On December 18, 2006, the European Parliament and the Council of the European Union adopted a regulation and a directive establishing the REACH system and setting up the European Chemicals Agency. REACH oversees the registration, evaluation and authorization of chemicals. It came into force on June 1, 2007, but most of the provisions will apply as of June 1, 2008. In many respects the European system resembles the Chemicals Management Plan instituted by the Canadian Environmental Protection Act, 1999. The Regulation commits European businesses which manufacture or import chemical substances, on their own, in preparations or in articles (consumer goods) to evaluate and to manage the risks resulting from their use. Manufacturers established outside the European Union which export chemical substances, on their own, in preparations or in articles, may appoint a natural or legal person established in the European Community, as their only representative, to fulfill their obligations. They may also let the importers fulfill the various obligations.
The components of the new regime are set out below.
European businesses which manufacture or import a chemical substance in quantities of one tonne or more per year must register the substance in a centralized database managed by the Agency. A substance that has not been registered cannot be manufactured or placed on the European market. New substances already notified within the meaning of the current legislation are considered to be registered. For substances that need to be registered, it is incumbent upon manufacturers or importers to prove that the risks associated with the substances are properly controlled.
For the purposes of registration, the manufacturer or importer must assemble a technical dossier of the chemical substance which includes its properties, uses and precautions. In addition, a registration submission for a substance imported or manufactured in quantities of more than 10 tonnes per year must include a chemical safety report detailing the risks associated with the substance, the various possible exposure scenarios and the risk management measures.
A special regime will apply to the registration of substances that are present in quantities of one tonne or more per year in articles imported into or manufactured in Europe. Registration will be compulsory when the substance is normally released into the environment when the article is used. For substances that are not normally released but present a specific hazard and are present above a concentration of 0.1% weight by weight, simple notification is required, on the basis of which the Agency may request a registration.
The obligation to register will apply as of June 1, 2008, but a phase-in period, extending until June 1, 2018 in some cases, will be put in place for certain substances.
II. DATA SHARING
The Regulation contains provisions regarding data sharing, in exchange for payment, to reduce testing on vertebrate animals and to reduce the costs to industry. The Regulation also requires that all registrants of the same substance submit their registration together. In addition, all parties up and down the supply chain must receive certain data, such as the identification of the substance, its composition and its properties, measures for risk-free use and transport, accidental release and firefighting measures as well as toxicological and ecological information. These provisions will come into force on June 1, 2008.
Evaluation allows the Agency to verify that industry is fulfilling its obligations and avoiding the use of unnecessary testing on vertebrate animals. Starting on June 1, 2008, two types of evaluation will be possible. Dossier evaluation will be compulsory for all applications involving the most stringent tests that mainly use vertebrate animals. Dossier evaluation in such cases is essentially designed to minimize the need for this type of experiment. Dossier evaluation will also be possible to verify the completeness of a registration. Substance evaluation will be conducted if there are grounds for suspecting a risk to human health or the environment. In such a case, the Agency will include the substance on a list and a designated Member State will conduct an evaluation to determine if further information is required from the registrant.
Starting on June 1, 2008, substances of very high concern will be subject to the authorization of the European Commission. A chemical substance is said to be of very high concern if it may cause cancer, damage genetic material or is toxic to reproduction. Any substance that does not degrade easily in the environment (persistent) and accumulates in living organisms (bioaccumulative) is also of very high concern, even if there is no proof of toxicity. The Agency will keep an updated list of these substances. The goal is to control the related risks and to progressively replace these substances by other substances or technologies if it is economically and technically viable.
If the risks can be adequately managed, authorization will be granted. Otherwise, and if there are no substitutes, the European Commission will consider the level of risk and the socio-economic benefits of using the substance before making a decision.
The restrictions and prohibitions deal with conditions for the manufacturer’s use and placing on the market of a substance. The restrictions will be developed by the Member States or by the Agency. They will come into force on June 1, 2009, except for the restrictions adopted pursuant to the directive currently in force for the management of chemical substances, which will be incorporated into REACH between June 1, 2007 and June 1, 2013.
VI. CLASSIFICATION AND LABELLING INVENTORY
The provisions in this chapter ensure that the classification of all dangerous substances manufactured in, or imported into, the European Union is available to all. Thus, businesses will be required to include all their classifications in the inventory managed by the Agency as of December 1, 2010. However, as of June 1, 2007, harmonized European Union classification and labelling are required for substances that are either carcinogenic, mutagenic or toxic to the reproductive system or are respiratory sensitizers.