In October 2003, the European Commission started drafting proposals for a new system regulating manufacturing, marketing and using chemical substances and their mixtures and products aiming to improve the previous EU legislation on chemical substances. Nine Commissions of the European Parliament, the Council of Ministers, the REACH Development Commission, four political parties (EPP-ED, PES, ALDE, UEN), CEFIC (European Chemical Industry Council) and other public organizations participated in drafting and amending the legislation.
On 13 December 2006, the European Parliament adopted in the second reading the REACH Regulation, new legislation regulating manufacturing, marketing and use of chemical substances. The official signing of the final text of REACH Regulation No. 1907/2006 was held in Brussels on 18 December 2006.
The REACH Regulation was published in the Official Journal of the EU on 30 December 2006, the amendments to the text were published on 29 May 2007. This Regulation entered into force on 1 June 2007.
The European Chemicals Agency (ECHA) established on 1 June 2007 in Helsinki, Finland manages the main aspects of the REACH system.
The REACH Regulation is based on such important elements as:
- Registration: manufacturers or importers shall register all chemical substances except for a number of chemicals outside the scope of the REACH Regulation. Manufacturers and importers are required to submit a Technical Dossier for substances produced or imported in quantities above 1 tonne per year and a Chemical Safety Report for substances produced or imported in quantities above 10 tonnes per year. Moreover, downstream users of products will need to ensure that their specific use of this substance is also registered.
- Evaluation: the European Chemicals Agency (ECHA) will evaluate the Technical Dossier and industry proposals for testing of a specific chemical substance. The Agency will also coordinate the evaluation of the substance by the Member States of the EU, which aims to identify chemicals that exceed the permissible level of risk.
- Authorization: The use of substances with properties of very high concern (carcinogenicity, mutagenicity, reproductive toxicity, environmental resistance and bioaccumulation) and their placing in the market for a particular use will be subject to an authorization requirement. The European Chemical Agency publishes a list of substances that fall into this category.
- Restriction: Manufacturing, placing in the market or the use of specific hazardous chemicals of very high concern may be restricted or prohibited.
- Agreed Classification and Labelling: Inventory of classification and labelling of hazardous chemicals will help intensify the process of harmonizing the classification of a specific substance within the industry.
- Access to Information: The rules of the REACH Regulation on Access to Information include public access to information via the Internet, the current system of information requests and specific rules for the protection of confidential business information.
The REACH Regulation applies to the Member States of the European Union, as well as to Iceland, Norway and Liechtenstein, members of the European Economic Area (EEA). However, importers and manufacturers established outside the EEA must take into account the requirements of the REACH Regulation in trade relations with European companies.
According to Article 8 of the REACH Regulation, non-European manufacturers may (but are not required to) designate a single representative who is a resident of the EEA to fulfil the REACH obligations. In the case of the appointment of a single REACH representative in the EEA, the manufacturer outside the EEA should inform European downstream importers about their appointment. In this case, European importers under REACH will be treated as downstream users.