Advancing chemical safety: the impact of new CLP hazard classes

New In late 2022, the European Commission (Commission) added three new hazard classes to the Classification, Labelling and Packaging (CLP) Regulation to further improve the protection of people and the environment. The changes entered into force in April 2023.

The CLP Regulation requires companies to appropriately classify, label and package their hazardous chemicals before placing them on the EU market. It implements the United Nation’s Globally Harmonized System (UN GHS) in Europe with the aim of protecting health and the environment, but also ensuring the free movement of substances, mixtures and articles.

New hazard classes

The new hazard classes include:

• endocrine disrupting properties, both for human health and the environment

These affect our hormones and can lead to adverse outcomes or effects, such as birth defects, developmental, reproductive or neurodevelopmental disorders in humans. They can also impact or disturb, for example, the sexual differentiation of wildlife populations;

• persistent, bioaccumulative and toxic (PBT) or very persistent and very bioaccumulative properties (vPvB)

These typically stay in the environment for a long time after their release as they do not easily break down. They also tend to build up in living organisms and in the food chain; and

• persistent, mobile and toxic (PMT) or very persistent and very mobile properties (vPvM)

These are chemicals where persistency is combined with high mobility. They can easily spread over long distances in the environment, for example, through waterways. It is currently difficult to predict how they will affect us and the environment in the long-term.

These hazards were added to CLP mainly because they were not adequately addressed by the existing hazard classes.

However, this does not mean that they are new to regulation. Endocrine disrupting and persistent, bioaccumulative and toxic properties were already being assessed, for example, as part of the substance of very high concern (SVHC) process under the REACH Regulation and under biocides and plant protection products regulations. The aspect of mobility is relatively new across European legislation.

Far-reaching impact

Adding the new hazards to CLP brings clarity as it allows substances and mixtures with these hazards to be regulated similarly to other severe hazards. This has many downstream effects under different pieces of legislation.

When a substance receives a certain classification, it may lead to obligations for companies or limitations in how the substance can be used, for example, under REACH, Biocidal Products Regulation, legislation on plant protection products and cosmetic products as well as different laws regulating health and safety of workers.

With links to many other laws, CLP is a key piece of European legislation that can have a far-reaching impact.

New obligations

As the new hazard classes may bring new obligations, companies should assess and review their portfolio of substances and mixtures against the new criteria. If the classification criteria are met, ECHA needs to be informed of the new classification. Companies can do this, for example, by updating their REACH registration dossier.

If the substance or mixture was not previously classified, but meets the criteria of a new hazard class, companies must notify the substance to the classification and labelling inventory hosted on ECHA’s website or make a new poison centre notification for the mixture.

Companies will also have to consider the new classification when preparing safety data sheets. This ensures that everyone in the supply chain gets the information they need for safe use.

Submit dossiers through updated IUCLID

IUCLID software was updated with the new hazard classes on 29 April 2024. Since then, companies have been able to include information on the new hazard classes when submitting dossiers to ECHA.

However, there are transition periods for applying the new classification criteria to substances and to mixtures.

For new substances on the market, companies must comply with the new rules from 1 May 2025, whereas for substances that have already been on the market, companies will have until 1 November 2026 to comply.

Separate transition times apply for mixtures. New hazard classes apply from 1 May 2026 to new mixtures, and from 1 May 2028 onwards for existing mixtures.

Support material

ECHA’s current guidance on the CLP criteria is being updated to include the new hazard classes and is expected to be ready in autumn 2024.

The guidance update process can be followed, and draft guidance can be accessed, from the ECHA website.

Currently, companies can refer to existing guidance for support on these hazards such as:

• the EFSA-ECHA guidance for the hazard identification of endocrine disrupting properties; and
• the REACH Guidance on Information Requirements and Chemical Safety Assessment, Part C (R.11): PBT/vPvB assessment for identifying persistent, bioaccumulative and toxic properties.

ECHA’s website also lists the main obligations for companies in detail with links to existing guidance and other information that can be helpful when they start to prepare or update their notifications.

Ongoing CLP revision

In April 2024, the European Parliament adopted a provisional agreement to update the CLP Regulation. The updated text, proposed by the Commission in December 2022, aims to better identify and classify hazardous chemicals, as well as improve the communication on chemical hazards.

The update is expected to cover, for example, the following changes:

• The Commission's right to initiate proposals for harmonised classification and labelling. This means that EU Agencies, such as ECHA or the European Food Safety Authority, can be asked to prepare a proposal for a harmonised classification on behalf of the Commission. Now, only Member States and industry have been able to initiate harmonised classification dossiers;
• Clarifications to the rules for classification of mixtures and for substances with more than one constituent. This means that substances containing more than one constituent will be classified following the same rules as for mixtures. In practice, if a substance consists of chemicals or constituents with known severe hazards above a certain threshold as defined by the regulation, companies must classify the whole substance accordingly. Substances extracted from plants or plant parts which are not chemically modified (e.g. essential oils) are exempted from this rule but the Commission will need to prepare a scientific report examining the information on such substances within five years of the entry into force of the new rules; and
• Changes concerning poison centre notifications and the classification and labelling inventory, online sales rules and the labelling and packaging requirements. These aim to improve the communication on hazards.

The new regulation is still to be formally adopted by the Council of Ministers, before it can be published and enter into force.

Listen to our #SaferChemicalsPodcast with Paul Ryan, the Head of ECHA’s Hazard classification unit to hear more about the new hazard classes and other expected changes.

More:

New hazard classes 2023

New CLP hazard classes will be included in IUCLID

Understanding CLP

Classification and labelling inventory

EFSA-ECHA Guidance for the identification of endocrine disruptors

Guidance on Information Requirements and Chemical Safety Assessment, Part C: PBT/vPvB assessment (R11), Version 3.0

Ongoing guidance consultations