The REACH regulations (Registration, Evaluation, Authorisation and Restriction of Chemicals) require that manufacturers submit an application for authorisation to put on the market or use the substances of very high concern (SVHC) listed in appendix XIV (list of substances subject to authorisation).
This authorisation procedure aims to ensure that the risks generated by these substances are properly controlled and that these substances are gradually replaced by appropriate alternative solutions while ensuring the proper functioning of the EU internal market.
Thus, use of any substance of concern which is contained in appendix XIV of REACH will be prohibited, unless an application for authorisation is submitted for a specific use and it is subsequently granted.
This procedure applies without any quantity threshold and may therefore include unregistered substances used in a quantities of less than 1 tonne per year.The application for authorisation must be submitted to the ECHA (European Chemicals Agency) and authorisation is granted by the European Commission.
Carry out your procedure:
With an online service
- Notification of intent to submit an application for authorisation / Request form for a pre-submission information session
- Application form for an application for authorisation
- Submission of the application for authorisation dossier
- Confirmation of participation in joint application for authorisation
All manufacturers and importers of substances contained in appendix XIV of REACH must submit an (individual or joint) application for authorisation for one or more given uses or for one or a group of substances, regardless of the quantity envisaged.
Downstream users of such substances are under no obligation to submit an application for authorisation to continue to use the substances. However, they may nonetheless choose to make an application for authorisation.
If the downstream user does not wish to make an application for authorisation, it is advisable to check that the party involved in the upstream part of its supply chain (e.g. manufacturers, importers, and suppliers) already has authorisation covering the use it plans to make of the substance.
In such cases, they have no need to submit an application for authorisation. Nonetheless, the user must notify the ECHA of how it plans to use the substance within 3 months of the first delivery of the substance in question.
Candidate substances subject to authorisation
The list of substances subject to authorisation is shown in appendix XIV of the REACH regulations.
The first step before inclusion in appendix XIV is to identify "substances of very high concern" – SVHC. These include in particular:
- category 1 & 2 substances which are carcinogenic, mutagenic or toxic for reproduction (CMR);
- persistent, bioaccumulative and toxic (PBT) substances;
- very persistent, very bioaccumulative substances (vPvB);
- substances identified as having serious, irreversible effects on human beings and the environment, resulting in a level of concern equivalent to that for CMR or PBT/vPvB substances, identified on a case-by-case basis (e.g. endocrine disruptors, sensitisers).
Once a substance is identified as being an SVHC, it is added to the candidate list of substances, updated by the ECHA twice a year.
After a two-stage regulatory procedure, substances on the candidate list of substances can then be added to the list of substances subject to authorisation, which corresponds to appendix XIV of the REACH regulations.
Applicants are advised to notify the ECHA of their intention to submit an application for authorisation for a given substance at least 8 months in advance. Such notification enables the ECHA to improve its planning and preparation for receipt of applications, thereby processing them faster.
Applicants also have the option to request a preliminary information meeting with ECHA representatives. This type of meeting must take place at least 6 months prior to submission of the application for authorisation and enables applicants to submit questions specific to their individual case before submitting their application.Lastly, applicants must create an account in the REACH-IT system, if they do not already possess one. The ECHA uses the information entered into REACH-IT to determine the amount of the fee payable.
Compiling an application for authorisation can take 12 to 24 months. It is therefore advisable to engage in the procedure as early as possible, in order to ensure compliance with the submission deadline as defined by the ECHA.
From the outset, it is important to stay informed about the candidate list of substances, as they may be added to appendix XIV and so subject to authorisation.
For substances listed in appendix XIV, it is important to identify two items of information:
- the expiry date (sunset date) which refers to the date following which the placing on the market, manufacturing/import add and use of the substance are prohibited unless authorisation has been granted;
- the latest application date which refers to the date following which it is advisable to have submitted an application for authorisation to the ECHA, thereby enabling the applicant to continue to use the substance after the expiry date, even if the application has not yet been approved or rejected.
