/>iThis week, the European Union (EU) published two significant regulatory pieces impacting the EU Regulation 1272/2008 on classification, labelling, and packaging of chemicals (‘CLP’).
First, a legislative amendment of the CLP and second, a long-awaited amended ECHA Guidance on Application of the CLP Criteria that will provide guidelines to classify products in three new hazard classes, in particular for endocrine disrupting properties. These new pieces are further developed below.
I. CLP Amendment
The main elements of the Amendment are as follows:
Incorporation of new hazard classes
The Amendment incorporates into Article 36 CLP new hazard classes – Endocrine Disruptors (‘ED’), Persistent, Bioaccumulative and Toxic (‘PBT’), very Persistent and very Bioaccumulative (‘vPvB’), Persistent, Mobile and Toxic (‘PMT’), and very Persistent and very Mobile (‘vPvM’) – that were introduced by Commission Delegated Regulation (EU) 2023/707. This entails that these new hazard classes will be prioritized for harmonised classification and labelling. In addition, the Amendment empowers the European Commission (‘Commission’) to adopt delegated acts in order to adapt the substance’s harmonised classification where it has been put on the REACH Candidate List due to its ED, PBT, or vPvB properties, or where it has been found to have such properties under the Plant Protection Products and Biocidal Regulations.
Changes in the harmonised classification and labelling procedure
The Commission will have a new possibility to initiate the harmonised classification and labelling procedure (so far, this was only for the Member States and for the companies). To do so, the European Commission may ask the European Chemicals Agency (‘ECHA’) or the European Food Safety Agency (‘EFSA’) to prepare a proposal. In turn, ECHA and EFSA can advise the European Commission and the Member States that a harmonised classification and labelling of a substance or a group of substances would be appropriate. Indeed, the Amendment further facilitates a grouped hazard classification, which should be prioritized “whenever considered scientifically justified and possible by a competent authority or the Commission.”
Changes in the notification to ECHA Classification and Labelling Inventory
The Amendment obliges notifiers who diverge from existing entries to provide justifications for such divergence. Notifiers would also have to update their notifications within six months, instead of the current 18 months. Finally, the identity of the notifiers would become publicly available.
Classification of specific forms or physical states of substances/mixtures
The Amendment adds that “if scientifically justified,” a classification may be elected for “specific forms or physical states” of the substance. This will typically relate to specific particle sizes.
Deadline for updating labels
So far, the CLP provides that labels must be updated “without undue delay” if there is more stringent new information. The Amendment introduces a 6-month deadline.
Introduction of the new approach methodologies (‘NAM’)
NAMs refer to various non-animal testing methods used with the objective of progressively phasing out animal testing. The Amendment specifically provides that data obtained from NAMs can be taken into consideration for hazard classification. While NAMs are not directly referenced in REACH as adaptations to the standard testing methods, the inclusion of such reference in the CLP may pave the way for an increased reliance on such methods under REACH.
Classification of multi-constituent substances
The Amendment aims to align these provisions with mixtures. Multi-constituent substances shall be evaluated both based on information available on their constituents and on information on the substance itself. However, with regards to CMR and ED properties, only information on constituents shall be used (unless information on the substance itself supports the CMR or ED classification). With regards to PBT, vPvB, PMT, and vPvM properties, information on the substance itself must be used only to the extent that it shows persistence, mobility, bioaccumulation, or a lack of degradations and that such information supports the conclusions made on the basis of the classification of the individual components.
Fold-out labels, new formatting rules
While the current ECHA guidance documents preclude their use for the purpose of accommodating multilingual labels, their use will now be permitted. However, information such as hazard pictograms, an abbreviation of the languages covered, and information on the manufacturer’s identity must appear at the front of the label, while the inner part is intended to contain labelling elements in the languages covered. The Amendment also includes a minimal font size and a mandatory font color.
Digital labels
The Amendment integrates the possibility to rely on digital labels, however, in a limited way. In a newly inserted Article 34a, the Amendment provides that while mandatory elements must, in principle, be present on the physical label, one may decide to exclusively rely on the digital label to include labelling elements, which are not instrumental to the protection of health, safety, and the environment and are not mandatory. The digital label is made accessible via a data carrier affixed either on the label of the product or on its packaging close to its label.
All these provisions will come into effect subject to various transition periods laid down in Article 2 of the Amendment.
II. New CLP Guidance Document
Also this week, ECHA published its long-awaited Guidance on the Application of CLP criteria, and in particular, its Part 3 (Health Hazards), which is related to ED for human health, and Part 4 (Environmental Hazards), which is related to ED for environment and to PBT/vPvP/PMT/vPvM.
Whereas criteria for PMT/vPvM are rather straightforward and criteria for PBT/vPvB do not deviate from REACH criteria, the major hurdle is the ED classification. Unfortunately, in our view, the Guidance does not add much clarification. First, it is based on current 2018 Guidance documents for identifications of ED under biocides and plant protection products regulations and on OECD 150 (Test Guidelines for ED). These guidelines have not been providing much clarity in practice. Second, the Guidance is not only based on EATS modalities (thyroid-estrogen-androgen-interference with hormone synthesis), but also on non-EATS modalities. The non-EATS modalities may lead to the extension of what is considered as ‘hormone.’ Third, the Guidance is based on some conservative assumptions, such as that any thyroid effect means ED effect.
All these hurdles may entail that companies will have difficulties to convincingly rule out the harmful ED effect to support the ‘no classification’ conclusion. Consequently, companies may be facing the need to classify many substances as Cat. 2 ED (‘suspected’ ED).
Unfortunately, the Guidelines shy away from giving specific borderline examples between ED Cat. 1, Cat. 2, and ‘no classification.’ As stated by ECHA during the webinar held on November 21, the draft Guidelines did include such examples; however, they were removed because of the lack of consensus. ECHA stated that it hopes that the Guidelines will be updated soon with further clarifications and examples based on the experience gained with harmonised classification procedures. So, for the time being, the criteria remain blurred. This also means that we do not expect any strict enforcement until the criteria are clarified. This is because the authorities will also have difficulties to carry out conclusive assessments.
Of relevance, during the webinar, ECHA emphasized that CLP does not require a generation of new data for the purposes of classification, and if there are no relevant available data for ED classification, then this supports ‘no classification.’
III. Concluding Remarks
The new regulatory pieces will likely lead to the increase of substances identified in the new hazard classes. This relates both to self-classification and harmonised classification. With respect to self-classification in the ED category, the ECHA Guidelines aim to help Industry make classification decisions. However, the Guidelines seem to have missed this point, at least until it is further updated based on the experience gained with harmonised classifications. With respect to the harmonised classification, the Amendment of the CLP makes it easier to initiate the harmonised classification procedure for the new hazard classes.
The ultimate EU goal here seems to be to subject the substances with harmonised classification and labelling in these new classes to generic restrictions, at least for consumer and professional uses (this will depend on the upcoming REACH revision proposal). Companies should pay utmost attention to these issues.
