication that 12 months can be considered as a reasonable
period for the authorisation process, and several Member States are capable of operating
within these deadlines, or even faster. These are not only Member States working on the
basis of high fees and/or with a large staff (UK, FR), but also smaller ones, with small teams
and low fees (AT, LT, LV, EE). The one thing they have in common is that they all operate
in a centralised fashion, with a straightforward decision system.


Introduction                                                                            Page 15
Some of the data in Figure 5 are marked as ”estimate, under recently changed process”. In
these countries the process changed recently, and not enough time has passed to allow a real
estimate under the new process. Therefore the estimate is based on experience with the
previous process, or on the time passed since the new process was introduced.

Although the setting of a legal or target timeline is no guarantee for adhering to it, or for an
efficient process, the Member States that have no legal or target timeline at all, have
processes that last 24 months or longer (Belgium, Portugal, Greece and Spain).




Figure 5


Transparency
Transparency of the process is generally regarded as driving factor for efficiency. The
transparency, as described in the country chapters hereafter, focuses on two main points: in
the first place the involvement of the applicant in the progress of the evaluation, and his
ability to address eventual issues identified during the process; in the second place, and
possibly more important, the direct communication between the applicant and the
evaluators. It is noted that the efficiency of the process is in general considered to be
improved significantly when evaluators contact the applicant directly when they have
questions, or require additional information. Whilst in some Member States this contact is
very open and direct, others consider this as a potential risk of the evaluators getting
influenced by the applicant, and channel all communication during the evaluation phase

Page 16                                                                       Introduction
through their coordinators. Others, like Hungary, have found a very practical compromise
solution: communication between evaluators and applicant takes place at a direct and
informal level, allowing minor issues to be solved efficiently. At the same time, when issues
appear to be or to become more important, or when solving them takes more time, they will
simultaneously be communicated formally, through the coordinators.

Quantifying transparency could only be done subjectively. Nevertheless, on the basis of the
descriptions in the country chapters, there seems to be a (positive) correlation between
transparency and efficiency of the process. Exceptions to the rule appear to be countries like
UK and France, who are both efficient, but actively minimise contact between evaluators and
applicants. The fact that two well resourced, high quality Competent Authorities are capable
of treating applications, with a minimum of dossier amendments, within 12 and 18 months
respectively, is again an indication that clear submission rules and consistency with European
requirements allow the submission of high quality dossiers and efficient processing.

On the other side of the scale, Greece and Italy have very transparent processes and open
communication, but require 3 and 4,5 years respectively for the authorisation process. For
Italy, this can be explained by the complexity of the evaluation and the large number of
bodies involved, in Greece the large backlog is a major element hampering efficiency,
indicating that resources are simply insufficient. Nevertheless, the Competent Authorities in
Greece have been able to reduce the delays from 5 years down to 3 years.

In general it can be concluded that the direct contact between evaluators and applicants can
improve efficiency, especially where resources are limited. However, transparency in a
bureaucratic and rigid system will not make the system more efficient, only more transparent.

Mutual Recognition
Directive 91/414, based on Article 95 of the Treaty, introduced the concept of Mutual
Recognition in the regulatory domain for Plant Protection Products. There are exemptions
possible from the obligation to authorise a product that was already authorised in another
Member State. Nevertheless, some countries (PL, RO) do not even have a system in place to
apply for authorisation under this provision. Many other Member States have procedures in
place, but some request additional data over and above providing evidence that “agricultural,
plant health and environmental (including climatic) conditions relevant to the use of the
product are comparable in the regions concerned” (Art. 10.1, first indent) (e.g. Sweden,
Denmark), or require the repetition of biological trials (most Member States).

Some of the additional data requirements concern country-specific conditions, such as
leaching potential under particular, vulnerable scenarios, or effects on regionally specific non-
target arthropods or beneficials.

Only very few Member States apply Mutual Recognition in the spirit of the Directive (AT,
LU). Almost all Member States that apply Mutual Recognition have interpreted the concept
as Mutual Recognition of evaluations, rather than Mutual Recognition of authorisations. In
practice, those Member States that apply Mutual Recognition in fact make use of the
Evaluation Report generated by the Member State that granted the original authorisation (the
“reference country”) as the basis for their own evaluation. Rather than verifying if the
conditions relevant to the use of the product are in the reference country are comparable to


Introduction                                                                             Page 17
the conditions in their own territory, most Member States conduct a more or less complete
risk assessment, using the Registration Report as their starting point. When comparing the
cost for a Mutual Recognition application with the cost for a standard application (see Figure
6), it becomes apparent that many Member States invest almost as much time in a Mutual
Recognition evaluation as in a complete evaluation7. Although the relative cost of a Mutual
Recognition application is not necessarily correlated to the Member State’s attitude towards
Mutual Recognition, it is clear that some Member States do not see the concept as an
opportunity to reduce their workload but rather as a threat of their autonomy.

The most problematic element in the application of Mutual Recognition appears to be the
biological dossier. Many Member States insist that at least a certain fraction of the biological
trials that are required is conducted within the Member State territory (often at least 50%).




    Figure 6


In the evaluation structure of the Member States, the efficacy evaluation is often located
within the Institutes or Departments that form the historical basis of the Regulatory
Authority, sometimes within the current Competent Authority, in other cases within the
former responsible body. The strict adherence to the need for national biological trials could
become a serious obstacle in the development of zonal evaluation and the application of
Mutual Recognition.




7
  The remarkably high figure for Italy appears to be the result a synchronisation issue with the updating of legal fees; it
is more likely that the fee for standard applications will go up in the future, than the Mutual Recognition fee to go
down.


Page 18                                                                                            Introduction
Conclusions
It can be concluded that the most efficient Competent Authorities are those who operate in
a centralised way, with the administration, evaluation, and decision all concentrated in one
body that can operate with a high level of autonomy. Especially when the legislative tasks
(development of new guidance, policy development, definition of requirements and criteria)
are separated from the executive tasks, the Competent Authority can work uninterrupted and
efficiently.

Many Member States struggle with the involvement of many Ministries and/or evaluating
bodies with decisive power, either for historical reasons, or with the intention that in order to
protect the environment or human health, the Ministry of Environment or Health should be
fully involved in every stage of both the legislative and the executive process. Several
Member States have demonstrated however that the involvement of multiple Ministries in
the executive tasks is not necessary, as long as they have a decisive role in legislative
decisions. Especially the allocation of parts of the evaluation to departments or Institutes
residing under other Ministries can have an adverse effect on the efficiency of the process.
This is worsened when these departments or institutes are given decisive power at the
evaluation level over the application. There are nevertheless countries where other Ministries
are involved in a more efficient manner: this is the case where the administrative and
evaluation tasks are concentrated in one body, and final decisions are taken by a Pesticide
Board in which all responsible Ministries are represented.

Efficiency is also determined by the resources available to the process: the most pragmatic
approach is where fees can be collected that are representative of the actual cost of the
process, and where these fees can be directly utilised by the Competent Authority. In
countries with a smaller agricultural market, as well as for minor crops or minor uses in other
larger agricultural economies, the direct correlation between fees and actual cost of
evaluation may not be desirable, because it could become disruptive for the availability of
sufficient products for certain crops. It is of course a policy matter whether additional funds
would be made available to the Competent Authority in order to support a sustainable and
competitive agriculture.




Introduction                                                                             Page 19
                                             Germany
Summary rev2
In spite of a very clear and detailed process-flow, the German evaluation and decision
process on average takes 2 years instead of the legal 12 months. The approach of strict
adherence to protocols is aimed at effectively managing the complicated workflow of the
involved bodies, with the unavoidable consequence of a certain limitation to flexibility and
direct communication. Germany attaches much importance to its autonomy in authorisation
decisions; consequently the concept of “forced Mutual Recognition” in the zonal context is
regarded with a certain reservation.

With the entering into force of the new Regulation8 BVL is reconsidering the entire
workflow and organisational structure of the process.

Resources
Responsibilities
The overall responsibility for the process, from submission to granting of an authorisation,
lays with the BVL9, under the Federal Ministry of Food, Agriculture and Consumer
Protection, BM ELV10. BVL has ca. 120 fte11 dealing with process control and management.
This includes a coordinator for the German process, 4 liaisons for applicants (F, I, H, and
rest), plus liaisons for the evaluation institutes. BVL is responsible for distribution of
dossiers to the Institutes for evaluation, process flow, documentation and archiving, IT, and
databases. BVL has a separate team dealing with European submissions. Within the
Institutes, the same evaluators deal with national and European submissions. However, the
drafting of the European DAR12 is done by BVL. In addition to the management of the
process, BVL also has the responsibility for the evaluation of the PhysChem section of the
dossier.

Also the JKI13 falls under the responsibility of the BM ELV. They have an estimated ca. 20
fte dealing with (mainly the efficacy section of) dossiers. The evaluation of the environmental
and ecotoxicological parts of the dossier falls under responsibility of the Umwelt Bundes Amt,
UBA14, under the Ministry of Environment15, with an estimated ca. 50 fte. Toxicology,



8
  Regulation 1107/2009(EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009
concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and
91/414/EEC, OJ L309/1 of 24/11/2009
9
  BundesInstitut für Verbraucherschutz und Lebensmittelsicherheit, the Federal Office for Consumer Protection and
Food Safety
10
   BundesMinisterium für Ernäheren, Landwirstschaft und Verbraucherschutz
11
   Fte = Full Time Equivalent (1 fte is one fulltime employee)
12
   Draft Assessment Report
13
   Julius Kühn Institut, (former BBA, Federal Biological Service Biologisches BundesAmt), responsible for biological
dossiers, and for bees
14
   Umwelt Bundes Amt, Federal Environment Agency
15
   BundesMinisterium für Umwelt, Naturschutz und Reaktorsicherheit, Federal Ministry for the Environment, Nature
Conservation and Nuclear Safety


Page 20                                                                                     Germany
operator and consumer risk, fall under the BfR16, under the Federal Ministry of Health17.
They have ca. 90-100 fte involved in Plant Protection Product dossier evaluation.

Final decisions are taken by the BVL, after hearing the opinion of the SVA meeting
(SachVerständigen Ausschuß, Expert Committee). The SVA has 25 members, appointed by
name for a period of 3 years (list published in official journal). They include representatives
from the above institutes, of which UBA has a veto-right, and BfR and JKI have a
consultative role; their opinion however will in practice not be ignored. In addition there are
representatives from Public Services (Amtlichen Diensten), such as Plant Protection Services
and Chambers of Agriculture (Landwirtschaftskammern), who will cover both geographical and
sectoral (horticulture, wine-growing, etc.) representation, and academic members from
universities and research institutes.

Finances
The German fee-system is relative to the workload of the different types of applications. For
the EU task as Rapporteur Member State, a fee between € 86.000 and € 143.000 is charged.
As co-rapporteur the fee is half of that. For national authorisations, the fees depend on the
number of crops, and/or the number of higher tier studies that need to be evaluated. For a
product for which all active substances are listed in Annex I, fees will range between € 12.000
and € 50.000. If at least one active substance is not listed, the cost will be between € 35.000
and € 143.000. Line extensions are typically between € 4.000 and € 16.000. Applications for
Mutual Recognition authorisation vary from € 3.500 to € 24.000.

Fees are payable to the Federal Main Treasury (Bundeshauptkasse). BVL receives a budget
from BM ELV, which is not linked to the fees collected. More work therefore does not
mean more resources available.

Process Description
Workflow
Applications are made to BVL. BVL coordinates the evaluation and decision process, and
performs the evaluation tasks for the PhysChem and Analytical Methods part of the dossiers.
Applications are made with 2 complete copies of an Annex II and Annex III dossier (paper
or electronic, CADDY). BVL writes to the applicant, confirming receipt of the application,
and with an invoice for 1/3rd of the evaluation-fee. Payment is to be made to the Federal
Main Treasury. After the Treasury has confirmed receipt of payment to BVL, the process
starts. First, every dossier is introduced into an electronic database. Paper submissions are
scanned and electronically stored.

A thorough completeness check is carried out, consisting of 2 steps: administrative (checking
if all declared documents are physically submitted) followed by a scientific completeness
check, which goes as far as verifying if no higher tier triggers have been ignored.
Simultaneously, there is a check on the manufacturing process, 5-batch analysis, crosscheck
with active substance used in registration studies, etc., as well as a first check on the
classification. In the case of minor data gaps, there is direct communication with the

16
     BundesInstitut für Risikobewertung, Federal Institute for Risk Assessment
17
     Bundesministerium für Gesundheit


          Germany                                                                       Page 21
applicant to supplement the missing information. In the case of more serious gaps in the
dossier, the applicant is informed in writing, and the evaluation process is suspended until
the missing data is supplied.

When completeness is satisfactory, this pre-evaluation phase is finished, and the evaluation
phase starts with the distribution of the dossier to UBA, BfR and JKI. These institutes carry
out the entire evaluation, and deliver their reports in due course back to the BVL. Here starts
the management phase, compiling the evaluations from the institutes into one evaluation
report, known as the SVA document (SVA Vorlage). If there are any outstanding issues that
require supplementary data, BVL will officially inform the applicant thereof, who can then
generate and submit the required data. This will set the timer back to the evaluation phase,
but in a shortened version (see “timelines”). Once there are no outstanding issues left, the
application is placed on the agenda of the SVA meeting. In this meeting a positive advice
can be confirmed, after which BVL will finalise the decision process by drafting and sending
the authorisation certificate and label to the applicant.

See under timelines and transparency for specific details on issue solving.

Timelines
The entire application, evaluation and decision process is officially carried out within 52
weeks. In practice, this period is on average 2 years, i.e. double time. A first reason for this
delay is that BVL, in spite of the legal time-limits, start their own counting in practice after
the pre-evaluation phase, thus adding a minimum 12 weeks to the process. The second main
reason for delays is the “loop” process in case of evaluation issues or missing data. Although
there are possibilities, under the “Akteneinsicht18” act, to know about upcoming issues in an
early stage, and even to discuss issues directly with evaluators, the official process does not
allow the submission of supplementary data during the evaluation phase. Only after this
phase is completed, and as an output of the subsequent management phase, the applicant
receives an official request for the supplementary data, and is allowed to submit these, via
BVL, who distributes the information to the Institutes, and initiates a new evaluation phase.
The standard evaluation phase is set at 29 weeks. A secondary evaluation phase is 10 weeks,
but again followed by a 9+1 week management phase. The decision phase, which follows, is
set at 15 weeks.

Even during the decision phase the process can be interrupted: it is possible that in spite of
favourable opinions from the Institutes, a negative decision is taken, or supplementary data is
requested. This depends on the overall context of an application, which can become only
clear to the Institute representatives when all elements are compiled, during the SVA
meeting.

Timelines are very difficult to predict: the time required for a formulation change can be
anything between 3 and 18 months. A line extension can require as much time as a full
submission. Even when less time is required, in practice the full available time-period will
always be used.



18
     “Access to records”


Page 22                                                                       Germany
Transparency
There is direct feedback to the applicant at the start of the start of each phase: pre-
evaluation, when confirmation of payment has been received, evaluation when completeness
is confirmed, and at completion of the management phase, if any problems have been
identified that require input from the applicant, or when the application is scheduled for the
SVA Meeting. For applicants who make an electronic submission, there is the incentive of
permanent online access to information on the progress of the dossier. Also at the start of
the process, during the completeness check, there is direct feedback on eventual minor data
gaps, which increases the efficiency of this phase of the process. During the evaluation, there
is no direct feedback when problems are identified. The compiled evaluation report is not
available to the applicant.

Direct contact between industry experts and evaluators is possible, although this is not
encouraged by BVL, for administrative reasons. However, direct contact with evaluators is
only possible at the initiative of the institutes on the basis of very specific issues.

Mutual Recognition
Language
Submissions can be made in English, with the exception of application forms. However, the
evaluation reports drafted by the Institutes are all in German. BVL has recently (2009)
started to generate Registration Reports; so far they are drafted in German, but the intention
is to prepare English versions as well in the near future. The Registration Report is shorter
(between 20-40 pages) than the usual German evaluation report.

Biological Data
Efficacy studies from other Member States are accepted, as long as they comply with the
GEP and GLP requirements; complete non-German biological dossiers are yet unknown. All
of the Landwirtschaftskammern and Pflantzenschutzdiensten are GEP certified, and can be equally
contracted for carrying out registration trials. In any case, comparative trials would usually be
required in order to confirm comparability of non-German trials.

“Special” Data requirements
Apart from the general request for country-specific risk assessment scenarios, there is also a
requirement for the use of German risk assessment models, for leaching, operator exposure,
and spray-drift. In addition to that, UBA frequently requires supplementary active substance
(Annex II) studies, e.g. for specific algae or non-target species.

Mutual Recognition attitude
Germany takes a rather reluctant position with regard to Mutual Recognition. Until now,
they have made themselves unlikely as a “sponsor” for Mutual Recognition authorisations,
because all evaluation documentation is generated in German. This may change in the near
future however. The German approach appears to be more focused on worksharing, i.e.
using the evaluations (Registration Reports) from other Member States to facilitate and speed
up the national evaluation. The German authorities however take a very serious position with
regard to carrying the full responsibility for the final authorisation decisions.



      Germany                                                                            Page 23
                                                   France
Summary rev5
The process as described refers to the current situation in France. It does not cover the
recent work on the backlog (applications submitted under the old process19) nor the foreseen
merger between AFSSA20 and AFSSET21. Nevertheless, backlog management interferes
probably with evaluation timings as part of the staff is dedicated to backlog.

Since 2006, a new process is followed in France, with the entire administration and
evaluation concentrated in one single unit, DiVE (Direction du Végétal et de l’Environnement).
This new unit is functioning efficiently, according to latest statistics, and although improving,
is not yet exactly within the set timelines. There is however very little feedback during the
process, even if communication with experts is possible when needed.. In contrast to the
evaluation phase, the decision process, under responsibility of the Ministry of Agriculture,
cannot cope, and is building up delays.

France’s approach to Mutual Recognition is not reflecting a desire to adopt decisions made
in other Member States. There is a declared interest in worksharing, but the main focus
remains on national sovereignty. Although France did not actively participate at peer-level in
Mediterranean worksharing pilot projects, they have now indicated their interest to take a
leading position in zonal evaluation in the Southern Zone.

Resources
Responsibilities
Main responsibility for the overall process lies with the Ministry of Agriculture. The
administration and evaluation of applications are completely handled by DiVE22, under
responsibility of AFSSA23. AFSSA stands under supervision of the Ministries of Agriculture
and of Health, but operates in an independent manner. The evaluation process is completely
contained within AFSSA DiVE. Other Ministries (Health, Environment, Labour and
Consumers) are involved only at the decision stage.

DiVE (with total 108 fte24) consists of 7 units: the administrative unit UGAMM25(with 10
fte), the Coordination unit UC26( 18 fte), and 5 Evaluation Units dealing with  PhysChem
and analytical methods27 ( 10 fte),  Toxicology28 ( 12 fte),  Ecotox and Efate ( 17 fte)29,



19
   For dossiers submitted before December 31, 2008 timelines can be multiplied by 3.
20
   Agence Française de Sécurité Sanitaire des Aliments, French Food Safety Agency
21
   Agence Française de Sécurité Sanitaire de l’Environnement et du Travail
22
   Direction du Végétal et de l’Environnement, Plant and Environment Department
23
   Agence Française de Sécurité Sanitaire des Aliments, French Food Safety Agency
24
   For dealing with the backlog, during a transitional period the staff was up to 135 fte
25
   Unité de gestion des autorisations de mise sur le marché
26
   Unité de coordination de l’évaluation et des affaires européennes
27
   Unité de physico-chimie et de méthodes d’analyses
28
   Unité de toxicologie et de santé au travail
29
   Unité d’écotoxicologie et d’environnement


Page 24                                                                                     France
 Efficacy30 ( 10 fte) and  Residues31 ( 13 fte). On top of those specific experts fte,18 fte
are support functions including management, computer support, secretariat..

The CES (Comité d’Experts Spécialisés) consists of 17 members (30 members before mid of
2009), who are appointed by an Arrêté de Gouvernement (governmental Order) for a period of 3
years. These members can be academics and scientists with a broad background. They are
not remunerated for their task, only reimbursed for expenses; they all file a declaration of
interest, which is intended to avoid any conflict of interest.

Finances
DiVE is financially independent, and is financed through the fees paid by applicants. These
fees therefore reflect the amount of work involved with the different types of applications.
Indications: up to € 200.000 for an EU dossier, € 40.000 for a new product authorisation (€
33 000 for a new product containing only “existing” active substances), € 15.000 for Mutual
Recognition authorisation, € 5.000 for a generic “me too” authorisation, € 600 for a parallel
import authorisation.

Process Description
Workflow
Applications for authorisation are made to a single point of entry in DiVE, the UGAMM.
This unit carries out a purely administrative completeness check, and forwards the dossier to
the Unité de Coordination (UC). The UC allocates the dossier to one of its Coordinators, who is
responsible for the dossier during the entire evaluation process. This Coordinator distributes
the dossier to the Evaluation units. These units of 10-30 fte each carry out the evaluation and
generate the respective parts of the evaluation report. These are compiled by the
Coordinator, and a presentation is prepared for the CES. The CES decides on the DiVE
proposals (and usually adopts them).

This AFSSA advice is forwarded to DGAL (Direction Général de l’Alimentation) of the Ministry
of Agriculture, and, for main dossiers (new registration, major extension of use…),
simultaneously to the Ministries of Labour32, Environment33, Health34 and Consumers35, who
can comment and ask to be consulted on the DGAL draft notification. The decision is
communicated to the applicant, and to AFSSA. After publication of the decision by Ministry
of agriculture, AFSSA publishes its advice on internet.

Timelines
The administrative completeness check is carried out by UGAMM in general in 2-3 weeks
(up to 6 weeks). For main dossiers (new registration, major extension of use), the entire
evaluation process in DiVE should be 10 months. According to AFSSA figures, the average
score in 2008 was 10,6 months. This process is 6 months for Mutual Recognition
applications, 5 months for Minor uses, Experimental Use Permits, label extensions, minor

30
   Unité d’efficacité
31
   Unité des résidus et de sécurité du consommateur
32
   Ministère du travail, des relations sociales, de la famille, de la solidarité et de la ville.
33
   Ministère de l’écologie, de l’énergie, du développement durable et de la mer.
34
   Ministère de la santé et des sports
35
   Ministère de l’économie, de l’industrie et de l’emploi.


        France                                                                                     Page 25
formulation changes, changes to use conditions, and 2 months for administrative changes or
experimental permit renewals. These periods can be extended by 2 months for submission of
required supplementary data plus the necessary time for evaluation of such data, which is
supposed to be around 6 months, but is rather 8 months or more. In some cases, DGAL can
ask AFSSA to prioritize a dossier, and timing for evaluation is then below these averages.

The subsequent decision process under responsibility of DGAL is supposed to last
maximum 2 months (or 1 month for “smaller decisions”). During this period, the other
Ministries can ask to have access to the draft decision, to be consulted on the content, and if
needed can call for a meeting between the different Services Currently (end 2009), DGAL
cannot cope with the output of AFSSA advices, and the 2 months timeline cannot be met.
The consensus process between the involved Ministries appears to become increasingly
difficult. Currently the expected period for decision-taking is between 2 and 6 months.

This brings the entire process at an estimated 18 months from submission to decision for a
new product.

Transparency
Transparency of the process is very limited. The first feedback to the applicant is the name
of the Coordinator for his dossier. During the evaluation process, all communication is done
exclusively via this Coordinator. In cases when considered necessary,, contact between
applicant scientists and evaluators can be established. This happens by phone, and when
needed by meeting. At the end of the evaluation process, the AFSSA advice is not
immediately communicated to the applicant. There is no feedback possible on progress, nor
on the expected outcome of the application, but discussions on the evaluation progress are
possible with the coordinators when needed. The process is intentionally kept very closed
with the goal to maintain the independency of the AFSSA.

