legislation feature | Understanding REACH
recommendations that may be used for the preparation of 2013 registration dossiers. Further clarifications may come this year from ECHA’s Board of Appeal as more decisions on compliance checks are made and ECHA’s position is deemed too conservative. The Board of Appeal is expected to hold against ECHA in the following proceedings: l ECHA’s decision requiring a 90-day repeated dose toxicity study on rabbits, by inhalation; and l ECHA’s decision rejecting a read-across approach between DMP and DMPA and requiring an in vitro gene mutation study on mammalian cells and a prenatal developmental toxicity study. Guidance on data sharing, registration, certain endpoints, and environmental and human hazards under the CLP (classification, labelling and packaging) Regulation are also under review this year.
2. Registration exemption for polymers All polymers are currently exempted from REACH registration, only the monomers must be registered. This exemption is currently being reviewed by the Commission, which commissioned Risk & Policy Analysts to conduct a study. The consultancy recently delivered a second interim report to the Commission and the final report is expected in July 2012. The question is whether criteria can be set to determine which polymers are potentially dangerous and should therefore be subjected to registration. How this issue is resolved will have a huge impact on the plastics industry. Revised guidance on polymers is also expected this
year. The updated document should, among other things, discuss the issue of unreacted monomers.
The new 2013 deadline applies to chemicals used in smaller quantities
3. Evaluation On the receiving end, ECHA is busy evaluating testing proposals and dossiers. It is legally required, by 1 December 2012, to check 5% of all registration dossiers and evaluate all testing proposals that were submitted by December 2010. According to its own Evaluation Report,
in 2011, it conducted 371 public consultations on testing proposals and 239 compliance checks. In addition, ECHA, having no competence to evaluate intermediate dossiers, has conducted so-called “verifications” of intermediate status in approximately 400 dossiers. Substance evaluation has also kicked in. The first
CoRAP, the list of substances subject to evaluation by Member States, was finalized in February. It currently contains 90 substances, including a few phthalates and bisphenol A. The schedule is for 36 substances to be assessed in 2012, a further 23 in 2013, and the remain- ing 31 in 2014. REACH regulates lightly how Member States should
evaluate these substances. There is, for example, no requirement to consult with stakeholders. The coming year will thus be important as Member States define their practice for the future.
4. Candidate List The Candidate List is relevant for plastics manufactur- ers because: (i) listing of a substance triggers an SDS (safety data sheet) requirement (of course, these substances are typically classified as hazardous and an SDS is thus already required before inclusion in the Candidate List); (ii) article suppliers are required to notify ECHA and inform their customers and consumers on the presence of these substances in their articles, and should therefore require that their plastics suppliers disclose the content of the plastic parts; and (iii) it is the first step before a substance is subjected to authorization. There was a political commitment to have 136
substances on the Candidate List by the end of 2012. This target is unlikely to be met; there are currently 73 substances on it, a single ongoing public consultation on a first batch of 13 substances, and little motivation from Member States to use extra efforts to close the gap by the end of the year. The Candidate List is updated twice a year. This year might also see the Member States and
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