Revision of Regulation (EC) No 1272/2008 on hazard classification, labelling and packaging of chemical substances and mixtures

In “A European Green Deal”

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In its work programme for 2022, adopted on 19 October 2021, the European Commission announced that it would put forward a revision of Regulation (EC) No 1272/2008 on hazard classification, labelling and packaging of chemical substances and mixtures (CLP regulation). This revision was foreseen under the EU Chemicals strategy for sustainability, part of the European Green Deal.

The CLP regulation aims to ensure a high level of protection of health and the environment, as well as the free movement of substances, mixtures and articles. It is based on the United Nations' Globally Harmonized System of Classification and Labelling of Chemicals. The CLP regulation requires manufacturers, importers or downstream users to assess whether the substances and mixtures they place on the market have harmful properties, based on the CLP criteria. The EU may adopt a harmonised classification, which then applies across the EU to all duty holders. This is the case, for instance, for substances of highest concern (carcinogenic, mutagenic, or toxic for reproduction).

Once a substance or mixture is classified, the identified hazards need to be communicated to other actors in the supply chain, including workers and consumers. The CLP contains detailed requirements on labelling (including pictograms, signal words and standard statements for hazard, prevention, response, storage and disposal). It further provides for general packaging standards to ensure the safe supply of hazardous substances and mixtures.

The legislative proposal for revising the CLP was tabled on 19 December 2022. The amendments proposed to the CLP regulation aim to ensure the comprehensive identification and classification of chemical hazards; to improve hazard communication (for instance through obligatory formatting rules, such as minimum font size and colour, as well as new provisions on chemicals sold in refillable containers, and on voluntary digital labelling); and to address legal gaps and ambiguities in the CLP regulation, in particular as regards online sales and poison centre notifications.

As part of the CLP regulation revision package, the European Commission adopted a delegated act adding definitions and criteria to enable substances and mixtures with endocrine disrupting; persistent, bioaccumulative and toxic; very persistent and very bioaccumulative; persistent, mobile and toxic; or very persistent and very mobile properties to be classified into established hazard classes. This act, which was subject to scrutiny by the European Parliament and Council, was published in the EU Official Journal on 31 March 2023, and entered into force on 20 April.

In Parliament, the file was referred to the Committee on the Environment, Public Health and Food Safety (ENVI), which appointed Maria Spyraki (EPP, Greece) as rapporteur on 3 February 2023. The Commission presented the proposal to ENVI Committee members on 22 March 2023. The ENVI Committee discussed its rapporteur's draft report, released on 12 April, at its meeting on 4 May 2023.

ENVI adopted its legislative report on 11 September 2023. The report clarifies the proposed rules for classifying substances with more than one constituent and introduces a derogation for those 'of renewable botanical origin', together with a review clause. It sets a one-year deadline for the Commission to decide on the harmonised classification and labelling of chemicals falling into the new hazard classes that are already on the REACH candidate list. It requires that CLH proposals prioritise groups of substances rather than individual substances where scientifically justified and possible; and that grouping of substances for CLH be based on clear scientific criteria, including structural similarity and similar evidence-based hazard profiles. The report further asks the Commission to look into the introduction of hazard criteria for immunotoxicity and neurotoxicity by the end of 2025; and to assess at least every 3 years progress in the development of alternative methods to animal testing. On 4 October 2023, the Parliament adopted its position in plenary with 519 votes in favour, 99 against and 8 abstentions. The matter was referred back to ENVI for interinstitutional negotiations with the Council, which adopted a general approach on the file on 30 June 2023.

On 5 December 2023, the co-legislators reached a provisional agreement in trilogue negotiations. The agreed text was approved by the Permanent Representatives' Committee (Coreper) on 22 December 2023, and by the ENVI Committee on 11 January 2024. 

 

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Author: Vivienne Halleux, Members' Research Service, legislative-train@europarl.europa.eu

As of 20/01/2024.