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February 18, 2014

Annex I Approval of Active Substances under the EU Biocidal Products Regulation (528/2012)

The ACTA Group

The European Commission (EC) recently published Commission Implementing Regulation (EU) 88/2014, specifying a procedure for the addition of new active substances to Annex I to the Biocidal Products Regulation (BPR) No. 528/2012. BPR Annex I lists active substances that are considered “low concern.” Biocidal products utilizing only these active substances are eligible for the simplified authorization procedure in accordance with BPR Article 25.

Active substances placed on BPR Annex I are subject to low fees from Competent Authorities (CA), and do not require renewals. Annex I active substances may be subject to certain use restrictions, however. These restrictions are often common sense measures such as limiting the amount present in any single biocidal product to below the classification and labeling threshold.

Active substances used by small- and medium-sized enterprise (SME) companies are often of low concern. Such substances may be used as biocides by a variety of entities and industry groups, including food preparation and packaging, cosmetics, and pest control. While CA fees for Annex I inclusion of an active substance are low, SME companies may also benefit from a reduction of up to 60% of the fee, based upon the size of the company.

The UK Health and Safety Executive (HSE) has recently confirmed that the exemption for food and feed used as attractants and repellents given in Article 2(5)(a) of BPR, will shortly be amended to include only food and feed supplied as such, and that the interpretation of this exemption will not include food and feed sold in or with biocidal products, where the intention is to be used as an attractant or repellent. This means that all food and feed materials currently supplied as attractants or repellents would need to be approved as for any other active substance. Inclusion of such materials or microorganisms in Annex I of BPR will allow for continued supply of these products with minimal (if any) disruption to supply.

Information requirements for addition of an active substance to Annex I are listed in the Annex to Commission Implementing Regulation (EU) 88/2014. Rather than providing a list of testing requirements, applicants must provide a “robust consensus of expert opinion that the substance does not give rise to concern.” Emphasis is placed upon the use of existing and historical test and literature data on the active substance, as well as alternative information generation methods, such as quantitative structure-activity relationship (QSAR) models, in vitro studies, and read-across to analogue/homologues. Data from historical human use and conclusions of other regulatory authorities and frameworks may also be used to provide evidence of consensus of expert opinion. Active substances listed on Annex I are subject to the same data protection and cost sharing provisions as other approved active substances (in accordance with Article 59 of BPR). Due to the low testing requirements, the costs for the right to refer to an existing approval are likely to be low.

This implementing regulation forms the latest part of the continuing amendment and refinement of BPR. Further refinements are expected in the next six to 12 months.