1. Chemicals Policy Area Up-date
Peter Korytár
European Commission – DG Environment – Unit D3
Brussels, 25 June 2010

2. Content Revision of Annex XIII of REACH (PBT criteria)
Overlaps between REACH and other EU legislation
Activities related to Mixture Toxicity
Activities under Community Strategy on Endocrine Disruptors
POPs 2

3. Annex XIII of REACH
Proposal for a revision of Annex XIII on criteria for identification of PBTs and vPvBs
Discussion and vote on the proposal foreseen for September 2010
The Commission adoption foreseen at the beginning of 2011 3

4. Annex XIII of REACH It keeps the numeric cut-off values
It allows ‘weigh of evidence approach’
It indicates information that could be used to assess PBT properties
Very close to current ECHA guidance
It sets out PBT screening criteria to clarify implementation of Annex I
Entry into force 3 days after publication and apply 2 years thereafter
Industry has 2 years to update their existing reg. dossiers 4

5. REACH Scope Review Article 138(6) of REACH
“By June 2012 the Commission shall carry out a review to assess whether or not to amend the scope of this Regulation to avoid overlaps with other relevant Community provisions. On the basis of that review, the Commission may, if appropriate, present a legislative proposal.” 5

6. REACH Scope Review Key elements of the review: tasks by the contractor
Perform an analysis of all the relevant sectoral Community legislation
Compare the elements analysed with those of REACH
Assess mechanisms to avoid double regulation
Identify gaps and give recommendations.
Timing
Contract signed December 2009; ends August 2011
Commission to finalise review by 1 June 2012 6

7. REACH Scope Review
A website was set up to collect input from stakeholders on identification of gaps, overlaps and synergies of the scope of REACH
Launched in March 2010
Active until December 2010 7

8. Mixture toxicity A state of the Art report on mixture toxicity
Finalized at the end of 2009
Published on DG ENV website – comments received until end of April
Request for opinion submitted to Scientific Committees – expected in March 2011
Beginning of 2012 – Commission to submit a report to Council on the way combination effects are dealt with together with suggestions for actions/initiatives
Workshop to discuss the report held on June 2010 8

9. Mixture toxicity Workshop conclusions:
Clear experimental evidence of mixture effects
The issue of mixture toxicity should be addressed in the context of chemicals risk assessment in the EU
Issue should be addressed not only in product and chemicals legislation, but also in WFD, Marine Strategy Directive, IPPC, Atmospheric pollution Framework Directive
Conceptual framework for estimating the toxicity of mixtures exists – concept of dose addition and independent action 9

10. Mixture toxicity Workshop conclusions:
Challenge is target when assessment of mixture effects are necessary. Prioritization is necessary - potential combinations are huge and resources limited. Some tools are available.
Further research would help to refine approaches
Need to use existing monitoring data more effectively – concept of data centre (water, air, soil, food, products, etc)
Challenge of how to get an integrated approach across different pieces of legislation
Challenge of liability. Who is liable for effects – random association of products 10

11. Endocrine disruptors REACH Article 138(7)
By 1 June 2013 the Commission shall carry out a review to assess whether or not, taking into account latest developments in scientific knowledge, to extend the scope of Article 60 (3) (socio-economic route) to substances identified under Article 57 (f) as having endocrine disrupting properties. On the basis of that review the Commission may, if appropriate, present legislative proposal
Plant Protection Product Regulation
Within four year from the entry into force of this Regulation, the Commission shall present to the Committee referred to in Article 79 (1) a draft of the measures concerning specific scientific criteria for the determination of endocrine disrupting properties to be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 79 (4) 11

12. Endocrine disruptors
Contract ‘State-of-the-art of the assessment of endocrine disrupters’
Signed in December 2009; Ends August 2011
The contractor is expected to
Task 1: Analyze scientific literature on endocrine disrupters
Task 2: Analyze approaches to assess endocrine disrupters
Task 3: Draw conclusions and answering policy relevant question 12

13. Endocrine disruptors Contract deliverables
Scientific review of the state-of the art – December 2010
Overview of assessment methodologies and initiatives – December 2010
Draft Final report – June 2011
Final report – August 2011
Consultations of final report with ECHA, EFSA, EMEA, Scientific Committees, OECD – June 2011 13

14. Endocrine disruptors OECD (6 tests methods adopted)
Uterotrophic Bioassay in Rodents: A short-term screening test for oestrogenic properties
Repeated Dose 28-Day Oral Toxicity Study in Rodents
The Stably Transfected Human Estrogen Receptor-α Transcriptional Activation Assay for Detection of Estrogenic Agonist-Activity of Chemicals
The 21-day Fish Assay: A short-term screening for endocrine or reproductive activity
The Hershberger Bioassay in rats: a short term test for (anti)androgenic properties
The Amphibian Metamorphosis Assay
OECD EDTA AG – guidance development for assessment of EDC 14

15. Endocrine disruptors Priority list of substances
Transfer of the database to DG JRC
Change of format and creation of web portal access
Mechanism for updating, further content, functionalities of the information system need to be decided
It should serve to all stakeholders (EC, MSs, ECHA, EFSA, EEA, NGOs, Industry, Scientists)
It should become a living database/information system 15

16. POPs COP-4 of Stockholm Convention (May 2009)
- and -hexachlorocyclohexane, chlordecone, hexabromobiphenyl, tetra-, penta-, hexa- and hepta-BDEs, lindane, pentachlorobenzene, PFOS
EB of LRTAP Convention (December 2009)
Hexachlorocyclohexanes, tetra-, penta-, hexa- and hepta-BDEs, hexachlorobutadien, pentachlorobenzene, PFOS, PCNs and SCCPs 16

17. POPs POP Regulation (850/2004)
Commission prepared proposal for amendment of Annexes to implement COP – 4 decisions
Positive vote by the Committee in April 2010
The proposal was sent to the Parliament and Council for scrutiny
Adoption by the Commission expected in the second half of the year
Need for delisting of PFOS and PBDEs from Annex XVII of REACH 17

18. http://ec.europa.eu/environment/ European Commission