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All uses of an Annex XIV substance must cease after the Sunset Date, unless there is an applied for or granted Authorisation; or there is a clear, accepted and documented exemption. But what if there is an unclear case? What if you determine your substance use to be intermediate, and consequently rely on the on-site isolated intermediate and transported isolated intermediate exemption, but ECHA disagree? What if there is some doubt and clarification is required, all the while the Latest Application Date and Sunset Date are approaching?

There are clear cases where the use of a substance is exempt from the need for REACH Authorisation, for example if the substance is present in a mixture at a concentration below 0.1 %(w/w) or on the basis of existing specific Community legislation imposing minimum requirements relating to the protection of human health or the environment for the use of the substance, the risk is properly controlled, for example use in biocidal products within the scope of Directive 98/8/EC; or use in medicinal products within the scope of Regulation (EC) No 726/2004, Directive 2001/82/EC and Directive 2001/83/EC.

Where there is some doubt, relying on an exemption can pose real problems for any business, and Authorisation can be used as a risk management measure to alleviate this risk.

Recently confusion has been growing in the in vitro diagnostics (IVD) industry which relies on an exemption for Scientific Research and Development for test kits following the inclusion of the group of substances 4-(1,1,3,3- tetramethylbutyl)phenol, ethoxylated – (also known as ‘4-tert-OPnEO’), which includes Triton X 100, a surfactant used by the industry. While it appears that some uses are covered by the SR&D exemption, it is unclear for many others. With the approaching Latest Application Date in 2019, the time required to prepare and submit applications for substances with such complex uses, and the strict regulatory environment governing the IVD sector, it is a huge issue with potentially wide-ranging impacts for the companies themselves and patient care.  

In the past a REACHLaw client relied on the use of their substance as an intermediate, however, following a compliance check, ECHA deemed that their use did not fulfill the intermediate definition and requested them to make a full registration, which, in turn, had far reaching consequences for the company as the substance had been placed on Annex XIV. As there was a risk that the appeals process would, at worst, result in ECHA’s Board of Appeal (BoA) agreeing with the ECHA position or, at best, only be complete after the Sunset Date for the substance, the client had to quickly decide on a course of action: cease use of the substance after the Sunset Date until a decision on the exemption was made, or prepare an application for Authorisation. They chose to protect their use through the Authorisation process, while simultaneously appealing to BoA.

This choice resulted in the granting of a 12 years review period. This provided security for their process irrespective of the decision from the BoA. Subsequently, the BoA found in favour of the client. Nevertheless, the dual strategy of appealing while applying provided business certainty and the strategy was vindicated.

What should you do if you are impacted in this way?

The first thing is to identify if and what uses are definitively covered by the exemption. This could be performed by outside consultation in the form of an exemption study. If it is still unclear for some uses, then you must decide on a company strategy. Ask yourself, is the cost of applying for Authorisation worth it compared to the cost of not being able to use a substance in a particular process if the exemption is not confirmed? In the vast majority of cases an Authorisation application will be considerably less expensive, even taking into account consultant costs and ECHA fees.

Our Support!

REACHLaw have supported companies in the IVD and other industries to understand their obligations through exemption studies and Authorisation Risk Management strategy development. This allows companies, who are currently engaged in lobbying for an exemption, to select a phased project approach. In this way, should the exemption be confirmed, the Authorisation project can be put on-hold and the costs associated with any pending phases stopped. This ensures that costs are kept to a minimum, while ensuring that valuable time to develop and prepare an Authorisation application is not lost.

Interested in our support? Contact Us!