The Biocidal Products Regulation (BPR) entered into application in September 2013, repealing the older Biocidal Products Directive (BPD). As required by Article 65(4) of the BPR, the Commission, based on reports submitted by Member States on the implementation of the BPR in their respective territories, was required to draw up a composite report for submission to the European Parliament and to the Council. MCEC analysed and identified the main highlights from the report which covers the period until the end of 2019.
Overall, the Commission highlights that the ongoing work on the Review Programme – the work programme for the examination of existing biocidal active substances contained in biocidal products – is clearly affected by significant delays: at the end of 2019, only 35% of the related work had been completed. The cause of this delay is due to the falling number of evaluations completed by Member States and submitted to ECHA. As a consequence, the report reads that “the majority of the products on the market (several tens of thousands) still fall under national legislation, which are very diverse among Member States”. This creates uncertainty for the industry and goes in the opposite direction of market harmonisation, which is needed to ensure a competitive level playing field in Europe for the biocidal sector. In addition, the report argues that Member States do not respect the deadlines foreseen by the regulation for the product authorisation procedure, making the system more unstable and challenging for producers and importers.
In this context, it is worth noting that the document stresses the “relatively small market for biocides and its fragmentation and the small returns on investment”, which leads to “very limited innovation on new active substances under the BPR”, making the objectives of the BPR more difficult to achieve. This confirms the point raised by several stakeholders on innovation often being hindered by high regulatory costs and overly long procedures.
MCEC considers it fundamental for the BPR to become a harmonised tool among Member States for authorisation of biocidal products. This is a prerequisite to ensure the sound use of these products, upon which the report points out: “the importance of biocides, notably of disinfectants for human hygiene and surface disinfection, was particularly highlighted during the COVID-19 pandemic”. However, effectiveness of biocidal products could be undermined if different approaches are taken within the European market.
Finally, a consistent approach is needed with regard to enforcement of controls to ensure compliance of imported products with the BPR: “The compliance rate of the controls carried out by Member States in the reporting period vary greatly between Member States. Some Member States reported high compliance rates with the BPR rules for making products available on the market, while in others compliance rates were low”. This data is concerning, and MCEC welcomes the projects led by the BPR Subgroup of the Forum for the exchange of information on enforcement (BPRS) – the second one is expected to be operational in 2022.
MCEC members remain open to co-operate with Member States and European authorities to find the best solutions to fill the identified shortcomings of the BPR implementation.