Classification and Labeling of Hazardous Chemicals: Regulation (EU) 2024/2865 is published
The labelling of hazardous chemicals is a key element in ensuring the safety of consumers, workers and the environment. Long awaited, Regulation (EU) 2024/2865, amending the CLP regulation, was published on November 20, 2024 and brings numerous changes.
Let’s focus on the impact of your labels
1. EU address on the label
According to the new regulation, the label of hazardous chemical products must include a physical address located in the European Union of a supplier responsible for the CLP compliance. This requirement is intended to facilitate the traceability of products and to allow rapid contact with those responsible in the event of an emergency or for any safety-related questions.
2. Identification of PBT, vPvB, PMT, vPvM and PE substances on mixtures label
Article 18 of Regulation (EC) No 1272/2008 on classification, labelling and packaging of substances and mixtures (CLP) stipulates that certain substances must be specifically identified on the label together with the trade name of the hazardous mixture in order to warn of potential risks associated with their handling and use.
From now, the identity of all substances, contained in a mixture, with properties of concern due to their persistence in the environment, bioaccumulation and toxicity, and identified as PBT (persistent, bioaccumulative and toxic), vPvB (very persistent and very bioaccumulative), PMT (persistent, mobile and toxic), vPvM (very persistent and very mobile) and ED (endocrine disrupting) which contribute to the classification of the mixture as regards of PBT, vPvB, PMT, vPvM properties, or endocrine disruption for human health or the environment must also be mentioned.
3. Fold-out label and “standard” format
Previously, fold-out labels were mainly used for small packages. Now, the fold-out label is becoming a standard format for products, while small packages can be labelled on a tie-on tag or on an outer packaging.
The classic fold-out label allows for better organization of information, in particular by presenting it in a more readable and structured manner for multi languages labels.
The content of the fold-out label is now specified in the regulation.
5. Reduced labeling for packaging of less than 10 mL
Another important development concerns small volume chemicals. Until now, reduced labelling for very small products (less than 10 mL) was reserved for research and development (R&D) products, as well as lab products. However, this measure has been extended to include some products outside the strict R&D / lab framework, and depending on their classification, making it easier to place small quantities of chemicals on the market while maintaining an adequate level of safety.
6. New requirements for hazardous substances or mixtures supplied to consumers and professional users via refill stations
The labelling of refillable chemical products at refill stations represents a crucial area of modern regulation.
Refill stations, which are responsible for making these products available, must ensure that rechargeable products are labelled in accordance with the regulatory requirements in force.
In addition, specific rules apply not only to the products themselves, but also to the refill stations and their personnel. This includes mandatory training on safe handling of the products, understanding chemical risks, and what to do in the event of an incident.
7. Font size and label accessibility requirements
One of the important developments in the regulation of chemical labeling is the establishment of rules regarding font size, line spacing and other typographic criteria based on the volume of the package. These requirements aim to ensure that the information on the label is legible, understandable and accessible to all users, regardless of the format of the package.
8. Digital label: A modern solution for accessibility and sustainability
The digital label represents a major step forward in the management of chemical labelling, providing access to all the information required by Article 17 of the CLP Regulation, but in a digital rather than physical format. This approach has several advantages, including reduced paper use, improved accessibility and more flexible updating of information.
The digital label rules stipulate several strict requirements to ensure its effectiveness and compliance. Among them :
- Content compliant with Article 17 : The digital label must contain all necessary information such as substance or mixture identifiers, hazard pictograms, hazard statements, ... required by CLP article 17
- Free accessibility : The digital label must be available free of charge and accessible to users at any time.
- Access in 2 clicks or less : It is essential that the user can access the digital label in two clicks or less, which can be particularly crucial for emergency situations.
- Availability for 10 years : The digital label must remain accessible for a minimum period of 10 years after the product is placed on the market.
- Accessibility for vulnerable groups : One of the key principles of the digital label is its accessibility to all users, including vulnerable groups (elderly, disabled, etc.). Thus, the label must be compatible with assistive technologies and be readable by reading aids, such as screen readers. This ensures equitable accessibility and reduces the risk of accidents for people who may have difficulty reading physical labels.
9. Update of the labels
The new regulation precises the timeline for updating the labels:
- in the event of a change regarding the classification or labelling of a substance or a mixture, which results in the addition of a new hazard class or in a more severe classification, or which requires new supplemental information on the label in accordance with Article 25, the supplier of that substance or that mixture shall ensure that the label is updated without undue delay and in any event no later than 6 months
- in the event of a change regarding the classification or labelling of a substance or a mixture, other than those referred below, the timeline is no later than 18 months.
Of course these timelines shall not apply where a change regarding the classification and labelling of a substance or a mixture was triggered by a harmonised classification and labelling of a substance set out in a delegated act adopted.
Need help to comply with all these changes?
EcoMundo offers software solutions and services by regulatory experts to make your day-to-day life easier. Contact us for a free, no-obligation consultation!
