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					European Commission Enterprise and Industry Directorate-General

European Commission workshop on RIP 3 Development of REACH Guidance for Industry
Brussels, 25 September 2006

Brief outline of timelines and obligations of industry under REACH
Otto Linher DG ENTR / G1 - REACH

Will we reach REACH?
ð REACH is a considerable challenge ð It covers a very wide range of issues and substances ð How can guidance help companies?
ð Companies will look for simple guidance ð Companies will ask us to cover their specific issues in sufficient detail

26/09/2006

2.

How can we reach REACH?
ð Simple guidance needs to be available
ðfor those with limited experience and capacities (normally also those with limited obligations under REACH) ðto give an overview for more experienced users

ð In addition, detailed guidance need to be provided
ðfor those who have more substantial obligations ðfor those who need specific information

26/09/2006

3.

HOW can you reach REACH?
Key steps: § Start today with analysing your portfolio of chemicals! § Check the scope of obligations § Identify your role and tasks under REACH § By when do tasks have to be fulfilled?
26/09/2006 4.

Scope of obligations
ð REACH applies to the manufacturing, import, placing on the market and use of substances § However, there are exemptions for certain:
§ Substances § Uses of substances

§ Reduced obligations for research, product and process related research and development (PPORD) and intermediates
26/09/2006 5.

Downstream users: Obligations
ð Downstream users are users of chemical substances that are neither produced nor imported by the company ð Be careful not to overlook that you also may be an importer!
u

Key question: Do you receive Safety Data Sheets?
ð If no:
only very limited obligations under REACH

ð If yes:
apply the risk management measures identified in the SDS

26/09/2006

6.

Downstream users: Rights
u

DUs have the right:
v

To make their uses known to manufacturers/importers To carry out their own CSA (e.g. for confidentiality reasons) To contribute to SIEFs

v

v

26/09/2006

7.

Manufacturers/Importers: Registration
§ Registration for all substances >1 t § Chemical Safety Report (CSR) for all substances >10 t ð In the absence of available information, tests may have to be conducted
ð Data sharing (in particular for vertebrate tests) ð Substance Information Exchange Fora (SIEFs)

26/09/2006

8.

Manufacturers/Importers : Registration
§ Timetable:
v

Non phase-in substances (neither in EINECS nor already registered): before a substance can be marketed Phase in substances: benefit from transition periods if preregistered
w

v

Pre-registration: 12 to 18 months after entry into force (except where newly produced/imported)
s s

Identify substance, manufacturer, tonnage band/deadline Agency will publish list

w

Registration: Transition period depending on the tonnage band

26/09/2006

9.

(Pre)Registration
Timeline REACH (not to scale)
Request Data SIEF December 2008

> 1t/a April 2018

Pre-registration PreApril 2008 – October 2008 EIF April 2007 EIO Agency April 2008

List + SIEF November 2008

>1000 t/a

Prepare testing strategies, CSA

CMR >1 t/a
aqu.tox.>100 t/a aqu.tox.>100

100 - 1000 t/a April 2013

April 2010

Reg ‘new’ subst. C&L notification (independent of tonnage)

26/09/2006

10.

Substances in articles
§ Registration required if:
§ Substance is intended to be released, and § Substance is present in quantities >1 t

§ Notification required if:
§ Substance is on candidate list for authorisation § Substance is present in quantities >1 t § Substance is present in concentration >0.1% by weight
(except where there is no exposure; at the earliest 42 months after entry into after force, or 6 months of identification of substance on candidate list) list)

26/09/2006

11.

Evaluation
§ Dossier evaluation: checking completeness and compliance of registration dossiers § Substance evaluation: checking whether further information is needed on a substance

26/09/2006

12.

Authorisation/Restriction
§ Authorisation: for substances of very high concern
§ Identification of SVHC § “Sunset date” by which manufacturing and use is only allowed if it is covered by an authorisation

§ Restriction: only minor changes compared to existing system
§ Also manufacturing covered § Wider range of possible measures

26/09/2006

13.

Will we reach REACH?
§ Most downstream users and SMEs will have limited obligations
ð Simple guidance will be available ð More information will come from manufacturers/importers

§ However, manufacturers/importers will have more significant obligations, depending on:
§ Hazards and risks of substances § Production volume ð Careful check needed to identify tasks and obligations ð Guidance will assist and can be used to look up details
26/09/2006 14.

European Commission Enterprise and Industry Directorate-General

ðThank you!
26/09/2006 15.


				
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