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 (Text with EEA relevance)

THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,

Having regard to 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 (1), and in particular Article 53(1) thereof,

Whereas:

(1) Parts 2 to 5 of Annex I to Regulation (EC) No 1272/2008 contain harmonised criteria for the classification of substances, mixtures and certain articles in hazard classes and in differentiations of those hazard classes and set out provisions on how those criteria are to be met as well as the corresponding labelling requirements. Part 3 of Annex I to Regulation (EC) No 1272/2008 contains criteria on health hazards and Part 4 of that Annex contains criteria on environmental hazards.

(2) The European Green Deal (2) sets out the goal to better protect human health and the environment as part of an ambitious approach to tackle pollution from all sources and move towards a toxic-free environment.

(3) The need to establish a legally binding hazard identification of endocrine disruptors, based on the definition established by the World Health Organization in 2002 (3) and building on criteria already developed for plant protection products (4) and biocidal products (5), and to apply it across all Union legislation, is highlighted in the Commission’s Communication ‘Chemicals strategy for sustainability towards a toxic-free environment’ (6). That Communication also points to the need to include new hazard classes and criteria in Regulation (EC) No 1272/2008 in order to fully address environmental toxicity, persistency, mobility and bioaccumulation.

(4) The Commission has conducted an impact assessment on the addition of new hazard classes and criteria in Regulation (EC) No 1272/2008, which encompassed an open public consultation, as well as a stakeholder consultation. The Commission has also consulted the European Chemicals Agency’s expert group on persistent, bioaccumulative and toxic chemicals, the competent authorities for REACH and CLP (CARACAL), as well as the subgroup on endocrine disruptors of that expert group, on the new hazard classes and criteria for classification and labelling of substances and mixtures, and has taken into account their scientific advice.

(5) Based on experience and increased scientific knowledge gained in identifying substances as substances of very high concern due to their endocrine disrupting properties as well as in identifying substances as PBT (persistent, bioaccumulative, toxic), vPvB (very persistent, very bioaccumulative), PMT (persistent, mobile, toxic) and vPvM (very persistent, very mobile) under Regulation (EC) No 1907/2006 of the European Parliament and of the Council (7), it is necessary to adapt Regulation (EC) No 1272/2008 to technical and scientific progress by introducing new hazard classes and criteria. The scientific criteria against which available evidence for classification in those hazard classes are to be assessed should reflect the current state of the science.

(6) Substances and mixtures with endocrine disrupting properties pose a concern to public health and the environment. It has been proven that endocrine disruption can lead to certain disorders in humans, among others birth defects, developmental, reproductive or neurodevelopmental disorders, cancer, diabetes and obesity, and that those disorders have a high and increasing incidence in both children and adults. It has also been demonstrated that endocrine disrupting properties can negatively affect animal populations.

(7) Experience shows that substances and mixtures with PBT or vPvB properties represent a very high concern. They do not easily break down in the environment and tend to accumulate in living organisms across the food web. Accumulation of those substances in the environment is difficult to reverse, as their environmental concentration does not readily decrease by lowering their emissions, and the effects of this accumulation are often difficult to predict in the long-term. Moreover, certain PBT and vPvB substances which undergo long-range transport have the potential to contaminate remote pristine areas. Once those substances are released into the environment, exposure to them is difficult to reverse, which leads to cumulative exposure of both animals and humans via the environment.

(8) PMT and vPvM substances pose concerns as, due to their high persistence together with a high mobility that is a consequence of their low adsorption potential, they can enter the water cycle, including drinking water, and spread over long distances. Many PMT and vPvM substances are only partly removed by wastewater treatment processes and can even break through the most advanced purification processes at drinking water treatment facilities. Such incomplete removal coupled with new emissions mean that the concentration of those PMT and vPvM substances in the environment increase over time. Once released into the environment, exposure to PMT and vPvM substances is difficult to reverse, which leads to cumulative exposure of both animals and humans via the environment. Any effects from this exposure are unpredictable in the long-term.

(9) In light of the increased scientific knowledge and experience gained in identifying endocrine disruptors for human health and the environment as well as PBT, vPvB, PMT and vPvM substances and mixtures, it is appropriate to introduce hazard classes and labelling requirements for those substances and mixtures and the corresponding scientific criteria to identify them.

(10) The level of evidence as regards endocrine disrupting properties may be of different scientific strength. It is therefore appropriate to create two categories of endocrine disruptors: known or presumed endocrine disruptors (category 1) and suspected endocrine disruptors (category 2), both for human health and for the environment.

(11) When developing guidance on the application of the endocrine disruptor criteria, the European Chemicals Agency can benefit from the experience gained from the implementation of legislation on plant protection products and biocidal products and other scientific justifications, in order to provide guidelines that clarify which effects not leading to chronic outcomes for human health and the environment could fall outside the definition of ‘adverse effect’.

(12) The intrinsic properties of PBT and vPvB substances and mixtures display similarities, but they differ substantially with regard to the toxicity criterion. It is therefore appropriate to create a new hazard class, with differentiation, while establishing common rules for the scientific assessment of the intrinsic properties related to persistency and bioaccumulation.

