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.

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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.

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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.

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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.

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UK releases guidance on chemicals regulation in case of ‘no-deal’ Brexit

Date: 17 October 2018

In view of the approaching Brexit in March 2019 the United Kingdom published in October 2018 technical notices as guidance in case UK leaves the EU without an agreement (‘no deal’ scenario). Although negotiations with the EU are ongoing, UK intends to ensure therewith to be prepared for all eventualities from day 1 after Brexit.

These published technical notices cover the following topics:

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Approval of new General PP1 Efficacy Standards by EPPO Council

Date: 9 October 2018

In its last session in Paris on 25 and 26 September 2018, the EPPO council approved among others two draft PP1 General Standards which are of particular interest for the plant protection industry. The new General Standard defining the General Principles for the development and registration of co-formulated mixtures of Plant Protection Products will provide detailed guidance for the needed and requested efficacy justifications and testing requirements for co-formulated mixtures, considering their potential advantages and disadvantages. A further main focus of this document will be on the examination of the appropriateness of such mixtures in terms of resistance management, which is taking on an added importance for the registration of plant protection products.
In the second new General Standard Efficacy considerations and data generation when making changes to the chemical composition or formulation type of plant protection products, EPPO will for the first time release a detailed guidance about data requirements and data generation in case of changes of the chemical composition or the formulation type of plant protection products. With this Standard any applicant thinking about a composition change will receive an essential tool whether the provision of accordant biological data (efficacy and selectivity) might be required or not and which necessary steps to take into account, if a significant composition change is intended. The establishment of General Standards by EPPO is a lengthy process: Both new standards were already discussed among authority and industry experts at the EPPO Workshop held in Sofia in October 2013. The new standards are of importance for future efficacy trial programs and should in particular be considered for bridging trials and the testing of new mixture products. SCC will provide a detailed analysis after official publication of the documents on the EPPO homepage, which is expected soon (see https://pp1.eppo.int/). The Standards will also be published in the EPPO Bulletin.

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Implications of Brexit for fertilisers

Date: 27 September 2018

On Sep 25th the European Commission published a new notice to stakeholders on the withdrawal of the United Kingdom and EU rules in the field of fertilisers.

In general, the EU rules for EC fertilisers, that is Regulation (EC) No 2003/2003 of the European Parliament and of the Council of 13 October 2003 relating to fertilisers, will no longer apply in the United Kingdom after Brexit which will affect imports and exports of fertilisers in various ways. In regards to the responsibilities for importers of fertilisers, the notice to stakeholders highlights that due to this, ‘a manufacturer established in the United Kingdom will no longer be an economic operator established in the EU [as required for EC fertilisers]. As a consequence, an economic operator established in the EU-27 and placing EC fertilisers coming from the United Kingdom on the EU-27 market, until then considered as a distributor, will become an EU importer in relation to such products. This operator will therefore have to comply with the respective obligations for manufacturers’.

Further information and updates are available on the EU Commission website.

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International Code of Conduct for the use and management of Fertilisers is released

Date: 24 August 2018

The FAO and the Intergovernmental Technical Panel on Soils (ITPS) released a zero-draft of an „International Code of Conduct for the Use and Management of Fertilizers“. This document highlights the need of fertilisers in modern agriculture but mentions also the adverse effects if fertilisers are not used according to Good Agriculture Practice. The code of conduct helps to keep a global perspective in mind, since fertilisers are regulated under several national legislations.

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The Code of conduct comprises voluntary standards of practice for all stakeholders and it was obtained by public consultation. It aims in generating a sustainable agriculture and food security from a nutrient management perspective. In more detail it intends to

  • be a response to the requests of the COAG (Committee on Agriculture) to increase food safety and safe use of fertilisers
  • facilitate the implementation of the VGSSM (Voluntary Guidelines for Sustainable Soil Management) to address nutrient imbalance and soil pollution
  • respond to the UNEA3 (United Nations Environment Assembly of the United Nations Environment Programme, 3rd session) declaration on soil pollution

It designates actions to governments, policy makers, the fertiliser industry, academia, research, agricultural and analytical service laboratories, agricultural extension and advisory services, civil society and users of fertilisers, including farmers. It gives advices in the field of

  • soil fertility and plant nutrition
  • fertiliser use and management
  • nutrient reuse and recycling
  • composition, limits and testing
  • access, distribution and labelling
  • information, extension and outreach
  • monitoring and observance

Additionally, the document includes terms and definitions commonly used in the field of fertilisers.
In the EU, several of these topics, especially the use and management of fertilisers, are already addressed in the new draft of the fertiliser/biostimulant regulation and are also part of the circular economy package.
For further information on the future EU fertiliser framework please refer to SCC’s news, published on the 28th May 2018.


Dr Carla Lorenz, Agrochemicals and Biopesticides - Biostimulants, Fertiliser, IPM
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SCC establishes SCC Japan K.K.

Date: 15 August 2018

For 11 years, SCC has been running a Liaison Office Japan to support our Japanese customers in registration of their active substances and products in the EU. The increasing interest of our Japanese and European customers in international registration services in recent years was decisive for us to take the next key step – the establishment of SCC Japan K.K., which we officially founded on 30 July 2018.
SCC Japan K.K. provides the perfect basis for us to further promote cooperation with our Japanese customers by offering scientific and regulatory services in Japan. We also actively support our customers in all registration issues in line with European and international regulations.
In Japan, we offer regulatory support in accordance with Chemical Substance Control Law (CSCL) and Industrial Safety and Health Law (IHSL). In addition, we are currently rounding out our services portfolio for the Japanese market by elaborating our expertise in registration of plant protection and biocides products.

We look forward to guiding your products to successful registration, be it in Europe, Asia-Pacific or Americas. The establishment of SCC Japan is a significant contribution to our business development. For further questions on international markets, please contact This email address is being protected from spambots. You need JavaScript enabled to view it..

We will keep you updated on further developments of our services in Japan and international markets.

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Biopesticide and biostimulant growth prompts need for registration

Date: 10 August 2018

While the global biorational market is booming and regulation agencies are taking pains to keep the pace, the significance of choosing the right registration strategy becomes even more evident.

Lars Huber, Head of Biostmulants, Fertiliser, IPM, shares in the interview for the Biologicals Special his considerations on recent developments in the biostimulants market, SCC's expertise in the field as well as what you need for a successful product registration.
To read the full article, please click here.

Dr Lars Huber, Head of Biostimulants, Fertiliser, IPM

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