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REACH
What to do next?
Registration, Evaluation,
Authorisation
(and Restriction)
of Chemicals
Workshop for the
Aerospace Industry
AGENDA
08:30 Registration and Coffee
09:15 Welcome – Terry Palmer, Lockheed Corporation
09:20 What is REACH, where we are up to in the timeline – Terry Palmer
09.40 Pre-Registration and Registration: what happens next?
– Tony Harmsworth, Goodrich Corporation
10.20 Questions
10.25 Coffee
11.00 Authorisation and Restriction: The process – Kerrill Grealy, Meggitt
11.30 The Candidate List – Bhav Panchal, Lockheed Insys
11.50 Questions
11.55 Tools from the Sector to help with REACH – ?TBA
12.30 Questions
12.35 Lunch
1.15 HSE – Enforcement, Help and Advice - ?TBA
1.45 Optional Workshops on planning for REACH, INCLUDING defence exemption issues,
discussions with presenters
2
4.00 close
What is REACH?
Manufacture
Importation
Placing on the market
Use
of substances
On their own In preparations In articles
Trichloroethylene Paints, Sealants, Resins Systems, Components, aircraft
3
REACH Key Words
Substance:
• A basic chemical, like iron, nickel,
trichloroethylene, solvent naphtha, lead
oxide…
• ANYTHING WITH A CAS No.
• It can be a pure substance or a distillate
fraction mixture but it has have its own CAS
No.
• These are the basic building blocks from
which everything is made.
• It can be a solid, liquid or gas.
• ALL substances are affected by REACH.
Even ones that are NOT HAZARDOUS in any
way!
4
REACH Key Words
Preparation / Mixture:
• A mixture of substances, like steel, adhesive, resin, paint, an
etchant, an NDT fluid.
• Anything that is a mixture of substances.
• It will contain more than one CAS No. substance.
• If the preparation is solid, then the shape isn‟t really important – it
is more for delivery than anything. You can do whatever you are
doing with it, even if it is a different shape.
Article:
• An object where the shape is more important than its chemical
composition:
• A billet, a rod, a diesel engine, a gasket, a spare part, a submarine,
a valve, a second hand product
• It could be an object made from a homogenous material, or it could
be an object made from several other objects
5
What is REACH?
Supply Chain and manufacturing use of Substances Authorisation
Registration to use in specific
Evaluation application
Pre-registration
Pre Registrants to submit
By ECHA.
Import substances into EU Safety Assessment for
For several substances
>1tonne/year each specific use of
this may already exist
substance Restriction
Substances of very High Concern (Candidate list)
Declaring Substances of Very High Concern in Articles to customers
0.1% of SVHCs 0.1% of SVHCs
Supplier In Articles Your company In Articles Customer
6
REACH Time Line
Any > 1k tpa End of
Registration
R50/53> 100 tpa phase in
Evaluation
CMR1/2 > 1 tpa
Pre-registration
Registration
Any > 100 tpa
Evaluation
Registration
Any > 1 tpa
Evaluation
Authorisation and Restriction
Go live
2009 2010 2011 2013 2018
2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017 2018
TODAY
FIRST DEADLINE: NEXT DEADLINE:
End of Preregistration: First „Candidate List‟
Nov 30 2008 Consultation ends 7
14 April 2009
Business Risks and REACH
Margin on sales of Product
Cost of registration for
the product constituents
Products are worth
the registration costs:
Substances are
pre-registered and Products are NOT worth the registration
then registered. costs. Substances are pre-registered
and then withdrawn prior to the
registration deadline
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21..
8
Product lines
Defence Exemption in REACH
When could a Defence Exemption be used?
•Where a material (Preparation) is classified
•Where the use of a material is classified
•Where other legislation prevents supply of data to support
REACH (e.g. International Traffic in Arms Regulations)
•Where the use of a SVHC is classified
•Where the defence uses of a materials is Authorised or
Restricted
•Where defence related PPORD is classified
Defence Exemptions
Member state Status
Denmark No progress
Finland Realisation of need
Germany Designated agency, no legislation
France Designated agency, no legislation
Spain Designated agency, no legislation
Greece Designated agency, no legislation
Italy Designated agency, legislation, but no actual
exemptions in process
Netherlands Designated agency, legislation, but exemptions in
process, weaknesses
UK Designated agency, legislation, but exemptions in
process, weaknesses being addressed
REACH
Pre-Registration and Registration:
what happens next?
11
REACH – legal overview
Supply Chain and manufacturing use of Substances Authorisation
Registration to use in specific
Evaluation application
Pre-registration
Pre Registrants to submit
By ECHA.
Import substances into EU Safety Assessment for
For several substances
>1tonne/year each specific use of
this may already exist
substance Restriction
Substances of very High Concern (Candidate list)
Declaring Substances of Very High Concern in Articles to customers
0.1% of SVHCs 0.1% of SVHCs
Supplier In Articles Rolls-Royce In Articles Customer
12
Pre-Registration
The pre-registration phase closed on 1st Dec 2008
• 150k substances pre-registered
• 65k companies
• 2.7M pre-registrations
Preregistration
• What should have been pre registered?
• All substances and mixtures manufactured in the EU
or imported into the EU in quantities of greater than 1
tonne per legal entity
• Some exemptions
• Waste, nuclear materials, medicines, etc
Preregistration
•Who should have pre registered
• Manufacturers in EU placing substances on the
market
• Importers of substances in volume greater than 1
tonne from outside the EU.
• European Chemicals Agency (ECHA) has now
published list of all substances pre registered
Preregistration
•Are your KEY substances pre registered?
•Has your non-EU supplier done the pre-registration for
you?
•The non-EU supplier is obliged to tell you if they are going
to establish an „Only representative‟ to do the pre-
registration for you. Have they contacted someone in your
company to tell you that they are going to do this?
Pre-registering substances in
Articles
Substances in articles required registration when the
substance is “intended to be released” and the mass of the
substance sold in articles is greater than 1 tonne per annum
• The INTENTION is important !
• The key test is whether the core function of the article is to release
a substance. (Examples: a welding rod, packing grease, stop-off)
• A hydraulic cylinder does not have an INTENDED release
• Normal wear is not considered to be an intended release
• Release during disposal is not an intended release
The Aerospace and Defence sectors have an opinion on
many grey areas – see your packs and
http://www.asd-europe.org/content/default.asp?PageID=43 17
Pre-registering substances in
Articles
The EU has developed guidance on articles - RIP 3.8.
