Comparative assessments (CAs) have become a common part in the registration process of plant protection products according to Regulation (EC) No 1107/2009[i]. The aim of comparative assessment and substitution is to gradually replace products containing active substances (or their individual uses) with high risk for environment and human health by safer options1, where a suitable option is available and has no significant disadvantages. To date, only very few products or their individual uses have been substituted (mainly mutual recognition applications). However, many assessments are ongoing and there are indications that there may be more substantial substitutions and label changes[ii].
Since CAs became obligatory for registration of new products/uses and re-registration of existing products containing active substances identified as candidates for substitution (CfS)* in 2015, industry and also the regulatory authorities had to find their way to put this obligation into practice. EPPO standard PP 1/271 (2)[iii] that focuses on the efficacy aspects of a CA and SANCO Guidance Document 11507/2013 rev. 12[iv], which supplements the EPPO standard and covers parts on human and animal health and the environment, outline the framework for an evaluation for both applicants and evaluators.
CAs are submitted and evaluated at national level and since 2015 many countries have introduced national templates (BE, HR, CZ, FR, IT, NL, PT, SL, ES) and/or national guidance documents (BE, HR, CZ, FR, DE, IT, NL, PT, SI, ES, UK). Following definition of the uses of a candidate product and determination of the alternatives to consider as substitutes for the uses of the candidate product, all countries follow a tiered approach outlined in the guidelines. However, the order of the assessment varies between some countries4.
After an initial EPPO workshop on Comparative Assessments in 2009 that resulted in the development of a first version of the EPPO standard PP 1/271, a new EPPO workshop was organised at the request of EPPO Member States concerned with CAs. Taking place in Lisbon in 2018, it was used as a platform to discuss the advantages but also the weaknesses of the current procedure. The outcome of this workshop was a revised EPPO standard (PP 1/271 (3)[v]) that was recently approved in September 2019.
As the overall feedback of regulatory authorities and industry was positive, the basic approach has not been altered. Overall, the points to be addressed remain the same as in the previous version of the EPPO standard. One change is that the CA decision scheme for efficacy has been grouped into four main assessment stages.
* Criteria for the classification of a CfS are listed in Annex II point 4 of Regulation (EC) 1107/2009
To accept the call for more flexibility, it is clearly indicated that the order of the different stages is not fixed and can be adapted according to common national procedure..
The other major improvement of version 3 of PP 1/271 is the guidance on conducting a CA on co-formulated mixtures containing an active substance which is a CfS. Attention is given to resistance management with the conclusion that this point should be considered at product level and that sufficient diversity of modes of action has to be maintained. Furthermore, guidance is given on the comparison of agronomic, economic and practical aspects. Typically, comparisons should be based on the mixture. Only in the case of active substances without overlap in activity within the co-formulation, can comparison be made between only the CfS and other products authorised for the same use.
Eurofins Agroscience Services have been preparing national comparative assessments for products containing candidates for substitution since this process was first implemented. During that time, our regulatory experts have gained extensive experience with a wide range of types of product and differences between national approaches. We offer the full service of determining the most robust strategy for a particular product, collecting all of the relevant information needed and preparing full CAs to national requirements for all EU countries. For further information, please contact our Senior Regulatory Efficacy Expert Adrian Cheshire.
[i] Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives79/117/EEC and 91/414/EEC
[ii] EPPO workshop Lisbon, 2018-10-24/25, Country responses to the EPPO questionnaire – Ms Mattock (CRD-UK on behalf of EPPO)
[iii] PP1/271 (2) Guidance on comparative assessment, EPPO Bulletin (2015) 45 (3), 388-391
[iv] Draft Guidance document on Comparative Assessment and Substitution of Plant Protection Products in accordance with Regulation (EC) No 1107/2009 SANCO/11507/2013 rev. 12, 10 October 2014
[v] PP1/271 (3) Guidance on efficacy aspects of comparative assessment, EPPO Bulletin (2019) 0 (0), 1-5