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 shifts a large part of the responsibility to manage the risks of chemicals for health and environment on industry.
Pre Registraton: Manufacturers and importers could pre-register substances (“phase-in-substances”) that were already in the Substance Inventory (EINECS). 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 these data and assessments to the European Chemicals Agency (ECHA).
Evaluation: ECHA will evaluate the conformity of the dossier and, if applicable, the testing proposals made by the registrant. ECHA will also coordinate substance evaluation, which will be conducted by the Member States and allows for a more in-depth risk assessment of certain chemicals of concern.
Authorisation: Authorisation will be required for those 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 for authorisation have to investigate the possibility of substitution with safer alternatives or technologies, and prepare substitution plans, if alternatives are available.
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 groups of substances if unacceptable risks to humans or the environment have been identified.
Classification and labelling inventory: The classification and labelling inventory is operated by ECHA and contains classifications submitted by industry for substances put on the market (not quality checked and including substances below 1 tonne/year if classified as dangerous) and information on classification and labelling included in registration dossiers.
Aim of authorisation and considerations for substitution
The aim of REACH 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 adequately 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 mentioned in Art. 64(4) a-b.
(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 will in general still be allowed to be manufactured and placed on the market. However, use may only take place under the conditions defined in the restriction. There may be exemptions for substance used for scientific research and development. Out of the substances, groups of substances and preparations which have so far been 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 (related to substitution): Only for existing installations purchased before 1 October 1985 the Member States may permit the use of PCTs under certain conditions, where for technical reasons it is not possible to substitute.
#23. Cadmium and its compounds (related to substitution):
Conditions of restriction: The Commission shall, in consultation with the Member States, assess if any substitutes or techniques for substituting cadmium and its compounds have been developed.
#51. The following phthalates: bis (2-ethylhexyl) phthalate (DEHP), dibutyl phthalate (DBP), benzyl butyl phthalate (BBP)
Conditions of restriction (related to substitution): The Commission shall re-evaluate, by 16 January 2010, if there is any knowledge of substitutes for these compounds. The respective report has been prepared by ECHA.
In 2018, the restriction (now extended with di-isobutylphtalate (DIPB)) was rephrased and implemented by the Commission. For more information, please click here.
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.
Termination of use and substitution of a substance are required if manufacturing, use or placing on the market of that substance causes an unacceptable risk to human health or to the environment.
7.1 Studies or publications about the legislation or its impact
7.2 Other relevant legislation
The successive amendments and corrections to Regulation (EC) 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: 21.06.2019