The acronym “REACH” stands for “Registration, Evaluation, and Authorization of Chemicals.” The main purpose of the legislation is to reduce risks to human health and the environment from the wide-spread use of chemical substances.
Q) Why is REACH needed?
REACH was developed to update and improve on current European chemicals legislation that has proved ineffective. REACH replaces 40 existing pieces of legislation and introduces a single coherent system for all chemicals whether “existing” or “new.” This system, through registration of chemicals manufactured or imported in the EU marketplace, will provide hazard and risk information for exposure at any point in the lifecycle of the substance.
Q) Who does REACH impact?
REACH will impact not only the manufacturers of the chemicals themselves, but producers and importers of goods that contain chemical substances within their products. Ultimately, REACH will affect anything from the workers in the chemical plants to the landfills, where these products are disposed.
Q) What chemical substances will be included?
REACH will be limited to chemical substances marketed in the EU in volumes above one ton. It is estimated that this may include as many as 30,000 substances out of more than 100,000 chemicals listed in the European Inventory of Existing Commercial Chemical Substances (EINECS). Manufacturers and importers of chemicals on EINECS will have from 12 to 18 months to pre-register their substances after REACH enters into force.
Q) What are the requirements under REACH?
REACH can be better understood if summarized under its four main components (Registration, Evaluation, Authorization, Restriction) as follows:
REGISTRATION:
The main focus of the REACH program is registration. It is important to understand that while registration is for the individual chemical substance itself, it will also encompass any preparations, solutions, and finished products that contain that chemical. REACH will affect any manufacturer, importer or retailer if they meet all of the following criteria:
the chemical, solutions or finished product, are produced or imported in a quantity greater than one ton per year;
the finished product intentionally releases the chemical substance from the article during normal/foreseeable conditions; and
the chemical substance has not been previously registered with REACH, or the finished product containing the chemical, has not been previously registered for that use.
Or
the chemical, solutions or finished product are produced or imported in a quantity greater than one ton per year;
the substance is a substance of very high concern (SVHC) and;
there is more than 0,1 w/w in the article.
Registration will have a phased-in approach over eleven years, with higher volumes needing to meet deadlines first. Manufacturers, importers, and producers who use more than 1 ton per year of the chemical, will need to submit to the European Chemical Agency (ECHA) a technical dossier for each substance, including documentation of its properties and information on safe handling practices.
Deadlines for registration of chemicals depend on the level of concern and on the volume. Timetable is:
June 2007: Legislation enters into force
June 2008: European Chemicals Agency becomes operational
June 2008: Pre-registration open for phase-in (existing) chemicals
December 2008: Chemicals that are not pre-registered have to be registered
December 2010: Registration deadline for chemicals in excess of 1,000 tons annually.
June 2013: Registration deadline for chemicals in excess of 100 tons annually
June 2018: Registration deadline for chemicals in excess of 1 ton annually
If registering an amount greater than 10 tons annually, a comprehensive chemical safety report is required. The report will indicate the planned uses by the manufacturer as well as downstream users, and will address waste management measures for eventual disposal.
For manufacturers and importers outside of the EU, an EU-based representative can be appointed for the purpose of registration. The representative can be a subsidiary, a consultant, or any legal person with experience in chemical handling
Additional Information About Registration:
Substances produced in different EU member states will be covered by one registration under the “one substance – one registration” rule (OSOR)
A consortia of companies producing the same chemical may choose to submit a registration jointly thus reducing individual costs
Importers of the same chemical from several different manufacturers need only register that chemical substance once, providing it is the identical substance
A registrant may request that information (such as disclosure of exact formulas) be kept confidential to safeguard sensitive commercial information
EVALUATION
After registration, it will be the responsibility of the European Chemical Agency (ECHA) to review and evaluate the submitted documentation. The ECHA has the authority, along with EU Member States, to request further data if information is incomplete, or if it appears the chemical or product poses a health or environmental risk. Substances may then be subject to authorization or restriction. (See sections: “Authorization” and “Restrictions”)
The evaluation process will also scrutinize proposals for animal testing, which under REACH is to be reduced to the absolute minimum. The European Community takes seriously the need to reduce needless suffering of laboratory animals and registrants who own an animal test report must share the information, if requested. Fair compensation for their data will be required.