The industry has prepared a document (GLOBAL AEROSPACE AND
DEFENCE INDUSTRY OPINION ON WHAT CONSTITUTES A
SUBSTANCE, PREPARATION AND ARTICLE) that provides guidance
on:
• PREPARATIONS or SUBSTANCES
• ARTICLES with intended release
• ARTICLES with no intended release
A rationale has been provided for each assumption
This is industry best guidance – but cannot be presumed to be the
interpretation that the courts will place on the regulation. When decisions
are made in the European Courts, they will supersede this guidance. 18
If not pre registered what then?
Late preregistration is only permitted for :
• Substances as listed on EINECS, being imported by the
legal entity or manufactured in the EU for the first time
• Substance manufactured in the EU, but not placed on
the market, at least once in the past 15 years.
• I.e. exported substance
• Evidence of the conditions must be available
• Substance is a so called „no longer polymer‟. These are
chemicals that used to be considered polymers in the
old regulation, but are now not considered to be
polymers (See handout for information)
Pre-registration or „Inquiry‟?
EINECS or ELINCS?
EINECS:
Substances existing before 1981: phase-in – should be
preregistered.
ELINCS:
Substances invented post 1981: Should be registered already,
or will require registration. Ask your supplier if they have already
registered the substance.
The ELINCS and EINECS databases can be seen at
http://ecb.jrc.ec.europa.eu/esis/index.php?PGM=ein
NEITHER ELINCS or EINECS: USE is illegal. You need to stop
using it, and make an inquiry to ECHA. See
http://echa.europa.eu/reachit/inquiry_en.asp 20
How to late preregister
•Go to the IT portal on the ECHA webpage
•You will require:
• Name of substance, CAS, EINECS or other
identification number
• Name & address of contact person
• Envisaged deadline for registration based tonnage band
• Identifier of any structurally similar chemicals you may
wish to rely on as part of registration process
REACH
QUESTIONS
23
REACH
Registration:
If you are a Down stream user
24
What is Registration?
• Pre registrants grouped together into SIEF‟s
(Substance Information Exchange Forums)
• Assemble portfolio of specified information that shows
how substance can be used safely
• Share costs of putting portfolio together
• Submit portfolio to ECHA by date determined by tonnage
band.
Supply chain communication
26
Supply chain communication
Management Measures
Chemical Aircraft
MSDS and Risk
Information
Manufacturers Manufacturer
or importer
INFORMATION
Major assembly
Distributor 1 OEM
USES
Formulator 1 Design / Make
System Supplier
Formulator 2
Distributor 2 Component
Supplier
Formulator 3
Metal Basher / base component
Fabricator…
Registration as a Downstream User
EACH Registrant, will make sure all of their own uses, and all of the main
downstream uses in their supply chain, are registered.
They are likely to include the obvious uses for the main markets:
• Trichloroethylene as a degreaser.
• Toluene and Xylene in paints.
• Epoxy resin in adhesives.
They may not know about the less obvious uses:
• The aerospace and defence sectors WILL have weird uses.
If your use is not covered in the registration, it will be ILLEGAL.
28
Uses not on the MSDS
This occurs when…
Substance use is outside the conditions described in the
“exposure scenario”,
Exposure scenario: The way in which a person, or the
environment, gets exposed to the substance. Such as:
Inhalation, Ingestion, Into water courses, Into soil.
Forms part of Registration dossier
How will they decide the Exposure Scenarios they will cover?
It depends on the likely routes. Substances in kettle heating
elements could be ingested. Substances in paint could
get into the body via inhalation, via dermal contact, and
can get into water courses, and possibly into soil (when
land filled)
Uses not on the MSDS
Options:
• Inform supplier: they then can create / modify
exposure scenario for your use
• Change your conditions of use to those on the MSDS
• find another supplier that is covering your
conditions of use,
• prepare a DU (Downstream User) chemical safety
report yourself
• find an alternative substance, preparation or process
and stop using the substance/preparation in
question.
What defines a “Use”?
Taken from
http://guidance.echa.europa.eu/docs/guidance_document/informat
ion_requirements_r12_en.pdf?vers=20_08_08
What information should be sent to
suppliers in relation to “uses”?
CEFIC (the chemical industry in Europe) are setting up two
standard ways to provide information to manufacturers and
importers:
• Generic exposure scenarios – these are provided by
companies to trade associations, who collate the
information and then tell the chemicals sector: “SBAC
members use substance X for purpose Y.”
• Specific exposure scenarios – using a standard form,
companies inform their suppliers or M/I directly of their
unusual uses of substances to ensure that the use is
included in the exposure scenario
CEFIC guidance on this is in the handout and on the web at:
http://cefic.org/Templates/shwStory.asp?NID=719&HID=714
Registration as a Downstream User
ACTION POINTS:
• Identify each of your uses for each substance and preparation you
cannot do without (strategically important substances).
• Download the „use descriptor system‟ from the ECHA website:
http://guidance.echa.europa.eu/docs/guidance_document/du_e
n.pdf?vers=29_01_08
• Identify the use, as defined in the descriptor system you have of
each substance or preparation by trade name and supplier.
• Find any health surveillance data or occupational hygiene data
(non-person specific) that you have concerning the substances and
preparations. Sanitize this so that individuals cannot be
identified.
33
Registration as a Downstream User
ACTION POINTS:
• Send your use descriptions to your supplier as soon as possible. Your
supplier is not likely to be the registrant, and they will need to cascade
the information up the supply chain, for use by the SIEFs when they are
formed early in 2009.
• You can also send the health surveillance data too, but be aware that
this may have value, and so you may not wish to part with it for free ,
just indicate that you have it.
• For your own purposes, keep a record of who buys the strategically
important substance / preparation and where in your facility it is used,
and on which products. It could be useful information to have, if you
have any continuity of supply issues, or the supplier refuses
to register the use of the substance.
34
Registration as a Downstream User
After sending in the uses of a substance, what happens next?
The manufacturer / importer doing the registration has THREE
choices. They can…
• Refuse to do the registration of the substance on economic
grounds, whereupon they have to stop supplying you.
• Do the registration of the substance for your use, and
include your use in the MSDS.
• Do the registration, but refuse to add the use to the MSDS,
because it is a dangerous use. Advise you that it is
dangerous. They can keep supplying you legally. 35
Registration as a Downstream User
ACTION POINT:
If the Manufacturer / Importer does not include your use on the
MSDS, you can write your own Downstream Users‟ Chemical
Safety Report in order to ensure continued supply.
