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In December 2006, the European Union adopted a new chemical regulatory policy, known as REACH (for Registration, Evaluation, and Authorization of Chemicals). Although the legislation is expected to be impractical, costly and burdensome, the first requirements for manufacturers and importers of chemicals will begin in June 2008. Other requirements, such as registration, are based on tonnage thresholds; compliance requirements will be spread over several years. Chemical manufacturers around the globe, and importers of chemicals into Europe, should begin now to prepare for implementation. Detailed (non-binding) guidance documents have been completed for some elements of REACH, although work is expected to continue into 2008 on other guidance documents.
Elements of the REACH ProposalPre-Registration
Eighteen months after the effective date of the legislation, all chemicals manufactured in or imported into Europe must be pre-registered regardless of applicable volume thresholds. Pre-registrations must identify the manufacturer or importer, the volume of chemical imported or manufactured, and whether or not animal data are available.
All chemicals produced in or imported into Europe (either on their own or in preparations) in amounts greater than 1 tonne per year must be registered. The registration deadlines begin in December 2010 and continue to June 2018, depending on the volume threshold (>1,000 metric tons, 100-1,000 metric tons, 10-100 metric tons, and 1-10 tons). Registrations are to include a detailed technical dossier on chemical hazards, uses and exposures, with incrementally more data required for chemicals at higher volume levels. Registration requirements increase as production or import volume increases. Registrations must also be accompanied by a risk assessment (Chemical Safety Report), to include a comprehensive assessment of hazards, exposures and risks based on “exposure scenarios” that address all “identified” uses (the registrant’s and any uses made known by downstream users). “No- effect” levels for health and environmental impacts are to be established by the registrant for all relevant human populations and all environmental media. Chemical safety reports are required for all chemicals produced in quantities of over 10 metric tons, and are intended to demonstrate that risks of the chemical in production and use are adequately controlled. Downstream users will likely have some responsibilities to disclose uses of chemicals, even those below 1 metric ton. Companies should consider the need to consult closely with downstream users to identify uses and other information, organize themselves for participation in the Substance Information Exchange Forum (SIEF), and make decisions on consortia formation and ownership of existing data. Importantly for many non-European companies, REACH does contain provisions for the designation of an “only representative” to represent the non-European interest in REACH registrations.
Individual member governments of the European Union will evaluate registration dossiers to determine the sufficiency of the data submitted with the registration, as well as any proposed plans to fill identified data gaps. Authorities can aggregate production/import volumes in the evaluation phase and may require additional testing/information.
The authorization system imposes a use-specific licensing program for chemicals that demonstrate certain hazard characteristics. These “substances of very high concern” (SVHCs) include carcinogens, mutagens, and reproductive toxins (CMRs), persistent, bioaccumulative, and toxic (PBT) substances, very persistent or very bioaccumulative (vPvB) substances, and “other substances of equivalent concern.” It is anticipated that the initial focus of the regulatory authorities will be on substances that are persistent and/or bioaccumulative, although no list of SVHCs or candidate list of chemicals for authorization has yet been developed. Authorized uses are expected to be time-limited. Authorization constitutes a separate regulatory track independent of regulation, although substances that have gone through registration and evaluation could be identified as future candidates for authorization.
Under REACH, the new European Chemicals Agency (EChA) will develop a “candidate list” of chemicals for authorization, although the number of chemicals on the list will far exceed the capacity of the agency to make regulatory decisions. This particular aspect of REACH - and the attendant “blacklist effect” - is perhaps the single greatest non-legislative threat to industry.
Authorization chemicals for which a suitable alternative exists must have a substitution plan - including a substitution timetable - accompany the authorization application. Authorization chemicals for which a threshold limit has been established can be granted a use license if the applicant can demonstrate that the risks are “adequately controlled.” Authorization chemicals for which no threshold has been established (by definition, all PBT and vPvB substances) can be granted a use license only upon a demonstration that the socio-economic benefits of continued use outweigh the risks.
