Approval to use an active substance in a pesticide
An applicant (for example, a pesticide manufacturer) must apply for the approval of an active substance to be used in a PPP in Great Britain (GB).
HSE is the assessing competent authority for GB and will evaluate the application.
A new active substance is evaluated in the areas of:
- physical chemical properties
- analytical methods
- mammalian toxicology
- operator exposure
- environmental fate
- consumer exposure
Enough information is needed to show an application meets the criteria in Article 4 of retained Regulation 1107/2009 (Legislation.gov.uk).
GB Approvals Register
The GB Approvals Register includes active substances that are approved in GB. Active substances listed in the approvals register may be used and sold in plant protection products in GB.
Types of approval
There are several kinds of active substance approvals with different approval periods:
- standard chemicals and microbials – maximum approval of 10 years (first approval)
- basic substances – maximum approval of 10 years
- low risk substances – maximum approval of 15 years
- candidate for substitution – maximum approval of 7 years
- emergency approval – maximum approval of 5 years
Use of active substance in a product
Only active substances that are approved in Great Britain (GB) may be authorised in a Plant protection product for use in GB.
You must apply for a trials permit (previously experimental approval) if you wish to carry out research and development work involving the release into the environment of a plant protection product that is not authorised.
There are 4 different types of trials permits:
- administrative trials permits
- extrapolated trials permits (ETPs)
- consumer-assessed trials permits
- fully assessed trials permits
Extra information will also be required in the submission depending on the permit type.
Active substance renewal
Once the approval of an active substance reaches its expiry date, it should be re-assessed to ensure it does not present an unacceptable risk to people or the environment under the latest standards of assessment.
Authorisation holders must submit any new information on the potentially dangerous effects of the product or active substance contained in the product for human or animal health, ground water or the environment.
Article 7 Amend the conditions of approval of an active substance
Conditions of approval may be amended if an amendment is applied for under Article 7 of the Regulation.
Article 21 Review of pesticide active substance approvals
Approval of an active substance may be reviewed if it comes to light that approval criteria may no longer be met.
Additional confirmatory information may be requested to be submitted to HSE shortly after an approval of an active substance.
Fees are charged according to the individual application.
New active substances, synergists, safeners, basic substances and renewal of existing active substances are charged the same fees.
Bio-pesticides and pheromones are charged lower fees.