Sustainable pesticide use – progress, shortcomings and implications for registration of plant protection active substances and products
Date: 15 December 2017
Directive 2009/128/EC on the sustainable use of pesticides (Sustainable Use Directive; SUD) was adopted on 21 October 2009 as part of the EU 2006 Thematic Strategy on the sustainable use of pesticides. The Directive aims at reducing the risks and impacts of pesticide use on human health and the environment by introducing different targets, tools and measures such as Integrated Pest Management (IPM) or National Action Plans (NAPs). Since entry into force, the regular reporting requirements of the Directive were met by various means such as a Commission assessment of the NAPs, two audit series on sustainable pesticide use performed between 2012-2016, a survey of all Member States as well as fact-finding visits to some Member States in 2017 to investigate the overall progress made with implementation of the Directive and the National Action Plans. “By 14 December 2018, the Commission shall submit to the European Parliament and to the Council a [final] report on the experience gained by Member States on the implementation of national targets established in accordance with paragraph 1 in order to achieve the objectives of this Directive. It may be accompanied, if necessary, by appropriate legislative proposals” (Dir. 2009/128, Art. 4). Read the whole article.
By Dr Lars Huber, Head of Biostimulants, Fertiliser, IPM
EU Agrochemical regulation system under scrutiny at the Agchem Forum in Nice, September 2017
Date: Dezember 2017
"Growing pains of EU agchem regulatory regime" is the article on the Nice conference by Robert Bicket entitled. Quoting a number of participants from authorities and industry, he paints a vivid picture of the difficulties and controversies currently surrounding the regulatory regime in the EU. SCC colleagues also participated actively in this lively discussion which detailed the prevailing complications and confusions. In a turn away from such controversies, the author then elaborated on the presentation given by SCC's Dr. Bernd Brielbeck on low risk substances. Of course the content of that presentation is already familiar to the readers of SCC’s Newsletter Vol. 17, No. 3, but here it can be re-visited from a refreshingly new and independent angle. _______________________________________________________________
New Organic Farming regulation to be expected in 2021?
Date: 6 December 2017
The trilogue agreement for a new organic regulation of June 2017 was adopted by the Special Committee on Agriculture (SCA) on 20. November 2017 and by the Parliamentary Committee on Agriculture (AGRI Committee) on 22.11.2017. According to the European Commission a new organic regulation will enter into force on 1 January 2021 and “will apply to the live and unprocessed agricultural products, including seeds and other plant reproductive material and processed agricultural products used as food and feed. Processed products could be labelled as organic only if at least 95 % of the agricultural ingredients are organic”. Organic farming is one of the most dynamic sectors of EU agriculture, currently growing at around 400.000 ha per year with a growth peak of 800.000 ha per year in the last two years.
Organic market had a mean yearly growth of 12.5 % in the last 10 years and is worth around €27 billion. The new legislation shall provide a simpler and more harmonized approach. Commission states that the main improvement of the new regulation will be the introduction of one set of EU-wide rules covering the whole EU organic sector and is going to apply also to non-EU farmers who export their organic products to the EU market. IFOAM (International Federation of Organic Agriculture Movements) EU acknowledged the huge effort made by the stakeholders to improve the text. However, IFOAM EU also showed some concerns as voting did not result in a strong majority in favour of the existing draft whereat Austria and Germany, two of the biggest players in the organic sector, did not endorse the text. Therefore, IFOAM called for a strong commitment by the EU Institutions and by the Member States to work together on further improvements on the legislative text.
New EU fertiliser regulation: “Dual use” for Plant Biostimulants and Plant Protection Products rejected by EU parliament
Date: 6 November 2017
On 23 to 26 October 2017, 404 amendments to the upcoming EU fertiliser regulation (“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) and thus the future on CE marked fertilizing products and biostimulants were debated in the European Parliament (see also SCC's “Current News” of 23 October 2017).
In the interview with AgroPages, Dr Lars Huber reflects on increasing interest of major multinationals, general regulatory trends and recent market changes. To read more, please follow the link.
Dr Lars Huber, Head of Biostimulants, Fertiliser, IPM _______________________________________________________________
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.
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.
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
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
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 Biopesticide _______________________________________________________________