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EU Biocidal Products Regulation under scrutiny
In July of this year, the first Implementation Dialogue on Biocides took place in Brussels. This was a series of discussions initiated by EU Commissioner Olivér Várhelyi, involving manufacturers, users, and representatives of civil society, regarding the implementation of the EU Biocidal Products Regulation (EU) 528/2012. Dr Anette Rose, Kurt Obermeier, participated in the dialogue as industry representatives. In an interview with European Coatings, she shares her impressions of Brussels and outlines the specific challenges that the current regulations present to paint manufacturers.
As a representative of the paint and printing ink industry, you attended the first Implementation Dialogue on Biocides in Brussels. What were your expectations of this dialogue beforehand?
Dr Anette Rose: The Commission launched the Implementation Dialogue format to hear the views of all stakeholders affected by the implementation of European legislation. Kurt Obermeier is a medium-sized company that manufactures wood preservatives and uses other biocidal products such as film preservatives and pot preservatives. We were delighted to be able to represent the paint and printing ink industry in Brussels.
Can you explain the main points of discussion in the dialogue in more detail? What topics were the focus of the talks between Commissioner Várhelyi and the participants?
Rose: The Commission structured the dialogue around three key questions, on which all participants commented. The focus was on the considerable delays in the review programme caused by extremely lengthy procedures for the evaluation of active substances and biocidal products.
The EU Biocidal Products Regulation 528/2012 is to be evaluated. From the perspective of the coatings and paints industry, where do you see the biggest weaknesses in the current regulation?
Rose: Like the industry as a whole, the coatings and printing inks industry is facing increasingly demanding data requirements and lengthy procedures with unpredictable outcomes. In addition, our industry is advocating a return to risk-based assessments. The Biocidal Products Regulation (BPR) has established models for risk assessment for humans and the environment, which we believe are a suitable instrument for achieving the protection goals.
Long time-to-market and high regulatory costs have been cited as factors that inhibit innovation. Can you specify how these problems affect paint manufacturers in practice?
Rose: In the area of active ingredients, we have been observing a decline in the available options for film protection and pot life preservation for years. Due to the high risks involved in the approval of new active ingredients, there are hardly any new developments in this area. Paint manufacturers are managing the shortage and have to adapt their product developments to the limited options available. The approval of biocidal products, in our case wood preservatives, is becoming increasingly difficult and involves considerable risks for companies. This represents a significant barrier to innovation.
The review programme for existing active substances is being significantly delayed. What impact does this delay have on the availability of preservatives for water-based coating systems?
Rose: Existing active substances that are undergoing the evaluation process remain available on the market. However, new hazard classes such as endocrine disruptors and stricter classifications often lead to restrictions on use. This makes it necessary to reformulate existing coating systems.
How are manufacturers dealing with the uncertainty of whether the active substances they currently use will remain available in the future?
Rose: Manufacturers are monitoring the ongoing procedures very closely so that they can respond to any possible tightening or restrictions.
Data protection was cited as an important factor for investment and innovation. How do you assess the current regulations on the protection of study data for biocides in comparison to other chemical regulations?
Rose: The deadlines for data protection for studies used in the review programme should be adjusted to the extension of the review programme. Commissioner Varhelyi has announced an initiative for 2025, and we expect the new regulations to be published this week.
How do you assess the European Commission’s willingness to actually make substantial changes to the Biocidal Products Regulation?
Rose: The Commission has signalled that it has recognised the problems. It remains to be seen whether this will result in substantial changes. The political will is there, but implementation will be complex.
Do you see opportunities for genuine simplification, or will it be more a case of cosmetic corrections?
Rose: I expect selective adjustments rather than fundamental reform. Genuine simplification would be desirable, but experience shows that regulatory systems are rarely radically changed.