Once the decision is taken, the applicant receives the certificate, plus the formatted AFSSA
advice, which is also published by AFSSA on the Internet.

Mutual Recognition
Language
The AFSSA advice is in French, and the entire process in AFSSA is in French. The AFSSA
advice is less detailed than the future Registration Report under the new Regulation.

Biological Data
All efficacy trials are carried out under GEP, by the company or by technical institutes who
have to be under surveillance of COFRAC36 (accreditation organisation). COFRAC evaluates
companies’ GEP compliance and the Ministry of Agriculture takes its final decision based on
COFRAC advice. Trials have to be notified in a centralised system, and have to follow
protocols based on methodologies issued by the CEB (Commission des Essais Biologiques). Study
reports can be done either in French or in English. There is acceptance of a part of the trials
to be carried out outside France, and this proportion is growing. Nevertheless, there are

36
     Comité Français d’Accréditation


Page 26                                                                        France
always French results required. For post-Annex I applications, also individual trial reports
can be used, even when drafted in English.

Data requirements
Usually, refined risk assessments based on local situation are required, (e.g. specific
groundwater scenarios)

Mutual Recognition attitude
The experience with Mutual Recognition applications and authorisations in France is rather
negative. In total, by the end of 2009, there are 8 authorisations in France that are based on
Mutual Recognition. However, Mutual Recognition is not treated in the “spirit” of the
Directive: the fact that the fees in DiVE are representative of the amount of work involved
in an evaluation, and that a Mutual Recognition application costs €15.000 against €40.000 for
a “normal” application is a clear indication that the treatment of a Mutual Recognition
application is based on using the Registration Report of the reference authorisation in order
to reduce the time for the DiVE evaluation rather than to adopt the authorisation as it was
granted in the original Member State. One difficulty for Mutual Recognition applications is
linked with the availability of the Registration Reports from the reference Member States,
and the compliance of those Registration Reports with the Uniform Principles. In the
absence of a Registration Report lacking clearly referenced compliance with the Uniform
Principles, DiVE feels compelled to repeat the risk assessment. It is important for DiVE to
maintain a full traceability for the risk assessments that support any regulatory decision.

Theoretically, the timeline for a Mutual Recognition application is shorter by 4 months, and
the cost is €25.000 less. In practice the outcome is very uncertain, and with the lack of
transparency and communication during the process, applicants are not motivated to follow
this route.




      France                                                                              Page 27
                            United Kingdom
Summary         rev4

The UK works along a very transparent process, and communicates very clearly in terms of
requirements and workflow. The UK attitude towards Mutual Recognition is very positive:
although it should be noted that in practice the focus is on providing clear background
information (Registration Reports) as a “sponsor” for Mutual Recognitions in other Member
States, but as a recipient the attitude is better defined as “work-sharing” rather than Mutual
Recognition. An ongoing reorganisation following the move in 2009 of the Competent
Authority from the Department for Environment Food and Rural Affairs (Defra) to the
Health and Safety Executive of the Department for Work and Pensions may change some
processes, but the same attitude will continue to apply. Defra has retained responsibility for
pesticides policy.

Resources
Responsibilities
In principle, the UK Chemicals Regulation Directorate (CRD) operates as a fully
autonomous agency: they manage the entire process from application to decision and issuing
of the authorisation. For this task they have ca. 190 fte at their disposal in York, plus 60 fte
in Bootle, spread over 4 Departments (Registration, Science, Finance & IT, and Policy &
Strategy). CRD is also responsible for other tasks such as Classification & Labelling,
REACH, biocides and detergents.

Only in the case of “ACP-applications” is the draft decision referred to the ACP (Advisory
Committee on Pesticides) for approval. The ACP consists of independent scientists, both from
academia and institutes or commercial organisations, appointed for a 3-year tenure, for a
maximum of 3 periods. ACP does not get involved in EU issues (only indirectly, if a
provisional authorisation is dealt with simultaneous to an EU evaluation as Rapporteur
Member State).

Finances
CRD operates, with regard to the national authorisation process, in a financially independent
manner: Their operating costs are covered by the fees charged (and pesticides levies). For
other tasks CRD receives funding directly from Defra (policy development) or other sources.

In the role of EU Rapporteur Member State the fee for completeness check is ca. € 5.700,
Evaluation € 120.000, plus an extra € 40.000 if there is a peer-review. For national
authorisations, the fees are based on the number of studies, or domains that need to be
evaluated. With separate fees for the sift (€ 170/200), for coordination (€ 2.000) and for each
domain for which evaluation is required (€ 1.150 for studies, € 290 for reasoned arguments),
an average application for a product containing an AI new to the UK, but on Annex I, would
cost roughly € 9.000. A line-extension would be around € 2.500 - € 3.500. The exact cost is
defined in the sift-meeting, and is basically non-negotiable.




Page 28                                                         United Kingdom
The fee for a Mutual Recognition application would depend on the number of areas that
would have to be evaluated, but could be estimated at ca. 50% of that for a standard
application, i.e. € 4.500.

Process Description
Workflow
Applications are received centrally at CRD in York; at the weekly “sift meeting”, all received
applications are discussed by a small team, and are allocated to the appropriate stream and it
is decided which fee is to be demanded. Applications can be made on paper, by mail with
electronic attachments on CD, or by email with attachments either electronically attached or
dispatched separately by regular mail on CD. CRD is working on a fully electronic
submission system, where applications are directly uploaded onto the CRD system via
Internet. CDs can be in CADDY or other format. The archive system under the old COPR37
and the subsequent PPPR38 is extremely accurate. Previously submitted study reports (even
submitted 30 years ago) need not be re-submitted, but only referred to by their archive-
number. Also no new Risk Assessments need to be submitted if a Risk Assessment for a
more critical use was submitted previously, only a reference and justification.

Following the Sift, the application is allocated to 1 of 5 “streams”, each with their own
timelines: “Administrative”, “No Data”, “Data”, “Data Plus” and “Major Change”, and is
then transferred to a technical coordinator. This technical coordinator will manage the entire
application. As a first step, he/she makes himself/herself known to the applicant, informs
the applicant of acceptance of the application in the sift, provides a reference number and
the target approval date. The application is invoiced via another department, payment is not
restrictive to continuation of the process, but is required before approval can be granted. The
application is distributed by the technical coordinator to the evaluators in Human Health Branch
(Chemistry, metabolism, residues, toxicology and Operator Exposure) and Environment Branch
(Efate, Ecotox and efficacy). Each Branch has a Resource Manager who assigns the applications
to an evaluator, if necessary according to issues identified in the sift. In principle, the
evaluators are generalists within their domain, dealing with the entire section of the
application for their domain, but they can fall back on the Senior Scientist that is available for
each sub-domain.

In order to improve efficiency, it is possible to arrange a pre-submission meeting with CRD
experts. Although this may give a good insight into the CRD attitude towards certain issues,
and the possibility to adapt the application accordingly, it does not give a guarantee because
it is possible that the application will be allocated to another evaluator who may have a
different view.

The evaluations are returned to the technical coordinator, increasingly in the form of a
Registration Report (RR), a copy of which is available to the applicant after the authorisation
is granted, as well as to other Member States on request. Currently (January 2010) applicants
are requested to submit, if possible, a draft RR with their submission in order to speed up the
evaluation process.

37
     Control of Pesticides Regulations
38
     Plant Protection Products Regulation


          United Kingdom                                                                  Page 29
Depending on the status of the active substance, an application will be treated as a non-ACP
process if all active substances are either on Annex I or are in products already approved in
the UK. This rule is not set in stone: for very major changes or other cases where CRD may
feel insecure, any application may shift from “non-ACP” to “ACP”. An application that goes
through ACP can result in further questions being raised; these can sometimes be answered
by CRD after in-depth study, but mostly it will result in CRD referring the questions to the
applicant, after which it follows the standard loop for additional questions (8 weeks for
responding, 5 weeks for assessment of supplementary data, plus in this case another round in
ACP).

For the non-ACP process, if all evaluators are in agreement for their part of the application,
the technical coordinator will prepare the necessary documentation for the authorisation. In
cases where one or more crops or uses are not agreed, the applicant can decide to let the
process continue for the agreed uses, and re-submit for the remaining crops, which will then
pass through the “Data” or “Data Plus” streams.

The Technical Coordinator has the authority to instruct the Administration section to send
out the approval documents (after verification of payment): the confidential document,
containing details of technical specs and formulation details, plus the published approval,
containing MAPP number, approval period, conditions of approval (packaging, label text).

Timelines
The timeline for the entire process depends on the “stream” for the application: 4 weeks for
the Administrative stream, 9 weeks for “No Data”, 18 weeks for “Data”, 30 weeks for “Data
Plus” (when data are submitted for 3 or more specialist domains) and 42 weeks for “Major
Change”. If any questions are asked during the evaluation, the applicant has 8 weeks to
respond. If supplementary data are submitted with the response, another 5 weeks is added
for evaluation of those by CRD.

An application in the “Data Plus” stream is unlikely to be completed without additional
questions. If the applicant needs the full 8 weeks for submission of supplementary data, plus
5 weeks extra for evaluation by CRD, this would lead to a total time of ca. 43 weeks.

Each company can submit one “fast track” application every year which will be processed
faster than the usual target time (by 9 weeks for “Data” or by 12 weeks for “Data Plus”
streams). Companies can use this for an application that is particularly important for them.

Transparency
CRD provides, on request, lists of non-protected studies for any substance, thus allowing
efficient preparation and submission of applications for generic products. Similarly, the
reference list of any submission is available, thus allowing data owners to verify correct
application of Data Protection provisions.

During the evaluation process, there is a clear point of reference at CRD: the technical
coordinator. Direct contact with evaluators is generally not possible; however, if questions are
raised that could be solved best through a direct contact between company scientist and
CRD evaluator, this is usually allowed on request.


Page 30                                                          United Kingdom
When eliminating certain uses from the application (and re-applying later) could speed up the
process, sometimes the technical coordinator will contact the applicant to suggest this option.
This is however not a structural process: it depends on the pragmatism of the technical
coordinator.

Mutual Recognition
Language
Obviously, the UK has English as standard language. All documentation is generated in
English, and only English documents will be accepted for submissions.

Biological Data
The UK is quite open to the submission of foreign biological trial data. In principle, CRD
would accept applications based on foreign biological data only (although meteorological and
agronomic comparison information are likely to be required). However, UK data are
considered to be helpful in speeding up the process, even in the case of Mutual Recognition
applications.

“Special” Data requirements
The UK does not “overrule” the EU Annex II and III data requirements. They require
however the use of certain specific risk assessment models, and the calculation of specific
scenarios, in particular UK Operator Exposure models, UK Dietary Risk Assessment model
and consumer database, bystander and worker exposure assessment, combined toxicity for
multiple active substances, leaching and drainflow.

Mutual Recognition attitude
The general attitude of the UK towards Mutual Recognition is very positive, both as
“reference” and as recipient: As a reference country, CRD is actively switching to the
preparation of standardised Registration Reports.

As a recipient however, UK is still critical with regard to risk assessment scenarios: CRD may
request supplementary scenarios to be submitted, even for a Mutual Recognition application.
In conclusion, the UK approach to Mutual Recognition is not Mutual Recognition strictu
sensu, but a willingness to work on the basis of evaluations from other Member States, thus
reducing the time and resources necessary for UK evaluation.

NOTE: When granting an authorisation, there is no mention whether or not it was granted
as a Mutual Recognition. This indicates in the first place that a Mutual Recognition
application is in fact treated as a normal application with reduced resource requirements,
using the sponsor Member State’s Registration Report as starting point for the evaluation;
secondly it means that the authorisation cannot be distinguished from normal authorisations,
and could therefore, under the new Regulation, be eligible as a “reference ”-authorisation for
a cross-zonal Mutual Recognition application.




      United Kingdom                                                                     Page 31
                                           Italy
Summary rev3
Italy’s authorisation process is primarily characterised by a lack of resources and
consequently long delays. Although no (draft) documents are shared with the applicant
during the evaluation and decision process, there is no lack of transparency with regard to
the timelines/delays or with regard to the involved evaluators.

Italy has declared an interest to set up an independent agency for the authorisation process.
There is already one example, in the pharmaceutical domain, with an agency that is
responsible for evaluation; decisions are still taken by the responsible Ministry however.

Lack of resources has also led to the fact that currently (end 2009) there is no procedure for
authorisations on the basis of Mutual Recognition. The current process will complicate
participation in future worksharing, or the adoption of Mutual Recognition (zonal)
authorisations.

Resources
Responsibilities
Administration & Coordination
Ultimate responsibility lies with the Ministry of Health (Ministero della Salute). A group of 18
people within Office VII of the Ministry is dedicated to the process. This group coordinates
the evaluation process and the workflow. Applications are dealt with by different (working-
)groups, depending on the type of application:

    1.    Products with new active substances
    2.    Products with (only) existing active substances
    3.    Re-registration applications (post Annex I)
    4.    MRL issues
    5.    Micro-organisms
    6.    Major changes, line-extensions

Each Group has a Group Secretary (who are staff of this Office) and a Group Coordinator
(one of the Evaluators). Some of the staff of Office VII work on temporary contracts, with
frequent difficulties of renewal.

Evaluation
The Evaluators are staff of public or semi-public bodies: Universities, Institutes or Research
Centres (connected to the Ministries of Health, Environment and Agriculture). The
evaluation of Plant Protection Product dossiers is part of their job description; they are not
separately remunerated for this task. They are only reimbursed for their expenses (travel to
Rome for meetings). Roughly speaking, less than 20% of the Evaluators can spend 50% or
more of their time on this task, although some may also be involved in more general Plant
Protection Product related work, such as the development of guidelines. There are altogether



Page 32                                                                            Italy
ca. 40 Evaluators available. Any conflict of interest of Evaluators is avoided, because their
Institutes do not work for industry.

Each Working Group has its own pool of Evaluators, but there are Evaluators that work for
more than one Group. Strictly speaking there are Evaluators and substitute Evaluators, but
the substitute Evaluators usually work alongside the Evaluators, dealing with their own
dossiers.

Decision-making
The Commissione Consultiva per i Prodotti Fitosanitari (CCPF) is chaired by the Ministry of
Health. It is formed by a Ministerial decree, and renewed every 4 years. It consists of 1
representative for each of the involved Ministries (Health, Agriculture, Environment, and
Economic Development), plus 4 appointed members for each of these Ministries (only
Health, Envi and Agri). Furthermore there are 3 members appointed by the Institute for
Health (Istituto Superiore di Sanità) and 2 by the Institute for safety (Istituto Superiore per la
prevenzione e la sicurezza del lavoro). The Group Secretaries join the CCPF Meetings, but they are
not members. The groups are represented by their Group Coordinators. Strictly speaking the
CCPF is a consultative body, but its proposals are always adopted by the Ministry of Health.
Several of the members of the CCPF are also Evaluators.

Finances
There are fees for each type of application, but the fees are low in comparison to other
European countries. The fees are payable directly to a central unit of the Ministry of
Economic Affairs. There is no direct correlation between the fees paid, and the resources
available in the Ministry, nor to the available Evaluators. As an indication, the fee for EU
Rapporteur for an active substance is ca. € 52.000, new product with existing DAR: €1.500,
provisional authorisation of a new product: € 7.700, line extension € 1.000, Mutual
Recognition authorisation: € 3.600, parallel or generic authorisation: € 500.

Funding is discontinuous, because the allotment of funding from the Ministry of Economic
Affairs to the Ministry of Health is not automatic. Every year, the Ministry of Health has to
apply for funding for the next year, and the Ministry of Economic Affairs can grant the
budget. As an example: in 2008 there were funds for a first round of post-Annex I
evaluations. In 2009 there are no funds for the next round. In addition, there are no funds
for the further processing of the evaluations done in 2008, causing new delays in the decision
process.

Process Description
Workflow

Applications for authorisation are made to a central address in the Ministry of Health (lead
Ministry). At receipt, all correspondence and dossiers queue first for conversion to an
electronic version. They are then electronically forwarded to Office VII of the Ministry
(Ufficio VII of the Direzione generale della sicurezza degli alimenti e della nutrizione.). This office is
separated in different groups, some with subgroups, dealing with different types of
applications (see under >Resources, >Responsibilities, >Administration & Coordination).
The application is allocated to the appropriate group, and is queued there. Each (sub-) group


       Italy                                                                                      Page 33
has its own queue. When the application reaches the head of the queue, the secretary of the
group allocates it to the relevant Evaluators, informs the applicant that the evaluation is
starting, and provides him with a list of the assigned evaluators and their addresses. There is
no (administrative or technical) completeness check. The applicant sends copies of the
relevant parts of the dossier to the different evaluators, who in due course provide their
written evaluation to the (sub-) group secretary. The secretary compiles the evaluations, and
places it on the agenda for the working-group meeting. All involved evaluators should be
present in this meeting. The minutes of all working group meetings serve as the basis for
discussions in the meetings of the Commissione Consultiva per i Prodotti Fitosanitari, the CCPF
(Consultative Committee for Plant Protection Products). Each of the Working Groups is
represented by the Group Coordinator in the CCPF. These Group Coordinators are
Evaluators, and are also appointed members of the CCPF (see under >Resources,
>responsibilities). The CCPF takes the final decision on authorisations, on the basis of the
opinions of the Working Groups. Following a positive decision, the Office VII of the
Ministry of Health will finalise the administrative details and prepare the official label, which
is sent to the applicant, possibly with changes to the originally proposed label, or with
specifications or restrictions.
Timelines
The official delay from submission to decision is 12 months. In practice it is 3.5-4 years
however. There is an estimated 4 weeks for the process for electronic conversion and internal
processing, followed by an average 2 years waiting in queue. The evaluation process as such
lasts ca. 9 months, including the discussion in the Working Group. The subsequent decision
process is dependent on the meeting frequency of the CCPF, which is 6 times per year (only
5 sometimes). After a decision is taken, 3 month is required for administrative completion.

Delays can occur when issues or concerns come up in the process, especially when they
occur during treatment by the CCPF: in this case, supplementary data may be requested, and
the process (for these data only) may be repeated from the evaluator level onward. Issues
occurring during the evaluation can be solved often in direct communication between
evaluator and applicant. This direct communication allows for the actual evaluation phase to
be short (9 months) in relation to the overall timelines.

Transparency
In terms of communication there is a high level of transparency. Applicants can check with
the group secretary if their application/dossier has been received in good order. When a
dossier reaches the head of the queue, and is moved into “active” evaluation, the applicant is
informed where to send copies of the relevant parts of the dossier, and is therefore aware of
the individual Evaluators. Although all communication about a dossier is officially to be
done via the group Secretary, many Evaluators can, for pragmatic reasons, discuss progress
of the evaluation with the applicant. In all cases there is direct communication with the
applicant when there are questions, or requests for additional data. Issues can often be solved
during the active evaluation phase, albeit with a further delay in the evaluation.

Administratively, transparency during the process is very limited. No draft assessments or
draft decisions are communicated with the applicant. None of the documents related to the
process are made public: the evaluation reports, the minutes of the working groups, and the


Page 34                                                                             Italy
minutes of the CCPF are not communicated to the applicant. Only if there is a particular
concern (i.e. refusal to grant an authorisation) the relevant part of the minutes will be
disclosed to the applicant. In such case the applicant has to compile a default module and
pay a fee (few euro cent per page).

The queues of waiting dossiers (containing only the names of the Plant Protection Products)
are published annually. However, the status of the waiting lists is often published ca. 8
months after the status quo date, which makes it out-of-date at the time of publication.

Mutual Recognition
Language
Italian authorisations are currently less suitable for use as the basis for Mutual Recognition or
for work sharing: all documentation is prepared in Italian, and evaluations are not available to
the applicant, or to the general public.

Since 2008, a majority of applicants has agreed to provide as part of their submissions a draft
Registration Report, instead of Document N (Tier 2 summary). This was in the first place a
requirement in the context of Post Annex I re-registration submissions, but applicants are
now also providing draft Registration Reports with applications for new products (both with
new and with existing substances).

Biological Data
Biological trials can be carried out by the certified organisations (including applicants); the
trials can be supervised by inspectors, appointed by the Ministry of Agriculture. They are
usually experts from Universities, Extension Services of the Ministry of Agriculture, Regional
Bodies, etc..

Efficacy trials from other countries are accepted (but only from Spain, Greece and
(Southern) France; however, for most types of applications a minimum number of studies
should be carried out in Italy. The exact requirements were published in 2008.

“Special” Data requirements
Italy adheres to the Annex II data requirements. With regard to Annex III dossiers, there are
often special requirements with regard to environmental risk assessment, taking into account
specific (Italian, regional) environmental conditions or scenarios. These requirements
however allow for custom-made solutions, rather than to narrow the possibilities for granting
authorisations: when lower tier assessments indicate that an overall authorisation is not
possible, specific risk assessments (i.e. for paddy rice fields, or for the use of drift-reducing
nozzles) may allow for the setting of risk mitigation measures that are feasible for Italian
agriculture, yet guarantee adherence to the Uniform Principles.

Mutual Recognition attitude
There is no experience with authorisations on the basis of Mutual Recognition. Although a
specific fee for such authorisations is defined, there is no specific procedure for the
application, and the general attitude is very reluctant; the Italian authorities take a very
serious approach to carrying the full responsibility for authorisation decisions, and in that
context there are disinclined to rely on decisions from other Member States.

      Italy                                                                              Page 35
                                                Spain
Summary            rev4

The Spanish process is one of the more complicated in Europe. Not only are multiple
institutions involved, there are also parallel evaluations of the same section, which are then
peer-reviewed in multi-institutional expert groups. In addition, direct communication
between evaluators and applicant is very limited, and there is a great backlog of work leading
to long delays in the process. The current process is designed with the aim of shared
responsibility between the Ministries of Agriculture, Health, Science, and Labor. The
involvement of the Ministries however is applied both at the evaluation and at the decision
level, which challenges the efficiency of the process.

A large backlog of applications, built up over the past years, together with limited resources
both at the coordination level (Ministry of Agriculture) and at the level of the Institutes
dealing with the evaluation, leads to very long waiting queues. The detailed scrutiny of risk
assessments, involving the demand for country-specific requirements for data or risk
assessments, leads to additional delays in the process.

Resources
Responsibilities
Responsibility for the authorisation process lies with the new Ministry of Environment,
Rural Means & Marine, MARM39. This Ministry is the result of a merger in 2008 between the
former Ministries of Agriculture, and Environment. Within MARM, the Sub-directorate
General for Means of Production, SGMP40, coordinates the entire authorisation process from
submission to certificate. SGMP is in general responsible for the means of agricultural
production. Apart from the authorisation process for Plant Protection Products SGMP is
responsible for authorising and maintaining the register of zoosanitary products, for
agricultural machinery, and for pesticide residues controls in plants at the level of primary
production, as well as for plant strengtheners and fertilisers. Within SGMP (about 15-20
people in total) only 10 fte are involved in the authorisation process; these are administrative
as well as scientific staff, a.o. the technical coordinators that chair the expert groups.
Currently (end 2009) the problems of understaffing are increasing, with the departure of
some of the 10 fte involved in the evaluation work.

Within the Ministry of Health and Social Policy, MSPS41, the Unidad de Productos Fitosanitarios,
with 6-7 fte, is responsible for the toxicological review.

Under the Ministry of Labour and Immigration42, the Instituto Nacional de Seguridad e Higiene en
el Trabajo, INSHT deals with (mainly) Operator Exposure and Re-entry, with a team of 4 fte:
the head -who is a member of the CEPF (Comisión de Evaluación de Productos Fitosanitarios)- and
3 evaluators.

