The authorisation process under the REACH regulation aims to ensure that the risks related to substances of very high concern (SVHCs) are properly controlled throughout their life cycle, while encouraging their progressive replacement by less hazardous substances or technologies, where economically and technically feasible alternatives are available.
The European Chemicals Agency’s Enforcement Forum for Exchange of Information on Enforcement (ECHA Forum) has finalised its 9th REACH-EN-FORCE (REF-9) project and published a report on March 8. The aim of this project conducted in 2021 was to assess compliance with REACH authorisation obligations. The enforcement authorities of 28 countries carried out 690 inspections at 516 companies. More than 31 different substances included in Annex XIV were covered in these inspections. For 90% of the inspections, the inspected company had a downstream user role, while it was the authorisation holder for only 10% of the inspections. Among these inspected companies, 65% were small and medium-sized companies.
At the end of these inspections, the main non-conformities found were as follows: • In about 1 in 4 (26%) inspections of downstream users, inspectors found that the substance was not used in accordance with the conditions set out in the European Commission’s authorisation decision granted to their supplier. As a result, in these companies, workers or the environment were not adequately protected from possible adverse effects of the SVHCs. In addition, for 35% of the checked substances, suppliers did not communicate to the rest of the supply chain the information concerning operational conditions, risk management or monitoring provisions specified in the authorisation decision. • The inspectors also found that for 20% of checked authorised substances, downstream users did not notify ECHA of their use. • 3% of inspections revealed companies using or marketing substances without having obtained or applied for authorisation or without being covered by an applicable exemption.
Even if the results show that most downstream users comply with the fundamental authorisation obligations, the level of compliance with the specific authorisation requirements can still be improved. To this end, recommendations were presented in the REF-9 project report, among which: • Better communication within the supply chain, including improving the quality and completeness of extended safety data sheets • Development of a comprehensive guidance document by ECHA for suppliers and downstream users of substances subject to authorisation • Control by downstream users that their use of a substance subject to authorisation complies with the conditions of use set out in the authorisation decision for their specific use • Establishment of more detailed authorisation decisions by the European Commission, containing in particular explicit and detailed provisions on duties for providing information in the supply chain between the authorisation holder and downstream users using authorised substances.