Authorisation – the ‘A’ in the REACH regulation
30 January 2014
Author: Dr Majella Cosgrave, manager, Health & Safety Authority Chemicals Helpdesk
Under the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) regulation (Regulation (EC) No 1907/2006), the supply and use of some hazardous substances is now subject to a licensing system, in a process known as authorisation. Once a substance is included on the ‘authorisation list’, companies must apply to the European Chemicals Agency (ECHA) to continue to use it.
Under the process, the use of a substance can continue once the risks associated with it are adequately controlled, or the socio-economic benefits of the use of the substance outweigh the risks and an authorisation has been granted to the user.
Substances are subject to authorisation once they are included on the authorisation list, also known as Annex XIV of REACH. Before a substance can be added to the authorisation list, it must firstly be identified as a substance of very high concern – such as CMRs (carcinogenic, mutagenic or toxic to reproduction), PBTs (persistent, bioaccumulative and toxic) and ‘substances of equivalent concern’ like endocrine disruptors – and included on the ECHA’s candidate list.
Periodically, the ECHA examines substances on the candidate list and recommends some of them for inclusion on the authorisation list, if they meet certain criteria. The recommendation of the ECHA is subject to a three-month public consultation, during which stakeholders can submit comments. The final decision on inclusion of a substance on the authorisation list is taken by the European Commission, in collaboration with the member states.
This means that the list is added to on a regular basis (currently yearly) and companies are recommended to check it regularly for updates. Both the candidate list and the up-to-date list can be found on the ECHA’s website www.echa.europa.eu.
LATEST APPLICATION DATES AND SUNSET DATES
Within the authorisation list, there are two dates specified for each substance:
- The sunset date is the date after which the placing on the market and the use of a substance is prohibited unless an authorisation is granted to the user;
- The latest application date (LAD) is the date by which the authorisation application must be received by the ECHA if the applicant wishes to continue to use the substance beyond the sunset date.
To ensure timely processing of the applications and to manage the workload, the ECHA has established specific submission windows for substances with the same LADs and these submission dates can be found on the ECHA’s website.
Advice for suppliers
- Consider whether a substance on the authorisation list can be substituted with a less hazardous one. If not, then consider whether to apply for an authorisation to cover your own use and uses in your supply chains (this will also apply to companies manufacturing or importing for their own use).
Advice for downstream users
- Consider if you can use a different substance to the one that is on the authorisation list. If this is not possible, then an authorisation must be in place for your specific use. Speak to your supplier to find out if it intends to apply for an authorisation and if it will cover your use. Provide information to your supplier so that your use can be covered in this application.
- If your current supplier does not intend to apply for an authorisation, or will not cover your specific use, then try to find an alternative supplier willing to do it. Alternatively, consider submitting your own application, which would allow a company immediately above you in the supply chain to supply you with the substance (without the supplier needing to have an authorisation in place itself).
Many Irish business sectors are potentially affected by this system, not least the pharmachem sector. The application process is likely to require the investment of considerable time and resources and this, combined with the overall uncertainty of a new system, should make companies consider if this is the best course of action for them or whether an alternative chemical or process is more suitable than the authorisation process.
However, it needs to be remembered that authorisation is not a ban on a substance. It is a licensing system to allow the continued use of certain hazardous chemicals, where their use needs to continue as there is no alternative available and where the control of risk can be demonstrated.
It is recognised that for some activities within the pharmaceutical manufacturing business, it is very difficult to substitute a substance within a process for a different one. Therefore, Irish pharmachem companies using critical substances that are on the candidate list and, therefore, likely to make it onto the authorisation list (e.g. a number of aprotic solvents) should now plan for authorisation.
An authorisation application is significant and companies should refer to the ECHA website for details of what needs to be in it and how to prepare it. In brief, the application will need to specify:
- The use(s) for which the authorisation is sought;
- A chemical safety report (CSR) covering the risks related to the properties that led to identification as a ‘substance of very high concern’ (unless already submitted as part of a registration dossier by the applicant);
- An assessment of alternatives;
- A substitution plan, if the conclusion is that there is a feasible alternative;
- For the socio-economic route, a socio-economic analysis along with information that there are no alternatives available.
There is a fee for each application for authorisation. The size of the fee will depend on a number of factors, including whether the submitting company is an SME (reduced fees) and the number of uses, substances and applicants covered by the application. Companies can use the EHCA’s fee calculator, which is available on the EHCA’s website, to estimate the fee before submission.
Companies must submit their authorisation applications to the ECHA. Decisions on whether to grant the authorisation or not will be taken by the European Commission and agreed by member states. It will take into account opinions from the EHCA’s Risk Assessment Committee and Socio-Economic Committee. The EHCA website contains information on applications for authorisation in a dedicated support section.
In addition, companies intending to submit an application can request a pre-submission information session with an EHCA representative, which will allow them to ask case-specific questions regarding the regulatory and procedural aspects of the process. Pre-submission information sessions should be held, at the latest, about six months before the submission of the application.
Companies with specific questions or concerns should contact the Health & Safety Authority’s Chemicals Helpdesk by emailing email@example.com or by calling 1890 289389.
Dr Majella Cosgrave is a senior inspector with the Health & Safety Authority, where she has worked for over 13 years. During that time, she has been involved in the enforcement of legislation in Ireland and in the development of European Union chemicals policy through her involvement in various EU committees. She was heavily involved in the implementation of the EU REACH regulation in Ireland. Currently, she works within the Chemicals Business Services Division of the HSA, with responsibility in areas such as the identification and evaluation of hazardous chemicals. Dr Cosgrove manages the Chemcicals Helpdesk within the Authority, a service set up to assist Irish companies to meet their regulatory obligations. She works closely with the ECHA and is Ireland’s representative on the EHCA’s Member State Committee.
This article is reproduced with kind permission from Irish PharmaChem.http://www.engineersjournal.ie/2014/01/30/authorisation-the-a-in-the-reach-regulation/http://www.engineersjournal.ie/wp-content/uploads/2013/12/Chemicals-1024x682.jpghttp://www.engineersjournal.ie/wp-content/uploads/2013/12/Chemicals-300x300.jpgChemchemical,European Union,pharma,regulations