First introduced in 2003 and adopted December 13, 2006, the legislation concerning the Registration, Evaluation and Authorization of Chemicals (REACH) requires importers and manufacturers of an estimated 30,000 chemicals to perform toxicity and other testing to demonstrate safety in consumer use. (Proposal for a Regulation of the European Parliament and the Council concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (“REACH” or the “Regulation”), establishing a European Chemicals Agency and amending Directive 1999/45/EC and Regulation (EC) {on Persistent Organic Pollutants}) REACH is the culmination of a long effort to improve and integrate chemicals regulation in the EU, and will replace 40 existing laws and regulations. It reverses the burden of proof with regard to chemical safety so that industry, rather than public authorities, will be responsible for identifying and controlling risks associated with chemicals manufactured and imported into the EU.
While the final version of REACH Regulation remains to be approved (REACH enters into force on June 1, 2007), the Regulation will include a reduced level of chemical testing for substances produced or imported in volumes between 1 and 10 metric tons annually (an estimated 20,000 chemicals), an exemption for volumes below 1 metric ton annually, a “polymers” exemption and provision for joint submissions by multiple manufacturers of a single chemical (the One Substance, One Registration or OSOR approach). REACH empowers a new Helsinki-based European Chemicals Agency (“ECHA”) to deny registration and ban manufacture and import of chemicals based on applications submitted, including consideration of cancer potency, reproductive impacts, bioaccumulation and persistence in the environment. REACH allows production and importation of certain chemicals under special conditions which would mitigate risk through regulated and enforceable control measures, as for example under the equivalent of U.S. Material Safety Data Sheets. The EU estimates that compliance with REACH will cost industry from €2.3 billion to €5.2 billion.
The basic elements of REACH are as follows:
Registration. All chemical substances produced or imported in quantities of one metric ton or more per year will have to be registered in a central database, to be managed by the European Chemicals Agency. Some groups of substances will not have to be registered (such as certain intermediates, polymers, and some chemicals managed under other EU legislation). Manufacturers and importers will be required to submit a “technical dossier” containing information on the properties, uses and safe handling of the chemicals. The information required will be proportional to production volumes and the risks that a substance poses. The safety information will be passed down the supply chain. General rules are set out for the use of existing information and the waiving of tests, with new tests only required when it is not possible to provide the information in any other permitted way. For substances manufactured or imported in quantities over 10 metric tons per year, a “chemical safety report” will also be required. This report will include an assessment as to whether the substance is persistent, bioaccumulative and toxic (PBT), or very persistent and very bioaccumulative (vPvB). For PBT and vPvB substances, the report must include descriptions of potential exposure scenarios for identified uses, along with corresponding risk management measures. To reduce costs to industry, the legislation allows registrants to form consortia which will submit information on the properties and classification of a substance on behalf of their members. Registration deadlines will range from 3 to 11 years after the Regulation goes into effect.
Evaluation. While the registration component of REACH discussed above will clearly require the evaluation of substances by industry, “evaluation” as it is referred to in the title of the legislation entails evaluation by Member State authorities of dossiers submitted by registrants and, in certain instances, of substances themselves. One of the primary goals of this step is to review any animal testing proposals to prevent unnecessary testing. This step is also intended as a compliance check to ensure that registration materials meet the requirements of the Regulation. Member State authorities may also clarify suspicions of risks to human health or the environment by requesting further information from industry.
Authorization. For approximately 1500 substances of “very high concern,” an authorization from the EU Commission is required for their use and marketing. Substances of very high concern are those which are: carcinogenic, mutagenic or toxic for reproduction category 1 and 2; PBTs and vPvBs; and substances identified as causing serious and irreversible effects to humans or the environment equivalent to those above on a case-by-case basis, such as endocrine disrupters. Once it has been determined that a substance must be authorized, the registrant must apply for an authorization, and in so doing must demonstrate that the risk from the use of the substance is adequately controlled or that the socio-economic benefits outweigh the risks, taking into account alternative substances and processes. Based on these factors, the Commission will decide whether a substance will be authorized, and can impose restrictions to ensure that the risks posed are acceptable.
For more information on REACH implementation,
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This memorandum is a summary for general information and discussion only and may be considered an advertisement for certain purposes. It is not a full analysis of the matters presented, may not be relied upon as legal advice, and does not purport to represent the views of our clients or the Firm. Eric Rothenberg, an O'Melveny partner licensed to practice law in New York and Missouri, has contributed to the content of this newsletter. The views expressed in this memo are those of the author.
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