化学品的注册、评估、许可和限制

IFRA supports keeping REACH’s core legislative text unchanged, and instead focusing on secondary legislation, targeted updates to annexes, guidance and better regulatory coordination to make REACH work better in practice. This matters for a sector made up of more than 750 SMEs alongside global companies, supplying ingredients used in over 500,000 consumer products.

IFRA’s recommendations at a glance:

1. Enhance dialogue and alignment with CLP

At stake: Overlapping REACH and CLP evaluations, and limited dialogue with ECHA and Member States, create confusion and unpredictability.

Key ask: Strengthen coordination between REACH and CLP processes, and structure dialogue with ECHA and Member States.

2. Proportionate rules for low-tonnage substances

At stake: More than half of registered fragrance substances, and 80 % of natural complex substances such as essential oils, fall in the lowest tonnage bands.

Key ask: Keep information requirements proportionate to actual exposure, backed by SME and competitiveness impact assessments.

3. An exposure-based prioritization roadmap

At stake: Broad restrictions with temporary exemptions create uncertainty and risk removing safely used ingredients (e.g. ethanol) without regard to actual exposure.

Key ask: Assess use and exposure data up front, and set a clear prioritization roadmap before new restrictions.

4. No blanket Mixture Assessment Factor (MAF)

At stake: An IFRA-commissioned case study estimates a generic MAF (factor of 10) could cut sector turnover by 33 %, without reliably improving safety.

Key ask: Oppose a blanket MAF; assess combined exposure case by case, on a scientific basis.

5. Accelerate regulatory acceptance of reliable animal-free approaches

At stake: Animal testing remains heavily required under REACH and exposure-based alternatives are often limited; new CLP hazard classes risk increasing this demand further while New Approach Methodologies (NAMs) are still under development.

Key ask: Support the validation of reliable NAMs and Next Generation Risk Assessment (NGRA) approaches and allow more flexibility for exposure exemptions and read-across, while ensuring animal testing remains available wherever no validated alternative yet exists.

6. Streamlined implementation

At stake: Fragmented enforcement and complex, unstable IT systems (e.g. IUCLID) raise costs and create market barriers, especially for SMEs.

Key ask: Ensure consistent enforcement across Member States, allow three-year average volumes for registration, and simplify IT systems.