No authority – no market: Mandatory bio-chemical regulation puts pressure on industry

No authority - no market: Mandatory bio-chemical 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 regulatory changes for real. It is clear: Biocidal products must have an authorization in accordance with harmonized requirements if you want to remain or enter the European market.

In other words: no authority – no market.

Manufacturers of biocidal products, however, come from a very diverse set of industries. As a result, the full impact of regulatory pressure in terms of time frame, workload and cost has been perceived very differently from industry to industry.

Here are the facts:
  • Around 20,000+ disinfection products to be authorized in the next five years
  • Time from start to end of authorization process: 1.5 years
  • An authorization is given for a maximum period of 10 years. Manufacturers have to apply for renewal about 1.5 years before it expires.

Requirements for the Disinfection Industry: Then and Now

One industry that is feeling regulatory pressure right now is the disinfection industry covering healthcare, food and feed, veterinary hygiene and personal hygiene. For a long time, the industry did not have to comply with harmonized regulations as work within the EU was heavily delayed. Furthermore, prior to the harmonization of regulations, 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 the application deadline for product authorizations approaching, the industry has been forced to take action not to lose market access. This is a major change in requirements and workloads, and the impact on the industry and the market is starting to show. Of course, it goes without saying that fewer products will be authorized and fewer market players will be left out due to the cost-intensive burden.

Why authorization application is such a big task

The level of data and documentation for authorization of biocidal products is based primarily on the exhaustive requirements known from the insecticide and pharmaceutical regimes. That is why preparing an application for an authorization is so demanding. The applicant must have the complete 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 because there was no such previous need for disinfectants. As a result, the data must be generated from scratch – and within a short period of time.

On top of the data requirements, applicants must prepare high quality exposure and risk assessments for human health and environmental impacts. Finally, applicants to the EU are required to report data and risk assessments in specific specialist formats such as IUCLID (Access Known) and PAR (Product Assessment Report).

In short, applicants must have in-depth skills and resources in analytical chemistry, efficacy, toxicity, and environmental toxicity to design successful biocidal products applications.

Where to start?

For small or medium-sized businesses, the task can seem overwhelming. What’s the best way to go about it? The most important thing is to start this process as soon as possible. Find out the exact formulation of your product and your requirement for further data. Then make it clear in which markets you want to sell your product. Also consider whether you want to present an authorization yourself or if you could benefit from doing it in collaboration with others. And of course, you should get an overview of estimated costs. Depending on your decision, there are various regulatory options you can pursue.

Michael Fink

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