EU's Revised CLP Regulation Officially Came into Effect on December 10, 2024

On November 20, 2024, the European Union published Commission Regulation 2024/2865 (REGULATION (EU) 2024/2865 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL) in its Official Journal, amending the EU CLP Regulation (Regulation (EC) No 1272/2008 on classification, labeling, and packaging of substances and mixtures). The amendment regulation takes effect on December 10, 2024, with most provisions becoming mandatory from July 1, 2026 (18 months), and the remaining provisions applicable from January 1, 2027 (24 months).

As global trade in goods continues to evolve, technological advancements and new sales methods such as online sales allow operators outside the EU to sell chemicals to the EU public online. The existing CLP Regulation 1272/2008 (EC) does not apply to economic operators established outside the EU. In the context of e-commerce, consumers lack instructions on the hazardous properties of chemicals, making it impossible to make informed purchasing decisions. In some cases, the emergency health response information for hazardous mixtures submitted to poison centers is insufficient. Therefore, it is necessary to require suppliers established within the EU to ensure that substances and mixtures comply with the CLP requirements. The amendment regulation facilitates compliance with CLP requirements for non-EU economic operators selling chemicals online to the EU.

It is important to note that the amended regulation also applies to Northern Ireland, and businesses in Northern Ireland manufacturing or importing chemical substances or mixtures must also meet the latest CLP regulation requirements (including goods transported from the UK to Northern Ireland). Since the UK GHS regulations are independent of the EU CLP regulations as GB CLP, businesses in Northern Ireland must also comply with GB CLP requirements.

The UK government has confirmed that, in the absence of a consensus with the United Nations' globally harmonized system, there are no plans to introduce the EU's new hazard classifications into GB CLP. Since April 2023, the new hazard classifications of CLP have been applicable in Northern Ireland.

The revision of CLP will lead to increased costs for businesses placing chemicals on the EU and Northern Ireland markets, mainly due to new labeling requirements, with relatively higher initial compliance costs for small and medium-sized enterprises. However, due to the simplified classification process and the introduction of digital labels, it is a cost-saving change in the long term.

This amendment includes a series of significant changes affecting chemicals, with the main updates as follows:

• New provisions for classification;
• New Hazard Classes and Criteria (Regulation (EU) 2023/707);
• Updated time limits for label updates;
• Introduction of foldable labels;
• Introduction of digital labels;
• Updated requirements for label sizes;
• Other changes to labels.

New provisions for classification

1. The harmonized classification in Annex VI applies to all forms or physical states unless specific forms or physical states applicable to the substance are listed in entries in Annex VI Table 3;
2. Substances containing more than one constituent are complex substances. From a toxicological point of view, substances containing more than one constituent are no different from mixtures composed of two or more substances. Initially, available information on the complex substance itself should be used for assessment and classification. If there is no available information on the complex substance, it can be assessed and classified in the same way as mixtures composed of two or more substances. Substances extracted from plants or plant parts containing multiple components are not subject to these provisions; "plant" refers to living or dead organisms of plant and fungal families, including algae, lichens, and yeasts.
3. Due to scientific limitations, it is difficult to assess the endocrine-disrupting characteristics, persistence, bioaccumulation, and mobility of substances or mixtures containing multiple components based solely on data of the substances or mixtures. Therefore, in some cases, data from multi-component substances may be appropriately used.
4. If an M-factor is not provided in Annex VI Table 3 for a harmonized classification, manufacturers, importers, and downstream users should set an M-factor for substances classified as hazardous to the aquatic environment - acute hazard - Category 1 or hazardous to the aquatic environment - long-term hazard - Category 1, based on existing data of the substance.
5. Acute toxicity estimates are essential in the classification process and should be included in the classification and labelling inventory, along with M-factors and concentration limits.
6. Variations in C&L notifications may lead to disagreements between notifiers and registrants or outdated classification entries, thus reducing the efficiency of hazard collection and communication and leading to incorrect classification. Therefore, when a notifier reports a differing classification, reasons must be provided. To avoid outdated classifications, notifiers need to update their C&L notifications within six months after changing the classification and labelling.
7. If distributors further distribute hazardous mixtures in other member states or repackage or relabel them, they need to fulfill the obligation to submit emergency health response information (PCN). Member states may appoint an EU-level poison center notification portal to receive emergency health response information to reduce administrative burdens. Emergency health response information can be used to improve risk management measures and supplement the use information submitted for registration.

