In recent times, we have noticed increased interest and concern from our clients regarding the compliance of safety data sheets with the requirements of Regulation No. 878/2020, which came into effect on January 1, 2023.
One of the areas drawing significant attention is endocrine disruptors and the inclusion of information in chemical documentation.
Endocrine disruptors are defined as chemicals that "may disrupt the endocrine system, consequently having harmful effects on humans and free-living animal and plant species." You can learn more about how endocrine disruptors affect our health in this article.
How do the aforementioned Regulation and endocrine disruptors connect?
With Regulation No. 878/2020, legislative changes have occurred, including new guidelines for listing hazards in Section 2, Section 11, and Section 12 of the safety data sheet. (A detailed overview of all changes brought by this Regulation can be found here).
In Section 2, point 2.3, Section 11, point 11.2, and Section 12, point 12.6, among other things, it is necessary to provide information on:
- whether the substance has been included in the list established in accordance with Article 59(1) of the REACH Regulation because it has properties of endocrine disruptors,
- whether this substance has been identified as having properties of endocrine disruptors.
Up to this point, everything seems straightforward. We simply look for the required information under the points specified by the Regulation.
However, life is never just black and white, is it?
In practice, it has already been shown that information about the properties of endocrine disruptors is often recorded as "No data." Can safety data sheets with such information be considered non-compliant with regulations?
My short answer is: No; we cannot generally claim that such safety data sheets are non-compliant with regulations.
Let me explain. Information about the properties of endocrine disruptors can be provided simply, for example, as:
2.3 Other hazards
Properties of endocrine disruptors: No data.
Or, more specifically:
2.3 Other hazards The mixture does not contain substances included in the list of substances with endocrine disruptor properties established in accordance with Article 59 of the REACH Regulation, in a concentration ≥ 0.1% w/w.
or
The mixture does not contain substances identified as having endocrine disruptor properties in accordance with the criteria of Commission Delegated Regulation (EU) 2017/2100 or Commission Regulation (EU) 2018/605, in a concentration ≥ 0.1% w/w.
In the case of endocrine disruptors, it is essential to understand that this information is in the hands of mixture manufacturers. Therefore, my advice is that in the absence of data in the above-mentioned points, you should contact them directly. Only then will you be certain of your situation.
For any additional questions regarding potential discrepancies in safety data sheets, feel free to contact me via email at spela.hudobivnik@bens-consulting.eu.
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