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The Republic of Srpska continues to align its chemical regulations with those of the European Union.
To this end, the Regulation on Amendments and Supplements to the Regulation on Classification, Labeling, and Packaging of Chemicals ("Official Gazette of the Republic of Srpska", No. 21/24) has been adopted. The annexes of the regulation are published in a special edition of the "Official Gazette of the Republic of Srpska".
The regulation comes into effect on March 14 2024, and today I bring you an overview of the most important changes.
Let me first remind you that the Regulation on Classification, Labeling, and Packaging of Chemicals partially incorporated the EU's CLP Regulation into the legal system of the Republic of Srpska. Annex VI of the regulation, which contains the harmonized classification and labeling of certain substances, was not included in this regulation. It was adopted through a separate document – the List of Classified Substances.
The original text of the regulation was adopted in 2020, and since then, European legislation on the classification and labeling of chemicals has been amended several times. Therefore, changes to the regulation were necessary.
The most significant changes involve the addition of new hazard classes, including:
- desensitized explosives (H206, H207, H208),
- endocrine disruptors for human health (EUH380, EUH381),
- endocrine disruptors for the environment (EUH430, EUH431),
- persistent, bioaccumulative, and toxic or very persistent and very bioaccumulative properties (EUH440, EUH441),
- persistent, mobile, and toxic or very persistent and very mobile properties (EUH450, EUH451).
Unlike additional hazard information (EUH codes) we are familiar with (e.g., EUH208), the new EUH codes have the same weight as hazard statements (H codes). This means that chemicals assigned these EUH codes will also be considered hazardous chemicals, which was not the case before.
Let's take a closer look at the new hazard class endocrine disruptors for human health. The term "endocrine disruptor" is defined, along with other terms significant for understanding this hazard class. According to established criteria, two categories are defined within this hazard class:
- Category 1: substances known or presumed to be endocrine disruptors for human health.
- Category 2: substances suspected of being endocrine disruptors for human health.
Criteria for classifying mixtures containing endocrine disruptors and labeling elements are further defined.
For this hazard class, no hazard pictogram or warning word is prescribed, and labeling is done with hazard statements:
- EUH380: May cause endocrine disruption in humans. (for category 1),
- EUH381: Suspected of causing endocrine disruption in humans. (for category 2).
These statements are accompanied by proposed precautionary statements (P codes).
The regulation addresses other new hazard classes in the same manner.
Let's look at the transition periods for implementing new hazard classes: the application of new hazard classes will be mandatory after May 1, 2025 for substances, and after May 1, 2026 for mixtures.
For substances on the market before May 1, 2025, the deadline for new classification is November 1, 2026. For mixtures on the market before May 1, 2026, the transition period is May 1, 2028.
The amendments also include the addition or deletion of some precautionary statements (P codes) and changes to some classification criteria.
Significant is the introduction of new additional hazard information for mixtures containing titanium dioxide. Labels are prescribed for mixtures containing 1% or more titanium dioxide:
- EUH211: "Warning! Hazardous respirable droplets may be formed when sprayed. Do not breathe aerosol or mist." (for liquid mixtures, if titanium dioxide particles have a diameter of 10 µm or less),
- EUH212: "Warning! Hazardous respirable dust may be formed when used. Do not breathe dust." (for solid mixtures).
It is important to note that the List of Classified Substances has not been updated alongside the regulation changes and remains in its 2020 version.
You can find the regulation amendments on the website of the Ministry of Health and Social Welfare of the Republic of Srpska.
If you have questions about applying the new rules for chemical classification and labeling, feel free to contact me at nina.pajovic@bens-consulting.eu.
nina.pajovic@bens-consulting.eu