New Hazard Classes and Criteria (Regulation (EU) 2023/707)

Additional labeling should be applied to all mixtures mentioned in Part 2 of Annex II of the CLP. Regulation (EU) 2023/707 introduces new hazard classes (Endocrine Disruptors (ED), Persistent, Bioaccumulative and Toxic/Very Persistent and Very Bioaccumulative (PBT/vPvB), and Persistent, Mobile and Toxic/Very Persistent and Very Mobile (PMT/vPvM)) and criteria that allow for the harmonised classification and labelling of substances of the highest concern with regard to human health and the environment. If these substances contribute to the classification of a mixture, they should also be indicated on the label.

Related Link

New Hazards Classes Introduced for CLP Regulation

Label Update Time Limits

1. If the classification or labeling of a substance or mixture changes, resulting in the addition of new hazard categories or a more severe classification, or if additional information is required on the label, the supplier of the substance or mixture must ensure that the label is updated promptly, and in any case, no later than 6 months after the supplier receives the new assessment results.
2. If any other changes occur to the classification or labeling of a substance or mixture, the supplier should not unduly delay and must complete the label update as soon as possible, and in any case, no later than 18 months after the supplier receives the new assessment results.
3. If the classification or labeling update of a substance or mixture is due to the harmonized classification, it should adhere to the effective date specified in the ATP (Adaptation to Technical Progress), which is typically 18 months after these provisions come into effect.
4. If the substance or mixture falls under the scope of regulations for detergents or biocidal products, the effective dates in the respective regulations take precedence.

Introduction of fold-out labels

Regardless of size or shape, labels can be directly adopted in the form of fold-out labels. The front page of such labels should include the following label elements:

1. the name, address and phone number of suppliers;
2. nominal quantity of the substance or mixture in the package made available to the general public, unless this quantity is specified elsewhere on the package;
3. the product identifiers in accordance with Article 18(2) for substances and Article 18(3)(a) for mixtures in all languages of the label that are used in the inside pages;
4. where applicable, the hazard pictograms;
5. where applicable, the signal words in all languages of the label that are used in the inside pages;
6. where applicable, the unique formula identifier, unless printed or affixed on the inner packaging in accordance with Part A, point 5.3, of Annex VIII to this Regulation;
7. a reference to the full safety information inside the fold-out label in all languages of the label or a symbol to inform a user that the label can be opened and to illustrate that additional information is available on inside pages;
8. an abbreviation of the language (country code or language code) for all the languages that are used in the inside pages.

The inner pages of the fold-out label shall contain all label elements except for pictograms and supplier information, using the language abbreviations mentioned on the front page.

The back page of the fold-out label shall contain all the label elements listed on the front page, except for the abbreviations of the languages that are used in the inside pages.

Introduction of Digital Labels

Under the old CLP regulation, the labeling elements for substances or mixtures were required to be physically attached to the product, referred to hereafter as physical labels. In addition to physical labels, digital labels can also be provided in digital form, facilitating access for visually impaired individuals and those who do not speak the language of the member state.

1. Where a digital label is used, a data carrier linking to that digital label shall be firmly affixed or printed on the physical label or on the packaging next to the label in such a way that it can be processed automatically by digital devices that are widely used.

Note: "data carrier" means a linear bar code symbol, a two-dimensional symbol or other automatic identification data capture medium that can be read by a device.

