Covington & Burling LLP | Practices, Industries & Regions

Covington & Burling LLP has extensively worked on REACH matters right from the Regulation’s early draft proposals. The EU Regulation on the Registration, Evaluation, Authorization and Restriction of Chemicals (the “REACH Regulation”) imposes extensive requirements on chemicals and products containing them, affecting not only chemical manufacturers and importers of chemicals, but virtually all producers using substances in their goods and manufacturing processes. We have advised associations of chemical manufacturers and downstream users by guiding them through the REACH legislative process and providing legal comments to the proposal. We’ve also advised trade associations during their participation in the drafting of the European Chemicals Agency’s guidance.

Using this experience, we offer legal and strategic advice to companies, helping them interpret the REACH rules and develop REACH compliance programs. We have been assisting manufacturers and importers in meeting their pre-registration requirements before the December 1, 2008 deadline; moreover, we’ve been advising on communications and contractual relations with their suppliers and customers, the selection and appointment of their only representatives, and on the contractual, data protection and sharing, and anti-trust issues concerning their participation in the Substance Information Exchange Fora.

We also provide advice on the interrelation between the REACH Regulation and other environmental, and health and safety legislation such as waste legislation, the RoHS Directive, and food and drug law. We are especially active in defending certain substances against proposals in the EU seeking to restrict or ban their use.

Our clients include manufacturers and importers of chemicals and products containing them, including paper tissue products, non-woven materials, tobacco, cosmetics, medicines, medical devices, food, electronic equipment, and military equipment. Below are a few of illustrative matters Covington & Burling has worked on for them.

Representative Matters

Advising a leading EU trade association representing the paper sector on the proposed REACH Regulation, including its impact on their businesses, the interplay between REACH and waste management issues, how REACH affects paper recycling, and advocacy advice on the definition of articles versus containers of preparations.
Providing regulatory and strategic advice to a large manufacture of consumer products on REACH pre-registration requirements, contractual arrangements with suppliers and customers, the appointment of only representatives, and the correct identification of substances.
Providing regulatory advice to a large manufacturer of military equipment on the impact of REACH on aerospace equipment, military equipment, and possible national defense exemptions.
Advising a large pharmaceutical company on the REACH requirements applicable to substances used in medicinal products and medical devices.

In effect, the entire supply chain is required to examine and disclose the properties of the substances they use and ensure that safety in downstream use is adequately supported.

The REACH requirements also apply to goods in the form of preparations (i.e., mixtures) and articles (i.e., objects), thereby encompassing practically all EU manufacturing processes and products marketed in the EU, such as cosmetics, medicines, medical devices, tobacco, electronics, equipment material, printers and ink cartridges, and food and food packaging, subject to certain exemptions. The requirements will be implemented by the European Commission and the new European Chemicals Agency, and enforced by the EU Member States.

The REACH rules are sweeping and complex. To aid in meeting these obligations, Covington & Burling LLP advises companies and trade associations on a variety of REACH issues, whether it be navigating its legislative process, interpreting the rules, developing compliance programs, participating in consortia, defending particular substances, and beyond.

The Main REACH Obligations

The Regulation imposes the following obligations, among others, on manufacturers and importers:

Registration. Manufacturers and importers of virtually all substances or products containing them in quantities above one ton per manufacturer/importer per year are required to submit a registration dossier with substantial information on the physico-chemical, toxic and eco-toxic properties of the substance. For substances manufactured or imported in quantities of ten tons or more, a chemical safety assessment may be required as well. This registration requirement also applies to substances contained in articles if they are intended to be released during the normal or reasonably foreseeable conditions of the article’s use.
Pre-Registration. The registration requirement has applied as of June 1, 2008. However, manufacturers and importers of so-called “phase-in” substances may benefit from a phase-in registration period if they pre-register their substances between June 1 and December 1, 2008.
Participation in SIEFS and Data Sharing. Pre-registrants are required to join the Substance Information Exchange Fora (“SIEFS”) where they must agree on the “sameness” of their substances and their classification, and must share data. In particular, data resulting from the testing of animal vertebrates is subject to strict sharing requirements. Manufacturers and importers may also engage in other cooperation forms, such as consortia, but are subject to the applicable competition law rules.
Provision of Information and Safety Data Sheets Through the Supply Chain. As of June 2007, a safety data sheet must be given to customers free of charge by suppliers of substances or preparations classified as “dangerous” or persistent, bioaccumulative and toxic substances (“PBTs”) or very persistent and very bioaccumulative substances (“vPvBs”), and preparations containing these substances in concentrations above specified thresholds. Customers themselves are required to disclose to their suppliers any new information on the hazardous properties of the supplied substances that they have available.
Chemical Safety Reports and Reporting Obligations. EU manufacturers of goods using substances procured from EU suppliers will be required to check the exposure scenarios of the safety data sheets provided by suppliers. Where their uses are outside those described in their suppliers’ exposure scenarios, they may be required to draft a chemical safety report and report their uses to the European Chemicals Agency.
Evaluation. The European Chemicals Agency will also decide on testing proposals, registration spot checks, and further evaluation of substances under which manufacturers and importers may be required to submit additional information on their substances.
Marketing and Use Restrictions. The Regulation also provides a fast-track procedure for adopting marketing and use restrictions on substances whose manufacture, use or placing on the market poses an “unacceptable risk” to human health or the environment.

Substances of Very High Concern

The REACH Regulation also imposes additional requirements on substances identified as substances of very high concern (“SVHCs”) and products containing them. SVHCs may include Category 1 and 2 carcinogens, mutagens and toxic to reproduction substances (“CMRs”), PBTs, vPvBs, and substances raising an equivalent level of concern. On June 30, 2008, the European Chemicals Agency published a first list of substances proposed as SVHCs.

In particular, SVHCs and products containing them will be subject to the following requirements, among others:

Notification to the European Chemicals Agency. EU producers and importers of articles may be required, beginning June 2011, to notify the Agency of the SVHCs that are present in their articles in concentrations above 0,1%.
Supply of Information to Customers. Suppliers of articles must give their professional customers information allowing the safe use of their articles if they contain SVHCs in concentrations above 0,1%. Suppliers must also provide the same information to consumers upon their request.
Prior Authorization. Substances identified as SVHCs are candidates to be listed as subject to authorization. Where a substance is subject to authorization, its manufacturers, importers, and users will be required to obtain an authorization for the use and marketing of the substance or products containing it. Authorizations will only be granted where applicants can prove that the risks resulting from the use of their substances are adequately controlled, or that the socio-economic benefits of the use outweigh the risks and there are no suitable alternative technologies. Applicants will also have to search for substitutes and present a substitution plan. The authorization requirement is unlikely to apply to imported articles, but the restrictions procedure may be used to ban the use of SVHCs in articles.