new european union clp hazard classesDownload As A PDFIntroduction The European Commission Delegated Regulation (EU) 2023/707 introduces new hazard classes to the European Union (EU) CLP Regulation, (EC) No. 1272/2008 governing the classification, labelling and packaging of substances and mixtures. The category codes for the six new hazard classes, hazard statement code and hazard statement are shown in the table below:
Note 1 The hazard category code and description of the hazard class are shown below:
New definitions, along with scientific and technical criteria to classify substances and mixtures to the new hazard classes are also incorporated within the revised regulation, which applies to all chemical substances and mixtures placed on the EU market. It is therefore binding to manufacturers, importers, downstream users and distributors placing substances on the European Union market. Member States will also refer to the new hazard classes and criteria when making proposals for harmonised classification and labelling. An overview of the new hazard Classes Endocrine Disruptors An endocrine disruptor is defined as follows: ”a substance or a mixture that alters one or more functions of the endocrine system and consequently causes adverse effects in an intact organism, its progeny, populations or subpopulations”. The hazard categories for endocrine disruptors on human health are as follows:
The generic concentration limits of components of a mixture classified as endocrine disruptor for human health that trigger classification of a mixture are as follows:
Note: The concentration limits in this Table shall apply to solids and liquids (w/w units) as well as gases (v/v units). Note 1: If a Category 2 endocrine disruptor for human health is present in the mixture as an ingredient at a concentration ≥ 0,1 % a SDS shall be available for the mixture upon request. The label elements are as follows:
Endocrine Disruptors, Environment:
Table 3.11.2 above specifies the generic concentration limits for components of a mixture classified as an endocrine disruptor for the environment that trigger classification of the mixture. These are the same as for the human health categories i.e. ≥ to 0.1% for Category 1 and ≥ 1% for Category 2. Label elements for endocrine disruptors in the environment:
PBT and vPvB The definitions of a PBT or vPvB substance or mixture are as follows: ‘PBT means a persistent, bioaccumulative and toxic substance or mixture that meets the classification criteria set out in Section 4.3.2.1 (see below). ‘vPvB’ means a very persistent and very bioaccumulative substance or mixture that meets the classification criteria set out in Section 4.3.2.2 (see below). 4.3.2.1. Classification criteria for PBT A substance shall be considered a PBT substance when it fulfils the persistence, bioaccumulation and toxicity criteria set out in Sections 4.3.2.1.1 to 4.3.2.1.3 and is assessed according to Section 4.3.2.3. 4.3.2.1.1. Persistence A substance shall be considered to fulfil the persistence criterion (P) where any of the following conditions is met: (a) the degradation half-life in marine water is higher than 60 days; (b) the degradation half-life in fresh or estuarine water is higher than 40 days; (c) the degradation half-life in marine sediment is higher than 180 days; (d) the degradation half-life in fresh or estuarine water sediment is higher than 120 days; (e) the degradation half-life in soil is higher than 120 days. 4.3.2.1.2. Bioaccumulation A substance shall be considered to fulfil the bioaccumulation criterion (B) where the bioconcentration factor in aquatic species is higher than 2 000. 4.3.2.1.3. Toxicity A substance shall be considered to fulfil the toxicity criterion (T) in any of the following situations: (a) the long-term no-observed effect concentration (NOEC) or ECx (e.g. EC10) for marine or freshwater organisms is less than 0,01 mg/l; (b) the substance meets the criteria for classification as carcinogenic (category 1A or 1B), germ cell mutagenic (category 1A or 1B), or toxic for reproduction (category 1A, 1B, or 2) according to Sections 3.5, 3.6 or 3.7 of the CLP Regulation; (c) there is other evidence of chronic toxicity, as identified by the substance meeting the criteria for classification: specific target organ toxicity after repeated exposure (STOT RE category 1 or 2) according to Section 3.9 of the CLP Regulation; (d) the substance meets the criteria for classification as endocrine disruptor (category 1) for humans or the environment according to Sections 3.11 or 4.2 of the CLP Regulation. 4.3.2.2. Classification criteria for vPvB A substance shall be considered a vPvB substance when it fulfils the persistence and bioaccumulation criteria set out in Sections 4.3.2.2.1 and 4.3.2.2.2 and assessed according to Section 4.3.2.3. 4.3.2.2.1. Persistence A substance shall be considered to fulfil the “very persistent” criterion (vP) where any of the following conditions is met: (a) the degradation half-life in marine, fresh or estuarine water is higher than 60 days; (b) the degradation half-life in marine, fresh or estuarine water sediment is higher than 180 days; (c) the degradation half-life in soil is higher than 180 days. 4.3.2.2.2. Bioaccumulation A substance shall be considered to fulfil the “very bioaccumulative” criterion (vB) where the bioconcentration factor in aquatic species is higher than 5 000. The assessment criteria set out in Section 4.3.2.3 is very detailed and therefore not included here. However, the classification thresholds for mixtures and label elements are as follows: A mixture shall be classified as a PBT or vPvB when at least one component contained in the mixture has been classified as a PBT or vPvB and is present at or above 0,1 % (weight/weight). Label elements for PBT and vPvB properties:
