Susanne Baker provides a summary guide to authorisation under REACH
Although the EU chemicals’ regulation, REACH, entered into force in June 2007, the authorisation process has only recently started. With so much attention initially focused on the requirement to register chemicals, there are fears that companies have overlooked the significance of authorisation.
REACH stands for the registration, evaluation, authorisation and restriction of chemicals and is aimed at controlling chemicals in the EU and improving the protection of human health and the environment from the risks of substances. It applies to substances on their own, in mixtures and in articles (objects). As such, REACH has the potential to have an impact all UK business sectors, from chemical manufacturers and retailers to builders, food manufacturers and printers.
Authorisation is one of the REACH processes for managing the risks of certain hazardous substances, known as substances of very high concern (SVHC), and promoting their replacement with safer alternatives. In the EU, a company may not use substances that are subject to authorisation unless it has been authorised to do so. This means that SVHCs will eventually be phased out of all non-essential uses.
Will authorisation affect your business?
A business will be affected if it relies on a substance that is going to be subject to authorisation. The effect can be either direct, if it uses the substance, or indirect, if the business purchases products or materials that use it. If an organisation’s specific use of the substance has not been authorised, it will no longer be able to use it in the EU regardless of how vital it is to the business.
Conversely, there could be market opportunities if a business provides alternatives that could be used to replace substances being considered for authorisation.
What are your options if a substance is subject to authorisation?
Users have five key options:
- replace the substance with a suitable alternative or adapt processes to avoid its use;
- switch to products (articles) that avoid the use of the substance;
- consider applying for authorisation for a specific use;
- ensure a specific use is covered by another authorisation; or
- cease use of the substance in the EU.
How to get permission to continue to use the substance
Companies need to apply to the European Chemicals Agency for permission to continue to use a substance subject to authorisation. Permission may be granted if the applicant demonstrates that risks are adequately controlled – that is, exposure does not exceed levels that may cause adverse effects to human health and the environment.
However, this route applies only to substances for which a safe level – defined as “derived or predicted no effect level” – can be determined.
Users may receive permission to continue using a substance if they can demonstrate that the risks to human health or the environment from the use of the substance are outweighed by socioeconomic benefits and there are no other suitable substances or technologies available. This is the route for SVHCs for which a safe level (derived or predicted no effect level) cannot be determined or when adequate control cannot be demonstrated.
The application for continued use needs to include:
- a chemical safety report covering the risks arising from the properties of the substance and demonstrating adequate control of the risk, if this is not already available;
- an analysis of options, including the technical and economic feasibility of using a different substance and any research and development activities in which the applicant is engaged to identify an alternative;
- a substitution plan outlining the actions and timelines required to switch to alternative substances and technologies if they exist but are not immediately available; and
- if required, a socioeconomic analysis.
The agency’s technical committees initially assess applications and the analysis of alternatives is open to public scrutiny. The European commission has the final decision on whether to grant authorisation.
Seeking authorisation can be time-consuming and resource-intensive. It may also be expensive to prepare and submit an application. A fee must be paid to the agency – €5,330 to €39,975, depending on the size of the business. Additional costs can be incurred from consultancy support, if the applicant needs access to technical information or if preparation work is carried out with others.
Rolls-Royce authorisation
Last year, Rolls-Royce became the first company to seek an authorisation under REACH. This is for the continued use of bis(2-ethylhexyl) phthalate (DEHP), which the company uses during the diffusion bonding and manufacture of aero-engine fan blades. The European Chemicals Agency concluded in January that adequate control had been demonstrated by Rolls-Royce for the specific use applied for. The final decision to authorise DEHP will be made by the European commission. The agency reported on 2 July that it had received 13 authorisation applications so far.
How are substances identified for authorisation?
There are three key steps to consider before a substance is subject to authorisation.
Step 1: identify the most appropriate risk management measure: Through screening activities, authorities identify potential substances of concern that might require further action. When there is sufficient understanding of the properties of the substance, the agency or the responsible member state will carry out a risk management options (RMO) analysis to decide whether measures are needed and, if so, the most appropriate regulatory route. The proposed approach is reviewed by a group of risk management experts. If it is agreed that authorisation is the most appropriate route, notification is through the agency’s registry of intentions, which provides advance warning of action.
Step 2: include SVHCs on the candidate list: After notification, the responsible member state or the agency prepares a justification dossier (also known as an annex XV dossier) to formally set out why the substance can be defined as SVHC and should be included on the candidate list for authorisation. The dossier is subject to a public consultation, during which interested parties can submit information. If comments are received during the consultation, unanimous agreement by the agency’s member state committee (MSC) is needed before the substance’s inclusion in the candidate list.
Step 3: prioritise and include in the authorisation list: The agency is required to periodically make a recommendation to the commission on the substances from the candidate list to be prioritised for authorisation. Prioritisation is based on the available information on the substance’s properties, uses and volumes. The draft agency recommendation is subject to a consultation, which is followed by the MSC’s opinion. The commission, in collaboration with member states, finally decides whether the proposed prioritised substances should be included in the authorisation list (annex XIV). Substances listed in annex XIV are subject to authorisation.
While not all substances on the candidate list will be recommended for authorisation, substances are being prioritised every year. Once prioritisation occurs, the inclusion in the authorisation list is a quick process.
How long do authorisations last?
Authorisations do not last forever. When an authorisation is granted, a time-limited review period is set. The duration of the review period is assigned on a case-by-case basis. The likely review periods are four, seven or 12 years.
How can I keep track of which substances are being targeted?
It is important to monitor developments in order to plan for, and manage, potential changes. Companies should monitor the registry of intentions, the candidate list and the authorisation list. The candidate list is usually updated twice a year and public consultations occur in March/April and September/October ahead of the update. The latest candidate list contains 155 susbtances. Consultations on new proposals typically run from June to September each year.
Companies can also sign up for agency news alerts or the HSE eBulletin. Organisations, such EEF and REACHReady, also provide free alerts.
More information
More information about authorisation and whether it will affect your business can be gathered from suppliers. You should also contact sector organisations, which may be coordinating or signposting relevant activity or may have developed guidance specifically for your area of business. The agency has recently introduced a partner service for applicants to help identify possible collaborators in preparing applications, which could also help to reduce costs. Finally, the HSE, the UK competent authority for REACH, provides a free helpdesk.
These questions have been taken from a new Q&A guidance document produced by the UK chemical stakeholder forum.
