REACH is a new European Community Regulation on chemicals and their safe use (TEXT OF THE REGULATION). It deals with the Registration, Evaluation, Authorisation and Restriction of Chemical substances. The new law entered into force on 1 June 2007.
The aim of REACH is to improve the protection of human health and the environment through the better and earlier identification of the intrinsic properties of chemical substances. At the same time, innovative capability and competitiveness of the EU chemicals industry should be enhanced. The benefits of the REACH system will come gradually, as more and more substances are phased into REACH.
The REACH Regulation gives greater responsibility to industry to manage the risks from chemicals and to provide safety information on the substances. Manufacturers and importers will be required to gather information on the properties of their chemical substances, which will allow their safe handling, and to register the information in a central database run by the European Chemicals Agency (ECHA) in Helsinki. The Agency will act as the central point in the REACH system: it will manage the databases necessary to operate the system, co-ordinate the in-depth evaluation of suspicious chemicals and run a public database in which consumers and professionals can find hazard information.
The Regulation also calls for the progressive substitution of the most dangerous chemicals when suitable alternatives have been identified. For more information read: REACH in Brief.
REACH has been developed in a climate of transparency and consultation. The Commission has held extensive dialogue with stakeholders before and after the proposal was presented. Stakeholders sent over 6000 responses during the REACH internet consultation and contributed to the REACH Impact Assessment both before and after the launch of the Commission REACH proposal in 2003. This helped the Commission to improve the design and cost-effectiveness of the system and subsequently the European Parliament and the Council of the European Union to amend the proposal under the co-decision procedure.
REACH provisions will be phased-in over 11 years. Companies can find explanations of REACH in the guidance documents and can address themselves to a number of helpdesks.
What chemicals REACH governs?
The provisions of REACH cover nearly all chemicals, however, a number of chemicals, such as plant protection products, biocides, medicinal products, cosmetics and food or feed additives, regulated by other EC law, are excluded from the scope of some or almost all provisions of the Regulation.
Does REACH affect my business?
REACH directly affect my business if I:
- Manufacture or import (from outside the EU) mixtures or chemical substances,
- Manufacture or import (from outside the EU) goods (construction materials, electronics, toys, machinery, spare parts, textiles and a number of others), which contain substances specified in Article. 57 of the Regulation, or that intentionally release chemicals during the application.
Provisions of the regulation also applies to producers of mixtures (paints, varnishes, oils, cleaners, and several others) and to some extent also professional users of chemicals.
REACH may also indirectly affect on my business, through its impact on the suppliers of chemicals purchased by me in the EU and beyond.
Why the REACH regulation has been created?
The former system for the control of chemicals in the European Union was based on a series of directives and regulations, which have been created over several decades. In this framework, there were separate rules for “existing” and “new” substances. Unfortunately, the system has not met the expectations. It was not possible to use it to get sufficient data about the effects of most substances on human health and the environment.
The term “Existing Substance” covered all the substances that were present at the European market in the period 1971-1981 (ca. 100 000) A “new” substances was considered any substance, which appeared on the European market after 19 September 1981.
Due to the fact that the obligation of detailed testing concerned only the “new” substance, no adequate information was available on the vast majority of substances present in the European market. It was impossible to effectively controll the risks posed by these substances.
The REACH Regulation amends this situation. In this framework, adopted a series of changes aimed at improving management and supervision of trade in chemicals in the European Union. There is no more division on “new” and “existing” chemicals – they are both covered by the REACH system. The burden of responsibility for carrying out a risk assessment and testing of the substance has been moved from the authorities to the industry. Manufacturers and importers are obliged to make the registration of substances. Downstream users have been introduced into to the system, so that information about the risks posed by the substances could be found in the entire supply chain.
The basic goals of the system created by the REACH regulation are:
- Protecting human health and the environment;
- Maintaining and strengthening the competitiveness of the European chemicals industry;
- Prevent the fragmentation of the internal market;
- Strengthening transparency;
- Integration of European activities with the activities taking place in the international arena;
- Reduce to a minimum research on vertebrate animals;
- Compliance with the EU’s WTO obligations.
For further information please consult the website of the ECHA
General obligation to register is based on Article 5 of the REACH regulation, under which:
Substances on their own, in preparations or in articles shall not be manufactured in the Community or placed on the market unless they have been registered in accordance with the relevant provisions of this Title where this is required.
Almost all chemicals are subject to provisions of the REACH Regulation, however, a number of chemicals, such as plant protection products, biocides, medicinal products, cosmetics and food additives or feed, are regulated by other community provisions. They are excluded from the activities of some or almost all of the provisions of Regulation. Substances derived from nature, unless they are dangerous and have not been chemically modified are exempted from registration.
With regard to certain categories of chemicals, the provisions of the REACH regulation does not apply or apply to a limited extent.
Registration is the process by which any manufacturer or importer (or producer of articles), of a substance within the scope of REACH must submit prescibed information to ECHA.
After creating a REACH-IT user account, and before submitting a registration, a company should either have pre-registered during the pre-registration phase or pre-register as a ‘late comer’ or submit an inquiry. When a substance is manufactured or imported by more than one company, these companies are required to submit certain information together (see Guidance on data sharing). This is called the joint submission of data.
For substances manufactured or imported at more than 10 tonnes per year, and where a Chemical Safety Report (CSR) is required, a format is being developed as part of the Guidance for Chemical Safety Report (to be made available in the Formats section of the ECHA guidance web pages).
For further information, incl. on practial issues, please consult following websites:
Source: Webiste of the European Chemicals Agency (www.echa.eu) and the website of the European Commission (http://europa.eu/agencies/community_agencies/echa/index_en.htm).