See the section on Downstream User Chemical Safety Reports
in the Downstream User guidelines
http://guidance.echa.europa.eu/docs/guidance_document/
du_en.pdf?vers=29_01_08
36
REACH
Registration:
If you are a Manufacturer / Importer
39
Doing Registration
Estimated Registration cost for one Substance
Volume tier Individual Average testing
registration cost per substance
(Euro)1 (Euro)2
1 - 10 tonnes 1,600 56,360
10 - 100 tonnes 4,300 279,838
100 - 1000 tonnes 11,500 799,562
> 1000 tonnes 31,000 1,582,616
1DraftRegulation on Fees and Charges, Individual Submission under Article 6, 7, or 11, October
2007, p. 16.
2 Source: Fleischer, M.,”Testing Costs Testing Capacity According to REACH Requirements –
Results of a Survey of Independent and Corporate GLP Laboratories in the EU and Switzerland,”
September 2007, pgs. 96-114
Some suppliers may look at these costs and decide that the cost of REACH
compliance is not worth it and terminate some products 40
40
Doing Registration
Suppliers/importers need information to write
chemical safety reports and identify
„Exposure Scenarios‟, including:
• Epidemiological studies, animal testing
• Typical uses and exposure data
EU manufacturers and importers must form
“Substance Information Exchange Fora”
(SIEFs) who must minimize testing.
41
DRAFT April 25, 2008
Doing Registration
ACTION POINTS:
1. If you have determined that you are a manufacturer or
importer and you are going to pre-register, you need to
seriously examine your ability to participate in the SIEF.
Do you have the right subject matter experts to participate
in the debates on animal testing, toxicology,
carcinogenicity?
Do you know what tests are relevant to all your and your
downstream user‟s uses are?
Seriously think about employing expert assistance.
42
Doing Registration
SIEFS and CONSORTIA
Each SIEF will comprise of a few large companies who
manufacture / import the majority of the substance, and a
myriad of companies (quite possibly thousands) who import
or use smaller amounts.
The larger companies will probably form consortia, to carry
out the animal testing that relates to the majority of their uses.
Where the uses that you need to register overlap, you will
need to buy the relevant data from the consortia as part of the
SIEF.
If the main consortia decides not to deal with the tests that
you need, you may have to develop your own mini-consortia
in the SIEF with others who need the same information.
43
Doing Registration
ACTION POINT:
2. Decide if you should join the CONSORTIA?
Advantages: You get to help set the agenda on what the
tests carried out should be. This way, you stand a better
chance of getting the tests you need, done in exactly the
way you need to reflect your uses.
You also are right in the thick of things – you know exactly
what is going on with your strategically important
substance.
Disadvantages: You will really need an expert to
participate in this. They will be expensive,
especially if you do not already have one.
44
IT Requirements
• Registration submitted through IUCLID 5
• This can be down loaded from ECHA website
• System is used for many purposes and is very complex
• Hence you will need training on its use
• Guidance document also available for down loading
45
REACH
QUESTIONS
46
Substances used in Research
Scientific research and development means any
scientific experimentation, analysis or chemical research
carried out under controlled conditions in a volume less
than 1 tonne per year (Article 3(23)).
Product and process oriented research and
development (PPORD) is defined as any scientific
development related to product development or the further
development of a substance, on its own, in preparations or
in articles in the course of which pilot plant or production
trials are used to develop the production process and/or to
test the fields of application of the substance (Article 3 (22)).
CSR Information requirements
CSR Guidance available
The Evaluation in REACH
• Once pre-registered, manufacturers and importers of
substances have to prepare DOSSIERS that will be
EVALUATED by the REACH Agency in Helsinki.
• This will decide whether registered substances are
„nasties‟(substances of very high concern). If they are, then
the European Commission could require them to go through
Authorisation or Restriction.
• On the whole, there is nothing to be done by Manufacturers,
Importers or Downstream Users for Evaluation.
53
REACH
QUESTIONS
54
REACH
Authorisation and
Restriction:
The process
“Registry of intent” “Priority list for
Authorisation”
“Substances of Very Candidate “Authorised
High Concern” List substances: 55
Annex XIV”
“Substances of Very High Concern”
TO BE A SUBSTANCE OF VERY HIGH
CONCERN (SVHC), MUST FALL INTO ONE OF
THE 4 FOLLOWING CRITERIA:
Carcinogens, Mutagens and Reproductive
Toxins (CMRs)
Persistent, Biocumulative and Toxic (PBT)
Very Persistent and Very Bioaccumulative
(vPvB)
Substances of Equivalent Concern (Endocrine
Disruptors)
NB: ALL Substances contained on the
„Candidate List‟ are SVHC‟s
Substances used in Products
and Processes
All substances
Substances that
150,000 meet the SVHC criteria
3,500
Registry of Intent
7 current
16 previous Candidate List
15
Priority CL
7
Annex XIV
Annex XVII:
Restriction
57
Candidate List: what is it?
• The Candidate List is a list of substances that are
subject to the Authorisation process. Controlled by
ECHA.
• Currently the list contains 15 SVHC‟s…HOWEVER this
shall be updated periodically.
• The 15 is the current legal obligation on all companies
within the EU.
• The 1st List was published on 28th Oct 2008.
• The „Candidate List‟ can be found at:
http://echa.europa.eu/chem_data/candidate_list_table_en.asp
Candidate List: what is it?
• MS may let companies know of their intentions to
propose substances to be on the „registry of intent‟
(See ECHA website).
• Registry contains 7 additional substances/families
which may be added to the candidate list in 2009
• MS nominate substances as fulfilling the criteria of
being SVHC‟s & then with ECHA, they decide which
will be incorporated in the Candidate List & which will
be restricted.
• Once on the candidate list the substance will definitely
be subject to Authorisation eventually…
Candidate List: what is it?
1 Benzyl butyl phthalate The top 7
2 Dibutyl phthalate
are the
3 Bis (2-ethyl(hexyl)phthalate) (DEHP)
substances
4 Short chain chlorinated paraffins
5 4,4'- Diaminodiphenylmethane
ECHA
6 Hexabromocyclododecane (alpha, beta, gamma) propose to
7 5-tert-butyl-2,4,6-trinitro-m-xylene (musk xylene) prioritise.
8 Sodium dichromate, dihydrate or anhydrate If you NEED
9 Cobalt dichloride Any of the
10 Bis(tributyltin)oxide Top 7 for
11 Diarsenic trioxide
Product
12 Diarsenic pentaoxide
Safety
13 Lead hydrogen arsenate
reasons
14 Triethyl arsenate
You need
15 Anthracene
to tell ECHA
Priorities will appear on Annex XIV in June 2009 NOW
Registry of Intent
The 7 potential substances are on the „registry of intent‟ and
may be added to the Candidate List or restricted in 2009
Residues (coal tar), pitch distn.
