Until 15 November 2021 the European Commission (“Commission”) is consulting on proposed revisions to Regulation (EC) 1272/2008 on the classification, labelling and packaging of substances and mixtures (“CLP Regulation”).
The proposal to revise the CLP Regulation was first announced in the Commission’s Chemicals Strategy for Sustainability (“Chemicals Strategy”), which was adopted in October 2020. The aim of the proposal is to simplify the existing regime and ensure that chemical use in the EU is made safer for humans and the environment.
The Commission considers that the CLP Regulation has failed to keep up with scientific developments and the rise of online retail for products containing chemicals. It is perceived that the CLP Regulation is somewhat unclear or incomplete in terms of the identification of the full range of chemical hazards and that this can mean that users of chemicals are not given sufficient information about hazards (e.g. on product labels). The Commission has also identified problems arising from the administrative burden of the CLP Regulation for companies and public authorities.
The consultation consists of two sections: a section seeking general feedback on how the CLP Regulation could be improved; and a section containing more targeted, technical questions for chemicals experts.
It is anticipated that the Commission will formulate and adopt the proposed amendments in Q4 2021, after which the amending regulation will need to be approved by the EU legislature. The changes are likely to be subject to a transitional period before taking full effect.
General feedback on the CLP regime
The Commission is seeking views on various general proposals to improve the functioning of the CLP Regulation. These includes proposals to introduce new hazard classes into the CLP Regulation, for (1) endocrine disruptors, (2) persistent, bio-accumulative and toxic (“PBT”) chemicals and (3) persistent, mobile and toxic (“PMT”) chemicals.
In recognition of the fact that introducing new hazard classes into the CLP Regulation will necessitate further animal testing, the Commission is also seeking feedback from the public on attitudes towards testing on animals. The Commission’s present position is that there are currently no sufficient alternatives to animal testing and that to discern whether a chemical is harmful, and understand which protective measures would be suitable, animal testing will need to be carried out. This aspect of the consultation is likely to draw a mix of views and is contentious.
The consultation also poses a number of questions regarding the approach to labelling under the CLP Regulation. The Commission notes that under the current legislation, labels often include a large amount of information and therefore seeks feedback on how easily understood the labels are and how they could be improved. In addition, feedback is sought on whether digital chemical labels would be desirable and how labels or chemical content information should be presented for small products, such as pens.
Noting that the online sale of chemicals is becoming more common, the consultation seeks to understand attitudes to how information on hazards should be provided when chemical products are purchased online. This includes asking at which point during the online purchasing process the hazard information should be made available.
The final series of questions in the general feedback section focusses on the scope of the CLP Regulation. Medicines, veterinary medicines, cosmetics, medical devices, food products and animal feed are currently exempt from the CLP Regulation since they are regulated by product-specific legislation. However, the consultation document notes that these legislative instruments do not require information on environmental hazards (such as toxicity to aquatic life) to be provided to users of these product types. The consultation therefore poses the question of whether such information should be provided when these products are bought or used.
Questions for experts
The second part of the consultation poses a series of questions which are intended for “people having an excellent or good understanding” of the CLP Regulation or chemical hazards.
Regarding the Commission’s proposal to expand the hazard classes under the CLP Regulation (see above), respondents are asked for feedback on the approach to defining, categorising and labelling the new hazard classes.
For example, the consultation asks for experts’ views on whether the World Health Organisation criteria for identifying endocrine disruptors should be reflected in the definition included in the amended CLP Regulation. Experts are also asked to indicate whether the criteria used to define PBT substances in the EU REACH Regulation should be updated before being transposed into the CLP Regulation.
With regards to PMT substances, the Commission notes that the introduction of the new hazard class aims to improve how sources of drinking water are protected from potential chemical contamination. The questions for expert respondents include whether environmental toxicity should be included as a toxicity criterion and what the most appropriate hazard statement on the chemicals label should be.
Experts’ views are also sought on whether new hazard classes or criteria should be developed under the CLP Regulation to account for immunotoxicity and neurotoxicity effects.
The Commission is also seeking feedback on whether the data currently available is sufficient for performing assessments to identify the new hazard classes in chemicals and/or whether further investment will be required to facilitate the necessary hazard assessments. Respondents are also asked a series of questions regarding what they perceive the impact of the new hazard classes will be, in terms of the number of chemicals impacted, the percentage of products that would need to be re-classified and relabelled, and the percentage of products that would be reformulated to avoid the new hazard classes.
Experts are also invited to provide responses to questions on classification rules under the CLP Regulation, including whether the Commission should have the right to initiate European classification for some substances and whether it should assist Member States to submit more dossiers. There is also a question on the approach authorities should take to reviewing dossiers and, for instance, whether substances that are highly suspected of containing hazardous chemicals should be prioritised. The consultation also seeks to understand whether experts would be confident classifying chemical products on the basis of alternatives to animal testing.
In terms of labelling, experts are invited to explain whether they have encountered issues caused by duplicated or contradictory labelling obligations under the CLP regime and other legislation for the same products. Views are also sought on the economic and environmental impacts of different approaches to labelling, such as exempting small products from certain labelling requirements.
The section on online sales also poses a number of important questions for experts, which may inform the design of the CLP regime in the future. The consultation seeks to gauge experts’ attitudes to whether online platforms should be responsible for complying with EU CLP requirements when non-EU chemicals are made available for purchase on their platforms. General feedback is also sought on whether the same CLP obligations should be applied to online sales as to traditional off-the-shelf retail and on what the main obstacles are to ensuring that there is a level playing field between different companies and a sufficient level of health, safety and environmental protection in online sales of chemical products.
Experts’ views are also sought on the interaction between the CLP regime and the product-specific legislation for medicines, veterinary medicines and so on, and whether this leads to “overlaps”, “gaps” or a “lack of clarity”, and the best options for ensuring that users of those products are made aware of environmental hazards.
Finally, the consultation also asks for feedback on the type of information which is submitted to poison centres (bodies in Member States which are tasked with providing emergency health responses if necessary). Views are also sought regarding what the appropriate length of time for the transitional periods should be before the amendments to the CLP Regulation take effect.
The Chemicals Strategy aims to achieve higher levels of protection for EU citizens and the environment from the adverse impacts of chemicals. This forms parts of the wider European Green Deal, which establishes the EU’s “zero pollution ambition for a toxic-free environment”.
The consultation outlines important proposals which should be considered thoroughly for all stakeholders affected. The changes are likely to broaden the categories of chemical hazards which need to be assessed and identified on labels. The basis on which assessments are required is likely to receive mixed responses. In addition, the proposals are intended to address perceived issues with the existing regime, such as the practical issues in labelling certain products, inconsistencies between the CLP regime and product-specific legislation and potentially unclear labelling.
The changes may also give rise to additional obligations for online retailers and chemical producers. As such, these reforms are likely to have a significant impact on the chemicals industry, and chemical producers, online retailers and other stakeholders should consider responding to the consultation.