What is REACH?
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Chemical substances form an unmistakable part of our world. They are processed in numerous products that we use each day, such as toys, furniture, cleaning materials, paints, medicines, clothing, etc. and they play an important part in the economy. Unfortunately, we must also observe that a large number of these substances comprise problems as regards health and the environment. This is partly a consequence of shortcomings in current European legislation that has allowed the commercialisation of numerous chemical substances without us really knowing their influence on human health and the environment. The acronym REACH stands for the Registration, Evaluation and Authorisation of Chemicals, and is the new European Regulation (1907/2006/EC) for chemicals. Regulations contain rules that directly apply to all people in the countries of the European Union. They have the same effect as national laws in each of the countries. As a result, REACH is directly applicable in all its parts in each Member State. During the session of 13 December 2006, the European Parliament voted by a large majority (529 for, 98 against) for an amended version of the Regulation, for which a compromise was reached with the Council of Ministers. Five days later, on 18 December 2006, President Borrell of the European Parliament and Finnish Prime Minister Vanhanen signed the Regulation. This entailed REACH being formally adopted. The final text of the Regulation appeared in the Official Journal of 30 December 2006. At the start of 2007 legal translators started examining the text thoroughly to ensure coherence between the different language versions of REACH. If necessary, a corrected version of the Regulation will appear in the Official Journal in the course of 2007. The REACH Regulation came into force on 1 June 2007. The first year after coming into force will mainly be devoted to setting up the new European Chemicals Agency (= ECHA) in Helsinki, the approval of the application modalities and the reviewing of certain annexes. Only one year after coming into force a start will be made on the first registrations. The purpose of this Regulation is to ensure a high level of protection of human health and the environment, including the promotion of the development of alternative methods for the assessment of hazards of substances. In addition, the Regulation aims to ensure the free movement of substances on the internal market, while enhancing competitiveness and innovation. Transparency must also increase, and the fragmentation of the internal market must be prevented. REACH is based on the principle that manufacturers, importers and downstream users must ensure that they manufacture, place on the market or use substances that do not adversely affect human health or the environment. REACH is based on the precautionary principle. To achieve these objectives companies producing, importing, processing or supplying chemical substances to customers must inventory the risks of the substances. The basis of the risk inventory entails obtaining information about the properties, use and danger with exposure to the chemicals. REACH changes nothing regarding the methodology of the risk assessment of a substance, but transfers responsibility for its completion for a large part to the producer or importer. REACH therefore shifts responsibility for the risk management of chemical substances to industry, so it is no longer a responsibility of the government as provided for by the current system. To this end, a system has been conceived in which the producer or importer must register all substances that they produce or import in the European Union. Registration is compulsory if the quantity of a substance is more than 1 ton a year per company. Substances with a volume of less than 1 ton a year per manufacturer or importer are exempted from the registration obligation. This does not detract from the fact that manufacturers and downstream users must assess the danger aspects of the substances involved. If applicable they must classify and characterise the substance. The Regulation states that chemical substances may only be manufactured or marketed in the European Community if they are registered. This applies to the substances themselves, substances in preparations, and in some cases substances in objects. REACH takes into account the tonnage class of the substance, and provides both in a number of exceptions and in progressive implementation. With the exception of a number of specific substance categories, all substances are in principle covered by REACH. All substances (as a substance, in a preparation or processed in an object) produced or imported inside the EU in quantities of over 1 ton a year per manufacturer/importer must comply with all REACH obligations. REACH is not applicable to:
Moreover, some groups of substances have been exempted from certain important obligations within the context of REACH. This concerns the following groups of substances and situations:
To simplify the practical workability of REACH, together with the participation of experts from groups of parties concerned, the Commission has started REACH Implementation Projects (RIPs) in preparation of this Regulation. Some projects are aimed at the drawing up of guidelines and the development of resources (manuals and IT tools) to assist the Commission, the European Chemicals Agency, the Member States, the manufacturers, the importers and downstream users of substances to suffice with regard to the obligations in real terms. Most are still in progress. Despite the fact that the legislation has already been adopted the details are currently still being finalised. On the web site of the European Chemicals Bureau (http://ecb.jrc.it/reach/rip/; documents; public access) the final versions of these RIPS are published. |
