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DRAFT 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

ENVI-PR-745493

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

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This is the rapporteur's draft report on the Commission proposal to amend Regulation (EC) No 1272/2008 on classification, labelling and packaging of substances and mixtures. It proposes 57 amendments to the Commission's text. The amendments delete the new definition of multi-constituent substances, require grouping of substances for harmonised classification to rest on scientific criteria and a weight of evidence, and set label update deadlines at 18 months. They also require the Commission to ensure new hazard classes can be satisfied with existing data aligned with the EU goal of replacing animal testing, and to give ECHA adequate resources under a separate budgetary line. The report proposes differentiated application dates of 18 months for substances and 24 months for mixtures, and changes to advertisement and distance sales rules so they target the general public.

Committee position. The rapporteur generally supports the Commission proposal but proposes 57 amendments to keep current best practices, align with the needs of citizens and industry, and provide clarifications. The main lines are deleting the multi-constituent substance definition, strengthening scientific criteria for grouping, extending label update deadlines to 18 months, ensuring new hazard classes can be satisfied without new animal testing, and giving ECHA adequate resources.

Key points

  1. Deletes the definition of multi-constituent substance, which the rapporteur says differs from the REACH guidance definition and could create confusion.
  2. Requires that data on a substance as a whole be taken into account in classification, and that information on constituents be used where data on the substance itself is not available.
  3. Sets the deadline to update labels after a change in classification at 18 months, replacing the proposed 6 months.
  4. Requires grouping of substances for harmonised classification to rest on clear and cumulative scientific criteria, including structural similarity and similar hazard and risk profiles assessed by weight of evidence.
  5. Requires ECHA to develop guidance on the scientific principles for grouping substances, and on when and how notifiers must justify divergences from the inventory.
  6. Requires the Commission to ensure, before introducing new hazard classes or criteria, that they can be fully satisfied with existing data aligned with the EU goal of fully replacing animal testing.
  7. Requires that all data, including animal and non-animal data, be evaluated comparably according to biological relevance, mechanistic understanding and suitability for the Regulation's requirements.
  8. Requires ECHA to be given adequate resources under a separate budgetary line, to be reflected in the ECHA Founding Regulation.
  9. Requires the Commission to assess the direct and indirect costs for producers and to establish an EU support scheme for the most vulnerable in the essential oils production chain, mainly micro, small and medium enterprises.
  10. Adds references to fold-out labels in Articles 17, 29, 31 and 32, and allows information in Article 17(1)(e) to (h) on inner pages of fold-out labels.
  11. Restricts advertisement requirements to the sale to the general public, requiring a request to 'always read and follow product label information', and restricts distance sales label requirements to the general public.
  12. Sets differentiated application dates: 18 months for substances and 24 months for mixtures, with transitional periods of 17 months for substances and 35 months for mixtures.

Who is affected

  • Manufacturers, importers and downstream users of substances and mixtures, who must follow the amended classification, labelling and packaging rules.
  • Suppliers of essential oils and natural complex substances, for whom a support scheme for compliance costs is proposed.
  • The European Chemicals Agency (ECHA), which would receive additional tasks and resources under a separate budgetary line.
  • Micro, small and medium enterprises in the production chain of essential oils, targeted by the proposed EU support scheme.
  • Notifiers to the classification and labelling inventory, who must justify divergences only where practically achievable without new data or studies.

Figures and deadlines

  • 18 months: deadline to update labels after a change in classification, replacing the proposed 6 months.
  • 18 months: application date for substances after entry into force of the Regulation.
  • 24 months: application date for mixtures after entry into force of the Regulation.
  • 17 months: transitional period for substances after entry into force.
  • 35 months: transitional period for mixtures after entry into force.
  • 18 months: deadline for the Committee for Risk Assessment to adopt an opinion on a harmonised classification proposal.
  • 30 days: minimum extension of the comment period where harmonised classification may lead to risk management measures under REACH.
  • 6 months: deadline for notifiers to update notifications after a decision to change classification.

Legal basis: Article 114 of the Treaty on the Functioning of the European Union.