REACH Authorisation in brief
Chemicals that are covered by an entry on Annex XIV of the REACH Regulation may only be used if the use is covered by an authorization or the use is outside the scope of the authorization (e.g. intermediate use). Annex XIV is known as the Authorisation List and currently there are 54 entries on the List. New entries are added based on recommendations from ECHA. The “pull” list for potential new entries is the “Candidate List”. This is a list of chemicals that have “SVHC” status. All chemicals that have SVHC status are potential candidates for inclusion on the Authorization List.
If you are a user of a chemical covered by an entry on the Authorisation List, your use will need to be covered by an authorisation. Authorisation means permission to continue using a chemical on the Authorization List for a time limited period for a specific use by specific users. The procedure for getting this permission is known as “application for authorisation”.
The application process is complex. To prepare the application reports, you will need to have expertise available to you in chemicals risk assessment, socio-economic analysis and knowledge on the alternative chemicals or technologies available for your specific use. Authorisation will only be granted if your application is complete, demonstrates that the risks coming your continued use are controlled, quantified and minimized and suitable alternatives are not available to you. For chemicals where adequate control cannot be demonstrated (e.g. non-threshold carcinogens), a socio-economic analysis must be submitted that demonstrates that the benefits from your continued use outweigh the monetized risks to your workers, humans via the environment, etc. as relevant for your case.
Our Authorisation Team here at REACHLaw has the expertise to help you prepare your application. We offer a full range of authorization services from giving advice to preparing the full application for you
Who can apply for Authorisation?
Manufacturers, importers, Only Representatives (ORs) and downstream users can apply and hold Authorisations for their own uses or for uses down their supply chain. It is important to note that the rules regarding who can be the Authorisation holder may have the potential to cause supply disruptions if there are missing links in the supply chain.
The REACHLaw Authorisation Team
Our Authorisation Team can help you navigate the application process from scoping to see if your specific use could be an exempted use, advise you on the application strategy to take, collect all the necessary information to prepare the application reports, prepare them following the ECHA guidance and submit them to ECHA via their IT system. Post submission, the team can assist you answering questions from the ECHA committees during their assessment of your application, respond to comments made on your application in the public consultation and comment on the Opinion of the ECHA committees if needed.
Our Reach Authorisation services Include
We can help you determine your options to applying for authorization, when you need apply, what kind of application you can submit, if you need to consider uses by your upstream supplier or by customers downstream in your supply chain.
We can help you set up and manage consortia to prepare joint applications with others who have the same use.
Full Authorisation Application
We provide a full application service where we will scope what you need to submit, collect the required information to prepare the application reports, do the analysis and prepare the reports. Post submission, we will assist you interaction with the ECHA committees in their assessment of your application, respond to non-supportive comments received in the public consultation, support you in the trialogue if organized and comment on the ECHA committee opinion. We will assist you interacting with the REACH Committee and the Commission as needed during their decision making on your application. Once you receive your decision from the Commission, we will assist you understanding any obligations it may bring you.
Are you a chromate user?
We are currently preparing downstream applications for chromium trioxide. See our overview of CTACSub and the implications for downstream users covered by the application
Chemical Safety Report (CSR)
The chemical Safety Report is a key element in the authorisation application since it is carried out to demonstrate that the risks from the exposure to the substance, during its manufacturing and use, are controlled when risk management measures and specific operational conditions are applied. REACHlaw support companies in compiling a robust CSR when the relevant Exposure scenarios will be communicated to downstream via the eSDS
Analysis of Alternatives (AoA) / Substitution Plan (SP)
Every authorisation application must include a robust Analysis of Alternatives (AoA). The aim of the AoA is to demonstrate whether there are suitable alternative chemicals or techniques to your current use of the chemical of concern.
The AoA identifies and compares alternatives based on their performance (technical feasibility), cost (economic feasibility) and the overall risk associated with their use.
REACHLaw supports companies by gathering quantitative and qualitative data on alternatives, conducting the alternatives assessment and compiling the results into a robust AoA report. Furthermore, REACHLaw helps companies describe the actions and timelines required to implement an alternative as well as the efforts and R&D activities carried out to find a potential substitute.
Socio-Economic Analysis - SEA
Socio-Economic Analysis is one integral part of the Authorisation dossier. Virtually the sole objective of the SEA is to demonstrate in an appropriate manner whether the related socio-economic benefits outweigh the risks of continued use of a substance of concern.
SEA assesses the impacts of a change against what would happen if the change did not occur. In an Authorisation dossier this could involve comparing a situation where the applicant continues using a substance of very high concern with a situation where it would be substituted with a safer but less effective one or where the applicant would relocate its use outside of the EU. The change-over may require investment and result in increased costs for both the company and other actors in its supply chain.
Various methodologies exist to analyse the impacts. REACHLaw usually uses cost-benefit analysis and/or cost-effectiveness analysis since they are the most widely-used methods. Cost-benefit analysis converts all benefits into monetary units so that they can be directly compared to the costs. The conversion is based on valuation techniques that derive the willingness-to-pay (WTP) to avoid certain health risks or environmental damage. Cost-effectiveness analysis, on the other hand, compares the impacts (in their natural units) to the costs.
Even though SEA always requires multi-disciplinary expertise as it relies on information related to a wide range of issues, REACHLaw’s SEA expertise is based on economists since economics is the core of SEA. Additionally, our economists have background in environmental sciences, market/business analysis and finance.
Chromium Trioxide application services
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