European Union’s New REACH Legislation
The European Union (EU) enacted new environmental legislation called REACH on June 1, 2007. The new law will have a significant and sweeping impact on companies that manufacture regulated chemicals in the EU, EU companies that import these substances or articles containing these substances into the EU, and non-EU businesses spanning the globe that export these substances or articles containing these substances to any EU country.
The new legislation is more stringent and more sweeping than similar U.S. laws. Manufacturers across the world will soon find themselves caught up in the REACH program. And, not just manufacturers of chemicals. Companies that make paints, inks, dyes, and pigments also fall within the purview of REACH. Even companies that make or export products that contain regulated chemicals may be subject to REACH – products like automobiles, electronics, textiles, and any product intended to release regulated chemicals during foreseeable use, including disposal.
REACH imposes responsibility on industry to manage the risks associated with chemicals and to provide safety information on process chemicals, mixtures of chemicals, chemicals used to prepare or manufacture products, and even chemicals that might be released from products (“articles” that have a particular shape or design that determines function, if a chemical is released from the article during normal use or disposal). Manufacturers and importers are required to gather information on the properties of their chemicals, so they may be handled safely, and to register the information in a central database run by the newly formed European Chemicals Agency (“Agency”). The Agency will act as the central clearing house in the REACH system: it will manage the databases necessary to operate the system, coordinate the evaluation of suspicious chemicals, and run a public database in which consumers and professionals can find information on the regulated chemicals. REACH also calls for the progressive substitution of the most dangerous chemicals when suitable alternatives have been identified.
The first step in REACH compliance is to determine whether chemicals and articles made in or imported/exported to the EU are, or contain, chemicals subject to regulation under REACH. If so, the quantity of each such chemical must be calculated. If the quantity of a chemical per producer or importer is 1.0 metric tonne per calendar year or more (about 1.1 tons), the chemical must be registered. Due to the large number of chemicals affected by REACH (estimated to be 30,000) there is a transitional or “phase-in” period for registration of chemicals that have been on the market for some time. To facilitate this process, there is a pre-registration period between June 1, 2008 and December 1, 2008. If a company takes advantage of the fairly simple pre-registration process, it will have much longer to compile the detailed technical dossier required for full registration. Full registration deadlines will be phased in over the next ten years depending on the quantity of chemicals that are manufactured in or imported/exported to the EU, and the degree of hazard associated with these chemicals.
Companies that are based outside the EU cannot register, or even pre-register, substances themselves, unless they have an EU-based subsidiary. Instead, they must appoint an “Only Representative” to do that for them. Only Representatives are EU-based legal entities that are considered competent to carry out the REACH registration process on behalf of companies based outside the EU.
FBT is uniquely positioned to shepherd clients through the REACH process from start to finish. Two FBT Intellectual Property attorneys have PhD’s in Chemistry. Several FBT Environmental lawyers have undergraduate degrees in Chemistry, Chemical Engineering, the biological sciences, or related disciplines. The Firm also employs Environmental Professionals with backgrounds in disciplines like civil and environmental engineering. Attorneys in FBT’s International Practice Group bring to the mix the business law skills needed to negotiate chemical supply contracts and collaborative agreements between companies that manufacture similar chemicals or chemical products.
Additionally, through its International and Environmental Practice Groups, FBT has established alliances and close ties with several law firms that have REACH practices in the EU, including firms in Great Britain and Germany. These firms are available to provide the EU law expertise needed to comply with REACH. In fact, one of the attorneys in FBT’s International Practice Group is also a member of a German law firm and is licensed to practice law in the EU. FBT has lawyers fluent in not only in German, but Spanish, French, Russian, Dutch, Flemish, and Swedish.
Finally, FBT has established relationships with Only Representatives and other chemical and regulatory consultants with expertise in REACH. They work collaboratively with FBT lawyers to help us meet the technical needs of our clients under the REACH program.
FBT’s multi-disciplinary team has the talent and expertise to take companies through the whole REACH program – pre-registration, registration, legislative and regulatory interpretation, multi-company collaboration and contracting, preparation of technical dossiers, risk assessments, substitution of chemicals, compliance management and monitoring, and taking up appeals when necessary. And, as a law firm, FBT is capable of protecting as confidential much of the sensitive information generated during the REACH compliance process.
Members of FBT’s Environmental and International Practice Groups are available to provide additional information about the REACH program at any time.