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Regulatory Science Services >> Latest News >> Commission sets up rules to identify endocrine disruptors and long-lasting chemicals, and to improve labelling

Commission sets up rules to identify endocrine disruptors and long lasting chemicals, and to improve labelling

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In December 2022, the European Commission published the Proposal for a revision of the CLP Regulation

The Proposal is currently open to a feedback period until 30 March 2023 and will then be subject to the approval of the European Parliament and Council as part of the ordinary legislative procedure.

Alongside the Proposal, the Commission has also adopted a Delegated Act to introduce new hazard classes under the CLP for endocrine disruptors (ED) and other harmful chemical substances which is expected to enter into force early 2023, after scrutiny from the European Parliament and Council.

This targeted revision of CLP Regulation is part of a series of actions prompted by the Chemical Strategy for Sustainability (CSS) and follows the European Commission’s commitment to move towards a toxic-free environment. The new hazard classes are the result of extensive scientific discussions which have taken place regularly since 2020. These include both stakeholder consultations and CARACAL expert group meetings (involving Competent Authorities for REACh and CLP, Member States and stakeholders).

An impact assessment was also carried out to determine the preferred policy option and was the base of this legislative Proposal.

1. Main elements of the legislative proposal

Comprehensive identification and classification of chemical hazards

The first set of amendments are dedicated to ensuring the comprehensive identification and classification of chemical hazards. Thus, the revised CLP proposes:

  • To add new hazard classes for substances having endocrine disruption, (environmental) toxicity, persistency, mobility and bioaccumulation properties and to prioritise them for harmonized classification. These new classes are:
    • Endocrine disruptors (EDs) for human health or the environment, Category 1 or 2,
    • PBT (Persistent, Bioaccumulative and Toxic) and vPvB (very Persistent and very Bioaccumulative) and
    • PMT (Persistent, Mobile and Toxic) and vPvM (Very Persistent and Very Mobile)

The specific criteria determining the classification of a substance under these new hazard classes (including the corresponding new hazard EUH-statements and mixture classification thresholds) are defined in the Delegated Act and its Annexes.

  • To grant the Commission a new power to initiate and fund more harmonized classification and labelling dossiers with the possibility to mandate ECHA or EFSA to develop a dossier.
  • Improvement of Companies’ classification of substances, notably by:
    • making available the reasons for diverging notified classifications in the ECHA’s inventory (CLI) and by making available the names of notifiers public
    • requiring updates of notifications of classifications within a certain early stages’ deadline.

Improve hazard communication

The second set of amendments relates to improve hazard communication with the introduction of obligatory formatting rules to increase of readability of labels, the reduction of packaging waste by selling chemicals in refillable containers and enabling voluntary digital labelling of chemicals.

Addressing legal gaps and ambiguities

The third set of amendments addresses legal gaps and ambiguities of CLP provisions in online sales and poison centre notifications.

2. Important points to emphasize

Endocrine Disruptors Classification

The definition of an endocrine disruptor and the criteria to identify them were built on work already undertaken as part of the pesticide (PPPR) and Biocide (BPR) Regulations. More specifically, substances classified as ED would satisfy the following three criteria: 1) presenting an endocrine activity, 2) having an effect on an intact organism or its offspring and future generation, and 3) having a biologically plausible link identified between the endocrine activity and the adverse effect. Nevertheless, the Commission proposes to separate out human health ED from environmental ED and both classes will be split into two categories: Category 1 for known or presumed endocrine disruptors and Category 2 for suspected endocrine disruptors. Consequently, a guidance on how to apply the criteria for the identification of Category 2 ED will need to be develop since the current ECHA/EFSA guidance[1] developed under PPPR/BPR is applicable only to Category 1 ED. Furthermore, the generic concentration limits (GCL) of components of a mixture classified as ED for human health or environment that trigger classification of the mixture will be ≥ 0.1% for Category 1 and ≥ 1% for Category 2.

