On Monday, 19 December 2022, the Commission issued its long-awaited Proposal for a revision of the Regulation on classification, labelling, and packaging of chemicals (CLP) (‘Proposal’).

The Proposal is currently subject to a feedback period until 3 March 2023. Any interested entity may submit comments through the Commission’s portal, which is meant to serve as input in examining the Proposal by the European Parliament and the Council.

Alongside the Proposal, the Commission also issued the final version of its Delegated Act on new hazard classes, which introduces the 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’) within the CLP. The Delegated Act is currently subject to a scrutiny period before the European Parliament and the Council, and is expected to be published in March 2023 in the EU Official Journal, provided that none of the two institutions vetoes it. Regarding the changes brought by this act, you may refer to our previous article and our 12 October 2022, REACH 30/30 webinar.

The most relevant amendments in the Proposal are as follows:

• Procedures for classifying and assessing hazards

• The proposal incorporates the new classes introduced by the Delegated Act into the text of CLP by adding them to Art. 36. This means that such hazards will be prioritized for harmonized classification and labelling.

• It grants the Commission a new power to initiate harmonised classification and labelling procedures under Art. 37 of the CLP. To initiate classification, the Commission may ask ECHA or EFSA to prepare a proposal. This represents an important change, as in the current state of the CLP, only the Member States and the industry (e.g., manufacturers, importers, and downstream users) can initiate it.

• The Commission would be obliged to prepare and adopt harmonised classification via delegated acts for substances that have been included in the Candidate list as ED, PBT, or vPvB under REACH and those that have not been approved (or have been approved via a derogation) under the Plant Protection Products Regulation and the Biocidal Products Regulation because they meet one of the exclusion criteria set out therein (including PBT, vPvB and ED). This would be done without the need for a prior proposal from the Member States or ECHA.

• The proposal also aims to incentivise uniform classification in the ECHA Classification and Labelling Inventory (‘CLI’), notably by means of the following:

• Notifiers that diverge from other entries for the same substance would have to provide reasons for such divergence;

• Notifiers would have to update their notifications within six months after a decision to change the classification of a substance has been taken, instead of 18 months at the moment (Art. 1(21) of the Proposal);

• The identity of the notifiers in the CLI would be disclosed, except where a notifier justifies that such publication would harm its interests (Art. 1(21) of the Proposal).

• Amendments to Article 10 CLP 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.

• Labelling and packaging aspects

• The Proposal sets out minimum formatting rules for fold-out labels for small packaging. However, it is unclear if, as a result of setting out the clear formatting rules, the Commission also intends to change its current restrictive approach towards the use of fold-out labels for multi-lingual labeling for normal-sized packaging (such restriction is introduced in the current version of the ECHA Guidance on Labelling and Packaging). There is no indication of this respect in the Proposal.

• The Proposal introduces new formatting rules within Art. 31 and Section 1.2.1.4 of Annex I to the CLP (incl. dimension, pictograms, and font size).

• It also introduces norms within Articles 34a and 34b of the CLP with regard to digital labelling, including mandatory formal and technical requirements. In principle, digital labeling may only be used in combination with physical labelling. By derogation, however, one may exclusively rely on a digital label for elements that are not instrumental in protecting health and safety and the environment and are not obligatory under GHS.

• It defines specific conditions for substances in very small containers, allowing for a reduction in the label elements to be presented.

• The Proposal 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.

Impact of the Proposal

The Proposal puts a strong emphasis on the implementation of the new hazard classes set out in the Commission’s Delegated Regulation. The impact of the Proposal 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 food contact materials (FCMs)). The Commission foresees that those revisions will “likely increase reliance on harmonized classifications,” thereby giving the CLP an increased weight. In this regard, the new hazard classes could trigger automatic restrictions under REACH and beyond.