N,N-dimethylacetamide (DMAC) and 1-ethylpyrrolidin-2-one (NEP) restrictions in REACH annex XVII published

Commission Regulation (EU) 2025/1090 of 2 June 2025 amending Annex XVII to Regulation (EC) No 1907/2006 of the European Parliament and of the Council as regards N,N-dimethylacetamide (DMAC) and 1-ethylpyrrolidin-2-one (NEP) was published on June 3 2025 in the EU Official Journal. 
 
It adds the following restrictions: 

•  entry 80. for N,N-dimethylacetamide (DMAC) (CAS: 127-19-5, EC: 204-826-4): 
   
  1. Shall not be placed on the market as a substance on its own, as a constituent of other substances, or in mixtures in a concentration equal to or greater than 0,3 % after 23 December 2026 unless manufacturers, importers and downstream users have included in the relevant chemical safety reports and safety data sheets, derived no-effect levels (DNELs) relating to exposure of workers of 13 mg/m3 for long-term exposure by inhalation and 1,8 mg/kg bw/day for long-term dermal exposure. 

2. Shall not be manufactured, or used, as a substance on its own, as a constituent of other substances, or in mixtures in a concentration equal to or greater than 0,3 % after 23 December 2026 unless manufacturers and downstream users take the appropriate risk management measures and provide the appropriate operational conditions to ensure that exposure of workers is below the DNELs specified in paragraph 1.
3. By way of derogation from paragraphs 1 and 2, the obligations laid down therein shall apply from 23 June 2029 in relation to placing on the market for use, or use, as a solvent in the production of man-made fibres.

• entry 81. for 1-ethylpyrrolidin-2-one (NEP) (CAS 2687-91-4, EC 220-250-6): 

1.Shall not be placed on the market as a substance on its own, as a constituent of other substances, or in mixtures in a concentration equal to or greater than 0,3 % after 23 December 2026 unless manufacturers, importers and downstream users have included in the relevant chemical safety reports and safety data sheets, derived no-effect levels (DNELs) relating to exposure of workers of 4,0 mg/m3 for long-term exposure by inhalation and 2,4 mg/kg bw/day for long-term dermal exposure. 

2. Shall not be manufactured, or used, as a substance on its own, as a constituent of other substances, or in mixtures in a concentration equal to or greater than 0,3 % after 23 December 2026 unless manufacturers and downstream users take the appropriate risk management measures and provide the appropriate operational conditions to ensure that exposure of workers is below the DNELs specified in paragraph 1.’

So, both restrictions are straightforward – you will only be able to place on the market as a substance on its own, as a constituent of other substances, or in mixtures in mixtures at < 0,3 % after 23. December 2026. Unless the stated DNEL values in the restriction are included in the safety data sheets and chemical safety reports. In that case the restriction conditions would not be met, and you would still be able to place them on the market. 

The second paragraphs relate to a similar derogation – if these DNEL values can be followed in practice by using risk measures to ensure the worker exposure is lower, you will still be able to manufacture these substances, use them and also include in your mixtures at ≥ 0.3 %. 

The aim of this regulation therefore mainly seems to be focused on providing a larger degree of protection of workers that are exposed to these substances. 

Restriction for: N,N-dimethylacetamide also has a specific derogation in paragraph 3:  
 
“the obligations laid down therein shall apply from 23 June 2029 in relation to placing on the market for use, or use, as a solvent in the production of man-made fibres.” 
 
So, what should you do now that you are familiar with these restriction? 
 
If you are a manufacturer or user of the substance and you still want to continue manufacturing or using it: 

1. check the current exposure of workers to the substance in your workplace
2. if the exposure is lower than the specified DNELs, you are already compliant with the restriction 
3. if the exposure is equal or higher to the specified DNELs, you will need to take the appropriate risk management measures and provide the appropriate operational conditions to lower the exposure after the compliancy date 

If you are a downstream user and include the substance in your mixtures, and place them on the market: 

1. first check the same as above for manufacturers or users of substance
2. check the concentration in the final mixture
3. if the concentration is lower than 0.3 % you can still place them on the market after the compliance date 
4. if the concentration is at ≥ 0.3 %, then you will need to include the relevant information on DNEL in the documentation you provide to your customers after the compliancy date 

If you are a distributer of the substance or mixtures containing the substance: 

1. you should receive the relevant documentation from your supplier (chemical safety report and safety data sheets) with the relevant DNEL values stated
2. check if these DNEL values are in accordance with the restrictions
3. if they are, you can continue distributing the substance on its own, as constituent of other substances or in mixtures at ≥ 0.3 %. 

I hope this was useful to you. If you are having challenges understanding these restrictions, you can always write to us at info@bens-consulting.eu.