The European Commission proposed on 19 December a revised Regulation on classification, labelling and packaging of chemicals (CLP) and introduced new hazard classes for endocrine disruptors and other harmful chemical substances to better protect people and the environment from hazardous chemicals.
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What is the Classification, Labelling and Packaging regulation?
The Classification, Labelling and Packaging (CLP) Regulation ((EC) No 1272/2008) requires manufacturers, importers or downstream users of substances or mixtures to classify, label and package their hazardous chemicals appropriately before placing them on the market. One of the main aims of CLP is to determine whether a substance or mixture displays properties that should lead to their hazard classification (e.g. explosives). Classification is the signal that informs us when hazard communication is necessary. It is based on the United Nations’ Globally Harmonised System (GHS) and its purpose is to ensure a high level of protection of health and the environment, as well as the free movement of substances and mixtures. Manufacturers, importers or downstream users are required to assess whether the substances and mixtures they place on the market have harmful properties, based on the CLP criteria.
Once a company classifies a substance or mixture, they must communicate the identified hazards to other actors in the supply chain, including consumers, via labels and to poison centres. Users of a hazardous substance or mixture are hence aware of the presence of a hazard and the need to manage the associated risks. The EU may adopt a harmonised classification which is legally binding for all actors placing that substance on the market, a tool which is used in particular for the most harmful substances, such as carcinogens.
CLP sets detailed rules on how to label hazardous chemicals: pictograms, signal words and standard statements for hazard, prevention, response, storage and disposal. CLP also sets general packaging standards to ensure the safe supply of hazardous substances and mixtures. In addition to the communication of hazards through labelling requirements, CLP provides the basis for further action to address and mitigate the risks of these substances under the REACH, biocidal products and other sectoral regulations.
Why do we need to revise the CLP Regulation?
The CLP Regulation has ensured both a well-functioning Single Market for chemicals and a high level of protection for human health and the environment since 2008. However, the Commission’s analysis showed that the Regulation should be updated to take account of scientific and technological progress or market developments such as the online market and refilling stations for chemicals. A targeted update of the Regulation is needed to optimise labelling rules. The revision will help to address the gaps and ensure more complete information about chemical hazards, as well as clarify the roles of different involved parties (manufacturers, importers, distributors). For example, the requirement for certain distributors to submit information to poison centres when they re-label a substance or mixture.
Which changes does the revision of CLP introduce?
The legislative proposal for the CLP revision contains various changes which aim at simplifying some burdensome and unclear provisions. The labelling requirements are updated, for example, when it comes to minimal font size, and/or chemicals in a form or size which is difficult to label, or digital labelling. The online Classification and Labelling Inventory, managed by the European Chemical Agency, streamlines hazard communication with clearer and more transparent information, making classification of substances and mixtures easier for smaller companies.
How does the proposal improve classification of chemicals?
The proposal makes the classification by manufacturers, downstream users and importers as well as ECHA’s Classification and Labelling Inventory more effective and fit for purpose. The inventory contains classifications of substances submitted by manufacturers and importers to the Agency (either directly or via inclusion in the registration dossiers under REACH) and is a very important communication instrument. These improvements should help SMEs classify substances quicker and better. When new data is available, companies should update their classification within 6 months.
Regarding harmonised classification, the proposal will improve the transparency of the process. More dossiers will be submitted to the European Chemicals Agency, as the Commission will also have the right to submit dossiers, in addition to Member States and companies in the chemicals industry.
Why do we need new hazard classes?
Workers, professionals and consumers should be made aware of the hazards displayed by certain chemicals. Classification in a certain hazard class triggers corresponding labelling, including safety instructions. Manufacturers, importers and downstream users should be encouraged to replace substances and mixtures with hazardous properties as much as possible by less hazardous ones.
The addition of new hazard classes in CLP was triggered by evidence supporting the fact that the substances and mixtures were harmful and not fully addressed via the existing criteria. Common to these new hazard classes is that they target substances and mixtures which are very harmful for the human health or the environment.
