The European Chemicals Agency (ECHA) has introduced significant updates to the European Union (EU) CLP (Classification, Labelling, and Packaging) regulation, strengthening its framework for classifying and managing chemical hazards. These updates reflect scientific advancements and aim to protect human health and the environment from potential chemical risks.
This blog explores the key updates to the CLP hazard classes and their implications for industries and regulatory compliance.
What Is the EU CLP Regulation?
The EU CLP regulation ensures that hazardous chemicals are classified, labeled, and packaged according to their risks. This system aligns with the United Nations' Globally Harmonized System (GHS) for chemical classification and labeling. Its goal is to provide clear and consistent information about chemical hazards to workers, consumers, and the environment.
The key objectives of this regulation are:
-
Hazard Identification and Classification: requiring companies to identify and classify accordingly substances and mixtures based on their inherited properties.
-
Standardized Communication: the use and implementation of consistent hazard symbols, signal words and precautionary statements on product labels to ensure clear communication of risks.
-
Packaging Requirements: ensure that the packaging of chemicals is secure, and the risk of harm is mitigated during transportation, handling or use. Such as the application of child resistant closures.
-
Alignment Across the EU: the regulation states a standardized classification and labeling system across the member states, ensuring consistency in how chemical risks are managed and communicated.
With the updated hazard classes, the EU CLP framework now encompasses new categories to better assess risks posed by certain chemical properties, especially those with long-term or indirect impacts.
Updated and New Hazard Classes
The guideline states four classes:
-
Endocrine Disruptors (EDs): Two new hazard classes target endocrine-disrupting chemicals, substances that interfere with hormone systems. These classes cover both: human health impacts which are mostly linked to reproductive, developmental, and systemic issues. Also highlights the growing concern regarding the prevalent use of EDs in products such as pesticides, cosmetics and plastics.
-
Persistent, Mobile, and Toxic (PMT) Substances: this is a new classification that addresses chemicals and substances that are persistent in the environment, travel easily via land and water and pose a hazard to drinking water resources and ecosystems.
-
Very Persistent and Very Mobile (vPvM) Substances: this classification is similar to PMT but centers on chemicals that are exceedingly resistant to breakdown and highly mobile, causing potential irremediable damage.
-
Refinements to PBT/vPvB Criteria: this criterion has been refined to attend substances that accumulate in living organisms and withstand degradation. These chemicals often have long-lasting impacts on food chains and ecosystems.
What’s Next for Industry Stakeholders?
With these updates and alterations to the regulation comes concerns for industry stakeholders as potential products may require evaluation. Concerning the adaptation of communication and labeling, industries could have to make alterations on the Safety Data Sheets (SDS) and product labels to comply. Some substances could require additional assessments to determine whether the product falls under the new hazard classification.
This also opens up a new necessity and focus to invest in Research and Development in order to innovate and prioritize suitable and non-toxic alternatives.
Biobide and Ally to Ecotoxicity Assessment in Aquatic New Alternative Models (NAMs)
Biobide offers a comprehensive arrangement of assessment for ecotoxicity and endocrine disruption evaluation. Employing New Alternative Models (NAMs) such as the Zebrafish, Algae and Daphnia. Employing Zebrafish as a New Alternative Model enhances the significance of all assays, ensuring statistical validity and reproducibility while retaining crucial insights into the potential human impact of the substances. The high genetic homology between Zebrafish and humans (>70%), particularly in genes associated with human diseases (>80%), underscores the relevance of this model.
Also the Daphnia and algae offer time and cost-effective screening assays to assess the aquatic toxicity of chemicals, following OECD Guidelines 201 and 202 respectively. Algae and Daphnia magna are extensively used in several ecotoxicity assays, in particular, the Daphnia Immobilization assay is performed to comply with regulatory requirements or support environmentally acceptable product label claims. It is suitable for High Content Screening (HCS) of test items, as well as the Alga Growth-Inhibition assay.
Endocrine Disruption Assessments Offered by Biobide
Biobide provides two advanced assays for evaluating endocrine disruption potential:
-
Thyroid Disruption Assay
Biobide’s Thyroid Disruption Assay is designed to screen the thyroid-disrupting potential of compounds using transgenic zebrafish embryos expressing the mCherry fluorescent protein. This fluorescence is driven by the thyroglobulin promoter, with red fluorescence localized in the thyroid gland. Increases in thyroglobulin levels correspond to intensified fluorescence, enabling quantification through image analysis.
The assay provides critical metrics such as the Benchmark Concentration (BMC) and the Thyroid-Disrupting Index (TDI) to evaluate potency and hazard profiles. To enhance the results, this assay can be complemented by gene expression analysis, allowing the characterization of genes involved in thyroid disruption pathways. Validation has been successfully conducted using several reference toxicants and environmental pollutants, underscoring the reliability of the method.
-
Estrogen Pathway Assay (OECD TG 250)
Biobide has also validated the OECD Test Guideline Nº250 assay, employing transgenic zebrafish embryos from the Tg(cyp19a1b:GFP) line. These embryos exhibit fluorescence in estrogen-sensitive regions due to GFP expression, which is regulated by estrogen receptor activation. This assay demonstrates exceptional sensitivity, detecting substances that either activate or inhibit estrogen receptors, even at low concentrations. This capability ensures robust and accurate evaluation of a compound’s impact on the estrogen pathway, making it an invaluable tool in endocrine disruption studies.
The updated EU CLP hazard classes mark a significant step forward in chemical safety and environmental protection. By addressing previously underrepresented risks, such as endocrine disruption and environmental persistence, the new criteria ensure that Europe remains a global leader in chemical regulation. For industries, these changes underscore the importance of proactive compliance and the pursuit of sustainable practices.
