“REACH” stands for “Registration, Evaluation, Authorization and Restriction of Chemicals”.
The REACH Regulation replaces over 40 earlier measures relating to chemicals produced or supplied in the EU, including legislation on existing and new substances, marketing and use restrictions, and the classification, packaging, and labeling of dangerous substances.
REACH became law throughout the EU on 1 June 2007, but deadlines for complying with its provisions vary.
REACH requires the registration and testing of all chemical substances manufactured in, imported into or used in the EU in volumes of 1 tonne per year (tpy) or more between 2008 and 2018, even those intended for export to third countries (around 30,000 chemicals). The most harmful chemicals will be phased out.
Thus compliance with REACH raises major technical and scientific, product management and marketing issues, and introduces important new responsibilities not only for the chemicals industry itself, but also for manufacturers and importers of finished products (“articles”) that contain chemicals.
REACH makes the manufacturers, importers and industrial or professional downstream users (DU) of all chemicals or preparations responsible for proving they are safe. DU formerly only had to provide information on chemicals classified as dangerous and supplied with a Safety Data Sheet (SDS) further down the supply chain.
REACH is not just environmental law. It also raises many other important legal matters: Intellectual Property Rights (IPR) protection; contracts with suppliers and customers; antitrust issues; and potential customs and trade law problems.
REACH will have far-reaching effects in third countries as well as Europe, for both the chemical industry itself and for DU and manufacturers and exporters of finished products.
Basic Facts About REACH
- REACH applies to virtually all individual chemical substances manufactured in, imported into or used as intermediates in the EU or placed on the EU market, on their own or in preparations or articles, whether or not they are classified as dangerous and even if they are ultimately exported.
- REACH affects EU manufacturers of substances, preparations and, in some conditions, articles, and EU importers of substances, preparations and articles produced in third countries. Third-country manufacturers are not directly affected, but they must either provide their EU importers with detailed information on the substances they supply or incorporate in their articles, or appoint a single EU-based legal representative to handle compliance with all their REACH obligations. EU-based DU also have significant obligations under REACH.
Registration and data-sharing
- All substances manufactured in the EU or imported in quantities of 1 tpy or more, dangerous or otherwise, must be registered with the European Chemicals Agency (ECHA). Substances not registered may not be manufactured in or imported into the EU (“no data, no marketing”).
- Registration of a chemical involves compiling and filing basic toxicity, exposure and other data on its health and safety factors and selecting appropriate risk management measures for it, to prove it is safe for all uses intended by any member of the supply chain or notified by an immediate DU. This will entail obtaining information from clients on how they use a chemical.
- DU should normally tell suppliers how they use a substance, so the use can be included in the supplier’s risk assessment. If they want to keep their use confidential or use a substance outside the conditions described by the supplier, they must carry out their own risk assessment and notify the use separately to the ECHA. This could prove very costly.
- The timing of registration and the information required vary according to the tonnage in which a substance is manufactured in or imported into the EU and how dangerous it is. Pre-registration of (phase-in) substances listed in the European Inventory of Existing Commercial Chemical Substances (EINECS) begins in 2008.
- The phase-in information will be used to organize forums where registrants of the same substance can try to agree to share data on existing studies and tests of the substance or arrange for new studies or tests.
- Operators will need to audit substances manufactured or imported in quantities of 1 tpy or more. If substantial and reliable data on the safety aspects of a substance are not available, they may have to be obtained from other registrants or scientific experts. Registration will generate substantial costs for all operators in the supply chain.
- Manufacturers and importers of the same substance can set up consortia for joint registration (“One Substance – One Registration” - OSOR). This may save them time and money, but before joining a consortium they should take specialized legal advice on whether this is really their best option. Managing collaboration between members will require resources, and the need for generalized datasharing will limit members’ freedom to choose their partners. Other factors to consider include the consortium’s opt-out rules, cost-sharing, the value of the information shared, IPR protection and the antitrust rules.
- The ECHA will verify that a substance dossier contains full information and complies with the requirements for registration, and will check testing proposals before any tests are performed (dossier evaluation). If the evaluation suggests the substance may cause a risk to health or the environment, the ECHA may request further information (substance evaluation). A substance can still be marketed during evaluation, but the ECHA may decide it should be subject to authorization or even to EU-wide restrictions.
- Particularly dangerous Substances of Very High Concern (“SVHC”) will eventually be subject to authorization. Authorization is use-specific and will only be granted if it can be shown that the risks arising from the uses made of the substance are adequately controlled, or that the socio-economic benefits of using it outweigh the risks connected with its use, and there are no suitable alternative economically and technically viable substances or technologies. REACH aims to phase out SVHC, so authorization should be considered as temporary while a safer alternative is sought.
- The ECHA will draw up a “candidate list” of some 1500 substances which will eventually be subject to authorization. Although only 25-30 of them will have to be authorized each year, there will probably be market pressure to replace them with less dangerous substances before authorization is actually required.
- Because of the risks and authorization requirements associated with SVHC, operators must identify any potential SVHC among the substances they manufacture or import as early as possible.
Articles (finished products)
- All substances present in articles in quantities of more than 1 tpy which are intended for release from the articles during normal and reasonably foreseeable conditions of use must be registered. SVHC in articles above a concentration limit of 0.1% weight by weight (w/w) and above 1 tpy must be notified to the ECHA, unless their exposure to humans and the environment during normal conditions of use, including disposal, can be excluded.
- Manufacturers and importers of articles should verify whether the articles are subject to REACH, and whether they may need to register/notify substances in the articles so they can be sold in the EU. They will also have to monitor the work of the ECHA, particularly to identify possible categorization of substances as SVHC.
- Operators must ensure that substances are manufactured, imported or placed on the market prudently and responsibly, so that they do not affect human health or the environment adversely under reasonably foreseeable circumstances.
- Member States must introduce “effective, proportionate and dissuasive” penalties for noncompliance with REACH, but national penalties may vary widely. REACH may also affect tort and contractual liability.
The European Chemical Agency
- The ECHA in Helsinki is at the core of the REACH system. It will play a key role in providing the Commission, the Member States and other players with technical expertise and manage the technical, scientific and administrative aspects of REACH. It also has significant decision-making powers, and its appeal board provides judicial review.