REACH Resource Center

Are you meeting your REACH obligations?

We apply an unrivalled depth of understanding to the practical challenges REACH presents. Our "one-stop shop" will help ensure compliance with all elements of the REACH Regulation (EC) 1907/2006 (concerning Registration, Evaluation, Authorisation and Restriction of Chemicals). Steptoe’s cost-effective compliance strategies draw not only on our conventional role of legal counsel to our clients, but also from hands-on experience acting as “Only Representative” (for non-EU companies) and “Third Party Representative” (for EU companies). Our multi-disciplinary REACH team brings together lawyers, and regulatory and scientific consultants, with decades of experience assisting companies in the international chemicals industry in EU regulatory matters.

REACH affects over 100,000 substances placed on the EU market and has an impact that extends far beyond chemical companies. All actors in the supply chain – from chemical substance producers or importers to formulators and manufacturers of finished products.  The central policy objective is to transfer responsibility for generation of data on chemical safety to industry, thereby placing direct obligations on EU manufacturers, importers and downstream users of substances on their own, substances in preparations and substances in finished articles.  Exporters to the EU face significant indirect obligations, in particular, protecting confidential business information.  And strict time limits must be respected in order to maintain market access. 

REACH forces data sharing and cooperation amongst competitors. All parties sharing data will need to ensure that they receive fair compensation. Steptoe’s clients benefit from our many years of experience in forming, participating in and running chemicals consortia (“task force agreements”) established for data sharing and/or joint dossier submissions to obtain regulatory approvals. We have a wealth of experience on the key issues of (1) data valuation and compensation, including facilitating agreements among companies obligated to share data; and (2) managing the competition law/antitrust risks which arise when companies cooperate.

The "no data, no market" principle, at the heart of REACH, means that those who did not Pre-Register existing substance by 1 December 2008 are now banned from the market. Those companies that did Pre-Register currently benefit from extended Registration deadlines, phased-in according to hazard classification and volumes manufactured/imported. Late Pre-Registration is available, but only under limited conditions.

Many companies were able to handle Pre-Registration without external support, but now require additional or alternative support (e.g. the replacement of its Only Representative) to meet the demands of Registration. The first Registration deadline, which is 30 November 2010, applies to companies whose substances are in quantities ≥ 1,000 tonnes or certain CMRs/toxic substances. In less than 2 years those companies must understand and execute all of the activities REACH Registration demands.  Work on Substance Information Exchange Fora (SIEF) establishment and (in parallel) Consortia should already be receiving serious attention.

Actions that will need to be taken from the date of pre-registration include:

• tracking other Pre-Registrants for each substance Pre-Registered, in particular identifying any SIEF formation facilitator, checking the total number of Pre-Registrants/identities, and keeping abreast of relevant information on status, use and related consortia;
• preparing for "sameness" discussions about problematic substances, such as Substances of Unknown or Variable Composition, Complex reaction products or Biological Materials (UVCBs) and substances with multiple identifiers;
• compiling an internal inventory of "own" data, including: confirming ownership documentation, assessing data quality, qualification for financial compensation and valuation;
• checking the availability of "orphan" data and determining whether it should be contested;
• determining all use patterns and availability of exposure data;
• exploring the possibility of obtaining data waivers or establishing read across for specific end points;
• making informed decisions on membership in existing consortia, with particular attention paid to pre-established conditions for membership and possible revisions to those conditions, including evaluating the need (or not) to transfer data to consortium as condition of membership; and
• considering the value of assuming a leading role or "founder" status in a consortium in formation or where no consortium has yet been formed.
  

 

REACH will lead to increasing pressure for product de-selection in certain sectors.  Through our professionals’ years of constructive interaction with policy makers in both Europe and the US concerning chemicals control policy Steptoe has the experience, knowledge and judgment to help our clients’ defend their core substances.  We work with clients to avoid adoption of unwarranted substance restrictions by informing policy makers and those in the value chain of issues which are arising and providing creative solutions to real and perceived difficulties.  We can be most effective when engaged to help clients with their product advocacy long before a core substance is placed on the ECHA Registry of Intentions or the Candidate List.

This REACH Resources Center provides access to a regularly updated range of materials explaining the intricacies and evolution of REACH. Please navigate to relevant material using the side bar on the left hand side of this page. 

For further information on how we might assist you please see our REACH Services Brochure and contact us at REACH@steptoe.com or + 32 2 626 0572.

Noteworthy

• Steptoe Brussels Regulatory Environment Group Ranked as Leading Firm by Chambers Europe 2009
• Brussels office recruits Dr. Anna Gergely to lead expanding environment, REACH & nanotechnology practice 
  

Publications

• EU Analyst: Environment & Life Sciences
  July 30, 2010
• EU Analyst: Environment & Life Sciences
  April 15, 2010
• "Nanotechnology in the EU cosmetics regulation"
  2009, Household and Personal Care Today
• REACH: Polymer-Specific Issues
  August 7, 2009, Plastics News

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