Summary of the new regulation:
On 20 November 2024, the new CLP Regulation (EU) 2024/2865 was published. It introduces significant changes to existing legislation on the classification, labelling and packaging of substances and mixtures (Regulation (EC) No 1272/2008). The aim of the revision is to better adapt the law to technological and societal changes, to increase health and environmental protection and to improve risk management of chemicals. This regulation enters into force on 10 December 2024.
Below are the most relevant changes:
5 new hazard classes have been introduced:
- Endocrine disrupting properties: In relation to human health and in relation to the environment (ED).
- Persistent, Bioaccumulative and Toxic (PBT).
- Very persistent and very bioaccumulative (vPvB).
- Persistent, mobile and toxic (PMT).
- Very persistent and very mobile (vPvM).
Adaptation to e-commerce:
A requirement for suppliers of chemicals sold over the internet to register a company in the EU has been introduced to increase control over product compliance. A substance or mixture will not be allowed to be placed on the market unless the supplier, established in the Union and identified on the label as part of an industrial or professional activity, complies with certain requirements.
The offer for sale of a product marketed by distance selling must clearly and conspicuously indicate the labelling elements referred to in Article 17 of the CLP Regulation.
PCNs have been introduced for distributors who place on the market mixtures classified as hazardous due to health or physical effects, who distribute these mixtures in other Member States, or who rebrand or re-label them. The above requirement does not apply as long as the distributor can demonstrate that the designated bodies have already received the same information from importers and downstream users.
Digital labels:
In addition to the traditional physical labels, the possibility of providing labels in digital form has been introduced. In addition, supplementary information in the form of EUH returns can only be provided on the digital label. If a digital label is used, the supplier must affix or print a data medium linking to the digital label and ensure that the digital label complies with the following rules: all elements of the label must be given together in one place, separate from other information, easily searchable, accessible to all EU users and must remain available for at least 10 years, or longer if required by other EU legislation. Digital labels must be accessible free of charge, without the need to register, download or install an app or enter a password. The information on the digital label must be compatible with all major operating systems and browsers, accessible with no more than two clicks, and if available in more than one language, the choice of language must not depend on the geographical location of the user.
The data medium linking to the digital label must be permanently attached or printed on the physical label or packaging next to the label to allow automatic processing by commonly used digital devices.
If the elements of the label are only accessible digitally, the phrase ‘You can find more hazard information online’ or a similar indication must be included.
Fold-out labels:
Changes have been made to fold-out labels, which previously only applied to small packages. The front side of such a label should contain the name, address, telephone number of the supplier, nominal quantity, product identifiers, and pictograms, signal words, UFI identifier, reference to full safety information and country code for all languages used on the inside pages of the label. The inner pages of the fold-out label must contain all label elements except the pictogram and supplier identification data in all languages listed on the first page, while the back side of the label must contain all elements on the front side, except for the abbreviations for the languages used on the inner pages.
New regulations for multi-component substances (MOCS):
Provisions have been introduced for multicomponent substances, including those containing impurities or additives, whereby the assessment of a substance should be based on the available information on these components, and on the substance itself. Relevant information for multicomponent substances that indicates the absence of certain properties or their less serious nature does not override relevant information for the individual components. This information shall not apply to substances extracted from plants or parts thereof, which are not chemically modified, including algae, lichens and yeasts.
Safety at filling stations:
For consumers and professional users, the possibility to refill packages via filling stations has been introduced when these meet certain conditions: they are labelled according to each substance or mixture supplied, which are permanently and horizontally positioned in a prominent place, apply measures to reduce the risk of exposure to humans (especially children) and the environment, and prevent uncontrolled use by children. In addition, the products must not react in a way that endangers customers or staff, and staff are adequately trained in their safety. The supplier is present during filling to provide technical and emergency assistance. At the same time, this possibility does not apply to substances or mixtures meeting the criteria of the following hazard classes: acute toxicity, toxic effect, corrosivity, mutagenicity, carcinogenicity.
New deadlines for updating labels:
Change of classification or labelling:
In the case of the addition of a new hazard class or a more stringent classification of the product, the supplier must update the label without undue delay and no later than 6 months after the results of the new assessment or notification of these results.
For other changes in classification or labelling, the label must be updated without undue delay and no later than 18 months after the results of the new assessment or notification of those results are available.
If justified, manufacturers, importers and downstream users shall classify specific forms or physical states of the substance or mixture.
Harmonised classification:
If the change is due to harmonised classification and labelling, the above deadlines do not apply. In this case, the supplier must update the label within the time limits specified in the relevant ATP delegated act.
Packaging adaptation:
Additional label size requirements have been introduced for packs not exceeding 0.5 litres, where the minimum font size should be 1.2 mm, and for packs larger than 0.5 litres up to 3 litres, where the font size should be 1.4 mm. The size of packaging from 3 to 50 litres has also been updated, for which the font on the label should be 1.8 mm high, while for packaging larger than 50 litres the font size should be 2 mm. The text on the label must be black on a white background, the distance between the lines must be at least 120% of the font size, and the font should be easily readable, unencoded, with appropriate spacing between the letters.
Advertising:
Any advertising of a substance classified as hazardous must appropriately include pictograms, signal words, hazard statements and supplementary hazard statements (EUHs).
In addition, advertisements for substances intended for the general public should include the phrase: ‘In all cases, follow the information on the product label’.
In addition, no advertisement for a substance or mixture classified as hazardous shall contain statements that are not stated on the label or packaging of that substance or mixture. In the case of non-visual advertising (e.g. broadcast on the radio), hazard pictograms and warning slogans may be omitted.
The amendment requires companies to adapt their production processes and labelling to the new legislation. Regulation (EU) 2024/2865 is a significant step forward in the regulation of chemicals within the EU. Despite the initial challenges companies may face, the new regulations are an important part of protecting health and the environment in a changing world. Adapting to the new requirements will be crucial for the further development of the chemical market in the EU.
Published December 6, 2024
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