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Candidate List of Substances of Very High Concern for Authorisation

The REACH Regulation sets up a system under which the use of SVHCs and their placing on the market may be made subject to authorisation. The aim of authorisation, besides ensuring the functioning of the internal market through an equal treatment of such substances, is to ensure that risks from SVHCs 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, consider their risks, and the technical and economic feasibility of substitution (Art. 55).

The substances that may be included in the authorisation system have intrinsic hazardous properties of such concern that the Community needs to decide about the adequacy of the control of the risks arising from their uses or whether the socio-economic benefits outweigh the risks arising from the use of such substances.

When an Authority (Commission or Member State) considers that a substance may meet the criteria for identification as a SVHC, the Authority (Agency or Member State) will prepare an Annex XV dossier (see also Guidance on identification of SVHC for details). Following completion of an Annex XV dossier the Agency shall publish a notice that an Annex XV dossier has been prepared for a substance. The substance may be included in the ‘candidate list’ for possible inclusion in Annex XIV through a procedure specified in Art. 59. Interested parties, Member States and Agency may comment during this procedure. The Agency shall publish the ‘candidate list’ on its website
with an indication which substances within this ‘candidate list’ are on its work programme. The Agency shall make further ecommendations on substances to be included in Annex XIV at least every second year. Priority will normally be given to substances with PBT or vPvB properties, with wide dispersive uses or that are manufactured or imported in high volumes

According to Art. 58, the Commission, through the regulatory procedure with scrutiny (Art.133(4)), shall include substances in the Annex XIV (list of substances which are subject to authorisation), considering the capacity of the Agency to process the authorisation applications, and shall specify:
(1) the identity of the substance;
(2) the intrinsic properties of the substance;
(3) the date after which the placing on the market and all uses are prohibited (called the sunset date), except for those uses for which either an authorisation was granted or an application has been submitted to the Agency at least 18 months before the sunset date;
ECHA will develop the prioritisation method while gaining experience during the development of the draft recommendations of priority substances to be included in the List of Substances subject to Authorisation.
(4) the date(s) at least 18 months before the sunset date by which authorisation applications must be received if the applicant wishes to continue to use the substance or place it on the market for certain uses after the sunset date; which also grant provisional continuation of the use after the sunset date until a decision has been taken,
(5) review periods for certain uses, if appropriate, and
(6) the uses and categories of uses which would be exempt from the requirements to apply for authorisation, if any and the conditions for such exemptions if they apply .

Once a substance (or a group of substances meeting the definition of a group of substances from Section 1.5 of Annex XI, see also Art. 62(3)) from the ‘candidate list’ is included in Annex XIV, it can only be used or placed on the market by any manufacturer, importer or downstream user for any use of the substance on its own, in a preparation or the incorporation into an article if:

the use has been authorised to himself or an immediate downstream user or his supplier, or
the use is exempted from the authorisation requirement, or
the sunset date has not yet been reached or
an application has been made before the date at least 18 months before the sunset date and no decision has been taken yet.

An authorisation decision will be taken by the Commission in accordance with the procedures described in Art. 60, 61 and 64. In order to obtain an authorisation, manufacturers, importers or users of substances included in Annex XIV must apply for an authorisation for each use, regardless of the quantity of the substance used, within deadlines set by the Commission. Manufacturers, importers and downstream users may apply jointly for an authorisation. Applications for authorisations are made to the Agency, according to the procedure outlined in Art. 62. The Agency via its Committees for Risk Assessment and Socio-economic Analysis provides opinions on the applications, which the Commission will use for its decisions on applications via the comitology procedure (Art. 133(2)). Summaries of the Commission decisions will be published in the Official Journal of the European Union.

All authorisation decisions will include a time-limited review period which shall be set on a case by case basis in accordance with Art. 61. Authorisation decisions may need to be amended or withdrawn, taking into account the principle of proportionality, as a result of a review. This can be done at any time when 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 new information on possible substitutes becomes available. The Commission is empowered to suspend the authorisation in cases of serious and immediate risk such as releases that would incur immediate or delayed
serious health effects for workers and the general public or irreversible significant and widespread damage to the environment. In addition, an authorisation can be reviewed when the environmental objectives as defined under the IPPC Directive (96/61/EC) or the Water Framework Directive (2000/60/EC) are not met because of diffuse emissions to water and/or air.

The need to withdraw an authorisation could for example arise as a consequence of a cause-effect relationship between the exceedance of the standard and the use of the substance for which an authorisation has been granted. The Commission shall withdraw the authorisation for the use of a substance that is prohibited or restricted under the Regulation (EC) No 850/2004 of the European Parliament and of the Council of 29.04.2004 on persistent organic pollutants.

For further information please consult - the website of the ECHA

Source: Webiste of the European Chemicals Agency (www.echa.eu) .