26 February 2026

Big changes on biocidal products' labels

The Act of November 7, 2025 (Journal of Laws 2025, item 1716) amended the Act of October 9, 2015, on Biocidal Products (consolidated text: Journal of Laws 2021, item 24, as amended). The amendment is intended to streamline and harmonize national regulations – its primary goal is to more fully base national regulations on EU legislation, in particular:

Regulation (EU) No. 528/2012 (BPR),
Regulation (EC) No. 1272/2008 (CLP).

The key change concerns Article 33 of the Act, which regulates the classification and labeling of biocidal products.

New wording of Article 33 – end of national case law

Previously, Article 33 contained an extensive, detailed list of mandatory biocidal product labeling elements. The national legislator essentially replicated the content of Article 69(2) of the BPR, specifying the information required on the label.

After the amendment, the provision was significantly simplified. In its current wording, a biocidal product must be classified, labelled, and packaged in accordance with the issued marketing authorisation and the CLP regulations. The labelling must include the information specified in Article 69(2) of the BPR. Furthermore, the prohibition on the use of misleading terms such as "low-risk," "non-toxic," or "harmless" has been maintained.

Therefore, the national, detailed enumeration of label elements was abandoned, replacing it with a direct reference to the EU regulation. This represents a change in legislative technique—from a repetitive model to a cross-referential model—that strengthens the direct application of the BPR.

Practical implications for marketing authorisation holders

The amendment to Article 33 does not introduce new substantive obligations, but changes the manner in which they are anchored in law. From now on, businesses cannot limit themselves to analyzing national legislation – a direct interpretation of Article 69 of the BPR and the content of the issued marketing authorisation is crucial. In practice, this means that labels must be verified for full compliance with the BPR.

Additionally, the amendment of November 7, 2025, introduced clear rules regarding marketing authorisations issued before February 6, 2026.

Above all, these authorisations remain valid. There is no obligation to reapply for a decision or automatically adapt all authorisations to the new legal status. This ensures the continuity of marketing of biocidal products.

However, the amendment to Article 21, point 11 of the Act is crucial. In the new wording, this provision includes recommendations for the use of the product (including the scope of use, target organisms, method of use, doses, and frequency of application). Under the previous legal framework, these elements functioned in practice as part of the approved labelling content, which was attached to the authorisation.

Currently, the legislator more clearly distinguishes:

conditions of use specified in the marketing authorisation decision,
labelling obligations arising directly from Article 69(2) of Regulation (EU) No. 528/2012.

Consequently, an application to amend the data covered by Article 21(11) is submitted only if the change concerns the scope of data in the new wording of the provision. Therefore, there is no obligation to "rewrite" all labels solely due to a change in legislative technique.

At the same time, authorisations are subject to amendment under the new Article 27(1a), which means that any modification to the scope of use, dose, or method of use must be analyzed according to the new rules.

Change from March 6 – two, not three, types of users

A significant amendment to Article 6(3) of the Act comes into force on March 6, reorganizing the categories of users of biocidal products.

Previously, three groups existed in practice:

general user,
professional user,
trained professional user.

Following the amendment, the legislator retains only two categories:

general user (using the product for their own, non-profit needs),
professional user (using the product in professional or business activities).

The "trained professional" category has been removed from the national system. From the perspective of the market – particularly the PCO industry and entities using fumigants – this is a change of significant operational and documentary significance.

New regulations for particularly hazardous products

The amendment also introduces the provisions of Articles 6a and 45a, relating to the rules for making available on the market and using particularly hazardous biocidal products intended for fumigation, as well as violations in this regard. Although these require a separate, in-depth analysis, they should be viewed as part of the tightening of oversight of the most risky product categories.

Summary

The amendment of November 7, 2025, simplifies the structure of the Act and clearly shifts the regulatory burden to the direct application of the BPR and CLP. The most significant practical effects include the full basing of biocidal product labeling requirements on Article 69 of the BPR, a stronger link between the label and the content of the marketing authorisation, the elimination of the "trained professional user" category, and the retention of only two user categories from March 6. These changes are not purely editorial in nature — they require a thorough review of labels, regulatory documentation, and the distribution practices of marketing authorisation holders.

In the face of these changes, professional regulatory support is crucial. A comprehensive label audit, analysis of documentation compliance with the BPR, and the proper implementation of changes to authorisations help reduce administrative risk and ensure safe market continuity. It is worth considering the amendment not only as an adjustment obligation but also as an opportunity to streamline processes within your organization. We encourage you to contact PICTOPLAN; we can manage together!