30 changes after the CJEU ruling. The Council of Ministers' standing committee will deal with the amendment to the Biocidal Products Act

• The Standing Committee of the Council of Ministers begins at 11:00
• The Committee will deal with, among others, the draft amendment to the Biocidal Products Act (UC52), which was submitted by the Minister of Health. A total of 30 amendments are planned
• The planned date of adoption of the project by the Council of Ministers is the second quarter of 2025.
• Biocidal products are divided into four categories: disinfectants, preservatives, pest control and other products - antifouling, embalming and dissecting fluids

1. In order to implement the judgment of the Court of Justice of the European Union of 23 November 2016 in case C-442/14 Bayer CropScience SA-NV, Stichting De Bijenstichting v College voor de toelating van gewasbeschermingsmiddelen en biociden, it is proposed to amend the wording of the provision on making available documentation submitted in the procedure for issuing a permit for marketing a biocidal product by adding the reservation referred to in Article 18 of the Act of 3 October 2008 on the provision of information on the environment and its protection, public participation in environmental protection and on environmental impact assessments (Journal of Laws of 2023, item 1094, as amended). In order to clarify the applicable provisions of the Act serving the proper application of Regulation 528/2012, it is proposed:

• a change in the scope of information published in the Biocidal Products List by deleting the content of the packaging labelling in connection with the proposed replacement of the packaging labelling attached to the authorisation with recommendations on the use, dose or quantity expressed in metric units for the scope of use of the biocidal product;
• extension of the catalogue of cases that may end up being left without consideration by the President of the Office due to failure to provide the required information in the proceedings;
• in relation to the comparative assessment of biocidal products, supplementing the current Article 12 paragraph 2 of the Act by referring to Article 23 paragraph 7 of Regulation 528/2012 in order to indicate the method of concluding the proceedings specified in this provision. Thus, the possibility of revoking the authorisation in whole or in part will be indicated , regulating the situation when a biocidal product containing an active substance eligible for substitution does not pass the assessment positively;
• limiting the documents required to be submitted with an application for a marketing authorisation to a study report confirming the efficacy of the biocidal product, a letter of access (if applicable) and information on the name of the supplier of the active substance or the supplier of the biocidal product appearing on the list referred to in Article 95 of Regulation 528/2012;
• waiving the requirement to submit the content of the biocidal product packaging label and the safety data sheet together with the application and, at the same time, ensuring the consistency of the provisions of the Act regarding the obligation of the President of the Office to submit safety data sheets to toxicological centres with the obligations of entities and the competences of the President of the Bureau for Chemical Substances resulting from the amended provisions on chemical substances and their mixtures;
• enabling applicants to attach to the application literature data confirming the efficacy of the biocidal product in the event of a threat to public health that cannot be contained by other means, this applies in particular to crisis situations such as the COVID-19 pandemic, where the regulatory tools specified in Article 55(1) of Regulation 528/2012 have been used;
• a clear indication in the provisions of the Act of the presence of which active substances qualifies the product for registration in the national procedure . In order to ensure the comprehensiveness of the solutions adopted in Article 89 of Regulation 528/2012, it is proposed to add to Article 19 paragraph 1 point 1 of the Act the possibility described in Article 89 paragraph 2 letter b of Regulation 528/2012, i.e. the possibility of combining active substances approved and still in the review programme. Currently, Article 19 paragraph 1 point 1 included the possibility of issuing a marketing authorisation in the cases specified in Article 89 paragraph 2 letter a of Regulation 528/2012, but did not include the possibility described in Article 89 paragraph 2 letter b. The proposed amendment to Article 19 paragraph 1 point 1 of the Act will therefore include all the possibilities indicated in Article 89 paragraph 2 of Regulation 528/2012 relating to transitional measures applied under national law;
• replacing the packaging labelling content attached to the authorisation with recommendations for use, dose or quantity expressed in metric units for the scope of use of the biocidal product;
• streamlining the conditions under which a marketing authorisation is terminated or revoked or proceedings are discontinued . In particular, it is proposed to clarify the legal consequences in the event of failure by the responsible entities to comply with the statutory obligation to submit to the President of the Office information on the supplier of an active substance or a supplier of a biocidal product included in the list referred to in Article 95 of Regulation 528/2012;
