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N,N-dimethylacetamide

CAS127-19-5
EC204-826-4

List details

Basic info

Status Opinion development
Details on the scope of restriction 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%).
Further substance information Substances relevant to this restriction proposal: N,N-dimethylacetamide (DMAC) (EC: 204-826-4) and 1-ethylpyrrolidin-2-one (NEP) (EC: 220-250-6). 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.
Reason for restriction 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.
CLP Annex VI Index Number
  • 616-011-00-4

Intention timeline

Date of intention 2019-12-09
Expected date of submission 2022-04-08
Latest update 2022-06-22

Support information

Restriction report and annexes

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Record history

The following timeline shows when we detected changes of this regulatory record (the date might slightly differ from the date of the actual change). Additions between versions are hightlighted in green color, red color shows data removed between versions.

July 13, 2022
  • Latest update: 2022-06-222022-06-27
This version
June 24, 2022
  • Latest update: 2022-05-132022-06-22
  • Restriction report and annexes: https://echa.europa.eu/documents/10162/733cfe8a-f40f-ed4b-72fd-208712fd5f7chttps://echa.europa.eu/documents/10162/a3b07a9a-1144-9507-69a0-ebfed72b1baa
  • Restriction report and annexes: https://echa.europa.eu/documents/10162/d59c5e7b-67f4-14ef-beb4-a0218540b67fhttps://echa.europa.eu/documents/10162/dff3eb3e-98ce-c1eb-99c9-1812dbb5e54d
  • Status: Conformity checkOpinion development
June 6, 2022
  • Latest update: 2022-04-192022-05-13
  • Status: SubmittedConformity check
  • Restriction report and annexes: https://echa.europa.eu/documents/10162/733cfe8a-f40f-ed4b-72fd-208712fd5f7c
  • Restriction report and annexes: https://echa.europa.eu/documents/10162/d59c5e7b-67f4-14ef-beb4-a0218540b67f
April 26, 2022
  • Details on the scope of restriction: 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).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%).
  • Latest update: 2021-10-012022-04-19
  • Remarks: Stakeholders are requested to provide relevant information to the Dossier Submitter. If justified based on robust risk and socio-economic information the Dossier Submitter may propose derogations from the proposed restriction. If a derogation is not proposed by the Dossier Submitter then it will be incumbent on the relevant stakeholders to do so during any consultation process with a full risk and socio-economic justification accompanying it.
  • Status: IntentionSubmitted
Oct. 8, 2021
  • Details on the scope of restriction: 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%).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).
  • Expected date of submission: 2021-10-012022-04-08
  • Latest update: 2020-11-192021-10-01
  • Reason for restriction: 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.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.
  • Remarks: Stakeholders are requested to provide any information relevant to the Dossier Submitter during the Annex XV Restriction Dossier process, either in any call for evidence or separately during the process. This information will be used, amongst other issues, to determine if any derogations are required for the potential restriction as these cannot be proposed without adequate risk and socio-economic information. If a derogation is not proposed by the Dossier Submitter then it will be incumbent on the relevant stakeholders to do so during any consultation process with a full risk and socio-economic justification accompanying it.Stakeholders are requested to provide relevant information to the Dossier Submitter. If justified based on robust risk and socio-economic information the Dossier Submitter may propose derogations from the proposed restriction. If a derogation is not proposed by the Dossier Submitter then it will be incumbent on the relevant stakeholders to do so during any consultation process with a full risk and socio-economic justification accompanying it.
Nov. 30, 2020
  • Expected date of submission: 2021-01-152021-10-01
  • Latest update: 2020-10-142020-11-19
Oct. 14, 2020
  • Latest update: 2020-10-072020-10-14
  • Remarks: Stakeholders are requested to provide any information relevant to the Dossier Submitter during the Annex XV Restriction Dossier process, either in any call for evidence or separately during the process. This information will be used, amongst other issues, to determine if any derogations are required for the potential restriction as these cannot be proposed without adequate risk and socio-economic information. If a derogation is not proposed by the Dossier Submitter then it will be incumbent on the relevant stakeholders to do so during any public consultation process with a full risk and socio-economic justification accompanying it.Stakeholders are requested to provide any information relevant to the Dossier Submitter during the Annex XV Restriction Dossier process, either in any call for evidence or separately during the process. This information will be used, amongst other issues, to determine if any derogations are required for the potential restriction as these cannot be proposed without adequate risk and socio-economic information. If a derogation is not proposed by the Dossier Submitter then it will be incumbent on the relevant stakeholders to do so during any consultation process with a full risk and socio-economic justification accompanying it.
Oct. 7, 2020
  • Expected date of submission: 2020-10-092021-01-15
  • Latest update: 2020-01-152020-10-07
Jan. 15, 2020
  • Expected date of submission: 2020-10-09
  • Latest update: 2019-12-182020-01-15
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