Use Limitations Imposed at Active Substance Level
At Kerona Scientific’s recent Biocide Symposium in March, Eléonore Mullier, Partner at Steptoe & Johnson, Belgium, outlined the use limitations imposed at active substance level under the Biocidal Products Regulation (BPR). Eléonore explained the challenges facing applicants whereby increasingly stringent conditions are being imposed on active substance (AS) approval and renewal decisions. These conditions are being applied to the approvals of treated articles and Biocidal Products (BPs), across all Product Types (PTs).
Eléonore provided examples of legal cases where substances have received non-approval decisions or where stringent conditions have been placed on authorisations. Many of these restrictions were based upon a lack of Risk Mitigation Measures (RMM) submitted for use in treated articles during the approval of the active substance. In the absence of such RMM data, BP authorisation may not be obtained based on the grounds of there being no safe use. Consequently, this has resulted in a significant limitation on the use in treated articles given that RMM data may only be submitted for assessment at the active substance stage and will not be evaluated during an application for BP approval. Similarly, non-approval decisions for BP treated articles have been observed based on a lack of efficacy data. Efficacy data must be provided for all claimed use of the BP, and therefore efficacy data on the active substance alone is not sufficient to support the use in treated articles but must be used in conjunction with efficacy data on the active substance when applied to the treated article, all submitted at the active substance level. This has hence restricted the approval of biocidal products where there is no efficacy data to support the use of the products in treated articles. The above examples have resulted in criticism of the current tiered approach to BP approval, where there have been claims that it is not realistic to expect that all potential use categories will be covered at the active substance approval stage, and that this approach does not support flexibility in the development of future BPs.
Eléonore then gave an account of how competent authorities have been holding various discussions to resolve some of these issues surrounding BP authorisations. One outcome of these discussions included a proposal by KEMI (the Swedish Chemicals Agency) to regulate all RMM at active substance level and to change the current regulatory approach of specifying forbidden uses of the active substance to specifying all allowed uses. Other suggestions include the introduction of an implementing act in support of article 58 of the BPR providing further guidance / direction on the RMM of treated articles under the BPR. However, it has yet to be decided whether the introduction of an implementing act such as this would be allowed under the BPR.
Eléonore ended the presentation by listing several legal provisions including Article 1(2)(e) BPR, Article 58(2) BPR, Article 58(3) BPR, Article 19(2)(b) BPR and Commission Delegated Regulation 2021/525 of 19 October 2020.
If you missed the Biocides Symposium, a copy of all the presentations is available on the Kerona website in the publications section here: https://kerona.ie/product/dublin-ppp-symposium-2023-speakers-presentations/
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