The labelling of hazardous chemicals is a key element in ensuring the safety of consumers, workers and the environment. Long awaited, Regulation (EU) 2024/2865, amending the CLP regulation, was published on November 20, 2024 and brings numerous changes.
Let’s focus on the impact of your labels
1. EU address on the label
According to the new regulation, the label of hazardous chemical products must include a physical address located in the European Union of a supplier responsible for the CLP compliance. This requirement is intended to facilitate the traceability of products and to allow rapid contact with those responsible in the event of an emergency or for any safety-related questions.
2. Identification of PBT, vPvB, PMT, vPvM and PE substances on mixtures label
Article 18 of Regulation (EC) No 1272/2008 on classification, labelling and packaging of substances and mixtures (CLP) stipulates that certain substances must be specifically identified on the label together with the trade name of the hazardous mixture in order to warn of potential risks associated with their handling and use.
From now, the identity of all substances, contained in a mixture, with properties of concern due to their persistence in the environment, bioaccumulation and toxicity, and identified as PBT (persistent, bioaccumulative and toxic), vPvB (very persistent and very bioaccumulative), PMT (persistent, mobile and toxic), vPvM (very persistent and very mobile) and ED (endocrine disrupting) which contribute to the classification of the mixture as regards of PBT, vPvB, PMT, vPvM properties, or endocrine disruption for human health or the environment must also be mentioned.
3. Fold-out label and “standard” format
Previously, fold-out labels were mainly used for small packages. Now, the fold-out label is becoming a standard format for products, while small packages can be labelled on a tie-on tag or on an outer packaging.
The classic fold-out label allows for better organization of information, in particular by presenting it in a more readable and structured manner for multi languages labels.
The content of the fold-out label is now specified in the regulation.
5. Reduced labeling for packaging of less than 10 mL
Another important development concerns small volume chemicals. Until now, reduced labelling for very small products (less than 10 mL) was reserved for research and development (R&D) products, as well as lab products. However, this measure has been extended to include some products outside the strict R&D / lab framework, and depending on their classification, making it easier to place small quantities of chemicals on the market while maintaining an adequate level of safety.
6. New requirements for hazardous substances or mixtures supplied to consumers and professional users via refill stations
The labelling of refillable chemical products at refill stations represents a crucial area of modern regulation.
Refill stations, which are responsible for making these products available, must ensure that rechargeable products are labelled in accordance with the regulatory requirements in force.
In addition, specific rules apply not only to the products themselves, but also to the refill stations and their personnel. This includes mandatory training on safe handling of the products, understanding chemical risks, and what to do in the event of an incident.
7. Font size and label accessibility requirements
One of the important developments in the regulation of chemical labeling is the establishment of rules regarding font size, line spacing and other typographic criteria based on the volume of the package. These requirements aim to ensure that the information on the label is legible, understandable and accessible to all users, regardless of the format of the package.
8. Digital label: A modern solution for accessibility and sustainability
The digital label represents a major step forward in the management of chemical labelling, providing access to all the information required by Article 17 of the CLP Regulation, but in a digital rather than physical format. This approach has several advantages, including reduced paper use, improved accessibility and more flexible updating of information.
The digital label rules stipulate several strict requirements to ensure its effectiveness and compliance. Among them :
- Content compliant with Article 17 : The digital label must contain all necessary information such as substance or mixture identifiers, hazard pictograms, hazard statements, ... required by CLP article 17
- Free accessibility : The digital label must be available free of charge and accessible to users at any time.
- Access in 2 clicks or less : It is essential that the user can access the digital label in two clicks or less, which can be particularly crucial for emergency situations.
- Availability for 10 years : The digital label must remain accessible for a minimum period of 10 years after the product is placed on the market.
- Accessibility for vulnerable groups : One of the key principles of the digital label is its accessibility to all users, including vulnerable groups (elderly, disabled, etc.). Thus, the label must be compatible with assistive technologies and be readable by reading aids, such as screen readers. This ensures equitable accessibility and reduces the risk of accidents for people who may have difficulty reading physical labels.
9. Update of the labels
The new regulation precises the timeline for updating the labels:
- in the event of a change regarding the classification or labelling of a substance or a mixture, which results in the addition of a new hazard class or in a more severe classification, or which requires new supplemental information on the label in accordance with Article 25, the supplier of that substance or that mixture shall ensure that the label is updated without undue delay and in any event no later than 6 months
- in the event of a change regarding the classification or labelling of a substance or a mixture, other than those referred below, the timeline is no later than 18 months.
Of course these timelines shall not apply where a change regarding the classification and labelling of a substance or a mixture was triggered by a harmonised classification and labelling of a substance set out in a delegated act adopted.
Need help to comply with all these changes?
EcoMundo offers software solutions and services by regulatory experts to make your day-to-day life easier. Contact us for a free, no-obligation consultation!