Distillates (coal tar), heavy oils
Distillates (coal tar), heavy oils, pyrene fraction
1.
Distillates (coal tar), pitch, pyrene fraction
Coal tar pitch, high temperature
Tris(2-chloroethyl) phosphate
Arsenic and its salts
Candidate List: Business risk
• Your continued supply is at risk – Supplier may not
consider it worthwhile continuing production.
• If you have no alternative, your ability to manufacture
your product is at risk. May need to start programs to
find alternatives.
• If you have any candidate list priority substances as
essential substances within your product/processes
or if your SUPPLIERS rely on the substance for
production, you will need to take action quickly.
Candidate List: Business Risk
• Any of these substances ON THE LIST must not be
USED, MANUFACTURED or IMPORTED without
authorisation from ECHA once the substance has been
included in Annex XIV of the REACH Legislation.
• Authorisation is EXPENSIVE, TIME CONSUMING AND
NOT GUARANTEED. IT IS NOT EVEN LIKELY IF THERE
IS AN ALTERNATIVE OUT THERE SOMEWHERE.
Candidate List: Article 33 Obligation
Current obligation upon a supplier of articles.
„Suppliers of articles which contain any SVHC which have a
concentration higher than 0.1% w/w, regardless of the tonnage
use must‟:
1. To the END-USER: supply sufficient information for the safe-use of the
article
2. To the CONSUMER: supply sufficient information for the safe-use of the
article within 45 days of the request.
(Article 33 REACH)
NB: This is a communication obligation.
NOTE THAT CURRENTLY THE ‘ARTICLE’ is the PRODUCT or SPARE but
interpretation by MEMBER STATES could mean ‘each constituent part’.
Authorisation vs restriction
• Substances of very high concern will be
identified and eventually be PHASED
OUT.
• Some substances will simply be banned –
this is the RESTRICTION process.
• Some substance cannot simply be banned
• they are used too widely,
• there are no „drop-in‟ replacements.
• These substances will go through the
AUTHORISATION process.
66
Candidate List to “Annex XIV” and Authorisation
• Substances on Annex XIV are PROHIBITED unless your
company has an AUTHORISATION to continue to use it.
• These AUTHORISATIONS are time limited.
• If the substance is a CMR and has a THRESHOLD value (it is
known to be safe, if exposure is below a certain level), then
you can continue with your authorisation BUT you will need a
substitution plan.
• If the substance has NO THRESHOLD or is a PBT / vPvB, you
MUST replace it. You will only be able to get an authorisation
if
There are no suitable alternatives AND
You have written a socio-economic analysis, as well as a
substitution plan.
Threshold / non threshold?
1 Benzyl butyl phthalate
2 Dibutyl phthalate The
3 Bis (2-ethyl(hexyl)phthalate) (DEHP) Highlighted
4 Short chain chlorinated paraffins substances
5 4,4'- Diaminodiphenylmethane CANNOT
6 Hexabromocyclododecane (alpha, beta,
gamma)
be used
if there
7 5-tert-butyl-2,4,6-trinitro-m-xylene (musk
xylene) is an
8 Sodium dichromate, dihydrate or anhydrate alternative
9 Cobalt dichloride available
10 Bis(tributyltin)oxide once the
11 Diarsenic trioxide substance
12 Diarsenic pentaoxide
is on Annex XIV
13 Lead hydrogen arsenate
14 Triethyl arsenate
15 Anthracene
Fees & Costs
• Tariffs dependant upon company size & if a joint dossier
is being submitted.
• Cost of creation of Technical Reg Dossier / Technical
Authorisation Dossier:
• Estimated cost of a small dossier approx €80k,
• Large dossier could cost several million Euro‟s.
• Charges shall be shared between companies submitting
jointly, according to the tonnage of the substance used.
• Table on next slide shows fees of an Authorisation
Dossier.
Authorisation Fees
Fees for an Authorisation Large Medium Small Micro
Dossier Company Company Company Company
Basic fee € 50,000 € 40,000 € 25,000 € 7,500
Additional fee per substance € 10,000 € 8,000 € 5,000 € 1,500
Additional fee per utilisation € 10,000 € 8,000 € 5,000 € 1,500
Additional fee per applicant
- The additional applicant is € 37,500
not an SME
- The additional applicant is
a medium company € 30,000 € 30,000
- The additional applicant is
a small company € 18,750 € 18,750 € 18,750
- The additional applicant is € 5,625 € 5,625 € 5,625 € 5,625
a microenterprise
Authorisation Costs
• 50,000 EUROS
• PER SUBSTANCE
• PER USE
• Every 3 years or so
• Technical Dossier
application for
Authorisation (80 – Ms of
EURO)
• Collaboration costs with
other users and
manufacturers
• Creation of in-house
substitution plan
• RESEARCH AND
DEVELOPMENT into
alternatives for each use
• Socio-Economic Analysis
REACH
What to do when you use a
Substance that is being Restricted:
Dealing with Restriction
72
Restriction vs Authorisation
• Authorisation can only apply to
substances on their own or in
preparations, before being incorporated
into Articles.
• Article imports that contain a candidate
list substance are not regulated under
Authorisation. But can be banned from
being imported via Restriction.
73
Restriction
Taken from
http://guidance.echa.europa.eu/docs/
guidance_document/du_en.pdf?vers
=29_01_08 (page 112)
Dealing with Restriction
• Initially, many restrictions are being carried over from the
Marketing and Use Directive, Dangerous Substances
Directive etc. into REACH.
• When the Restrictions from the existing directives are
imported into REACH, you cannot assume that any existing
exemptions to the restrictions will still stand. They will need
to be re-negotiated.
• Authorisation can only apply to substances on their own or
in preparations, before being incorporated into Articles.
• Article imports that contain a candidate list substance are
not regulated under Authorisation. But can be banned from
being imported via Restriction.
75
Dealing with Restriction
• Companies may have to adopt internal
actions similar to:-
• Removal of asbestos
• Elimination of nonylphenol in detergents
• Phase out of pentabrominated
diphenylether (PBDE) in non-metallics
etc.
• Very little will change from the way that
substances have historically been
restricted in the EU.
76
Dealing with Restriction
• For example substances could be
restricted for sale to the general public,
and authorisations required for use in the
EU by industry.
• This is a likely area for the use of the
Defence Exemption, by any jurisdictions
that choose to have one. This will enable
the MoD and other defence agencies to
continue to use and maintain equipment in
the field, until industry has viable
alternatives to the substance for their
applications.
• Example: There are still some defence
uses of asbestos in the UK.