Companies can thus plan the replacement of these substances, or prepare an application for authorisation.
Before submitting an application for authorisation, applicants must generate the application authorisation form, available on the ECHA website, by entering details of the substance concerned and its planned uses.
A personalised PDF form will either be created immediately or sent by email to the address given by the applicant.
If the applicant is involved in a joint submission, it must indicate that this is the case by completing a confirmation of participation in a joint submission online on the ECHA website.
The application for authorisation must include:
- the identity of the substance(s) concerned;
- the applicants' names and contact details, together with any other relevant contact information;
- the application authorisation form, giving details of the use(s) for which authorisation is requested and covering use of the substance in compounds and/or, if applicable, its inclusion in products;
- a chemical safety report (CSR) covering the risks (to health and the environment) associated with the properties which have led to inclusion of the substance in appendix XIV (unless this has already been submitted as part of the registration process). The Chesar tool enables preparation of CSRs;
- an analysis of alternative solutions (substances or technologies) assessing the risks they contain and their technical and financial feasibility, including, if applicable, information on planned or ongoing research and development activities aimed at developing such alternative solutions;
- if an appropriate alternative solution is available, a replacement plan explaining the substitute solution and setting out the applicant's proposed timetable for action.
In addition, applicants can attach the following to the application:
- a socio-economic analysis (obligatory if appropriate control of risks cannot be demonstrated or if no substitute solution can be provided);
- a justification for not taking risks to human health and the environment into account in specific cases.
Applicants may refer to earlier applications for authorisation relating to the same substance(s) or use(s), provided they have the consent of the previous applicant or holder of the authorisation.
They may also refer to the following parts of an earlier application:
- chemical safety reports;
- analyses of alternative solutions;
- replacement plans;
- socio-economic analyses.
The application for authorisation is deemed to be received only when the ECHA has received the fee connected with the application.
The amount varies depending on the following:
- the type of application submitted (joint or not);
- the number of substances and uses concerned;
- the size of the company.
Granting of authorisation by the European Commission
Authorisation is granted if the risks to human health and the environment resulting from use of the substance can be controlled.
Otherwise, and if no alternative solution exists (a substitute or alternative technology), the Commission assesses the level of risk and the socio-economic benefits of use of the substance, then decides whether or not to authorise the substance.
The granting of authorisation results in the updating of the Safety Data Sheets (SDS) on which the authorisation number must be shown in section 15.
The authorisation number must also be shown on the product label before the substance or compound containing the substance is placed on the market.
The same applies to downstream users which use an authorisation granted for a specific use to a party based upstream in their supply chain (e.g. their supplier).
Review period and validity of authorisation
Authorisation granted is subject to a review period determined on a case-by-case basis. As part of a review, the Commission may amend or withdraw the authorisation if the context has changed, including in the case of appropriate alternative solutions then being available.
In order to continue to benefit from authorisation, the holder of the authorisation must submit a review report at least 18 months before expiry of the review period deadline.
The review report must only cover items in the initial application which have changed. It must contain the following items:
- the currently valid authorisation number;
- an updated analysis of alternative solutions, together with, if applicable, information relating to relevant research and development activity by the applicant;
- an update to any replacement plan included in the initial application;
- if it emerges from the updated analysis of alternative solutions that an appropriate alternative solution is available: a replacement plan, setting out the applicant's proposed timetable for action;
- if the holder cannot demonstrate proper control of the risk: an updated socio-economic analysis (SEA);
- if the holder can now demonstrate proper control of the risk: an updated chemical safety report;
- updated versions of any other item in the initial application which has changed.
Furthermore, authorisation may be reviewed at any time, particularly if:
- the circumstances under which initial authorisation was granted have changed such that the risk to human health or for the environment, or the socio-economic impact are affected;
- new information on potential alternative substances becomes available.
In the event of a serious, immediate risk to human health or the environment, the European Commission may suspend the authorisation pending reassessment.