CEUREG Forum 24-25 October 2017 - Bratislava, Slovak Republic

Date: 30 October 2017

On occasion of the recent CEUREG Forum (http://www.ceureg.com) held in Bratislava, plant protection products regulation experts from Central and Eastern European countries met to discuss various important issues related to the authorisation process under current EU legislation, the reduction of the risk of pesticides use, misuse of the parallel trade, illegal trade as well as application of pesticides in/near residential. Please find here the presentations Dr Karin Lauber and Dr Bernd Brielbeck have given on 24 October 2017 at that XXI CEUREG Forum in Bratislava as invited speakers to that Forum.


New EU fertiliser regulation: “Dual use” for Plant Biostimulants and Plant Protection Products under debate in EU parliament

Date: 23 October 2017


Yesterday the upcoming EU fertiliser regulation and the future on CE marked fertilizing products were debated in the European Parliament.
Subject of the debate is a report of the Committee on the Internal Market and Consumer Protection on the proposal for a regulation of the European Parliament and of the Council laying down rules on the making available on the market of CE marked fertilising products and amending Regulations (EC) No 1069/2009 and (EC) No 1107/2009.


The amendments under discussion contain significant changes, especially for the new Product Function Category (PFC) of Plant Biostimulants which also includes microorganisms. According to the current proposal, Part II of Annex I shall be amended, setting out the requirements for Plant Biostimulants as: “The plant biostimulant shall have the effects that are claimed on the label for the plant specified thereon. Where the plant biostimulant contains one or more ingredients that have been approved under Regulation (EC) No 1107/2009, the information provided during conformity assessment will provide compelling empirical evidence of the biostimulant effect, taking into account relevant parameters […]”
Regulation 1107/2009 shall be amended accordingly, defining Plant biostimulant as “a product containing any substance or micro-organism stimulating plant nutrition processes independently of its nutrient content, or any combination of such substances and/or micro-organisms, with the sole aim of improving one or more of the following characteristics of the plant or the plant rhizosphere: (a) nutrient use efficiency; (b) tolerance to abiotic stress; (c) crop quality traits."
The suggested amendments would close the regulatory gaps between biopesticides and biostimulants, allowing for an increase in product registrations.

For further information on biostimulants and the upcoming EU Regulation, please also refer to the special edition of SCC Newsletter No. 2/2016  on the Draft Fertilising Products Regulation (COM(2016) 157 final) or the critical review on current development of biostimulants by Dr Lars Huber in Agrow's supplement Biologicals 2017.

Please click here, to read the full text of the Committee report.
Dr Lars Huber, Head of Biostimulants, Fertiliser, IPM


Low risk substances: New EPPO guidance on principles of efficacy evaluation for low risk plant protection products

Date: 19 October 2017


The new EPPO (European and Mediterranean Plant Protection Organization) guidance PP 1/296(1) on principles of efficacy evaluation for low-risk plant protection products was adopted in September 2017 and will be published soon. This guidance sets out the requirements for efficacy testing and data requirements for products based on low risk active substances.

 The new guidance provides more detailed information on several aspects of efficacy evaluation for the different types of possible low risk active substances and products such as (bio)chemicals, substances derived from animals, botanicals, minerals, micro-organisms, extracts from micro-organisms, semiochemicals including pheromones, baculoviruses or substances of synthetic origin.


Dr Lars Huber, Head of Biostimulants, Fertiliser, IPM


Commission warning on Brexit

Date: 27 September 2017


Low risk substances: New Commission Regulation (EU) 2017/1432 amending Regulation (EC) No 1107/2009 of the European Parliament and the Council

Date: 17 August 2017

Furthermore, the new amendment specifically addresses micro-organisms. As sole criterion for micro-organisms to be considered as being of low risk, the non-existence of multiple resistance to anti-microbials at strain-level is given. Due to their host- specificity, Baculoviruses are considered as being of low risk, provided they show no adverse effects on non-target insects at strain level.
Commission Regulation (EU) 2017/1432 shall apply as of 28 August 2017. To view the new regulation, please follow this link.

Dr Lars Huber, Head of Biostimulants, Fertiliser, IPM


Low risk substances in the EU

by Dr Bernd Brielbeck in Agrow’s Latin America supplement 2017

Date: 31.07.2017

The article summarizes the current legislative situation of the low risk substances in the EU, focusing on today’s challenges and prospects ahead. To read the article, please click on the link.

Dr Bernd Brielbeck, Senior Manager Regulatory Affairs, Agrochemicals and Biopesticides



New head of Chemicals business unit since July 2017


Thomas Roth has a PhD in food chemistry and is a certified expert for toxicology. He has been with SCC for more than 8 years now, leading the Toxicology group within the Regulatory Science business unit before taking the new responsibility this summer. Prior to joining SCC, Thomas Roth worked in the chemical industry for 10 years gaining his considerable professional experience in chemical toxicology and regulation.

Moving towards simpler registration conditions for biostimulants in the EU?

A critical review on current development of biostimulants by Dr Lars Huber in Agrow's supplement Biologicals 2017

Date: 30.05.2017

To view the article, please follow the link.

 Dr Lars Huber, Head of Biostimulants, Fertiliser, IPM _______________________________________________________________

Latest developments in efficacy assessment in agriculture

by Dr Norbert Weissmann

Date: 15 February 2017

Please follow this link to view Norbert’s report on efficacy assessment in agriculture as presented at the Crop and Chemicals Europe in Berlin in February 2017. It provides an overview of current regulatory developments in efficacy, focusing on efficacy testing in 3-dimensional crops, data requirements for re-formulated products and key factors for efficacy testing of biopesticides and biostimulants.  
For a brief summary of Norbert's presentation, please click here.

Dr Norbert Weissmann, Senior Manager Regulatory Affairs – Agrochemicals and Biopesticides, Head of Efficacy group                          _______________________________________________________________

Low risk substances: a comprehensive overview

by Dr Bernd Brielbeck

Date: 15 February 2017

Click here to download Bernd’s guidance on low risk substances as presented at the Crop and Chemicals Europe in Berlin in February 2017. This presentation offers you a comprehensive overview on regulatory and political framework of low risk substances, guidance documents, handling of low risk criteria, hands-on experience and the outlook in the future. To view the synospsis of Bernd's presentation, please follow this link.

Dr Bernd Brielbeck, Senior Manager Regulatory Affairs, Agrochemicals and Biopesticides                           _______________________________________________________________