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Biopesticides Home

Biopesticide/Biocide - what is the difference?

Biopesticides are plant protection products which contain biological control agents (microbials, pheromones, plant extracts) for use as agricultural, horticultural and home garden pesticides. Further information is provided below.

Biocides are non-agricultural (public hygiene) pesticides and biocides (chemical or biological control agents) used to control unwanted pests (excludes plant protection products) e.g. wood preservatives, insecticides, algaecides and repellents. Information about these products is held on the main HSE website at the following link: http://www.hse.gov.uk/biocides/index.htm.

Biopesticides 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, but for the purpose of our Biopesticide scheme these are divided into four categories:

1. Products based on pheromone and other semiochemical (for mass trapping or trap cropping)
2. Products containing a microorganism (e.g. bacterium, fungus, protozoa, virus, viroid)
3. Products based on plant extracts
4. Other novel alternative products

Approvals are granted by the HSE on behalf of Ministers under a range of specific pesticide related legislation.

Applicants supporting products must provide evidence that pesticides 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 Regulatory Update 09/2006

I am new to pesticide registration — what sort of things do I need to consider?

There are a set of data requirements for all pesticides, 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.
• Ecotoxicolgy: effect of the active/product on the environment and non-target organisms.
• Fate and behaviour: effect of the environment on the active ingredient, what does it break down to, does it persist?
• Efficacy and crop safety trials: proof of a consistent level of control/effect. Please see the Efficacy Guidance for Biological Products.

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 pesticide 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 (e.g. laboratories must be to Good Laboratory Practise (GLP), accredited, field work must be carried out by Officially Recognised organisations).

Pre-submission meetings

We understand that if you are new to the regulatory process the system may seem complicated. CRD can offer assistance and advice, please contact the Biopesticides champion Mrs Lisa Moakes: Tel 01904 455952 or email lisa.moakes@hse.gsi.gov.uk .

We can arrange free pre-submission meetings where we can give specific guidance to applicants, cover legislation, discuss how to meet data requirements and advise on the best way forward with a view to the most cost effective way to gain approval. We urge potential applicants to contact us at the early stages of product development.

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 purpose of the product (proposed uses and which pest(s)/disease(s) are to be controlled?

All enquiries submitted to CRD are treated as commercial in confidence.

Guidance

Pheromones and other Semiochemicals

Products marketed for use as traps are pesticide products and require an approval by the CRD before they can be marketed. For detailed information on which products do or do not fall within the scope of the relevant legislation Directive 91/414/EEC please see Regulatory Update 10/2006.

Semiochemicals

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 in Guidance for Registration Requirements for Pheromones and Other Semiochemicals Used for Arthropod Pest Control’ (OECD Series on Pesticides, number 12). Further guidance on data requirements for plant protection products made from plants or plant extracts is given in another Commission document Draft guidance document (SANCO 10472 Rev 5) for Applications on Plant Protection Products made from plants or plant extracts.

In addition draft guidance number 220 Data Requirements and Trials Design for Mating Disruption Pheromone Products is available.

Relevant news for Pheromone products:

Regulatory Update 37/2008

Microbials

The data you need to submit for the approval of a pesticide containing a microbial that is new to the UK/EU 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 e.g. pathogenicity/infectivity in humans and animals, sensitisation of users, the production of toxins and the potential for multiplication in the environment. (Directive 2001/36/EC of 16 May 2001).

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/EEC (doc. Sanco/10754/2005).

Guidance on preparation of your OECD Dossier Guidance (for industry) Microbials.

Applicant Handbook (Biological Control Agents)

Relevant news for microbial products:

Regulatory Update 31/2008

Plant Extracts

There is a large spectrum of plant extracts, i.e. 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 European Commission working document which specifies data requirements for active substances of plant protection products made from plants or plant extracts, SANCO/10472 rev.5.

Relevant news for Plant Extract products:

Regulatory Update 37/2008

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.