PACT - Public Activities Coordination Tool

The public activities coordination tool (PACT) provides an overview of the substance-specific activities that authorities are working on under REACH and the CLP Regulation. These activities are being carried out in line with ECHA’s Integrated Regulatory Strategy.

PACT provides up-to-date information on the activities planned, ongoing or completed by ECHA and/or MSCAs for a given substance in the following areas:

Data generation and assessment – dossier evaluation, substance evaluation, informal hazard assessment (PBT/vPvB/ED).
Assessment of regulatory needs (ARN).
Regulatory risk management – harmonised classification and labelling (CLH) , SVHC identification, recommendations for inclusion in the Authorisation List, restriction.

A summary of all the substance-specific activities can be found under ‘Details’ for each entry.

N,N-dimethylacetamide (DMAC); 1-ethylpyrrolidin-2-one (NEP)

EC / List no: - CAS no: -

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Regulatory risk management

Restriction

Restriction 1

Status

Opinions adopted

Date of intention

09-Dec-2019

Withdrawal date

Submitter(s)

Netherlands

Remarks

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%).

Restriction report (and annexes)