The Ministry of Health will simplify regulations regarding the registration of biocidal products

• On September 9, the first reading of the government bill amending the Act on Biocidal Products took place in the Parliamentary Health Committee.
• The project will contribute to the stabilization and consolidation of the current system for making biocidal products available on the Polish market - said Aleksandra Wilczyńska, vice-president of the Office for Registration of Medicinal Products, at the meeting.
• The Health Committee adopted the draft law

The draft amendment to the Biocidal Products Act is primarily aimed at implementing the judgment of the Court of Justice of the European Union of 23 November 2016. The judgment concerned the release of plant protection products and biocidal products into the environment. The amendment will apply to Article 30 of the aforementioned Act, which concerns the disclosure of documentation submitted in the procedure for issuing a permit to trade in biocidal products. Currently, the Act requires a mandatory demonstration of a legal interest in obtaining such information.

"This could significantly limit the right to obtain information regarding environmental emissions. (...) The bill amends Article 30 of the Act by adding a provision that information about the environment and its protection (...) is made available without the need to demonstrate a legal or factual interest," explained Aleksandra Wilczyńska, Vice President of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products.

The amendment is also intended to clarify the provisions for the proper application of the Regulation of the European Parliament concerning the making available and use of biocidal products on the market, as well as to simplify the existing Act.

"The draft has a significant deregulatory impact. We see a need to simplify the provisions of the act, including those related to the registration of biocidal products, including documentation requirements, the scope of data covered by marketing authorizations, and clarification of the provisions regarding the validity periods of marketing authorizations, as well as the rules of conduct in the event of a change in the duration of work involving the systematic assessment of active substances used in biocidal products," indicated Aleksandra Wilczyńska.

What changes has the ministry proposed?

• Waiver of the requirement to submit the contents of the biocidal product packaging and a safety data sheet with the application (the waiver of submitting the safety data sheet will be effective from 1 January 2031).
• Replacing the packaging content previously attached to the permit with recommendations regarding the scope of use of a given biocidal product
• Clarification of procedures for dealing with public health emergencies: applicants will be able to attach data from the scientific literature confirming effectiveness to their applications. This will be particularly relevant in unprecedented crisis situations, such as the COVID-19 pandemic.

- The project will contribute to the stabilization and consolidation of the current system for making biocidal products available on the Polish market - added Vice President Wilczyńska.

The draft law was adopted by the Commission.

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