Europe - GHS Status

The Globally Harmonized System of Classification and Labelling of Chemicals (GHS) is being implemented in the EU with the Classification, Labelling and Packaging (CLP)-Regulation ((EC) No 1272/2008). It entered into force on 20 January 2009 and progressively replaced the Classification and Labelling of Dangerous Substances Directive (67/548/EEC (DSD)) and Dangerous Preparations Directive (1999/45/EC (DPD)). Both directives were repealed after a transitional period, on 1 June 2015.

The CLP Regulation is legally binding across the EU/EEA Member States. It requires manufacturers, importers, and downstream users of substances or mixtures to classify, label, and package their hazardous chemicals appropriately before placing them on the market. During the 12th Adaptation to Technical Progress (ATP) to the CLP Regulation, the EU amended its CLP Regulation to align with the changes in the United Nations’ 6th and 7th biannual revision of the GHS. The CLP Regulation includes provisions for two types of classification, i.e. Harmonised Classification and Labelling and Self-Classification.

Harmonised Classification and Labelling

The classification and labelling of certain hazardous chemicals is harmonised (an entry in Annex VI to CLP) to ensure adequate risk management throughout the EU. The harmonised classification and labelling of hazardous substances is updated through an Adaptation to Technical Progress (ATP) adopted yearly by the European Commission, following the opinion of the Committee for Risk Assessment (RAC). The most recent ATP is the 18th ATP which amends Annex VI of CLP Regulation with the addition of harmonised classification and labelling for 39 new substances, the modification for 17 substances, and the deletion of one substance. It was published on 3 May 2022 in the Official Journal of the European Union and will come into force on 23 November 2023.

22nd ATP 

The European Union notified a draft regulation to the World Trade Organization (WTO) on 18 January 2024. This regulation is the 22nd ATP (Adaptation to Technical and Scientific Progress) of the Classification, Labelling and Packaging of Substances (CLP) Regulation.

New CLP Hazard Classes 

On 31 March 2023 the European Commission adopted a Delegated Act amending the Regulation on Classification, Labelling and Packaging of Chemicals (CLP). The revision of CLP, together with the planned revision of REACH is an important part of the European Commission’s Chemicals Strategy for Sustainability (CSS) and the European Green Deal. The Regulation entered into force on 20 April 2023. 

The Delegated Act amends Annex I of the CLP Regulation and divides the hazard class for endocrine disrupting chemicals (EDCs) into two categories: 

• Category 1: Known or presumed endocrine disruptors for human health/the environment 

• Category 2: Suspected endocrine disruptors for human health/the environment 

Furthermore, hazard classes for the following properties are introduced: 

• Persistent, Bioaccumulative and Toxic (PBT) 

• Very Persistent and very bioaccumulative (vPvB) 

• Persistent, Mobile, and Toxic (PMT) 

• Very Persistent, very Mobile (vPvM) 

Substances must be labelled in accordance with the amended Regulation from 1 May 2025. However, substances placed on the market before 1 May 2025 will not have to be labelled until 1 November 2026. For mixtures, the corresponding dates are 1 May 2026 and 1 May 2028. 

Self-Classification

A substance must be self-classified when it has no harmonised classification in Annex VI to CLP and it presents hazardous properties. Mixtures must always be self-classified before being placed on the market, as they are not subject to harmonised classification and labelling (CLH).

Local Adaptation of GHS

The 12th ATP aligns the CLP criteria with the 6th and 7th revised editions of the UN GHS. The following GHS building blocks are not implemented in the EU:

• Chemicals under Pressure, all categories             

• Flammable Liquids, Category 4

• Acute Toxicity, Category 5

• Skin Corrosion/Irritation, Category 3

• Serious Eye Damage/Eye Irritation, Category 2A and 2B

• Aspiration Hazard, Category 2

• Acute Hazards to Aquatic Environment, Category 2 and 3

CLP Labelling Requirements

A substance or mixture needs to be labelled in accordance with the CLP rules before placing it on the market, when:

• The substance or mixture is classified as hazardous.

• The mixture contains one or more substances classified as hazardous above a certain threshold.

• The article has explosive properties.

The label should be firmly attached to one or more of the packaging’s surfaces and it should be large enough to contain all the label elements while remaining legible. The label needs to be written in the official language or languages of the Member States where the substance or mixture is placed on the market unless the Member State concerned provides otherwise. The following elements must be included on the label:

• The name, address, and telephone number of the supplier

• The nominal quantity of a substance or mixture in packages made available to the general public, unless this quantity is specified elsewhere on the package.

• Product identifiers

• Where applicable: hazard pictograms, signal words, hazard statements, precautionary statements, and supplemental information

• Unique Formula Identifier (UFI), if applicable

The minimum dimensions for labels and pictograms for various package sizes are listed in the table below.   

Minimum dimensions of labels and pictograms under the CLP Regulation

Safety Data Sheets

Annex II to the REACH Regulation lays down the requirements for the compilation of Safety Data Sheets (SDSs) used to provide information on chemical substances and mixtures placed on the EU market. It was amended by Regulation (EU) 2020/878 which was published in the official journal on 18 June 2020, entered into force on 1 January 2021, and applies to all SDSs authored from 31 December 2022.

General Requirements for Safety Data Sheets in the EU are as follows:

• The SDS must include the 16 standard sections.

• The SDS must be in the official language of the country in which it is placed on the market.

• The information must be consistent with the information in the registration and in the chemical safety report, where required. Where a chemical safety report has been completed, the relevant exposure scenario(s) shall be placed in an annex to the SDS.

• The SDS shall enable users to take the necessary measures relating to protection of human health, safety at the workplace, and protection of the environment.

• The writer of the SDS shall take into account that an SDS must inform its audience of the hazards of a substance or a mixture and provide information on the safe storage, handling, and disposal of the substance or the mixture.

• The SDS must be prepared by a competent person who shall take into account the specific needs and knowledge of the user audience, as far as they are known. Suppliers of substances and mixtures shall ensure that such competent persons have received appropriate training, including refresher training.

• The language used shall be simple, clear, precise, avoiding jargon, acronyms, and abbreviations. Statements such as “may be dangerous”, “no health effects”, “safe under most conditions of use” or “harmless” or any other statements indicating that the substance or mixture is not hazardous or any other statements that are inconsistent with the classification of that substance or mixture shall not be used.

• The date of compilation or issuance of the safety data sheet shall be given on the first page.

When an SDS has been revised and the new revised version is provided to recipients, the changes shall be brought to the attention of the recipients in Section 16 of the SDS, unless the changes have been indicated elsewhere. For the revised safety data sheets, the date of compilation, identified as “Revision: (date)”, shall appear on the first page, as well as one or more indications of which version is replaced, such as version number, revision number, or supersedes date.