The authorisation procedure under REACH Regulation aims to assure that the risks from Substances of Very High Concern are properly controlled and that these substances are progressively replaced by suitable alternatives while ensuring the good functioning of the EU internal market.
In order to achieve these goals, during the authorisation process, European authorities establish a list of substances of very high concern, also known as the candidate list. Substances in the candidate list are gradually included in a definitive list of substances to be prohibited in the EU (Authorization list). Substances subject to authorisation cannot be placed on the market without previous approval by the European Commission.
The candidate list of substances of very high concern, whose substitution is a safety priority, includes substances with the following adverse effects:
Member States evaluate certain substances to clarify whether their use poses a risk to human health or the environment. The selected substances are listed in the Community Rolling Action Plan (CoRAP) . The evaluation may in the end conclude that the risks are sufficiently under control with the measures already in place. Otherwise, it may lead to the proposal of EU-wide risk management measures such as restrictions, identification of substances of very high concern, harmonised classification or other actions outside the scope of REACH.
The CoRAP includes a short description of the initial concern for each substance. In many cases, these initial concerns are related to potential persistency, bioaccumulation and toxicity (PBT), endocrine disruption, or carcinogenicity, mutagenicity and toxicity to reproduction (CMR).
Once a substance has been identified as of very high concern it is included in the candidate list. EU legislation recognizes workers’ and consumers’ right to receive basic information on the use of these substances. Such information must grant safe use and in the workplace, it is included in Safety Data Sheets (SDS) which is mandatory for any product containing a substance of very high concern included in the candidate list.
If any substances included in the candidate list are used at a workplace (on their own or contained in a product) and workers do not have access to the relevant SDS, the situation must be reported to the competent authority.
When a substance of very high concern is included in the REACH Authorisation list, its use is prohibited in the EU, unless authorisation for specific use is granted by the EC.
Therefore any workplace use of a substance included in the authorisation list (on its own or contained in a product) must be reported to the competent authority, whenever the product or substance information does not include an appropriate number that proves that it has been duly authorised.
In any event, elimination or substitution must be the priority preventive measures to be implemented on substances included in the candidate list or the authorisation list. Such chemicals must be replaced by alternative products, technologies or processes that do not pose human or environmental risks.
Council Directive of 12 June 1989 on the introduction of measures to encourage improvements in the safety and health of workers at work (89/391/EEC)
Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC.
Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006.
Council Directive 98/24/EC of 7 April 1998 on the protection of the health and safety of workers from the risks related to chemical agents at work (fourteenth individual Directive within the meaning of Article 16(1) of Directive 89/391/EEC).
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