The European Commission has issued a report providing an overview of current applications for Union Authorisation of biocidal products.
Union Authorisation, a concept introduced by the Biocidal Products Regulation (EU) 528/2012 (the BPR), aims at facilitating the making available on the market throughout the EU of certain biocidal products with similar conditions of use in all Member States. Applications can be submitted under Article 43 of the BPR or under Article 4 of the Same Biocidal Products (SBP) Regulation (EU) 414/2013.
According to the report (which is available here), a total of 115 applications for Union Authorisation had been submitted by the end of 2017: 70 under Article 43 of the BPR, and 45 under the SBP Regulation. So far, no decisions on authorisation have been made, although 3 applications have gone through validation and evaluation by the evaluating competent authority and are now at the ECHA-level peer-review stage. Of the 70 applications under Article 43, some 41 were submitted to the Netherlands, with the rest being distributed among 8 other evaluating competent authorities.
Half of the applications under Article 43 of the BPR required more than 6 months for the validation step, and the Commission suggests that this time could be reduced by the applicants better preparing the dossier and checking its completeness before submission, and by the evaluating competent authorities avoiding any assessment of the quality or adequacy of the data submitted until the evaluation step.
Over 80% of the applications were for authorisation of biocidal product families rather than single products, and 85% of applications were intended for more than one product type. About 49% of applications were for disinfectants, while another 45% were for products with combined uses as disinfectants and preservatives. The most common active substances in the applications were peracetic acid, hydrogen peroxide, CMIT/MIT, and propan-2-ol.
The report also found that about 21% of the applicants are small or medium enterprises (SMEs), which is significantly lower than the proportion of SMEs active in the biocides sector.
If you have any questions about authorisation of biocidal products or other regulatory issues, please email the Kerona Scientific team at firstname.lastname@example.org or contact us on +353 1 849 5284. Further information on the BPR is available in our BPR Vademecum.