77
REACH
COFFEE BREAK
78
REACH
The requirement to declare
Candidate List „Substances of
Very High Concern‟ to your customer,
their customers, and in some cases, to
ECHA: Making declarations
83
REACH – legal overview
Supply Chain and manufacturing use of Substances Authorisation
Registration to use in specific
Evaluation application
Pre-registration
Pre Registrants to submit
By ECHA.
Import substances into EU Safety Assessment for
For several substances
>1tonne/year each specific use of
this may already exist
substance Restriction
Substances of very High Concern (Candidate list)
Declaring Substances of Very High Concern in Articles to customers
0.1% of SVHCs 0.1% of SVHCs
Supplier In Articles Rolls-Royce In Articles Customer
84
Candidate List: Consequences
This requirement is what many companies have been trying to find out as
the following obligations apply from this:
Suppliers of articles which contain any SVHC which have a
concentration higher than 0.1% w/w, regardless of the tonnage
use must:
1. To the END-USER: supply sufficient information for the safe-use of the
article
2. To the CONSUMER: supply sufficient information for the safe-use of the
article within 45 days of the request.
(Article 33 REACH)
Making Declarations:
Notification of ECHA
You have a legal obligation to NOTIFY the REACH Agency
(ECHA) AND Customers about SVHCs contained within
YOUR product (REACH Article 7(2)) if the following apply:
• >0.1% w/w AND
• > 1 tonne sold (of SVHC per year) AND
• Cannot show that the substance will not be
released at any point in the life cycle (including
disposal) (REACH Article 7(3))
This is a subset of the information needed for the customer
86
Making Declarations:
Information flow
Substance of Very
High Concern
Candidate List
(ECHA Website)
Exam Question:
Incorporated into
a Preparation
What is the percentage
of the SVHC
Incorporated into
a Component a) In the component sold as a spare
And sold as a and
spare part b) in the article?
Incorporated into
an Article 87
REACH and the need for I.T
COLLECTING THE DATA REQUIRED FOR REACH FOR THE
ARTICLES YOU MAKE IS PROBABLY GOING TO NEED NEW
OR MODIFIED I.T.
• How will you collect the „bill of substance‟ information for
the articles you make?
• How will you extract the information from the supply chain
about the SVHCs in the articles you supply?
88
REACH and the need for IT:
ACTION POINTS:
Set up a REACH IT business project to enable you to get the
IT you need to store and manage REACH related data.
• Develop an IT strategy for dealing with Declaration
• Get an agreed policy for the declaration of substances in the articles you
buy across stakeholders in your legal entities.
• Implement contractual clauses to enable you to get the information you
need from suppliers, as inputs to your IT
• Create and issue a business requirements document for the IT to support
declaration
• Agree the concept design
• Agree the detailed design
• Go live on the IT
89
Substances used in Products
and Processes
All substances
Substances that
150,000 meet the SVHC criteria
3,500
Registry of Intent
7 current
16 previous Candidate List
15
Priority CL
7
Annex XIV
Annex XVII:
Restricted
92
Substances in our Products and Processes
All substances
Substances that
meet the SVHC criteria
Declarable Substances
SAE and ASD-STAN standard 9535 / 9536
Candidate List
Priority CL
Annex XIV
Annex XVII:
Relevant to Restricted
YOUR business
93
The Declarable Substances list
A compilation of all the substances that have been identified as being…
• CMRs category 1& 2 (annex 1 of directive 67-548 as amended) [CLP]
• Substances defined as vPvB or PBT (OSPAR* listed substances)
• Ozone Depleting Substances as defined by Montreal Protocol
• Persistent Organic Pollutants as defined by the Stockholm Convention,
etc.
• Substances listed within Annex XVII (restricted substances)
*OSlo/PARis Convention for the Protection of the Marine Environment of
the North East Atlantic
94
ACTIONS for everyone
ACTION POINTS
1. Up-to-date COSHH inventories
• CHECK that all substances / preparations you buy are supplied with an MSDS,
and check that it goes to your HSE people
• Are there people outside purchasing that have delegated authority to purchase
substances and preparations?
• How do you ensure these people get the MSDS to the HSE function?
• Tighten up these processes!
95
The Declarable Substances list
ACTION POINTS: How can you use this list?
2. Go through all your MSDS‟s for your facilities, and see which of the
substances on the declarable substances list you are using.
3. Repeat the exercise for MSDSs with material specifications and with
the non-metallic substances used to make your products.
4. If you assemble products, the component articles you buy may contain
SVHCs. You can either:
• Create a check list and ask your suppliers to confirm that none of the
substances on the list are within the product they supply
• Apply TR 9535 and TR 9536 in contracts. This will tell you
if there are SVHCs within the product.
96
The Declarable Substances list
ACTION POINTS: How can you use this list?
5. If you find a substance on the declarable substances list in
an MSDS, in a material spec or in a component you can:
• See if there is something safer out there
• See if the supplier is likely to reformulate the preparation
• See if it is a strategically important substance, which is a
significant risk to your business.
6. Create a business continuity plan for each of the
substances in each of the tradenames/specs /articles that is
strategically important to you.
97
REACH
QUESTIONS
98
REACH
ASD AIA JOINT APPROACH
TO MANAGING „SVHC‟ AND
CANDIDATE
LIST MATERIALS
(other presentation) 99
Tools for you to use…
Phased declaration List:
This list contains the most currently issued list of substances
known to be used in the sector. Issue 1 of this list (in your packs)
still contains a mixture of
Process A and B substances.
These are being split and declaration will only be against process
A substances in issue 2 of the list. The latest version can be
downloaded at…
www.asd-europe.org and click on the REACH link.
It is the recommendation from ASD-Europe‟s REACH group, that aerospace
and defence companies require their suppliers to declare any candidate list
substances in their articles (whole products and spareable items) immediately,
and that they develop the capability to declare against the process A list,
recognising that this list will be dynamic and will grow in length.
100
Tools for you to use…
The Declarable Substances Standards:
SAE AP 9535 and SAE ARP 9536 / ASD-STAN TR9353
/ TR9536
The standard comprises of 3 parts:
1. 9535 – This standard is intended to be used to require
declaration of substances present in articles supplied
to you.
• Suppliers can declare ALL the substances in the article
• Suppliers can declare whether the article contains any
of the substances listed.
2. 9536 – This explains how to do the declaration using
the spreadsheet form
3. The spreadsheet itself. 101
Tools for you to use…
Using 9535
• This standard can be called up in contracts,
and you can choose to require either the total
declaration or the declaration against the list
• The next version of this standard will enable
you to choose declaration against the
candidate list or against the process A list.
• Both the candidate list and the process A list
will change, and suppliers will be expected to
always declare against the latest version at the
time of supply.
