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What are the European Union Classification, Labelling and Packaging Regulations?

Date:2023-04-23 09:37:00 Classification :【Statute】 Visits:
The EU Classification, Labeling, and Packaging (CLP) regulation (EC) No 1272/2008) requires manufacturers, importers, or downstream users of substances or mixtures to properly classify, label, and package their hazardous chemicals before placing them on the market. One of the main objectives of CLP is to determine whether a substance or mixture exhibits characteristics that should lead to its hazard classification (such as explosives). Classification is a signal that informs us when a danger notification is required. It is based on the United Nations' Globally Harmonized System (GHS), which aims to ensure a high degree of protection for health and the environment, as well as the free flow of substances and mixtures. Manufacturers, importers, or downstream users need to evaluate whether the substances and mixtures they place on the market have harmful characteristics based on CLP standards.


After the company classifies the substance or mixture, they must communicate the identified hazards to other participants in the supply chain, including consumers, through labels and poison centers. Therefore, users of hazardous substances or mixtures are aware of the existence of hazards and the necessity of managing related risks. The EU may adopt a unified classification, which is legally binding on all participants who put the substance on the market. It is a tool specially used for the most harmful substances (such as carcinogen).


CLP has developed detailed rules on how to label hazardous chemicals: pictograms, signal words, and standard instructions for hazards, prevention, response, storage, and disposal. CLP has also established universal packaging standards to ensure the safe supply of hazardous substances and mixtures. In addition to conveying hazards through labeling requirements, CLP also provides a basis for further action to address and mitigate the risks of these substances in accordance with REACH, biocide products, and other departmental regulations.


Why do we need to modify CLP regulations?

Since 2008, CLP regulations have ensured the good operation of the single market for chemicals and a high level of protection for human health and the environment. However, the committee's analysis suggests that the regulation should be updated to take into account scientific and technological progress or market development, such as online markets and chemical refueling stations. Targeted updates to regulations are needed to optimize labeling rules. The revision will help bridge the gap, ensure more complete information on chemical hazards, and clarify the roles of different stakeholders (manufacturers, importers, distributors). For example, certain distributors are required to submit information to the Poison Center when re labeling substances or mixtures.

What changes have been brought about by the revision of CLP?


The legislative proposal for CLP revision includes multiple changes aimed at simplifying some cumbersome and unclear provisions. Label requirements will be updated, for example, when it comes to chemical or digital labels with minimum font size and/or difficult to label forms or sizes. The online classification and labeling list managed by the European Chemicals Administration simplifies hazard communication through clearer and more transparent information, making it easier for small companies to classify substances and mixtures.

How does the proposal improve the classification of chemicals?

This proposal makes the classification of manufacturers, downstream users, and importers, as well as the classification and labeling list of ECHA, more effective and in line with the purpose. This list contains the classification of substances submitted by manufacturers and importers to the agency (either directly or through registration dossiers under REACH), and is a very important communication tool. These improvements should help small and medium-sized enterprises classify substances faster and better. When new data becomes available, the company should update its classification within 6 months.

Regarding unified classification, this proposal will enhance the transparency of the process. More files will be submitted to the European Chemicals Administration, as in addition to member states and companies in the chemical industry, the committee also has the authority to submit files.


Why do we need a new hazard level?

Workers, professionals, and consumers should be made aware of the hazards displayed by certain chemicals. The classification of specific hazard categories will trigger corresponding labels, including safety instructions. Manufacturers, importers, and downstream users should be encouraged to replace substances and mixtures with less hazardous characteristics as much as possible.

The addition of new hazard categories in CLP is triggered by evidence that supporting substances and mixtures are harmful and have not been adequately addressed by existing standards. The common feature of these new hazard categories is that they target substances and mixtures that are very harmful to human health or the environment.

In addition, new hazard categories (see below) have been added to existing hazard categories, such as carcinogenicity and aquatic toxicity. When substances meet the classification criteria for these very serious hazard categories, they usually need to be evaluated and classified uniformly at the EU level.


How does the revised version set new hazard levels for chemical substances?

The committee authorized the bill to introduce new hazard categories and substance and mixture classification standards in the CLP regulations. The new hazard categories are:

Endocrine disruptors (ED) to human health or the environment,

Persistence, bioaccumulation, and toxicity (PBT); Very persistent and highly bioaccumulative (vPvB),

Persistence, fluidity, and toxicity (PMT); Very durable and highly mobile (vPvM).

This authorization bill is the result of multiple scientific discussions held by scientific experts from the European Chemical Administration (ECHA), the committee, member states, and stakeholder organizations within the framework of ECHA or committee expert groups, in accordance with REACH and CLP regulations.

Some of these hazards have been partially covered in other legislation: endocrine disruptors and PBT/vPvB (REACH/Plant Protection Products and Biocide Products Regulations), while PMT/vPvM hazards are new in EU legislation.

In addition, in the committee's legislative proposal for CLP revision, the committee suggests that when substances meet the classification criteria for those very serious hazard categories, they typically need to be evaluated and coordinated for classification at the EU level.

How will consumers benefit from this revision?

The proposal will include new hazard information format rules, such as labeling. Due to new requirements for minimum font size and color, these labels will become more readable. In addition, the new hazard categories will inform consumers of the hazards of various household chemicals (such as cleaning products), especially those that are harmful to the environment, and enable them to make more informed decisions when purchasing such products.


What is the impact of the revision on small and medium-sized enterprises?

The new hazard categories and the unified classification of chemicals belonging to them will mean an increase in the company's labeling obligations. However, these additional requirements will be mitigated by expected simplification of the labeling of substances and mixtures, which will be particularly helpful for small and medium-sized enterprises. New rules have been proposed for the sale of chemicals in refillable containers, which will reduce packaging waste and contribute to the circular economy and lower packaging costs for enterprises. In addition, it will allow for wider use of foldable labels. The use of new labeling technology will enable companies to leverage economies of scale. For chemicals sold in bulk to consumers (such as fuel) and very small packaging (such as various writing tools), further reduction will be introduced.


How will the CLP revision promote the planned revision of REACH?


REACH and CLP revised versions are complementary. For example, the new information requirements under the revised REACH will provide information on the inherent characteristics of substances, allowing them to be classified based on the proposed new hazard categories and the updated classification rules in the revised CLP. Conversely, the unified classification of substances targeting these hazards will serve as the basis for strengthening risk management in accordance with the revised REACH and other departmental legislation currently being revised.


How will the revision promote the goals of the European Green Agreement related to addressing climate change, reducing pollution, and strengthening the circular economy?

This proposal is one of the deliverables of the EU Chemicals Sustainable Development Strategy, which sets out the actions announced in the European Green Agreement to achieve zero pollution and non-toxic environmental goals. Revising CLP regulations is necessary to achieve our ambition to innovate safe and sustainable chemicals, as well as strengthen the protection of human health and the environment from hazardous chemicals.

The main actions listed in the chemicals strategy that the committee aims to address through proposals are to establish:

According to the definition of WHO, based on the standards already established for insecticides and biocides, legally binding hazard identification of endocrine disruptors is carried out and applied to all legislation; and

New hazard categories and standards to fully address environmental toxicity, persistence, mobility, and bioaccumulation issues.

The revised CLP regulatory proposal will allow for the identification of the most harmful substances. It will enable other legislation to take appropriate action to limit the use of these substances, especially in consumer goods, ultimately achieving a non-toxic environment. These joint actions will help address climate change, reduce pollution, and strengthen the recycling of non-toxic materials in the circular economy.

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