Biopesticides and the Biopesticide Scheme
Before any pesticide can be used, sold, supplied, advertised or stored it must be approved for use.
Biopesticide' covers a wide spectrum of potential products used as plant protection products (PPP), but for the purpose of our Biopesticide scheme these are divided into four categories:
- products based on pheromone and other semiochemical (for mass trapping or trap cropping)
- products containing a microorganism (for example bacterium, fungus, protozoa, virus, viroid)
- products based on plant extracts
- other novel alternative products
Approvals are granted by HSE on behalf of Ministers under a range of specific pesticide related legislation.
Applicants must provide supporting evidence that their PPPs are safe and effective before an approval can be issued. This includes biopesticides. Following a pilot, the ‘Biopesticides Scheme’ was launched which offers reduced fees for biopesticides evaluations (Fees information page).
See further details of the biopesticide scheme.
I am new to plant protection product registration — what sort of things do I need to consider for biopesticides?
There are a set of data requirements for all PPPs, and there are specific data requirements pertinent to the different categories of biopesticides, (please see the specific category types). The following list gives those new to the registration process a feel for the areas considered by our risk assessment:
- chemistry: including technical specification of the active ingredient(s) physical/chemical properties and storage stability of the product
- mammalian toxicology: how toxic to humans, product classification
- residues: trials data for use on edible crops
- operator and bystander protection: 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. Please see the Efficacy Guidance for Biological Products.
Information on gaining active substance approval can be found at Introduction to the decision making process for active substances.
Full details on how to submit an application are given in The Applicant Guide however this is a summary:
- applications for approval must be made in writing using the relevant application form. Approval is given for uses of a product
- approval can only be given once all the data and/or information on the safety, efficacy and, where relevant, humaneness, of the PPP are considered to be acceptable
- all uses of a product must be supported by data. Data must be generated from work carried out to certain standards by appropriately recognised organisations (for example laboratories must be to Good Laboratory Practise (GLP), accredited, field work must be carried out by officially recognised organisations).
We understand that if you are new to the regulatory process the system may seem complicated. HSE can offer assistance and advice. We urge potential applicants to contact us at the early stages of product development to ensure any work carried out can be consider in the light of regulatory requirements, thus ensuring the most cost effective way to gain approval. When contacting us, it would be very helpful if you would provide the following information:
- what is the proposed product (active ingredient and other co-formulants present)?
- what is the active ingredient's mode of action?
- what are the natural background levels of the active ingredient?
- what are the intended purposes of the product (proposed uses and which pest(s)/disease(s) are to be controlled?
Please contact the Biopesticides champion via email: [email protected]
We can arrange pre-submission meetings where we can give specific guidance to applicants, discuss data requirements in detail, dossier preparation and advise on the best way forward. There may be a charge for these meetings but this charge will be refunded if an application is accepted.
All enquiries submitted to HSE are treated as commercial in confidence.
Pheromones and other Semiochemicals
The intended use of a pheromone will determine whether an assessment of a pheromone as active substance of a plant protection product (PPP) is required, as well as the need of authorisation of a product as a PPP. A pheromone is considered as active substance of a PPP if the pheromone aims to protect the plant or plant products.
This is the case when the pheromone is used for sexual confusion or in the case of mass trapping. However, pheromones are not considered as active substances of PPPs, when they are used to only monitor the population cycle of the insects.
Such traps used for monitoring purposes may contain the same substances assessed under 1107/2009 (GB/NI), but in this case neither the product has to be considered as PPP, nor has the pheromone to be considered as active substance in the sense of Regulation No. 1107/2009 (GB/NI).
Another situation to consider is the case of a pheromone added to attract insects which in the end are killed by an insecticide.. In this case the pheromone can be considered as an adjuvant in a type of formulation, where the active substance is the insecticide and therefore in this case the pheromone itself is considered out of the scope of the Regulation.
Semiochemicals are chemicals emitted by plants, animals and other organisms — and synthetic analogues of such substances — that evoke a behavioural or physiological response in individuals of the same or other species. They include pheromones and allelochemicals.
Guidance on data requirements for pheromones and other semiochemicals can be found at:
- Guidance for Registration Requirements for Pheromones and Other Semiochemicals Used for Arthropod Pest Control' (OECD Series on Pesticides, number 12).
- SANTE/12815/2014 rev. 5.2 Guidance Document On Semiochemical Active Substances And Plant Protection Products
In addition draft guidance number 220 Data Requirements and Trials Design for Mating Disruption Pheromone Products is available.
Relevant news for Pheromone products:
A new Guidance document is currently being produced.
The data you need to submit for the approval of a plant protection product containing a microbial that is new to the UK must be sufficient to allow a full risk assessment to be performed. The data requirements you need to address are not as extensive as those set for chemical active substances but take into account specific factors for microbials. For example pathogenicity/infectivity in humans and animals, sensitisation of users, the production of toxins and the potential for multiplication in the environment.
Data requirements should be fulfilled at strain level unless it can be proved that it is not necessary for the particular strain in question. For more details see Taxonomic level of micro-organisms to be included in Annex I to Directive 91/414 (doc. Sanco/10754/2005) found under Procedural Guidance/Procedures.
Visit The Guidelines on Active Substances and Plant Protection Products page to view the following documents:
- SANCO/0253/2008 rev. 2 - Guidance Document On The Assessment Of New Isolates Of Baculovirus Species Already Included In Annex I Of Directive 91/414
- SANCO/12116/2012 –rev. 0- Working Document on Microbial Contaminant Limits for Microbial Pest Control Products
- SANCO/12117/2012 –rev. 0 - Working Document to the Environmental Safety Evaluation of Microbial Biocontrol Agents
- SANCO/12823/2012 –rev. 4 - Guidance Document For The Assessment Of The Equivalence Of Technical Grade Active Ingredients For Identical Microbial Strains Or Isolates Approved Under Regulation No 1107/2009
Relevant news for microbial products:
There is a large spectrum of plant extracts, meaning unprocessed extracts representing a 'cluster of substances' or highly refined containing one active substance. In addition, the risk associated with the use of plant extracts may vary between low and very high risk. For this reason they are assessed on a case by case basis.
There is a working document which specifies data requirements for active substances of plant protection products made from plants or plant extracts, SANCO/11470/2012 found under Procedural Guidance/ Dossier and draft assessment report.
Other Novel Alternative Products
As the description suggests these are potential products which do not easily sit within a specific category and as such the data requirements will have to be assessed on a case by case basis. If you have such a product, please contact us in order for us to consider if it is eligible for the biopesticides scheme and consider data requirements.
You must apply for a Trials Permit if you wish to carry out research and development work (including developing IPM systems) involving the release into the environment of an approved or unapproved active substance and/or plant protection product that is not approved for the proposed use. More information can be found the Trials Permit section.