AUTHORIZATION
The authorization process is independent from the registration and evaluation process and applies to chemicals that are identified by the European Chemical Agency as being “substances of very high concern” (SVHC) will be subject to use-specific authorization. Even if the chemical substance is not intended to be released from a finished product (eg. dye in clothing), once it is identified as a SVHC present in a concentration of 0,1% or more, it still requires notification.
Please note: Authorization can apply to chemicals in volumes below the 1 ton per year threshold set for registration.
SVHCs are chemicals considered carcinogens, or mutagenic and toxic to reproduction (CMRs), or persistent, bio-accumulative and toxic substances (PBTs), or very persistent and very bio-accumulative substances (vPvBs). Industry will be required to seek authorization for their use and placement on the market in order to ensure risks are properly controlled, and that alternate substances are used when feasible.
Ultimately, SVHCs will be published in Annex XIII of REACH, based on a candidate list established after dossiers are studied and considered. Those manufacturers or importers using these chemicals in their products will need to demonstrate that risks associated with them are adequately controlled, or that socio-economic benefits outweigh the risk of their use, and that there are no suitable alternatives. When suitable alternatives are available, it is mandatory that the applicant include a substitution plan
There are some substances exempt from authorization, including those already covered by other legislation. Items such as food, substances used in the interest of defense, medicinal products, biocides, radioactive substances, cellulose pulp, and waste are exempt, as are other naturally occurring substances such as: ores; ore concentrates; minerals; crude oil; coal; oxygen; hydrogen; nitrogen; and noble gases. At present, polymers are excluded from REACH, but monomers need to be registered, if present in a quantity greater than 2%, and total tonnage of more than 1 ton annually.
RESTRICTIONS
The restriction clause of REACH allows for any EU Member State to propose that a chemical substance be “challenged” as being harmful and subject to a restriction or ban, similar to European Directive 76/769/EEC (“restrictions on the marketing and use of certain dangerous substances and preparations”). Any chemical substance on its own, or in a solution, or present in an article, may be submitted to the European Chemical Agency to make a final determination on possible restrictions.
The Restrictions and the Authorization stages of REACH are interdependent. Thus, a substance that is restricted at the EU level cannot be authorized for a particular use.
Q) Who will enforce the regulations?
The European Chemicals Agency, based in Helsinki, will manage the registration process, carry out dossier evaluations, coordinate the evaluation process, handle requests for exemptions, facilitate sharing of animal test data, and generally administer the REACH program.
Q) How does REACH impact retailers and other “downstream users”?
There are communication requirements under REACH to ensure that not only manufacturers and importers of chemical substances, but retailers, distributors and consumers (“downstream users”) be provided by the supplier with information for safe use. Information uncovered during the REACH process will primarily be passed along through the familiar avenue of safety data sheets .
The downstream users of chemicals are expected to apply risk management measures for dangerous chemicals. Retailers and distributors alike bear the responsibility of protecting customers, employees in the workplace, and ultimately the environment. The downstream user can also make known their uses to suppliers, so that the suppliers can include their input when they file a chemical safety assessment. A downstream user has the option to conduct their own chemical safety assessment and report the findings for submission to the European Chemical Agency.
Q3) Will REACH provide a list of recognized laboratories for testing data or obtaining information?
REACH is not intended as a testing program, and places the onus on industry to obtain adequate information. It does expect that toxicological or ecotoxicological tests and analyses will be carried out in accordance with Good Laboratory Practice, or other recognized international standards.
Q) What preparation is recommended for REACH?
European and non-European manufacturers and importers need to know what substances are present in their preparations or products to ensure they are complying with the law. Companies should:
Identify the chemical substances they manufacture in or export to Europe, either the chemicals themselves, or in preparations or in finished products.
Check if their substances are covered or exempted from REACH. If they are regulated, they should determine the annual volumes manufactured in or exported to the EU or calculate the weight percentage of that substance in finished goods.
Consider any advisory or legal input to protect the company’s interests.
Engage in dialog with suppliers and customers, in particular to identify uses of substances and weight. Query your suppliers if any of these chemicals are “substances of high concern.” Will any of your substances likely need an alternative?
Consider if there are suitable parties in which one could enter into a consortia.
Access information, such as available studies, and particularly animal testing. Ensure that safety data sheets are available and up-to-date.
US based companies should consider the option of having an EU representative handle the registration on their behalf.
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