Interview: "It can be expected that the application of biocidal active substances will continue to decrease"

Microbicide regulations remain a hot topic in the paint and coatings industry.
we have talked to Dr Annette Bitsch of Fraunhofer ITEM about the effects of active substances and research and development in this area.
current research and development focus on fungicides?
Annette Bitsch:
Based on increased awareness of climate protection, there is an increased demand for biological, natural and "green" products, but the efficacy of target organisms such as bacteria, viruses or fungi should be maintained . It is known that established active substances are CMR substances or substances harmful to the environment, such as persistent and toxic compounds that affect non-target organisms, and it is therefore necessary to identify new active substances or substitutes that have the same reaction to the target organism. Coatings will be of particular concern.
Annette Bitsch of the Fraunhofer Project.
"hot topic" on biocide research and development is the assessment of the damaging endocrine properties of all ingredients in the product, which is complex and requires a wide gap in data.
to avoid a large number of new animal tests, alternative testing strategies need to be developed and accepted, such as combining in-body and insotrophy assays with computer methods.
, it is important to take into account that the ED guidelines are applicable in most cases to active substances with large packets.
for most inactive substances, only limited data are available and new methods for inactive substances are needed.
, there is always a need to update the current default values and parameters to describe exposure scenarios for humans and the environment.
this has been treated primarily for product types representing major category 1: disinfectants and other major categories of individual PTs.
, however, there is still much research and work to be done on other PTs to better and more realistic assessment of potential risks to humans and the environment.
do you expect to develop and approve new active substances?
:
development of new bioactive substances will be a problem in the future, " bitsch said.
, especially in certain product types, no longer support many active substances or refuse approval status.
may be due to substance-specific properties or to stricter regulations.
these cases, only a few alternatives for specific purposes remain on the market.
, the continued reduction in the application of bioactive substances can be expected.
, however, the development of new active substances appears to be low due to the heavy workload, time frame and cost of developing them.
recent changes to the Biotaics Ordinance?
:
as mentioned earlier, endocrine assessment has become a new requirement in the Biocides Regulation (BPR, (EU) 528/2012).
7 June 2018, assessing the endocrine interference characteristics of all ingredients in the product becomes a new element of the data requirements.
this additional assessment and the increased workload of applicants and competent authorities, as well as the sterilization products committee, the assessment and authorization process has been expanded.
another point is the implementation of the concept of a bio-killing product line.
to allow applicants to submit more reliable and predictable applications and to limit the resources and time required to evaluate them to the extent possible.
of the discussion was to clarify the issue of "similarity" and to make recommendations.
ca documentation for the company was released in July 2019. In addition to these themes, the development and refinement of exposure scenarios (human/ecological environment) and efficacy guides are also under way.
are there regional differences in the regulation of microbicides?
Bitsch
that since BPR is a regulation, its implementation applies directly to the entire Eu union.
, BPR is the regulatory basis for all member states and provides regulatory guidance to applicants.
view, the differences between member states should be as small as possible.
, however, there were some differences in the cost and response of Member States and in the time required to assess the submission of data.
addition, some (smaller) local requirements may have to be met.
addition, only a few Member States serve as competent bodies authorized by the Union.
you will be the target of the European Coatings Symposium on 9 October 2019 in Amsterdam, the Netherlands.
participants expect from the workshop?
Bitsch
: For the workshop, several topics will be discussed.
, all participants will receive an introductory overview of BPR, including an introduction to the definition of fungicides and different types of fungicides.
In addition, participants will be introduced and discussed general regulatory aspects, such as efficacy assessments, exposure assessments, and current talking points and critical cases of regulatory discussions (e.g., products covered by regulations other than BPR).
interview with Vanessa Bauersachs
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