Since 2012, companies have been submitting applications to the European Commission in order to receive REACH authorisations and allow the use of that substance in the EEA after the substance’s sunset date. When an authorisation is granted, it applies to the applicant, their immediate supplier, and the entire downstream supply chain.

In a downstream application, it is typically the user of the substance that creates and submits the authorisation application for their well-defined use. These applicants typically have a better understanding and much more information available in order to demonstrate that the substance’s risks are controlled to justify an authorisation being granted.

Some applicants have decided to support upstream applications, where the importer and/or the manufacturer submits the application, with the intention that it would cover the entire downstream supply chain. However, in an upstream approach, applicants may not always know all of the uses and conditions that are being applied for. The upstream approach greatly benefits complex supply chains where there could be hundreds of companies involved in the production of complex articles, such as in the medical device, aerospace and defence industries.

A recent case serves to illustrate the risks of upstream REACH authorisation.

In 2016, the European Commission granted authorisation to Dominion Colour Corporation (DCC) for the sale of lead chromates in paint and pigments for use in a wide variety of applications including road markings, plastics and coatings. Sweden then filed a court case, claiming that there were alternatives available to the authorised substances and, in 2019, the EU General Court ruled in favour of Sweden. The ruling, effective immediately, meant that DCC could no longer sell these products on the EU market. This was the first time that an authorisation application had been refused or overturned in the history of REACH and shows that companies need to be careful when applying for authorisation.

Since this case, the European Chemicals Agency has communicated that they are undertaking an initiative that aims to improve the REACH authorisation process, specifically highlighting the issues with upstream authorisation applications.¹ This could mean that the authorisation strategies employed by companies may be at risk.

If you are depending on an upstream authorisation then TSG suggests that you use alternatives if they are technically and commercially feasible. If substitution is not possible in the short term, then companies should seriously consider making their own authorisation applications. In order to minimise risk, this should be undertaken as soon as possible, or if an upstream authorisation has been granted, it should be timed to be in place before that review period is over.

TSG is currently supporting companies that have decided to mitigate the risks of upstream authorisation applications. Remember that if authorisation is not granted, then you cannot use that substance in the EEA. If there is no alternative, then there is no business.

¹ https://newsletter.echa.europa.eu/home/-/newsletter/entry/improving-reach-registration-and-authorisation