No authorisation – no market: Mandatory biocidal regulation puts pressure on industry

With the ongoing implementation of the EU Biocidal Products Regulation (BPR), industries dealing with biocides in their products are feeling the regulatory changes for real. It’s clear-cut: If you want to stay on or enter the European market, biocidal products must have an authorisation in accordance with the harmonised requirements.

In other words: No authorisation – no market.

Manufacturers of biocidal products, however, come from a very diversified group of industries. Consequently, the full impact of the regulatory pressure in terms of deadlines, workload and costs has been perceived very differently from industry to industry.

Here are the facts:
  • Approximately 20,000+ disinfection products to be authorised in the next five years
  • Time from start to finish of authorisation process: 1.5 years
  • An authorisation is granted for a period of maximum 10 years. Manufacturers must apply for renewal approximately 1.5 years before it expires.

Requirements to the disinfection industry: Then and now

One industry feeling the regulatory pressure right now is the disinfection industry covering healthcare, food and feed, veterinary hygiene and private hygiene. For a long time, this industry did not have to comply with the harmonised rules since the work was heavily delayed within the EU. Furthermore, before harmonisation of the rules, most EU countries had very few regulatory requirements, mostly in the form of minor notification schemes or similar. As a result, disinfection manufacturers were accustomed to easy market access.

But with application deadlines for product authorisations approaching, this industry has been forced to take action in order not to lose market access. This is a major shift in requirements and workload, and the impact on the industry and the market is starting to show. Of course, it goes without saying that fewer products will be authorised and fewer market players will be left due to the cost-intensive burden.

Why an authorisation application is such a huge task

The level of data and documentation for authorisation of biocidal products is based mainly on the exhaustive requirements known from the pesticides and pharmaceutical regimes. This is why preparing an application for an authorisation is so demanding. The applicant needs to have a full set of data for the biocidal product. This includes data on physical and chemical properties, analytical data, efficacy data, toxicological data, ecotoxicity and fate data. Many of these data do not exist since there were no such previous requirements for disinfectants. As a result, the data must be generated from scratch – and within a short time span.

On top of the data requirements, applicants must prepare high-quality exposure and risk assessments for human health and environmental impacts. Finally, the EU requires applicants to report data and risk assessments in specific expert formats such as the IUCLID (known from REACH) and the PAR (product assessment report).

In short, applicants must possess in-depth skills and resources in analytical chemistry, efficacy, toxicity and eco toxicity to prepare successful biocidal products applications.

Where to begin?

For small or medium-sized businesses, the task may seem overwhelming. What is the best way to go about it? Most importantly, start the process as early as possible. Ascertain the exact formulation of your product and your requirement for further data. Then make it clear to which markets you want to sell your product. Consider also if you want to submit an authorisation on your own or if you may benefit from doing it in collaboration with others. And of course, you should get an overview of the estimated costs. Depending on your decision, there are different regulatory options you can pursue.

 

About the author

Michael Fink
Michael Fink
Sales Manager, Environment and Toxicology, DHI Denmark | Michael is the biocidal regulatory expert at DHI and supports the industry in obtaining authorisations of insecticides, disinfectants, antifouling products and preservatives. He has also successfully supported clients that work with in-situ generated biocidal active substances to obtain cost-efficient authorisations. Michael has profound experience in performing toxicological risk assessments, human exposure scenarios and efficacy for dossiers on biocides. In addition, his experience includes management of industry consortia and he is highly skilled in communicating with regulatory bodies.

Author: Michael Fink

Sales Manager, Environment and Toxicology, DHI Denmark | Michael is the biocidal regulatory expert at DHI and supports the industry in obtaining authorisations of insecticides, disinfectants, antifouling products and preservatives. He has also successfully supported clients that work with in-situ generated biocidal active substances to obtain cost-efficient authorisations. Michael has profound experience in performing toxicological risk assessments, human exposure scenarios and efficacy for dossiers on biocides. In addition, his experience includes management of industry consortia and he is highly skilled in communicating with regulatory bodies.

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