Persistent Mobile and Toxic Classification

Although some of these new hazards are already partially covered in other legislations (ED and PBT/vPvB are current exclusion criteria under Plant Protection Products and Biocidal Products Regulations), the PMT/vPvM hazards are new in EU legislation. The hazard classification for PMT and vPvM has being added since the combination of these properties (very persistent and very mobile or persistent, mobile and toxicity) can pose a threat to drinking water sources. It should be noted that the identification of the PMT/vPvM properties (as well the PBT/vPvB) also apply to relevant constituents or impurities of a substance along with relevant transformation and/or degradation products. Regarding the criteria for mobility and very mobile properties, they revolve around organic carbon partition coefficients (Koc) and Koc with pH values for ionizable substances: i.e., a log Koc of less than three meets the criteria for M, and a log Koc of less than two is considered vM. 

Harmonized classification for PPP and BPR active substances

The amendment of Article 37 of the Proposal inserts an obligation for the Commission to prepare and adopt harmonized classification and labelling via delegated act notably for substances that have not been approved (or have been approved via a derogation) under the PPP and the Biocide Regulations because they meet one of the exclusion criteria (ED, PBT, vPvB). This would be done without the need for a prior proposal from the Member States or ECHA. Furthermore, this should contribute to the Commission objective to move towards “One substance – One assessment” for chemicals.  The aim of this approach proposed in the Chemical Strategy for Sustainability is to avoid that different bodies, under different legislations, often using different data set, would potentially leading to seemingly different outcomes.

Clarification of classification rules for complex substances

The amendment to Article 2 introduces a definition for multi-constituent substances and the new Article 5(3) sets out that ‘multi-constituent substances’ shall, normally, be classified following the same classification, labelling, and packaging rules as mixtures and includes the identification and examination of available information on these multi-constituent substances. It should be noted that the classification of UVCB[2] substances (which are considered as multi-constituent substances under REACh) such as plant extracts or petroleum substances, will be particularly impacted by this revision. Further characterization will be needed and the potential presence of constituents with CMR[3] or ED properties above the CLP classification cut-off will automatically classify the entire substance as CMR or ED. Indeed, even if relevant available information is available on the multi-constituent substance itself showing absence of these properties or less severe properties, this shall not override the relevant available information on the constituents.

3. Impacts of the proposal

Without doubt, the CLP amendment will oblige all manufacturers and importers to gather the relevant data to conclude on these new hazard classification and label substances and mixtures accordingly.

This will include the notification of the classification to ECHA’ inventory (CLI) and the updating of REACh dossiers. Industry will have 24 months after the date of enter in force of the Delegated Act, to classify the substances in accordance with the new criteria while the substances already on the market should be reclassified within 42 months. For mixtures, the transitional period was proposed as 36 months and 60 months for mixtures already on the market. 

Beyond REACh Regulation, the changes proposed in the Delegated Act will have significant consequences on the use of chemicals in many value chains, including Plant Protection Products (notably regarding co-formulants). Indeed, the assignment of new hazard classes to substances could trigger automatic restrictions and bans under REACh with the future extension of the Generic Approach to Risk Management (GRA). Indeed, the GRA, which relies on harmonized classification as a starting basis, is currently under review under REACh. Thus, by increasing reliance on harmonized classification, the Commission Proposal will give the CLP an increased weight, leading to more restrictions/bans of chemicals under REACh and beyond.

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Reference/sources

Proposal for a revision of the Regulation on classification, labelling and packaging of chemicals (CLP) and Impact Assessment report.

Delegated Act establishing new hazard classes

Chemicals Strategy for Sustainability

[1] EFSA/ECHA (2018): Guidance for the identification of endocrine disruptors in the context of Regulations (EU) No 528/2012 and (EC) No 1107/2009. http://onlinelibrary.wiley.com/doi/10.2903/sp.efsa.2018.EN-1447/full

[2] UVCB: Unknown or Variable composition, Complex reaction products and Biological materials

[3] CMR: Carcinogen, Mutagen, Reprotoxic