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Placing a biocidal product on the EU market is a two-step process outlined in the Biocidal Products Regulation No. 528/2012 (BPR) beginning with active substance approval. An active substance must be granted an approval decision for the relevant product-type(s) prior to obtaining BPR biocidal product authorisation (Figure 1).


Prior to the implementation of the BPR, the Biocidal Products Directive 98/8/EC (BPD), which was repealed and replaced by the BPR, had a fee structure which lacked in harmonisation across the EU. The arrival of the BPR saw a new role in biocides for the European Chemicals Agency (ECHA) with associated fees for industry to cover complete management and coordination demands of the BPR, for example, production of guidance documents and overseeing the peer-review aspect of regulatory submissions. Further, biocidal product authorisation application evaluation fees are payable to the Member State evaluating Competent Authority (eCA). The submission fees payable to ECHA are related to the overall management of biocidal product authorisation applications. Although the BPR came into force in 2013, some Member States have yet to publish their fees.


Biocidal product authorisation applies to the manufacturer, formulator, supplier or importer of a biocidal product. Applications for biocidal product authorisation must be submitted via the Register for Biocidal Products portal (R4BP 3). Information requirements for biocidal product authorisation can be found in Annex II and Annex III of the BPR.


Substance Approval: Biocidal Product Authorisation Budgeting


A Clear Cost Comparison of National Authorisation, Mutual Recognition and Union Authorisation Written by Orla Myers, Regulatory Scientist at The REACH Centre


There are a number of product authorisation routes available; National Authorisation, Mutual Recognition, Union Authorisation and Simplified Authorisation. These routes of authorisation can apply to single biocidal products, same biocidal products and biocidal product families. This review will compare the costs associated with single biocidal product authorisation via National Authorisation, Mutual Recognition and Union Authorisation. Each biocidal product authorisation has an associated expiration date and will require renewal after a maximum of 10 years. Fees applied by the EU and EEA eCAs are reviewed and discussed focusing on the variability of costs among Member States (Table 1 and Table 2). The data used in this review was extracted from the Member State CA websites, the 58th Competent Authority meeting ‘Report on Fees’ and the ECHA website. The information is publically available and this analysis was correct at the time of publication.


National Authorisation


Applications for National Authorisation must be made to the Member State of marketing in accordance with the rules and regulations within the BPR.


Figure 1. Placing a biocidal product on the EU market is a two-step process beginning with active substance approval followed by biocidal product authorisation.


Figure 2. Graph displaying variation in fees between National Authorisation and Mutual Recognition for the concerned Member States (CMS) in each Member State. The National Authorisation fee includes the biocidal product evaluation and annual fee (if any) and may be subject to additional fees of that Member State. Note that some Member States are not included as fees are currently undergoing review or are charged at an hourly rate (UK). The conversion rate on 28/09/2016 was used in this calculation.


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LUBE MAGAZINE NO.136 DECEMBER 2016


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