This article explores the challenges faced with authorisation of chemicals under the REACH Regulation.
The REACH Regulation (1907/2006) concerns the Registration, Evaluation, Authorisation and restriction of CHemicals. It impacts manufacturers, importers and suppliers (including distributors and retailers) of chemicals and products containing a Substance of Very High Concern (SVHC). See our article on the impact of REACH on Retailers
For many, Authorisation is likely to be the next big challenge of REACH. Many are now familiar with REACH registration and obligations to pass on information regarding SVHCs in articles. However, far fewer have had to deal with a substance in their product being included on the Authorisation List (Annex XIV of REACH).
Once a substance is included on the Authorisation List it cannot be placed on the market or used after a given date, unless an Authorisation is granted for the specific use, or a relevant exemption applies. Authorisation aims to ensure that the risks from SVHCs are properly controlled and that these substances are progressively replaced by suitable alternatives.
Businesses, especially those using SVHCs, need to monitor proposals to include new substances on the Authorisation List, respond to consultations and develop a strategy to ensure ongoing compliance should the substance be included on the Authorisation List.
The Authorisation List
The European Chemicals Agency (ECHA) prioritises SVHCs to determine which to include on the Authorisation List. Priority is given to substances considered the most dangerous i.e. to substances that are persistent, bioaccumulative and toxic and those which are very persistent and very bioaccumulative, and which are widely used or used in high volumes.
ECHA publicly consults on any draft recommendation to include a substance on the List with potentially affected businesses having a formal opportunity to input into the decision making process. The Member State Committee of ECHA also issues an opinion on the draft recommendation. ECHA takes this and any comments received during the public consultation into account when finalising and issuing its opinion to the European Commission.
The European Commission then determines whether to include the substance on the Authorisation List and passes relevant legislation.
If one of your substances is included on the Authorisation List you will need to develop a strategy for how to proceed. The substance’s entry on the List will include a:
- “Sunset Date” – the date from which placing the substance on the market/or using the substance will be prohibited unless an authorisation has been granted; and
- “Latest application date” – date by which applications for authorisation must be received to allow the supply or use of the substance to continue after the Sunset Date and in advance of the application for authorisation being determined.
Your strategy will need to include exploring whether there are safer alternatives to the substance and whether it is possible to substitute them. Alternatively an application for authorisation may be needed.
In developing an application strategy a range of issues will need to be considered, including whether a joint application can be submitted or whether an individual application is necessary, whether there are any potential substitutes which could be developed and timeframes, and issues regarding confidentiality.
Developing an application is time consuming, costly and is likely to require input from external specialists. There is no guarantee that an authorisation will be granted but a robust application will maximise the chances that your use will be allowed to continue after the Sunset Date.
There has also been concern that at present there is no method by which an authorisation or an application for an authorisation can be transferred. Industry has raised this issue with ECHA and we are expecting ECHA to issue guidance on this issue shortly.