• It will be important for suppliers to have
systems in place to accommodate this in their
declarations. 102
Tools for you to use…
Using the spreadsheet
The spreadsheet currently contains the Declarable Substances
list, which at the time of issue, was the best estimate that the
sector had, of substances that could one day be declared
„substances of very high concern‟.
• This list can be used as a searchable list to check the MSDS
you have in your own facilities. If you have any of these
„high risk‟ substances in preparations / mixtures that are
business critical, you may wish to consider managing the
business risk associated with continued use.
• You can use the same list to check materials specifications
called up in designs, to see if you have any articles that
contain high risk substances. If you do, you may wish to
consider the business risk and your development strategies
for new uses of these materials.
103
Tools for you to use…
The SBAC and ASD-Europe REACH groups:
Groups exist for you to join, to help you with advice and to put you
in touch with other companies using the same at-risk substance.
• In the first instance, if you have a use of a priority candidate
list substance that is safety critical, you should contact SBAC
who will put you in touch with ASD-Europe‟s group for the
substance. SBAC: kevin.morris@sbac.co.uk or
anthony.burn@sbac.co.uk
• You can also ask technical REACH questions and they will try
to help you or put you in contact with an appropriate expert.
• You can join the SBAC REACH group, and benefit directly
from the experience around the table (contact Kevin / Anthony
for details). ASD also has a REACH group comprising of
trade associations like SBAC and large OEMs.
104
Tools for you to use…
Work of the SBAC REACH group:
• Seeking approval and informing members of progress
at the ASD – Europe level.
• Sharing best practice amongst the group at meetings
• Input into SBAC lobbying activities and consultations
in relation to REACH and other chemical regulations.
• Producing useful guidance and advice on the website
www.sbac.co.uk/reach
• Organizing these workshops
• Acting as a „hub‟ for companies wishing to seek
funding for the development of technical alternatives
for high risk substances where the project can best
be done at a national level (for example, using BERR
technology program funding)
105
Tools for you to use…
Work of the ASD-Europe group:
• Creating tools like the REACH implementation
working guidelines and annexes (in your packs).
• Together with AIA in the US, creating the 9535 and
9536 standards on materials declaration
• Recognised stakeholder to the European Chemicals
Agency
• Lobbying and influencing developments on REACH,
CLP and other chemicals regulations with the EC and
European Parliament
• Acting as a “hub” for companies interested in seeking
EU funding („LIFE‟ or Framework 7 & 8) into technical
alternatives to high risk substances, particularly those
on the candidate list
106
Official sources of guidance
and advice
ECHA WEBSITE:
http://ec.europa.eu/echa/home_en.html
European Commission:
http://ecb.jrc.it/reach/
DEFRA:
http://www.defra.gov.uk/corporate/consult/reach-
enforce/index.htm
HSE: THE UK „Competent Authority‟:
0845 408 9575
UKREACHCA@hse.gsi.gov.uk
107
Other sources of guidance and
advice
http://www.reachready.co.uk
General Manufacturing Industry:
http://www.orgalime.org/publications/guides/reach.htm
Aviation/Automotive Industry:
http://www.asd-europe.org/Content/Default.asp?PageID=41
http://www.sbac.co.uk/reach
Chemicals Industry:
http://www.reachcentrum.org/
Coatings Industry:
http://www.coatings.org.uk and search on OutREACH
Metals Industry:
108
REACH
QUESTIONS
109
REACH
LUNCH
110
REACH
PRESENTATION
BY THE REGULATOR
111
REACH
AFTER LUNCH WORKSHOP:
REACH Programme Management
112
Decision points for senior managers
1. If you lost a substance, preparation or article (it is no longer
supplied to you) – Do you care?
• Will your senior managers provide the resources to manage the
strategically important substances?
2. Are there any products in your portfolio that you will cease to
produce because of REACH / CLP?
• Will your senior managers authorise the spend necessary to make
your products comply with CLP and REACH?
– SUBSTANCES and MIXTURES
– ARTICLES / PARTS / PRODUCTS
Most distributors and stockists who are importers ARE UNAWARE
OF THEIR OBLIGATIONS (according to UK HSE & DEFRA). Many 113
smaller stockists intend to stop supplying, because of the costs!!
Assessing where you are at…
For stuff you supply – have you got enough
information:
1. SUBSTANCES / MIXTURES:
• a compliant MSDS for the chemicals you supply
• Labelling information for packaging
• How you and your customers use each substance,
so that your uses will continue to be legal
2. ARTICLES:
• information about safe use and 0.1%w/w of
candidate list substances for REACH
• Labelling requirements for articles packaging
Most distributors and stockists who are importers ARE UNAWARE
OF THEIR OBLIGATIONS (according to UK HSE & DEFRA). Many 114
smaller stockists intend to stop supplying, because of the costs!!
ACTION POINTS
1. Inform senior managers about REACH and the risks it
poses. Get them to appoint someone to manage it.
2. Hold a workshop inside your company, looking at REACH.
How to run the workshop – see the „REACH Checklist‟
handout
3. Start building a plan to manage REACH
4. Ask your supplier if they (OR THEIR UPSTREAM
SUPPLY CHAIN) pre-registered AND if they intend to
REGISTER the substances (or the substances within
the preparations) that they supply to you.
115
ACTION POINTS
5. Create an Inventory of all the substances you use
• In preparations in your facilities
• In articles you fabricate yourself
• Start to consider the best way to collect the
information for the composition of substances
within the articles you buy.
– IT tool? Spreadsheet?
116
ACTION POINTS
6. Decide on a course of action for each „At risk‟
substance, preparation or article.
You can:
• Trust your supplier to take care of you
• Try to find other suppliers in the EU who will take care of
you
• Find the best person in your company to look into
alternatives, and to look for others in the same sector who
may be in the same boat, and willing to work with you.
• If you are an SME, Discuss it with your customer, who
may already be working on the same problem.
117
ACTION POINTS:
Authorisation
7. For these substances on the candidate list or registry of
intent, identify ALL your uses of these substances
• In your product
• In your process chemicals
• In any quantity
• Whether there by accident or by design.
118
Action Points:
Authorisation
8. For each use of each substance, collect together any / all
occupational hygiene, health surveillance, toxicological data
and claims data.
9. Are any of these uses or candidate list substances,
“substances of strategic importance” to your business?
• Is there a safer alternative you can use instead?
• Will changing to the alternative be cost-prohibitive to your
business (watch your margins!)
• How long will it take your business to adapt to life without the
substance?
119
Action Points:
Authorisation
10. Does the substance have a threshold value, below which it
is considered „safe‟?
