In the summer of 2022, the European Commission is expected to reveal its plans for the revision of the EU rules on the classification, labelling and packaging of chemicals (CLP), one of the important cornerstones of EU chemicals legislation. In HEAL’s view, a well-crafted revision addressing the current limitations of CLP can make it a more efficient tool at the service of health and environmental protection in Europe.
The CLP Regulation sets out how the EU classifies and communicates about the hazardous properties of chemical substances and mixtures. Introduced in 2008, CLP has created one single harmonized process for the identification and labelling of the hazardous properties of substances, which applies across all sectors and uses.
One of the main aims of CLP is to determine whether a substance or mixture meets certain classification criteria to be considered as hazardous for human or environmental health. It is therefore an essential aspect of hazard communication throughout the manufacturing, use, distribution and trade of chemicals, as well as towards consumers. Under sectoral chemicals legislation, the existence of a CLP classification can trigger specific actions, including bans and restrictions. Therefore, proper hazard identification under CLP is piece and parcel to guaranteeing high levels of health protection, efficiency and coherence across all EU chemicals legislations.
The European Chemicals Strategy for Sustainability (CSS) released in October 2020 acknowledges some limitations in the current architecture and functioning of CLP and commits to the following actions:
- Amend the CLP Regulation to introduce new hazard classes for endocrine disruptors, PBTs/vPvBs and persistent and mobile substances, and apply them across all legislation;
- Amend the CLP Regulation to give the European Commission the mandate to initiate harmonized classification;
- Assess the need for specific criteria for immunotoxicity and neurotoxicity (which are currently covered under the hazard classes for ‘specific target organ toxicity’ and ‘reproductive toxicity’).
Current limitations of the CLP Regulation
In HEAL’s view, important limitations that should be addressed in the upcoming revision include the following:
- Not all hazards relevant for health and the environment are currently covered. While CLP includes hazard classes for important health endpoints such as carcinogenicity, mutagenicity or toxicity to reproduction, it does not appropriately address other very important endpoints such as endocrine disruption, neurotoxicity and immunotoxicity. On the environmental side, hazard classes for persistence, bioaccumulation and toxicity (PBT/vPvB) and persistence, mobility, and toxicity (PMT/vPvM) are also missing.
As a consequence, substances with such properties can be placed on the market without being properly identified and without information provision for workers and consumers.
- Only EU Member States and companies can kickstart the classification process of chemicals. The European Commission is not allowed to propose the classification of a substance, nor propose revisions thereof.
- The process is slow and not fully transparent. Under current provisions, it can take several years before a classification process is finalized.
- The system relies heavily on companies to provide information, often at the disfavour of independent peer-reviewed data. Moreover, because toxicity studies provided by companies in the hazard classification procedure are not publicly available, it is difficult for independent scientific observers and civil society to meaningfully scrutinize the process.
The ABC for reform
The CLP Regulation has much unleashed potential to become a more effective tool to protect at the service of enhanced health and environment protection. Key elements that in our view should guide the reform process include:
Adding new relevant hazard classes for:
- Human health: endocrine disruption, neurotoxicity and immunotoxicity.
- Environment: persistence, bioaccumulation, toxicity (PBT/vPvB); persistence, mobility, toxicity (PMT/vPvM).
These hazard classes should reflect the different levels of scientific evidence available on chemical substances, through the inclusion of subcategories in each of them. This would be coherent with what already exists under other hazard classes. For instance, for carcinogens, mutagens and reprotoxicants that are classified as follows: 1A (known), 1B (presumed), 2 (suspected).
Zooming in on the need to include legally binding criteria for the identification of endocrine disruptors under CLP:
Endocrine disrupting chemicals (also referred to as hormone disruptors or EDCs) are synthetic chemicals that are not produced by the human body and that disrupt the normal functioning of our natural hormone system. This can lead to various adverse health effects, to which children, adolescents and pregnant women can be particularly vulnerable.
Scientific evidence of the harmful impacts of exposure to hormone disruptors has been piling up for years. Unfortunately, there are presently no harmonized criteria to identify such chemicals across sectors, uses and legislations in Europe. Under EU laws, scientific criteria to identify EDCs only exist for pesticides and biocides, while the REACH regulation foresees provisions to identify EDCs through the identification process for substances of very high concern.
In 2020, under the Chemicals Strategy for Sustainability, the European Commission committed to propose legally binding hazard identification of endocrine disruptors through the creation of a hazard class under the CLP Regulation. HEAL strongly supports this proposal, which could contribute to increased coherence in the European identification of endocrine disruptors and better health protection.
Such hazard class for endocrine disrupting chemicals should:
- Cover substances with endocrine disrupting properties for human health as well as for the environment.
- Be in line with the World Health Organization’s definition of an endocrine disrupting chemical, which is commonly accepted as the basis for the EU regulatory approach on EDCs.
- Reflect the different levels of scientific evidence available to support the identification of the substances at play by including subcategories. This is important because lack of data is particularly common for information relating to endocrine disruptors and often hampers identification. As is the case for carcinogens, mutagens, and reprotoxicants, the categories should allow for identification of ‘known endocrine disruptors’ (Category 1 A), ‘presumed endocrine disruptors’ (Category 1 B) and ‘suspected endocrine disruptors’ (Category 2). The latter category is needed to reflect those substances for which there is some evidence of endocrine disrupting properties, but not sufficiently to meet the criteria for category 1.
- Be accompanied by new pictograms and hazard statements for endocrine disrupting chemicals that are easy to understand for workers and the public. Such pictograms and hazard statements should also reflect the subcategories as described above and the endocrine disruptor’s potential to harm future generations and the environment.
- Finally, the discussions for the inclusion of substances in this hazard class should weigh of all of the available scientific evidence (including independent scientific evidence) and leave room for expert judgement. As the identification of endocrine disruptors is complex, the EDC classification under CLP should allow for a case-by-case approach.
Bringing greater flexibility for increased health protection, by granting the European Commission the mandate to initiate the classification process. Overhauls in the legal text should help authorities speed up the hazard classification process and guarantee that the process remains fully focused on hazard considerations, and not on any risk considerations.
Committing to scientific excellence in the assessment process for classification. The provisions to guarantee a better use of all available data, including all relevant independent scientific literature, need to be clarified throughout the classification process. This is important not only to ensure that the system is less reliant on toxicity studies coming directly from companies, but also to help reduce reliance on animal studies.
In the long term, HEAL supports a system where toxicity studies of a substance or mixture are no longer provided by companies but are commissioned by an independent institution (for example, the European Chemicals Agency or a public authority), and are carried out in independent laboratories. In line with the ‘polluter pays’ principle, the costs should be paid by companies and fed into a fund managed by the independent institution in charge.
In our view, the system would also benefit of improved guidance in relation to transparency and independence in the classification process (for instance through the development of an independence policy for the authorities involved).
To summarize our vision for reforming the EU rules on the classification, labelling and packaging of chemicals to better protect health, HEAL published an easy-to-use infographic:
This campaign page will be frequently updated with new resources and updates throughout 2022.