Making available on the market and use of biocidal products

The Commission presents a report on the sustainable use of biocides pursuant to the 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 (‘the BPR’).

The objective of the BPR is to improve the functioning of the internal market whilst ensuring a high level of protection of human health, animal health and the environment. It was applicable from 1 September 2013.

The BPR covers 4 main groups of biocidal products themselves divided into 22 product-types ranging from disinfectants for human hygiene to embalming and taxidermist fluids, through in-can preservatives, insecticides, rodenticides and antifouling products.

The report is based on a preliminary study, which included a large survey of representatives from Member State Competent Authorities, industry and NGOs. It gives an overview of the findings of the study and shows how the BPR is contributing or can contribute to the sustainable use of biocides.

The main elements include:

• promotion of best practices to reduce the use of biocidal products;
• effective approaches for monitoring the use of biocidal products;
• best practices for integrated pest management principles (IPM) and use of biocidal products;
• risks in specific areas such as schools, workplaces, kindergartens etc.

The report also looks at the need to introduce additional measures, in particular for professional users, in view of reducing the risks posed to human health, animal health and the environment by biocidal products. It notes that the BPR has only been fully operational since 1 September 2013. This means that limited experience has been gained to date with the current legislation. However, the report draws the following conclusions:

Exclusion, substitution and comparative assessment: the exclusion and substitution criteria for active substances, and the comparative assessment for biocidal products containing active substance candidates for substitution, as provided by the BPR, provide very powerful mechanisms to phase out the use of substances of high and very high concern. In addition, this creates incentives to develop better alternatives. These mechanisms have not yet reached their full potential. Consequently:

• the completion of the on-going assessment of all the active substances that were already on the market when the BPD entered into force and the authorisation of biocidal products containing these active substances, must be the first and main priority with a view to promoting the sustainable use of biocidal products;
• Member States as well as industry need to concentrate their efforts and resources on substance approval and product authorisation. In addition, Member States will need to invest additional resources on enforcement activities to ensure that no product is illegally placed on their market and that biocidal products are properly labelled.

Additional measures to reduce the risks posed by biocidal products: the study concluded that the risks are already addressed appropriately by measures imposed through the conditions of approval of active substances or the authorisation of biocidal products.

• For professional users, the study concluded that the control measures applied under EU worker health and safety legislation as well as chemicals legislation combined with the risk mitigation measures specified at the stage of the biocidal product authorisation were sufficient – if adhered to – to address risk from exposure.
• Furthermore, due to the very diverse nature of biocidal products and the variety of applications, it does not seem appropriate to simply extend the scope of the Framework Directive on the Sustainable Use of Pesticides to biocidal products. Instead, the key objectives of that Directive in relation to biocidal products may be achieved through different means and more targeted actions.
• For the same reasons, extending the scope of the Machinery Directive to biocidal products does not seem appropriate either.

Dissemination of appropriate guidance or information: with regard to the means and targeted actions, the Commission considers that the correct, safe and sustainable use of biocidal products requires the availability and effective dissemination of appropriate guidance or information, whether that use be in a professional context or not:

• for industrial use, when the 'best available techniques reference documents' (BREFs) are developed under the framework of Directive 2010/75/EU on industrial emissions, best practice guidelines on the use of biocidal products should, where relevant, be incorporated;
• for professional use, developing guidance documents, providing training and certification of the users on application of best practices, go hand in hand;
• for non-professional use, the report emphasises the provisions on the authorisation and the labelling of the product. Technical solutions like smart tags or quick response codes (QR) providing a link to the authorisation holder’s website can be helpful to allow users to refer to specific product properties and use instructions.

Measures to be taken: the Commission will pursue the following actions, and invite Member States to do the same:

• focus and strengthen efforts on the review programme of existing active substances to ensure it is completed at the latest by end 2024;
• ensure that once active substances are approved, product authorisations are granted, amended or cancelled within 3 years;
• invest additional resources on enforcement activities;
• benefit from the legislative tools available, in particular by closely following the developments of BREFs that can be relevant for biocidal products used in industrial processes;
• encourage communication and awareness raising campaigns to inform end-users, through websites, in-store leaflets or videos, quick response codes on biocidal products, etc.;
• encourage the development and implementation of standards (e.g. under CEN) that could contribute to the sustainable use of biocidal products;
• welcome research initiatives on the sustainable use of biocides and alternatives to biocidal products.