Composition or formulation type changes of PPP: Release of EPPO Standard PP 1/307(1)

Date: 19 November 2018

For the first time EPPO (European and Mediterranean Plant Protection Organization) releases a detailed guidance about data requirements and data generation in case of changes of the chemical composition or the formulation type of plant protection product. With Standard PP 1/307 (1) Efficacy considerations and data generation when making changes to the chemical composition or formulation type of plant protection products,  any applicant considering a composition change receives an essential tool which helps hem to decide whether the provision of accordant biological data (efficacy and selectivity) might be required or not and which necessary steps are to be taken in case of a significant composition change. The new EPPO Standard also specifies the requirements for the development of a new product. These requirements are to be based on the principle of comparing with, and ‘bridging’ to, an existing formulation, which for its part should be supported by a full data package.

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The definition of chemical composition change follows EU Guidance document SANCO/12638/2011, whereas any further details about formulation types are given in Manual on development and use of FAO and WHO specifications for pesticides (FAO and WHO, 2016).
The first part of the Standard provides a description of the criteria which are relevant to efficacy of the key components and types of changes which may have an impact on relevant efficacy properties, especially effectiveness and selectivity of a plant protection product.
In the decision process it is essential to have information regarding the nature and magnitude of the proposed change. This encompasses information on the chemical nature of the co-formulant(s) being changed, and explanations of their chemical similarity, if relevant.
For changes which have only a non-significant impact on biological aspects of a plant protection product, no efficacy data are required. Even though no special efficacy data are required, an explanation of the biological non-significance of the composition change should be given as an integral part of a justification to explain why the proposed change is considered as unlikely to have an impact on efficacy.
On the other hand significant changes in chemical composition are those regarded to have some potential impact on the biological activity of a plant protection product, requiring assessment and supporting data. Of special relevance for most formulation types, e.g. for foliar applied products, are changes in the solvent and the surfactant system.
The second part of the new Standard provides substantial information about the type and extent of data required for biologically significant formulation changes. The scope of data to be submitted depends on how similar the new formulation is to the existing one of the already approved product. The new Standard gives detailed recommendations for the necessity of glasshouse or field trials, distribution of trials and the number of trials to be provided to authorities, depending also on formulation types with the main focus on efficacy and selectivity trials.
If comparability in trials based on a trial program as outlined above could not be demonstrated, further efficacy data may be required. In the worst case, even a full data set according to EPPO Standard PP 1/226 Number of efficacy trials might be needed, if the old and new formulation are proved to be not comparable.
Further detailed information concerning any potential impact of a chemical composition change on the generation of efficacy data will be provided in the forthcoming SCC Newsletter.

Please contact This email address is being protected from spambots. You need JavaScript enabled to view it., head of the efficacy group at SCC, in case of any questions concerning the data requirements related to composition changes of plant protection products.


Development of co-formulated mixtures: Release of new General EPPO Standard PP1/306(1)

Date: 16 November 2018

With the new Standard PP 1/306 (1) about the General Principles for the development of co-formulated mixtures of Plant Protection Products,  the European and Mediterranean Plant Protection Organization (EPPO) releases a detailed guidance for the needed and requested efficacy justifications when using mixtures, considering their potential advantages and disadvantages. The new EPPO document primarily examines the appropriateness of such mixtures in terms of resistance management, which is getting more and more important for the registration of plant protection products.
Co-formulated mixtures are defined as plant protection products containing more than one active substance. This includes the mixing of different pesticide types, e.g. fungicide plus insecticide, and also considers the mixture of e.g. fungicides with plant growth regulators. Although the new Standard does not specifically address mixtures with safeners or synergists, the general principles may be of relevance for them as well. The new Standard does not consider, however, the provision of individual active substances in separate containers in a common product package (the so-called ‘combi- or twin-packs’).
Applicants are required to explain and substantially demonstrate in their submissions the rationale for, and the specific benefits of a proposed mixture product, taking into consideration the fact that the evidence needed for the authorisation support will vary, depending upon the rationale for the mixture.

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The new EPPO Standard describes in detail the potential advantages and disadvantages of mixtures with respect to the effectiveness which is to be considered when preparing an accordant justification as part of a submission. Accordingly, the comparison of a mixture with the respective solo products should be used as a benchmark. The Standard also represents the general principles to be taken into account for mixture justifications as well as the issues relevant for the justification of mixtures as part of resistance management.
Helpful for applicants is the checklist attached to the new Standard specifying the key issues to be considered when supporting the authorisation of a mixture. The most relevant principles encompass i.a. the efficacy of mixtures (e.g. whether there is a clear benefit), the ratio of active substances in mixture products, resistance or relevance of a mixture across the EPPO zone.
In addition, the Standard provides further details for mixtures of fungicides, herbicides, insecticides, seed treatment products and plant growth regulators. In this context please note that the old standard PP 1/277 Insecticide co-formulated mixtures has already been withdrawn and been replaced by the new standard.
Further information concerning the principles requested for mixture justifications will be provided in the forthcoming SCC Newsletter.

Please contact This email address is being protected from spambots. You need JavaScript enabled to view it., head of the efficacy group at SCC, if you would like any kind of support related to the development of co-formulated mixtures of plant protection products.


Regulation concerning evaluation of ED criteria in the renewal procedure for a.s. under Regulation (EC) 1107/2009 including pending applications

Date: 9 November 2018

On 7 November 2018, the Commission released Regulation (EU) 2018/1659 amending Regulation (EU) 844/2012 in view of the scientific criteria for the determination of endocrine disrupting properties. Those criteria are to apply as of 10 November 2018 to applications for the renewal of the approval of active substances, including pending applications.

In addition, the Commission adopted an official communication outlining its strategy for the protection of citizens and the environment from all hazardous chemicals.


Biopesticide and biostimulant growth prompts need for registration

Date: 5 November 2018 (see our original news dated 10 August 2018)

Dr Lars Huber's interview on recent developments in the biostimulants market for the 2018 Biologicals Special, which we earlier gave account of in Current News, is now available in Chinese as well.