2. If labeling elements are provided on the digital label, the data carrier shall be accompanied by the statement “More hazard information available online” or by a similar indication;

3. The provision should be free of charge, and if there are barriers to using the digital label, an alternative method for providing the labeling elements should be offered;

4. Supplier shall ensure that the digital label satisfies the following general rules and technical requirements:

1. All label elements shall be provided together in one place and separately from other information;
2. the information on the digital label shall be searchable;
3. the information on the digital label shall be accessible to all users in the Union and shall remain accessible for a period of at least 10 years or for a longer period where required by other Union legislation;
4. the digital label shall be accessible free of charge, without the need to register or to download or install applications, or to provide a password;
5. the information on the digital label shall be presented in a way that also addresses the needs of vulnerable groups and supports, as relevant, the necessary adaptations to facilitate access to the information by those groups;
6. the information on the digital label shall be accessible with no more than two clicks;
7. the digital label shall be accessible through digital technologies widely used, and compatible with all major operating systems and browsers;
8. where the information on the digital label is accessible in more than one language, the choice of language shall not be conditioned by the geographical location from which that information is accessed.

It shall be prohibited to track, analyse or use any usage information for purposes going beyond what is absolutely necessary for the provision of digital labelling.

Updates to Label Size Requirements

The requirements for label size, pictogram dimensions, and font size for letters have been adjusted. The revised version specifies font sizes, adding a column for "minimum font size." It also sets specific requirements for labels, pictograms, and font sizes for containers with a capacity of ≤0.5L.

For inner packaging labels of containers with a capacity of ≤10ml, the font size may be smaller than specified in the table, provided that it is clear and legible. It is crucial to include key statements such as hazard statements or EUH statements, provided that the outer packaging complies with the corresponding requirements of CLP Article 17. Additionally, under certain conditions (e.g., for R&D purposes), the label elements required by Article 17 can be omitted from the inner packaging.

New Edition	Old Edition

The text on the label shall have the following characteristics:

1. printed in black on a white background;
2. the distance between two lines shall be at least 120 % of the font size;
3. a single font that is easily legible and without serifs shall be used; and
4. the letter spacing shall be appropriate for the selected font to be easily legible.

Other Changes to Labels

For inner packaging labels that are exempt from labeling and packaging due to size, shape, or form not meeting general labeling rules, the minimum information requirements have been changed from four label elements (pictogram, product identifier, supplier's name, and telephone number) to five label elements, with the addition of a new element—signal word.

For respiratory sensitizers, germ cell mutagens, carcinogens, and reproductive toxins, if there is sufficient information to classify them as Category 1A or 1B, they should be classified as such to avoid over-classification or under-classification.

For safety and human health protection, revised parts 3 and 5 of Annex II of the CLP introduce specific rules for labeling and packaging of substances or mixtures supplied at gas stations and without packaging, including specific requirements for gas stations.

Regulating the advertisement of hazardous substances and mixtures, all such advertisements (except non-visual advertisements) must include the hazard pictograms, signal words, hazard statements and supplemental EUH statements (if applicable). Terms indicating non-hazardousness such as "non-toxic," "harmless," "non-polluting," "eco," or similar must not appear. If the advertisement is non-visual, hazard pictograms and signal words may be omitted. Any advertisement for sale to the general public shall, in addition, state: “Always follow the information on the product label.” For remote sales, online quotes for hazardous products should clearly specify label elements.

The CLP regulation revision also adds Article 54a, concerning reporting and review. By December 11, 2029, the Commission should submit a scientific report to the European Parliament and Council, reviewing information on substances containing more than one component extracted from plants. If appropriate, this report may be accompanied by legislative proposals; by December 11, 2029, the Commission should submit an evaluation report to the European Parliament, Council, and European Economic and Social Committee, assessing the necessity of extending the requirements for child-resistant fasteners and tactile warnings in Sections 3.1 and 3.2 of Annex II to other hazard categories. If the report indicates a need, the Commission will issue an ATP to take action.

The publication of the CLP regulation revision provides corresponding transition periods for different clauses. Chemicals already on the market do not need to be reclassified or relabeled according to this regulation. Suppliers may also voluntarily apply the new provisions before the effective date.

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Further Information

Regulation (EU) 2024/2865