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Registry of restriction intentions until outcome

The registry of restriction intentions until outcome lists the intentions and Annex XV restriction proposals received by ECHA.

A restriction proposal may be prepared by a Member State or by ECHA at the request of the Commission or on its own initiative for substances in the Authorisation List. It is a legal requirement for a Member State to notify ECHA of its intention to prepare a restriction dossier. The advance notice enables interested parties to plan and prepare for commenting later on.

Interested parties can follow the progress of a proposal through the restriction process, from the notification of the intention to the adoption of the final opinions by the Committee for Risk Assessment (RAC) and the Committee for Socio-economic Analysis (SEAC), and the adoption of the restriction by the European Commission.

Stakeholders are encouraged to submit any relevant information to the dossier submitters during the preparation of the restriction proposal and during the public consultations. Information to motivate any exemptions to the scope described in the intention is particularly useful to receive in the preparatory phase of the dossier.

N,N-dimethylacetamide

EC / List no: 204-826-4 CAS no: 127-19-5
CLP Annex VI Index number
616-011-00-4
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.
Submitter(s)
Netherlands
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%).
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.
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.
Status
Intention
Date of intention
09/12/2019
Expected date of submission
09/10/2020
Withdrawal date
Reason for withdrawal
Start of Call for Evidence public consultation
18/12/2019
Deadline for comments on the Call for Evidence
13/03/2020
Start of second Call for Evidence public consultation
Deadline for comments on the second Call for Evidence
Start of third Call for Evidence public consultation
Deadline for comments on the third Call for Evidence
Restriction report (and annexes)
Information note on restriction report
Start of Annex XV report public consultation
1st deadline for comments on Annex XV report
Final deadline for comments on Annex XV report
Comments on Annex XV report
Opinion of RAC (and minority positions)
Draft opinion of SEAC
RAC & SEAC (draft) Background document (and annexes)
Start of SEAC draft opinion public consultation
Deadline for comments on SEAC draft opinion
Comments on SEAC draft opinion
Compiled RAC and SEAC opinion (and minority positions)
Final background document (and annexes)
Adopted restriction/Commission communication
Latest update
15/01/2020

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