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Adopted text

Classification, labelling and packaging of substances and mixtures

TA-9-2023-0340 · P9_TA(2023)0340 · PE745.493

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Parliament's amended version of a proposed regulation amending Regulation (EC) No 1272/2008 on classification, labelling and packaging of substances and mixtures. It requires a supplier established in the Union for chemicals sold online, and sets rules for substances containing more than one constituent, including those of renewable botanical origin. It allows voluntary digital labelling, broader use of fold-out labels, and sets minimum font size and formatting requirements. It requires advertisements for hazardous substances and mixtures to show the hazard pictogram, signal word, hazard class and hazard statements, and bans certain environmental claims. It sets rules for harmonised classification of groups of substances, updates to the classification and labelling inventory, and a right to request action from authorities. It defers application of some provisions and allows substances and mixtures already on the market to continue without re-classification and re-labelling for a period.

Key points

  1. Requires a supplier established in the Union to ensure substances or mixtures placed on the market, including via distance sales, meet the regulation's requirements.
  2. Sets rules for evaluating substances containing more than one constituent, using data on individual constituents and on the substance itself.
  3. Exempts substances containing more than one constituent of renewable botanical origin that are not chemically or genetically modified from the evaluation rules, without prejudice to Regulations (EU) No 1107/2009 and (EU) No 528/2012.
  4. Requires the Commission to review the identification and examination of such botanical substances and assess the social and economic impact on micro and small enterprises.
  5. Allows voluntary digital labelling and broader use of fold-out labels, and requires minimum font size and formatting requirements for readability.
  6. Requires the hazard pictogram, signal word, hazard class and hazard statements to remain on the on-pack label.
  7. Requires advertisements for hazardous substances and mixtures to indicate the hazard pictogram, signal word, hazard class and hazard statements, and for those sold to the general public to add 'always read and follow the information on the product label'.
  8. Prohibits environmental claims for substances and mixtures classified as hazardous due to germ cell mutagenic, carcinogenic, toxic to reproduction, endocrine disruption, PBT, vPvB, PMT or vPvM properties.
  9. Requires notifiers to provide reasons for divergence from the most severe classification or for introducing a more severe classification, without needing new data or studies.
  10. Requires all information notified to the classification and labelling inventory to be publicly available free of charge, including the identity of notifiers.
  11. Allows harmonised classification and labelling proposals for groups of substances, prioritising groups over individual substances where scientifically justified.
  12. Gives any natural or legal person the right to submit substantiated evidence on hazardous properties to competent authorities or the Commission, which must assess it and initiate enforcement or harmonised classification if needed.

Who is affected

  • Suppliers of substances and mixtures, including those selling online, who must ensure compliance and labelling requirements.
  • Manufacturers, importers and downstream users, who must classify substances and mixtures and provide reasons for classification divergences.
  • Consumers and professional users, who benefit from clearer labels, digital labelling and refill station rules.
  • The European Chemicals Agency, which receives notifications, publishes information and may provide scientific advice.
  • Micro and small enterprises dealing with substances of renewable botanical origin, whose social and economic impact will be assessed.

Figures and deadlines

  • Notifiers must update notifications within 6 months after a decision to change classification and labelling.
  • The Commission shall adopt delegated acts by 1 January 2026 to amend Annex VI for certain hazard classes.
  • The Commission shall assess the introduction of hazard criteria for immunotoxicity and neurotoxicity by 31 December 2025.
  • The Commission shall evaluate alternative test methods at least every three years.
  • The Commission shall adopt a delegated act to update Annex I no more than twelve months after non-animal data are included in UN harmonised criteria.
  • The power to adopt delegated acts is conferred for a period of five years.
  • Substances and mixtures already on the market may continue without re-classification and re-labelling until 42 months and 48 months after entry into force, respectively.
  • The Commission shall present a review report no sooner than six years after entry into force regarding substances of renewable botanical origin.