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Obligation for Authorisation for Substances of very High Concern

How we are engaged in the authorisation process in accordance with the REACH Regulation

REACH envisages an authorisation obligation for substances of very high concern (SVHCs). This means that the risks that they pose should be properly controlled and efforts should be made to promote their substitution. We can propose substances which we believe to be of very high concern.

Participation of the REACH Assessment Unit OSH

The REACH Regulation aims to promote incentives for substituting substances of very high concern (SVHCs) with less hazardous alternatives. For this purpose, the competent authorities in the Member States are able to initiate an obligation for authorisation for substances, the use of which may pose a risk to human health or the environment.

In this respect, the REACH Assessment Unit OSH considers substances that have hazardous properties. In particular, it focuses on substances which are carcinogenic, mutagenic or toxic to reproduction. Besides, substances which properties give rise to an equivalent level of concern are considered.

For this purpose, it examines different uses and the associated exposure of workers across Europe and at least in Germany. This examination does not focus on exposure in specific individual companies but, according to realistic estimates, rather on an assessment of the degree of risk in various sectors. The analysis is supplemented by discussions with companies, trade associations, trade unions and further stakeholders.

If the Assessment Unit comes to the conclusion that exposure and the associated risks to workers cannot be excluded, it summarises these results in a report. This report is sent to the European Chemicals Agency (ECHA) in the form of a dossier in accordance with Annex XV of the REACH Regulation. In its turn, this triggers a regulatory process in the European Union.

Inclusion in the candidate list and in Annex XIV

Once the dossier has been reviewed and discussed by the Member States Committee (MSC) which is part of ECHA, the substance can be included in the candidate list. For manufacturers or importers of a substance, this triggers information obligations (according to Article 7(2) and 33 of REACH).

Substances in the candidate list can be proposed by the MSC for inclusion in Annex XIV of REACH. The corresponding decision is taken by the European Commission.

If a substance is listed in Annex XIV, subsequent to a specified transitional period ending with the sunset date), it may no longer be used. It may still be used, however, if an authorisation is granted to the manufacturers and users upon their corresponding application.

Opportunities to comment for involved actors and interested parties

During the course of the process involved actors and interested parties have several opportunities to comment. The first opportunity occurs when a substance is named publicly in the Public Activity Coordination Tool (PACT). In a consultation process initiated by Germany, the Assessment Units gather information with the purpose of determining the most appropriate risk management measure for the corresponding substance. Following the assessment of the comments, the possible risk management options are analysed and a decision is made regarding the further approach. The results are reported in a so-called Risk management options analysis (RMOA).

Additional opportunities are available to comment at the European level during the procedure for inclusion in the candidate list and in the scope of the procedure for inclusion in Annex XIV.

Up to now the REACH Assessment Unit OSH has proposed the following substances for identification as SVHC:

  • Aluminosilicate Refractory Ceramic Fibres
  • Zirconia Aluminosilicate Refractory Ceramic Fibres
  • 4.4'-Diaminodiphenylmethane (MDA) (Annex XIV: Entry no. 2)
  • Formaldehyde, oligomeric reaction products with aniline (Technical MDA) (Annex XIV: Entry no. 23)
  • Chromium trioxide (Annex XIV: Entry no. 16)
  • Acids generated from chromium trioxide and their oligomers (Annex XIV: Entry no. 17)

Other tasks

Further Information

REACH

Registration, evaluation, authorisation and restriction of chemicals.

Find out more : The REACH Regulation …