Interview: “An on-going decrease of biocidal active substance applications can be expected”
Where does research and development currently focus in biocides?
Dr Annette Bitsch: Based on the raised awareness of climate protection, the demand on biological, natural and “green” products has increased. However, the efficacy against target organisms, like bacteria, viruses or fungi, should be maintained simultaneously. Some of the established active substances are known to be CMR substances or environmental hazardous, like persistent and toxic compounds affecting non-target organisms. Thus, there is a need to identify new active substances or alternatives with the same response to target organisms. Especially the development of new coatings will be of special interest.
Another “hot topic” regarding research and development of biocides is the assessment of endocrine-disrupting properties of all ingredients in a product. The assessment is quite complex and there is a huge gap of data which are required for the assessment. To avoid an immense number of new animal tests, there is a need to develop and accept alternative testing strategies, like a combination of in vitro and ex vivo assays and in silico methods. In addition, it needs to be taking into account that the ED guidance is in most cases applicable to active substances with a big data package available. For most non-active substances only limited data is available, therefore new approaches for non-active substances are needed.
In general, there is always a need to update current default values and parameters to describe the exposure scenarios for humans and the environment. This was already done mainly for the product types representing the main group 1: disinfectants and for individual PTs of other main groups. However, there is still a lot of research and work to be done for the other PTs to get a better and more realistic assessment of the potential risks for humans and the environment.
Dr Annette Bitsch, Fraunhofer ITEM, will be giving the European Coatings Seminar Biocides on October 9 in Amsterdam.
Do you expect further new active substances to be developed that will receive approval?
Bitsch: In our opinion, the development of new biocidal active substances will be an issue in the future. Especially in some product types, where many active substances are no longer be supported or the approval status is rejected. This might either be due to substance specific properties or due to stricter regulations. In these cases, only few alternative products for specific uses are left on the market. Thus, an on-going decrease of biocidal active substance applications can be expected. However, as the workload, timeframe and costs for the development of new actives are immense the activities for new active substance development seem to be rather low.
What have been recent changes to the Biocides Ordinance?
Bitsch: As already mentioned the endocrine assessment became a new requirement for the Biocidal Products Regulation (BPR, (EU) 528/2012). Since 7th June 2018 the assessment of endocrine-disrupting properties of all ingredients in a product became a new part of the data requirements. Due to this additional assessment and the increased workload of the applicants and the competent authorities as well as of the Biocidal Products Committee, the evaluation and authorisation process is extended.
Another point is the implementation of the concept of biocidal product families. The intention is to allow applicants to submit more robust and predictable applications and limit as far as possible the resources and time required to evaluate those applications. The main discussion point was to clarify the issue of ‘similarity’ and to provide recommendations. The corresponding CA document was published in July 2019. Beyond these topics the development and refinement of exposure scenarios (human/eco) and efficacy guidelines are continuously ongoing.
How much regional variation is there in the regulation of biocides?
Bitsch: As the BPR is a regulation, the implementation applies directly within the whole EU. Therefore, the BPR is the regulatory basis for all member states and gives regulatory guidance to the applicants.
From this point of view, the variations between the member states should be as small as possible. However, the member states show some variation in cost and the time taken for the response and the assessment of submitted data. In addition, some (minor) local requirements may have to be met. Furthermore, only some member states take over the role as competent authority for Union Authorisations.
You will be the referent for the European Coatings Seminar Biocides on October 9 in Amsterdam, the Netherlands. What can participants expect from the seminar?
Bitsch: For the seminar, several topics will be addressed. In the beginning, all participants will get an introductory overview of the BPR, including the definition of a biocide and an introduction into the different biocidal product types. In addition, regulatory aspects in general like efficacy assessment, exposure assessment, as well as current discussion points and borderline cases (e.g. products which are also covered by other regulation than the BPR) of the regulatory assessment will be presented and discussed with the participants.
Interview by Vanessa Bauersachs