scholarly journals Toward a conceptual framework for food safety criteria: Analyzing evidence practices using the case of plant protection products

2020 ◽  
Vol 127 ◽  
pp. 104683 ◽  
Author(s):  
Christine Hassauer ◽  
Jutta Roosen
Keyword(s):  
Food Safety ◽  
Conceptual Framework ◽  
Plant Protection ◽  
Plant Protection Products

scholarly journals Application of the Threshold of Toxicological Concern (TTC) in Food Safety: Challenges and Opportunities

2021 ◽  
Vol 3 ◽  
Author(s):  
Rositsa Serafimova ◽  
Tamara Coja ◽  
George E. N. Kass
Keyword(s):  
Food Safety ◽  
Plant Protection ◽  
Plant Protection Products ◽  
The European Union ◽  
Use Of Data ◽  
Challenges And Opportunities ◽  
Guidance Documents ◽  
Threshold Of Toxicological Concern ◽  
Active Substances

The safety assessment of chemicals added or found in food has traditionally made use of data from in vivo studies performed on experimental animals. The nature and amount of data required to carry out a risk assessment is generally stipulated either in the different food legislations or in sectoral guidance documents. However, there are still cases where no or only limited experimental data are available or not specified by law, for example for contaminants or for some minor metabolites from active substances in plant protection products. For such cases, the Threshold of Toxicological Concern (TTC) can be applied. This review explores the use of the TTC approach in food safety in the European Union, in relation to the different food sectors, legal requirements and future opportunities.

Linking the effects of plant protection products on biodiversity and ecological processes to potential impairment of ecosystem functions and services—A multidisciplinary conceptual framework.

2022 ◽  
Author(s):  
Stéphane Pesce ◽  
Annette Bérard ◽  
Marie-Agnès Coutellec ◽  
Alexandra Langlais-Hesse ◽  
Mickaël Hedde ◽  
...  
Keyword(s):  
Ecosystem Services ◽  
Conceptual Framework ◽  
Policy Making ◽  
Plant Protection ◽  
Plant Protection Products ◽  
Risk Assessments ◽  
Ecosystem Functions ◽  
Environmental Sciences ◽  
Ecological Processes ◽  
Scientific Experts

There is growing interest in using the ecosystem services framework for environmental risk assessments of plant protection products (PPP). However, there is still a broad gap between most of the ecotoxicological endpoints used in PPP risk assessment and the evaluation of the risks and effects of PPP on ecosystem services. Here we propose a conceptual framework to link current and future knowledge on the ecotoxicological effects of PPP on biodiversity and ecological processes to their consequences on ecosystem functions and services. We first describe the main processes governing the relationships between biodiversity, ecological processes and ecosystem functions in response to effects of PPP. We define 12 main categories of ecosystem functions that could be directly linked with the ecological processes used as functional endpoints in investigations on the ecotoxicology of PPP. An exploration of perceptions on the possible links between these categories of ecosystem functions and groups of ecosystem services (by a panel scientific experts in various fields of environmental sciences) then finds that these direct and indirect linkages still need clarification. We illustrate how the proposed framework could be used on terrestrial microalgae and cyanobacteria to assess the potential effects of herbicides on ecosystem services. The framework proposed here uses a set of clearly-defined core categories of ecosystem functions and services, which should help identify which of them are effectively or potentially threatened by PPP. We argue that this framework could help harmonize and extend the scientific knowledge that informs decision-making and policy-making.

scholarly journals Bibliographic review of phytopharmacovigilance actions and measures on plant protection products in Morocco

2021 ◽  
Vol 319 ◽  
pp. 01034
Author(s):  
Madiha Bahouq ◽  
Hanane Bahouq ◽  
Abdelmajid Soulaymani
Keyword(s):  
Food Safety ◽  
Plant Protection ◽  
Integrated Approach ◽  
Plant Protection Products ◽  
Alternative Methods ◽  
Maximum Residue Limits ◽  
High Maximum ◽  
Potential Risks ◽  
Agricultural Use ◽  
Active Substances

Plant protection products present major risks to human health. Like other countries, Morocco is adopting phytopharmacovigilance measures. These steps are part of Morocco’s integrated approach aiming the rational use of pesticides. A census of the various actions and measures undertaken by Morocco through the National Food Safety Office (ONSSA) in terms of monitoring and controlling the use of pesticides for agricultural use will be presented. Between 2018 and 2020, Morocco proceeded with the withdrawal of 15 active substances and 48 pesticides and the discharge of 10 tons of imported pesticides that did not comply with standards with a review of 10 active substances harmful to humans and animals. A quantity of 17641 tons of food products unfit for consumption by excess of pesticides, 136 tons of potatoes and 125 tons of mint were sent back and destroyed due to high maximum residue limits or use of unauthorized pesticides. In the same context, training workshops for farmers on the proper use of pesticides and the management of potential risks of poisoning are organized. As well as the adoption by the Moroccan government in 2020 of a law project to limit the use of dangerous pesticides and promote alternative methods.