39
   Ministerio de Medio Ambiente y Medio Rural y Marino
40
   Subdirección General de Medios de Producción
41
   Ministerio de Sanidad y Política Social
42
   Ministerio de Trabajo e Inmigración


Page 36                                                                          Spain
INIA43 falls under the responsibility of the Ministry of Science and Innovation44. Within
INIA, the Unidad de Productos Fitosanitarios covers the Ecotox, Efate and efficacy sections of
the submissions, with 7 fte.

The evaluation of the agronomic part of the residue dossier (verification of crop-
extrapolations, link between residue trials and applied GAP, etc..) is contracted out to
Tragsatec, a unit of Tragsa, a public state owned company, which is involved inter alia in animal
health and food safety. The role of Tragsatec is restricted to the verification of applied GAPs
against existing MRLs; for the setting of MRLs a different path is followed, under
responsibility of INIA, operating under contract with the applicant, preparing a submission
for further treatment by the EFSA45.

Apart from the physical bodies involved, there are four expert groups (the Grupos de Expertos,
G.E.) to cover the different sections of a submission. Each expert group is coordinated by a
person from SGMP, but consists of members from different departments, Institutes or
Ministries. AEPLA, the Spanish Crop Protection Association, is allowed one observer seat
in all expert meetings.

The four expert groups are known as:

     1. GEA (Grupo de Expertos de Analítica): method of analysis, physchem etc. Coordinated
        by 1 SGMP member, with further membership from SGMP (2), INSHT (1) and 1
        DGIMA46 plus 1 AEPLA observer;.

     2. GEE (Grupo de Expertos de Ecotoxicología): ecotox & efate; coordinated by 1 SGMP
        member, with further membership from, INIA (4), MARM (3), plus 1 AEPLA
        observer;

     3. GEF (Grupo de Expertos de Fitoterapéutica): efficacy & phytotoxicity, crop rotation etc..;
        coordinated by 1 SGMP member, with further membership from INIA (1) and
        SGMP (2), plus 1 AEPLA observer;.

     4. GES (Grupo de Expertos de Seguridad): Opex. : coordinated by 1 SGMP member, with
        further membership from MSPS (1), INSHT (3) and SGMP (1), plus 1 AEPLA
        observer.

     5. (Previously a 5th expert group, the GER (Grupo de Expertos Residuos dealt with all
        aspects of residues but disappeared when the new Regulation on MRLs47 entered into
        force.)

There is no expert group on toxicology, since this section is covered separately by MSPS.


43
   Instituto Nacional de Investigación y Tecnología Agraria y Alimentaria
44
   Ministerio de Ciencia y Innovación
45
   EFSA: European Food Safety Authority
46
   Dirección General de Industrias y Mercados Alimentarios from MARM
47
   Regulation (EC) No 396/2005 of the European Parliament and of the Council of 23 February 2005 on maximum
residue levels of pesticides in or on food and feed of plant and animal origin and amending Council Directive
91/414/EECText with EEA relevance., OJ L 70/1 of 16.03.2005


       Spain                                                                                             Page 37
Finally, the Comisión de Evaluación de Productos Fitosanitarios, CEPF, has the final authority to
grant or reject authorisations. The CEPF is chaired by the Director-General of MARM
(usually delegated to the sub-Director). The GEF coordinator (from SGMP) is secretary to
the CEPF; there are three more members from MARM (1 from SGMP, 2 from the former
Ministry of Environment); 1 from MSPS, 1 from AESAN (Agencia Española de Seguridad
Alimentaria y Nutrición, the Spanish equivalent of the EFSA), 1 from INSHT, 1 from INIA, 1
from ENAC (Entidad Nacional de Acreditación, the Spanish national accreditation body), 17
Region Heads of the Plant Protection Service, plus observers without voting right from
AEPLA and AEFISA (Asociación Española Fitosanitarios), both crop protection industry
associations, COAG (Coordinadora de Organizaciones de Agricultores y Ganaderos) and CCAE
(Confederación de Cooperativas Agrarias de España), two associations of cooperatives, and ASAJA
(Asociación Agraria Jóvenes Agricultores) and UPA (Unión de Pequeños Agricultores y Ganaderos) both
farmers’ associations.

Finances
For reference: Spain charges ca. € 150.000 for the task of EU Rapporteur Member State (i.e..
€ 2.700 for MARM, and ca. € 146.000 for INIA. The fee for the evaluation of a new
product, containing active substances that are new to Spain, is € 3.700 if a DAR is available,
or € 2.000 after Annex I inclusion. The same fee, € 2.000, is charged for a product containing
active substances already authorised in Spain. Other fees: Mutual Recognition: € 1.350, label
extension: € 810, minor change: € 400-550.

Fees are paid directly into the general State budget and do not directly reflect on the budget
that is allocated to the work in SGMP, MSPS, INSHT, or others, with the exception of the
fee for INIA in the case of a European evaluation as Rapporteur Member State.

Process Description
Workflow
Applications for authorisation are made to MARM. Fees have to be paid in advance, and the
payment receipt is to be added to the application. Submissions are made on CD, in PDF or
Microsoft® Word format. Spain does not accept dossiers in CADDY format. In SGMP, 1
person is responsible for carrying out an administrative completeness check. The same
person is also responsible for GEA. When found complete, the dossier is allocated a dossier
number, which determines the queuing position of the dossier. The dossier number is
communicated to the applicant by the main coordinator, who is demanded at the same time
to send additional copies of the relevant sections of the dossier to SGMP; these copies are
intended for use by the SGMP coordinators, and for MSPS for the tox section. Since there is
no direct communication with MSPS, all correspondence has to go via SGMP. As a next
step, the applicant receives a request (via the sub-Director of SGMP) to send additional
copies to the relevant Institutes, such as INIA, Tragsatec and INSHT.

Each evaluating unit has its own queue, and conducts the evaluation of their respective
section of the dossier when it reaches the front of this queue, with the observation that the
operator exposure assessment by INSHT can only be carried out after completion of the tox
evaluation by MSPS. Parallel to the evaluations carried out by the institutions, the SGMP
coordinators carries out its own assessment, which will be used as the basis for the
discussions in the expert group meetings. Tragsatec is also involved in the initial evaluation of

Page 38                                                                            Spain
these other sections of the dossier: Operator Safety, Environment... Non-expert technical
fte’s, frequently rotating, support the Ministry coordinators for the evaluation, before the
discussions within the expert groups.

The evaluation results are discussed in the 4 expert group meetings, the Grupos de Trabajo
Fitosanitario, with exception of the tox section, which is dealt with exclusively within MSPS.
During these expert meetings, there may be proposed label changes (risk mitigation, R&S
phrases, or elimination of crops that are not considered acceptable). On the basis of the
expert meetings the coordinators draft their respective evaluation reports; MSPS drafts the
evaluation report for the tox section. If there are any issues, these are communicated by the
respective coordinators to the applicant by means of an evaluation table (e-mail) or official
note. The applicant responds directly to the coordinators.

Once all expert group meetings (plus the report from the SGMP coordinator for Tragsatec,
and MSPS via their SGMP coordinator) are in agreement, the application is tabled for a next
CEPF meeting (by the GEF coordinator from SGMP, who also acts as secretary to the
CEPF).

After a decision is taken in the CEPF, a draft certificate is produced and sent to the
applicant. On the basis of the draft certificate, the applicant has to submit a final proposal
for the label, which is checked in SGMP. When approved, the final certificate, including the
final label text, is issued.

Timelines
The time required for completeness check is on average 6-8 months.

The evaluation and decision process is partly dependent on the work by the different
Institutes and the respective expert groups.

   • GEA delivers on average within ca. 6 months after completeness.
   • GEF also completes their report well ahead of GES and GEE.
   • GES is dependent on the work by INSHT, who in turn are dependent on the
     evaluation from MSPS. MSPS would normally need 24-30 months for the tox
     evaluation, most of which is queuing time, followed by the INSHT evaluation, which
     requires another 6-12 months.
   • GEE relies on the work by INIA, who currently have a waiting queue of ca. 36
     months, followed by ca. 2-3 months of actual evaluation time.

The CEPF usually meets three times per year, which may add another delay to the decision
process. As the global coordination of the progress of the different expert groups is poor,
the CEPF meetings only can take decisions on a short list of products with a completed
evaluation.

The last stages of the process, after decision in the CEPF, are relatively fast: 1-2 weeks for
generation of the draft certificate, and 1-2 months for finalisation of the certificate after
receipt of the final label text proposal from the applicant.



      Spain                                                                              Page 39
Despite the fact that by law (Ley de Sanidad Vegetal) the evaluation should be realized within
12 months the total time for a normal application for a new product is estimated at minimum
48 months, with an estimated average of 54 months; there are examples where the process
lasted 72 months or longer (which can be partly due to complicated issues arising during the
evaluation process, and the communication of such issues with the applicant). By the way,
SGMP is very strict with dates with applicants when these are mentioned in an Official text.

In Theory, there was a preferential treatment of Mutual Recognition applications, with MSPS
using a separate queue for those. Although much faster than the standard applications, a
Mutual Recognition application used to take ca. 24 months or more from application to
decision. In practice, the system is currently blocked.

Transparency
The communication with SGMP is open and transparent, and the large majority of
communication with applicants during the process is through the coordinators of SGMP.

The evaluation reports generated by the relevant Institutes are not available to the applicant.

Solving issues that may be raised by the Institutes is mainly done via the SGMP coordinators,
and mostly following an Expert meeting, when the coordinator will draft an evaluation table,
listing all outstanding issues and questions. Only in rare cases some of the Institutes will
communicate directly with the applicant. It is nearly impossible for an applicant to get
further clarification of an issue or to discuss a proposal with the experts. In addition to this,
MSPS insists on the use of exclusively paper mail, thus slowing down communication, and
increasing the risk of documents getting lost in the system.

Mutual Recognition
Language
So far, only internal evaluation reports are generated, and only in Spanish. These are not
available to the applicant. Since the beginning of 2009 SGMP started to request the applicant
to add a draft Registration Report to the application (with part A in Spanish, and part B in
English). Such draft Registration Reports will serve as the basis for the Registration Report
that will be generated by SGMP.

Biological Data
Spain is relatively open about the acceptance of biological trials from other (Southern
European) countries. There are no hard criteria for the number of national trials expected vis-
à-vis non-Spanish ones. Important is that there is a common GAP throughout the biological
dossier, all studies are carried out under EPPO guidelines, a common standard was used
across the zone, and there is a national standard included as well.

“Special” Data requirements
The evaluating Institutes follow a very meticulous approach to risk assessment. As a result, it
is quite common that for applications in Spain applicants have to carry out supplementary
risk assessments or studies, or apply parameters or scenarios in the risk assessments that are
very specific to the Spanish approach. Some of those are related to the local conditions, such


Page 40                                                                          Spain
as the requirement of specific non-target arthropods to be tested (in relation to the possibility
for the requested use to be integrated in IPM). ). Also for greenhouses evaluations, none of
the EU models is accepted and local non-standardized and very restrictive criteria are
followed. In general an increasing and alarming disengagement of evaluators is observed,
resulting in data requests that are considered to be outside the scope of the Directive, and
irrelevant to the agronomic reality.

Mutual Recognition attitude
There is a positive attitude towards the application of Mutual Recognition. MARM actively
participates in (Southern European) worksharing projects, which they consider as important
for building trust between the Member States in the Southern zone. However, the favourable
attitude of the MARM currently faces the refusal of the MSPS to accept evaluations from
other countries. In fact after several cases where MR was successfully used for the
registration of a product, the system is currently blocked. Although there was even a
separate queue for Mutual Recognition applications in order to treat them faster, the process
is no more an accelerated one, since applications need to be evaluated by the experts groups.
No visibility of timelines is currently available. However, even under Mutual Recognition
procedures, especially for greenhouse uses additional risk assessments are required, using the
“specific and critical Spanish greenhouse model”.




      Spain                                                                              Page 41
                                                 Poland
Summary             rev3

Poland works with a very decentralised evaluation system, with involvement of several
institutes. The fragmentation of the evaluation is partly compensated by the open
communication, but delays are currently long, partly due to a backlog.

Currently, Poland takes a waiting attitude towards Mutual Recognition: there is no procedure,
and hence there are no Mutual Recognition authorisations. Also the attitude with regard to
the use of non-Polish biological studies is very rigid, suggesting a reluctance to adopt
evaluations an/or authorisations from neighbouring countries.

Resources
Responsibilities
The authorisation process in Poland is controlled by the Ministry of Agriculture48, but with
involvement in the legislative process of the Ministries of Public Health49 and Environment50.

Within the Ministry of Agriculture, the Department of Plant Breeding and Protection HOR51
coordinates the evaluation and authorisation process for pesticides. The Department has one
Director and 2 vice-Directors (one responsible for the Plant Breeding Unit, one for the Plant
Protection Unit). The Plant Protection Unit has 18 fte, including the (vice-) Director. The
vice-Director manages two processes: the one dealing with the authorisation process, and a
Unit dealing with the Sustainable Use Directive (with 3 fte, including the head). The Unit of
Plant Protection Products deals with the completeness check, coordination of the evaluation
process, compilation of evaluations, and preparation for the Registration Commission.

There are 6 Units (outside HOR) involved in the evaluation process:

     1. The Institute of Environmental Protection IOS52, (operating under the Ministry of
        Environment. It deals with Ecotox, Efate and PhysChem, with a unit of 6-7 fte
        evaluators for Efate and Ecotox (including the head, who also participates in the
        evaluation work), and 2 fte for PhysChem.

     2. The National Institute of Hygiene53 (PZH) under the Ministry of Health deals with
        toxicology, PhysChem, MRLs (consumer risk), with 2 fte toxicology, 2 fte residues, 1
        fte PhysChem, with a possibility of further backup support from within the Institute.




48
   Ministry of Agriculture and Rural Development, Ministerstwo Rolnictwa Rozwoju Wsi
49
   Ministry of Health, Ministerstwo Zdrowia
50
   Ministry of Environment, Ministerstwo Środowiska
51
   Departament Hodowli i Ochrony Roslin
52
   Instytut Ochrony Środowiska
53
   National Institute of Public Health – National Institute of Hygiene, Narodowy Instytut Zdrowia Publicznego -
Państwowy Zakład Higieny (PZH)


Page 42                                                                                           Poland
       3. The Bureau for Chemical Substances and Preparations54, also under the Ministry of
          Health, deals with toxicology and PhysChem, with 2 fte toxicology plus PhysChem
          (but with further support from within the Bureau).

       4. The Plant Protection Institute (IOR, Instytut Ochrony Roślin) deals with efficacy (6 fte
          including the head), and residues (MRLs consumer risk) 1 fte.

       5. The University (Uniwersytet Warminsko-Mazurski) can be involved in the efficacy
          evaluation. They have 4 evaluators available for this, but this task is only a part of
          their job description.

       6. Institute for Organic Industry55 can be involved in the PhysChem evaluation, with 1-
          2 evaluators (not fulltime).

The Registration Commission is established by law, and consists of (7) members appointed
by the Minister of Agriculture. The Commission is chaired by personal nomination
(currently, end 2009, the former head of the IOR). Further, there is one member relevant to
each section of the dossier (Efate/Ecotox, PhysChem, Tox, Residues, Efficacy). The law
does not state the exact number or position of the members, but the Commission must be of
a balanced composition.

Finances
The fee-system of the Polish process is rather complicated. There is an administrative fee
charged by HOR, which depends on the type of application. For a new product this fee is
€ 2.400 (Zł 10.000), for line extensions this is less. For evaluation, each institute charges its
own fee, separately, and directly to the applicant. The fees depend on the application type,
the number of crops/uses, number of active substances in the product, whether or not there
are higher tier studies involved, and vary per Institute. Depending on the Institute, the
money from the fees goes into the Institute budget, and may or may not impact the “share”
of Ministry funding of the institute.

The fee for acting as Rapporteur Member State for an EU submission is fixed at ca. € 30.000
(Zł 120.000).

For national authorisations the average fee for a new product is estimated at € 25.000 -
€ 40.000, depending on the points mentioned above. The fee for a parallel import
authorisation is only € 240 (Zł 1000) administrative fee. For line extension the fee depends
much on the number of crops, the required supplementary studies, etc..

There is no fee for Mutual Recognition, because there is no process.




54
     Biuro do Spraw Substancji i Preparatów Chemicznych
55
     Instytut Przemysłu Organicznego


          Poland                                                                            Page 43
Process Description
Workflow
Applications for authorisation are made to the Department of Plant Breeding and Protection
(HOR). Fees are paid directly to the Ministry of Agriculture, and proof of payment is added
to the application. HOR provides a written confirmation of receipt of the application, with
the allocated application number. The application enters one of 2 queues for completeness
check: the post Annex I queue or the queue for new applications or “normal” re-
registrations56. HOR carries out an administrative completeness check. During the
completeness check supplementary data can be requested, or explanations or further
assessments. Completeness is confirmed in writing to the applicant, informing him which
institutes are allocated to the dossier, and where to send copies of the relevant parts of the
dossier. All institutes require a copy of the full dossier in CADDY, plus “their” summary
dossier in paper. With regard to the different sections that the different institutes can
evaluate, the dossier can be distributed between 3 and 5 different institutes. For pragmatic
reasons, HOR’s intention was to allocate dossiers to institutes that evaluated the substance
before. However, it seems that currently other criteria, like workload, determine the
allocation of dossiers.

Each Institute has its own waiting queue. Due to the overall long queues (up to 2 years), it
happens frequently that data requirements have changed between completeness check and
evaluation, with the result that evaluators no longer consider the dossier complete and
request again supplementary data. Each institute has a separate unit dealing with the
evaluation of Plant Protection Products (see >Resources, >Responsibilities). After receipt of
their section of the dossier, the institutes inform the applicant about the cost of the
evaluation. The invoice is sent only after evaluation, when the institute also sends their
evaluation report to HOR plus to the applicant. When issues come up during the evaluation,
these should be communicated via HOR. In practice it is possible that institutes
communicate also directly with the applicant, for efficiency reasons. Where possible and
necessary, some institutes will allow also direct communication between evaluators and
company scientists.

Applicants can comment within 1 month after receipt of the last evaluation report. Usually
comments are submitted directly after receipt of each of the section evaluation reports. The
applicant’s comments can be annexed to the evaluation report, for the benefit of the
Evaluation Commission.

One difficulty of the Polish system is that it is never certain which institute will evaluate a
certain section of the dossier. Since the institutes have different backgrounds, they have a
different approach to the evaluation, and the results can be different.

If considered necessary, the applicant may be requested, after the evaluation, to modify the
GAP in order to bring it in compliance with the Uniform Principles. HOR assesses the
company’s amended proposal; they may modify it if they are not in agreement, and present
the final version to the Commission.

56
  In fact, Poland has no extensions of authorisations. Instead, a new authorisation is granted upon expiry of the old
authorisation, with a new registration number.


Page 44                                                                                             Poland
When the comments on the Evaluation Report, and the final GAP, are received, HOR can
schedule the dossier for the Registration Commission meeting, and sends all parts of the
Evaluation Dossiers to the different Commission members. HOR prepares the agenda for
the meetings, distributes the papers, and acts as secretary to the meetings.

After approval by the Registration Commission, the applicant receives the final draft for the
label plus the meeting conclusions from the Commission. The applicant has 7 days to react
to the decision. If the applicant does not agree, they can comment, and it is possible that the
file is returned to the agenda of a next Commission meeting for re-discussion. After
“approval” by applicant, the registration certificate is received with ca 1 week.

Timelines
The completeness check should be done within 4 months. In practice this can take up to 2
years however (on average ca. 18 months). Currently, end 2009, there are ca 300+
applications in the process. After completeness check the legal period for evaluation and
decision is 12 months. This period is usually adhered to, with an average of 8 months for
evaluation, and 4 months for the decision process. The estimated average time from
submission to decision is more than 30 months.

There is a positive change visible, with more efficiency in the administrative completeness
check. Target is for the entire process to take not more than 16 months.

Transparency
Poland can be considered as very transparent, in the sense that the applicant receives a copy
of the institutes’ evaluation reports, and has the possibility to comment on them. The
possibility of direct communication with evaluators is reflected in the relatively short period
for evaluation. HOR is also accessible to provide estimates of the expected time of an
application in the queue.

Mutual Recognition
Language
Until now (end 2009) Evaluation Reports were drafted in Polish, but there is currently a shift
to the EU format Registration Report underway (in English). The speed of change depends
on the individual institute.

Biological Data
Poland maintains rather strict criteria for the acceptability of biological studies from other
Member States: not only does the GAP in that Member State have to be identical to the one
applied in Poland, and the agronomic and climatic conditions of the trials similar to those in
Poland (while “similarity” is not always clearly defined), also it is obligatory that the product
was authorised in the other country at the time of the trials, which is not usually the case.
Studies must be conducted under GEP. Many State Institutes, and several private
organisations, including some of the larger companies (Bayer CropScience, Syngenta, Dow,
BASF) are GEP certified.




      Poland                                                                              Page 45
“Special” Data requirements
With the exception of the rather strict rules with regard to biological trials, there are no
specific requirements for risk assessments: FOCUS scenarios required, no special Operator
Exposure parameters, no special requirements for non-target arthropods, etc.

Mutual Recognition attitude
Until now (end 2009) there is no possibility for Mutual Recognition applications. The
Ministry of Agriculture is well aware that the new Regulation57 and its future impact on the
Member States’ obligation to apply Mutual Recognition, but there is no known policy to
adapt the current process. In terms of worksharing, a certain willingness is visible. There is
currently very little experience with the use of other Member States’ Registration Reports,
because the Polish law did not foresee such use. Nevertheless, the Ministry of Agriculture
has publicly stated that Poland has the intention of operating as an attractive Member State
for selecting as Designated Member State for Zonal Evaluation.




57
  Regulation (EC) No 1107/2009 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 21
October 2009 concerning the placing of plant protection products on the market and repealing Council
Directives 79/117/EEC and 91/414/EEC, OJ L 309/1, 24 Nov. 2009


Page 46                                                                            Poland
                                               Romania
Summary rev4
The Romanian authorisation process is extremely decentralised and complicated. A large
number of Institutions are involved, but the system still reflects the historical model, with a
strict approach to the biological section of the dossier. Today, in Romania there is no
possibility to apply for an authorisation under Mutual Recognition, nor a policy for
introducing the concept into the Romanian model. For the future, Romania is open for
Mutual Recognition to a certain extent, but maintains the right to have the last decision in
specific cases for a locally adjusted national evaluation of the dossier.

Resources
Responsibilities
Administratively, the process is managed by the National Phytosanitary Agency (NPA58)
within the Ministry of Agriculture and Rural Development59 (MADR). This Agency consists
of 4 fte, responsible for coordination of the authorisation process. The NPA runs the
secretariat60 for the National Commission for Registration of Plant Protection Products
(NCRPPP), or CNOPPP61. This Commission is composed of members of all involved
Ministries and Institutes and Laboratories. It was formed in its current composition when
the European process (see under >Process Description >Workflow) was created.

In addition to the Ministry of Agriculture, also the Ministry of Environment62 and the
Ministry of Health63 are involved.

Within the Ministry of Environment, the Directorate for Management of Waste and
Dangerous Substances64 deals with Ecotox and Efate (3 fte) but only for National Procedure
(see under >Process Description, >Workflow). Ecotox and Efate evaluation for the
European Procedure is under responsibility of National Environment Protection Agency
ANPM65, in the General Direction for Implementation of Environmental Policies66 (4 fte),
under the same Ministry. Under the Ministry of Health, the Institute for Public Health
(INSPB67) deals with the Toxicology and residue section of the dossier both for National and
European Procedures..