PMT and vPvM The definitions of a PMT or vPvB substance or mixture are as follows: ‘PMT. means a persistent, mobile and toxic substance or mixture that meets the classification criteria set out in Section 4.4.2.1 (see below). ‘vPvM’ means a very persistent and very mobile substance or mixture that meets the classification criteria set out in Section 4.4.2.2 (see below). 4.4.2.1. Classification criteria for PMT A substance shall be considered a PMT substance when it fulfils the persistence, mobility and toxicity criteria set out in Sections 4.4.2.1.1, 4.4.2.1.2 and 4.4.2.1.3. and assessed according to Section 4.4.2.3. 4.4.2.1.1. Persistence A substance shall be considered to fulfil the persistence criterion (P) in any of the following situations: (a) the degradation half-life in marine water is higher than 60 days; (b) the degradation half-life in fresh or estuarine water is higher than 40 days; (c) the degradation half-life in marine sediment is higher than 180 days; (d) the degradation half-life in fresh or estuarine water sediment is higher than 120 days; (e) the degradation half-life in soil is higher than 120 days. 4.4.2.1.2. Mobility A substance shall be considered to fulfil the mobility criterion (M) when the log Koc is less than 3. For an ionisable substance, the mobility criterion shall be considered fulfilled when the lowest log Koc value for pH between 4 and 9 is less than 3. ‘log Koc’ means the common logarithm of the organic carbon-water partition coefficient (i.e. Koc). 4.4.2.1.3. Toxicity A substance shall be considered to fulfil the toxicity criterion (T) in any of the following situations: (a) the long-term no-observed effect concentration (NOEC) or ECx (e.g. EC10) for marine or freshwater organisms is less than 0,01 mg/l; (b) the substance meets the criteria for classification as carcinogenic (category 1A or 1B), germ cell mutagenic (category 1A or 1B), or toxic for reproduction (category 1A, 1B, or 2) according to Sections 3.5, 3.6 or 3.7 [of the CLP Regulation]; (c) there is other evidence of chronic toxicity, as identified by the substance meeting the criteria for classification as specific target organ toxicity after repeated exposure (STOT RE category 1 or 2) according to Section 3.9 [of the CLP Regulation]; (d) the substance meets the criteria for classification as endocrine disruptor (category 1) for human health or the environment according to Sections 3.11 or 4.2 [of the CLP Regulation]. 4.4.2.2. Classification criteria for vPvM A substance shall be considered a vPvM substance when it fulfils the persistence and mobility criteria set out in Sections 4.4.2.2.1 and 4.4.2.2.2 and assessed according to Section 4.4.2.3. 4.4.2.2.1. Persistence A substance shall be considered to fulfil the “very persistent” criterion (vP) in any of the following situations: (a) the degradation half-life in marine, fresh or estuarine water is higher than 60 days; (b) the degradation half-life in marine, fresh or estuarine water sediment is higher than 180 days; (c) the degradation half-life in soil is higher than 180 days. 4.4.2.2.2. Mobility A substance shall be considered to fulfil the “very mobile” criterion (vM) when the log Koc is less than 2. For an ionisable substance, the mobility criterion shall be considered fulfilled when the lowest log Koc value for pH between 4 and 9 is less than 2. The assessment criteria set out in Section 4.4.2.3.is very detailed and therefore not included here. However, the classification thresholds for mixtures and label elements are as follows: A mixture shall be classified as a PMT or vPvM where at least one of its components has been classified as a PMT or vPvM and is present at or above 0,1 % (weight/weight). Label elements for PMT and vPvM properties:
Implementation dates Member States have been permitted to submit harmonised classification and labelling (CLH) proposals in accordance with the criteria set out for the new hazard classes since April of this year. Manufacturers, importers, downstream users and distributors have also been permitted to self-classify substances and mixtures to the new criteria since April 2023. However, transitional arrangements are in place, the timescales of which depend on whether the substance/mixture has already been placed on the market. In case of the supply of new substances to the market, companies will be required to evaluate products against the criteria for the new hazard classes from 01 May 2025. A deadline of 01 November 2026 applies to substances already on the EU market.
In the case of new mixtures, the new rules apply from 01 May 2026 with a deadline of 01 May 2028 to update the classification and labelling for existing mixtures.
The transitional arrangements for substances and mixtures are somewhat out of synchronisation, as newly created mixtures using ‘existing’ substances will potentially be required to be classified to the new criteria (1 May 2026) before existing substances already on the market i.e. with a deadline of 1 November 2026. Northern Ireland The EU CLP Regulation continues to apply in Northern Ireland (NI), under the terms of the Northern Ireland Protocol (Annex 2, paragraph 23). Consequently, NI-based businesses will be required to classify and label substances covered by the new hazard classes and criteria. Where there is no harmonised classification and labelling, NI-based companies will be required to evaluate and self-classify substances and mixtures for the new hazard classes defined in EU CLP before they can be placed on the EU Single Market. UN-GHS The internationally agreed system for the classification and labelling of chemicals is the United Nations Globally Harmonised System (UN-GHS). The established convention for introducing new hazard classes is via a proposal submitted to the biennium work programme at the UN-GHS Committee. Amendments and additions are incorporated into a revised edition (update) of the UN GHS, if agreed at that Forum. The published ‘biennium’ edition is then typically scrutinised by countries and jurisdictions and adopted into international or national domestic legislation, according to national timescales. UK Position An Explanatory Memorandum was published by the UK Government in February of this year entitled: ‘Explanatory Memorandum for European Union legislation within the scope of the UK/EU Withdrawal Agreement and Northern Ireland Protocol’. According to this Memorandum:
It is not certain the UN GHS Sub-Committee will introduce all or any of the EU new hazard classes to the UN GHS. In the meantime, the need to comply with the revised EU-CLP regulation incorporating new hazard classes is perceived as offering a competitive advantage to EU-based companies accessing the EU Single Market, over countries located outside of the EU. The information contained on this website is intended to be correct at the time of publication. However, it is provided in good faith. We make no representations or warranties of any kind, express or implied, about the completeness, accuracy, reliability, suitability or availability of the information provided. Any reliance you place on the information published is strictly at your own risk. Page reviewed: September 2023
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