EU Reaches for Stringent Chemicals Regulation

Herbert Estreicher
Covington & Burling, Washington, D.C.
Candido Garcia Molyneux
Covington & Burling, Brussels

The European Commission has just begun an eight-week Internet consultation on its draft proposal for a Regulation on the Registration, Evaluation, and Authorization of Chemicals (Draft REACH Regulation). The Draft REACH Regulation is intended to replace the European Union’s (EU) current chemicals regime and to create a regulatory model for many of the countries that as of today have limited chemical controls.

The Draft REACH Regulation follows the main principles of the Commission’s White Paper on a Strategy for a Future Chemicals Policy of 2001, by proposing an aggressive application of the EU’s precautionary principle and thus requiring manufacturers, importers and downstream users to prove that their chemicals are safe. (Commission of the European Communities, “White Paper on a Strategy for Future Chemicals Policy,” COM (2001) 88 final (Feb. 27, 2001).) It would require: (1) the registration of substances manufactured, imported or used in quantities above one ton per year per manufacture; (2) the evaluation of high volume and priority substances; (3) the prior authorization of substances of very high concern (i.e., carcinogens, mutagens, and reproductive toxicants (CMR); persistent, bioaccumulative, and toxic substances (PBT); very persistent and very bioaccumulative substances (vPvBS); and substances that raise similar levels of concern such as endocrine disruptors), such authorization only to be granted if the manufacturer, importer, or downstream user demonstrates that the risk to human health and/or the environment from the specific use of the substance is “adequately controlled”; and (4) classification and public information on substances. In addition, the proposal would impose a duty of care on all chemical manufacturers, importers and downstream users, and establish a fast-track procedure for the adoption of restrictions on the marketing and use of substances that pose an “unacceptable risk to human health or the environment.”

As currently drafted, the proposal would apply to most chemical manufacturers, importers into the EU and downstream users of substances that are new as well as those that have long been in use (e.g., EINECS substances). Subject to some variations for the different requirements, the Draft REACH Regulation would not apply to: (1) GMOs; (2) radioactive substances; (3) a limited list of substances (e.g., fats, fatty acids, and extracts); (4) a limited list of categories of substances such as byproducts that are not manufactured or imported; (5) substances used only in medicinal products, as food additives, as flavorings, as additives in feeding stuffs, and in animal nutrition; and (6) authorized, or in the process of being authorized, active substances for biocidal products and pesticides. The requirements of the Draft REACH Regulation, however, would apply to many other downstream uses such as: (1) cosmetic ingredients; (2) substances in food contact materials; (3) most of food supplements; (4) substances in medical devices; (5) substances used in magistral formulas; (6) substances and intermediates used for the production of medicinal products; and (7) inerts in pesticides and biocides. Polymers and isolated intermediates would also be subject to the proposed requirements with some limitations.

Registrations and authorizations would be substance/use/person specific. Thus, as a general rule, downstream users would be able to procure their substances only from registered/authorized suppliers, unless they register or obtain authorization on their own.

As currently drafted, however, importers of preparations containing chemicals (e.g., cosmetic products) would always be required to register/apply for authorization for the use of their substances, even if their supplier has registered/been authorized. In contrast, downstream users established in the EU (e.g., EU producers of cosmetic products) would be subject to limited requirements if their supplier has registered/been authorized. At a minimum, downstream users will in effect be required to monitor the registrations and authorizations of their suppliers and to share at least part of the costs of registration and authorization of the substances they use.

Substances used in articles (e.g., paper, electronic equipment, vehicles) would also be subject to all the requirements of the Draft REACH Regulation if: (1) present in articles in quantities above one ton per year per manufacturer; (2) during use and disposal the substance may be released in sufficiently high amounts and in such a way as to adversely affect human health or the environment; and (3) the chemical supplier of the manufacturer of the article has not registered and/or been authorized. While most other chemical regimes include articles only if the substances are intended to be released, the Draft Reach Regulation would focus on possible release during both use and disposal of the article. In addition, whether there is release in sufficiently high amounts would in effect depend on the toxicity of the substance used.

The Draft REACH Regulation is likely to further increase transatlantic trade tensions and to violate several obligations of World Trade Organization (WTO) law. While the European Commission is relying on the WTO Report on Asbestos of 2001, the Draft in effect goes beyond the limits of discretion granted by the jurisprudence of the WTO.