• With a Threshold: you can prove you are using it
safely, and write a substitution plan to develop and
use alternatives
• Without a Threshold: you need to prove using a
„Socio-Economic Analysis‟ that it is essential to be
able to continue to use the substance.
11. A problem shared? Can you collaborate to share R&D
costs when proving alternatives will be OK?
Actions for Everyone: Planning
Step Milestones for Activities
1 All level 3 plans (site level) rolled out and governance in place
2 a) Pre-Registration complete
b) Registration complete
3 a) Inventory of all preparations used and their manufacturing use code
b) Inform our suppliers of preparations of our uses
c) Continuity plans for all key preparations with substances on the
Declarable Substance List
4 Authorisation - awaiting clarification of legislation
5 Agreed concept for all businesses to comply with Declaration (art. 33)
6 a) Continuity plans for all substances in Articles which are also on the
Declarable Substance List
b) First candidate list:
c) Continuity plans for all substances in Articles which are also on the
Candidate List
7 Communication completed to all internally affected areas
8 New Quality Procedures issued and implemented
Actions for Everyone: Planning
REACH level 1 Milestone Plan
2008 2009
Section Activity A M J J A S O N D J F M A M J J A
All level 3 plans (site level) rolled out and governance in
1 place
Pre-Registration complete
2
Registration complete
Inventory of all preparations used and their
manufacturing use code
3 Inform our suppliers of preparations of our uses
Contiunuity plans for all key preparations with
substances on the Declarable Substance List
4 Authorisation - awaiting clarification of legislation
Agreed concept for all businesses to comply with
5 Declaration (article 33)
Continuity plans for all substances in Articles which are
also on the Declarable Substance List
6 Receive first candidate list
Continuity plans for all substances in Articles which are
also on the Candidate List
Communication completed to all internally affected
7 areas
8 New GQPs issued and implemeted
Actions for Everyone: Planning
REACH Milestone Chart Legal Entity :
V2 Last Updated : Plan Owner :
Step and Status
Activities Lead Support
Apr May
Status Status
REACH Programme
plan
1.1 Define Point of Contact for legal entity REACH Exec Exec Team
actual
plan
1.2 Define scope of legal entity POC
1 1.3 Hold initial workshop POC Exec Team
actual
plan
actual
plan
1.4 Governance of Actions POC REACH PM
actual
Pre-Registration and Registration
plan
2.1 Determine any Articles with intended release Engineering
actual
plan
2.2 Determine what needs to be pre-registered (incl. analysis of imports) POC Procurement
actual
2 2.3 Determine how it will be preregistered (self, own rep etc) POC Procurement
plan
actual
plan
2.4 Complete Pre - registration Corp HSE POC
actual
plan
2.5 Complete registration Substance Owner As required
actual
Business Risk from Preparations
Collate inventory of Substances and Preparations used in RR facility to plan
3.1 manufacture product
Local HSE Local Lab
actual
plan
3.2 Categorise the manufacturing use of each preparation (as defined by RIP3.2.2) Local Lab Local HSE
actual
plan
3.3 Inform suppliers of our uses and request that this use will be registered Procurement
actual
plan
3.4 Analyse the Safety Data Sheets for substances also on the DSL Local HSE Corp HSE
actual
3 3.5 Contiunuity plans for substances in Safety Data Sheets and in DSL Substance Owners Local lab
plan
actual
plan
3.6 Risk Analysis of preparation suppliers and mitigation actions Procurement
REACH
QUESTIONS
125
REACH
AFTER LUNCH DISCUSSION:
REACH Defence Exemption issues
126
REACH – The Legal Overview
Supply Chain and manufacturing use of Substances Authorisation
Registration to use in specific
Evaluation application
Pre-registration
Manufacturer / Pre Registrants to submit of
By ECHA.
Importer of substances into Safety Assessment for
For several substances
EU >1 tonne/year each specific use of
this may already exist
substance to ECHA Restriction
Substances of Very High Concern
Declaring Substances of Very High Concern in Articles to customers and ECHA
0.1% of SVHCs 0.1% of SVHCs Defence Agency
Supplier In Articles Defence Supplier In Articles and ECHA
Defence Exemption in REACH
1) REACH applies in its entirety to all defence
products through registration of all the
substances that they are made from.
2) A Defence Exemption has to be created in
the law of a Member State to manage the
Defence Security and Operational Capability
issues compromised by REACH.
3) Defence Exemptions have been included in
REACH to help the Defence Agencies
maintain security and capability – not to
help industry ignore REACH.
Defence Exemption in REACH
When could a Defence Exemption be used?
•Where a material (Preparation) is classified
•Where the use of a material is classified
•Where other legislation prevents supply of data to support
REACH (e.g. International Traffic in Arms Regulations)
•Where the use of a SVHC is classified
•Where the defence uses of a materials is Authorised or
Restricted
•Where defence related PPORD is classified
REACH – The Legal Overview
Supply Chain and manufacturing use of Substances Authorisation
Registration to use in specific
Evaluation application
Pre-registration
Manufacturer / Pre Registrants to submit of
By ECHA.
Importer of substances into Safety Assessment for
For several substances
EU >1 tonne/year each specific use of
this may already exist
substance to ECHA Restriction
Substances of Very High Concern
Declaring Substances of Very High Concern in Articles to customers and ECHA
0.1% of SVHCs 0.1% of SVHCs Defence Agency
Supplier In Articles Defence Supplier In Articles and ECHA
UK MoD Defence Exemption
UK MoD foremost in preparing a system for Defence
Exemptions in EU
Defence Exemption introduced into UK Law in 2008
Status for Applications
Pre-registration Complete
Registration To start – Draft process in place
PPORD Process under discussion
Authorisation Process under discussion
Restriction* Process under discussion
Notification Process under discussion
*MoD policy is to restrict material uses where EChA introduces
them, where capability is not compromised.
Defence Exemption in REACH
The UK defence exemption does not allow suppliers to
defence agencies to ignore REACH.
The material or use must be classified, or capability
compromised for MoD to provide Defence Exemption.
It provides a mechanism for compliance that will:
•Enable secrets to be kept secret
•Enable products in the field to remain operational
•Still permit the phasing out of „Substances of Very
High Concern‟
Security & Collaborative Projects
Concerns : Defence Collaborative Projects
1) Collaborative Projects between Member States
a) Not all have Defence Exemptions.
• Defence Collaborative Projects prejudiced –
security implications
b) Variation in Defence Exemption Frameworks
• Issues in workability – concerns on security.
2) Collaborative Projects outside the EU
a) Vital to the viability of the defence sector.
b) Compromised if defence suppliers are unable to
source non-EU classified defence materiel.
