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 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 (DMAC); 1-ethylpyrrolidin-2-one (NEP)

EC / List no: - CAS no: -

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

Status

Opinions adopted

Date of intention

09-Dec-2019

Expected date of submission

08-Apr-2022

Withdrawal date

Reason for withdrawal

Start of Call for Evidence consultation

18-Dec-2019

Deadline for comments on the Call for Evidence