Iniziate a preparare la vostra domanda
There are two possible routes to apply for an authorisation to use an Annex XIV substance:
- Adequate control route: by demonstrating that the risk from using the substance is adequately controlled, i.e. that the exposure is below the derived no-effect level (DNEL).
- Socio-economic analysis route: by demonstrating that the socio-economic benefits of using the substance outweigh the risks and that there are no suitable alternative substances or technologies (for non-threshold substances or when the exposure is above the DNEL, this is the only possible route).
Before you start to prepare your application you should read the relevant guidance documents and the information on how applications are evaluated by ECHA's scientific committees. You should also carefully read the "questions and answers" that have been prepared for applicants to address specific topics that have required clarification. We also recommend reviewing the examples of analyses of alternatives and socio-economic analyses identified on our website. All these sources of information are available by following the links on this page.
The information (assessment reports) required in an application will depend on whether you can demonstrate adequate control of the risks and whether there are suitable alternative substances or technologies available for the use you are applying for. While a socio-economic analysis is not mandatory when adequate control can be demonstrated, it is recommended that one is undertaken.
Iniziate a preparare la vostra domanda
The preparation of these reports requires a substantial amount of data (e.g. on conditions of use, potential alternatives to using the substance and socio-economic information), which may only be available to various different actors in the supply chain. Supply chain communication is therefore important for information gathering. However, companies sharing data need to ensure that they protect confidential business information and comply with EU Competition Law.
Defining the use that you will apply for is a key step in preparing your application. You should carefully consider the breadth of your use as this will need to be supported by the chemical safety report, analysis of alternatives and socio-economic analysis of your application.
When describing uses within upstream (manufacturer/supplier) applications, identify if there are any (sub)uses within the scope of the use description that have been already successfully substituted and thus don't need to be supported by an application.
The chemical safety report should cover the risks to human health and/or the environment from the use(s) of the substance. Unless critical for an assessment of alternatives, the chemical safety report only needs to cover the hazard properties of the substance listed on Annex XIV.
If you use the reference derived no-effect levels (DNELs) and dose-response relationships published by RAC, the chemical safety report only needs to include part A, the exposure assessment (Section 9) and risk characterisation (Section 10) for each of the uses applied for as well as the physico-chemical properties of the substance that are relevant to any exposure modelling performed. This is particularly important for downstream users, if they do not have access to the registration chemical safety report.
You need to include a succinct summary of the risk management measures and operational conditions in your application. The succinct summary is an extract of the full set of conditions described in the chemical safety report and will be used to support the enforcement of authorisation decisions.
In the analysis of alternatives, you should analyse the technical feasibility, economic feasibility, availability and risk reduction potential of alternative substances or technologies. The analysis of alternatives should also include information about relevant research and development activities.
If an alternative substance is equally or more hazardous than the Annex XIV substance for which the authorisation is applied for (e.g. as established by its harmonised classification, or presence on the candidate list), this is generally sufficient to demonstrate that it is not a suitable alternative. No additional analysis of the technical or economic feasibility of this alternative is normally necessary. Exceptions could be if the alternative would be used in far lower quantities or in ways where the risks could be substantially reduced or adequately controlled compared to the Annex XIV substance, or if the use of the substances would be important in the "non-use" scenario described in the socio-economic analysis.
The socio-economic analysis describes what would happen if the authorisation for the use of the substance was not granted, as well as what costs and benefits this would create for society. A large part of the costs often stem from the effort and investment required to adopt an alternative substance or technology. Because of this, the socio-economic analysis is closely interlinked with the analysis of alternatives. The two analyses can be presented together in a single document by using the combined format.
To estimate the impact to human health of continued use of the substance, you can use the reference values in Appendix B of the SEA guidance as well as the findings of an ECHA study published in 2015 on "willingness-to-pay" to avoid certain health impacts.
- How to apply for authorisation - a step-by-step guide for applicants [PDF]
- How to develop the description of uses in the context of authorisation[PDF]
- Guidance on the preparation of an application for authorisation
- Guidance on the preparation of socio-economic analysis as part of an application for authorisation
- Guidance on information requirements and chemical safety assessment
- Guidance on occupational exposure estimation[PDF]
- Guidance on how to prepare a downstream user chemical safety report[PDF]
- Information on how applications for authorisation are evaluated, including DNELs and dose-response curves for SVHCs
- Examples of analysis of alternatives and socio-economic analysis
- Willingness to pay to avoid certain health impacts
- Socio-economic analysis in REACH
- An elaboration of key aspects of the authorisation process in the context of aviation industry [PDF]