Authorisation is required for Substances of Very High Concern (SVHC) that are listed in 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.
Unless Authorisation has been granted for a specific substance for specific use(s), or the use has been exempted from the requirements for Authorisation for a certain use, substances included in Annex XIV cannot be placed on the market or used after the Sunset Date.
Who can apply for Authorisation?
Manufacturers, importers 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.
What do I need in order to apply for Authorisation?
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 appropriate, a Substitution Plan should also be provided to the authorities for their evaluation.
When should I begin to plan to apply for Authorisation?
Authorisation is a time-consuming and highly complex process requiring strategic business thinking. A poorly prepared application runs the risk of not receiving an Authorisation or having a short review period. It also requires the support of a dedicated multi-disciplinary team of experienced experts.
As a result, it is important that companies begin to approach and plan their application early. The preparation of these reports requires a substantial amount of data that may only be available to various different actors in the supply chain. The entire application preparation process, including strategy development, information collection and report compilation takes time.
Consequently, REACHLaw advise that you begin the process of preparing your application as soon as possible.
REACHLaw Support – Our 360° approach
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 our clients 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.
Our Support Includes: