1. Plasticisers An update from ECPI PVC Network Meeting Ostend June 17 2008 Tim Edgar

2. www.ecpi.org 2 ECPI Update  ECPI Secretariat  EU Risk Assessments  REACH and REACH Preparation  Plasticiser Issues –Medical –Pyjamas –Toys –Shower curtains –Danish school supplies –RoHS Directive –Game consoles  ECPI Communications

3. www.ecpi.org 3 ECPI Secretariat  Dr Marie-Amélie Paul –Joined ECPI from ExxonMobil on 1 June 2008 –PhD in polymer chemistry –Masters in Biochemistry –Diploma in materials science

4. www.ecpi.org 4 EU risk assessments  DEHP –Final consolidated version of the risk assessment (environment and human health) published online on June 6 2008 Downloadable from the DEHP Information Centre website (www.dehp-facts.com)www.dehp-facts.com –Nothing new: risk assessment / risk reduction summaries published in the EU Official Journal in February 2008 ECPI PVC Network presentation of February 12 2008

5. www.ecpi.org 5 EU risk assessments  BBP –Final consolidated version of the risk assessment (environment and human health) published online on 22 February 2008 Downloadable from the BBP Information Centre website (www.bbp-facts.com)www.bbp-facts.com –Risk assessment / risk reduction summaries published in the EU Official Journal 14 June 2008 Requirement for fish study already completed – no concerns Similar measures as for DEHP to be put in place with regard to emissions from plants: –Use will be forbidden unless there are adequate emission controls

6. www.ecpi.org 6 REACH  Pre-registration began on June 1 –The major phthalates have already been pre-registered –Registration has to be completed before December 2010  Phthalates are among the best prepared substances –They already have most of the data required  REACH consortia –DEHP and 2-EH –DINP –Phthalic anhydride

7. www.ecpi.org 7 REACH  REACH Communication –Ensuring that downstream customers and users are aware that all the main phthalates are well-prepared for REACH DINP/DIDP = Registration DEHP = Registration and authorisation –Addressing the concerns of retailers and brand-owners Article 33: Requirement to provide information within 45 days on substances on the Candidate List Deselection –Addressing the concerns of customers Substitution –Ensuring that DINP / DIDP are not captured as substances of equivalent concern

8. www.ecpi.org 8 REACH

9. www.ecpi.org 9 REACH

10. www.ecpi.org 10 REACH

11. www.ecpi.org 11 REACH  The Candidate List –“Substances of very high concern” which will eventually go forward for authorisation Includes CMR substances such as DEHP, DBP and BBP –Member State proposals / dossiers by June 7 Sweden = DEHP / Austria = DBP and BBP –Vote by member states (must be unanimous) in October –Publication of Candidate List on ECHA website expected on January 14 2009 –First priority list for authorisation (10 substances) before 1 June 2009 – Full timetable available on the ECPI Extranet

12. www.ecpi.org 12 REACH  NGO Shadow candidate list –NGOs will publish their own version of a REACH Priority List at a substitution conference September 17 Organised by ChemSec, the NGO-funded International Chemical Secretariat  Cefic Substitution conference for retailers and brand owners –September 30 2008 –Being organised by Cornelia Tietz cti@cefic.be +32 2 676 7249

13. www.ecpi.org 13 Plasticiser issues  Medical devices –Opinion of the Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR) Published in March –Amendment to the EU Medical Devices Directive: Requirement to label devices containing “CMR phthalates” from 2010

14. www.ecpi.org 14 Plasticiser Issues  SCENIHR Opinion –“… there is limited evidence suggesting a relation between DEHP exposure and some effects in humans" –“… there is no conclusive scientific evidence that DEHP exposure via medical treatments has harmful effects in humans", –“Even in the absence of clinical or epidemiological evidence for harmful effects in humans there is a reason for some concern for prematurely born male neonates for which the DEHP exposure may be transiently above the dose inducing reproductive toxicity in animal studies". Also male foetuses and male infants of pregnant women or lactating mothers exposed to DEHP Patients who undergo frequent or very large blood transfusions

15. www.ecpi.org 15 Plasticiser Issues  SCENIHR Opinion (continued) –Eight alternatives were considered Some: “could not be properly evaluated due to lack of data..” Some: “could be suitable to replace DEHP in certain medical devices" Others: "it may be difficult to achieve the same functionality as for PVC plasticised with DEHP" –SCENIHR clearly stated: "the risk and benefit should be carefully evaluated according to established protocols, for each individual medical device and each medical procedure in which the alternatives are intended to be used".

