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REACH stands for the Regulation for Registration, Evaluation, Authorization and Restriction of Chemicals. The REACH Regulation went into effect on June 1, 2007, as a way to streamline and improve the former legislative framework for chemicals of the European Union (EU). In addition, REACH created the European Chemicals Agency (ECHA), which serves as the headquarters for the registration, evaluation, authorization and restriction processes for chemical substances to ensure consistency across the countries in which REACH applies.
The objectives of REACH are to:
- Protect human health and the environment
- Maintain and enhance the competitiveness of the EU chemicals industry
- Prevent the fragmentation of the internal market
- Increase transparency
- Integrate with international efforts
- Promote non-animal testing
- Comply with EU international obligations under the WTO
Main Benefits of REACHREACH systematically identifies chemical hazards and risks, with the aim of allowing companies to identify and communicate appropriate risk-management measures through the supply chain. In addition, it is expected that better chemical knowledge and more efficient risk-management communication measures will help prevent health problems caused by chemical exposure. This should lead to a lower occurrence of occupational diseases and preventable deaths, thus lowering costs to national health systems.
Downstream users of chemicals get relevant information on the safe use of the chemical substances they use, thus helping them to better protect their workers. Everyday products are expected to become safer for consumers and the environment, facilitating the implementation of companies' corporate and social-responsibility policies.
Thermal Ceramics pre-registered its relevant products in 2008 and says it will soon complete final registration. Registrations were completed through its European parent company but will cover U.S.-produced products exported to Europe. The main products the company registered included all types of high-temperature fiber products; since these fall into several different chemical families, a corresponding number of registration dossiers have been completed.
"REACH is the logical way to bring the control of potentially hazardous chemical substances into a single legal framework," says Ron Wainwright, global Technical director for Thermal Ceramics. "We have seen that China has started a registration process similar to REACH and would expect the U.S. to do likewise at some time in the future."
How the REACH Regulation WorksCompanies that manufacture or import 1 ton or more of a chemical substance annually are required to register it in a central database at the European Chemicals Agency. This involves submitting a technical dossier containing information on the substance and guidance on how to handle it safely. For quantities of 10+ tons, companies also need to submit a Chemical Safety Report to document a safety assessment of the substance that demonstrates safe handling for all identified uses and manufacturing.
Evaluation allows regulatory authorities to determine if further testing is needed and to assess whether information provided by industry complies with the requirements (dossier evaluation). Substances suspected to pose a health or environmental risk are selected for substance evaluation, which may lead to the actions detailed under the restrictions or authorization procedures.
Substances of very high concern, such as those that are toxic to the reproductive system, bio-accumulative or toxic, are subject to an authorization procedure. Companies that apply for authorization need to demonstrate that the risks posed by these substances are adequately controlled or that the socio-economic benefits from their use outweigh the risks. The aim is to give industry the incentive to progressively substitute these substances with safer alternatives whenever technically and economically feasible.
Registration ProcessPre-registration of so-called phase-in substances took place from June 1 to December 1, 2008. Pre-registration allowed companies to communicate with other companies that intended to register the same substance and gave them sufficient time to set up substance information exchange forums (SIEFs). In a SIEF, companies were obliged to share animal testing studies to keep the number of animals used for testing to an absolute minimum. They may also have voluntarily shared other data.
"The SIEF system, whereby all suppliers collaborate to produce one set of H&S data, avoids any conflict between the registrations filed by different companies," Wainwright says. "It is important to prepare a good-quality REACH dossier as this will become the H&S information on file relating to the substance for future reference."
By December 1, 2010, the following will have to be registered with the European Chemicals Agency: all substances produced or imported in quantities equal to or greater than 1000 tons/year; carcinogens, mutagens and substances toxic to reproduction (CMR category 1 and 2) equal to or greater than 1 ton/year; and substances classified as very toxic to aquatic organisms (R50/53) at and above 100 tons/year.
On June 1, 2013, all substances produced or imported in quantities of 100 tons/year or more will need to be registered; by June 1, 2018, all substances produced or imported in quantities equal to or greater than 1 ton/year will need to be registered. Manufacturers and importers that have not met the deadline to register substances according to the appropriate volume levels will no longer be able to manufacture in or import that substance to the EU market.
Non-phase-in substances need to be registered before they are manufactured or imported. Their registration started on June 1, 2008. Substances in articles that are on the "candidate list of substances of very high concern" will need to be reported to the European Chemicals Agency starting on June 1, 2011.
Coverage and ExemptionProducts such as construction material, electronic components, toys and vehicles are covered by REACH if they contain substances that are intentionally released. These substances need to be registered. Products with substances on the candidate list of very-high-concern substances will need to be reported to the agency
Low-risk substances, such as water, oxygen, noble gases and cellulose pulp, are excluded from registration. While REACH applies to substances occurring in nature as defined by Article 3(39) of the REACH Regulation, Annex V of the regulation states that the following substances occurring in nature are exempted from registration if they are not chemically modified: minerals, ores, ore concentrates, raw and processed natural gas, crude oil and coal.
Other substances occurring in nature are exempted from registration if they are not chemically modified, unless they meet the criteria for classification as dangerous according to Directive 67/548/EEC or unless they are persistent, bioaccumulative and toxic, or very persistent and very bioaccumulative in accordance with the criteria set out in Annex XIII, or unless they were identified in accordance with Article 59(1) at least two years previously as substances giving rise to an equivalent level of concern as set out in Article 57(f). The term "not chemically modified substance" is defined in Article 3(40) of the REACH Regulation.
Classification and LabelingMany REACH provisions refer to and build on classification and labeling, such as registration, chemical-safety assessment, preparation of safety data sheets, authorization, and restriction. The EU's chemical legislation has long required industry to classify and label dangerous substances and preparations according to standard criteria. The current EU classification and labeling legislation will be replaced in the coming years. The European Commission is currently finalizing a proposal for a new regulation that is based on the UN Globally Harmonized System for the Classification and Labeling of substances (GHS). Relevant REACH provisions will be updated accordingly. c
For more information on REACH, visit www.echa.europa.eu.
Editor's Note: Information provided by European Chemicals Agency website, www.echa.europa.eu.