According to ECHA’s SVHC Roadmap to 2020 Implementation plan, ECHA is committed to have “all relevant currently known SVHCs included in the candidate list by 2020”. The candidate list includes substances that can be recommended for inclusion in the Authorisation list ( REACH Annex XIV).
This said, companies with SVHC substances are advised to take a proactive approach to influence on the outcome of their business, by having a well maintained inventory of the substances they manufacture, use or import, to screen their SVHCs and determine their importance on their business. After that, companies will be ready to start preparing an adequate business strategy towards authorisation.
As the candidate list is updated twice per year, it is important for companies to monitor ECHA’s website and check whether their SVHCs have been included or not on the candidate list.
Our Advocacy Services
At REACHLaw, we support your company to create a proper authorisation strategy by assessing the relevance of your SVHCs for your business and by analyzing the risks associated to them. Also, we help you to meassure the impacts of the SVHCs not only in your company, but also in the economy and in your business sector.
Furthermore, REACHLaw supports you with the Public Consultations and RMOA phases by providing you with the right information, at the right time, to the right counter-parties and with the right strategy. In fact, REACHLaw has been a strategic advisor for a number of advocacy projects.
Authorisation is required for Substances of Very High Concern (SVHC) that are listed in REACH Annex XIV (the Authorisation list). The aim of Authorisation is to ensure the good functioning of the internal market while assuring that the risks from SVHCs are properly controlled. Authorisations are granted only if the risks arising from their use are adequately controlled, where this is possible; if there are no alternatives available which are economically and technically viable by the Sunset Date; or if the use can be justified for socio-economic reasons.
Who can apply for authorisation?
Manufacturers, importers, Only Representatives 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 can be the authorisation holder may have the potential to cause supply disruptions if there are missing links along the supply chain.
What are the key elements of an AfA?
The Authorisation application needs to contain an Analysis of Alternatives (AoA), Chemical Safety Report (CSR) and we recommend to also include a Socio-Economic Analysis (SEA) with every application. In addition, where appropiate, a Substitution Plan should also be provided to the authorities for their evaluation.
What makes an application succesful?
An authorisation application is a matter of how convicing the argumentation presented in your application is. Your company will need to have enough resources and expertise in-house to be able to compile all the required information in a clear and convincing way, to be presented to all the ECHA Committees for making their opinions, and for the European Commission (EC) to make its decision on granting or not an authorisation for the use(s) you have applied for.
The Analysis of Alternatives (AoA) is a key element of the Authorisation process where the applicant should be able to identify all relevant alternative substances and technologies and determine whether they are feasible or not. For each identified alternative, the applicant should consider several aspects e.g. technical and economic feasibility etc. In our experience, it is important to include all information on past and currently on-going studies the applicant has conducted on alternative substances and technologies. The applicant should provide evidence of real efforts made.
For the shortlisted alternatives, the applicant has to present detailed information on the technical and economic feasibility, availability and risk reduction potential.
In the technical feasibility section, the applicant should show that the alternative substance or technology does not perform as well or in a high enough level in the process conditions.
In the economic feasibility section, the applicant should list all the costs resulting from substituting the hazardous substance with the alternative, e.g. investment costs, raw material costs etc.
In the availability section, the applicant should consider whether alternatives are available by the sunset date.
In the risk reduction section, the applicant should demonstrate that the alternative substance is less hazardous or at least as hazardous as the substance that it is going to be substituted. At REACHLaw, we also consider how worker exposure would change if the alternative substance would be used in the current process.
The aim of the SEA is to analyse and document whether the socio-economic benefits outweigh the risks imposed by the use of the substance in use. An SEA is required for an authorisation application if no adequate control route for use of the substance exists.
Preparation of a SEA is considered mandatory for reasons of due diligence, even if the substance was eligible for the adequate control route. This is because if the RAC doesn’t agree with the applicant’s conclusion of demonstrated adequate control, the application will automatically go through the SEA Route.
With a good quality SEA you can demonstrate that the benefits outweigh the risks of your use in a manner that is approved by the regulator. It must include the justification for granting an authorisation and provide a clear view of the costs and benefits of a granted authorisation. That is the key for a successful authorisation application and the continuation of your business.
What is important in SEA?
First of all the approach needs to be systematic and the scope relevant. It is essential to identify the “non-use” scenario early in the process and consider all possible types of responses to non-availability of the substance. An important question that needs to be answered: What would your company, your supply chain and your customers do in the “non-use” scenario? Consultation with the relevant stakeholders is also very important. You will probably need confidential business information from both your company and the relevant supply chain. The impacts should be assessed and presented in transparent manner to produce an unbiased SEA.
Minimising and analysing uncertainties in your assessment is critical to give the regulator a comprehensive insight into your case.
The CSR is one of the key documents that is used by the authorities to assess the validity of your application. You will need to provide a CSR irrespective of the route of your application, i.e. the adequate control route and the Socio-economic route.
What is the difference between a CSR for REACH Registration and one for REACH Authorisation?
A Registration CSR is used by a SIEF to cover all the intended uses of the supply chain. These uses can be many and varied, in many different industry sectors and for multiple sites of the SIEF members throughout the EEA.
An Authorisation CSR, however, can be much more specific. It only covers the exposure resulting from the worker tasks for the specific use of the Authorisation application and for the SVHC property for which the substance has been listed on Annex XIV and for the sites covered by the application. Also while modelled data can be used for an Authorisation CSR, there is an expectation by the authorities that relevant, specific measured data is used.
Nevertheless, group applications are also permitted with Authorisation. As has been seen with some group applications submitted already, if the application strategy is not well developed and the exposure is not deemed representative, then the authorities will likely shorten the Review Period.
Thanks to the experience we have gained by submitting so many applications for Authorisation already and our experience of dealing with the RAC and SEAC committees, REACHLaw has developed a standardised approach to Authorisation applications of all types. Though we understand that all applications are different, the general information needed to develop the strategy, AoA/SEA and CSR is very similar in all cases. It is, therefore, a matter of gathering the information and then defining what is the unique argument for your case.
Once we have identified the arguments to be used, we can then incorporate this into the application documents followed by Pre-submission Information Session with ECHA and then submission, once the documents meet your expectations.
REACHLaw supports you all the way through the Authorisation process: from project kick-off until the Commission provide your Authorisation number.
As we are based in Helsinki, the home of ECHA, we are also able to easily liaise with them and represent your interests when dealing with the authorities.