EU / December 2006 / July 2009
European Union Regulation, to be implemented by all EU Member States according to the subsidiary principle by their means.
REACH is the Regulation for Registration, Evaluation, Authorisation and Restriction of Chemicals. It entered into force on 1st June 2007 to streamline and improve the former legislative framework on chemicals of the European Union (EU). REACH places greater responsibility on industry to manage the risks that chemicals may pose to the health and the environment.
Pre Registraton: Manufacturers and importers must pre-register substances that are already on the EU market. The pre-registration period was established from 1 June 2008 to 1 December 2008.
Registration: REACH requires manufacturers and importers of chemical substances (larger than or equal to 1 tonne/year) to obtain information on the physicochemical, health and environmental properties of their substances and use it to determine how these substances can be used safely. Each manufacturer and importer must submit a registration dossier documenting the data and assessments to the European Chemicals Agency (ECHA).
Evaluation: ECHA will evaluate the dossier to assess the testing proposals made by the registrant to check that the registration dossiers comply with the requirements. ECHA will also coordinate substance evaluation, which will be conducted by the Member States to investigate more in depth chemicals of concern.
Authorisation: Authorisation will be required for the prioritised substances of very high concern (SVHC) that are included in Annex XIV.
Companies applying for authorisation will have to demonstrate that risks associated with uses of these substances are adequately controlled or that the socio-economic benefits from their use outweigh the risks.
Applicants will also have to investigate the possibility of substituting theses substances with safer alternatives or technologies, and prepare substitution plans, if appropriate.
Restrictions: The European Union can impose restrictions and prohibit or set conditions for the manufacture, placing on the market or use of certain dangerous substances or group of substances when unacceptable risks to humans or the environment have been identified.
Classification and labelling inventory: A classification and labelling inventory will be developed by ECHA from notifications submitted by industry on substances (including those below 1 tonne/year if classified as dangerous) and from information on classification and labelling included in registration dossiers.
Aim of authorisation and considerations for substitution
The aim of Title VII Authorsisation is to ensure the good functioning of the internal market while assuring that the risks from substances of very high concern are properly controlled and that these substances are progressively replaced by suitable alternative substances or technologies where these are economically and technically viable. To this end all manufacturers, importers and downstream users applying for authorisations shall analyse the availability of alternatives and consider their risks, and the technical and economic feasibility of substitution.
Granting of authorisations
4. If an authorisation cannot be granted under paragraph 2 (referring to evidence that the risks are properly controlled), an authorisation may only be granted if it is shown that socio-economic benefits outweigh the risk to human health or the environment arising from the use of the substance and if there are no suitable alternative substances or technologies. This decision shall be taken after consideration of all of the following elements and taking into account the opinions of the Committee for Risk Assessment and the Committee for Socio-economic Analysis
(a) the risk posed by the uses of the substance, including the appropriateness and effectiveness of the risk management measures proposed;
(b) the socio-economic benefits arising from its use and the socio-economic implications of a refusal to authorise as demonstrated by the applicant or other interested parties;
(c) the analysis of the alternatives submitted by the applicant under Article 62(4)(e) (see below) or any substitution plan submitted by the applicant under Article 62(4)(f), and any third party contributions submitted under Article 64(2) (containing information on alternative substances or technologies);
(d) available information on the risks to human health or the environment of any alternative substances or technologies.
5. When assessing whether suitable alternative substances or technologies are available, all relevant aspects shall be taken into account by the Commission, including:
(a) whether the transfer to alternatives would result in reduced overall risks to human health and the environment, taking into account the appropriateness and effectiveness of risk management measures;
(b) the technical and economic feasibility of alternatives for the applicant.
Review of authorisations
1. A holder of an authorisation granted in accordance with Article 60 shall submit an update of the analysis of alternatives referred to in Article 62(4)(e), including information about any relevant research and development activities by the applicant, if appropriate, and any substitution plan submitted under Article 62(4)(f) . If the update of the analysis of alternatives shows that there is a suitable alternative available taking into account the elements in Article 60(5), he shall submit a substitution plan, including a timetable for proposed actions by the applicant. If the holder cannot demonstrate that the risk is adequately controlled, he shall also submit an update of the socio-economic analysis contained in the original application.
2. Authorisations may be reviewed at any time if:
(a) the circumstances of the original authorisation have changed so as to affect the risk to human health or the environment, or the socio-economic impact; or (b) new information on possible substitutes becomes available.
3. In its review decision the Commission may, if circumstances have changed and taking into account the principle of proportionality, amend or withdraw the authorisation, if under the changed circumstances it would not have been granted or if suitable alternatives in accordance with Article 60(5) become available. In the latter case the Commission shall require the holder of the authorisation to present a substitution plan if he has not already done so as part of his application or update.
Applications for authorisations
4. An application for authorisation shall include the following information:
(e) an analysis of the alternatives considering their risks and the technical and economic feasibility of substitution and including, if appropriate information about any relevant research and development activities by the applicant;
(f) where the analysis referred to in point (e) shows that suitable alternatives are available, taking into account the elements in Article 60(5), a substitution plan including a timetable for proposed actions by the applicant.
Restrictions on the manufacture, placing on the market and use of certain dangerous substances, preparations and articles.
A substance that is restricted in Annex XVII must not in general be manufactured, placed on the market or used. There may be exemptions for substance used for scientific research and development. Out of the 52 substances, groups of substances and preparations listed in Annex XVII three have restriction conditions specifically related to substitution:
1. Polychlorinated terphenyls (PCTs). Preparations, including waste oils, with a PCT content higher than 0,005 % by weight.
Conditions of restriction (involving substitution): Only for existing installations purchased before 1 October 1985 the Member States may permit the use of PCTs under certain conditions, where it is not possible for technical reasons to use substitute articles.
23. Cadmium and its compounds (involving substitution):
Conditions of restriction: The Commission shall, in consultation with the Member States, assess if there are developed any substitutes or techniques for substituting cadmium and its compounds.
51. The following phthalates: bis (2-ethylhexyl) phthalate (DEHP), dibutyl phthalate (DBP), benzyl butyl phthalate (BBP)
Conditions of restriction (involving substitution): The Commission shall re-evaluate, by 16 January 2010, if there is any knowledge of substitutes for these compounds.
An important objective of this Regulation is to encourage and, when possible, to ensure that substances of very high concern are eventually replaced by less dangerous substances or technologies where suitable economically and technically viable alternatives are available.
All applicants for authorisation should provide an analysis of alternatives considering their risks and the technical and economic feasibility of substitution.
Substitution of a substance is required when manufacturing, use or placing on the market of that substance causes an unacceptable risk to human health or to the environment, considering the availability of suitable safer alternatives.
7.1 Studies or publications about the legislation or its impact
7.2 Other relevant legislation
The successive amendments and corrections to Regulation (EEC) No 1907/2006 have been incorporated into the original text.
AMENDMENTS TO THE ANNEXES
More detailed information on the above documents can be found here.
Last update: 18.11.2010