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PlasticisersAn update from ECPI
PVC Network MeetingOstendJune 17 2008
Tim Edgar
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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
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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
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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)
– Nothing new: risk assessment / risk reduction summaries published in the EU Official Journal in February 2008
• ECPI PVC Network presentation of February 12 2008
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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)
– 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
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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
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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
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REACH
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REACH
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REACH
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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
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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
• +32 2 676 7249
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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
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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
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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".
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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
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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
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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 …
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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
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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
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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
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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)
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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)
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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
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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
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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
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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
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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
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