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.
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 the emission does not readily cease by lowering their concentration, 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.
PMT and vPvM substances pose concerns as, due to their high persistence together with their low absorption potential and mobility, 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.
Overall, 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 for those substances and mixtures and the corresponding scientific criteria to identify them.
On 20 September 2022, the European Commission started a public consultation on a draft act that would introduce new hazard classes as part of its revision to the CLP Regulation on classification, labelling, and packaging of substances. The consultation is open until 18 October.
The four new hazard classes are:
- Endocrine disrupting property for human health
- Endocrine disrupting property for the environment
- Persistent, Bioaccumulative and Toxic properties (PBT or vPvB)
- Persistent, Mobile and Toxic properties (PMT or vPvM) (v stands for ‘very’)
The criteria in each class include classification and labelling for both substances and mixtures.
Classification Criteria for Mixtures
Endocrine disruptor for human health – Categories 1 &Â 2
A mixture shall be classified as an endocrine disruptor for human health where at least one component has been classified as a Category 1 or Category 2 endocrine disruptor for human health and is present at or above the appropriate generic concentration limit.
Endocrine Disruptor for the environment – Category 1 & 2
A mixture shall be classified as an endocrine disruptor for the environment where at least one component has been classified as a Category 1 or Category 2 endocrine disruptor for the environment and is present at or above the appropriate generic concentration limit.
Persistent, Bioaccumulative, and Toxic (PBT) or Very Persistent, Bioaccumulative (vPvB) substance
A mixture shall be classified respectively as a PBT or vPvB when at least one component contained in the mixture has been classified respectively as a PBT or vPvB and is present at or above 0,1% (weight/weight).
Persistent, Mobile and Toxic (PMT) or Very Persistent, Very Mobile (vPvM) substance
A mixture shall be classified as a PMT or vPvM where at least one of its components has been classified as a PMT or vPvM and is present at or above 0,1% (weight/weight).
Transitional Period
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.
To ensure that suppliers of substances and mixtures have time to adapt to the new classification and labelling provisions, the application of the obligation to classify and label substances and mixtures in accordance with this Regulation should be deferred. Substances and mixtures which are already placed on the market before the end of that deferral period, should be allowed to continue being placed on the market without being re-classified and re-labelled in accordance with this Regulation, to avoid additional burden on suppliers of substances and mixtures.
There are two distinct and successive transitional periods for substances and mixtures placed on the Union Market: at least 18 months for substances and 36 months for mixtures after the date of entry into force of this Regulation. Only compliant substances and mixtures shall be made available on the market, 42 months (for substances) and 60 months (for mixtures) after the date of entry into force of this Regulation.
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.
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.
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.
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.
Labelling Obligations
The new hazard classes and the harmonised classification of chemicals belonging to them will imply increased chemical 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.
