The first major milestone of the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) is now behind us. Pre-registration ended on 1 December 2008 and now the hard work of preparing Registration dossiers is well underway. REACH has far reaching effects not only on the European chemical industry, but also on non-European companies that ship products into the European Union (EU). Not only will manufacturers, importers and users of industrial chemical products be impacted, but also companies that produce non-industrial chemical products, such as food packaging materials, cosmetic ingredients, and pesticidal and biocide inerts. The 2.7 million pre-registrations (only about 200,000 had been anticipated by the European Commission) emphasize the fact that REACH poses major challenges for companies trying to manage their REACH obligations strategically and efficiently.
REACH is very data and time intensive, with specific deadlines that need to be satisfied in order to stay on the market. Many companies will need to fulfill the bulk of their REACH responsibilities by 1 December 2010. Thus, there is little time to prepare to meet these challenges, and time is already slipping away. Companies will need to expend considerable resources to comply with REACH and substantial legal and scientific expertise is necessary. Strategic thinking will be crucial to save cost and avoid shortage of testing capacities.
THE REACH SYSTEM
The Four Legs of REACH
REACH is a four-part regulatory system comprised of:
Registration of most chemicals, both new and old, that are manufactured or imported into the EU in quantities exceeding 1 metric ton per year. The registration obligation falls on manufacturers and importers, but downstream users will also need to ensure that their specific uses are registered. The amount of information and data needed for registration will depend on the quantities or tonnage of the chemicals with more data needed at higher tonnage levels. Built into the REACH system are provisions for avoiding unnecessary animal testing and for data sharing among registrants. Where new animal testing is needed to support registration, the registrant must first submit a testing proposal to the regulatory authorities. REACH also requires the preparation of a Chemical Safety Report (CSR), essentially a risk assessment and risk management report that describes the chemical, its uses, the hazard and exposure potential, and recommends practices for reducing risk and exposure.
Evaluation of registration dossiers and animal testing proposals by the regulatory authorities, as well as special provisions to allow the call-in of additional data on chemicals of highest concern to the EU regulators.
Authorization of substances of very high concern, defined as carcinogens, reproductive toxicants, mutagens, persistent and bioaccumulative toxicants, and substances that pose similar problems. The Authorization is user and product specific and depends in part on the availability of lower risk substitutes.
Restrictions of high risk chemicals or uses where the risks can not adequately be managed and community-wide regulation is needed.
REACH established the European Chemical Agency (ECHA), headquartered in Helsinki, Finland, to administer the regulations with the assistance of the Competent Authorities within the various European Member States. REACH also established a classification and labeling inventory of all industrial chemicals, provided new enforcement authority to the Member States, and established various administrative and legal procedures.
The Timetable for REACH Compliance
The strict timetable for REACH is already well under way, and companies will find that they have little time to comply with REACH registration obligations. The pre-registration phase for existing chemicals has already closed. Companies that pre-registered their chemicals during that 6 month window received the benefit of phase-in status for their existing chemicals. This status allows them to provide Registration dossiers in either 3.5, 6, or 11 years after entry into force, with high volume and high risk chemicals required to be registered first. Indeed, the first registration deadline is 1 December 2010, less than two years away. As a practical matter, the vast majority of activities for this first deadline must be completed in 2009. Meanwhile, consortia have formed, the Substance Information Exchange Fora (SIEFs) are sharing data, and companies are working in earnest to compile dossiers on their chemicals. Concurrently, ECHA is developing candidate lists of substances of very high concern that will trigger obligations for article producers and forms the basis for nominating substances to be subject to use authorizations. There are only limited opportunities to support these substances before the authorities. Obviously, companies that have an interest in substances that may be listed will need to take proactive measures to defend their products. And all of this is going on in addition to the normal day-to-day business of running your company.
REACH – The Next Steps
Companies are actively taking steps to meet their ongoing REACH obligations, including:
(1) working within consortia and interacting with other SIEF members. To limit data costs and shortage of testing capacities, SIEF interactions must include not only the pre-registered substances but also any potential read-across substances needed to complete the data package.