Also under the responsibility of the Ministry of Agriculture, the Central Laboratory for
Phytosanitary Quarantine LCCF68, and more specifically its division the Laboratory for


58
   ANF, Agentia National Fitosanitara
59
   MADR, Ministerul Agriculturii şi Dezvoltǎrii Rurale, Ministry of Agriculture and Rural Development
60
   CNOPPP, Secretariatul Comisiei Naţionale de Omologare a Produselor de Protecţie a Plantelor
61
   CNOPP, Comisia Naţionala de Omologare a Produselor de Protecţie a Plantelor
62
   MMP, Ministerul Mediului si Padurilor, Ministry of Environment and Forest
63
   Ministerul Sănătăţii
64
   Directia Gestiunea Deşeuri şi Substanţe Periculoase
65
   ANPM, Agenţia Naţională pentru Protecţia Mediului, National Environment Protection Agency
66
   Direcţia Generală pentru Implementare Politici de Mediu
67
   INSPB, Institutul National de Sanatate Publica Bucuresti (National Institute for Public Health, Bucharest)
68
   LCCF, Laboratorul Central de Carantina Fitosanitara


        Romania                                                                                                 Page 47
Pesticide Quality Control69 deals not only with the evaluation of the PhysChem section of
the dossiers, but is also responsible for post-registration inspections and PPPs quality control
monitoring program. Another institute operating under the Ministry of Agriculture is the
Central Laboratory for the Control of Pesticide Residues in Plants and Plant Products70
(LCCRPPPV), responsible for Analytical Methods, and also for the monitoring of residues.

Still under the Ministry of Agriculture is the Academy for Agricultural and Forestry Sciences
ASAS71 that coordinates all the agricultural R&D network:
     • INCDP72, national research and development institute for fruit growing
     • ICDLF73, research and developing institute for vegetables and flowers
     • INCVVV74, national research and developing institute for viticulture and oenology
     • INCDA75, national research and developing institute for agriculture
     • ICDPP76, research and development institute for plant protection
     • INDCDSZ77, national research and development institute for potatoes and sugarbeets.
The Agricultural Research Institutes are involved in the efficacy part of the application, in
particular with the Registration Trials. These Institutes are specialised in certain sectors of
agriculture and horticulture, and are located in the counties, The Institutes have certified
experts and cover the evaluation of the efficacy sections of the dossier. Each national
institute performs the biological tests using their own regional research stations placed all
over the country.
Finances
The payment of fees is complicated: fees are paid to each of the involved evaluating
institutions, including the CNOPPP Secretariat for application, for completeness check and
decision document issue. With the exception of the ICDPP, which has an independent
budget, all other fees are collected by the national budget do not directly return into the
registration process. Adding up all individual fees, the cost for a new product under the
European Procedure (active substances placed on Annex I, DAR available) is ca. € 10.000.
Under the National Procedure, the fee for one year testing, in 3 locations, is € 2.400; the
administrative fee for the CNOPPP Secretariat is € 200 per crop for new registration and
label extension and € 150 for prolonging a registration; the fee for sanitary agreement is €
100. There is no fee established for Mutual Recognition applications, because Romania has
no process for such.



69
   LCCPPP, Laboratorul de Control al Calitatii Produselor de Protectia Plantelor (Central laboratory for pesticides
residues control in plants, food and feed)
70
   LCCRPPPV, Laboratorul Central pentru Controlul Reziduurilor de Pesticide în Plante şi Produse Vegetale
71
   ASAS, Academia de Ştiinţe Agricole şi Silvice “Gheorghe Ionescu-Şişeşti”
72
   INCDP, Institutul National de Cercetare-Dezvoltare pentru Pomicultură
73
   ICDLF, Institutul de Cercetare-Dezvoltare pentru Legumicultură şi Floricultură
74
   INCVVV, Institutul National de Cercetare-Dezvoltare Viticultură şi Vinificaţie,
75
   INCDA, Institutul National de Cercetare-Dezvoltare Agricolă
76
   ICDPP, Institutul de Cercetare-Dezvoltare pentru Protecţia Plantelor Bucuresti (general)
77
   INCDCSZ, Institutul Naional de Cercetare-Dezvoltare pentru Cartof şi Sfeclă de Zahăr, Brasov Potatoes &
Sugarbeets


Page 48                                                                                      Romania
For the role as Rapporteur Member State for a European submission, Romania charges ca. €
45.000.

Process Description
Workflow
There are two different workflows in Romania: one stream for products containing active
substances pending European (re)-evaluation (either old substances, or NPAs), and one
stream for “European” registrations, i.e. products for which a compliance step (stage 1) can
be conducted.

National Procedure
For the pre-Annex I, or national stream, several submissions must be made to the different
Institutions prior to an application for authorisation, following published data requirements.
Each of the Institutes carries out its evaluation, decides on the submission through its own
internal Commission, and issues its own report or certificate: the Ministry of Environment
issues its Aviz de Mediu (Environmental Agreement), the Central Laboratory LCCF issues the
PhysChem Bulletin, and the Ministry of Health produces the Aviz Sanitar (Health
Agreement).

In addition, for new products and for the label extension, official registration trials must be
carried out by the appropriate institutes under ASAS (see under >Mutual Recognition
>Biological Dossiers). Plant Protection Regional units (see under 72, 73, 74, 75, 76, 77), belonging
to NPA, supervise the large-scale plots organised in the second year biological trials. The
Institutes send their Biological reports to the ASAS Commission, who will validate it. The
ASAS Commission is chaired by a member of the CNOPPP, and has members from all
Research Institutes (not only the Directors, but also the involved researchers). The 2-pages
conclusion of the “Biological Report” produced by the Institutes is validated in ASAS
Commission and submitted later to the Registration Commission CNOPPP.

All agreements, bulletin, and reports are sent to the National Registration Commission
CNOPP. When all are received by the Commission, the company can submit its application
to the Commission Secretariat, who will process the application and will place on the next
agenda. The CNOPP meets 5-6 times per year. An official list of the CNOPP Meeting is
published about one month after meetings. The applicant, when a favourable decision is
taken, is invoiced by the CNOPP Secretariat. When payment is received the certificate will be
issued.

European Procedure
For applications under the European Procedure, a dossier needs to be prepared and
submitted to the Commission Secretariat. This is a complete Annex III dossier, containing
also the biological part.

The Secretariat first confirms in writing the acceptance of the dossier for which a fee is
charged, than carries out an administrative completeness check. After the completeness
check, the Secretariat distributes the dossier to the different Institutions. The evaluation
follows in principle the same pathway as under the National Process, with the exception that
two more Institutes are involved. For Efate and Ecotox evaluation, the Ministry of


       Romania                                                                                Page 49
Environment forwards the dossier to the ANPM for evaluation. In this case, the fee is
payable directly to the ANPM. The ANPM sends its evaluation report to the Ministry of
Environment for supervising, who forwards it to the CNOPPP Secretariat. For Tox, the
dossier is forwarded to INSPB (Public Health Institute), who also charge their fee directly to
the applicant. The PhysChem dossier goes to the Central Laboratory LCCF/LCCPPP (who
charge their fee directly), plus a copy to the LCCRPPPV (for Phys Chem & Residue
methods evaluation) who do not charge a fee. The methods Report from the LCCRPPPV is
forwarded to the LCCF/LCCPPP, who generates one single report for the CNOPPP
Secretariat. For the Biological Dossier, the Research and Development Institute for Plant
protection ICDPP receives the biological dossier; The Institute charges its fee and decides if
they will evaluate it internally, or allocate it to one of the Agricultural Research Institutes.

After receipt of the dossier, the Institutions must issue their invoice within 3 days to the
applicant. The applicant forwards the confirmation of receipt from each of the Institutions
to the CNOPP Secretariat.

The decision process is similar to that under the National Procedure.

Timelines
The EU process started first in April 2008. Until now (end 2009) one decision has been
taken under this procedure, although the Institutions are supposed to deliver their evaluation
within 20 weeks after receipt of the confirmation of fee payment (if DAR is available). For all
timelines the clock starts from the date of confirmation of receipt of fee payment by the
institution. Within 2 weeks after submission of the dossier, the Secretariat of CNOPPP
confirms receipt of the dossier and start of the completeness check that should be done
within 12 weeks. The entire process from submission to decision should not take longer than
12 months, if no data gaps are identified.

Currently, there are serious delays within the Secretariat for compliance check that might take
3 times longer than scheduled, and in INSPB and ANPM, because of a serious shortage of
resources, and additional responsibilities in other domains for the experts involved in the
assessment.

Transparency
There are no procedural restrictions with regard to direct contact between applicant and
evaluators. Depending on the Institution, upcoming issues will be communicated directly
with the applicant, under the national procedure. Under the EU procedure, all
communication is done only through Secretariat of the CNOPPP. There is however a lack of
transparency with regard to the meeting schedule of the CNOPPP.

Mutual Recognition
Language
The Agricultural Research Institutions write their registration trial reports in Romanian, or in
English if so required by the applicant. Under the European Procedure, the evaluating
Institutions write their part of the Evaluation Report in English.



Page 50                                                                     Romania
Biological Data
Romania is one of the very few, if not the only European country that maintains a system
(for National Procedure) where Biological trials must be carried out by the authorities. This
task is conducted by the Agricultural Research Institutes under ASAS. The Institutes are
linked to the County Plant Protection Offices, which supervise the large-scale trials (1ha) that
are conducted as 2nd year trials. The Institutes send their summary (2-pages) trial reports to
the ASAS Commission, who will decide and give the green light for the “Biological Report”,
which is then sent to the CNOPPP.

Under the new European procedure only GEP trials are accepted. Agricultural Research
Institutes are not GEP certified although they are working largely according to GEP
standards; therefore trials carried out by these institutes are accepted, but only under the
national procedure (for pending active substances). The legislation regulating the certification
process is expected to be officially published in 2010.

“Special” Data requirements
Romania does not impose any country-specific data requirements.

Mutual Recognition attitude
Today, in Romania there is no possibility to apply for an authorisation under Mutual
Recognition, nor is there a policy for introducing the concept into the Romanian model. For
the future, Romania is open for Mutual Recognition to a certain extent, but maintains the
right to have the last decision in specific cases for a locally adjusted national evaluation of the
dossier.

It is currently unclear how Romania will adapt to zonal evaluation, or to “obligatory” Mutual
Recognition under the new Regulation, The authorities are concentrating on a legislation
initiative to implement the new EU regulation and the outcome is expected in the near
future.




      Romania                                                                              Page 51
                                         Netherlands
Summary rev4
The Dutch authorisation process is characterised by a very high level of autonomy in the
decision process for the Competent Authority Ctgb78, who are open to communication with
applicants. Nevertheless, due to administrative and legalistic complexities that lead to short
authorisation periods and consequently to frequent reviews, the system is still overloaded,
and delays are 2-3 times longer than the system legally allows for.

Although the Netherlands strongly supports Mutual Recognition, the formalistic approach to
the Uniform Principles, and the rather specific interpretation of especially higher tier studies
and their assessment, make the application of Mutual Recognition often difficult; Ctgb applies
a form of worksharing, making use of other Member States’ evaluations, than of Mutual
Recognition of authorisations, in the sense of the Directive.

Resources
In general, resources are insufficient. One reason for this is that due to many short
authorisation periods, there is a need for frequent re-evaluation of each authorisation. As a
result of case-law, it is not always possible to administratively extend authorisations, with the
result that many of the extensions must be based on an informed decision. This causes a
significant increase of the workload, with consequent extra delays.

Responsibilities
The Ministries of Agriculture LNV79 (lead), Public Health VWS80, Environment VROM81,
and Social Affairs/Labour/Welfare SZW 82 plus the Ministry of Transport, Public Works and
Water Management V&W83 (esp. for surface water issues) are responsible for drafting laws
and the rules of procedure for the Ctgb. In this process the Ministries have a strong influence,
e.g. with regard to the timing of the introduction and application of new European guidance
documents. The introduction of new European policy is also under the control of the
Ministries, and is often expanded with specific national interpretations. Ctgb is however fully
autonomous in their evaluation and decision process, and the Ministries do not intervene in
that process. Only recently, the Minister of Agriculture has “ordered” Ctgb to modify a
previously taken decision; the legal status of this intervention is yet to be validated.

Ctgb consists of the Board (College) and a secretariat. The Secretariat (hereafter referred to as
Ctgb) is responsible for coordination and administration of the entire authorisation process.
The Board consists of a Chairman, a secretary, 4 fixed members and 3 replacement


78
   College voor de Toelating van Gewasbeschermingsmiddelen en Biociden, College for the authorisation of crop
protection products and biocides
79
   Ministerie van Landbouw, Natuurbeheer & Voedselkwaliteit, Ministry of Agriculture, Nature and Food Quality
80
   Ministerie van Volksgezondheid, Welzijn en Sport, Ministry of Health, Welfare and Sports
81
   Ministerie van Volkshuisvesting, Ruimtelijke Ordening en Milieu, Ministry of Housing, Spatial Planning and the
Environment
82
   Ministerie van Sociale Zaken en Werkgelegenheid, Ministry of Social Affairs and Employment
83
   Ministerie van Verkeer & Waterstaat


Page 52                                                                                Netherlands
members. These members are appointed, for a period of 4 years, by the Minister of
Agriculture. They are appointed in a private capacity, and fulfil their duties independently.

For European processes, Ctgb functions as the Competent Authority. The evaluation process
follows similar procedures, including the use of external EI84’s. The Netherlands is however
represented in the SCFCAH by the Ministry of Agriculture, supported by the Ctgb, and on
mandate by the other involved Ministries.

Ctgb has ca. 60-70 fte administrative and scientific staff. There are 1,8 main
evaluators/coordinators for EU files, and 5,4 for national submissions). Internally, Ctgb has
approximately 3,6 fte evaluators for Toxicology, 3,4 fte for Ecotox, 3,5 fte Efate, 0,9 fte
PhysChem, 3 fte Residues, and 1 fte Efficacy. In addition, part of the evaluation can be
contracted out to EI’s. Ctgb uses a pool of accredited EI’s; these can be government institutes
(RIVM85), semi-government institutes (TNO, Plant Protection Service PD86- efficacy), (semi-
) academic institutes (Alterra, PRI87) and contract-laboratories (Notox, Linge, efficacy).
Altogether, an estimated ca. 10 fte from external EI’s are permanently involved in the
evaluation process.

Finances
The Ctgb is fully autonomous, and is financially independent, i.e. they are self-supporting on
the basis of evaluation and authorisation fees. Fees are therefore reflecting the actual
(average) cost of evaluation of specific types of assessments. Indicative rates are € 250.000
for an EU Annex I inclusion dossier, € 28.000 for an evaluation for a new product, € 550 for
a minor formulation change, € 8.000 for Mutual Recognition application.

Process Description
Workflow
The entire administrative, evaluation and decision process is done within or under
responsibility of the Ctgb. Submissions are made to the Ctgb, with one electronic (CADDY)
dossier, and 1 paper copy. After 2-3 weeks, Ctgb sends a letter acknowledging receipt, with an
invoice for the requested evaluation fee. After receipt of payment, an administrative
completeness check is carried out, followed by a technical completeness check, verifying
compliance with CIPAC & OECD guidelines, GLP, etc.. Each dossier is allocated to a “main
evaluator”. One general Planning Coordinator manages the availability of all internal
evaluators, and distributes the relevant sections of the dossier accordingly. The Main
Evaluator follows the evaluation process of “his” dossiers throughout the process. The
administrative and technical completeness checks are always carried out internally by Ctgb.
After these checks, dossiers may be re-distributed, according to resource availability. The
different modules of the evaluation, drafted by internal and/or external (EI) evaluators are
collected by the Main Evaluator, who compiles them into a report, the “C-document” (C-
stuk), which also contains identified open issues and eventual data-gaps, plus a
recommendation for a decision. When the different parts of the (external) evaluations arrive,
the Main Evaluator does not pro-actively communicate these to the applicant; only when all
84
   Evaluerende Instanties, Evaluating Bodies
85
   Rijks Instituut voor Volsgezondheid en Milieuhygiëne, National Institute for Public Health and the Environment
86
   Plantenziekenkundige Dienst
87
   Plant Research International


        Netherlands                                                                                           Page 53
sections have arrived, the compiled list is communicated. This can cause unnecessary delays
in the process, since the applicant cannot start solving issues immediately as they are
identified. It is possible however for the applicant to check with the Main Evaluator about
progress, and about eventual issues that may already have arrived from evaluators.
The C-document is forwarded to the Board, the College. The Board usually follows the
recommendation of the Main Evaluator. The decisions of the Board are administratively
processed by Ctgb, and followed by publication. Only positive decisions are published,
including the complete evaluation report, which may be adjusted after the Board meeting.

Timelines
The first administrative receipt & confirmation period is 2-3 weeks, followed by the period
for the applicant to pay the fee. After receipt of the fee, there is 4 weeks for administrative
completeness check. This is followed by 10 weeks for the technical completeness. After each
of these completeness checks, it is possible that the applicant receives a request for
supplementary data, deliverable within 8 weeks. After each delivery, the process re-
commences with 4 weeks for administrative completeness, plus 10 weeks for technical
compliance. For the full evaluation plus decision process, a period of 34 weeks is allocated:
this includes evaluation, compilation, decision by the College and publication. All periods are
utilised to the maximum; nevertheless the total period of 48 weeks (4 + 8 + 34) is usually not
met, and runs out to 100-125 weeks. Usually these delays are caused (or covered) by asking
supplementary data, which can lead to repeating loops (delivery time + 4 + 10 weeks).

The exceedance of legal timelines is open for appeal. There is a formal complaint process,
followed by the possibility to take legal action. However, with the lack of resources, and as a
result of case law, Ctgb can only take negative decisions if the evaluation cannot be completed
within the required timelines, which is why applicants do not usually appeal against
exceedance of timelines.

In principle, it is possible to swap a new and important application with another
(comparable) one that has already further advanced in the queue, within the portfolio of one
applicant. In reality this rarely happens though.

Transparency
Communication with applicants, and feedback on dossier treatment is very open and
transparent. Main communication runs via the Main Evaluator for the dossier. However,
even the Director of Ctgb and the Chairman of the College are approachable for relevant
issues. Contact between applicant and external EI-evaluators however is not allowed by Ctgb.
It is possible for the applicant to check with the Main Evaluator about progress, but there is
no pro-active communication from the Main Evaluator about issues when they arrive, i.e. not
until the entire evaluation is compiled.

The applicant receives a copy of the draft C-document (evaluation report). If an application
contained several crops, and one of those is not considered ready for authorisation, normally
the entire application has to be rejected, since it is treated as a whole. On the basis of the
draft C-document however, the applicant has the possibility to withdraw any element of his
application that could jeopardise authorisation of the remaining ones. Withdrawn elements
(crops) will have to be re-applied from the start.


Page 54                                                               Netherlands
Mutual Recognition
Language
All correspondence, and applications, can be done in both Dutch or in English. The entire
evaluation is carried out in English, and the C-document (Evaluation Report) is generated
only in English. The only element that is obligatory in Dutch is the label text and the
registration certificate.

Biological Data
Efficacy trials can be carried out by any GEP accredited organisation. Most agrochemical
companies in the Netherlands are accredited organisations. The Netherlands accepts efficacy
trials from any country with comparable climatic and agronomic conditions. It is not a
prerequisite that any efficacy trial is carried out in the Netherlands.

“Special” Data requirements
The Netherlands follows a very strict approach to the Uniform Principles; basically, every
single point from the Uniform Principles is checked. In addition, the Netherlands follows a
very strict, and sometimes unique interpretation of higher tier guidance, which leads to
specific study protocol requirements, and risk assessment methodology. E.g. all risk
assessments involving spray-drift are treated with special attention: due to the agronomic
situation in the Netherlands (many small plots, surrounded by ditches/surface water) risk
mitigation (the use of drift-reducing nozzles vs crop-free zones) can be very specific.

Mutual Recognition attitude
The Netherlands is open minded about Mutual Recognition. However, there is only little
experience with granting registrations based on Mutual Recognition, since the positive
attitude towards Mutual Recognition became only effective since August 2008. The
Netherlands is particularly meticulous with regard to assessing every single point from the
Uniform Principles. There is a tendency to reject Mutual Recognition applications if the
reference authorisation is not supported by a Registration Report that is just as detailed as
Ctgb would have done. In fact, the treatment of a Mutual Recognition application is more
treated as a normal application, with the use of the Registration Report from the reference
country as the basis for the decision process. The entire evaluation however is double-
checked, which means that the Mutual Recognition procedure still takes as long as a standard
national authorisation. One Main Evaluator has recently (May 2009) been appointed to
handle all Mutual Recognition requests. The Dutch Ministry of Agriculture is positioning the
Netherlands as initiator and leader in the field of minor uses; this requires a high level of
worksharing willingness.

The Netherlands considers themselves as an ideal candidate for RMS and zonal Rapporteur:
speed (?), language (English), process transparency, and quality of assessments are their
selling points. Since the appointment of the new Ctgb director in April 2009 an internal
process is running within Ctgb to improve on speed, transparency (better insight in where the
application is in the process, closer contacts to internal Evaluators), and on customer focus.
All in all, the Netherlands is currently more suitable as a reference country for Mutual
Recognition purposes, than as a receiver.



      Netherlands                                                                      Page 55
                                              Greece
Summary            rev2

The Greek authorisation process shows rather long delays, caused mainly by a backlog
because of limited resources. The actual process requires only ca. 6 months, but the waiting
queues increase the processing time to ca. 3 years, which is already an improvement to the
previous delays of up to 5 years.

The evaluation is rather centralised, with only the relevant Ministry (of Agriculture)
Department, and the Benaki Institute involved. Therefore communication lines are short,
and direct contact between evaluators and applicant keep the evaluation phase also short.

Greece takes a very positive approach to Mutual Recognition, but certain changes in the
generation of evaluation reports is required in order to become a “zonal player” under the
new Regulation.

Resources
Responsibilities
The entire authorisation process, under responsibility of the Ministry of Agriculture88, is
under control of the General Directorate of Plant Produce, Directorate of Plant Produce
Protection, Department of Pesticides. This Department has 3 fte coordinators dealing with
national authorisations under Directive 91/414 (both new products and re-authorisations
post-Annex I), 1 fte dealing with European dossiers, and 3 fte coordinators dealing with
national authorisations under former national legislation. There is however a gradual shift of
the work of the staff dealing with former national applications, to the post-Annex I
authorisations. Another 2 fte within the Department are responsible for biocides evaluation.

The actual evaluation work is split between the Department in the Ministry, and the Benaki
Institute89. Within the Benaki Institute, the Department of Pesticides Control and
Phytopharmacy90 has 6 laboratories, dealing with Biological Control of Pesticides, Pesticides
Residues, Chemical Control of Pesticides, Toxicological Control of Pesticides, Pollution
Control of the Environment by Pesticides, and Insecticides of Public Health Importance.
The evaluators in the Ministry and the Benaki institute deal with both pesticides and
biocides. There are different evaluation teams: PhysChem (4fte in Benaki, 1 fte in Ministry;
dealing with FAO specifications, analytical methods, etc.), Efficacy (all in Benaki:1 fte head, 6
fte evaluators, partly temporary, partly permanent), Toxicology (all in Benaki: 1 head (who is
also head of the Department), plus 3 toxicologists), Residues (2 fte in Ministry, 1 fte in
Benaki), Efate (1 fte in Ministry, 2 fte in Benaki), and Ecotox (2 fte in Ministry + 1 trainee).

