- REACH: Obligations and Pre-Registration Period
- August 28, 2008
- Law Firm: Holland & Knight LLP - Tampa Office
As of July 1, 2008, companies doing business in the European community or selling products in the European Union (EU), have responsibilities under the Registration, Evaluation, Authorization and Restriction of Chemicals regulation (REACH) (Regulation (EC) 1907/2006 of the European Parliament and of the Council of 18 December 2006). REACH entered into force on June 1, 2007, with a stated purpose of streamlining the former legislative framework on chemicals used in the EU. REACH established the European Chemicals Agency (ECHA or the “agency”) to implement and coordinate REACH activities. This article is a summary of REACH requirements and of relevant information provided by ECHA on its Web site.
Who and what is covered?
The regulation places the majority of the burden for risk management on industry. Any company that ships product to the EU, manufactures in the EU, or has offices based in the EU has responsibilities under the regulation. REACH applies to all chemicals in the EU, not only those chemicals used in industrial processes, but also any chemicals used in consumer products, cleaning products, electronics, clothing, etc. The regulation applies to substances, preparations and articles. (Definitions, Article 3)
What is the manufacturer’s responsibility?
Manufacturers and importers of chemicals in the EU must identify and manage risks linked to the substances they manufacture and market. After June 1, 2008, for substances produced or imported in quantities of one ton or more per year, any company that manufactures and imports must demonstrate that they have appropriately identified and managed the risks by means of a registration dossier, submitted to the agency. (Article 6, registration can be found in Annexes VI to XI). If a company manufactures a candidate list substance present in products greater than 0.1 percent weight/product, that company must provide information to the customer. Manufacturers and importers must provide their downstream users with the risk information needed to use the substance safely. This must be done via a classification and labeling system and safety data sheets (SDS). For substances manufactured or imported in quantities of 10 tons or more, the chemical safety report (CSR) will be used to document the hazardous nature and classification of the substance and include an assessment as to whether the substance is PBT or vPvB (persistent bio-accumulative and toxic, or very persistent and very bio-accumulative). (Duty to Register: Article 21, see also ECHA Guidance on Registration, April 2008.)
What are the special rules that apply to articles?
An article is any object that has been given a particular shape, surface or design so that it can be used for a specific purpose. (Article 29) All substances that are intended to be released from articles during normal and under foreseeable conditions must be registered according to REACH rules. (Article 7.1) Notification is required for substances included in the candidate list above a certain concentration. Notification consists of sending a dossier to the agency and must contain the identity of the notifier, the identity of the substance, its classification and labeling, a brief description of its use and the tonnage range. (ECHA Guidance on Registration, April 2008.)
What will the authorities do with this information?
The goal of the REACH authorization system is to ensure that substances of very high concern are adequately controlled and progressively substituted with safer substances or technologies, or only used when there is an overall benefit for society of using the substance. The candidate list (REACH, §59(1)) containing substances of very high concern is expected to be published in December 2008 and will also be included in Annex XIV of REACH. If included in Annex XIV, industry will be required to submit applications to the agency to get authorization for continued use of these substances. In addition, the EU authorities may impose restrictions on the manufacture, use or placing on market of substances causing an unacceptable risk to human health or the environment.
What is pre-registration?
REACH requires that manufacturers and importers of substances in quantities greater than one ton per year can only manufacture and import the substance if it’s registered. For products and substances on the market prior to June 1, 2008, (“phase-in substances”) transitional arrangements exist, provided the manufacturer or importer pre-registers the substances. (Article 28) If a manufacturer or importer fails to pre-register a phase-in substance, that substance will need to be registered before it can continue to be manufactured or imported. Companies may submit pre-registration dossiers to the agency during the period of June 1, 2008, to December 1, 2008. Pre-registration allows companies to continue to manufacture or import the phase-in substances for several years until the registration deadline is reached. Pre-registration also allows downstream users to ascertain that all substances needed in its own processes are on the list and that there will be no discontinuity of supply. (See, ECHA_FAQ_version 2.0 _ 2007-12-04 9)
How can my company register if it has no EU office?
An “Only Representative” can be appointed by a non-EU manufacturer/producer of substances, preparations or articles whose products are imported into the EU. According to Article 8(1) of the REACH Regulation, “a natural or legal person established outside the Community who manufactures a substance on its own or in preparations, formulates a preparation or produces articles imported into the Community may by mutual agreement appoint a natural or legal person established in the Community to fulfill, as his Only Representative, the obligations on importers regarding the registration of substances.” The non-EU manufacturer/producer must inform the importer(s) within the same supply chain of the appointment of an Only Representative.
Every importer or user of chemicals (substances, preparations or articles) doing business in the EU must evaluate obligations under REACH carefully. REACH obligates every actor in the supply chain to be informed or inform others of the potential risk of using chemicals. Companies doing business in or with the EU must comply with REACH or risk losing access to the EU market.
Guidance documents and legislation relied upon to draft this summary can be found on the ECHA Web site. http://reach.jrc.it