A new report on the compliance of biocidal products within the European Union reveals alarming insights into the industry's adherence to regulations. The findings, which emerge from the latest enforcement project, "BEF-2," highlight significant issues in product authorisation, labelling, chemical composition, and overall regulatory compliance.
Widespread Non-Compliance in Authorisations
The report indicates that only 79% of inspected EU biocidal products meet the authorisation requirements, a critical factor for safe product use. Alarmingly, this compliance rate has not improved over the past 15 years, pointing to a persistent challenge in the industry.
Despite compliance with national language requirements, the report found technical information on labels, such as exposure time, often lacking. More concerning is the high prevalence of misleading labels, a trend unchanged since the EuroBiocides 2008 project. Additionally, 42% of biocidal product advertisements were found non-compliant, failing to provide essential safe use information.
Chemical Analysis Uncovers Deviations
The report also sheds light on chemical composition, revealing that around 25% of biocidal products deviated from their stated concentrations of active substances, raising questions about product efficacy and safety.
Reflecting on the 18% non-compliance rate in biocidal products, the report notes that these deficiencies led to various enforcement actions, ranging from verbal advice to criminal prosecutions. The report recommends regular updates on the ECHA website regarding substances and authorised products, urging the industry to enhance legal awareness. It also calls for continued Member State training and campaigns to improve knowledge of the Biocidal Products Regulation (BPR).
Products Investigated
The key product types investigated included:
Disinfectants: A significant portion of the chemical analysis (56%) was conducted on disinfectants, specifically those falling under product types 1, 2, and 4. These types represent common biocidal products used for sanitation and hygiene purposes.
General public use products: The majority of non-compliant biocidal products lacking authorisations belonged to product types 2, 18, and 19. These product types are typically intended for use by the general public, suggesting a direct impact on consumer safety and public health.
Varied biocidal products: Overall, the non-compliant products inspected in the BEF-2 project were mainly from product types 1, 2, 18, and 19, indicating a range of biocidal products with major deficiencies in terms of authorisations, active substances, labelling, and advertisement.
Overall evaluation of BEF-2 findings14
| Topic |
Result |
| Non-compliant biocidal products lacking authorisations |
Poor |
| Presence of allowed active substances in biocidal products |
Good |
| Chemical analysis and correctness of active substance concentrations |
Poor |
| Labels in national languages |
Good |
| Labelling requirement in line with Article 69(2) points a) to o) of the BPR |
Medium |
| Misleading labelling |
Poor |
| Advertisement requirements indicating the obligatory phrase ‘use biocides correctly [..]’ |
Poor |
| Misleading advertisement |
Poor |
| Compliance with Article 95 |
Good |
Recommendations
ECHA’s Website
The European Chemicals Agency (ECHA) website, a key resource for national inspectors, is highlighted for its role in disseminating vital information on active substances and authorised biocidal products. Regular updates on the ECHA website, especially regarding the status of active substances, are deemed essential.
Industry's Role in Compliance
The report emphasises the need for the industry to bolster its understanding and awareness of legal responsibilities. With a notable number of biocidal products exhibiting deficiencies, the industry is identified as a crucial player in driving improvements. The report underscores the importance of the industry's proactive involvement in ensuring the safe availability of biocidal products in the EU market.
Member States' Responsibilities
Member States are called upon to continue providing training and information campaigns to National Enforcement Authorities and the industry. This initiative aims at enhancing their knowledge of Biocidal Products Regulation (BPR) requirements. Furthermore, the report stresses the need for general knowledge among Member States about biocidal products and active substances to be regularly updated.
Collaboration for Review Programme Conclusion
The BEF-2 report highlights the significant role of Member State Competent Authorities, the European Commission, and the industry in concluding the review programme of active substances. The report points out the challenges arising from the coexistence of the BPR and transitional authorisations, which lead to difficulties in harmonising enforcement actions across the EU and create an uneven playing field for companies. The collaborative efforts of these entities are deemed crucial for resolving these issues and ensuring a safer and more compliant biocidal product market.
The findings of the BEF-2 report underscore the pressing need for improved compliance and regulation in the biocidal product sector. With recommendations aimed at both the industry and regulatory bodies, the report serves as a wake-up call for a safer market and level playing field within the EU.
