What’s Changing?

As of June 23, 2025, the European Commission has officially restricted:

• DMAC (N,N-Dimethylacetamide)
• NEP (1-Ethylpyrrolidin-2-one)

Both are classified as Category 1B reproductive toxicants and added to Annex XVII of REACH.

Compliance Criteria (Effective Dec 2026)

Products containing ≥0.3% of DMAC or NEP may only be used if:

1. Worker exposure remains below DNELs:

o DMAC:

Inhalation: 13 mg/m³
Dermal: 1.8 mg/kg bw/day

o NEP:

Inhalation: 4 mg/m³
Dermal: 2.4 mg/kg bw/day

2. Controls and documentation are in place:

o Exposure control systems
o Updated Safety Data Sheets (SDS) with DNELs
o Revised Chemical Safety Reports (CSR)
o PPE and ventilation where applicable

Industries Affected

• Textiles & Man-made fibers
• Adhesives & Paints
• Electronics & Semiconductors
• Cleaning & Solvent manufacturing
• Chemical intermediates & resins

Note: Fiber manufacturing gets a longer adjustment period (until mid-2029) for DMAC.

Action Checklist for Compliance

🔍 1. Assess Your Inventory

• Identify products, processes, or formulations with ≥0.3% DMAC or NEP.

🧾 2. Update SDS & CSRs

• Include DNELs and exposure-related controls as required under REACH Annex II.

🧪 3. Measure Workplace Exposure

• Conduct workplace exposure assessments.
• Compare actual exposure levels to DNELs.

🛡 4. Implement Risk Mitigation

• Introduce engineering controls, PPE, or process modifications as needed.
• Ensure workers are trained and protected.

🔄 5. Plan Substitution or Reformulation

• Explore safer solvent alternatives to reduce long-term compliance costs and risks.

📝 6. Maintain Documentation

• Be prepared for inspection or regulatory audit.
• Keep exposure records, SDSs, and risk assessments current.

Regulatory Context

This restriction is part of the EU’s broader strategy on chemical safety, worker protection, and the Green Deal’s zero pollution ambition. It mirrors increasing global regulatory scrutiny of reproductive toxicants and solvent exposure in industry.

Reference: EUR-Lex – Regulation (EU) 2025/1090

 

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