Navigating Complex E.U. Regulation as Dec. 1 Deadline Looms for REACH

In the European Union, signs, billboards and media warn industry about the proximity of the first major deadline for REACH. The United Kingdom’s public announcement on REACH frankly reminds everyone: “No data, no market.”In contrast, U.S. industry lacks these constant reminders of the impending Dec. 1 deadline, leaving U.S. companies in the dark that this is the first major deadline in a long line of deadlines and obligations to come for those who export apparel to the E.U. Someone should be telling you that failure to meet your obligations under REACH not only subjects you to fines but also may completely shut you out of the E.U.’s apparel market.

REACH—or the Regulation (EC) 1907/2006 on Registration, Evaluation, Authorization and Restriction of Chemicals—establishes a new E.U. chemical regime.However, REACH directly affects not only E.U. companies but also non-E.U. manufacturers, formulators, exporters and producers of apparel. The central objective of REACH is to transfer responsibility from national authorities to industry. It is expected to affect more than 30,000 existing substances, irrespective of whether they are used individually, in preparations or in final articles, such as textiles and apparel products. In order to maintain uninterrupted market access, the Dec. 1 pre-registration deadline for these substances must be met.

REACH regulates chemical substances on their own, in preparations (formulations) and released from articles (finished products). This means that manufacturers of textiles and apparel, not only chemical companies, will have to address REACH requirements.

For the textile and apparel industry, all substances in textiles and apparel that are intended to be released under normal or reasonably foreseeable conditions of use, and are present in articles above 1 metric ton per year per E.U. importer, must be registered with the European Chemicals Agency (ECHA). Submission requirements vary depending on the hazard of the substance in question and the volume manufactured. REACH provides transitional registration periods for so-called “phase-in” substances (mainly substances listed in the European Inventory of Existing Commercial Chemical Substances) but only if the substance has been pre-registered between June 1 and Dec. 1.

Additionally, the ECHA must be notified, and certain specific information must be provided for each substance in an article that meets the “substances of very high concern” (SVHC) criteria, including:

bull; The substance is present in the articles in quantities totaling more than 1 metric ton per importer or manufacturer.

bull; The substance is present in the articles above a concentration of 0.1 percent weight by weight.

bull; The producer or importer cannot exclude exposure to humans or the environment during normal or reasonably foreseeable conditions of use of the article, including disposal.

Finally, even substances in small quantities (under the 1 metric ton threshold for registration) may be subject to obligations under REACH, including those obligations concerning restrictions, authorization and safety data sheets (SDSs).

Who and what’s affected by REACH?

REACH affects apparel manufacturers and exporters, textile producers and finishers, and dye and ink manufacturers.

Under REACH, American textile and apparel manufacturers cannot directly pre-register substances. Normally, this would mean that E.U. importers would be responsible for pre-registration. However, rather than being tied to specific E.U. importers, REACH permits an American apparel exporter to appoint a registration agent to assume the pre-registration obligations.

If you manufacture specialty fabrics, apparel or footwear designed to release substances—such as deodorants, anti-microbials, or other chemicals or metals—you are more than likely required to register those substances. If you manufacture flame-retardant, permanent-press or stay-dry fabrics, you may be using a “substance of very high concern” and be required to notify the ECHA.

To determine whether a company is required to register or notify ECHA of chemical substances that it uses in its textile and apparel products, ask yourself if there is an intentional release of a chemical substance orare there substances in your textiles or apparel or footwear that are carcinogens or toxins. If so, the issue then becomes the amount of this chemical substance imported into the E.U. by you each year.

REACH requirements

Immediately after an SVHC has been added to the candidate list, REACH requires suppliers of articles containing SVHCs to forward information on the listed SVHC(s) contained in the article (above a concentration of 0.1 percent weight by weight) to the industrial or professional user (or distributor) being supplied with the article. Suppliers must also, upon request, supply a consumer with the same information within 45 days of receipt of the request.

Non-governmental consumer and environmental organizations are campaigning for the progressive removal of SVHCs in all contexts, wherever possible. The International Chemical Secretariat, with the assistance of a number of non-governmental organizations (NGOs), recently published its “Substitute-It-Now” (SIN) list, which contains more than 200 hazardous substances that they believe should urgently be added to the candidate list for authorization. Companies using substances on the SIN list will need to develop strategies to manage increasing pressures from consumer groups and customers who may choose to use the list in the product specifications that they impose on suppliers.

If you are in the textile and apparel industry, be sure you have a comprehensive REACH-compliance strategy in place. Additionally, consider seeking assistance from an outside REACH consultant who can help your company effectively and efficiently navigate this complex E.U. regulation. n

Rich Reinis is of counsel in the Los Angeles office of Steptoe & Johnson LLP. He had assistance on this article from Laura Atlee in Steptoe’s Brussels office. Reinis practices corporate counseling, commercial transactions, and trademark and copyright law, including distributor agreements, licensing, portfolio management and counseling. He is a member of Steptoe’s REACH team, which is made up of lawyers as well as technical and regulatory specialists with more than 30 years of experience handling E.U. regulatory matters. The firm’s team is based in Brussels and frequently coordinates with regulatory lawyers in London and Washington, D.C. In addition, Steptoe works closely with Regulatory Compliance Ltd., a team of eight technical specialists led by Graham Lloyd. Graham has more than 25 years of experience in European chemicals regulation and directly works on various E.U., U.K. and other national regulatory programs. Steptoe’s REACH professionals include a network of more than 500 legal professionals across eight offices. For additional information, visit www.steptoe.com/REACH.