• adding the right for the President of the Office to set a deadline for the submission by the responsible entity of additional data or information concerning the risk to human health, animals or the environment as a result of the use of a biocidal product. At the same time, it is necessary to add the possibility of revoking the marketing authorisation in the event of failure by the entity to submit the above data or information and in a situation where the information and data provided do not confirm the absence of a risk to human health, animals or the environment or fulfilment of the conditions specified in the marketing authorisation. Conducting administrative proceedings will enable precise determination of the risk and application of legal instruments to eliminate it, i.e. revoking or amending the existing marketing authorisation. Also for safety reasons and the need to update data concerning the responsible entity and the biocidal product itself, the possibility of revoking the marketing authorisation in the event of failure to inform the President of the Office of the data and circumstances that influenced the change of the conditions necessary for issuing the authorisation should be added to the draft regulations;
• sorting out issues related to the proper making available of biocidal products on the market , by clarifying the wording of the current Article 33 of the Act and indicating that a biocidal product should not only be labelled and classified in accordance with the provisions on chemical substances and their mixtures, but also packaged in accordance with these provisions. The above implements the provision of Article 2 paragraph 3 of Regulation 528/2012. In connection with the amendment of Article 33 of the Act, it will be necessary to repeal Article 31 of the Act duplicating information on product packaging. In connection with the repeal of Article 31, the references to the repealed article in Article 34 and Article 46 paragraph 1 point 2 will be deleted;
• clarifying that a change to the marketing authorisation for an active substance is a change consisting in adding or removing the active substance;
• clarification of the provision of Article 51 of the Act by indicating in paragraph 1 that the discontinuation of the proceedings for issuing a marketing authorisation , a change of the marketing authorisation or a change of the responsible entity may occur in the event of approval of the last active substance contained in the product, i.e. in a situation when all substances contained in the product have the status of "approved". In this situation, the Member State may no longer apply the national procedure for issuing authorisations for the making available and use of biocidal products, but procedures in accordance with the provisions of Regulation 528/2012. Consequently, proceedings pending on the date of issuing a decision not to approve the active substance contained in the biocidal product will be discontinued;
• clarification of the provisions on granting a period for using up stocks of a biocidal product in a situation where a marketing authorisation is changed, revoked or expires. In order to eliminate interpretational doubts, the draft provisions will explicitly indicate the possibility of granting a period for using up stocks of a biocidal product in the event of a change of the responsible entity;
• clarification of Article 35 of the Act, concerning the expiry of a marketing authorisation in the event of a decision of the European Commission not to approve a substance that is an active substance of a given biocidal product covered by that authorisation;
• clarification of the wording of Article 36 point 2 of the Act in accordance with Article 89 of Regulation 528/2012 in a way that takes into account the conditions for the expiry of a marketing authorisation in the event that an application for authorisation has been submitted no later than the date of approval of the last active substance;
• grouping the actions of the President of the Office into those undertaken in accordance with the terms of a decision not to approve a substance and an implementing regulation on the approval of a substance in order to properly apply the provisions of Article 89(2), subparagraph 2, in conjunction with paragraph 3 of Regulation 528/2012, relating to transitional measures for the making available and use of biocidal products. Issues relating to the deadlines for using up stocks of a biocidal product for which the authorisation has expired or been amended in accordance with the terms of a decision not to approve an active substance or has been expired or amended in accordance with the terms of an implementing regulation on the approval of a substance will also be regulated. Analogous issues will be clarified in the case of biocidal products for which all active substances have been approved;
• the need for changes in the area of ​​fees for the activities of the President of the Office undertaken in the scope related to the implementation of the provisions of Regulation 528/2012. The provisions were revised taking into account the guidelines indicated in Article 80 paragraphs 2 and 3 of Regulation 528/2012, including the specific workload of the authority. In Article 44 paragraph 2 point 1, it is planned to repeal letter h, referring to fees charged for the assessment of the completeness of the application for the repeal of a national authorisation, submitted in accordance with Article 49 of Regulation 528/2012, considering the above as an excessive burden for authorisation holders. The waiver of the above fee is to encourage authorisation holders to complete the formalities in the event that they cease to make a given product available, so that authorisations for biocidal products that are no longer made available in practice do not appear in the Biocidal Products List.

