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Organic production systems rely on different combinations of agronomic levers to ensure their sustainability, notably seeds and crop protection products. These inputs were mostly developed for conventional farming, which is the main market, and then evaluated under organic conditions. However, the growth of organic farming raises the question of producing inputs more specifically designed for this type of production, with its technical constraints, concepts and ethics. Recently, changes to European regulations on organic farming have opened up new perspectives, particularly in terms of varietal selection and evaluation, with introduction of the notions of “organic variety” and “organic heterogeneous material”. These two notions challenge and question the concept of variety, as well as the classic methods for evaluating their performance. With regard to crop protection products, a number of products can now be used on oilseed crops, including basic substances, low-risk substances and biocontrol agents but, the list remains limited, particularly for sunflower and soybean. However, new innovations are emerging, particularly in biocontrol agents, which augur new possibilities for controlling diseases and pests for which no solution is currently available. It is therefore necessary to support research in order to provide rapid solutions, and also to ensure that regulations evolve to promote their integration and availability to farmers. The use of inputs (seeds and plant protection products) in organic farming is governed by a number of European regulations, which are sometimes difficult to harmonize.

PurposeInduction chemotherapy (IC) before radiotherapy lowers distant failure (DF) rates in locally advanced squamous cell carcinoma of the head and neck (SCCHN). The goal of this phase III trial was to determine whether IC before chemoradiotherapy (CRT) further improves survival compared with CRT alone in patients with N2 or N3 disease.Patients and methodsTreatment-naive patients with nonmetastatic N2 or N3 SCCHN were randomly assigned to CRT alone (CRT arm; docetaxel, fluorouracil, and hydroxyurea plus radiotherapy 0.15 Gy twice per day every other week) versus two 21-day cycles of IC (docetaxel 75 mg/m(2) on day 1, cisplatin 75 mg/m(2) on day 1, and fluorouracil 750 mg/m(2) on days 1 to 5) followed by the same CRT regimen (IC + CRT arm). The primary end point was overall survival (OS). Secondary end points included DF-free survival, failure pattern, and recurrence-free survival (RFS).ResultsA total of 285 patients were randomly assigned. The most common grade 3 to 4 toxicities during IC were febrile neutropenia (11%) and mucositis (9%); during CRT (both arms combined), they were mucositis (49%), dermatitis (21%), and leukopenia (18%). Serious adverse events were more common in the IC arm (47% v 28%; P = .002). With a minimum follow-up of 30 months, there were no statistically significant differences in OS (hazard ratio, 0.91; 95% CI, 0.59 to 1.41), RFS, or DF-free survival.ConclusionIC did not translate into improved OS compared with CRT alone. However, the study was underpowered because it did not meet the planned accrual target, and OS was higher than predicted in both arms. IC cannot be recommended routinely in patients with N2 or N3 locally advanced SCCHN.

Radiolabeled peptides are valuable tools for diagnosis or therapies; they are often radiofluorinated using an indirect approach based on an F-18 prosthetic group. Herein, we are reporting our results on the F-18 radiolabeling of three peptides using two different methods based on click reactions. The first one used the well-known CuAAC reaction, and the second one is based on our recently reported hetero-Diels-Alder (HDA) using a dithioesters (thia-Diels-Alder) reaction. Both methods have been automated, and the 18F-peptides were obtained in similar yields and synthesis time (37-39% decay corrected yields by both methods in 120-140 min). However, to obtain similar yields, the CuAAC needs a large amount of copper along with many additives, while the HDA is a catalyst and metal-free reaction necessitating only an appropriate ratio of water/ethanol. The HDA can therefore be considered as a minimalist method offering easy access to fluorine-18 labeled peptides and making it a valuable additional tool for the indirect and site-specific labeling of peptides or biomolecules. [ABSTRACT FROM AUTHOR]

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.

Since the EU Directive (EC) No 128/2009 (SUD) was approved by the European Parliament, the establishment of a general framework aimed at securing the sustainable use of pesticides was laid down, and European Union (EU) Member States adopted National Action Plans in accordance with this Directive. Specifically, for EU Member States, pesticides, objectives and quantitative targets were created. Therefore, the EU Commission provided a methodology for risk assessment as the derivation of two harmonised risk indicators: HRI_1 and HRI_2. The present study focuses on HRI_1, as this can be implemented at the country level. Each EU Member State delivers annual harmonised risk indicators values to the Commission based on calculations using their own data and results. However, only the EU Commission can derive this HRI_1 (concatenated) indicator at the EU level. Therefore, the present study is an attempt to shed some light on the modus operandi used by the EU Commission to compile this HRI_1, and it also aims to clarify these calculations. Data originating from twenty-seven EU Member States were analysed. These data were compared to data published on the EU Commission website over time. Possible virtual developments including the modification and evolution of active substance statuses are envisaged. [ABSTRACT FROM AUTHOR]

