CLP: Introduction of new hazard classes

CLP: Introduction of new hazard classes – Legal concerns

The European Commission has introduced new hazard classes into the CLP Regulation through Delegated Regulation (EU) 2023/707 of 19.12.2022.

As a result, the new hazard classes are already effective and have to be observed before the planned revision of the CLP Regulation by the amendment proposal COM (2022) 748 final. In detail, new hazard classes for endocrine disruptors as well as for persistent, bioaccumulative and toxic substances (PBT) or very peristent and very bioaccumulative substances (vPvB) and persistent, mobile and toxic substances (PMT) or very persistent and very mobile substances (vPvM) have been introduced (text available HERE).

The introduction of the new hazard classes by way of a Delegated Regulation is surprising. It is true that corresponding legislative powers of the Commission are not unusual and are also anchored in Art. 53, 53a CLP. However, the Commission’s powers are limited. The introduction of new hazard classes cannot be based on this.

A. Disregard for the principle of democracy

The European Parliament, together with the Council, have the central legislative function, whereas the Commission exercises coordinating, executive and administrative functions in accordance with the Treaties. Although the Commission plays a decisive role in the legislative process within the Union through its right of initiative, it does not itself have any original power to legislate in a legislative procedure pursuant to Article 289 para. 3 TFEU. The delegated act within the meaning of Art. 290 TFEU, on the other hand, is an act that merely enables the Commission to supplement non-essential provisions of a basic act or to amend them within this framework. However, the fundamental decisions are always reserved for the basic act and cannot be delegated to the Commission without violating the principle of democracy.

B. Infringement of Community law

Art. 53, 53a CLP merely empower the Commission to adapt, inter alia, Annex I to CLP to technical and scientific progress, whereby amendments may only cover non-essential provisions of the Regulation. However, the introduction of new hazard classes is not a mere adaptation to technical progress or an immaterial amendment. Although the concept of materiality in Article 290 TFEU lacks clear contours, the purpose of a delegated act must be taken into account when interpreting it. Such an act of the Commission is only intended to relieve the Union legislator of detailed regulations, but cannot supplement or amend secondary law beyond the delegation. According to the case law of the European Court of Justice, regulations that amend or extend the scope of the basic legal act are to be regarded as essential. However, this is obviously the case with the introduction of new hazard classes for substances and mixtures with ED, PBT, vPvB, PMT and vPvM properties, as the scope of the CLP Regulation is not only modified but extended in this respect. Substances and mixtures that were not previously classified as hazardous due to the lack of corresponding hazard classes are now subject to the corresponding legal obligations as a result of the additionally introduced hazard classes. In addition, the introduction of new hazard classes naturally also has indirect effects, insofar as other legal acts, for example, are generically based on the mere hazardousness of substances or mixtures in the sense of the existence of hazard properties and have so far not covered substances and mixtures with ED, PBT, vPvB, PMT and vPvM properties.

However, even if one disregards the limits arising from Article 290 TFEU with regard to the introduction of new hazard classes by delegated act, the provision of Art. 53 para. 1 CLP in its currently applicable version would in any case not give the Commission the right to introduce such new hazard classes. This is because the essential parameters of the delegation, such as the objective, content, scope and duration, must be laid down in the authorizing legislative act and may not be left to the legislative power of the executive. Measured against these standards, the introduction of new hazard classes also violates Art. 290 para. 2 TFEU, since the Commission has thereby exceeded the scope of action currently set for it by the Union legislature. Such a violation could also not be remedied by the fact that, within the framework of a subsequent amendment of CLP, the authority for the Commission is to be extended and the ineffective act of delegation is to be subsequently given legitimacy.

C. Violation of Principles of International Law

From the point of view of the self-obligation of the EU, in particular and especially of the Commission, the procedure of the Commission shown above also contradicts principles of international law.

In the CLP Regulation, the Community affirms in the recitals that it wishes to contribute to the worldwide harmonization of criteria for the classification and labeling of potentially hazardous substances, mixtures and certain specific articles, taking particular account of the United Nations GHS regime (Globally Harmonized System of Classification and Labeling of Chemicals), by transposing into Community law the criteria developed there with great care to simplify world trade and protect human health and the environment. Although the requirements of the GHS cannot be classified as a treaty under international law, they must be regarded as so-called “soft law” under international law, i.e. as a legally non-binding agreement which can, however, contribute to the formation of binding international law and, above all, develop over time into opinio juris. Such a customary law developed by the GHS must be assumed in view of the time since its entry into force as well as its continuous updates and the numerous legal provisions worldwide based on it. Irrespective of this, this gives rise to central points of reference for the interpretation of other legal acts.

In this sense, the ECJ has repeatedly ruled that international conventions take precedence over secondary Community law, especially if they have been ratified by the Community itself. According to established case law, the Community is thus bound by its own obligations, which means that Community law may not infringe ratified international conventions.

According to its meaning and purpose, this case law is to be applied to the interaction between the GHS, the CLP Regulation established for its implementation and the Delegated Regulation (EU) 2023/707 specifically at issue here. It follows inevitably from the case law of the ECJ that the Commission is not authorized to revise the CLP Regulation in such a way that it thereby violates the self-binding nature of the harmonization of hazard classes at global and European level that came to light with the adoption of the GHS into Union law.

Delegated Regulation (EU) 2023/707 violates the principle of democracy under Art. 10 TEU to the extent that it inadmissibly undermines the legislative power of the Parliament. At the same time, the legal act also violates the specifications and requirements pursuant to Art. 290 paras. 1 and 2 TFEU, since it precisely brings about substantial changes to the basic legal act. And finally, the regulation also violates the Community’s self-binding obligation under international law to harmonize substances that are potentially harmful to health and the environment worldwide within the framework of the GHS by introducing new hazard classes into Community law without having first initiated harmonization at the United Nations level.

Due to the multiple violations of the law, Delegated Regulation (EU) 2023/707 raises significant concerns. However, it remains to be seen whether companies or associations will take legal action and whether the European courts will be given the opportunity to assess the legal concerns. In the interest of further legal certainty in the design of legislative powers in favor of the Commission and the resulting consequences for industry, this would be desirable in any case.

Do you have any questions about this news, or would you like to discuss it with the author? Please contact: Martin Ahlhaus

12. May 2023 Martin Ahlhaus