Final decisions are taken by the “Board of Pesticides”, the ASYGEF91. This Board is
established under the Greek Pesticide Law. Members are appointed for 2-year periods by the
88
   Ministry of Rural Development and Food, YAAT, Υπουργείο Αγροτικής Ανάπτυξης και Τροφίµων
89
   Benaki Phytopathological Institute, Μπενάκειο Φυτοπαθολογικό Ινστιτούτο
90
   Τµήµα Ελέγχου Γεωργικών Φαρµάκων και Φυτοφαρµακευτικής
91
   Greek Committee for Authorisation of Plant Protection Products and Biocides, ASYGEF, Ανώτατο Συµβούλιο
Γεωργικών Φαρµάκων


Page 56                                                                                     Greece
Minister of Agriculture. The Board is chaired by the Director-General of the Ministry, the
head of the Department is a member, and one of the staff-members of the Department is
secretary/scribe (without a vote) to the Board Meetings. Other members (currently) are the
(head) professor of the Farmacology faculty of the Agricultural University of Athens, the
Head of Farmacology of the Thessaloniki University (delegated to the assistant professor), a
toxicologist from the Medical University of Athens, Professor of Entomology (Athens
University), Professor of Plant Pathology (Athens University), one official advisor of the
extension service in one of the Prefectures (representing the Chamber of Agronomists in
Greece), a representative of the Ministry of Health (usually a doctor), and a legal counsel of
the Ministry of Agriculture. Members of the Board of Pesticides are appointed by name.

Finances
In the role of Rapporteur Member State for a European submission, Greece charges a fee of
€ 80.000. For a normal national authorisation (i.e. active substance on Annex I, DAR
available, active substance new to Greece) the fee is € 10.000. Also for existing active
substances the fee for a national authorisation is € 10.000. For line extensions, this is € 3.000,
for minor changes, manufacturing changes, etc, there is a fee of € 300, or € 1.000 if an
evaluation is involved. The fee for Mutual Recognition is set at € 5.000.

Process Description
Workflow
Applications are made to the Department of Pesticides. Before submission, the fee must be
paid to the central Government budget (on the basis of the official pricelist), and the
submission must be accompanied by the receipt of payment. The applicant receives a registry
number on receipt of the submission. This registry number accompanies the application
throughout the process. Within ca. 1 month a (mainly) administrative completeness check is
carried out, and the application enters the queue. The queue is published on the official
website of the Ministry, and therefore transparent to all stakeholders. It is shown which
applications are scheduled to be treated within a certain year. Depending on the place in the
queue, applications are placed on the agenda of the Board of Pesticides, and work on the
dossiers is adapted to this agenda. This means that evaluation starts often late, and is carried
out under time-pressure. Within the team (Ministry plus Benaki) the work is completely
mixed: evaluators deal with EU and national evaluations, with active substances and
products, MRLs, etc. Post Annex I evaluations (step 2) are prioritised in the queue, in order
to meet the EU deadlines, which again increases the pressure on the remaining files in the
queue. Not only evaluators have to work under permanent time pressure, also applicants
have to solve any upcoming issues under similar time pressure. Although this system is far
from ideal, it has also helped to reduce the delays from ca. 5 years to currently ca. 3 years. If
a dossier is not ready in time for the Board meeting that it is scheduled for, it will be
postponed to a subsequent meeting.

The coordinators in the Department manage the treatment of the dossiers: they “feed” the
dossiers to the evaluators in time for the Board meetings. The evaluators deliver their section
of the evaluation report with a proposal (yes, no, yes with restrictions or risk mitigations,
etc..).




      Greece                                                                              Page 57
If issues come up during the evaluation, the evaluators contact the applicant directly, and try
to solve the issue. The coordinator is informed about the issue and copied on the
communication between evaluator and applicant. If an issue cannot be solved “quickly” (i.e.
in time for the scheduled Board meeting), the applicant can ask for a stop-the-clock. In case
the applicant decides to continue with the application, this will result (depending on the
issue) in a negative decision, restrictions, elimination of certain crops, risk mitigation
measures, etc.

When all sections are evaluated, the coordinator compiles them into a single proposal. This
proposal is the basis for discussion in the Board, and has the form of an Evaluation Report
plus a recommendation for decision. Applicants can be “on hold” during meetings of the
Board, to be called in if questions arise, or they can ask for a hearing, or even be present
during discussion of a particular topic.

If the Board decides favourably, the Department drafts the certificate, with the GAPs, the
label text, R&S phrases, etc. This process can take 2 months. If the decision is negative, the
applicant can appeal, and the application can be re-reviewed by the Department, and go once
more for decision by the Board. This happens regularly, and can be effective, depending on
the strength of the case.

Timelines
There are no legally defined time-limits for the authorisation process. Currently, the
estimated time from submission to decision is 36 months (assuming that there is no stop-
the-clock during the evaluation).

Most of the time is lost in the waiting queue: the completeness check takes only 1 month, the
actual evaluation only a few months, and the administrative finalisation of a decision
maximum 2 months.

For Mutual Recognition applications there is an official timeline of 4 months. In practice an
average delay of 6 months is achieved. There is also a fast-track process for Provisional
Authorisations, similar to the Mutual Recognition process, but pre-Annex I.

Transparency
The applicant does not get a copy of the proposal, when it goes to the Board (ASYGEF),
neither before, nor after the meeting. Because the contact with the evaluators is very open,
the applicant is normally aware of upcoming issues. Also the coordinator may provide an
update of the status of the dossier.

Mutual Recognition
Language
The proposal from the coordinator in the Ministry as it is sent to ASYGEF is drafted in
Greek. Currently there is no communication from the Ministry of any intention to switch to
the EU Registration Report format, in English. Nevertheless, the evaluation reports from the
evaluators are in English, and are compiled in the format of the EU Registration Report. The



Page 58                                                                       Greece
applicant can submit his dossier in English, but the Tier III summary must be provided in
Greek.

Biological Data
Dossiers with only non-Greek efficacy data are possible, but Benaki will still ask for “a few
trials” from Greece. For a smooth handling of the dossier it is therefore wise to always
include at least some Greek trials in the dossier, especially phytotoxicity trials for minor
crops where no Greek trials exist. Since 2006 efficacy data must be generated under GEP.
Currently, the larger companies, and some commercial organisations, have a GEP
accreditation. None of the Universities of State Institutes are currently GEP compliant.

“Special” Data requirements
Greece does not demand any specific data, such as country-specific FOCUS scenarios.
However there are certain particular requirements with regard to the formatting of certain
parts of the (summary) dossier, such as special tables summarising the efficacy data. It is
expected that in 2010, an overview of specific national requirements will be published.

Mutual Recognition attitude
Greece is very open to Mutual Recognition, with the normal conditions: reference
authorisation must be post-Annex I, decision based on EU endpoints, full Annex III dossier
and Uniform Principles, and a Registration Report must be available. The process skips the
evaluation phase: the coordinators prepare a proposal for ASYGEF on the basis of the
Registration Report from the reference country.

For line extensions the Mutual Recognition approach can also be followed. One condition is
that the reference-label must include the already authorised Greek uses. The reason for this
condition is that it is claimed that the risk-cup may overflow if the other country does not
have all uses authorised as well.

For Mutual Recognition the submission of a full dossier is required, for reference purposes
only. The dossier is not evaluated: the decision is based on the Registration Report. For
Mutual Recognition, no additional Greek efficacy trials are required.




      Greece                                                                            Page 59
                                              Portugal
Summary            rev3

The Portuguese authorisation process is characterised by a very straightforward
responsibility: only a small team of ca. 25 people within the Ministry of Agriculture is
involved in the entire process from administration to evaluation and decision. This is also the
weakness of the system, because the limited resources make the process very vulnerable to
external prioritisations (i.e. EU responsibilities). Possibly as consequence of this, Portugal is
showing a very open-minded approach to Mutual Recognition, especially as “recipient”.

Resources
Responsibilities
The entire process is under responsibility of the Ministry of Agriculture92. Within the
Ministry, the regulatory process for authorisation of pesticides falls under the Direction-
General for Agriculture and Rural Development (DGADR93, formerly Direcção Geral de
Protecção das Culturas), and more specifically the Sub-Directorate that deals also with
phytosanitary measures, plant propagating materials & certification, wood preservatives,
sustainable agriculture, etc. This Sub-Directorate has two divisions: Phytosanitary & Plant
propagating materials94, and Plant Protection Products & plant health95. The latter deals with
the regulatory process, with two divisions: the Authorisation & Evaluation Division, and the
Biological Evaluation Division (efficacy & selectivity, IPM). The total number of evaluators
is limited: 1fte tox, 1 fte Efate + Ecotox, 2 fte residues, 1 fte PhysChem, plus ca. 7 fte for
biological assessment. In addition there is secretarial staff, plus coordinator and heads of the
divisions. This team deals with both national and EU evaluations.

Finances
DGADR operates on a budget within the Ministry of Agriculture. The collected fees are
consigned to the general state budget.

For the task as Rapporteur Member State, Portugal would charge € 60.000 - € 100.000. For
national applications, an application-fee of € 320 is charged. At the end of the evaluation, a
second fee is charged, of € 350 - € 750 (if the active substance is already authorised in
Portugal), or € 3.200 - € 6.500 (if the active substance is new to Portugal). The cost for a line
extension ranges from € 160 - € 650, for a Mutual Recognition it is € 680. Payment of the
fees does not delay the process; however, an authorisation certificate is not issued until
payment is received.

In addition there is an annual fee of € 700 for each authorisation.




92
   Ministério da Agricultura, do Desenvolvimento Rural e das Pescas
93
   Direcção-geral de Agricultura e Desenvolvimento Rural
94
   Direcção de Serviços de Fitossanidade e de Materiais de Multiplicação de Plantas
95
   Direcção de Serviços de Produtos Fitofarmacêuticos e de Sanidade Vegetal


Page 60                                                                               Portugal
Process Description
Workflow
Applications go directly to Oeiras, where the Direction-General for Agriculture and Rural
Development DGADR is located. The dossier is treated completely within the DGADR;
there is no involvement of external people, not even within the Ministry of Agriculture.
Normally, the application is not treated for a few weeks, and then a completeness check
follows. There is no written procedure of the completeness check, but mostly the applicant
receives in due course confirmation of completeness (or comment about missing data).
These confirmations are sent separately by the relevant expert teams (tox, ecotox + efate,
residues, biological..). The Evaluation team has one coordinator who will keep track of the
progress of all applications, and of the prioritisation.

The biological dossier or the PhysChem dossier is evaluated first, before the other domains
are involved. Once the biological and PhysChem sections are evaluated and finished (can be
2 months up to 1 year), the applicant receives a letter informing them of approval (or request
for more or different trial data, more details, etc..). Only when these teams finalise their
evaluation, the dossier will move to the end of the queue in the other division, for further
evaluation. A dossier is treated by the different domains sequentially, not simultaneously.
Each domain will compile all questions that arise, and communicate them with the applicant
when his/her partial assessment is completed. If the issues arising are considered crucial, the
expert waits for the applicant’s answer, and the dossier remains on his desk until the issue is
satisfactorily solved. For minor issues the problem can be solved while the evaluation
continues its sequence with the other evaluators.

After all domains have given their approval, the applicant receives a letter with eventual
changes in the label text for the product (the application is accompanied by the proposed
label text). After submission of the final label (exact (!) copy of the proof label), the
authorisation certificate is provided (if the proof label is approved, and if all payments are
received).

Timelines
There are no legal timelines. Completeness check is usually done from several to many weeks
after submission, and confirmed by each individual team. Nevertheless, the average time
from submission to decision is estimated at 30-42 months for a new product with new (for
Portugal) active substances, and 12-18 months for a new product with known active
substances, or for a line-extension. On the other hand, EU work is given priority; therefore
delays are directly affected by community tasks that are also performed by the same time.
During the Portuguese presidency the national evaluation process came to an almost
complete standstill.

The prioritisation of an application can be changed by the Directorate; especially if there is a
known need for the product in agriculture, an application can be moved to the head of the
queue. Also European obligations take priority over national ones. Applicants have no
influence on the prioritisation.




      Portugal                                                                            Page 61
Transparency
Communication with the Ministry is very open. The coordinator can and will provide (when
requested) a best estimate of the expected delay; this is however not a guarantee, since
prioritisation may change at any stage.

However, there is no written evaluation of the dossier: only correspondence with questions
or comments exists.

Mutual Recognition
Language
The application form and proposed label are in Portuguese. Study reports however can be
submitted in English, French or Spanish, as well as in Portuguese.

Biological Data
Especially for major crops it is considered to be mandatory that at least part of the biological
dossier is generated in Portugal. Only very recently a guidance document to that effect was
issued by the Ministry. For minor crops there is more flexibility, and dossiers with exclusively
foreign studies may be accepted. Biological trials must be carried out by GEP accredited
organisations, such as the major agrochemical companies, and commercial trial stations.

“Special” Data requirements
Portugal does not normally request studies beyond the European data requirements. Also
risk assessments generated for other countries are generally accepted for Portuguese
applications.

The only specific data requested by Portugal are in the biological domain, and more
specifically in the domain of resistance management. Also specific information is sometimes
requested for Integrated Pest Management; there are lists of beneficial insects for which data
must be provided.

Mutual Recognition attitude
The Portuguese decision process, since it does not include the generation of any Registration
Report or alternative evaluation document, does not make Portugal very suitable as a
reference country for Mutual Recognition applications. There is a clear desire and intention
in the Portuguese evaluation team to produce Registration Reports, however there are simply
no resources to do this, for the time being.

The Portuguese approach as recipient for Mutual Recognition authorisations appears to be
very positive. Recently (early 2009) guidelines and data requirements for Mutual Recognition
applications have been issued. Although the Ministry has indicated that additional data may
be requested, it seems that these would mainly be in the biological domain. Otherwise the
approach to Mutual Recognition appears to be fully in the spirit of the Directive and of the
future Regulation, i.e. Mutual Recognition of authorisations, and not like in most other
Member States Mutual Recognition of evaluations.




Page 62                                                                     Portugal
Portugal participated in the Southern European worksharing pilot project, but this
experience is not considered favourable by the Competent Authorities: ultimately the
worksharing caused more work instead of less. This may have been caused by the fact that
Portugal was responsible for the biological part of the dossier, which appears to become the
least “mutually recognisable” part of European dossiers.




      Portugal                                                                        Page 63
                                              Belgium
Summary rev3
The Belgian national authorisation process is relatively fast, in relation to the small number
of staff involved. Altogether, probably not more than maximum 15 evaluators are involved,
who nevertheless deliver detailed comments. There is a pragmatic approach to reducing
administrative workload: applicants are expected to distribute the dossier-sections directly to
evaluators, and are requested to submit a draft Registration Report. Communication is
possible both at administrative and at scientific level.

Resources
Although resources are rather limited, the output and quality of evaluations is considered to
be high. This is partly due to a relatively high level of involvement of the applicant in the
process. There is a mix between direct funding (fees used for evaluation purposes) and
indirect funding (general funds from Federal Government), explained in more detail under >
Finances.

Responsibilities
Belgium operates as a Federation, with separate Ministries for the Flemish and Walloon
Regions. Certain Ministers are covered by a complete federal public service, but not the
Minister of Agriculture, relying on sub-units of other federal public services. The national
authorisation process of pesticides is covered by the Federal Public Service for Public
Health, Food chain Safety and Environment96. Under this Federal Service, the Directorate
General “Animal, Plant and Food” (DG IV) comprises the Pesticides and Fertilisers Service97
that plays a central role in the national authorisation process; the service also covers the
Belgian responsibilities with regard to European evaluations. The Service has ca. 25 fte staff,
(of which 2 fte for fertilisers) including administrative. Of this team, 5-6 fte have the role of
“dossier manager”, with the responsibility to manage the entire evaluation- and decision
process for a submission.

The staff responsible for pesticides is divided in two groups (including the internal
evaluators): one for national authorisations, and one for the European process. This
separation leads to unbalanced workload, since the staff of the two groups is normally not
interchangeable. For the national authorisations, the Service has approximately 1 fte
evaluators for Toxicology, 1,5 fte for Ecotox, 2-3 fte Efate, - fte PhysChem, and 1,8 fte
Residues.

Part of the evaluation is outsourced to experts from external (governmental) institutes (see
also under >Finances). Altogether, these are not more than 5 fte (3 for Efficacy at the
Wallonian Agricultural Research Center98, 1 for PhysChem and 1 for Tox).



96
   Federale Overheidsdienst Volksgezondheid, Veiligheid van de Voedselketen en Leefmilieu - Service Public Federal
Santé Public, Sécurité de la Chaine Alimentaire et Environnement
97
   Dienst Pesticiden en Meststoffen – Service Pesticides et Engrais
98
   Centre wallon de Recherches agronomiques


Page 64                                                                                     Belgium
The Authorisation Committee99, established by law, is composed of 12 members appointed
by the Minister of Agriculture: 3 from the Directorate General “Animal, Plant and Food100”
(which is responsible for the evaluation process), one from the Directorate General
“Environment”101 of the same Service, 2 experts from the Scientific Institute for Public
Health102, one from the Federal Agency for the Safety of the Food Chain103, one from the
Veterinary and Agrochemical Research Centre104, one expert from the Federal Public Service
for Employment, Labour and Social Dialogue105, and one each for the three Regions.

Finances
The financing of the evaluation process can be divided into two sources: partly, the involved
staff are “regular civil servants” and are financed out of general means. The fees, payable for
the different types of applications, are transferred into the “Budgetary Fund for Raw
Materials106”. This fund receives money from several sectors, such as the one under
discussion. These funds are subdivided into their own sectors, and the expenditure is
managed by the Council for the Fund for Raw Materials. This Council consists of members
from the Federal Government, the Food Agency, plus members from contributing Industry
Associations (feed, wheat and commodity traders, chemicals, agrochemicals, and biocides).
The Council decides on the spending of the funds. The funds that are collected from
authorisation fees are spent on:  minor crops projects (efficacy and/or residue trials), 
pesticide-related horizontal projects (drift-reduction projects, literature research, IPM-related
research,  contract-workers, posted either in the Pesticides and Fertilisers Service, or in the
Institutes that part of the evaluation work is outsourced to.

Therefore, the fees are partly used for the evaluation work, and partly for more horizontal
pesticide related research. Reversely, part of the evaluation work is funded from the fees.

As an indication the following fees are charged: EU Rapporteur: € 110.000 - € 150.000, NPA:
€ 4.500, new product with Annex I listed substance: € 1.500, authorisation on basis of
Mutual Recognition: € 1.500, line extension € 375, formulation change € 1.000.

Process Description
Workflow
The workflow of the Belgian regulatory system is rather straightforward: there are no clear
deadlines for different phases in the process, which allows for a certain ambiguity.
Applications are made to the “Pesticides and Fertilisers Service” of the Federal Public
Service. This application is with a limited dossier-package only. Every dossier submission is

99
   Erkenningscomité voor de bestrijdingsmiddelen voor landbouwkundig gebruik- Comité d’agréation des pesticides à
usage agricole
100
    Directoraat Generaal Dier, Plant en Voeding - Direction générale Animaux, Végétaux et Alimentation
101
    Directoraat Generaal Leefmilieu – Direction générale Environnement
102
    Wetenschappelijk Instituut Volksgezondheid - l'Institut scientifique Santé publique
103
    Federaal Agentschap voor de veiligheid van de Voedselketen - Agence fédérale pour la Sécurité de la Chaîne
alimentaire
104
    Centrum voor Onderzoek in Diergeneeskunde en Agrochemie - Centre d'Etudes et de Recherches Vétérinaires et
Agrochimiques
105
    Federale Overheidsdienst Werkgelegenheid, Arbeid en Sociaal Overleg - Service Public Federal Emploi, Travail et
Concertation sociale
106
    Begrotingsfonds voor de Grondstoffen – Fonds Budgétaire des Matières Premières


       Belgium                                                                                             Page 65
always separated into several dossier packages, for distribution to the different evaluators.
For initial submission, only the “Administrative package” needs to be delivered. After
receipt, the applicant receives an invoice. When payment is received, the applicant receives
from the allocated dossier manager a confirmation and instructions as to where to send the
different dossier packages. The dossier manager is also responsible for placing the
application on the “docket” (dag-orde – ordre du jour) of the Authorisation Committee. Both
the applicant and the allocated evaluators are informed of the meeting number for the
Authorisation Committee

There is no completeness check. The evaluators deliver their advice, in the form of the
Registration Report or of a Product File Note (see >Data Requirements) to the Dossier
Manager. The Authorisation Committee decides on the basis of the Evaluators’ advice.
However, it is not uncommon that one or more Evaluators do not deliver their advice on
time for the scheduled meeting of the Committee. Depending on the importance of the
section involved, the Committee may decide on authorisation, but “under reserve”; in such
case the Service can finalise the authorisation without further intervention by the Committee,
when the missing part(s) of the assessment are delivered, and in line with the decision.
Normally, the Committee will follow the advice of the evaluators. In cases where issues arise,
the Committee will be able to establish the severity of the issue, and balance eventual risks
against the benefits of the applied use.

For smaller decisions (minor changes in the formulation, change of production-site, etc.) the
Pesticides and Fertilisers Service can complete the application without involvement of the
Authorisation Committee.

Timelines
There are no legally established timelines for the evaluation and decision process. The
average delay is 2-2,5 years for a new product, containing a new (for BE) active substance,
with the prerequisite that a DAR is available. For a new product with an already known
active substance this would be 18 months. The process for an authorisation under Mutual
Recognition, or for a line extension is estimated at 12 months. These timelines however are
valid only for submissions that contain a draft Registration Report, or a draft Product File
Note (see >Data Requirements). Without these documents, delays can be infinite.

The process for publication is quite fast: the applicant can expect the authorisation decree
within 2-3 weeks after decision in the Committee meeting.

Transparency
The process is reasonably transparent. Immediately after payment of the required fee, the
allocated Dossier Manager becomes the point of contact for the process follow-up. There is
no pro-active problem-solving attitude. When data is (considered to be) missing, evaluators
do not systematically contact the applicant in order to solve the problem, but there is a
possibility for evaluators to cross-examine the applicant directly, in order to maintain
efficiency of the process. Also communication with the head of the Service is open and
cooperative.

Applicants can always request copies of the evaluators’ advice to the Committee.


Page 66                                                                     Belgium
If a Registration Report is generated (which is only the case if the applicant supplied a draft
Registration Report as part of the application), this is available upon request to the applicant.
The Registration Report is not yet made public.

Mutual Recognition
Language
Belgium is officially bi-lingual (or even tri-lingual, counting German). Dossiers can be
submitted in either French or Dutch, but also entirely in English (with exception of
proposed label). This includes the draft Registration Report. The advice of evaluators can
still be a mixture of different languages in a single document, but there is a tendency towards
English-only.

Biological Data
With the introduction of European dossiers, the Competent Authority (Federal Public
Service) accepts entirely non-Belgian biological dossiers.

“Special” Data requirements
Belgium adheres to the European data requirements, with the normal requests for specific
risk assessments, if and when necessary.

The only elements that are often required (depending on the crop and type of product) are
specific data on non-target arthropods, in relation to the possible impact on IPM. Such
studies are now often integrated in the biological dossier, in order to streamline the
assessment.

One special issue is the delivery, as part of the submission, of either a draft Product File
Note (PFN) or a draft Registration Report (RR). The PFN is in fact an early version, or a
“light” version of the RR, in a table-like fashion. Neither the PFN, nor the RR are obligatory;
however, applications that do not have either a PFN or a RR, tend to make no progress
through the system. Since there are no legal timelines, and infinite delays are therefore hard
to challenge, it is de facto obligatory to submit one of these documents.

Mutual Recognition attitude
Belgium takes a very pragmatic approach to workload and worksharing. The applicant is
already expected to prepare a draft for the Registration Report, as part of the submission. In
addition, Belgium is an enthusiast promoter of worksharing and of Mutual Recognition. The
Belgian Competent Authority is actively involved in Post Annex I worksharing with the UK
and the Netherlands. Also applications on the basis of Mutual Recognition are welcomed,
and treated relatively fast and cheap. Nevertheless, the Mutual Recognition process is in fact
rather a mutual recognition of evaluations (to be adapted to local conditions) than mutual
recognition of authorisation.




