12 December 2021, US: Biopesticides are becoming more and more a major part of our daily lives, but they’re not necessarily getting easier or cheaper to register. In fact, most people don’t realize 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.
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 the purposes of 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 USA 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 behind 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 own 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.
Some of the US and UK laws that govern pesticides
In order to navigate the regulations in any country or region, the first thing you need is a good lawyer who knows their way around the relevant regulations. They will save you both time and frustration in achieving your goals and getting your product registered as quickly as possible.
Here is a list of the various laws that apply in the US and UK – as you can see, there is considerable complexity in the current system!
The United Kingdom and Northern Ireland –
The United States –
ESA – Endangered Species Act
European Union and other laws –
- Regulation (EC) 852/2004 of the European Parliament and of the Council on the hygiene of foodstuffs
- Regulation (EC) 183/2005 of the European Parliament and of the Council on the hygiene of feed
- Carriage of Dangerous Goods and Use of Transportable Pressure Equipment Regulations 2004
- Chemicals (Hazard Information and Packaging for Supply) Regulations 2002 (CHIP)
- Clean Air Act 1993
- Conservation of Natural Habitats and of Wild Fauna and Flora 92/43/EEC (‘Habitats Directive’)
- Environment Act 1995
- Environmental Protection Act 1990
- Environmental Protection (Duty of Care) Regulations 1991
- Hazardous Waste Regulations 2005
As you can see by the sheer number of laws applicable, and how they are applied, it becomes is simply common sense to have legal representation to you in drawing up your application for biopesticide registration.
Likewise, talking to other companies who have been through the process several times for their own products, can give you important insights into the process and real-world experience.
If you would like to talk to one of our experts at Bionema, please reach out and we would be very pleased to educate you on the pitfalls and challenges you are likely to face in trying to get your product to market.
Checklist of requirements
If you are new to the registration process, here’s a helpful list of data requirements for all PPPs and their specific categories:
- All biopesticides must have an active ingredient.
- You must provide adequate directions on how to use the new product, as well as safety information (including in case of incorrect or excessive use; (examples include weed killer restrictions).
- Chemistry: including technical specification of the active ingredient(s), physical/chemical properties and storage stability
- Mammalian toxicology: toxicity to humans, product classification
- Residues: trial data for use on edible crops
- Operator and bystander protection: evidence that the product is safe to use
- Ecotoxicology: effect of the active/product on the environment and non-target organisms
- Fate and behaviour: effect of the environment on the active ingredient; breakdown products; does it persist?
- Efficacy and crop safety trials: proof of a consistent level of control/effect.
What is included in the application?
Once you are ready and your legal representative has approved your dossier for submission, It can be included in one of three categories:
- Register a new pesticide active ingredient
- Register a new product for an existing pesticide
- Register to add a new use to an existing product.
Typical applications also require the following additional items:
- Service fee(s) required by the Pesticide Registration Improvement Act (PRIA)
- Forms describing the requested action
- The identity and quantity of all chemicals in the product
- Data on potential risks to human health and the environment, including about the potential for pesticide residues on food (if applicable)
- Proof that the product manufacturing process is reliable
- Labelling, including directions for use, contents, and appropriate warnings
- Evidence of meeting all legal and financial obligations.
Reach out for help and advice
In conclusion, the time and effort you invest at the beginning, by doing your due diligence and speaking with a range of professional bodies and industry partners, can ensure you minimise your time and money spent on the registration of your new biopesticide.
At Bionema, we understand that the regulatory process of the system can seem complicated and confusing. Please feel free to call us to discuss your requirements and how best we can orientate you through this process.
Likewise, in the UK, you can also reach out to the HSE – the Health and Safety Executive will guide you if you are at the early stages of product development to ensure any work carried out can be considered in the light of regulatory requirements. This will ensure the most cost-effective way to gain approval in the UK.
Professional Bodies to contact to support you:
- HSE – Health and Safety Executive
- FDA – Food and Drugs Administration
- EPA – Environmental Protection Agency
- EA – Environment Agency
- EFSA – European Food Safety Authority
- ECHA – European Chemicals Agency
This kind of peace of mind is invaluable to securing your registration and not overlooking issues that will haunt you further on in your project.