Biocontrol agent (BCA) plant protection active substances composed from microorganisms, semiochemicals and substances from natural origins are increasing in Europe, since their entry into force of Regulation (EC) 1107/2009, in number and as a percentage of total active substances. As they are included in the scope of plant protection products (PPPs), this raises the question as to whether they are only substitute active substances, more socially acceptable, sustainable and environmentally preferable, or really another way of managing bioaggressors, pests and diseases. As we have conducted a survey of all active substances listed in all Parts of Regulation EU 540/2011 and compared chemical to BCA active substances, described their evolution and characteristics since 2011 and predicted the global perspective in the future years for both chemical, which are in decline, and BCA AS separately, these works raised the question of whether these BCA AS are a substitution, as is often the case for users, for the previous chemical AS, or whether they are fundamentally different new substances, which clearly obey a new vision of crop protection. This study therefore encompasses all active substances approved at any time in Europe since 2011 for both categories, whether still approved or not. At the end of this assessment, the following conclusion can be drawn: BCA AS are mainly fundamentally different substances from chemical AS, in all the compartments studied. A comparison between BCAs and chemical active substances allowed under (EC) 1107/2009 PPP Regulation is described together with a characterisation of BCA AS listed in EC 540/2011 PPP Regulation. Finally, the specific distinction of BCA vs. chemical active substance profile is analysed. This work allows us to conclude on the evolution of crop protection and the means that must be implemented to face current and new threats. [ABSTRACT FROM AUTHOR]

Basic Substances are a newly effective category of Plant Protection Product under EC Regulation No 1107/2009. The first approved application of Equisetum arvense L. opened Part C of Implementing Regulation (EU) No 540/2011, which lists the basic substance approved. Although E. arvense was described as a fungicide extract, subsequent applications like chitosan were related to non-biocide molecules. Consequently, plant protection product data were collected from research on alternative or traditional crop protection methods. They are notably issued or derived from foodstuffs (plants, plant by-products, plant derived products, substances and derived substances from animal origin). Applications are currently submitted by our Institute, under evaluation at different stages of the approval process or already approved. Remarkably, this Basic Substance category under pesticide EU Regulation was surprisingly designed for these non-biocidal plant protection products. In fact, components described as the “active substance” of most of the actual applications are food products like sugars and lecithin. Basic Substance applications for these foodstuffs are therefore a straightforward way of easily gaining approval for them. Here we describe the approval context and detail the agricultural uses of theses food products as Biological Control Agents (BCAs) or biorationals for crop protection. From all deposited or approved Basic Substance Application (BSA), a proof has been provided that non-biocide and food products via physical barrier or lure effects may be effective plant protection products with an acceptable low profile of concern for public and agricultural safety.

The use of macro-organisms for crop protection is one of the four pillars of biocontrol. These predators or parasitoids of crop pests are used, by introduction or conservation, in fields, greenhouses and orchards in order to reduce the impact of sucking (sap-feeding) or chewing (phytophagous) insects. However, plant protection is not the only usage of these macro-organisms, and the category was recently expanded to include global usefulness for plants in Europe. Since 2012, under the provisions of Articles L. 258-1 and -2, R. 258-1 of the French Rural and Maritime fishing Code (CRPM), and Decree no. 2012-140 of 30 January 2012, the introduction of non-indigenous macro-organisms has been regulated. Using all published national regulations, organism lists and outcomes from the French Agency for Food, Environmental and Occupational Health Safety (ANSES), we have characterized these indigenous and allowed non-indigenous macro-organisms in a systemic and complete way. After first studying these regulations and their impact in 2018, we analyze here the macro-organisms involved and their implementation regarding their origins, targets and applications in crop growth and protection. [ABSTRACT FROM AUTHOR]

The specific status of active substance candidates for substitution (CfS) is detailed by Article 24 of plant protection Commission Regulation EC No 1107/2009 (PPP Regulation). The criteria of candidates for substitution are now clearly defined: low acceptable daily intake/acute reference dose/acceptable operator exposure level or two persistent, bio-accumulative or toxic criteria, or by nature of the critical effects: non-active isomers, carcinogen 1A/1B, toxic for reproduction 1A/1B or endocrine disruption properties, with these later properties now being well characterised. The total number of active substances CfS has been in constant evolution since 2011, with the first batch of candidates for substitution being published in 2015 and updated since then. After a slow decrease, growth is again observed, with another list of active substances being granted this status. CfS are substances targeted by the PPP Regulation that are supposed to be cancelled or non-renewed at the active substance level or substituted at the market authorisation level. CfS are also supposed to be replaced by substances with better toxicological profiles. However, after five years of implementation of the status, their number, which is intended to decrease, remains high, at sixty residual CfS. We exhibit here their evolution. [ABSTRACT FROM AUTHOR]

The HDA reaction of dithioesters was developed as a new click-reaction compatible with the indirect 18F-labelling of peptides. It involves dithioester-peptides and a radiofluorinated diene as a novel prosthetic group. The method was applied to a PSMA-ligand for the in vivo detection of LNCap tumors in xenografted mice. [ABSTRACT FROM AUTHOR]

Signed in 2009, the plant protection Commission Regulation EC No 1107/2009 created a new category of active substances, the low-risk substances, with specific status defined in Article 22. The initial and specific criteria, not suitable for microorganisms and natural substances, were modified in 2018, and the first low-risk substance, allocating Part D of Regulation EC No 540/2011, was granted in the same year. Since then, thirty-three low-risk substances have been granted with this specific status through approvals and renewals, while a larger list of potential low-risk substances from already-approved active substances was published. This list is only exploited during renewals, and this process would take another five years to complete. After four years of the implementation of this status, the number of such substances is still low, but is intended to increase slowly. Two more low-risk substances are already pending in 2021, which will bring the number of low-risk substances to thirty-five, while the initial list of potential low-risk substances (only renewals) included fifty-seven substances. [ABSTRACT FROM AUTHOR]