Beveridge & Diamond
Related Practices
Related Practices
Related Industries
Related Industries

REACH Compliance

Regulation No. 1907/2006, concerning the Registration, Evaluation, Authorization, and Restriction of Chemicals (REACH), is the chemical control law in the European Union (EU).  REACH has far-reaching effects for a wide range of companies doing business in the EU.  Beveridge & Diamond advises clients and closely follows the development and implementation of REACH, which falls at the intersection of our strong chemicals and international environmental law practices.  Although REACH primarily affects the chemical industry, virtually any industry sector that uses chemicals to do business in the EU has already faced significant burdens under REACH or will do so in the future. 

As supply chains stretch around the globe, REACH requires an unprecedented level of due diligence, cooperation, and communication to ensure continued market access and regulatory compliance.  In addition, the requirements for the generation, collection, sharing, and publication of data on chemical hazards and risks have heightened the potential for disclosure of confidential business information, disputes over data rights, and the filing of tort liability lawsuits.  To supplement the internal resources they have devoted to addressing these substantial challenges, many of our clients have sought outside assistance. 

Beveridge & Diamond’s REACH team assists companies in a variety of industry sectors to address a wide range of REACH issues.  Our primary focus to date has been on REACH compliance for non-EU manufacturers, but as our non-European clients often have facilities in the EU, we have addressed the obligations of those facilities as well. 

We have advised U.S.-based chemical, biotechnology, pharmaceutical, and medical device companies on:

  • establishing a qualified Only Representative (OR) to handle direct and indirect imports to the EU;
  • OR compliance with the registration obligations;
  • benchmarking on supply chain management issues;
  • preregistration of phase-in substances;
  • preparing for data sharing and compensation negotiations with potential registrants in Substance Information Exchange Forums (SIEFs);
  • the structure and content of agreements with Asian toll and contract manufacturers to ensure compliance with REACH registration obligations;
  • registration obligations for import, export, and manufacturing of components of biotechnology products and medical devices, as well as pharmaceutical products, ingredients, and intermediates;
  • the requisite due diligence to identify the contents of certain complex products;
  • supply chain communication obligations for potential Substances of Very High Concern (SVHCs);
  • the recycling exemption and waste exclusion for EU manufacturing operations;
  • the use of Third Party Representatives to mask a registrant’s identity;
  • the registration and notification obligations applicable to articles;
  • drafting contracts with key suppliers to ensure comprehensive REACH compliance;
  • compliance with the registration, notification, and communication obligations for articles;
  • compliance with the registration obligations associated with importing formulated chemical products used in IT equipment;
  • due diligence protocols to evaluate the compliance of potential acquisition targets; and
  • supply chain due diligence strategies to address the potential for SVHCs in manufactured articles imported into the EU.

The evolution and implementation of REACH will continue to present companies with both immediate and future challenges requiring dedicated resources.  For instance, the European Chemicals Agency (ECHA) and the Member States periodically nominate substances to the SVHC “Candidate List”: those substances that may eventually be prohibited from further use, unless specifically “authorized.”  As more substances are nominated, affected companies may want to submit comments, either directly or through trade groups, during the public consultation process.  Others may want to expand their product due diligence efforts, or revisit their contractual arrangements or communications with customers and suppliers. 

Until at least June 1, 2018, when the final registration deadline passes, companies that have pre-registered phase-in substances will continue to participate, or prepare to participate, in consortia and SIEFs.  The activities of these groups involve a number of important issues, including contractual and other arrangements for data collection, sharing, compensation, confidentiality, and use.  Even the entrance of new companies to the EU market beyond 2018 may raise some of these issues as they seek access to existing data to register their substances. 

The Firm’s experience in related practice areas, such as data sharing, compensation, and confidentiality under U.S., Canadian, and other pesticide laws is of substantial value to our clients facing these challenges.  Beveridge & Diamond has longstanding and extensive experience representing individual companies in some instances and serving as general counsel to consortia in others.  We help clients successfully address issues associated with the establishment and management of consortia, data sharing and generation activities, appropriate mechanisms to protect confidential business information, and effective strategies for addressing non-member issues.

Lastly, we partner with local counsel in the EU on particular REACH matters when local knowledge or contacts are necessary.  Our clients have found that our ability to work efficiently with local counsel on discrete, targeted issues provides a cost-effective model for many aspects of their REACH planning and compliance.