Business Risks and REACH
Industry concerns
1) When an SVHC requires authorisation or restriction it
will be lost to mainstream use, and difficult to source
for Defence use.
2) Materiel substitution for defence products difficult &
time consuming.
a) Harsh operational environment
b) Re-qualification requirements
3) The UK Chemical Industries Association believes
registration for significant numbers of existing
substances will not be economically viable (regardless
as to whether the substance is hazardous or not).
Defence Exemptions in the EU
Member state Status
Denmark No progress
Finland Realisation of need
Germany Designated agency, no legislation
France Designated agency, no legislation
Spain Designated agency, no legislation
Greece Designated agency, no legislation
Italy Designated agency, legislation, but no actual
exemptions in process
Netherlands Designated agency, legislation, but exemptions in
process, weaknesses
UK Designated agency, legislation, but exemptions in
process, weaknesses being addressed
SBAC view on Defence Exemptions
A Defence Exemption in all Member States
is needed to ensure the long term
maintenance of existing defence assets and
battlefield capability.
• The Defence Exemption should have common
framework in all Member States.
• A Defence Exemption raised by one Member
State should be recognised as such in all
others.
• The Defence Exemption needs to ensure that
classified information from any country (inside
and outside the EU) is respected and not
disclosed to others.
ACTION at EU level
Moves are being made to raise the awareness of
the issue at ASD-Europe (the EU level trade
association for our sector).
Actions:
• You can get involved with other EU Defence businesses
who are affected by the exemption (or lack of
exemption).
• Businesses can support ASD and SBAC in lobbying
member states to enact their own defence exemption in
line with our position, and to encourage the European
Defence Agency to play a part.
• The group can advise the UK MoD and other MoDs in
the future direction of the exemption, with respect to
ITAR interpretation, Authorisation and Restriction
exemptions – which are still not addressed adequately.
REACH
QUESTIONS
138
REACH
AFTER LUNCH DISCUSSION:
REACH and the CLP regulations
139
REACH – legal overview with COSHH and MSDS
Supply Chain and manufacturing use of Substances Authorisation
Registration to use in specific
Evaluation application
Pre-registration
Pre Registrants to submit
By ECHA.
Import substances into EU Safety Assessment for
For several substances
>1tonne/year each specific use of
this may already exist
substance Restriction
MSDS: COSHH
Risk Assessments
Legally Enforceable
„Risk Management Measures‟
Compliant technical controls (LEV), PPE etc.
140
CLP Regulations:
Harmonisation of classification
• Suppliers of products containing
Carcinogens, mutagens and reproductive
toxins (CMRs) at category 1A, 1B or 2, or
sensitisers (category 1) will be subject to
HARMONISED Classification and Labelling
according to the GHS. Packaging has to be
marked accordingly.
• For these substances, the supplier MUST
use the classification laid down in the CLP
regulations and cannot use their own
interpretation.
• This will apply to any supplier in any country
applying the GHS.
141
CLP – legal overview
Supply Chain and manufacturing use of Substances Authorisation
Registration to use in specific
Evaluation application
Pre-registration
Pre Registrants to submit
By ECHA.
Import substances into EU Safety Assessment for
For several substances
>1tonne/year each specific use of
this may already exist
substance Restriction
US information
EU information
UN Consensus on
Classification
Canadian information
For substance
Chinese information
Classification
Japanese information
Added in GHS,
Australian information published by UN, and
added to the EU‟s
Korean information
CLP Regs. 142
CLASSIFICATION: CLP and GHS regulations
• GHS AND CLP:
• Flammable, explosive, oxidising
• Carcinogenic, Mutagenic, Reprotoxin
• Toxic (acute, chronic), specific organ
• Corrosive, irritant
• Respiratory / skin sensitizer
• Environmental (aquatic)
• CLP only:
• Persistant Organic Pollutants (POPs), ozone
depletants, vPvBs, PBTs. 143
LABELLING: CLP and GHS regulations –
• Results in consistent labelling for supply, use and
transportation of chemicals.
• Labelling requirements include:
• Name, address and telephone no. of supplier
• The name as given in the CLP list of harmonised
substances, or if it is not listed, the „IUPAC‟ Name of
the product
• The CAS number(s), the product code and quantity
• The specified signal word („danger‟), the hazard
statement as required by the classification, the
associated pictogram, and precautionary statements.
• These are NOT the same as R and S codes, but have
the same basic purpose. 144
PACKAGING: CLP and GHS regulations –
• Contents cannot escape
• Contents will not damage / degrade the packaging
• No hazardous products will be formed from interaction
between contents and packaging
• The packaging label will have all the „labelling‟
information clearly visible
• Information has to be shown on each packaging layer
(unless the packaging is seethrough)
• Some specific hazard phrases may have to be added to
packaging if the risk is specifically to do with transport.
• If the product is sold to the general public, there has to
be a tactile warning added.
145
CLP regulations legal overview
Producing MSDS in accordance with REACH and CLP Regulations
Manufacture or Hazardous
NO LIMIT ON NOTIFY ECHA so
formulation of a QUANTITY Substances on their
own or in mixtures
gets included in
substance or SUPPLIED
the inventory
preparation / mixture
Identify ALL
relevant
toxicological
information and PROVIDE the
Manufacture of an uses information: MSDS
ARTICLE with a CLASSIFY the CLASSIFIED
substance intended to substance in Substances (GHS)
accordance with Restricted substances
be released, or and SVHCs are
containing an SVHC, GHS
1 tonne limit declared LABEL the
or where ECHA asks p.a. packaging using
for registration / GHS symbols,
notification of a hazard statements
substance in an article etc.
CUSTOMER INFORMS OF
NEW USE
REACH
Authorisation
Pre-registration Registration Evaluation
Restriction
146
REACH “Substances of Very
High Concern” Labelling in
GHS / CLP
• Carcinogens, mutagens and
reproductive toxins (CMRs)
• Persistent, Biocumulative and Toxic (PBT)
• THERE ARE CURRENTLY NO LABELS for very persistent
and very bioaccumulative (vPvB) or for many substances of
equivalent concern in GHS, CLP or in the rules for the
transport of dangerous goods.
147
The positive outcomes of REACH
and the CLP regulations
REACH will have BENEFITS for human health, and the
environment because some really hazardous chemicals in use
will not be allowed in future.
• More information will be available about the hazards and how
to manage them (on the MSDS)
• Greater consistency in classification and labelling for the
same product supplied from all round the world
• Most risk assessments will be easier to put together and to
audit against – Users are required to follow the Risk
Management Measures on the MSDS
148
REACH
QUESTIONS
149
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