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Understanding REACH | legislation feature


REACH: where do we stand and where are we going?


REACH has been in force for about four years and has become one of the most complex regulatory regimes in the world. For a number of reasons, 2012 is shaping up to be a pivotal year in its implementation. The experience thus far allows us to draw some


interim conclusions on ongoing processes, such as registration and the Candidate List. Other processes, mainly authorization and substance evaluation, will start in 2012. In addition, some major issues may also finally be resolved, such as the interpretation of the 0.1% w/w of SVHC (Substances of Very High Concern) in complex articles. One certainty is that plastics and additives will be under the spotlight this year.


1. Registration The main challenge for industry is meeting the upcoming May 2013 registration deadline for substances manufac- tured or imported above 100 tonnes per year. Expecta- tions regarding the total number of substances that will be registered by this deadline have been significantly scaled down: based on a survey, the European Chemicals Agency (ECHA) currently expects to receive registration dossiers for approximately 2,530 substances. The full list is available at: http://bit.ly/REACH2013 While affected companies appear to have been able


to get in their registrations for higher volume materials (more than 1,000 tonnes/year) by the 2010 deadline, the 2013 deadline will not necessarily be an easy ride. Industry has gained significant experience and devel- oped multiple tools, such as generic exposure scenari-


www.compoundingworld.com The plastics industry is entering a


critical period in the implementation of Europe’s complex chemicals


legislation, REACH. Lucas Bergkamp and Nicolas Herbatschek examine the implications


os, that will help. However, the industry expects less information to be available on substances covered by the 2013 registrations, plus less organization overall, for example through consortia. The 2013 process will also involve more small- and medium-sized companies which have less experience and resources to deal with regulatory issues. In addition, 2013 registrants must also keep track of updates that will occur in 2012, such as a new IUCLID5 database software update and adaptation of the Test Methods Regulation, which need to be integrated into a successful registration strategy. Furthermore, the quality of 2010 registrations dossiers


increasingly appears not to be in line with the expecta- tions of ECHA, which has complained about insufficient quality of registration information overall. ECHA’s recent 2011 Evaluation Report details the shortcomings. The Commission has also expressed its concern. The ECHA Evaluation Report provides several


April 2012 | COMPOUNDING WORLD 17


Plastics will be under the REACH


spotlight this year


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