scholarly journals The role of the European Food Safety Authority in the active substance approval and renewal procedures within the EU pesticide policy

2021 ◽  
Vol 60 (90) ◽  
pp. 165-187
Author(s):  
Slađana Mladenović
Keyword(s):  
Food Safety ◽  
Active Substance ◽  
Plant Protection ◽  
Plant Protection Products ◽  
Scientific Output ◽  
European Food Safety Authority ◽  
Scientific Quality ◽  
Analysis Model ◽  
Member States ◽  
The Eu

The EU decentralised agencies are involved in various sectorial EU policies and related composite procedures. One of the agencies, the European Food Safety Authority (EFSA), has a prominent role in the composite procedures within the EU pesticide policy - the active substance approval and renewal procedures. These procedures represent the initial steps in the complex administrative process of placing on the market and control of use of plant protection products. The procedures are arranged under the linear risk analysis model within which the scientific risk assessment is performed by Member States and the EFSA, while the political risk management is performed by the Commission and Member States in the comitology procedure. After a brief analysis of the key stages and outcomes of the procedures, the paper discusses two topics. The first relates to the properties of three key aspects of the EFSA's role in the procedures: 1) involvement in adopting guidance documents; 2) publishing appropriate documents and deciding on confidentiality requests; and 3) preparing and submitting the conclusion, its main scientific output related to active substance. The second topic includes five elements of confidence in the EFSA regarding the course and outcome of the procedure: efficiency, independence, transparency, high scientific quality and effective risk communication. The paper discusses the properties of the elements, the main identified challenges associated with them, as well as ongoing and future responses to these challenges, especially those introduced by the Transparency Regulation, adopted in 2019 and applicable from 27 March 2021.

scholarly journals Risk Assessment of the Metabolite M44 of Bixafen, One of the Active Substancesin Aviator Xpro EC225

2019 ◽  
pp. 317-318
Author(s):  
Jan Ludvig Lyche ◽  
Hubert Dirven ◽  
Marit Låg ◽  
Asbjørn Magne Nilsen ◽  
Katrine Borgå ◽  
...  
Keyword(s):  
Food Safety ◽  
Plant Protection ◽  
Experimental Studies ◽  
Plant Protection Products ◽  
Guidance Document ◽  
Developmental Effects ◽  
Historical Control Data ◽  
The Eu

Aviator Xpro EC 225 containing the active substance bixafen was assessed by VKM in spring 2013, and it was concluded that the metabolite M44 has potential for groundwater contamination. Furthermore, VKM assessed in late 2013 the relevance of this metabolite in accordance with the EU guidance document on metabolites in groundwater, and concluded that the malformations observed in rabbits exposed to the metabolite should be considered treatment related. VKM also concluded that the data presented to evaluate the possible genotoxic properties of the metabolite was insufficient to reach a conclusion. Based on this, the Norwegian Food Safety Authority rejected the approval of Aviator Xpro EC 225. The applicant has now submitted results from an in vivo study to strengthen the basis for assessment of genotoxic properties, and also submitted new historical controls in relation to the experimental studies on foetal developmental effects in rabbits. The VKM Panel on Plant Protection Products has discussed the questions raised by The Norwegian Food Safety Authority on the basis of the new data, and has the following opinion: On the assessment of genotoxic properties of the M44 metabolite of bixafen, one of the active ingredients of Aviator Xpro EC 225. It is the view of VKM Panel on Plant Protection Products that the new in vivo mouse micronucleus study, supplemented together with a separate study demonstrating bioavailability, overrides the results of the in vitro clastogenicity studies. Taken together, it is the opinion of VKM that under the conditions studied, M44 should be considered as non-genotoxic. On the assessment of the relevance of the foetal malformations in M44 exposed animals. VKMs Panel on Plant Protection products has assessed the arguments and new historical control data presented by the applicant, intended to show that metabolite M44 is not teratogenic. It is however the opinion of the Panel that the arguments and the new historical data provided by the applicant do not alter the panel’s previous conclusion; that the malformations observed in rabbits exposed to the metabolite M44 should be considered treatment related.

scholarly journals Risk Assessment of the Active Plant Protection Product Ingredient MCPA (4-chloro-2-methylphenoxyacetic acid): AOEL and ADI Determination

2019 ◽  
pp. 38-39
Author(s):  
Asbjørn Magne Nilsen ◽  
Hubert Dirven ◽  
Jan Ludvig Lyche ◽  
Marit Låg ◽  
Katrine Borgå ◽  
...  
Keyword(s):  
Food Safety ◽  
Plant Protection ◽  
Absorbed Dose ◽  
Plant Protection Products ◽  
Dermal Absorption ◽  
Renal Effects ◽  
In Vivo Experiments