In addition, the new hazard classes (see below) are added to existing ones, for example carcinogenicity, aquatic toxicity. When substances fulfil the criteria for classification in those very serious hazard classes, they are normally subject to assessment and harmonised classification at EU level.
How does the revision set new hazard classes for chemical substances?
The Commission Delegated Act introduces in the CLP regulation new hazard classes and criteria for classifying substances and mixtures. The new hazard classes are:
- endocrine disruptors (ED) for human health or the environment,
- persistent, bioaccumulative and toxic (PBT); very persistent and very bioaccumulative (vPvB),
- persistent, mobile and toxic (PMT); very persistent and very mobile (vPvB).
This delegated Act is the outcome of multiple scientific discussions involving scientific experts from the European Chemicals Agency (ECHA), Commission, Member States and stakeholders’ organisations, held at ECHA or in the framework of the Commission expert group under the REACH and CLP Regulations.
Some of these hazards are already partially covered in other legislation: endocrine disruptors and PBT/vPvB (REACH/Plant Protection Products and Biocidal Products Regulation), whereas the PMT/vPvM hazards are new in EU legislation.
In addition, in the Commission’s legislative proposal for the CLP revision the Commission proposes that, when substances fulfil the criteria for classification in those very serious hazard classes, they are normally subject to assessment and harmonised classification at EU level.
How will consumers benefit from this revision?
The proposal will include new formatting rules for hazard communication, for example on labels. These labels will become more readable thanks to new requirements for minimum font size and colour. Also, the new hazard classes will inform consumers about the hazardousness of various household chemicals such as cleaning products, especially those for environment hazards, and enable them to make more informed decisions when purchasing such products.
How will the revision affect small and medium companies?
The new hazard classes and the harmonised classification of chemicals belonging to them will imply increased labelling obligations for companies. However, these increased requirements will be toned down by the simplifications that are foreseen for labelling of substances and mixtures which will help SMEs in particular. New rules are proposed for selling chemicals in refillable containers which will reduce packaging waste and contribute to the circular economy as well as to lowering packaging costs for businesses. In addition, a broader use of fold-out labels will be allowed. The use of new labelling technologies will enable companies to take advantage of economies of scale. Further derogations will be introduced for chemicals sold to consumers in bulk, such as fuel, and in very small packaging, such as various writing instruments. In consultation with stakeholders, ECHA will provide guidance to facilitate compliance with the new rules.
How will the CLP revision contribute to the planned revision of REACH?
REACH and CLP revisions are complementary. For example, new information requirements under a revised REACH will provide information on the intrinsic properties of substances allowing their classification under the new hazard classes envisaged and the updated classification rules in the revised CLP. In turn, the harmonised classification of substances for those hazards will be the basis for increased risk management under the revised REACH, but also other pieces of sectorial legislation currently under revision.
How will the revision contribute to European Green Deal objectives related to tackling climate change, reducing pollution and enhancing the circular economy?
The proposal is one of the deliverables of the EU Chemicals Strategy for Sustainability which sets out actions towards the zero-pollution ambition for a toxic-free environment, announced in the European Green Deal. The revision of the CLP Regulation is necessary to achieve our ambition for innovation for safe and sustainable chemicals and for increasing protection of human health and the environment against hazardous chemicals.
The main actions listed in the Chemicals Strategy that the Commission aims to address with the proposal are to establish:
- legally binding hazard identification of endocrine disruptors, based on the definition of the WHO, building on criteria already developed for pesticides and biocides, and apply it across all legislation; and
- new hazard classes and criteria to fully address environmental toxicity, persistency, mobility and bioaccumulation.
The proposal for the revised CLP Regulation will allow the identification of the most harmful substances. It will enable other legislation to take appropriate actions to restrict the use of those substances, in particular in consumer products, ultimately leading towards a toxic-free environment. These combined actions will contribute to tackle climate change, reduce pollution and enhance toxic-free material cycles in the circular economy.
Proposal for a revision of the Regulation on classification, labelling and packaging of chemicals (CLP)
Delegated Act establishing new hazard classes
Source: European Commission
