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10 Things You Should Know About REACH

  • REACH is expected to affect some 30,000 chemical substances on the EU market.
  • Manufacturers or importers are prohibited from placing such substances on the EU market in quantities greater than 1 tonne per year unless that substance, and its particular use, is pre-registered with the European Chemicals Agency within stipulated deadlines and, if a substance of high concern, has secured authorisation (the 'no data, no market' principle).
  • The 'no data, no market' principle applies to chemical substances themselves, preparations of such and articles incorporating these substances where those substances are intended to be released during reasonably foreseeable conditions of use of the article.
  • Companies must identify all their substances (including in finished products) subject to the REACH registration requirements in order to prepare for the initial pre-registration stage.
  • A non-EU manufacturer producing a substance and exporting it to the European Union is directly affected by REACH, but it is unable to register.  Registration, and all other REACH obligations will be carried out by the importer of  the non-EU manufactuer’s substance. Alternatively, the non-EU manufactuer may choose to appoint an “only representative” (OR) within the EU to fulfil REACH obligations, in order to safeguard sensitive data, rather than the importer assuming this responsibility.
  • Comprehensive and detailed information on the properties of such substances must be gathered to demonstrate safe use, identify related risks and provide guidance on safe use.  This imposes major administrative responsibilities on EU producers and importers, the costs of which are estimated to amount to billions of euros.
  • Downstream users, including producers of finished articles incorporating these substances, will be significantly affected.  They must apply the risk management measures for dangerous substances identified on the chemical substance supplier's Safety Data Sheet (SDS).  They can also insist that the manufacturer of a substance which it uses lists its particular use as an 'identified' use.
  • Manufacturers and importers will be required either to include any 'identified' downstream uses reported to them in their chemical safety assessments or pass the request up the supply chain.
  • Restrictions may be imposed on the use of registered substances (whether on own, in a preparation or in an article) in certain products or their use may be totally banned.
  • REACH requires cooperation between undertakings in data sharing and new data development regarding dossier development and for joint registration.  Undertakings will likely form consortia to manage data, benefit from cost sharing and protect confidential business information.  Significant legal and technical resources will be required to set these up.
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