      Belgium                                                                             Page 67
                                   Czech Republic
Summary rev3
The Czech process is relatively straightforward, and although decentralised only two bodies
are involved in the evaluation, and decision remains centralised. Some delays have occurred
as a result of reorganisation in one of the evaluation bodies, but these are expected to be
temporary. Reliance on national efficacy studies continues partly, and evaluation reports are
all drafted in Czech; nevertheless the Czech Republic is open to Mutual Recognition
applications.

Resources
Responsibilities
The State Phytosanitary Administration SRS107 is the central place for the entire authorisation
process. They coordinate and carry out the entire process, with he exception of the tox
evaluation, which is delegated to the State Health Institute (SZU, Státní Zdravotní Ústav),
falling under responsibility of the Ministry of Public Health108. SRS works on a budget from
the Ministry of Agriculture109, but operates otherwise independently with regard to
administration, evaluation (except tox) and decisions. In addition, SRS also covers GEP
accreditation of testing stations and the supervision of GEP trials.

Within SRS, an administrative unit operates with 8 fte, some purely administrative, others
with both administrative and legal responsibilities. There are 7 fte coordinators, each dealing
with his/her “own” application dossiers. SRS has 4 evaluation units: Efficacy (6 fte),
PhysChem (4 fte), Ecotox (4 fte) and Efate (ca. 3 fte).

The toxicology department in SZU was recently re-organised: it comprises now a total of 17
fte: a head, 4 toxicologists, 5 residue experts, 5 operator exposure experts and 2 MSDS &
labelling experts. This department however also covers the Czech activities for REACH110
and CLP111.

The Advisory Council for Plant Protection Products112 of SRS is a body consisting of 9
elected members, all renowned external academics. Members are nominated by SRS for
indefinite period. The responsibility of the Advisory Council is to comment on matters
regarding the authorisation of plant protection products containing active substance(s) that
were not previously authorised in any product in the Czech Republic, and further to
comment on matters regarding the cancellation of authorisations, before a final decision is
taken.


107
    Státní Rostlinolékařská Správa
108
    Ministerstvo Zdravotnictví
109
    Ministerstvo Zemĕdĕlství
110
    Registration, Evaluation and Authorisation of Chemicals, Regulation 1907/2006 of 18 December 2006, OJ L396/1
of 30 December 2006
111
    Classification, Labelling and Packaginag of substances and mixtures, Regulation 1272/2008 of 16 December 2008,
OJ L353/1 of 31 Dec. 2008.
112
    Rada pro přípravky na ochranu rostlin


Page 68                                                                        Czech Republic
Finances
SRS is granted a budget by the Ministry of Agriculture for its operations. This budget is not
related to the amount of work requested of SRS. There are separate administrative fees, and
evaluation fees are split between a fee for SRS, and one for SZU. Any administration and
evaluation fees for SRS are paid directly into the general State budget. On the contrary,
evaluation fees for SZU go into the budget of the Institute, which is partly funded by these
fees, and partly by a budget from the Ministry of Health.

The administrative fee is max. € 230. The evaluation fee for acting as Rapporteur Member
State is € 70.500 (SRS € 64.500, SZU € 6.000). For a product containing Annex I listed
substances: € 17.000 (SRS € 11.000, SZU € 6.000). For line extensions € 8.000 (SRS € 6.000,
SZU €2.000). Fees for SZU are defined in a detailed pricelist, depending on the elements that
need to be evaluated, mentioned average fees are reduced if e.g. no residue assessment is
involved and are therefore in the range of € 200 - € 6.000.

The fee for a Mutual Recognition application is € 200 - € 250 as administrative fee, plus
€ 4.900 for evaluation (SRS € 3.100, SZU € 1.800).

Process Description
Workflow
Authorisation applications are made to SRS, with a complete dossier, with a verified copy of
the application for Tox assessment submitted to the Ministry of Public Health. In parallel, a
dossier (without the efficacy section), is submitted to SZU. Within a few days, SRS confirms
in writing receipt of the application, and informs the applicant about the contact person in
the Administrative Unit (the allocated coordinator). The confirmation also states the
application fee. Only after receipt of payment of this fee, a completeness check is carried out.
Each evaluation unit reports back its findings to the coordinator; the application is discussed
in an internal meeting, and any demands for supplementary data or explanatory
documentation are forwarded to the applicant. The process is “suspended” for the time
needed by the applicant to present the required information. Once the dossier is considered
complete, the applicant is notified in writing.

Issues coming up during the evaluation are communicated immediately to the applicant, via
the coordinator. Although efficient with regard to problem-solving, it means that questions
can come in during the entire evaluation process, even several times from one evaluation
unit.

The Coordinator receives from each unit their Risk Assessment & Risk Management report,
and compiles these into the Registration Report (in Czech). The Registration Report can
contain changes with regard to the original application, in case the Authority disagrees with a
specific claim from the applicant. At this stage, the Advisory Council may be involved (if the
active substance is not yet authorised in the Czech Republic.

Subsequently, the Registration Report is provided to the applicant for approval. After
confirmation, the coordinator drafts the registration certificate and sends it, via the head of
coordination/legal, to the administrative unit, who finalise it. The certificate is sent to the
applicant, and the authorisation is published on the SRS website.


      Czech Republic                                                                     Page 69
Since 1 November 2009, the Authority is obliged to communicate with applicants exclusively
through a special electronic route (known as “Data Boxes”). Applicants are allowed to
communicate either electronically, or through regular mail. However, due to this new
obligation, the Czech authorities can no longer provide signed and stamped registration
certificates. If certified hard copies are required for official purposes however (court cases,
claims, etc.), these can be generated via a complicated administrative procedure.

Timelines
There are fixed deadlines for dossier treatment (evaluation plus decision), which are extended
by any time of interruption (for completeness, or for answering questions/supplementary
data during the evaluation phase). Re-organisations during 2008-2009 have led to delays at
the SZU, but these are expected to be of a temporary nature.

The official deadline for completeness check is 6 months from the date of submission. The
evaluation period, for products containing active substances included in Annex I, or with a
high probability to be included, is 18 months from completeness check until issuing of the
Registration Report. If a product contains existing substances, or for line extensions, or for
prolongation decisions for which an evaluation is required, this period is 12 months, for
administrative changes it is 2 months. After the applicant has confirmed his agreement with
the Registration Report, up to 2 months are required for administrative finalisation of
certificate.

In practice the completeness check is usually carried out within 2-4 weeks, but on occasion
this can take up to 6 months. The total time between submission and issue of the certificate
is estimated at 18 to 30 months when no special supplementary data are requested that lead
to longer “stop the clock” periods. For line extensions the average total process is estimated
at ca. 12 months.

Transparency
The applicant is informed directly which coordinator is allocated to his application. The
coordinator can be contacted for information on progress of the application. Direct contact
with evaluators is only by exception, when it is considered useful for the progress of the
evaluation. Such contact may be at the suggestion of the coordinator.

Mutual Recognition
Language
Since 2004, the SRS generates Registration Reports, in Czech, on the basis of the Risk
Assessment & Risk Management reports generated by the evaluation departments (also in
Czech).

Biological Data
The switch from government-conducted registration trials to supervised (GEP) trials was
made in 1996. Most GEP-accredited organisations are privatised former state-owned
stations, or University or research institutes. Very few agrochemical companies have a GEP
accreditation.



Page 70                                                          Czech Republic
Currently, submissions for major crops are expected to contain at least 50% Czech studies.
The remaining studies must be carried out (under GEP) in countries with clearly reported
evidence that they were carried out under climatic, agronomic and environmental conditions
that are similar to the main Czech cultivation areas.

“Special” Data requirements
Several specific data requirements are distinguished for Czech applications: certain
PhysChem information (particle size distribution for flowable formulations, specific
analytical method for determination of seed adherence for seed treatment products
containing multiple active substances, 2 years stability study, and additional Ecotox
information (for seed treatment products containing multiple active substances).

There are also novel special requirements for Efate risk assessment – for PECsw calculation
Step 3 calculations must be provided.

Mutual Recognition attitude
The Czech Republic is relatively open-minded about granting Mutual Recognition
authorisations. A prerequisite is that the authorisation in the “reference”-country is granted
after Annex I inclusion (and post re-registration following Annex I inclusion, for existing
substances), with the exception of authorisations from Germany, where a statement that they
were granted under EU criteria suffices. A Mutual Recognition application must contain a
Registration Report from the reference-country, plus a registration certificate, a label,
MSDS113, information about package-sizes and –types, etc.. In addition, a justification of
comparability of the agronomic, climatic and environmental conditions with the Czech
conditions is required. Submission, MSDS and draft label must be in Czech, other
documents either in English or translated into Czech. Any translations must be done by a
“sworn translator”.

There is no need for additional Czech efficacy trials; however, particular trial reports may be
requested for the efficacy trials that were contained within the dossier of the reference
country. Both SRS and SZU will assess the original evaluation from the reference-country.

The timelines for a Mutual Recognition application are identical as those for a standard
application, in practice however they are usually shorter.




113
      Material Safety Data Sheet


          Czech Republic                                                                Page 71
                                              Hungary
Summary
The Hungarian authorisation system has recently undergone a significant change: from a de-
centralised system with involvement of three Ministries to a centralised system contained
within two Departments in the Central Agricultural Office. Unfortunately, the responsible
Departments do not appear to have sufficient resources to cope with the workload that
comes with the new responsibilities.

On another note, Hungary maintains a strict approach to the biological section of the
dossier: they demand an (almost entirely) Hungarian efficacy dossier. There are no signs that
this is likely to change in the near future.

Resources
Responsibilities
The Agricultural Office114 (under the leadership of a chairman) is a central budgetary
organisation working under the direct control of the Ministry of Agriculture and Rural
Development115. The organisation comprises nineteen regional offices (on level of county)
and a headquarter: Central Agricultural Office116 (CAO) with 3 deputy chairmen. The
Directorate of Plant and Soil Protection117 (under the Food Chain Safety Deputy
Chairman118), has two Departments dedicated to the authorisation process: the Department
of Authorisation (for national process) and the Department of Evaluation (for EU process).
The process was recently centralised in the Departments (since March 2009); until then the
Ministries of Health119 and Environment120 were also involved. The Departments have
independent Heads with 8 fte staff each. There is no common leader for the two
departments, and it is not yet clear how the 2 departments will work together. Within the
Department of Evaluation (for EU process) the following experts/evaluators are working:
1 fte Tox (in contrast to previously 2-3 fte in the Ministry of Health, plus the 1 fte in the
Department), 1 fte Efate, 1 fte Residue, 1 fte Efficacy (there were 4 till 2009). It is as yet not
clear how the workload will be shared between the Evaluation Department and the
Authorisation Department. In addition, the Departments made use of external experts, from
the Directorates of Plant and Soil Protection of the County Agricultural Offices,: 2 fte
Ecotox plus 2 fte Efate. Currently (end 2009) these have contracts only for applications still
made under the old system.

Finances
With the recent centralisation of the regulatory process, the fee system is also considerably
simplified. In the past, the fees were paid into the CAO, and subsequently redistributed to
the Ministry of Environment (20%, and half of this amount was distributed to the County

114
    Mezőgazdasági Szakigazgatási Hivatal
115
    Földművelésügyi és Vidékfejlesztési Minisztérium
116
    Mezőgazdasági Szakigazgatási Hivatal Központ
117
    Növény- és Talajvédelmi Igazgatóság
118
    Élelmiszer-lánc biztonsági elnökhelyettes
119
    Egészségügyi Minisztérium
120
    Környezetvédelmi és Vízügyi Minisztérium


Page 72                                                                       Hungary
Agricultural Offices that would carry out the actual evaluation of efate and etox), and the
Ministry of Health (20%).

Today, all fees go into the CAO budget, not into the Registration Departments’ budget.
Even direct payments to County Plant and Soil Protection Directorate for registration trials
are forwarded to the County Agricultural Office budget.

Hungary charges a fee of ca. € 55.500 (HUF 15.000.000) for the task of EU Rapporteur
Member State. For a new product evaluation (new active substance, DAR available) the fee is
ca. € 13.000 (HUF 3.500.000), for a new product with existing active substances ca. € 9.000
(HUF 2.500.000). The cost for line extensions depend on the number of evaluators that
needs to be involved in the evaluation: per domain € 370, plus € 180 fixed fee. The cost for a
Mutual Recognition application is € 550.

Process Description
Workflow
Applications made before March 2009 will continue to be evaluated under the old system,
which is not described in this report.

Applications are made directly to the Authorisation Department. The Administrative staff
will send an invoice (depending on the type of application), but work will start regardless of
receipt of payment (certificate however is not sent unless payment is confirmed..).

A completeness check exists only theoretically; the application enters directly into the waiting
queue. Dossiers are allocated to one of the three coordinators, depending on indication
(Fungicide, Herbicide or Insecticide). In function of the waiting queue, the coordinator
forwards the dossier to the evaluators. If issues arise during the evaluation, they contact the
applicant directly. Issues are solved informally as much as possible, either through discussion,
or submission of supplementary data. When supplementary data is considered to be
necessary/useful, there is simultaneous direct submission to the evaluator, and an official
request plus submission through the Registration Department.

Evaluators draft their conclusions in a summarised form (not in the form of an Evaluation
Report) and forward these to the Coordinator, who compiles the conclusions. On the basis
of the expert conclusions, and following a certificate template, the coordinator prepares a
draft certificate. The draft certificate is sent to the applicant, who has the possibility to
comment. After agreement on the draft certificate, the applicant submits a proposed draft
label text, which will be included in the final official certificate.

Timelines
Under the previous process, the waiting queue was on average 6 months. Under the new
process, there are fewer experts available for evaluation. Since the process started only
recently, it is hard to estimate how long the waiting queue will be, but it seems unavoidable
that delays will be longer than before. The official timeline for the entire process is 18
months: in practice this is only achieved if the applicant pushes very hard with the
Department. There is a possibility to prioritise applications, within the portfolio of an
applicant (applicant can swap earlier with later submissions). The waiting queue is also


      Hungary                                                                           Page 73
dependent on the type of application: for a line extension the entire process from submission
to certification is 3-6 months.

Transparency
The process is very transparent, and communication is always possible, both with
coordinators and with experts/evaluators. Expert assessments are made available on request
(by the coordinator) before receipt of the certificate. Upcoming issues are solved as much as
possible informally. For more serious issues, there is a simultaneous official communication
with the applicant.

Mutual Recognition
Language
Expert assessments are drafted in Hungarian. The Registration Department has the intention
to switch to the EU Registration Report format (in English) but there is no known deadline.
The efficacy reports drafted by the County Stations are drafted bilingual (Hungarian &
English).

Biological Data
The current Hungarian approach to biological studies is still a reflection of the historical
situation. Before the Agricultural Office was created from 7 institutes, the plant protection
organisation was independent with 19 County Plant and Soil Protection Services which were
operated under the Plant and Soil Protection Central Service (today: Central Agricultural
Office, Directorate of Plant and Soil Protection). 19 County Services could carry out the
regulatory trials, under coordination of 4-8 experts from the Central Service.

In the current situation, the County Services (today: County Plant and Soil Protection
Directorates) belong to the independent County Agricultural Offices. Applicants have to
contract out their registration trials separately to these County Directorates.

Only 1 efficacy expert (instead of 4) works for the Authorisation Department, and evaluates
all biological trials (still generated by the County Directorates, or by independent companies).
One Department in the Central Office now has the role of certification body (the other 3
former efficacy experts went to this dept). Currently (end 2009) only 8 out of 19 County
Offices are GEP certified. The remaining ones are scheduled to receive GEP certification in
2010. Also independent bodies, including some companies, have now a GEP certification.

The dossier for national authorisation must contain a certain percentage of HU trials. There
are no clear criteria, and foreign studies are only accepted from Slovakia and a part of
Austria. Because many of the recent Austrian authorisations are based on Mutual
Recognition, and Slovakia does not have a GEP accreditation body, this means that in
practice only Hungarian trials can be used.

 “Special” Data requirements
Hungary does not demand any specific regulatory studies in addition to the standard
European data requirements.



Page 74                                                                     Hungary
Mutual Recognition attitude
Currently there are no Mutual Recognition authorisations in Hungary. Several companies
tried to apply under the Mutual Recognition conditions: active substance(s) in Annex I,
product (re-)registered in the reference country post-Annex I, under Uniform Principles,
identical GAP, and a Registration Report must be available. In addition, the original dossier
must contain sufficient Hungarian trials (which of course is never the case for authorisations
from other countries). Theoretically, a Mutual Recognition application, supplemented with
national trials, and with the relevant Focus scenarios included in the reference registration (or
added for HU), should be acceptable. However, no Mutual Recognition authorisations have
been granted until now.

It is generally understood that in the near future, under the new Regulation, Hungary will
continue to demand Hungarian Registration trials, and will ultimately decide on the GAP,
which may diverge from the authorised GAP in the reference Member State.




      Hungary                                                                            Page 75
                                       Sweden
Summary             rev6

The evaluation process in Sweden is a relatively “closed” system. The process does not
encourage direct contact with the applicant; as a result, issue-solving can be less efficient.
Although Sweden is a strong supporter of a zonal approach to evaluation, the Swedish
experience of Mutual Recognition authorisations is as yet very limited.

Resources
Responsibilities
KEMI (Kemikalieninspektionen, Swedish Chemicals Agency) is the central body for the
authorisation process. KEMI works independently, under general guidance of the Ministry of
Environment (Miljödepartementet). They are responsible for the administrative part of the
process, part of the evaluation process (all sections except biological and food safety), and
for the decision phase. The evaluation of the biological part of the dossier is allocated to the
Swedish Board of Agriculture (Jordbruksverket), Food Safety assessment is under responsibility
of the National Food Administration (Livsmedelverket). In the decision phase the Swedish
Environmental Protection Agency (Naturvårdverket) is consulted before the final authorisation
certificate is issued.

In KEMI ca. 26 fte are fully dedicated to the work on pesticides authorisations national (6
tox, 15 Ecotox/Efate, 3 agronomists, 1 PhysChem); for EU there are another 25 fte, dealing
with both pesticides and biocides (estimated ratio 50/50 for the two sectors; 12 fte for
pesticides: 6 tox, 6 Efate/Ecotox). Currently (end 2009) a staff-increase of ca. 20% is being
discussed for the KEMI pesticide section.

The involved staff in Jordbruksverket (4-5 fte) is only partly involved in pesticide efficacy
evaluation; they also work in the advisory service (except one fulltime coordinator). The
evaluators are specialised in herbicides, fungicides or insecticides. Within Livsmedelverket there
are ca. 2-3 fte dealing with pesticides (consumer risk assessment, MRL setting). They are also
responsible for residue monitoring programs.

Finances
The pesticides unit in KEMI is financed through both annual charges and application fees.
On 1 March 2010 the application fees were increased considerably, in order to generate extra
resources to deal with the workload. The annual charges do not change, and remain at 2,6 %
of the sales value the previous year for chemical pesticides, with a minimum of €200 and a
maximum of €20.000. The fees, which used to cover ca. 10% of the cost of the unit, are
expected to cover ca. 50% of the cost in the future.

In the previous system, the fee for the evaluation of a new product with a known active
substance, already authorised in SE, was €1.000, for an active substance new to SE this was
€ 4.000. As of 1 March 2010, there will be a single fee of € 13,500121. The fee for applications

121
      SEK 131.000


Page 76                                                                        Sweden
under Mutual Recognition will rise from € 4.000 to € 6.000122. Reduced fees (at 35% of the
normal fee) are available for products/uses on minor crops (<3000 ha). Line extensions stay
the same at €500, but can be more expensive, depending on the number of additional crops
and the difference with already registered ones (with respect to risk assessment).

As Rapporteur Member State Sweden will continue to charge €450.000 as the maximum fee
for an application by one company.

Process Description
Workflow
It should be noted that the workflow of the Swedish authorisation process has recently
changed (starting in 2008). As a result, applications in the pipeline may have been introduced
under the old system, and continue to be treated under the provisions of the new systems,
once they reach the head of the waiting queue. The main change in the system is the
introduction of a thorough completeness check. This should enhance efficiency of the
evaluation, because dossiers will in theory be (more) complete before the evaluation starts.

Applications are made to KEMI; the fee system is clear, and the applicant will be aware of
the level of the fee for his application, and can make the payment of the fee simultaneous
with dossier submission. The application will only proceed once payment has been received.
The dossier will normally have to wait in queue before the next step, which is distribution by
the coordinator to the internal units in KEMI (tox, Ecotox & Efate, PhysChem), to
Jordbruksverket (biological part) and to Livsmedelverket (consumer safety, residues). Each
section fulfils its part of the completeness check, which usually results in a detailed list of
requests for supplementary data, explanations, risk assessments etc. The applicant has 1
month to satisfactorily respond to these requests. If the applicant cannot fulfil the
requirements within the set deadlines, the application will be withdrawn. If the dossier is
considered to be complete, the evaluation can start.

Issues arising during the evaluation, are compiled centrally, and communicated to the
applicant once all sections have reported back. This means that certain issues may have been
known internally for quite a while, before they are jointly communicated to the applicant.
The applicant has again 1 month to respond. Again, if the open points consider all applied
uses, the application will be withdrawn if they are not resolved within these deadlines;
alternatively the application can continue for those crops for which the issue is not
applicable. It happens however that new issues come up after the compiled issues were
communicated. These can sometimes be resolved informally.

If all questions are answered, and all issues satisfactorily resolved, an authorisation can be
granted, after Naturvårdverket has had an opportunity to verify the proposed draft decision for
eventual oversights or omissions with regard to environmental impact. Once Naturvårdverket
has given the green light, KEMI can sign the authorisation certificate, and forward it to the
applicant.



122
      SEK 60.000


          Sweden                                                                        Page 77
KEMI has resources for treating ca. 20-30 applications for new products (or line extensions)
per year. This has caused a certain backlog, which should be resolved through the
introduction of the completeness check and increased resources.

Timelines
In the future, once the backlog has been cleared, the new process should enable KEMI to
deliver decisions for new products on average within 12 months after submission. These
target timelines are generally considered to be optimistic.

In the previous system (where the target timeline was 18 months) the waiting queue has
grown to quite substantial proportions, resulting in average (estimated) times from
submission to decision of 3-4 years. For complicated applications the delays have been
known to last up to 8-9 years. There were some possibilities to prioritize newer applications
if there were e.g. resistance problems.

Transparency
In spite of Sweden’s reputation with regard to its public access to information, this basic
right does not extend to working material within the authorities, and the transparency of the
evaluation process is rather limited. The information about upcoming issues is limited to the
official communication at the time of completeness check and after a first phase in the
evaluation, when all compiled issues are forwarded to the applicant. Direct contact with
KEMI is normally limited to the coordinator. Direct contact with evaluators is only possible
when they pro-actively contact the applicant.

The evaluation report (or more recently, the Registration Report) is only communicated after
authorisation. By that time, it is also available to third parties.

Mutual Recognition
Language
Sweden has always produced complete evaluation reports, but in Swedish (ca. 20 pages).
There is a tendency to switch to English, and to the standardised Registration Report, at the
latest by 2011. Companies can already submit a draft Registration Report with their
application, since recently.

Biological Data
There is a clear preference for dossiers containing at least a number of Swedish trials. Trials
in Sweden can be carried out by any GEP accredited organisation (certain agrochemical
companies, Jordbruksverket, Hushållningssällskapet, some commercial organisations). Dossiers
with exclusively non-Swedish trials are acceptable, but Jordbruksverket (as evaluators) demand
individual study reports with raw data in that case. The desire for Swedish studies is mainly
caused by the desire to generate and maintain sufficient know-how for the advisory services.
Also Hushållningssällskapet (Swedish Rural Economy and Agricultural Societies) organises
annual small plot marketing trials. Although they are not conducted under GEP,
Jordbruksverket attaches great importance to these trials, when evaluating biological dossiers
supporting applications for re-registrations.



