The 18th International Akademie Fresenius Conference on the European Biocidal Products Regulation (BPR), which took place in Dusseldorf on 2 and 3 April, provided producers, importers and downstream users with an overview of what they needed to be aware of when assessing biocidal products and putting them through the authorisation process. The organiser was able to win the support of many internally-acclaimed experts from the authorities, the industry and consulting trade and the research sector for this event.
Whilst the parliament in London was busy debating whether to go ahead with the Brexit or not, the conference experts and participants took a look at the impact a possible Brexit may have on the regulation of biocidal products. Although the Brexit debate was a topic of major importance, the speakers did not fail to place other urgent topics currently under discussion in the limelight. This included reports from representatives from the EU Commission and the European Chemicals Agency (ECHA) on the latest developments to hit European Biocidal Products Regulation.
Biocidal Products Regulation (EU) No 528/2012 governs the making available on the market and use of biocidal products (BP). Additionally, it includes requirements for placing goods on the market that have been treated with biocides. This means that a large number of manufacturers and traders are actually affected by the provisions of the BPR.
Representatives from the industry question the priorities set when examining the endocrine disruptive effects of biocidal products
The EU wants to step up its efforts in the fight against endocrine disruptors (hormone-active substances). To achieve this, the EU has supplemented its Biocidal Products Regulation by setting down new criteria for detecting hormonal substances. These criteria have been mandatory since June 2018. Representatives from the industry and the national authorities discussed the impact and applicability of these criteria at the Akademie Fresenius Conference.
Sylvia Jacobi of the Albemarle chemical group described the way in which the authorities and the industry dealt with these new criteria six months after their coming into force as “learning by doing”. She said that examining substances for their endocrine disruptive effects cost a great deal of time and money - both from an industrial and governmental point of view. She also stated that the “weight of evidence” approach was a complicated one and did not make it easier to make decisions. In many cases, additional studies were required in order to provide a detailed analysis. Sylvia Jacobi questioned the priorities set by the authorities and the Expert Group of the European Chemicals Agency, ECHA, that supplies scientific opinions on the examination of endocrine disruptors. For example, consideration was only given to dose response later on in the authorisation process. Effects that are observed when extremely high doses are applied in an experimental system may possibly prove totally irrelevant when considering real-life exposure. As a result, Jacobi demanded that such substances should not be excluded from the market.
On the wish list: Uniform approach to interpreting data for determining endocrine disruptors
Stine Jensen, representing the Danish Environmental Protection Agency, also took stock of the first six months following the introduction of the EU criteria for endocrine disruptors. She explained that there had been challenges with the presentation of the data and how detailed the assessment should be conducted, but that the first ED assessment for a biocidal active substance would be ready for the Biocidal Products Committee (BPC) in June. She mentioned that endocrine endpoints were difficult to assess as a general rule and that, therefore, the main focus was currently on harmonising assessment within the Member States and the ECHA. Stefan Nave of Lanxess also criticised the fact that the limited experience in interpreting the endpoints so far gained by the applicants and the authorising bodies made it difficult to forecast whether a biocidal product would be authorised or not. All in all, the procedures were too complex, too expensive and data protection inadequate. Nave concluded from this that the number of active substances on the market would drop.
Challenges facing in-situ generated active substances
Helena Gräf of Ecolab dealt with the difficulties in creating dossiers for in-situ generated active substances. Despite the fact that new rules of procedure have now been made available by the European authorities, she stated that numerous questions remained unanswered - for example, concerning precursors and isolated cases. That led to misunderstandings and made harmonisation difficult. Dominik Altmann of the Environment Agency Austria also mentioned the fact that the rules of procedure were either still being developed or not clear enough. He recommended all applicants to closely follow the discussions and resolutions of the European working groups and to supply an exact as possible description of the in-situ system when submitting an application.
Substantiating claims: The more specific, the better. Validating biocides in treated articles will prove difficult
David Ashworth, consultant and biocides expert, provided the congress visitors with practical tips for wording efficacy claims. He supplied manufacturers with one golden rule. “The better I understand the performance of my product, the easier it is to prove that it is true.” Manufacturers should only make a claim, if it can actually be documented.
Treated articles pose a special challenge when drafting efficacy claims for biocidal products. Ashworth assumed that the industry would have to prepare itself for more complex descriptions and, as a result, for delivery delays. The requirements pertaining to biocidal products contained in treated articles were not yet final and should be viewed as “work in progress”, he concluded.
Die Akademie Fresenius GmbH
Die Akademie Fresenius GmbH