Basic substances: a new opportunity for approval copper at EC phytopharmaceutical regulation 1107/2009

Bio control agents: BCA, promising for plant protection are the combination of macro organisms, microorganisms, chemical mediators (pheromones, semiochemicals), and natural substances (from mineral, animal, or vegetal origin). EC regulation: Following, the enter in vigour of the new phytochemical EC Regulation 1107/2009 on May 14th 2011, the opportunity of approval at EU level, for new categories, are now available. Together with regular active substances, as previously managed by Dir 91/414, two new categories were introduced “Basic Substances” described via Article 23 and “Low Risk Substances” defined in Art. 22. Further specific EU-Guidance documents, regarding data requirement, are available or in progress for BCAs sub-category: microorganisms (baculovirus), pheromones (sclp) or botanicals. a. Opportunity of testing the first category (basic substances) for plant extract and light compounds as agriculture aid was engaged by ITAB in 2011 and ended up with an EU-Guidance document, available as working document (SANCO/10363/2012 rev.7) managed by DGSanco in one hand, and Equisetum (Horsetail) BSA pilot project in the other hand. b. Implementation of the second category (Low Risk substances) is in progress in order to produce equivalent Guidance document for early 2014. Basic substances: As matter of fact, these approvals as basic substance are by derogation to general pesticide regulation. Opportunity of the use of plant water extract (Nettle) and food compounds (sugars) in agriculture was not previously attach to any regulation, except in organic farming although some were approved at EC Directive 91/414 (Garlic extract, acetic acid) but as phytopharmaceuticals. Among these alternative products used for crops protection, notably from plants, natural extracts used traditionally by gardeners or farmers, are deemed potentially interesting. The use of these natural extracts preparations can be done now in compliance with regulatory requirements as plant protection substitution product, or plant defense enhancer for agriculture, and especially organic farming

Basic Substances under EU Pesticide Regulation: An Opportunity for Organic Production?

Some of the active substances allowed in organic production are now approved as basic sub- stances under the EU plant protection products regulation. Previously, all organic farming permitted active substances were approved as conventional plant protection products. In accordance with the criteria of Article 23 of the EU regulation (EC) No 1107/2009, basic substances are granted without maximum residue limits and have a good prospect for being included in Annex II of organic farming Regulation (EC) 889/2008. In fact, most of them are already permitted in organic farming. At this stage, it seems desirable to organize applications in order to avoid duplications and to clarify strategy across Europe. This organization should be planned in order to identify corresponding knowledge and data from field experiments, and to further constitute the most crucial issues related to organic production. A work of this nature was initially supported by IFOAM-EU for lecithin, calcium hydroxide and Quassia extract. The Institut Technique de l’Agriculture Biologique (ITAB) was previously engaged in a large-scale approval plan motivated by the continuous demand for the regularization of compounds/substances already in use and has a mandate for testing and approving new compatible substances. Thus, the horsetail extract (Equisetum arvense) was the first approved basic substance and ITAB has obtained 11 of the 15 basic substances approved at the EU level

Novel Plant Protection Regulation: New Perspectives for Organic Production

So called ’active substances’ (A.S.) which are allowed in Organic Production are regularly criticized for different reasons. Previously, although permitted in Organic Farming some substances were not approved under EU general plant protection products (PPP) regulation; therefore they were removed for their toxicity or exhibited characteristics (persistence, broad spectrum). Recent approbations under different new Articles of the EC regulation 1107/2009, gave rise to substances granted without maximum residue limits (MRL). We previously described approved basic substance (Art. 23) as potential candidates for organic farming; here we describe low risk substances (Art. 22) as new implements for substitution of controversial organic biopesticides and consequently as candidates for substitution (Art. 24)

A Decade of Antifungal Leads from Natural Products:2010-2019

In this review, we discuss novel natural products discovered within the last decade that are reported to have antifungal activity against pathogenic species. Nearly a hundred natural products were identified that originate from bacteria, algae, fungi, sponges, and plants. Fungi were the most prolific source of antifungal compounds discovered during the period of review. The structural diversity of these antifungal leads encompasses all the major classes of natural products including polyketides, shikimate metabolites, terpenoids, alkaloids, and peptides

Imaging thrombosis with 99mTc-labeled RAM.1-antibody in vivo.