Page 78                                                                      Sweden
“Special” Data requirements
Sweden goes a step further than many other Member State with regard to specific
requirements for risk assessments: most Member States demand only specific scenarios to be
processed in the assessment, SE also insists on the use of different input parameters (weight
of operator, hours of application per day, etc..). In addition, also SE-specific scenario’s are
demanded, e.g. for FOCUS calculations.

Mutual Recognition attitude
The specific approach to risk assessment impedes the application of Mutual Recognition.
Pragmatism facilitates the treatment of Mutual Recognition applications that fit well within
the national agricultural policy, but in general the Swedish advanced implementation of new
guidance and criteria, far ahead of EU standardisation hinders the application of Mutual
Recognition.




      Sweden                                                                            Page 79
                                              Austria
Summary            rev2

The approach of Austria is very businesslike, both in time-efficiency and cost-calculation.
The process is very transparent, and an open dialogue allows efficient problem-solving.
Austria demonstrates a high level of pragmatism in the application of Mutual Recognition,
without affecting the levels of human and environmental safety.

Resources
Responsibilities
The entire authorisation process takes place in the Austrian Agency for Health and Food
Safety AGES123. AGES operates under the Governmental Food Safety Service BAES124,
which falls under the Ministry of Agriculture and Environment125. Within AGES, certain
staff members work under BAES, which is responsible for the actual issuing of authorisation
certificates. In practice however, the entire operation operates under the flag of AGES.

AGES operates partly independently, partly under instructions from both the Ministries of
Agriculture and of Public Health. The Agency deals with both EU and national
authorisations

Within AGES, the coordination/administration unit exists of 2 fte. The evaluation groups
each consist of a head and evaluators: Efate & Ecotox >15 fte, Tox 8 fte, residues, analytical
methods & PhysChem 10 fte, Efficacy 7 fte, risk management, administration and
inspections 10fte. On specific topics, AGES may consult external experts, but purely on a
consultative basis.

Finances
AGES operates for one part independently (on basis of collected fees) and partly on a
budget from the Ministries.

As Rapporteur Member State, Austria charges € 320.000. For a new product (new active
substance, DAR available and the active ingredient is in Annex I), the fee is € 19.800, if the
active substance is an existing one, the fee is € 28.600. If no DAR is available, the fee for a
new product is € 22.500. For line extensions, the fee depends on the existing authorisation: if
it is an “original” Austrian authorisation, the fee is € 4.000, if the existing authorisation is on
the basis of Mutual Recognition the fee is : € 2.700. Fee for a Mutual Recognition
authorisation (most common) is € 7.200.

The above fees are indicative: the actual fees are split between cost for application,
completeness check, and evaluation, and also depend on the number of crops/uses in the
application. Also, if an evaluation becomes very complicated and time-consuming, AGES
can invoice additional, on a time-basis.

123
    Österreichisches Agentur für Gesundheits und Ernährungs Sicherheit
124
    BundesAmt für Ernährungs Sicherheit
125
    Bundesministerium für Land- und Forstwirtschaft, Umwelt und Wasserwirtschaft


Page 80                                                                            Austria
Process Description
Workflow
The workflow of the Austrian authorisation process is characterized by pragmatism: focus is
on efficiency of the process, rather than procedures. Submissions are received by the
coordination unit of AGES, and allocated to a coordinator, who will invoice the applicant
and distribute the dossier to the evaluation groups. Invoicing is done as a matter of trust: the
evaluation process continues separated from the invoicing and payment procedure; invoices
are sometimes sent even after issuing of the registration certificate. Within the evaluation
units, one evaluator will cover the entire section of the dossier for that unit. Before starting
the actual evaluation, each unit will first carry out a completeness check. If data gaps are
identified, that unit will stop the process until their section of the dossier is completed. This
has to be done within 2 months. If major delays in completion of the dossier become
apparent, the entire evaluation process is suspended until the missing data is provided. The
application is not withdrawn however, and there is no need for complete re-submission.
Within the evaluation groups, one person deals with the entire section for that group, and
prepares his/her part of the registration report. The conclusions of all groups are discussed
in a regular meeting, and the coordinator compiles the sections into the single Registration
Report and prepares the draft certificate. In case of a negative conclusion, there is still the
possibility to discuss with Experts . If possible, risk-mitigating measures may resolve the
issue, if warranted by agricultural importance of the product/use.

Timelines
There is no clear, visible queue in AGES. Applicants can however, within their own
portfolio of running applications, indicate their priorities to AGES. Thus, some applications
may take longer, if they remain low on the priority list of the applicant.

The duration of the administrative, evaluation and decision process is in principle similar for
normal applications and for line extensions or other types of applications: 3 months for
completeness check, and 12 months for evaluation plus decision. Roughly the same timelines
apply for Mutual Recognition. In practice the timelines depend on the priority level of the
application: in exceptional cases, the entire process can be as short as 3 months, priority 2
would last ca. 12 months, priority 3 could last 2 years or longer.

Transparency
The entire evaluation and decision process is characterised by a high level of transparency.
There is an open communication between the applicant and the coordinators, but if
questions arise during the evaluation, evaluators can discuss these directly with the applicant.
Only in case of more important issues, requests for supplementary data are pre-sent by email
for efficiency reasons, and sent later by regular mail, by the coordinator. Questions are not
collected and compiled, but sent directly by each section. It is also possible that questions
from one section are communicated more than once. Although this does not allow the
applicant to generate a complete overview of all outstanding issues before he decides
whether or not it is economically feasible to proceed with the application, it allows a very
rapid issue solving.




      Austria                                                                             Page 81
The coordinator will also on request inform the applicant which individual evaluators are
allocated to the dossier. These can be freely contacted for information on progress of the
evaluation. The applicant also receives the draft authorisation certificate, in order to verify it
for factual errors.

Mutual Recognition
Language
Austria has always generated some form of Registration Report. This used to be in German,
but since 4 years this is done in English. In recent years, the Registration Report is drafted in
the current EU (draft) format.

Biological Data
In principle, an application can be based on purely non-Austrian efficacy data if the efficacy
trials where done in a country with comparable climatic conditions. Depending on the quality
of he data, AGES may request additional Austrian trials. However, depending on the
urgency, such studies may be requested as a condition before authorisation, or as
confirmatory studies afterwards.

“Special” Data requirements
AGES does not require any additional data, certainly not for applications under Mutual
Recognition. However, they may decide on a different classification than the reference
authorisation.

Mutual Recognition attitude
Austria is demonstrating in general a very pragmatic approach to Mutual Recognition,
implementing the real spirit of this provision. Especially for authorisations from Germany
and the Netherlands, the risk assessment conditions are considered to be equivalent to those
for Austria, and these authorisations are adopted in their entirety. For NL and DE, even pre-
Annex I authorisations can be used as the basis for a Mutual Recognition, based on the fact
that these countries already implemented EU data requirements and criteria in their national
authorisation process.

Also as a sponsor country, Austria has adapted its registration reports to EU standards, has
switched to English, and is drafting these reports with a higher level of detail, aiming at
increasing their usefulness elsewhere, as basis for Mutual Recognition.

The normal Mutual Recognition application process follows the same route as other
applications, with the main difference that there is normally no request for supplementary
data, and it is cheaper, and potentially faster.

In addition, there is a separate procedure for Zulassung durch das Gesetz (authorisation by Law):
this is specific to products authorised post-Annex I in NL or DE, and requires the product
to be imported directly from those countries, with the original label (plus a translated label,
for NL). Authorisation of these products is published directly on the AGES website. Several
transport and sales documents (Lieferscheine, Rechnungen, ) must contain the AGES
authorisation number and the registration number of the country of origin.



Page 82                                                                          Austria
                                      Denmark
Summary rev3
Denmark shows on the one hand a very open communication with applicants, and a
pragmatic approach to solving problems that arise during evaluation. On the other hand,
their approach to the level of protection of man and environment is diverging from the
European approach, and makes the application of Mutual Recognition very complicated and
difficult.

Resources
Responsibilities
Under the Danish Ministry of the Environment (Miljøministeriet), the Environmental
Protection Agency (Miljøstyrelsen) is responsible for the entire authorisation process.
Miljøstyrelsen is responsible for chemicals legislation, waste, environmental factors and health,
ecotechnology and soil management. Within Miljøstyrelsen one unit (Pesticider & Genteknologi,
P&C) deals with pesticides, biocides and GMO crops. This unit works for the evaluation of
pesticides closely together with two other organisations: the National Food Institute126 of the
Technical University of Denmark127, and a unit within DJF (Det Jordbrugsvidenskabelige Fakultet,
Faculty of Agricultural Sciences) of the Aarhus University. This unit in DJF is active both in
the testing of pesticides, and in evaluation of efficacy dossiers.

Within Miljøstyrelsen the P&C unit has two sections: one dealing with tox, and one with
Ecotox and Efate. The units cover both national authorisations and European ones. In total,
ca. 15 fte are employed for the evaluation of pesticides. In the Fødevareinstituttet ca. 3-4 fte
deal with consumer safety, but not fulltime. DJF is part of the Aarhus University; therefore
the staff has educational tasks as well as research tasks and contract research, plus the
evaluation work carried out for Miljøstyrelsen. Ca. 6-7 senior scientists are involved, but not
fulltime in evaluation work.

Currently (2009) special funds are available for temporary staff or external contractors for
working through the backlog.

Finances
Denmark has a unique system of financing national evaluation work. There are no fees
involved. Instead, there are levies on the prices of pesticides, the levels of which depend on
the category (25% for herbicides and fungicides, 33% for insecticides). This money goes
partly to Miljøstyrelsen for the funding of the evaluation unit; another part goes “back” to
agriculture: partly to subsidise farmers who switch from conventional to organic farming,
and partly to relieve soil-taxes that are paid by all farmers.

Currently (2009) there is a change in the levy system under development: levies will become
variable on the basis of “hazard”, most likely as a cumulative score for human tox, Efate,
Ecotox and R-phrases.

126
      Fødevareinstituttet
127
      Danmarks Tekniske Universitet


          Denmark                                                                        Page 83
For evaluation work on behalf of the EU, Denmark charges a fee of € 223.000 as Rapporteur
Member State.

Process Description
Workflow
Dossier submissions are made to Miljøstyrelsen, where an administrative completeness check is
done. This check is not an in-depth, qualitative completeness check. Receipt of the
“complete” dossier is confirmed in writing to the applicant by the coordinator/administrator
who is the central contact point for the applicants. The application enters the queue. There
are possibilities for applications to be prioritised, if there is a strong need expressed in the
agricultural community; also until recently applications for new active substances were
prioritised, in order to stimulate the introduction of new chemistry (and allow it to replace
older chemistry). There are internal procedural timelines within Miljøstyrelsen, but these are
not publicly available.

When the dossier hits the head of the queue, the coordinator distributes the dossier to the
internal evaluators in Miljøstyrelsen and to DJF and the Fødevareinstituttet. The head of the
Efate/Ecotox section also operates as coordinator for the evaluation phase. The head is the
point of information for the applicant about the progress of the evaluation.

Upcoming issues are usually directly communicated by the evaluators to the applicant, and
solved in dialogue when possible. If at any point during the evaluation a major issue arises
(either a clear no-go, or an issue that cannot be resolved within a reasonable time) a negative
decision will be prepared.

Once all sections give the green light, Miljøstyrelsen can finalise the authorisation. The
applicant will receive the authorisation certificate plus the evaluation report.

Timelines
There are no legal timelines for the different phases in the process, although Denmark aims
at a timeline of 24 months for the entire process. The completeness check is usually reported
within 3 months (sometimes completeness is not confirmed at all). During the period that
priority was given to new substances (see under Workflow) the average timeline for products
with new substances was ca. 2 years. Timelines for products with existing substances became
considerably longer.

Transparency
There is no formal process for following the progress of an application in the queue.
Miljøstyrelsen allows direct contact between the applicant and the evaluators or other institutes.

Mutual Recognition
Language
The current evaluation report is sometimes drafted in Danish, sometimes in English. Lately
they are mostly drafted in English. The evaluation reports do not yet follow the EU
Registration Report format. There is no (published) policy for switching to the Registration
Report format.

Page 84                                                                       Denmark
Biological Data
Denmark prefers to have at least part of the biological dossier based on Danish trials. This is
even agreed between DJF and the Danish crop protection association. Since DJF also plays
an advisory role for agriculture, their involvement in the trials can be helps them to form
their opinion, and thus affect their final opinion, and advice. There is also the Landscentret
(Danish Agricultural Advisory Service, a partnership made up of 32 local advisory centres
and a national centre, who sell advice and services to Danish farmers), who carry out
demonstration trials for farmers.

“Special” Data requirements
Denmark has a number of very specific requirements that make their application of Mutual
Recognition in the “true” sense of the word very difficult. In the first place there are specific
Danish scenarios to be provided in risk assessments for operator exposure and
environmental fate. On top of that, Denmark uses different safety factors in certain risk
assessments. More important is the fact that Denmark considers (as a result of their drinking
water laws) all metabolites as relevant. Therefore the standard European dossier is in
many/most cases insufficient to satisfy the requirements of the Danish authorities. It can
also lead to authorisation rejections where all other Member States would grant an
authorisation.

Mutual Recognition attitude
With regard to the biological part of the dossier, the general Nordic approach (generating
data across most of the Nordic Member States) is usually sufficient. For several reasons
Denmark is very reluctant with regard to Mutual Recognition. Mainly, the specific Danish
data requirements would always necessitate additional data and risk assessments. The Danish
authorities have stated that they simply do not have the time or the resources to invest in
investigating the “similarity” (and the differences) with the conditions in the other Member
States, and therefore cannot (yet) rely on decisions taken elsewhere.




      Denmark                                                                             Page 85
                                              Slovakia
Summary rev5
The Slovak regulatory system is hampered by fragmentation of the evaluation process
between several specialised institutions acting under the auspices of the Ministries of
Agriculture, Environment, Health and Education.

The decision process of the current system is centralised within the ÚKSÚP, under the
Ministry of Agriculture, but contact between applicants and evaluators during the evaluation
phase is limited. Also there is a strong adherence to government-controlled biological trials,
and a lack of a GEP accreditation system. All evaluation documents are currently drafted in
Slovak, which is an additional obstacle to full participation in zonal evaluation and Mutual
Recognition.

Resources
Responsibilities
The authorisation process in Slovakia is managed by the Central Control & Testing Institute
in Agriculture (ÚKSÚP128). This Institute, operating under a budget from the Ministry of
Agriculture (MP SR129), has responsibilities in the domains of feedstuffs, seeds & varieties,
fertilisers, organic farming, viticulture and wine-making, and plant health care. The Institutes
is organised in 10 departments, one of which is the Department of Pesticides Registration130.
Through this Department, ÚKSÚP is responsible for administration, coordination, (part of
the) evaluation and decisions in the authorisation process for pesticides. The Department of
Pesticides Registration has a total of 15 staff, including the Head, 1 fte secretary, 1 fte
administration, 1 fte legislation, 4 fte coordination, 2 fte PhysChem, 1 fte Analytical Methods
for residues, 3 fte Efficacy, and 1 fte minor crops.

In addition to ÚKSÚP, evaluations are carried out by:

      1. Institute for Public Health131 (4 fte not fulltime, responsible for Toxicology: Operator
         Exposure, Residues & consumer exposure) falling under the Ministry of Public
         Health(MZ SR)132; the Institute also deals with classification issues for pesticides and
         other responsibilities.

      2. Bee Research Institute133 (bee risk, ), falling under the Ministry of Agriculture (1 fte
         partly pesticide evaluation, also other responsibilities)

      3. National Reference Laboratory134 (NRL) for Pesticides at the University of Veterinary
         Medicine of Košice (rest of Ecotox) (4 fte dedicated to pesticide evaluation, but with

128
    Ústredný Kontrolný a Skúšobný Ústav Poľnohospodársky
129
    Ministerstvo pôdohospod Slovenskej republiky
130
    Odbor registrácie pesticídov
131
    Úrad verejného zdravotníctva
132
    Ministerstvo Zdravotníctva Slovenskej republiky
133
    Animal Production Centre Nitra, Institute of Apiculture, Centrum výskumu živočíšnej výroby Nitra, Ustav vcelarstva
134
    Národné referenčné laboratórium pre pesticídy, Univerzity veterinárskeho lekárstva


Page 86                                                                                       Slovakia
         additional teaching and research tasks at University; sometimes NRL relies on
         external resources, e.g. other universities) under Ministry of Education (MŠ SR135);

      4. Water Research Institute136 (4 fte, not fulltime, dealing with Efate, groundwater),
         under the Ministry of Environment (MŽP SR )137

      5. Hydro-meteorological Institute138 (3 fte involved, not fulltime, dealing with Efate,
         surface water), also under the Ministry of Environment.

      6. Technical & Testing Institute for Agriculture139 SKTC 106 (2 fte, not fulltime, dealing
         with packaging) falling under the Ministry of Agriculture

Total staff is ca. 25-30 fte

In addition to the bodies involved in the evaluation, there is a Registration Committee
established by law under the Ministry of Agriculture, with 14 members: Chair from the
Ministry of Agriculture (1) , and members from the Ministry of Health (2), Ministry of
Environment (1), Bee Research Institute (1), National Reference Laboratory (1), Water
Research Institute (1), Hydro-meteorological Institute (1), Packaging Institute SKTC 106 (1),
Industry (2), ÚKSÚP (2), and the National Forestry Centre140 (1) . The Committee has an
advisory function, but operates mainly on horizontal level (policy making in the field of
sustainable use of plant protection products), strategic issues (e.g. aerial applications, bee
issues, resistance policy, education, National Action Plans). The representative for the
Ministry of Agriculture in the Registration Committee is also the Slovak representative at the
EU level (in SCFCAH).

Finances
Each of the Institutes involved in the evaluation must be paid separately by the applicant.
ÚKSÚP payments go into the general government budget. The fees for the Institute for
Public Health go into the Institute budget. The same is valid for the other Institutes: they are
all partly funded by the income from fees, and partly through a governmental budget.

The total level of the fees varies per Institute, and per type of application, depending on the
amount of work involved.

A complete evaluation for a new product (with one active substance, (on Annex I or not),
one crop, one pest) will be ca. € 3000 and depend on the case. The cost for a product with 2
active substances will be more, but not double. The fee for a line extension is less, but it will
always depend on the case.

As EU Rapporteur Member State, Slovakia uses a system with separate modules; the average
total cost can be estimated at € 135.000.

135 Ministerstvo Školstva Slovenskej republiky
136
    Výskumný Ústav Vodného Hospodárstva
137
    Ministerstvo Životného Prostredia Slovenskej republiky
138
    Slovenský Hydrometeorologický Ústav
139
    Technický a skúšobný ústav pôdohospodársky
140
    Národné lesnícke centrum


        Slovakia                                                                          Page 87
Process Description
Workflow
Applications are made to ÚKSÚP, with a complete dossier. ÚKSÚP accepts CADDY
dossiers, but part of the submission must always be in paper (Tier 2 summaries, Analytical
methods, PhysChem section). The dossier is received by the Department of Pesticides
Registration, who uploads the dossier to the server, and carry out an administrative
completeness check (done by the coordinators). ÚKSÚP sends out a confirmation of
completeness to the applicant, who can then apply for an opinion to the 6 institutions (see
>Resources >Responsibilities). The relevant part of the summary dossier is sent to the
institutions on paper; all institutions have access to the CADDY dossier on the server. All
institutions, plus ÚKSÚP (PhysChem, Analytical methods and Efficacy) carry out their part
of the evaluation. Ultimately, the Institutions send a complete assessment report to ÚKSÚP,
plus the summary part of the assessment and their advice (conditions, risk mitigation, etc.) to
the applicant. At this time in the process, the Institutions also send their invoices to the
applicant.

ÚKSÚP probably compiles an evaluation report, but this is not available externally (at least
not to the applicant; possibly it could be available to other Member States, but it would be
drafted in Slovak). There is no possibility for the applicant to comment on the summary
assessments that he receives. However, there are possibilities to appeal against the
conclusions, to discuss with the institutions and to seek for acceptable solutions.

Note: In order to provide a better co-ordination of plant protection products evaluation
processes between and among the said specialised institutions involved, monthly sessions are
convened by ÚKSÚP since 2008.

If all opinions & standpoints from the Institutions are favourable, the next step is for the
applicant to apply for authorisation at ÚKSÚP, taking into account all the comments,
conditions or risk mitigation from received from the Institutions. ÚKSÚP (coordinators) will
verify the application against the Institutions’ assessments and recommendations, and issues
the authorisation. The authorisation certificate is issued within ca. 3 months, signed by the
head of ÚKSÚP.

Timelines
The official timeline between submission and completeness decision is 4 months, which is
normally adhered to. The evaluation phase is officially 8 months, but in practice lasts 12-18
months. The finalisation, after receipt of all standpoints, is ca. 3 months. Extra delays have
been caused by changes in the legislation between dossier submission and standpoint
preparation: if a standpoint no longer complies with the new legislation or criteria, the
section of the dossier will have to be re-evaluated.

A particular problem is observed in cases where products have an expiration date post
Annex I, but before the end-date for the step 2 re-registration. These authorisations first
have to be extended under the old national legislation (principally administrative process if
no problem with data), and then shortly after again, under Uniform Principles. This causes
extra complications, and additional workload for the already limited resources.



Page 88                                                                     Slovakia
Transparency
During the process, there is little or no communication with the evaluating Institutions. If
there is a need for additional data, this is communicated directly by the Institutions, or
through ÚKSÚP coordinators. Consequently, there is very little contact between Institution
scientists and company scientists. Most of the direct contact is between the Institution and
the applicant registration manager. Only in exceptional cases a meeting between the
applicant’s scientists and the Institution’s experts will be allowed. In general however there is
little or no feedback before the Institutions send their opinion to ÚKSÚP and the summary
to the applicant.

Mutual Recognition
Language
All generated documents are drafted in Slovak. There is no known policy to switch to
English, or to the standard EU Registration Report format.

Biological Data
Until ca. 2006 ÚKSÚP conducted 100% of the registration trials, but under pressure from
the European Commission they abandoned this process. On average 30% of registration
trials can be carried out by “external organisations”, the remaining part is still done by
ÚKSÚP. Also the evaluation of the biological trials is now done in a different Department
than the generation of the trials. The distribution between ÚKSÚP and external depends on
crop: e.g. trials in vineyards are done 100% external, maize herbicide trials are done 100% by
ÚKSÚP.

It should be noted that there is no GEP accreditation system in Slovakia, although it is
currently in development. ÚKSÚP has to accredit the external trial stations before their trials
are accepted for regulatory purposes.

Official registration trials must all be performed before submission (because of dossier
completeness).

At least 50% of the efficacy trials must be Slovak trials; the remaining ones may be from
(relevant part of) Czech Republic, (part of) Hungary or (Southern part of) Poland.

“Special” Data requirements
Slovakia requires 4 specific Focus scenarios for the risk assessment, including the (very
sensitive) Piacenza scenario. All 4 scenarios must pass.

Mutual Recognition attitude
Currently, only a few authorisations are granted in Slovakia under Mutual Recognition.




      Slovakia                                                                            Page 89
                                        Ireland
Summary rev1
Ireland has a very high level of commitment to the European process, and not only
contributed to its development but now also implements the EU legislation to its spirit. The
Irish Competent Authority works in a completely centralised manner, and actively seeks for
the submission of Mutual Recognition applications. The Competent Authority works in a
transparent manner, and communicates with applicants in a solution-oriented fashion,
leading to relatively short timelines.