16. www.ecpi.org 16 Plasticiser Issues  Medical Devices Directive - Amendment –In 2007, EU institutions agreed to the labelling of medical devices containing phthalates with hazard classification Medical device manufacturers will have to justify use in applications for children or pregnant women in technical documentation EU to mandate European standardisation body (CEN) to establish standard (by October 2008) –Mid-2010 – Medical devices industry to comply with labelling provisions End 2011 – Harmonised standard likely to be completed

17. www.ecpi.org 17 Plasticiser Issues  Medical Devices Directive – Amendment (continued) –ECPI has held meetings with the medical device industry and participated in an exploratory Commission meeting at the end of April. –We have proposed (with the support of the medical device industry) a circle containing two numbers 3.2 (3 for PVC and 2 for Repro Category 2) or 3.1 (3 is PVC and 1 is category 1A (old Cat. 1) or 1B (old Cat. 2) under the globally harmonised system (GHS) –The code in a circle eliminates the need for translation and avoids any specific mention of PVC, DEHP or phthalates. 3.1

18. www.ecpi.org 18 Plasticiser issues  Pyjamas –Test Achat (Belgium): Report on Toxic pyjamas (March 2008) –Not a new issue November 2003: Greenpeace pyjama campaign in the UK August 2004: ECPI and ECVM held joint discussions with Disney in London. US PEP also held discussions with Disney. –Question raised in European Parliament Belgian EPP MEP Frieda Brepoels –We continue to monitor …

19. www.ecpi.org 19 Plasticiser issues  Phthalates in toys –Still remain under a great deal of pressure in the US Californian restrictions come into force from January 2009 Several other State and Federal bills being introduced –In Europe The revision of the Toys Safety Directive is highlighting the issue again All CMR substances to be banned which brings other substances in line with DEHP, DBP and BBP

20. www.ecpi.org 20 Plasticiser issues  Shower curtains –Another example of activist driven paranoia. –Produced by the Center for Health, Environment and Justice Failed to detect phthalates when tested for offgassing Conceded that they didn’t know whether lead or mercury could migrate from the curtains in a way that someone might absorb them –Vinyl Institute has responded –ECPI will make more information available related to phthalates

21. www.ecpi.org 21 Plasticiser issues  Danish school supplies –Danish request to extend toy ban to school equipment –Two Danish EPA studies conducted: One focussed on DEHP but including some information on DINP, DIBP and DBP The other on DINP – found in erasers –Referred to the EU Scientific Committee on Health and Environmental Risks (SCHER) –ECPI pointed out the EU Risk Assessments have taken into account potential exposure from school wear/equipment

22. www.ecpi.org 22 Plasticiser issues  Breast cancer –Report by the Centre for Toxicology at the school of Pharmacy, University of London suggested a link between phthalates and breast cancer –Presentation to MEPs –There is no evidence that phthalates cause breast cancer or contribute to the disease –For more information please see ECPI Extranet (carcinogenicity) ECPI Extranet

23. www.ecpi.org 23 Plasticiser issues  RoHS Directive –Restriction of the Use of certain Hazardous Substances in Electrical and Electronic Equipment Lead, mercury, cadmium, brominated flame retardants have to be substituted in equipment put on the market since July 1 2006. –To be revised in 2008 –Additional substances added –Two new categories (medical devices and monitoring and control equipment)

24. www.ecpi.org 24 Plasticiser issues  RoHS Directive (continued) –Sweden formally asked the Commission to evaluate whether DEHP should be included. –The German Öko-Institut still includes DEHP in its recommendations –The use of DEHP in such applications is small but as this is a legislative procedure (involving Parliament and Council) it is likely to draw further attention to DEHP and phthalates

25. www.ecpi.org 25 Plasticiser issues  Phthalates in game consoles –Greenpeace Report “Playing Dirty” –Sony's PlayStation 3, Nintendo's Wii and Microsoft's Xbox 360 consoles tested and found they all contained “hazardous chemicals and materials” such as “PVC, phthalates, beryllium and bromine.” –All three companies defended their products, saying they complied with environmental standards

26. www.ecpi.org 26 General ECPI Communications  Plasticiser workshop for regulators –Five participants from DG Enterprise and DG SANCO Policy and Assistant Policy Officers –Presentations on plasticisers and the benefits of flexible PVC, REACH, Regulations, and a laboratory demonstration –Other workshops to be considered for the future MEPs National Authorities Retailers/Brand holders

27. www.ecpi.org 27 General ECPI Communications  ECPI Inform Newsletter –Issue 14 published at the end of May 2008 –Ideas / content for issue 15 now being sought –Issue 15 will be published in October / November

28. www.ecpi.org 28 General ECPI Communications  ECPI websites –New DINP Information Centre website is now live –New DEHP Information Centre website and new ECPI website are under construction –New DPHP website will be constructed this summer