REACH Authorisation in brief
Our Authorisation Team is ready to assist you in the development of your authorisation strategy, preparation of the application and successful navigation of the assessment process.
The REACH Authorisation List gives the list of chemicals that are subject to the Authorisation requirement. In practice, this means that chemicals covered by an entry on the List may only be used based on a granted authorisation from the European Commission unless otherwise exempted from the authorisation requirement (e.g. intermediate use, SR&D exemption, defence exemption). The list is regularly updated and in principle, any chemical with so called “substance of very high concern (SVHC)” status may be added. There are currently 59 entries on the Authorisation List and 230+ entries on the SVHC list.
If you are a user of a chemical listed (e.g. chromium trioxide) or you use components/products that require use of the chemical in their production (e.g. chrome plated parts), the authorisation requirement will impact your business. Without a granted authorisation, use must cease after a date given in the entry (the so-called sunset date). For example the sunset date for use of chromium trioxide was the 27 September 2017. If you need to continue use of a chemical on the Authorisation List after the sunset date, you will need authorisation. Authorisation is granted by the European Commission via a formal application process.
Your authorisation strategy
Our team will assist you develop your strategy (use mapping, number of uses in scope, uses exempt from authorisation, applying as an individual user or a group of users) and then assist you at every step in the application process.
The authorisation application process
The application consists of 3 main parts
- An analysis of alternatives (AoA) report that describes your efforts to identify suitable alternatives and either an R&D plan or substitution plan to phase out your current use
- A chemical safety report (CSR) that includes your exposure assessment and risk characterisation that demonstrates the chemical is used safely
- A socio-economic analysis (SEA) that demonstrates that the benefits from continued use outweigh the monestised risks
After submission to ECHA, the ECHA committees will assess the reports and give their recommendation on granting/refusing authorisation in an opinion issued to the European Commission. The committees may ask for additional information during their assessment. The European Commission will take a decision based on the opinion and their own assessment.
Contact our team
We have prepared more than 30 applications covering upstream and downstream, individual and joint. We have the expertise in-house and will assist you with every step towards a successful application
Is your use covered by an exemption or do you need to apply for an exemption (e.g. defence)?
We also prepare Defence exemptions following the European Defence Agency (EDA) code of conduct – contact us for more information
Do you consider your use is exempt? We can assist you documenting your decision – contact us at firstname.lastname@example.org for more information.
Our Reach Authorisation services Include
Do you need assistance with your Authorisation Strategy?
Our team can assist you determining your optimal strategy for authorisation and will assist you determining
- what are the uses subject to the authorisation requirement
- the number of uses you will need to consider
- who can apply
- what to consider in terms of the review period you will request
- the merits of upstream versus downstream applications
- single downstream user versus joint downstream user application
We offer full authorisation services
Our team will assist you at every step in the process from identifying the best application strategy for your use case to collecting the necessary information to prepare the reports, drafting the reports and their submission to ECHA. After submission, we will assist you with your interaction with the ECHA committee during their assessment of your application including the public consultation, responding to their questions and commenting on their draft opinion.
Once their final opinion has been issued to the European Commission for decision-making, we will assist you track the decision-making on your application.
Do you want to prepare a group application?
Our team will assist you with prepare and submit a joint application with other users. We have assisted our clients form consortia for the purpose of authorisation and acted as consortium manager. We can assist you with upstream stream applications covering your downstream users and joint downstream user applications.
Do you need assistance with individual reports?
If you have a letter of access to some of the reports from other applications, we can assist you preparing the other reports and with submission. Our team can offer services as needed for your particular situation.
Do you think your use may be exempt from the authorisation requirement?
Some uses are exempt from the authorisation requirement (for example, “intermediate use”, use for scientific research & development (SR&D)). It is the responsibility of users themselves to decide if their use is exempt. National enforcement authorities may check the decision they take.
If you think that your use may be exempt from the authorisation requirement, we can assist you with the documentation of your decision such that it is available if requested by your national enforcement authorities.
Do you need to apply from an exemption from the authorisation requirement for defence related uses?
As per Article 2(3), “member States may allow for exemptions from this Regulation in specific cases for certain substances, on their own, in a mixture or in an article, where necessary in the interests of defence”.
Our team can assist you request for a defence exemption from the authorisation requirement for specific uses following the European Defence Agency (EDA) Code of Conduct on Defence Exemptions.
Do you use a chemical that is covered by an entry on the Candidate List?
There are currently 230+ entries on the Candidate List. Candidate-listed chemicals are chemicals that have “SVHC” status under REACH and are candidates for inclusion on the Authorisation List. ECHA regularly reviews the candidate-listed chemicals and recommends those that fulfil the prioritization criteria for inclusion on the Authorisation List. The European Commission ultimately takes the decision on which recommended chemicals to include on the list.
Our team can assist you in determining your authorisation obligations should a chemical be ultimately be included in the Authorisation List. We can help you scope which uses would be subject to authorisation and the likelihood that authorisation would be granted if you were to apply for authorisation.