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, 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 in 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 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. The ENVI Committee 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,  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. 

Among other elements, the Council proposes to delete the new provisions on multi-constituent substances altogether and insert a review clause requiring the Commission to present, within 4 years of the entry into force of the revised CLP Regulation, a report on the classification of those substances, possibly accompanied by a legislative proposal. Concerning labelling, the Council proposes to adjust the minimum font sizes and other requirements on text legibility. It adds specific requirements on the form and design of the front page of fold-out labels, and seeks to clarify the concept and rules for digital labelling. 

On 5 December 2023, the co-legislators reached a provisional agreement on the file. They notably agreed that substances containing more than one constituent (MOCs) will be evaluated using the available information on its known constituents as well as on the substance itself. MOCs extracted from plants or plant parts (essential oils) and not chemically modified are exempted. Within 5 years of entry into force, the Commission should present a scientific report regarding the examination of the information on such substances, possibly accompanied by a legislative proposal. The co-legislators agreed on minimum label formatting rules to increase the readability of labels, while adding requirements for fold-out labels, specifying in particular the elements that must appear on the front pages. The agreement also includes rules on voluntary digital labelling and related technical requirements. At Parliament's request, the use of 'green claims' (such as 'non-toxic' or 'non-polluting') will be banned for substances or mixtures classified as hazardous.

The agreed text was approved by the Permanent Representatives' Committee (Coreper) on 22 December 2023, and by the ENVI Committee on 11 January 2024. Parliament formally adopted it on 23 April 2024 by 533 votes to 11 and 65 abstentions. 



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Author: Vivienne Halleux, Members' Research Service,

As of 20/06/2024.