It has been announced that the European Commission has amended Annex I of Regulation (EC) No 1272/2008 to add hazard classes to the classification, labelling, and packaging of substances and mixtures and to introduce new classification criteria to identify endocrine disrupting chemicals (EDCs) and persistent and mobile substances.

The new hazard classes introduced are-

1. ED HH in Category 1 and Category 2 (Endocrine disruption for human health)
2. ED ENV in Category 1 and Category 2 (Endocrine disruption for the environment)
3. PBT (persistent, bioaccumulative, toxic), vPvB (very persistent, very bioaccumulative)
4. PMT (persistent, mobile, toxic), vPvM (very persistent, very mobile)

EU harmonised classifications normally apply to these items

• • All chemical substances and mixtures placed on the EU market under REACH.
  • Active substances in biocidal products.
  • Active substances in plant protection products.

Important Dates for Application of Substances and Mixtures

• 20th April 2023: The new rules are in force i.e., Member States can make proposals for harmonised classification and labelling (CLH) with the new hazard classes and manufacturers, importers, downstream users and distributors can self-classify their substances and mixtures accordingly.

SUBSTANCES

• • 20th April 2023 to 1st May 2025 (24 months): Substances on the market.
  • 1st May 2025 to 1 November 2026 (18 months): Transition period i.e., As of 1 May 2025, companies need to comply with the new regulations for new substances on the market, while substances already on the market must comply by 1 November 2026.
  • From 1 November 2026: New classification and labelling will be mandatory.

MIXTURES

• 20th April 2023 to 1st May 2026 (36 months): Mixtures on the market.
• 1st May 2026 to 1 May 2028 (24 months): Transition period i.e., Hazard classes will change for new mixtures from 1 May 2026, while existing mixtures will have until 1 May 2028 to update their classification and labelling.
• From 1 May 2028: New classification and labelling will be mandatory.

For more information, please reach out to info@auxilife.com or info@eu.auxilife.com

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Auxilife Scientific Services Pvt. Ltd. Global Product Compliance (GPC)