Keller and Heckman is a recognized authority on the European Union’s REACH (Registration, Evaluation, Authorization and Restriction of Chemicals) Regulation and has extensive experience assisting clients with its requirements. Our lawyers, scientists and regulatory affairs experts have been involved with REACH from the beginning with the development of the 2001 Commission White Paper on the Strategy for a Future Community Policy for Chemicals. We are at the forefront of helping clients adapt to and comply with the complex requirements imposed by REACH.
REACH impacts substances manufactured in or placed on the European Economic Area (EEA) market (the 28 EU member states plus Iceland, Liechtenstein and Norway). Its broad scope affects not only chemical companies but the entire supply chain, and not only industrial chemicals but also ingredients used in food packaging and cosmetics.
As a leader in the use of interdisciplinary approaches, Keller and Heckman attorneys and scientists understand the complex interaction between product-specific legislation and REACH. We have counseled clients in the chemical, fuel, food, food packaging, cosmetic, soap and detergent, and other affected industries on REACH-related matters.
Keller and Heckman’s experienced range of services includes product defense, strategy and compliance matters.
Product Defense: Keller and Heckman attorneys protect our clients’ rights under REACH. We represent clients in legal proceedings to rebut proposed restrictions and dossier rejection decisions; we represent companies in negotiations on data sharing and Substance Information Exchange Forum (SIEF) contractual matters; and we advise and represent companies on competition (antitrust) considerations, including those who wish to press or are faced with an enforcement action. We represent clients in appeals against decisions by the European Chemicals Agency (ECHA) and the European Court of Justice. We were the first law firm to take an ECHA Board of Appeals case to an Oral Hearing (A-005-2011).
Strategy: We advise on contractual, regulatory and competition matters specifically related to SIEF participation, data sharing and protection of confidential business information. Keller and Heckman advised on one of the first data sharing disputes involving Article 30-31 REACH where interim measures allowing REACH registration pending resolution of the data sharing dispute were successfully obtained. We also counsel clients on how to establish scientific and legal strategies to limit the risk of authorization and work with them to minimize the costs and impacts of REACH. This includes assisting with product portfolio audits; advising on the regulatory status of substances, preparations and articles; and helping determine the availability of data.
Compliance: Keller and Heckman provides representation in SIEF and other consortia, manages consortia, and assists with registration and preregistration for non-EU manufacturers as only representative (OR). Our attorneys were recognized in the trade media for their efforts in obtaining an internal European Commission (EC) decision to allow REACH ORs the ability to submit and obtain REACH authorization.
We assist clients with dossier compilation, including the preparation of cost-effective testing strategies and testing proposals for exposure assessments and chemical characterization, and the monitoring of studies. Our attorneys act as third parties for handling of confidential business information. We advise clients on substances of very high concern (SVHC) designations and the identification of possible substitutes, and provide experienced counsel on the status of bio-based chemical substances, among other products, under REACH.
Representative Matters:
- Successfully lobbied for amendments to be made to Annexes IV (Substances exempted from registration) and V (Categories of substances exempted from registration) resulting in the substantial widening of Annex V (9) provisions
- Challenged the Technical Guidance Document (TGD) regarding ORs and ensured that indirect as well as direct imports of non-EU manufactured substances were covered by OR registrations
- Challenged ECHA views regarding “super-importer” status of ORs and resolved issues regarding requirement that ORs submit one registration as per each non-EU entity represented
- Influenced amendments made to the TGD on substances in Articles (Appendix 3) as regards requirement to register substances in semi-finished products
- Facilitated ECHA in resolving issues regarding the status of food intermediates under REACH
- Led industry efforts to ensure that EC and ECHA did not deny ORs the ability to submit and obtain REACH authorization, focusing efforts on internal Commission/ECHA advocacy and raised concerns regarding obstacles to trade in relevant WTO forums
- Successfully represented a client in an Oral Hearing before an ECHA Board of Appeals concerning an ECHA decision to require vertebrate animal (VA) testing of a multi-billion dollar chemical substance used worldwide
- Advised on private party REACH data sharing disputes involving mediation and alternative disputes resolution procedures, including one of the first data sharing disputes involving Article 30-31 REACH where interim measures allowing REACH registration pending resolution of the data sharing dispute were successfully obtained