(2) reviewing the available data on subject chemicals to determine data gaps and making decisions on what testing to conduct, QSARs to run, or waivers to prepare to fill those gaps.
(3) working with EU customers to identify the uses of the substance that should be supported for Registration. All identified uses must be supported with few exceptions. If a use is not identified, the customer will need to provide information directly to the Authorities.
(4) working on developing appropriate safe practices for handling the substance in cases where the data suggest there may be some risk.
(5) assessing PBT, vPvB, CMR and equivalent concern status, and subsequent preparation for possible restrictions under the Authorization phase of REACH.
(6) implementing Regulation 1272/2008/EC on Classification, Labelling and Packaging of substances and mixtures.
KELLER AND HECKMAN LLP AND REACH
Working in close collaboration with our offices in Washington, D.C., San Francisco, and Shanghai, Keller and Heckman clients conducting business in the EU have been assisted since 1982 by attorneys and scientists in the firm's Brussels office. With respect to the REACH proposal, our Brussels Office has been actively involved on REACH counseling and assistance since the release of the 2001 Commission White Paper on the Strategy for a Future Community Policy for Chemicals, the internet consultation, the publication of the Commission's 2003 proposal, and the more recent processes at the Council and European Parliament to adopt a consensus and final REACH regulatory text. Beginning with the release of the Council Common Position in December 2005, Keller and Heckman has been counseling clients on strategies for implementing REACH on a daily basis. Our Brussels and Washington D.C. professional staff routinely teach training courses designed to help clients understand the practical aspects of REACH for their businesses and to begin preparing for REACH compliance. We have prepared many consortia agreements, manage consortia, determine exemption status, properly identify chemical substances, provide key strategic advice, and are currently are preparing the Registration dossiers for a number of REACH consortia.
Keller and Heckman also has long-standing experience in assisting consortia under the REACH, but also under the U.S. High Production Volume (HPV) chemicals challenge program, as well as under the EU Biocidal Products Directive (BPD). This includes, for instance, assistance with the management of consortia, with the development of registration strategies and scientific argumentation, and with legal issues such as the protection of consortia or companies' data and compliance with competition law.
Keller and Heckman LLP REACH Services
Keller and Heckman provides a range of services designed to assist companies in preparing for REACH and in complying with REACH obligations after the legislation takes effect.
These services include:
Legal and Scientific Support for Strategic Decision-Making
• Assistance in auditing product portfolios
• Determination of exemptions from REACH Registration
• Assessment of the regulatory status of substances, preparations and articles
• Determination of available data and assessment of possible cost of registration
• Setting up of scientific and legal strategies limiting the risk of authorization and/or paving the way to easier granting of authorization through the preparation of appropriate registration dossiers and communication with customers
Legal and Scientific Support on Registration
• Representation in the Substance Information Exchange Forum (SIEF) and consortia
• Registration and pre-registration for non-EU manufacturers as "only representative" in special cases
• Consortium set up/management
• Technical consulting to consortia and companies
• Third party for handling of CBI-sensitive information
• Dossier compilation
• Preparation of robust study summaries
• Preparation of CSRs and SDSs
• Exposure assessment/modeling/scenarios
• Chemical characterization
• Preparation of cost-effective testing strategies and testing proposals
• Placing and monitoring of studies (all endpoints)
• Preparation of waivers for specific endpoints
• Follow-up of evaluation with the Rapporteur Member State and the Agency
Legal and Scientific Support on Authorization
• PBT/vPvB evaluation and/or rebuttals
• Rebut substances of equivalent level of concern
• Representation and advocacy concerning Candidate List inclusion and SVHC designations
• Authorization request compilation
• Identification of possible substitutes
• Scientific and socio-economic analysis of substitutes
• Follow-up Authorization request with the Agency
• Rebut proposed Restrictions
Litigation
• Appeals against decision of the Agency (e.g., data disclosure)
• Legal actions against adverse, arbitrary or disproportionate procedures and decisions