Resources
Responsibilities
The Pesticide Control Service (PCS), of the Department of Agriculture, Fisheries and Food,
manages the entire authorisation process. In addition to implementing the regulatory system
for Plant Protection Products, PCS is also responsible for the regulatory system for biocides,
and for the national regulations controlling pesticide residues in food.

Altogether, PCS employs ca. 40 fte staff. It is not possible to establish the exact number of
staff dedicated to the national authorisation process for Plant Protection Products, since the
same people are responsible for the evaluation of pesticides and biocides, and for the
national and the European responsibilities.

The coordination unit consists of 4-5 fte, plus another 1-2 fte responsible for enforcement
activities, although these tasks are not entirely separated. For evaluation work (national plus
EU, pesticides and biocides) PCS has ca. 2 fte available for PhysChem, 2-3 fte for Efate, 1-
2 fte Ecotox, ca. 4 fte Tox, 1-2 fte Residues (consumer risk), 2 fte Efficacy. There are ca. 3-
4 fte administrative and support staff. In addition, there is staff for the laboratory for residue
analysis for food monitoring.

Finances
For the role as EU Rapporteur Member State Ireland charges a fee of € 308.000. For national
applications the standard fee is € 5.000, regardless whether the product is based on existing
or new active substances. The fee for a use extension is € 300.

The cost of a Mutual Recognition application is € 2.500.

In addition to the authorisation fee, there is an annual fee of € 300 for each authorisation,
which can be reduced to € 150 for sales below a certain threshold, or € 100 if there were no
sales at all of the authorised product (in the previous year..).

All acquired fees are consigned to the consolidated funds of the Ministry of Agriculture; PCS
is allocated a budget from the Ministry, which is not fully compensated by the collected fees:
as mentioned above, PCS responsibilities cover more than the national and EU evaluation
activities for Plant Protection Products.




Page 90                                                                         Ireland
Process Description
Workflow
Applications are made to the coordination unit within PCS. The procedure requires a “sift”
to be carried out, similar to a completeness check. If a submission is accepted, the applicant
will be invoiced accordingly. Simultaneously, the applicant is informed of acceptance of the
application, and of the application number that is allocated to it. The application number
determines the position in the queue. There is only one queue, for all types of applications.
The placing in the queue is not determined by receipt of payment of the fee; payment is
however a prerequisite for issuing of the registration certificate at the end of the process.
Normally, each application will be allocated to one coordinator. Because of the small scale of
the PCS however, and the multi-functionality of its staff, the coordination of a submission
can be taken over ad hoc by another coordinator if the situation so requires. Dossiers are
uploaded to central server, from where they are available to evaluators once they reach the
head of the queue. During the evaluation, any questions that come up are directly
communicated with the applicant by the coordinator. Although contact is in the first place
through the coordinator, it is possible to discuss upcoming issues directly with the evaluators
if this is considered useful and necessary, but only after agreement from the coordinator.
Evaluators draft their section of the Registration Report, which is ultimately compiled by the
coordinator, who also the drafts the general section of the Registration Report. If any issues
remain, there is an open and constructive communication with the applicant about
possibilities for risk mitigation.
When all outstanding issues are solved, the coordinator is empowered to finalise the decision,
and to draft the registration certificate and sign it off.
Timelines
The initial sift and invoicing is usually done within weeks after submission.

The average time from submission to issuing of the certificate is estimated at 18 months for
an application for a new product, containing a new active substance (already on Annex I,
with DAR available). For products containing already authorised substances, the overall time
is shorter, down to ca. 12 month. The same is valid for Mutual Recognition applications.
Most of these 12 months is waiting time in the queue; the actual treatment of a Mutual
Recognition application is very rapid, and is for the major part carried out by the
coordinator.

In principle, there are possibilities for an applicant to swap applications within his own
portfolio in the queue, on a “like-for-like” basis (i.e. swap one Mutual Recognition
application with another one). This allows companies to accelerate the treatment of a
product that is important to them, without causing any undue obstacles for other applicants.

Transparency
The process is very transparent, and communication between applicants and PCS (mainly
with the coordinators) is open and constructive. This allows for rapid solving of identified
issues, and for pragmatic problem solving, without compromising to safety.



      Ireland                                                                           Page 91
Mutual Recognition
Language
Although Ireland has two official languages, the authorisation process relies entirely on
English, including final label texts.

There is even a mutual agreement between the UK and Ireland for dual labelling, allowing
one label for use in both UK and Ireland.

Biological Data
In principle, dossiers can be submitted with non-Irish studies only. Only for crops/uses
whereby the Irish (wet) conditions can be of specific interest to the efficacy of the product,
Irish trials may be requested in addition to the non-Irish efficacy dossier. This is for a limited
range of uses only though. Otherwise, the possible need for additional trials would depend
on the comparability of the available trials to the Irish conditions. Trials from the UK would
in most cases suffice.

“Special” Data requirements
Except for the small range of specific uses mentioned under >Biological Data, there are no
data requirements in Ireland that diverge from the standard requirements from Directive
91/414.

Mutual Recognition attitude
Ireland follows the true spirit of Mutual Recognition: if the reference authorisation comes
from a country with comparable conditions to the Irish ones, there is no repetition of the
evaluation, and there are no supplementary data requirements. What is required is a copy of
the registration certificate and product label from the reference country, and list of the data
that was submitted to the Competent Authority of that country. Only where the reference
country is obviously very different from the Irish conditions (e.g. potato blight in Spain..)
there could be a request for supplementary data. It is the responsibility of the applicant to
justify comparability, when he applies on the basis of Mutual Recognition.

Also for the application of Provisional Authorisations Ireland will rely on evaluations carried
out in other Member States (provided that they are based on a complete EU dossier, and
follow the Uniform Principles).

The Irish Competent Authority actually stimulates industry to apply on the basis of Mutual
Recognition.




Page 92                                                                         Ireland
                                              Lithuania
Summary rev3
Lithuania has a small and well-organised Competent Authority. The process is simple and
straightforward, and communication with applicants is direct and transparent. This leads to a
high efficiency, and strict adherence to the formal deadlines.

Lithuania makes efficient use of all possibilities under Directive 91/414, in terms of work
sharing and Mutual Recognition. They are advanced in the drafting of Registration Reports,
and follow a pragmatic policy with full regard of the national responsibility and autonomy.

Resources
Responsibilities
The State Plant Protection Service, SPPS (VAAT, Valstybinė Augalų Apsaugos Tarnyba) is the
Competent Authority in Lithuania, responsible for Phytosanitary measures (including
forecasting of pests & diseases) and the placing on the market of Plant Protection Products,
and their handling and control. It operates under the responsibility of the Ministry of
Agriculture (Žemės Ūkio Ministerija). One of the 6 technical divisions of the VAAT the Plant
Protection Division141 is responsible for authorisation process, forecasting, coordination of
inspectors, and certification of equipment. The Plant Protection Division also represents
Lithuania at the European level. It has one coordinator, and 8 experts (1 PhysChem, 2 Tox
(general toxicology, Operator Exposure, and Consumer Risk Assessment), 1 Residues,
1 Efate, 2 Ecotox, and 1 Efficacy).

In addition, there is the Advisory Committee (Konsultavimo komisija); this Committee is
installed by law and has 11 members. It is chaired by a member from the Lithuanian Institute
of Agriculture142, and has members from that same Institute (1), the Institute of
Horticulture143 (1), the Ministry of Environment144 (1), Ministry of Health145 (3), Ecological
Institute146 (1), Vilnius University (1), State Plant Protection Service (1) and the Kaunas
Technological University147 (1). The Advisory Committee is responsible for offering a (non-
binding) proposal to the Director of VAAT.

Finances
VAAT works on a general budget. Fees are payable to the State Tax Inspectorate, and go
into the general State budget. The level of the fees depends on the type of application. For a
new product (DAR or no DAR available) the fee is € 5.800, for a Mutual Recognition
authorisation this is € 2.900. Re-registration fees (including step 2 post Annex I evaluations)
are € 2.900, NPA € 4.350. For minor crops/uses the fee is € 580 per product. Line
extensions for a normal use are € 580, for a minor crop € 145.
141
    Augalų Apsaugos Skyrius
142
    Lietuvos Žemdirbystės Institutas
143
    Lietuvos Sodininkystės ir Daržininkystės Institutas
144
    Lietuvos Respublikos Aplinkos Ministerija
145 Lietuvos Respublikos Sveikatos Apsaugos Ministerija, Higienos Institutas (Institute of Hygiene)
146
    Vilniaus Universiteto Ekologijos Institutas
147
    Vilniaus Gedimino Technikos Universitetas


        Lithuania                                                                                     Page 93
The fee for Lithuania acting as Rapporteur Member State for a European submission is
€ 78.000.

Process Description
Workflow
Applications for authorisation are made to VAAT. Payment of fee is done simultaneously to
the State Tax Inspectorate of the Ministry of Finance148, who communicate payment details
to VAAT. When confirmation of payment is received, VAAT initiates the evaluation
process.

In principle there is no communication with the applicant until the evaluation process has
started, and then only when there are supplementary data requests. The application enters the
queue, and when it reaches the head of the queue the dossier is forwarded to the evaluators.
The evaluators draft their section of the Registration Report, in English, following the EU
format. If issues come up during the evaluation, they are discussed directly by the evaluator
with the applicant, and solved where possible. When all sections are completed, the
coordinator compiles all sections into a single Registration Report.

This report goes to the Advisory Committee, who meets in general once every 8 weeks. The
Committee decides by voting on the basis of the Registration Report prepared by VAAT.
The Committee is considered to be very pragmatic in their attitude. Although their advice is
not binding, their recommendations (by vote, not always unanimous) would always be
adopted by the Director of VAAT. As a next step, the conclusions are communicated to the
applicant, with the final GAP, registration number, classification etc. The applicant prepares
the final label text, and submits it for approval. As soon as this label text is approved, VAAT
prepares the registration certificate plus the written registration decision and the officially
approved label text.

Timelines
The official timeline, from submission to decision, is 12 months. VAAT successfully adheres
to this timeline. There is no legal timeline for Mutual Recognition applications, but in
practice they are treated considerably faster than standard applications, although there is only
one single queue for all applications.

Transparency
Transparency of the process is very high, and communication lines are short: the
Coordinator informs applicants when their application is on the agenda for the next
Registration Committee, and evaluators are in direct contact with the applicant if any issues
come up during the evaluation.

Mutual Recognition
Language
Lithuania already generates Registration Reports in EU format, in English.


148
      Valstybinė Mokesčių Inspekcija prie Lietuvos Respublikos Finansų Ministerijos


Page 94                                                                               Lithuania
Biological Data
There is no obligation for national trials: key criterion is that trials are conducted under GEP,
and within the same EPPO climatic zone. Trials from other EPPO zones can be acceptable
too, if sufficient agronomic and meteorological data are provided to prove comparability
with the Lithuanian conditions. Within Lithuania there are currently three accredited (all
governmental) institutions. Two of them are separate research stations, all falling under the
same Institute of Agriculture. VAAT is also the GEP accreditation body in Lithuania.

“Special” Data requirements
There are no specific data requirements over and above the EU requirements.

Mutual Recognition attitude
VAAT displays a positive attitude to Mutual Recognition, both as a reference and as a
“recipient”. They generate EU-standard Registration Reports, in English, as part of the
evaluation process. For a Mutual Recognition application in Lithuania, a copy of the original
label and certificate are required, as well as a Registration Report from the reference country-
country, and a full CADDY dossier. There is NO need for additional (biological) studies.
Following Directive 91/414, the reference authorisation must be post Annex I, and
evaluated and (re-)authorised under Uniform Principles

Lithuania actively pursues a role in the zonal evaluation process. They participated actively in
the Nordic worksharing project, and are extending their experience to another small “sub-
zonal” Baltic worksharing project.




      Lithuania                                                                          Page 95
                                                 Latvia
Summary            rev2

The Latvian process is characterised by short communication lines in a simple and
straightforward process, and open communication and good collaboration between the
Competent Authority and applicants. The timelines are short, and adhered to. Latvia is taking
a forward looking approach to Mutual Recognition and zonal evaluations, and is adapting to
an actively participating role.

Resources
Responsibilities
Within the Ministry of Agriculture149, the State Plant Protection Service, SPPS, VAAD150,
deals with seeds & varieties, fertilisers, phytosanitary measures, plus, in the “Plant Protection
Department” (Augu Aizsardzības Departaments) all activities with Plant Protection Products.
This includes an Integrated Plant Protection Division151, Environment and Ecotoxicology
Division152, and the Plant Protection Products Registration Division153. The Integrated Plant
Protection Division deals with inspections, including MRL monitoring. Both the
Environment and Ecotoxicology Division and the Plant Protection Products Registration
Division, deal with the authorisation process. The entire team of the Environment and
Ecotoxicology Division and the Plant Protection Products Registration Division consists of
8 fte, including the Heads of Division, 2 fte efficacy, 1 fte PhysChem, 1 fte tox (including
Operator Exposure & consumer risk assessment), 1fte Ecotox, 1 fte Efate, 1 fte residues
and 1 fte admin. The Head of Department is also directly involved, including representing
Latvia to the SCFCAH, and in the final decision process.

In addition to the team in the Ministry, there is a Registration Commission of Plant
Protection Products154. The Commission consists of 7 members, appointed by the Minister
of Agriculture: two members of VAAD (incl. the Head of Dept., chairing the Commission),
one representative of environmental sciences, one representative of medical sciences, one
representative of biological sciences and two representatives of agricultural sciences. The
Commission offers a non-binding proposal to the VAAD.

Finances
Evaluation & Registration fees go directly into the VAAD budget. In addition, there is a
State fee of € 43 that goes into the general State budget, at the end of the process.

In case Latvia operates as Rapporteur Member State for a European submission, the fee
would be € 49.800. For national registrations, the fee for a new product (with or without a
DAR available) is € 2.900. For Provisional authorisations this is € 2.900. For a Mutual

149
    Zemkopības Ministrijā
150
    Valsts Augu Aizsardzības Dienests
151
    Integrētās augu aizsardzības daļa
152
    Vides un ekotoksikoloģijas daļa
153
    Augu aizsardzības līdzekļu reģistrācijas daļa
154
    Augu Aizsardzības Līdzekļu Reiģeistrācijas Komisija


Page 96                                                                          Latvia
Recognition application this is considerably less at € 1.150. The fee for re-registration (which
includes EU step 2 evaluations) is € 710.

Although the fee for a national authorisation is relatively moderate, the size of the Latvian
market is such that for smaller crops (vegetables, fruits, etc..) the cost can still be a restrictive
parameter for agrochemical manufacturers.

Process Description
Workflow
Applications are made to VAAD (more specific: to the Plant Protection Products
Registration Division within the Plant Protection Department). Based on the type of
application, an invoice is sent to the applicant. After payment, directly to VAAD, an
administrative completeness check is carried out. In principle, there is no feedback to the
applicant until the evaluation has started, and then only when eventual issues arise, or
supplementary data are requested. When an application reaches the head of the waiting
queue, the dossier is distributed to the evaluators, who complete their work with an
evaluation report (in Latvian, and national format). Only recently VAAD has started to
produce EU formatted Registration Reports, in English. There is a very direct
communication between evaluators and applicant, and it is not uncommon that one
evaluator communicates additional questions or supplementary data requests several times
for one dossier. If certain issues are not satisfactorily resolved during the evaluation, the
evaluator informs the applicant that the evaluation report will be forwarded to the
Registration Commission with a negative advice. The applicant can however ask for
suspension of the dossier, in order to solve outstanding issues.

When the evaluation is completed, the application is scheduled for the agenda of the
Registration Commission, who meets 5 times a year. The Registration Commission decides
by voting (if there is a quorum) on the basis of the evaluation report prepared by the
VAAD. In cases where the Commission requests for additional information, the evaluation
report can be handed back to VAAD, who will discuss with the applicant about possible
amendments to the applied GAPs, in order to make them acceptable for a next Registration
Commission meeting.

VAAD takes a final decision on the basis of the evaluation report and the Registration
Commission proposal (recommendation). The conclusions are communicated to the
applicant, together with the agreed final GAP, registration number, classification, etc. The
applicant prepares the final label text and submits this for approval together with proof of
payment of the State fee to VAAD. The process is finalised by preparing the authorisation
certificate and the written authorisation decision, which are sent to the applicant together
with the officially approved label text.

Timelines
The official timeline for the completeness check is 3 months. From dossier completeness to
decision should not take longer than 12 months.

In practice the entire process, including the completeness check, takes ca. 12 months.



      Latvia                                                                                 Page 97
The timeline for a Mutual Recognition decision is limited to 3 months, which is strictly
adhered to.

Transparency
In general, the process is very open. Questions and issues usually only arise during the
evaluation phase, when there is a direct communication between evaluators and applicant.

Mutual Recognition
Language
Until recently (2009) only internal summary evaluation reports were generated, in Latvian.
Latvia has however the intention to actively participate in zonal evaluations, and will require
applications to be accompanied by a draft Registration Report in English, as of October
2010. This is the deadline for such submissions, but they are already accepted with an
English Registration Report instead of the former Document M (Tier II summary).

Biological Data
There is an obligatory requirement to submit 1 or 2 years of national trials (depending on the
type of application). Trials must be carried out under GEP; there is only one accredited
(state-) institution in Latvia. VAAD is the accreditation body for GEP certification.

One particularity of the Latvian approach to efficacy is that label-texts contain a legal dose
range, which has to be adhered to. With regard to maximum dose levels this is the same in all
Member States, but in Latvia farmers are not allowed to use rates lower than the one on the
label (which is why the minimum effective dose must be incorporated in the dose range).

“Special” Data requirements
There are no specific data requirements in Latvia.

Mutual Recognition attitude
Latvia takes a positive attitude towards Mutual Recognition. For applications the original
label and the authorisation certificate from the reference Member State are required, as well
as a full (CADDY) Annex III dossier and a Registration Report. No additional (biological)
studies are required. VAAD takes a serious approach to Mutual Recognition, and adheres
strictly to the 3 months deadline. The reference-authorisation must be post Annex I, and in
compliance with the Uniform Principles. This pragmatic approach is in principle valid for
reference countries within the same EPPO-zone. For countries from another EPPO zone, a
justification of comparability of agronomic conditions is required. According to the national
legislation a justification of comparability of agronomic (climatic & soil conditions) has to be
submitted for all mutual recognition applications.

Latvia has decided as a matter of national policy that they will play an active role in the future
zonal worksharing process. They intend to do their share of work as a zonal Rapporteur.

Latvia has also (informally) indicated their intention to maintain the current high evaluation
and decision standards, and not increase them after adopting zonal evaluation standards.



Page 98                                                                          Latvia
                                        Estonia
Summary
The Estonian system is characterised by simplicity and transparency: the entire process is
centralised, administration, coordination, evaluation and decision are all within the same
small team, and communication with applicants is direct, open and constructive. The number
of applications on an annual basis is limited, but the fact that the responsible unit in the State
Plant Production Inspectorate manages to deal with the workload (mainly) within the legal
timelines is primarily due to the simplicity of the organisation and the transparency of the
process.

Resources
Responsibilities
The Agricultural Board155, PA, is a governmental authority under the Ministry of
Agriculture156, managing the areas of land improvement, plant protection, plant health, plant
variety rights, seed and plant propagating materials, organic farming, fertilizers and
horticultural products. Inside PA the Plant Protection Departments (Taimekaitse osakond)
deals specifically with the authorisation process, as well as inspections (in the field), including
MRL monitoring. The entire team of Plant Protection Department consists of 8 fte: the
head, 1 deputy head (also responsible for completeness check and efficacy), 1 administrative,
1 toxicologist (dealing with general toxicology and Operator Exposure), 1 residue expert
(both agronomic and consumer risk assessment), 1 Efate plus Ecotox plus PhysChem, and 2
dealing with inspections.

PA is the only body involved in the authorisation process.

PA does not represent Estonia at the SCFCAH in the EU Commission; this is done by the
Ministry of Agriculture. PA however participates to peer review meetings at EFSA.

Finances
If Estonia is selected as Rapporteur Member State for a European submission, they would
charge an evaluation fee of € 23.100. For the evaluation of a new product for Estonia
(regardless of the status of the active substances in the product) the evaluation fee is € 500.
For a Mutual Recognition authorisation this is reduced to € 320.

Process Description
Workflow
Applications are made directly to PA, with simultaneous payment of the fee to the Ministry
of Finance. Simple but efficient procedures allow the Ministry of Finance to report received
payments to PA, which can there be linked to the received applications. When receipt of
payment is confirmed, PA starts the work with the completeness check. If payment is not
received, PA informs the applicant directly.

155
      Põllumajandusamet
156
      Põllumajandusministeerium


          Estonia                                                                          Page 99
The completeness check is purely administrative, and completeness is confirmed in writing
to the applicant. Although there is a waiting queue, timelines are seldom exceeded. Since the
Plant Protection Department is relatively small, coordination is done at a direct level between
the evaluators, on the basis of the queue and the deadlines for the applications.

The evaluators draft an evaluation report for their section of the dossier. Every (ca.) 6 weeks,
there is a “final assessment meeting” with the entire team, during which the finished
applications are treated. In the meeting the experts’ proposals, on the basis of their respective
sections of the dossier, are discussed, and a decision is prepared. On the basis of the
decision, the authorisation certificate is prepared. This certificate is relatively “open”: it
contains the main conditions of the authorisation, as well as the label text (an amended
version –if necessary- of the originally submitted proposed label text). The decision is then
communicated to the applicant, together with the authorisation certificate.

Timelines
The legal deadline for completeness check, 3 months after submission, is usually adhered to,
and sometimes even faster. The legal deadline for evaluation plus decision is 10 months after
completeness check. The average timeline for the entire process is estimated at 12 months.

There is even a possibility, in good cooperation between authorities and applicant, to swap
earlier and later submissions, in order of their importance to the applicant. This is not
without limits, but in function of importance and season, later submissions can be swapped
with earlier ones from the same applicant, within reason.

The entire process for a Mutual Recognition application is 3 months from submission to
decision.

Transparency
When issues come up during the evaluation, the evaluators communicate directly with the
applicant, in order to solve the issue.

Neither the “old” evaluation reports nor the current Registration Reports are automatically
available to the applicant. The Report is however available to the applicant upon request.

Because of the very direct and open communication between applicant and evaluators, and
because of the very centralised administrative, evaluation and decision process, applicants are
usually well aware of the status of their application when it moves to the final assessment
meeting. Any risk mitigation measures or label changes (dose-rates, applied crops, etc..) are
discussed already in the evaluation phase with the applicant.

Mutual Recognition
Language
Since 2007/2008, Estonia generates Registration Reports, in English, following the EU draft
format.




Page 100                                                                      Estonia
Biological Data
Only recently efficacy trials must be carried out under GEP. In Estonia there are currently 2
GEP certified (government) institutes. PA is also the GEP certification body. GEP trials
from the entire (EPPO) North-East zone are accepted.

“Special” Data requirements
There are no specific data requirements.

Mutual Recognition attitude
Estonia actively encourages the submission of Mutual Recognition applications, and treats
them with priority (especially when so requested by growers’ organisations. A Mutual
Recognition application must contain a copy of the authorisation certificate from the
reference country, as well as the label from that country, a Registration Report, plus a
complete Annex III dossier in CADDY format, plus a label proposal (should be identical to
the authorised label from the reference country).

Estonia is quite flexible with regard to Mutual Recognition; applications can even be based
on non-post-Annex I authorisations. Although there is a need for the submission of a
complete Annex III dossier, the application relies on the Registration Report from the
reference country. As a result, Mutual Recognition applications are cheaper, and considerably
faster.




      Estonia                                                                         Page 101

								
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