In 2021, the European Union and EEA countries conducted a large-scale project to assess compliance with REACH authorization requirements. The project, called REF-9, focused on substances of very high concern that are included in Annex XIV of the REACH regulation. The goal was to ensure that companies only used or marketed these hazardous substances if they had received authorization from the European Commission. The project involved 690 inspections in 516 companies across 28 countries, and the results were analyzed in a project report. This blog post will examine the key findings of the project report, including the enforcement measures taken, the non-compliance rates, and the recommendations for improving compliance with REACH authorization requirements.
Inspectors found that 26% of substance inspections were not in compliance with Article 56(2), which requires the use of substances in accordance with the conditions of a granted authorization to an actor upstream in the supply chain for that use. Additionally, 26% of substance inspections were not in compliance with Article 37(5), which requires downstream users to identify, apply and, where suitable, recommend appropriate measures to adequately control identified risks. Furthermore, 20% of substance inspections were not in compliance with Article 66(1), which requires the notification of downstream users using the substance in accordance with Article 56(2).
The REF-9 project focused only on substances listed in Annex XIV to the REACH Regulation with sunset dates that have passed by the project start date (January 2021). Out of the 502 substance inspections, 31 different Annex XIV substances were addressed, with chromium trioxide and strontium chromate being the most frequently inspected substances. The inspected company had a downstream user role for 90% of the reported Annex XIV substance inspections, while it was the authorization holder for only 10% of the reported substance inspections.
At the time of reporting the inspection, 254 enforcement measures were imposed by the enforcement authorities for the 203 substance inspections where non-compliances were identified. The most frequent enforcement actions were written advice in 111 inspections and administrative orders in 62 inspections.
The REF-9 project shows an overall non-compliance rate of 40%, which is higher than the usual average level of non-compliance found by inspectors for provisions of EU chemicals legislation. The report suggests that this could be partly related to the fact that placing authorized substances on the market and using authorized substances in accordance with the conditions of the authorization decision are new and complex duties for the duty holders affected. Additionally, duty holders are finding it difficult to comply with the obligations under Annex VII of the REACH Regulation as there is currently no comprehensive ECHA guidance document available for suppliers and users of authorized substances, which would clearly set out the details of the duties and requirements.
Non-compliance can also be related to the presence of very complex supply chains that present serious challenges in relation to the communication of information in a clear and concise form to the downstream users using the authorized substance. In general, the highest non-compliance rates observed in this project were for duties related to downstream users.
The REF-9 project highlights the need for clear guidance documents for suppliers and users of authorized substances, as well as the importance of effective communication along the supply chain to ensure that downstream users are aware of their obligations. The results of the project also demonstrate the need for products, as they are subject to the same obligations under REACH.
It is clear that more work needs to be done to improve compliance with REACH Authorisation (Annex XIV) obligations, particularly in relation to downstream user duties. This could include providing clearer guidance for suppliers and users of authorized substances, as well as improving communication and information sharing within complex supply chains.
Overall, the findings of the REF-9 project highlight the importance of effective enforcement and monitoring of REACH authorization obligations and the need for continued efforts to improve compliance across the EU. Only by working together can we ensure the safe and sustainable use of chemicals in Europe.
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