Pharma must be ready for REACH; will US follow EU lead?

ECHA estimates that it will have the task of reviewing some 180,000 dossiers in the next six months, and will work towards publishing a candidate list of substances of 'very high concern' by the end of the year. The agency currently has around 200 staff, due to swell to 450 by 2010, with an annual budget of around €90m on average over the next 15 years. REACH (Registration, Evaluation and Authorisation of Chemicals), which came into effect on January 1 this year, requires that European companies register any chemical substances made or imported in amounts of more than a tonne per year. Registration will involve supplying a technical dossier providing information on safety, toxicology and other scientific parameters. The aims of the scheme are to protect public health and the environment, make the supply chain for chemicals more transparent, as well as foster innovation and enhance competitiveness, according to the European Commission. However, critics allege that the legislation places a cost burden on industry that could undermine its competitiveness and serve as a trade barrier. A pre-registration phase, until 1 November 1, is designed to notify ECHA of the intention to fully register a substance between 2010 and 2018, depending on the tonnage of the substance produced or imported into the EU. Pharma must not ignore REACH ​ There are exceptions to REACH. Medicinal products such as pharmaceuticals, for example, are exempt, provided they are used in accordance with EC Directive 2001/83. However, according to Sylvie Thevenet of Dow Corning, it is not safe to assume that all excipients used in pharmaceutical products are excluded from the newly-implemented system, because under the legislation every use of a chemical must be recorded under REACH. "Any substance that is used in other applications as well as pharmaceuticals still has to go through the preregistration process, and fully registered between 2010 and 2018​." That means that if a substance is used in pharma as well as other industries, its pharmaceutical application has to be listed in the dossier. "Failure to do some means that after December 1, 2008, it will no longer be legal for that substance to be used in that application, unless it immediately goes through a full registration process​," said Thevenet. So for pharmaceutical companies, the onus is to ensure that any substances it uses are exclusive to medicinal products, and if not "to work with suppliers to make sure the substance is pre-registered and then registered​," she concluded. US following EU lead? ​ Meanwhile, there are signs that the US is considering a move towards a REACH-style regulatory system for chemicals, with senior politicians such as Senator Barbara Boxer (Democrat, California) calling for a European-style system that puts the onus on companies proving that a chemical is safe, rather than on regulators proving risk. Sen, Boxer is chair of the Senate Environment and Public Works Committee, and issued the call at a committee meeting last month. The proposal is already meeting staunch resistance from industry groups. For example, the Synthetic Organic Chemical Manufacturers Association (SOCMA) urged lawmakers to "thoughtfully consider whether it is necessary or wise to adopt a monolithic new regulatory regime for chemical regulation​." Jim DeLisi, president of Fanwood Chemicals and a member of SOCMA, echoed those concerns. "Whether REACH will improve human health or the environment will not be known for years, if ever, but its ability to tie up regulators and commerce is already clear​," he said. "In short, REACH has outreached the EU's capabilities. Americans cannot afford to emulate this unproven, highly bureaucratic approach to chemical regulation.​" Sen. Boxer is not alone in calling for a change to regulatory system for chemicals in the US. Other supporters of such a move include Sen. Frank Lautenberg (Democrat, New Jersey), who in 2005 introduced the Child, Worker and Consumer Safe Chemicals Act, which would have required REACH-like testing but never became law and was cleared from the books in 2007. An updated version of this bill was introduced to Congress by Representative Hilda Solis (Democrat, California) last month.