2. The catalogue of activities subject to a fee has been extended to include activities of the President of the Office performed in proceedings:

• concerning the amendment and renewal of the authorisation referred to in Article 26 of Regulation 528/2012;
• regarding changes to the EU authorisation;
• concerning the authorisation of the same product, in accordance with the provisions of Commission Implementing Regulation (EU) No 414/2013 of 6 May 2013 specifying the procedure for the authorisation of the same biocidal products in accordance with Regulation (EU) 528/2012 and Commission Implementing Regulation (EU) 2016/1802 of 11 October 2016 amending the aforementioned Regulation;
• concerning the amendment of Annex I to Regulation (EU) No 528/2012, in accordance with Commission Implementing Regulation (EU) No 88/2014 of 31 January 2014 laying down a procedure for amending Annex I to Regulation (EU) No 528/2012 of the European Parliament and of the Council concerning the making available on the market and use of biocidal products;
• concerning the notification of the placing on the market of a product belonging to the biocidal product family;
• concerning the notification of the placing on the market of a product for which an authorisation has been granted in another country as referred to in Article 26 of Regulation 528/2012;
• concerning the granting of a Union authorisation submitted in accordance with Article 55(2) or any amendment thereto;
• concerning the issuing of a Union authorisation submitted in accordance with Article 55(1) of Regulation 528/2012 or its amendment;
• concerning the issuing of a Union authorisation submitted in accordance with Article 55(3) of Regulation 528/2012 or its amendment.

3. In addition, the project assumes:

• expanding the list of acts subject to punishment specified in Article 46 of the Act by imposing sanctions for violating the provisions of Article 26 of the Act, for making available and using a product after its expiry date and for using a product contrary to the issued permit or marketing permit and parallel trade permit;
• adding a provision according to which in the event of a change in the duration of the work programme consisting in the systematic assessment of all existing active substances referred to in Article 89 paragraph 1 of Regulation 528/2012, the President of the Office shall ex officio amend the marketing authorisation to the extent concerning the adjustment of its validity period to the duration of the programme;
• clarification of the provision of Article 52 of the Act by indicating that marketing authorisations issued under Article 54 of the previously applicable Act become marketing authorisations within the meaning of this Act and remain valid until the date of completion of the work programme consisting in the systematic assessment of all existing active substances referred to in Article 89 paragraph 1 of Regulation 528/2012, taking into account, however, the provisions of Article 35 paragraphs 1 and 2 and Article 36 of this Act.

The project also specifies transitional provisions related to the changes introduced in the Act, enabling responsible entities and the President of the Office to adapt to the amended regulations.

Biocidal product means any substance or mixture, in the form in which it is supplied to the user, consisting of, containing or generating one or more active substances, the purpose of which is to destroy, deter, render harmless, prevent the action of or control harmful organisms by any means other than mere physical or mechanical action.

An active substance is a substance that acts on or against harmful organisms.

A product treated with biocidal products means any substance, mixture or product that has been treated with or has been treated with at least one biocidal product or intentionally contains at least one biocidal product. In practice, these may be textiles treated with biocidal products to ensure their durability and freshness or, for example, water-based paints protected against decomposition during storage. Unlike a biocidal product, the product is treated with it primarily to protect the product, not necessarily to have a biocidal function on the outside. A product treated with biocidal products with a primary biocidal function is considered a biocidal product (and therefore requires registration).

Biocidal products are divided into four categories:

• disinfectants,
• maintenance products,
• pest control,
• other biocidal products (antifouling, embalming and dissecting fluids).

Due to the fact that substances contained in biocidal products may pose a risk to humans and the environment, biocidal products are subject to evaluation and registration before being placed on the market.

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