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Biocidal products: International Fresenius conference discusses the current legal situation and latest authorisation developments

The EU Regulation on Biocidal Products (BPR, Regulation (EU) No. 528/2012) has been in force for just under four years. The objective was to enable the biocidal product market to function better whilst simultaneously guaranteeing a high level of health and environmental protection. Accordingly, the need for talks and discussions between the authorities, the industry and consumer protection organisations on how to implement this regulation is great. Currently, the discussions are focused on the advantages of a Union-level authorisation which allows companies to market their biocidal products throughout the Union without having to obtain specific national approval. The question of how to deal with endocrine disruptors is one that stirs people’s emotions. On 6 and 7 April, an international conference staged by Akademie Fresenius in Düsseldorf provided a wealth of practical tips for producers on how to compile dossiers. It also highlighted legal and regulatory issues. The organiser was able to win the support of 17 acclaimed experts from the authorities, the industry and the research sector for this event.

Paloma Lopez of the European Chemicals Agency (ECHA) in Helsinki provided an overview of the latest and upcoming legislation changes. Helena Ufelmann of Ecolab looked at the status of the EU-wide authorisation process for biocides from an industry perspective. She explicitly welcomed the harmonisation approach. She said that in the end the consumers would also benefit: They would be able to better understand and compare the usage and effects of biocidal products once the same labelling obligations and assessment criteria applied throughout the EU. She also noted that the industry was prepared to collaborate on improving the authorisation process across Europe. “To date, our experience has been of a highly positive nature, apart from the administrative effort involved which could actually be reduced, if we were to exploit our most recent experiences.” Ufelmann views the “Same Biocidal Products Regulation” (SBP), which came into force last year, as a good example of how to improve the process. This regulation gives due consideration to the needs of small and medium-sized companies. It makes it easier to apply for national authorisation of identical products, if the reference product has already been authorised by the Union. Ufelmann considers the SBP to be a great example of how the law-making process can facilitate the practical implementation of the Biocidal Products Regulation.

Industry interested in consistent implementation

Jack Poppleton of Lonza Wood Protection (Great Britain) emphasised the importance of implementing the regulation. In his presentation, he took a look at the requirements, mechanisms and advantages of a strict application: “Companies that act in compliance with the regulations have made huge investments which is why they are interested in ensuring that these efforts are accordingly protected. One of the main pillars of the Biocidal Products Regulation is its innovative capability. And if that is the case, the industry needs to be adequately protected in order to be confident that their investment in innovations is also accordingly rewarded.” 

It is up to the EU Member States to implement the regulation. Poppleton regards the fact that it is at the discretion of the States to decide how to enforce the regulation as problematic. Up until now, there has been more talk about enforcing the implementation than actual action. The enforcement structures within the different countries vary considerably as opposed to what is really required: Central coordination, greater awareness of this topic and a consistent and transparent set of rules for enforcing penalties. 

The companies concerned have a lot to lose. Poppleton calculated that the cost of getting an active substance approved could amount to well over four million Euros. The cost of getting approval for a product licence could be anything up to one million. On top of this, there are salaries for internal experts and fees for external advisers to consider. Poppleton criticised the fact that the costs incurred as a result of the BPR had a negative impact on profitability and, thus, on the innovative strength of whole industrial sectors. This makes enforcing the BPR all the more important: To prevent unfair competition and sustain innovative capacity within the industry.

Under discussion: Dealing with endocrine disruptors

Andy Adams of Bayer Crop Science highlighted the EU’s plans for dealing with endocrine disruptors (ED). Endocrine disruptors include both natural and chemical substances that may modify hormone system functions or have negative effects on humans and/or animals. In June 2016, the European Commission presented two draft bills designed to allow EDs in pesticides and biocides to be more precisely identified based on scientific criteria. On 28 February, the Standing Committee on Plants, Animals, Food and Feed met in Brussels to discuss the proposals made by the European Commission. However, to date there has been no vote on the subject. The next biocides meeting is scheduled for April 7. Andy Adams reported that the exact wording of the criteria was still being intensively discussed. “We need clarification because the consequences will have a significant impact”, Adams stressed. He said that the topic of endocrine disruptors was a very emotional one. Curbing the number of hazardous substances was, of course, an option. “But that shouldn’t become an obsession, especially when there are so many chemicals around that are of significant and essential benefit to both health and the environment – and where there are ways of applying these safely.” For example, there are innovative new ways of reducing the risk through new formulas and delivery systems which minimise exposure, Adams stated.

In situ generated active substances – need for clarification 

Michael Werner, chemist and toxicologist and consultant for the Dr. Knoell Consult company, provided practical tips for compiling dossiers for active biocidal substances that are generated in-situ. Contrary to the old Biocide Directive, the Biocidal Products Regulation incorporates the generation of active substances using precursors. Biocidal active substances are described as being “in situ” (“generated in the same place”) when they are created from one or several precursors at the point of application. The approval of such substances requires the assessment of the active substance generated as well as the precursors from which it was produced – within the context of the respective product type.

This means that an in situ-generated biocide may only be used, if its combination of active substance and precursor has been approved and accordingly authorised. These substances as a whole then become a permanent part of the in situ system and need to be accordingly documented. Werner drew the attention of the audience to a number of unresolved issues. For example, there is uncertainty with regard to the question of how much data is required for in situ-generated active substances and the precursors used to generate these substances. Clear guidelines still need to be developed. 

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