IT'S OFFICIAL: NEW CLP HAZARD CLASSES OFFICIALLY PUBLISHED

IT'S OFFICIAL: NEW CLP HAZARD CLASSES OFFICIALLY PUBLISHED

On March 31st, 2023, the European Union's Classification, Labelling and Packaging Regulation (CLP) underwent a significant amendment with the issuance of the delegated regulation EU 2023/707.

The purpose of this amendment is to add new hazard classes and criteria to address toxicity, persistence, mobility, and bioaccumulation in the environment, as well as endocrine disruption properties.

The new hazard classes are:

  • •ED HH in Category 1 and Category 2 (Endocrine disruption for human health).
  • •ED ENV in Category 1 and Category 2 (Endocrine disruption for the environment).
  • •PBT (persistent, bioaccumulative, toxic), vPvB (very persistent, very bioaccumulative).
  • •PMT (persistent, mobile, toxic), vPvM (very persistent, very mobile).

new-EU-hazard-statements

Figure: ECHA website, published 20th april 2023


This article will cover the main novelties of the amendment and their implications for manufacturers, importers and downstream users.

  • - Sections 3.11 and 4.2. Endocrine Disruptors: impact on human health and the environment

    • The new amendment adds a new section, Section 3.11, to Annex II of the CLP Regulation, covering endocrine-disrupting hazardous properties to human health. It introduces new label requirements and classification criteria for substances and mixtures that alter one or more functions of the endocrine system, resulting in adverse effects on intact organisms, their offspring, populations, or subpopulations.

    The classification criteria are divided into two categories, Category 1 and Category 2, based on the degree of certainty of their endocrine-disrupting properties. Category 1 includes substances that are known or presumed to be endocrine disruptors for human health. To classify a substance in Category 1, it must be demonstrated that the substance has endocrine activity, adverse effects on organisms or their descendants, and a biologically plausible link between the endocrine activity and the adverse effects.

    Category 2 includes substances that are suspected of being endocrine disruptors for human health. A substance can be classified as Category 2 if it has endocrine activity and adverse effects on organisms or their descendants, but the evidence is not convincing enough to classify it in Category 1.

    Manufacturers and importers are required to identify and classify substances according to the new section 3.11 and to include the appropriate hazard pictogram and warning on labels. The new regulation will impact a wide range of products, including pesticides, cosmetics, and plastics.

    In section 4.2, the new amendment also updates the regulations regarding the classification and labeling of substances that disrupt the endocrine system, potentially causing harm to the environment, including reproductive and developmental problems in aquatic life, as well as damage to the immune and nervous systems of wildlife.

  • - Section 4.3.: Persistent, Bioaccumulative and Toxic (PBT) or Very Persistent, Very Bioaccumulative (vPvB) substances

    • Section 4.3 of the new EU chemical regulation is dedicated to Persistent, Bioaccumulative and Toxic (PBT) or Very Persistent, Very Bioaccumulative (vPvB) substances.

    These substances pose a risk to the environment as they persist for a long time and accumulate in living organisms, causing long-term damage. PBT substances are those that fulfill the criteria of persistence, bioaccumulation, and toxicity, while vPvB substances fulfill the persistence and bioaccumulation criteria. The regulation sets out specific criteria for each of these properties, such as degradation half-life, bioconcentration factor, and toxicity thresholds.

    The regulation also requires the identification of relevant constituents, additives, or impurities, and their PBT/vPvB properties, as well as transformation or degradation products.

  • - Section 4.4. : Persistent, Mobile and Toxic (PMT) and Very Persistent and Very Mobile (vPvM)

    • In Section 4.4 of the new regulation, Persistent, Mobile and Toxic (PMT) and Very Persistent and Very Mobile (vPvM) properties are defined and differentiated. PMT substances are persistent, mobile and toxic, while vPvM substances are very persistent and very mobile.

Application dates

aplication-dates

Starting from April 20th, 2023, Member States can propose harmonized classification and labeling (CLH) with new hazard classes, and manufacturers, importers, downstream users, and distributors can self-classify their substances and mixtures accordingly. Transitional periods apply before the new hazard classes become mandatory. During this time, companies can apply the new hazard classes on a voluntary basis. All manufacturers, importers, downstream users, and distributors must apply the new hazard classes at the end of the transitional periods.

New substances on the market must comply with the new rules from May 1st, 2025 while substances already on the EU market have until November 1st , 2026 to comply. Separate transition times apply to mixtures: new mixtures on the market must comply with the new rules from May 1st, 2026, whereas mixtures already on the EU market have until May 1st, 2028 to comply.