(13) The intrinsic properties of PMT and vPvM substances and mixtures display similarities, but they differ substantially with regard to the toxicity criterion. It is therefore appropriate to create a new hazard class, with differentiation, while establishing common rules for the scientific assessment of the intrinsic properties related to persistency and mobility.

(14) In order to allow for adequate classification of substances and mixtures as PBT and vPvB, whether or not registered under Regulation (EC) No 1907/2006, the existing criteria for identification of PBT and vPvB substances set out in Section 1 of Annex XIII to Regulation (EC) No 1907/2006 should be included in Regulation (EC) No 1272/2008. In this regard, any introduction of hazard categories for PBT and vPvB in Regulation (EC) No 1272/2008 would not be appropriate in view of the high level of scientific strength of the evidence required to fulfil the PBT and vPvB criteria – which mirror those so far laid down in Annex XIII to Regulation (EC) No 1907/2006. Moreover, the screening information laid down in that Annex, to be considered when screening for P, vP, B, vB and T properties, serves a different purpose than hazard identification and classification. In addition, the development of criteria for further hazard categories based on that screening information would lead to overclassification and significant overlaps with existing environmental classification. Therefore, it would not be appropriate to introduce additional hazard categories for PBT and vPvB in Regulation (EC) No 1272/2008.

(15) The classification criteria for M/vM relate, in particular, to the log Koc (soil adsorption coefficient) value. The Koc value is the organic carbon-water partition coefficient and reflects the ability of a substance to be adsorbed on the organic fraction of solid environmental compartments such as soil, sludge and sediment, and is therefore inversely related to the substances’ potential of entering into ground water. It is therefore appropriate to assess the mobility criterion against the log Koc value of a substance, a low Koc implying a high mobility.

(16) Providing for new hazard classes entails introducing those classes with their name, their respective hazard statements and their respective hazard category codes. It is therefore necessary to include those hazard classes, hazard statements and category codes in Annexes I, III and VI to Regulation (EC) No 1272/2008. ‘EUH statements’ – (EU hazard statements) – should be included and they should function as ‘H-statements’(‘main’ hazard statements).

(17) Pictograms are an essential tool to communicate hazard information. They should be added to the hazard information on the new hazard classes, upon their adoption at the UNGHS in order to avoid interference with the use of the existing pictograms covering current hazards. In case new pictograms are created for these new hazard classes, they should be agreed at UNGHS first so that they can apply across the UNGHS members.

(18) To ensure that suppliers of substances and mixtures have time to adapt to the new classification and labelling requirements, provisions on deferred application of the obligation to classify and label substances and mixtures in accordance with this Regulation should be included in Annex I to Regulation (EC) No 1272/2008. That Annex should also provide for the possibility for substances and mixtures which are already placed on the market before the end of that deferral period, to continue being placed on the market without being classified and labelled in accordance with this Regulation, to avoid additional burden on suppliers of substances and mixtures.

(19) In line with the transitional provisions set out in Regulation (EC) No 1272/2008 which allow the application of the new provisions at an earlier stage on a voluntary basis, suppliers should have the possibility of applying the new classification and labelling provisions before the date of application of the obligations to classify and label substances and mixtures in accordance with this Regulation.

(20) Regulation (EC) No 1272/2008 should therefore be amended accordingly,

HAS ADOPTED THIS REGULATION:

Article 1

Regulation (EC) No 1272/2008 is amended as follows:

(1) Annex I is amended as set out in Annex I to this Regulation;

(2) Annex II is amended as set out in Annex II to this Regulation;

(3) Annex III is amended as set out in Annex III to this Regulation;

(4) Annex VI is amended as set out in Annex IV to this Regulation.

Article 2

This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels, 19 December 2022.

For the Commission The President Ursula VON DER LEYEN

(1) OJ L 353, 31.12.2008, p. 1.

(2) Communication from the Commission to the European Parliament, the European Council, the Council, the European Economic and Social Committee and the Committee of the Regions – The European Green Deal (COM(2019) 640 final, 11 December 2019).

(3) WHO/IPCS (World Health Organization/International Programme on Chemical Safety), 2002. Global assessment on the state of the science of endocrine disruptors (WHO/PCS/EDC/02.2), https://apps.who.int/iris/bitstream/handle/10665/67357/WHO_PCS_EDC_02.2.pdf.

(4) Commission Regulation (EU) 2018/605 of 19 April 2018 amending Annex II to Regulation (EC) No 1107/2009 by setting out scientific criteria for the determination of endocrine disrupting properties (OJ L 101, 20.4.2018, p. 33).

(5) Commission Delegated Regulation (EU) 2017/2100 of 4 September 2017 setting out scientific criteria for the determination of endocrine-disrupting properties pursuant to Regulation (EU) No 528/2012 of the European Parliament and Council (OJ L 301, 17.11.2017, p. 1).

(6) Chemicals Strategy for Sustainability, COM(2020) 667 final.

(7) Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC (OJ L 396, 30.12.2006, p. 1).