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REPORT (COM(2022)0748 – C90433/2022 – 2022/0432(COD))

On the proposal for a regulation of the European Parliament and of the Council amending Regulation (EC) No 1272/2008 of the European Parliament and of the Council on classification, labelling and packaging of substances and mixtures

A-9-2023-0271

Committee on the Environment, Public Health and Food Safety · Rapporteur: Maria Spyraki

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Parliament's amended version of the Commission proposal to amend Regulation (EC) No 1272/2008 on classification, labelling and packaging of substances and mixtures. It requires a supplier established in the Union for online sales, and sets rules for substances containing more than one constituent, including a carve-out for those of renewable botanical origin. It allows voluntary digital labelling while keeping key safety elements on the on-pack label, permits broader use of fold-out labels, and sets minimum font size and formatting rules. It changes rules on harmonised classification and labelling, including grouping of substances, notification and publication of proposals, and a deadline for endocrine disruptor and PBT entries. It requires notifiers to justify divergent classifications, makes inventory information public, and bans environmental claims in advertisements. It promotes non-animal testing methods, requires the Commission to assess immunotoxicity and neurotoxicity criteria by 31 December 2025, and defers application of some provisions.

Committee position. The Committee on the Environment, Public Health and Food Safety proposes amendments to the Commission proposal, covering online sales, multi-constituent substances, digital labelling, harmonised classification, inventory transparency, advertisement rules, non-animal testing, and deferred application.

Key points

  1. Requires a supplier established in the Union to ensure substances or mixtures meet the Regulation's requirements when placed on the market, including via distance sales.
  2. Sets classification rules for substances containing more than one constituent, using data on known constituents, impurities and additives, and allows data on the substance itself in certain cases.
  3. Exempts substances containing more than one constituent of renewable botanical origin that are not chemically or genetically modified and not covered by Regulation (EU) No 1107/2009 or Regulation (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, but keeps the Unique Formula Identifier, hazard statement, precautionary statement, signal word and hazard pictogram on the on-pack label.
  6. Permits broader use of fold-out labels and requires minimum font size and formatting rules; for multilingual labels, languages must be ordered logically, e.g. alphabetically.
  7. Requires notifiers to give reasons for divergence from the most severe classification or for a more severe classification, without needing new data or studies.
  8. Makes all information notified to the classification and labelling inventory publicly available free of charge, including the identity of notifiers.
  9. Requires advertisements for hazardous substances and mixtures to show the hazard pictogram, signal word, hazard class and hazard statements, and bans environmental claims.
  10. Requires the Commission to adopt delegated acts by 1 January 2026 to include endocrine disruptor category 1 and PBT, vPvB, PMT and vPvM substances in Annex VI where they are on the candidate list on 1 January 2025.
  11. Promotes non-animal testing methods, requires the Commission to evaluate their development at least every three years, and to assess immunotoxicity and neurotoxicity criteria by 31 December 2025.
  12. Defers application of some provisions: substances from 18 months and mixtures from 24 months after entry into force, with longer transition periods for products already on the market.

Who is affected

  • Suppliers of substances and mixtures, who must ensure a Union-established supplier for online sales and follow new labelling rules.
  • Manufacturers, importers and downstream users, who must classify substances containing more than one constituent and justify divergent classifications.
  • Notifiers and registrants, who must make every effort to agree on inventory entries and provide reasons for divergences.
  • The European Chemicals Agency, which must publish information, provide guidance, and receive adequate and stable funding.
  • Consumers and professional users, who benefit from refill station labels, digital label access, and advertisement information.

Figures and deadlines

  • Notifiers must update notifications within 6 months after a decision to change classification and labelling.
  • The Commission must adopt delegated acts by 1 January 2026 to include certain substances in Annex VI.
  • Substances on the candidate list on 1 January 2025 are covered by the delegated act deadline.
  • The Commission must assess immunotoxicity and neurotoxicity criteria by 31 December 2025.
  • Delegated acts are conferred on the Commission for a period of five years.
  • The European Parliament or Council may object to a delegated act within two months of notification.
  • Substances may be classified under old rules until 18 months after entry into force; mixtures until 35 months.
  • Substances placed on the market before 18 months after entry into force are exempt until 42 months; mixtures until 48 months.

Legal basis: Article 294(2) and Article 114 of the Treaty on the Functioning of the European Union