The REACH Regulation is the Regulation (EC) No 1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals, entered into force on 1 June 2007. It is binding legislation and directly applicable in all Member States. The most important objectives of the Regulation are to ensure a high level of protection of human health and the environment, to enhance the competitiveness of the chemical industry within the EU, and to guarantee the free movement of goods in the single European market.
The REACH Regulation assigns the industry with increased responsibility regarding potential risks that may arise from chemicals to health and the environment. It has transferred the responsibility for providing proof of chemicals safety from the authorities to the industry. The Regulation applies to substances as such, and substances in mixtures and articles.
The CLP Regulation (EC) No 1272/2008 on the Classification, Labelling and Packaging of Substances and Mixtures, significant for to the REACH Regulation entered into force on 20 January 2009. Apart from the articles related to classification, labelling and packaging, the CLP Regulation articles 57–59 lay down certain amendments to the REACH Regulation, which has seen a great number of corrigenda and amendments to date.
In Finland the Finnish Safety and Chemicals Agency (Tukes) acts as the competent authority regarding the REACH and the CLP Regulations, which oblige the national competent authorities to maintain a national helpdesk from which entrepreneurs and businesses can get answers to their questions about the scope of application of the Regulations.
Around 30,000 chemicals registered
All substances manufactured or imported in quantities totalling over one tonne per year must be registered in the REACH database managed by the European Chemicals Agency. There are around 30,000 of such chemicals used in Europe, with new substances entering the EU market at a rate of around 300 a year. The registrations will take place in three phases by the year 2018. Substances not registered may not be manufactured or imported.
The registration requires that chemicals manufacturers and importers acquire information about issues including the hazardous properties, uses and safe handling of the substances. Today the majority of the 30,000 substances in use are such that there is not sufficient information about their health or environmental effects.
Reports must also be submitted to the Agency on substances which are intended to be released from articles as well as those that are particularly hazardous.
Safety-related information must be conveyed throughout supply chains to ensure the safe and responsible conduct of enterprises such as those using chemicals in their own manufacturing processes.
Documents and substances are evaluated
The European Chemicals Agency evaluates whether registration dossiers are compiled as required. The Agency also examines all testing proposals that call for animal testing with the objective of preventing unnecessary animal testing.
Authorities in the Member States evaluate substances that are suspected of posing a risk to human health or the environment. Evaluation may lead to action being taken under the restriction or authorisation procedures.
Restrictions and authorisations
The European Commission may use the restriction procedure to introduce conditions for or prohibitions of the manufacture, use or placing on the market of a substance if the substance poses a significant risk to health or the environment.
The use of the most hazardous substances will be subjected to authorisation. The authorisation procedure applies to substances that cause serious long-term adverse effects to health or the environment (such as carcinogens and persistent and bioaccumulative substances). Authorisation applications are processed by the European Chemicals Agency and authorisations are granted by the European Commission.
European Chemicals Agency
The European Chemicals Agency (ECHA) was established in Helsinki under the REACH Regulation. The Agency's duties include maintaining the chemicals database, receiving the registration dossiers, administering the authorisation procedure, making recommendations about chemicals risk reduction and providing guidance to manufacturers, importers and competent authorities.
The Agency also houses the following scientific and technical committees:
- the Committee for Risk Assessment
- the Committee for Socio-economic Analysis
- the Member State Committee
- the Forum for Exchange of Information on Enforcement.
The Committees play a key role in the practical implementation of the REACH Regulation. Their members are appointed on the basis of nominations by EU Member States, and stakeholder representatives may also be invited to participate as observers.
The Agency's work is directed and supervised by the Management Board. For more information about the Agency, its tasks and organisation visit the ECHA website.
Substances of very high concern (SVHCs) in articles
Substances of very high concern are carcinogenic, mutagenic, toxic for reproduction or persistent, bioaccumulative or toxic. The list of these substances, the Candidate List, has been published on the European Chemicals Agency website, and is updated regularly. Manufacturers or importers of articles must provide sufficient information about the safe use of the article to the recipient and, on request, consumers if a substance included in the Candidate List is present in the article above a concentration of 0.1% by weight. This duty of information provision enters into force as soon as the substance is published in the Candidate List.