Revision of the CLP Regulation: What to Expect Following the Release of the European Parliament and the Council’s Compromise Agreement
On Monday, 19 December 2022, the Commission issued its Proposal for a revision of the Regulation 1272/2008 on classification, labelling and packaging of chemicals (CLP) (‘Proposal’)[1].
Following interinstitutional negotiations, the European Parliament and the Council reached an agreement on an amended version of the Proposal on 19 December 2023[2], which will, provided that it is approved in its current state by a vote of the two institutions, constitute the final version of the CLP Amendment Regulation (‘CLP Amendment’).
The CLP Amendment has to be considered within the broader context of the “One substance, one assessment” (‘OSOA’) initiative[3], by way of which the European Commission intends to place the CLP Regulation[4] as the centerpiece of the EU’s chemicals legislative framework in relation to hazard assessment.
This article is intended to highlight the most significant changes that would be induced by the adoption of the 19 December 2023 version of the CLP Amendment.
I. Procedure for assessing and classifying hazards
- Incorporation of the new hazard classes
In line with the adoption of Commission Delegated Regulation (EU) 2023/707[5], the CLP Amendment incorporates into Article 36 of the CLP the 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’) into the CLP Regulation[6]. This entails that the new hazard classes will be prioritized for harmonized classification and labelling (Art 1(17 of the CLP Amendment).
Consistent with the one substance, one assessment approach, the CLP Amendment also fosters coordination between CLP and other regimes. It empowers the Commission to adopt delegated acts in order to adapt the substance’s classification where it has been integrated in the REACH Candidate list due to its ED, PBT, or vPvB properties, or where it has been found to have such properties by competent authorities in the context of an assessment under the Plant Protection Products Regulation and the Biocidal Products Regulation (Art 1(18)(f) of the CLP Amendment).
- Evolution of the classification procedure
The CLP Amendment substantially increases the competencies of the European Commission in relation to hazard classification by empowering it to initiate the classification and labelling procedure. To do so, the European Commission may ask the European Chemicals Agency (‘ECHA’) or the European Food Safety Agency (‘EFSA’) to prepare a proposal. (Art 1(18)(a) of the CLP Amendment). This is an important change, as in the current state of the CLP Regulation, only the Member States and the industry (e.g., manufacturers, importers, and downstream users) can initiate it.
In turn, ECHA and EFSA can also, on their own initiative, advise the European Commission and the competent authorities of the Member States that a harmonised classification and labelling of a substance or a group of substances would be appropriate.
The notification procedure to ECHA’s Classification and Labelling Inventory will also be impacted. The CLP Amendment incentivizes the use of a uniform classification by imposing on 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, after a decision to change the classification of a substance has been taken pursuant to a review under Article 15. Finally, the identity of the notifiers would, in principle, be disclosed except where they provide justification that this would harm their interests (Art. 1(21)(22) of the CLP Amendment).
- Introduction of the new approach methodologies
Direct references to the use of new approach methodologies (‘NAMs’) have been added, in the perspective of an increased reliance on non-animal testing. NAMs refer to various testing methods combining in silico, in chemico, and in vitro assays as well as conventional methods, used with the objective of progressively phasing out animal testing. The CLP Amendment provides that data obtained from NAMs may be taken into consideration amongst other data in the determination of the hazard classification of a substance or mixture under Articles 5 and 6 of the CLP Regulation (Art 1(4) and (5) of the CLP Amendment).
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.
ECHA has placed the development of NAMs amongst its top priorities, focusing notably on the developments of test methods for neurotoxicity, immunotoxicity, and endocrine disruption[7].
- New approach to the classification of substances
Consistent with the European Commission’s increasing focus on grouping, the CLP Amendment facilitates a grouped hazard classification, which should be prioritized “whenever considered scientifically justified and possible by a competent authority or the Commission” (Art 1(18) of the CLP Amendment).
Substances shall be grouped based on “clear scientific reasoning,” taking into account how the available information supports it and how it allows the property(ies)s of the substance(s) to be reliably predicted from other substances in the group.
With regards to the decision to classify a substance, the CLP Amendment adds that “if scientifically justified,” a classification may be elected for “specific forms or physical states” of the substance (Art 1(7a) of the CLP Amendment). This will typically relate to specific particle sizes.