Additional restrictions on the manufacturing, use or sale of a substance can be proposed by the individual European member states or the European Commission, on the basis of a review of exposures, risks, socio-economic benefits and the availability of substitutes. This is a process separate from authorization.
The draft regulations establish limited exemptions from registration and authorization. Polymers are generally exempt from registration, at least until the commission develops criteria for registering polymers (polymers containing other unregistered substances in amounts totaling more than 1 ton per year must be registered). Intermediates isolated on-site or transported must provide more limited registration information/data. Other exemptions (e.g., a five-year exemption for process-oriented research and development, with a possible five-year extension) may be too limited to be of practical value. No de minimis exemption is provided, and there is no “dual use” exemption for products with both commercial and military applications.
Downstream ImpactsThe draft regulations apply to the downstream users of chemicals and chemical products. Downstream users are required to compile a chemical safety report where the manufacturer or importer has not registered the use. Downstream users may have to register chemicals if their specific uses are not covered by the manufacturer/importer’s registration, and may be required to apply for use-specific authorizations. Downstream users must report every use of substances requiring authorization. Articles that contain substances that are intended or likely to be released in amounts greater than 1 ton per year must be registered (“release” is not defined in the text). In some cases, downstream users may be able to rely on MSDSs to satisfy communication requirements of REACH, but MSDSs must address all identified uses.
Preparing for REACH ImplementationAlthough some elements are already available, the REACH Implementation Projects (RIPs) to develop guidance on specific elements of REACH compliance are still under way. However, it is not too early for companies to begin taking the initial steps to prepare for implementation. The following activities will help companies prepare to meet the REACH requirements (e.g., the submission of pre-registration information and registration dossiers). Initial planning can now help companies decide on the resources they may require in the future to meet REACH implementation requirements.
- Develop an inventory of individual chemical substances and mixtures your company may produce in Europe, export to Europe, and purchase from Europe. The inventory should help identify whether the company is a producer, importer or downstream user as those terms are defined in REACH. The inventory should include the CAS numbers (and ELINCS or EINECS numbers, if possible) and annual volume of production or import. Volume totals drive the registration process under REACH, with the highest volume substances (production or import > 1,000 metric tons annually) required to be registered within 42 months of the effective date of the regulation. Companies may also wish to prioritize their inventory to identify critical raw materials, intermediates or catalysts, as well as those substances that may be subject to authorization.
- Companies that export polymers to Europe should determine what monomers they are made from. Monomers from which exported polymers are made will be required to be registered, even if the monomer is not itself on the European market.
- Identify possible consortia partners (other manufacturers or users).
- Identify customers for the company’s substances, as well as suppliers.
- Gather and evaluate all available information regarding intrinsic properties, and data that might assist in waiving data requirements for registration. The information should indicate whether the data is based on vertebrate animal tests, and should (to the greatest extent possible) include classification and labeling information. This would also be a good opportunity to compile relevant documentation supporting study costs and previous payments to be used in future data-sharing discussions, and to identify any data in which the company has an ownership interest or other agreement on the use or sharing of the data.
- Begin collecting information useful in addressing exposure and use scenarios in the development of a REACH-required chemical safety report (including information on possible environmental or human exposures, either in the manufacturing process or at downstream user sites), as well as information on final uses. Some believe it is too early to solicit detailed use information from customers or suppliers, or it is too early to begin to compile the technical dossiers or chemical safety reports that will accompany REACH registrations. However, it has been suggested that preliminary discussions with distributors and/or suppliers on the question of possible collaboration once REACH is put into effect could be useful at this point.
For further information on REACH, contact Mike Walls, American Chemistry Council, at email@example.com.
Reprinted from the Polyurethanes 2007 Technical Conference. Published with permission by the Center for the Polyurethanes Industry of the American Chemistry Council.