BLOG TOPIC: CLP Regulations sets New Hazard classes in Europe
Industrial and professional users of hazardous substances and mixtures are informed about hazards through Safety Data Sheets (SDSs) and labels on the product packages. Consumers are informed through the labels on the products.
A product can pose physical hazards and/or a hazard to human health or the environment. For instance, a solvent-based ink can contain a solvent that makes the ink flammable, which is a physical hazard. This solvent can also be, for example, irritating to the skin (human health hazard) or be hazardous to aquatic life (environmental hazard). There are different types of physical, human health, and environmental hazards, also called hazard classes.
In Europe, the Classification, Labelling and Packaging (CLP) Regulation lays down the criteria that determines if a substance or a mixture of substances is hazardous. The Regulation determines the types (classes) and severities of the hazards, as well as the information to be included within the Safety Data Sheet and printed on the product label.
The CLP Regulation is binding to manufacturers, importers, downstream users, and distributors placing substances in the EU market.
How do you know if an ink is classified as hazardous?
Inks are mixtures of substances. The hazard(s) of an ink is determined by the criteria in the CLP Regulation. An ink formulation that meets one or more hazard criteria, has one or more hazard classifications. If an ink formulation does not meet the hazard criteria, we say that the ink is not classified.
So, what is new within the scope of CLP?
In March of 2023, The European Commission published a Delegated Regulation ((EU) 2023/707) introducing new hazard classes and the criteria for classification.
The new hazard classes are:
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Endocrine disruptors for Human Health (ED HH) and/or the environment (ED ENV)
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Substances that are Persistent, Bioaccumulative and Toxic (PBT) or Very Persistent, Very Bioaccumulative (vPvB)
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Substances that are Persistent, Mobile and Toxic (PMT) or Very Persistent, Very Mobile (vPvM)
These new rules are in force as of April 20th, 2023. However, there are transitional periods in place. After the transitional period, the supply chain must have applied the new hazard classes in their SDS, labels, and REACH registration dossiers of substances.
Other important dates (see Figure 1):
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May 1st, 2025: Compliance needed for all new substances in the market
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November 1st, 2026: Substances already in the market must comply
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May 1st, 2026: New hazard classes apply for new mixtures
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May 1, 2028: New hazard compliance applies for existing mixtures already in the market
How does this affect our ink business?
The new hazard classes could trigger additional compliance obligations and restrictions. Flint Group will check all its ink formulations against the additional criteria of the new hazard classes. In case that an ink must be classified and labelled with the new hazard classes, the manufacturing of this ink must be re-assessed to remove the hazardous substance. Consequently, the downstream users might need to re-approve the ink formulation for their respective applications.
Figure 1
Note: As illustrated by the ECHA - New hazard classes 2023 - ECHA (europa.eu)
Flint Group’s Product Stewardship and Regulatory Affairs department is at the core of Flint Group and fostered throughout the company’s entire value chain. We strongly encourage customers to contact us at any time to discuss risk management or other regulatory topics. Please email us at info@flintgrp.com.
More information can be found:
https://eur-lex.europa.eu/eli/reg_del/2023/707/oj