Examining the approvals process for biopesticides

One of CHAP’s five strategic focus areas is Innovative Crop Health Strategies, a fundamental part of our Changing Perceptions campaign. The ethos of this campaign is to champion the benefits of novel plant protection products including biological solutions (bio-solutions) while helping to facilitate evidence and demonstrate the on-farm value of such products. CHAP Innovation Sector Lead Richard Glass discusses the approval process for biopesticides.

Biopesticides are becoming an integral part of integrated pest management (IPM) programmes particularly in the horticultural sector, and are likely to play an increasingly important role for crop protection within the arable sector.

The reliance on synthetic products is declining due to the continued withdrawal of active substances and an increase in cases of pest and disease resistance to commonly used pesticides. An example here is mancozeb – a multi-site fungicide for diseases such as potato late blight, which was withdrawn by the European Commission in early 2021. Continued use beyond 2023 would require approval by the UK regulator the Chemicals Regulation Division (CRD).


Under review

The approval of biopesticides follows the same procedure used for all plant protection products (PPPs), i.e. Regulation (EC) 1107/2009, which is currently being reviewed by the European Commission. There is now a “low-risk substance” category within the Regulation, which most biopesticides should fall into, allowing a faster approval process and approval being granted for 15 rather than 10 years. The approval of biostimulants in the UK is expected to follow the EU Fertiliser Regulation (EC) 219/1009 when it comes into force in 2022.

Product approvals are granted by the CRD on behalf of Ministers, using a set of important legislation criteria. Just like traditional PPPs, applicants looking for approval for biopesticides must provide evidence that their products are safe and effective before that approval can be awarded.


Criteria to consider

As detailed on the CRD’s website, there is a range of criteria to consider when submitting a biopesticide for approval.

  • Technical specification of the active ingredient(s), physical/chemical properties and storage stability
  • Mammalian toxicology
  • Residues: trial data for use on edible crops
  • Operator and bystander protection, is the product safe to use?
  • Ecotoxicology: the effect on the environment and non-target organisms
  • Fate and behaviour: how the product breaks down and if it persists in the environment
  • Efficacy and crop safety: proof of a consistent level of performance

It’s important to note that to carry out trials for research and development-related purposes for biopesticides, a permit must be obtained.


Product development

So although these products are classed as ‘natural’ there is a lot to be considered when developing them and bringing them to market. A useful application guide can be found here. The HSE also offers guidance, urging applicants to contact them in the early stages of product development to help ease the regulatory process.

Commonly used biopesticides in the UK contain entomopathogenic bacteria such as Bacillus thuringiensis and Bacillus amyloliquefaciens, used on crops such as strawberry and grapevine. The entomopathogenic fungi Beauveria sp. and Metarhizium sp. are commonly used in tropical and subtropical agriculture, with increasing interest in developing biopesticides for more temperate agriculture.


Risk models

The use of biopesticides often requires a more precise timing of application, which is where the development of risk models and early detection technology is seeing greater uptake. This evidence and best practice stewardship could prove favourable during the product registration process.

Proof of consistent performance and mass production may require new processes, particularly for the fungal organisms where spores need to be produced for the final product.

Another regulatory challenge will be ensuring the formulated biopesticide product has an adequate shelf-life. Products will need to show compatibility with co-formulants, and ultimately the application technology used in the field.


Looking ahead

It is clear that bringing new biopesticide products to market can be a complex and costly process. However, with the rapid decrease in available and effective synthetic products, we need to address how best to overcome existing hurdles to allow new biological products to enter the market.

That is why CHAP is aiming to ease the process with the development of a Biologicals Pipeline Accelerator and Demonstrator. To learn more about this go to Demonstrator, or watch our animated video.

To find out about our facilities relevant to this article, go to Fungal Biopesticide Development Lab and National Reference Collection. You can also read about our work to develop a biopesticide for cabbage stem flea beetle.


If you have any questions about working with CHAP, please send us an email using the enquiries form at the bottom of our homepage.

Please note, the opinions expressed in this article are the author’s own and do not necessarily reflect the views or opinions of CHAP.