Platelets play a major role in thrombo-embolic diseases, notably by forming a thrombus that can ultimately occlude a vessel. This may provoke ischemic pathologies such as myocardial infarction, stroke or peripheral artery diseases, which represent the major causes of death worldwide. The aim of this study was to evaluate the specificity of radiolabeled Rat-Anti-Mouse antibody (RAM.1).We describe a method to detect platelets by using a RAM.1 coupled with the chelating agent hydrazinonicotinic acid (HYNIC) conjugated toWe demonstrated a quick and strong affinity of the radiolabeled RAM.1 for the platelet thrombus. Results clearly demonstrated the ability of this radioimmunoconjugate for detecting thrombi from 10 min post injection with an exceptional thrombi uptake. Using FeClThanks to the high sensitivity of SPECT, we provided evidence that [journal articleresearch support, non-u.s. gov't2018 062018 03 17importe

Regulatory Evolution of Neonicotinoid Insecticides as Plant Protection Active Substances in Europe

Neonicotinoid (NN) insecticides derived from natural insecticide nicotine are EU chemical crop protection systemic active substances that are controversial regarding their toxicity and ecotoxicity, especially versus pollinators and birds. Clearly, the last European evaluation by the European Food Safety Authority exhibited a danger to wild and managed bees. Concomitantly, the decline in birds was partially attributed to this class of substances, which constitutes a family in itself, both in Europe and the USA. At the regulatory level, following the initial approval waves in 2011 and 2019, and mainly taking into account these ecotoxicological considerations, the commission banned the use of three NN insecticides in 2013 (imidacloprid, clothianidin, and thiamethoxam), and later, only one NN (acetamiprid) was renewed. Four NN approvals were removed by the end of approval or non-renewal in 2019 and 2020, and two are currently concerns for renewals in 2025, even if extensions of the approval durations of these NNs are to be expected due to the current slowness of the renewal procedure. Therefore, from the total number (17) of NN insecticide molecules known all over the world, up to seven NN were approved by the EU plant protection Regulation EC 1107/2009 between 2011 and now. All of these active substances are listed in Parts A and B of Regulation EU 540/2011 managing active substances. The regulatory evolution of these agrochemicals is analysed in this work, from the corresponding global modifications in terms of the number of active substances, employment, functions, uses covered, protected crops, and maximum residue limits. We also analysed their ability to persist as an agrochemical family and the potential of the inclusion of new NN members together with their current restrictions during their active substance life in Europe

Basic and low-risk substances under European Union pesticide regulations: a new choice for biorational portfolios of small and medium-sized enterprises

Directive 2009/128/EC of the European Parliament and of the Council of 21 October 2009 established a framework for Community action to bring about the sustainable use of pesticides and encourage low concern biorationals. Basic substances described in article 23 of EC phytopharmaceutical Regulation No 1107/2009 consist of a new operative category for crop protection products with 16 substances approved so far. Another status, ruled by article 22 is also operative with 11 approved low-risk substances (see EU pesticide database). Now small and medium-sized enterprises (SMEs) have the opportunity to register biorationals at the EU level in one of the two categories. Our institute previously provided technical expertise on how to complete the Basic Substance Application (BSA), together with a description of first results. However it is clear that there is a need for a shorter survey of the two parallel procedures for SMEs. Here we provide a concise sequence of the necessary steps for SMEs, including strategic approach, a rapid steps description, a timeframe for the global pathway, up to the final step, after approval by the Plants, Animals, Food and Feed Standing Committee (PAFF). We present in detail the advantages and limitations of the two statutes. The introduction of approved substances into organic farming is also discussed. Currently basic and low-risk substance pathways are now accessible for biorationals handled by SMEs. Therefore, the option is open for SMEs to seek a possibly low-risk active substances endorsement with market authorizations or a basic substance approval with no plant protection product claims depending on the selected strategy

