EU Revises CLP Regulation on Substances and Mixtures

The newly released CLP revision adds several new hazard classes and introduces digital labeling.

On November 20, 2024, EU’s revised Classification, Labelling, and Packaging (CLP) Regulation was published on the Official Journal as Regulation 2024/2865 of The European Parliament And Of The Council of 23 October 2024 amending Regulation (EC) No 1272/2008 on classification, labelling and packaging of substances and mixtures (hereinafter referred to as the Revision). This Revision comes into force on December 10, 2024.

The CLP revision was first announced in the Chemical Strategy for Sustainability on December 19, 2022, as part of the efforts under the EU Green Deal to ensure a toxic-free environment. It aims to better identify and classify hazardous chemicals, improve communication on chemical hazards and address legal gaps and high levels of non-compliance.

New hazard classes

The Revision adds new hazard classes of:

• Endocrine Disrupting for Human Health, Cat 1 or 2
• Endocrine Disrupting for Environment, Cat 1 or 2
• Persistent, Bioaccumulative and Toxic (PBT)
• very Persistent and very Bioaccumulative (vPvB) Persistent, Mobile and Toxic (PMT)
• very Persistent and very Mobile (vPvM)

Notification to CL Inventory

If the notified substances are already included in the CL Inventory, the notifiers are now required to provide reasons for divergence from the most severe classification or for introducing a more severe classification per hazard class for the same substance to the European Chemical Agency (ECHA). The notifiers should update their notifications within 6 months in case of changes on the classification and labeling.

The notified information shall be publicly available online and free of charge, including the name of notifiers.

Classification of multi-constituent substances

As per the Revision, a multi-constituent substance should be evaluated based both on available information on those known constituents and the substance itself. However, with regard to CMR , ED, PBT, vPvB, PMT, and vPvM properties, only information about the constituents can be used. It should be noted that this rule does not appy to multi-constituent substances extracted from plants or plant parts and which are not chemically modified. 

Digital labeling 

The Revision allows for voluntary digital labeling of chemical products. A data carrier linking to a digital label shall be affixed or printed on the physical label so that it can be processed automatically by digital devices.

The digital label should include all information as provided in the physical label. Supplemental information may be omitted on a digital label with an accompanying statement “More hazard information available online” or a similar indication. The digital label should be accessible for at least 10 years to all EU users free of charge.

Fold-out labels

The regular use of fold-out labels is allowed under the new regulation. The front page of fold-out label should include at least the following elements:

• name, address and phone number of suppliers;
• nominal quantity
• product identifiers
• hazard pictorgams, if applicable;
• signal words, if applicable;
• unique formula identifier, if applicable;
• a reference to the full safety information;
• an abbreviation of the language for all the languages used in the inside pages.

The inner pages shall contain all the required label elements except for those mentioned on the front page. The back page should contain all the information provided on the front page. The Revision also includes a minimal font size and a mandatory font color.

Deadline for updating labels

The Revision stipulates that all labels should be updated without undue delay. A 6-month deadline is provided for any change resulting in a new hazard class or in a more severe classification. In other cases, the labels should be updated within 18 months. 

Additionally, other notable changes introduced under this Revision are summarized below:

• Allows the self-classification of a substance or a mixture differently depending on the form or physical state;
• Introduces “acute toxicity estimates” for substances classified as acutely toxic for human health;
• Introduces the new approach methodologies (NAMs) ;
• Introduces provisions for labeling and packaging of hazardous substances or mixtures supplied via refill stations;
• Advertisement for hazardous substances and mixtures must contain essential safety information (hazard pictogram, signal words, hazard statements and supplemental EUH statements);
• Distance sales like online sales of hazardous substances or mixture should also comply with the CLP requirement;
• All relevant actors including distributors need to comply with Poison Center Notification (PCN) requirements.

Transitional period

All suppliers shall comply with the requirements set out in the Revision after July 1, 2026. Specifically, the new PCN requirement shall apply from January 1, 2027. 

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