Unfortunately, the EU and UK are still lagging in understanding the difference between chemical pesticides and biopesticides. Dr Minshad Ansari, Founder and CEO, Bionema, UK shares an insight
Biopesticides are becoming more and more a major part of our daily lives, but they’re not necessarily getting easier or cheaper to register. Most people don’t realise that it takes an average of 5-10 years and £3-5 million in the EU compare to $300-400k registration and regulatory fee in the US.
So, how hard is it to obtain biopesticide registration for your new product?
SMEs are struggling to register biocontrol products due to an expensive and overly complex regulatory process. This guide offers the necessary insights for bringing your products to market, navigating the regulatory system with minimal fuss and expense.
Regulatory bodies
Before any pesticide can be used, sold, supplied, advertised, or stored anywhere in the world, it must be approved for use by the regulatory authorities in that country.
Applicants must provide evidence that their plant protection products (PPPs) are safe and effective before an approval can be issued. This includes biopesticides.
The term ’biopesticide’ refers to a broad range of possible PPPs. However, for most regulatory authorities’ systems, these are classified into four categories:
- Products containing a microorganism (for example bacterium, fungus, protozoa, virus, viroid)
- Products based on beneficial biocontrol agents (predators, parasitioids and nematodes
- Product-based on semiochemicals (for mass trapping includes pheromones)
- Products based on botanical extract (plant extracts)
In the EU, the European Food Safety Authority (EFSA) is the agency responsible for reviewing and approving new biopesticides, while in the UK. Approvals are granted by the Health & Safety Executive (HSE), and in the US the US Environmental Protection Agency (EPA) is responsible for new approvals. In these and other countries, approvals are subject to a range of specific pesticide-related legislations.
Regulation and legal background
The majority of pesticides are used as PPPs (Plant Protection Products). These products protect plants or crops from pests or plant diseases, and they are classified by the organism they are supposed to protect plants from herbicides, insecticides, fungicides, bactericides, nematicides and others.
In the EU (European Union), Regulation (EU) 1107/2009 sets the requirements for the authorization of PPPs. The EC (European Commission) assesses the active substance for human health and environmental safety.
When pesticides are sprayed according to Good Agricultural Practice, the MRL (Maximum Residue Level) will be set in line with Regulation (EC) No 396/2005 for food and feed.
Following the approval, the PPPs are authorised in each of the EU member states. The EC, EFSA, and ECHA (European Chemicals Agency) are the EU’s accountable authorities (European Chemicals Agency).
The EPA (Environmental Protection Agency) is responsible for regulating pesticides in the United States under the FIFRA (Federal Insecticide, Fungicide, and Rodenticide Act) and the FQPA (Federal Quality Pesticide Act) (Food Quality Protection Act).
The USDA (United States Department of Agriculture) and the FDA (Food and Drug Administration) set rules for the amount of pesticide residue that can be present in crops.
Alternatively, in the UK we have the Environment Agency and the HSE who regulate pesticide registration.
A key difference between requirements for the US EPA, compared with the EFSA and HSE in the EU and UK, is that the US EPA recognises that biopesticides are natural products, that they act differently to conventional chemical pesticides, and therefore the data required for registration of biopesticides in the US is markedly different to the data required for chemical pesticides.
Unfortunately, the EU and UK are still lagging in understanding the difference between chemical pesticides and biopesticides, and they treat both types of products very similarly – even though one is a chemical product, and the other is biological.
This makes the current EU and UK regulatory processes for new biopesticides overly complex, frequently requesting unnecessary or unsuitable data and adding unnecessary expense to the registration procedure.
Numerous efforts are already ongoing to address this issue. For example, the International Biocontrol Manufacturers Association has been struggling to gain traction in the EU for the past 25 years.
Much more recently, post-Brexit, the World Bioprotection Forum (WBF) has initiated its campaign for change in the UK. It is hoped that the WBF will achieve change in the UK within the next couple of years and that this success will make a significant contribution to IBMA’s ongoing calls for change in the EU.
—Dr Minshad Ansari, Founder and CEO, Bionema, UK