Novel Plant Protection Regulation: New Perspectives for Organic Production

So called ’active substances’ (A.S.) which are allowed in Organic Production are regularly criticized for different reasons. Previously, although permitted in Organic Farming some substances were not approved under EU general plant protection products (PPP) regulation; therefore they were removed for their toxicity or exhibited characteristics (persistence, broad spectrum). Recent approbations under different new Articles of the EC regulation 1107/2009, gave rise to substances granted without maximum residue limits (MRL). We previously described approved basic substance (Art. 23) as potential candidates for organic farming; here we describe low risk substances (Art. 22) as new implements for substitution of controversial organic biopesticides and consequently as candidates for substitution (Art. 24)

Evolution of Directive (EC) No 128/2009 of the European Parliament and of the Council Establishing a Framework for Community Action to Achieve the Sustainable Use of Pesticides

The EC Directive No 128/2009 established a regulatory framework for Community action to achieve the sustainable use of pesticides (phytopharmaceuticals) that entered into force in 2011. The Directive manages all aspect of pesticides approved under Regulation (EC) No 1107/2009 and listed in implementing Regulation (EU) No 540/2011 outside the approval and approval procedure, including all relevant National Action Plans (NAP), training, sales of pesticides, information awareness-raising, pesticides storage, application and equipment (i.e. inspection of equipment in use), specific practices and uses (i.e. aerial spraying), indicators and reporting on pesticide uses. This study examines the evolution of these dispositions framing the use of pesticides in Europe and the recent implementation of the harmonized risk indicators (HRI), which are expected to diminish in numbers over time. Calculation of the annual HRI values, and analysis of their evolution through the years is, therefore, for the first time, a method to quantify the evolution of the theoretical impact of pesticides at the pan-European level and to measure the progress against the original purpose of the directive, and therefore, its success. https://www.doi.org/10.21423/jrs-v07marchan

Les substances naturelles à usage biostimulant : statut réglementaire et état des lieux de ces préparations naturelles peu préoccupantes (PNPP)

Les problématiques posées par les intrants sous leurs diverses formes ont récemment bénéficié d’une plus large prise en compte, et d’un gain d’intérêt auprès du grand public et des autorités compétentes. Cette demande sociétale se traduit par une augmentation et une diversification des solutions alternatives aux intrants d’origine chimique, que ce soit avec les produits de biocontrôle pour la protection des plantes, la fertilisation ou la biostimulation. Les autorités publiques cherchent donc à cadrer l’utilisation de ces nouveaux intrants à l’aide de réglementations nationales en publiant décrets et arrêtés. C’est ainsi qu’en France est née la catégorie des Préparations naturelles peu préoccupantes (PNPP) en 2006. Cette catégorie contient les substances de base, mais aussi les substances naturelles à usage biostimulant ayant récemment fait l’objet d’une modification d’ampleur de leur réglementation, dont nous analysons ici les conséquences en termes de nombre de substances autorisées. La liste des Substances naturelles à usage biostimulant la plus exhaustive possible est obtenue à partir de différents documents officiels concernant les plantes considérées comme alimentaires pour l’être humain et l’animal. L’augmentation considérable du nombre de substances naturelles à usage biostimulant est une opportunité pour les agriculteurs et représente une évolution sans précèdent dans la réglementation, passant d’une approche positive avec des substances explicitement autorisées, à une approche négative où certaines substances sont interdites et toutes les autres sont autorisées. Cet article tente d’éclaircir la situation en permettant aux agriculteurs de disposer d’une base de données de plantes utilisables sans crainte que la substance ou la plante ne soit considérée comme non alimentaire par les autorités, et donc soumise à d’autres contraintes