EU – A New Restriction Intention on DMAC and NEP

​The Netherlands has submitted an intention to restrict N,N-dimethylacetamide (DMAC) and 1-ethylpyrrolidin-2-one (NEP) ​ on December 9, 2019. Connected to this intention, there is a call for evidence open through ECHA’s website inviting stakeholders to send information that could help to prepare the intended restriction. The call evidence is open until March 13, 2020. The substances are two polar aprotic solvents. Both of them have been registered under REACH, and have a harmonized CLP classification as reprotoxic category 1B. Manufacturers, importers and downstream users of the substance on its own (regardless of whether DMAC, NEP are a (main) constituent, an impurity or a stabilizer) or in mixtures in a concentration equal or greater than 0.3 % shall use in their chemical safety assessment and safety data sheets by [date to be specified] a worker-based harmonized Derived No Effect Level (DNEL) value [to be specified] for long-term inhalation exposure, and a worker based harmonized DNEL value [to be specified] for long-term dermal exposure. Manufacturers and downstream users are to implement appropriate risk management measures ensuring exposure of workers remains below the specified DNEL(s). The scope may become wider during the development of the Annex XV in case unacceptable risk is identified for consumers due to DMAC and/or NEP presence in consumer articles (or product formulations below 0.3%). ​ Widespread industrial and professional uses of DMAC and NEP. There is a high potential for worker exposure as some of the uses are open applications. Based on available information and following existing guidance DNELs should be significantly lower than applied in REACH registration dossiers. The RMOA on polar aprotic solvents concluded restriction as the most appropriate RMO. The proposal is consistent with the approach taken in the existing restriction on NMP and the recent Italian restriction proposal on DMF. ​