Efficacy for Plant Protection: Active Substances

In the EU product performance and efficacy are mainly in scope as part of a product authorisation procedure. However, due to the importance of dose rates and application schedules, it is also included as part of the necessary risk assessments of active substances. Both the application for approval of a new active substance and the renewal of existing active substances, resort to product performance and efficacy data.

New active substance

“An active substance alone or associated with a safener or synergist shall only be approved where it has been established for one or more representative uses that the plant protection product, consequent on application consistent with good plant protection practice and having regard to realistic conditions of use is sufficiently effective”. (Regulation 1107/2009; Annex II)

The main objective of the efficacy evaluation in scope of an active substance approval, is to provide proof for realistic dose rates and uses (GAP, Good Agricultural Practice) submitted for the risk assessment and being representative for all subsequent product authorisations.

Regulation 1107/2009 does not include a definition of “sufficiently effective”, however, various guidance documents, such as Commission Regulation 546/2011 or respective EPPO standards are available. Due to the complexity of this issue and the huge variety of active substances, Modes of Actions, etc., guidance is deliberately vague. For example, the guidance for low risk substances reads: “the net result of the positive and negative effects [of the use of the plant protection product] should be a sufficient overall benefit to plant protection in order to justify the use of the product. The level of benefit from the use of a product should be appropriate to the agronomic setting in which the product will be used. Moderate effectiveness may be acceptable, e.g. when the pest pressure is low, when a product will be used as a component of an IPM programme, in some specific situations such as organic farming or where the product will make a particular contribution to managing other issues such as resistance”. (EPPO, 2017)

For new active substances, instead of the typical dossier for efficacy evaluation, the Biological Assessment Dossier (BAD), a so-called “Concise Summary” has to be submitted for evaluation.
For new products, based on a new active substance, a special fast-track product authorisation procedure exists which can reduce the authorisation time for the first authorisation of a new product considerably.

Approved active substances (Renewal)

Compared to the efficacy information to be submitted for a new active substance, the data requirements for existing active substances within the renewal process are further reduced. According to draft Guidance Document SANCO/2012/11251, the dossier to be submitted for renewal of approval should include only an overview of the efficacy information concerning the uses already authorised in Member States. This overview needs to be based on the format provided in Guidance Document SANCO/10181/2013. This means that the range of supported uses should reflect a representative use pattern, including the uses evaluated for the first approval. The efficacy data compilation has only to consider the formal requirements, including e.g. the description of function and Mode of Action, application details and basic resistance information.

Considering that the substance is approved and authorisations of plant protection products containing the substance have already been evaluated according to the Uniform Principles (Regulation (EC) No 546/2011), no other efficacy documentation is considered to be necessary for the renewal process.