Biopesticide covers a wide spectrum of potential products used as plant protection products (PPP).
Within the Biopesticide scheme these are divided into 4 categories:
- products based on pheromone and other semiochemical
- products containing a microbial (for example bacterium, fungus, protozoa, virus, viroid)
- products based on plant extracts
- other novel alternative products
Before any pesticide can be used, sold, supplied, advertised or stored it must be approved for use. This includes biopesticides.
Applicants must provide evidence that biopesticides are safe and effective.
This information must address the data requirements for chemicals or microbials in Regulation 283/2013 and 284/2013.
For all plant protection products the data requirements can be met by:
- submitting new or unpublished data studies
- submitting a reasoned scientific case as to why the data requirement does not need to be addressed by a study
- submitting published studies, or other information, from scientific journals or other sources that are in the public domain
- a combination of any of the above three sources
The 'Biopesticides Scheme' offers reduced fees for biopesticides evaluations.
More information on the Biopesticide Scheme.
The regulatory process can seem complicated, HSE can offer assistance and advice.
Please contact us during the early stages of product development to make sure any work carried out considers regulatory requirements, this is the most cost-effective way to gain approval.
When contacting us, please tell us:
- the proposed product (active ingredient and other co-formulants present)
- the active ingredient's mode of action
- the natural background levels of the active ingredient
- the intended purposes of the product (proposed uses and which pests and diseases are to be controlled)
The intended use of a pheromone determines whether an assessment of a pheromone as an active substance of a plant protection product (PPP) is required, as well as needing authorisation of a product as a PPP.
A pheromone is considered an active substance of a PPP if the pheromone aims to protect the plant or plant products. An example of this is 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 but here neither the product is considered a PPP or the pheromone to be considered as active substance under Regulation No. (EC) 1107/2009.
Where a pheromone is added to attract insects, which are killed by an insecticide, the pheromone can be considered as an adjuvant in a formulation, where the active substance is the insecticide and so the pheromone itself is considered out of the scope of the regulation.
Semiochemicals are chemicals emitted by plants, animals and other organisms that evoke a behavioural or physiological response in individuals of the same or other species. They include pheromones and allelochemicals and synthetic analogues of such substances.
Guidance on how to meet data requirements for pheromones and other semiochemicals can be found at:
To approve a new GB plant protection product containing a microbial the data you submit must be sufficient to allow a full risk assessment. The data requirements 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 read Taxonomic level of micro-organisms to be included in Annex I to Directive 91/414 (doc. Sanco/10754/2005) (European Commission website)
To view the following documents on the European Commission website, visit page The Guidelines on Active Substances and Plant Protection Products:
- 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
There is a large spectrum of plant extracts, meaning unprocessed extracts representing a 'cluster of substances' or highly refined containing one active substance. The risk associated with the use of plant extracts may vary between low and very high risk, so they are assessed on a case-by-case basis.
There is a working document on the European Commission website which specifies how to address the data requirements for active substances of plant protection products made from plants or plant extracts, SANCO/11470/2012.
Other novel alternative products
As the description suggests these are potential products which do not easily sit within a specific category. Please contact HSE for these applications as the data requirements will have to be assessed on a case-by-case basis.
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.
Some but not all biopesticides will meet the low-risk criteria.