The CLP Amendment also incorporates, for the first time, provisions specifically regulating the classification of multi-constituent substances. Such substances shall be evaluated in light of both information available on their constituents as well as information on the substance itself. This entails that information on the multi-constituent substance itself must be taken into account if it shows CMR or ED properties. With regards to PBT, vPvB, PMT, and vPvM properties, information on the substance 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 (Art 1(4) of the CLP Amendment).
The CLP Amendment also introduces amendments to Article 10 CLP that will require manufacturers, importers, and downstream users to establish acute toxicity estimates that allow for the calculation of thresholds at or above which a substance or mixture is to be classified as acutely toxic.
II. Labelling and packaging of substances and mixtures
- Fold-out labels & new formatting rules
The CLP Amendment brings about greater flexibility regarding the use of fold-out labels. While the current ECHA guidance documents preclude their use for the purpose of accommodating multilingual labels, their use will be permitted under the CLP Amendment (Article 1(13) of the CLP Amendment). In such case, formatting rules set out under the amended Section 1.2.1.6 of Annex I of the CLP will apply. The new provisions notably foresee that 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 all the other labelling elements provided for in Article 17(1) in the languages covered.
Other amendments relating to formatting include a minimal font size and a mandatory font color (Annex I (2) of the CLP Amendment).
- Digital labels
The CLP Amendment integrates the possibility to rely on digital labels, however, in a limited way. In a newly inserted Article 34a, the Amendment provides that digital labels may be used to complement the physical label (Article 1(15) of the CLP Amendment). While mandatory elements set out under Article 17 of the CLP Regulation 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 under the GHS (Article 1(15) of the CLP Amendment). In such case, operators must still be able to provide a physical version of the label upon request.
The formatting of digital labels is regulated via a new article 34b (Article 1(15) of the CLP Amendment). 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. The mention “more hazard information available online” or a similar indication must be included on the physical label (Art 1(13) of the CLP Amendment).
- Packaging
Finally, the CLP Amendment fosters the use of refillable containers and defines conditions under which such containers may be used without compromising safety. This includes specific requirements for fuel refill stations.
III. Our intake
The impact of the CLP Amendment will largely depend on the extension of the generic approach to risk management under the review of REACH and product legislation (including cosmetics, toys, and FCMs). The Commission foresees that those revisions will increase reliance on harmonized classifications, including in new hazard classes, thereby giving the CLP an increased weight. In this regard, the new hazard classes could notably trigger automatic restrictions under REACH and beyond.
These stringent elements are somehow balanced out by the facilitation of the use of multilingual fold-out labels and by the introduction of the digital label (although its scope is rather limited).
Please do not hesitate to contact Ales Bartl (bartl@khlaw.com), or your existing contact at Keller and Heckman if you have any questions.
[1] Available at: https://environment.ec.europa.eu/publications/proposal-clp-revision_en
[2] Available at: https://data.consilium.europa.eu/doc/document/ST-16721-2023-INIT/en/pdf?mc_cid=edbffcbb1d&mc_eid=f18c3f102b
[3] The Commission’s press release is available at: https://ec.europa.eu/commission/presscorner/detail/en/ip_23_6413
[4] Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006, OJ L 353, 31.12.2008, p. 1–1355. Available at: https://eur-lex.europa.eu/legal-content/FR/TXT/?uri=celex%3A32008R1272
[5] Commission Delegated Regulation (EU) 2023/707 of 19 December 2022 amending Regulation (EC) No 1272/2008 as regards hazard classes and criteria for the classification, labelling and packaging of substances and mixtures, OJ L 93, 31.3.2023, p. 7–39. Available at: https://eur-lex.europa.eu/legal-content/EN/ALL/?uri=CELEX%3A32023R0707
[6] With regards to the changes brought by this act, you may refer to our previous article, and our REACH 30/30 webinar.
[7] ECHA, Key areas of Regulatory Challenge, November 2023. Available at: https://echa.europa.eu/documents/10162/17228/key_areas_regulatory_challenge_en.pdf/fbaa76cf-acd0-0c8a-5dd7-3195379946aa