MCPA (4-chloro-2-methylphenoxyacetic acid) is the active ingredient in several registered herbicides. VKM concluded in 2006 that the effects observed in experiments with dogs were of little relevance to humans, and an AOEL value of 0.036 mg/kg bw/day was proposed, based on renal effects in a 90-day study in rats. The manufacturer is of the opinion that AOEL should be set to 0.11 mg/kg bw/day, and ADI to 0.05 mg/kg bw/day, based on the view that since a 90-day and 2-year study in rats were conducted in the same lab using the same rat strain, it is reasonable to eliminate effects which are not reproduced in both sets of data. The Norwegian Food Safety Authority has therefore requested VKM’s Panel for Plant Protection Products for an opinion on the determination of NOAEL values based on the 90-day and 2-year studies in rats, and consider if it is acceptable to use the manufacturer's approach for an overall consideration of the submitted studies. The Panel has discussed the findings in the two rat studies and concluded that it is not considered acceptable that individual studies separated by several years, in this case studies performed in 1985 and 1988, are taken together and data not reproduced in both sets eliminated. The Panel is still of the opinion that both AOEL and ADI for MCPA should be set to 0.036 mg/kg bw/day based on a NOAEL of 3.6 mg/kg bw/day (50 ppm) from assessment of the renal effects in the 90-day study in rats. The manufacturer has also requested a reconsideration of the present values for dermal absorption which was set by the Norwegian Food Safety Authority during the administrative review of the product MCPA 750 Liquid in 2013. VKM’s Panel on Plant Protection Products supports the conclusion of the Norwegian Food Safety Authority concerning the determination of values for dermal absorption of MCPA. This includes the consideration of remaining substance in skin after washing as part of the absorbed dose in the in vitro studies, and the use of the same experimental time period in the in vitro and in vivo experiments as a basis for the so-called “Triple-pack-approach” for determination of human dermal absorption.

scholarly journals Official controls on food safety: Competent Authority measures

2020 ◽  
Vol 9 (2) ◽  
Author(s):  
Alfredo Rossi ◽  
Giovanni Rossi ◽  
Alfonso Rosamilia ◽  
Massimo Renato Micheli
Keyword(s):  
Food Safety ◽  
Plant Protection ◽  
Animal Health ◽  
Competent Authority ◽  
Plant Protection Products ◽  
Legal Analysis ◽  
Legal Cases ◽  
Health Authorities ◽  
Official Control ◽  
Principle Of Proportionality

Since December 14th, 2019, Regulation (EC) No 882/2004 has been replaced by Regulation (EU) 2017/625, which sets the activity of the official control on food safety, extending the scope of the previous regulation. The broader scope of the new regulation aims to ensure compliance across the European Member States in the Union in the fields of food, feed, animal health and welfare, plant health and plant protection products. The administrative measures that the Competent Authorities adopt following the finding of a non-compliance regarding food hygiene, should be take into account not only the risk assessment, but a series of criteria dictated by both European and national legislation and comply with the generals principles governing administrative action. The aim of this study is to conduct a legal analysis of: (i) the provisions set out in Regulation (EU) 2017/625 concerning executive actions in the case of noncompliance, and (ii) the criteria used to assess the appropriate remedial measures. The study was completed by analysing recent legal cases on food safety, which in many cases have censure the work of the Local Competent Authority, and has brought to light a distorted and uneven application of the legislation on food safety, especially in cases in which drastic measures had been adopted, such as the closure of the productive activities, which has a heavy impact on the food business operators in the food sector concerned. In addition to an incorrect application of the specific health legislation, there is also a violation of the principle of proportionality, of community origin. Indeed, the principle of proportionality, an essential factor in administrative review, which has been used as a leading criterion in the adoption of administrative measures by of the Health Authorities of the Competent Authority.

scholarly journals Effect of the Application Date of Fertilizer Containing Silicon and Potassium on the Yield and Technological Quality of Sugar Beet Roots

Plants ◽  
2021 ◽  
Vol 10 (2) ◽  
pp. 370
Author(s):  
Arkadiusz Artyszak ◽  
Dariusz Gozdowski ◽  
Alicja Siuda
Keyword(s):  
Sugar Beet ◽  
Foliar Application ◽  
Plant Protection ◽  
Plant Protection Products ◽  
Water Shortage ◽  
The European Union ◽  
Yield Increase ◽  
Time Of Application ◽  
Technological Quality

Water shortage and drought are a growing problem in Europe. Therefore, effective methods for limiting its effects are necessary. At the same time, the “field to fork” strategy adopted by the European Commission aims to achieve a significant reduction in the use of plant protection products and fertilizers in the European Union. In an experiment conducted in 2018–2020, the effect of the method of foliar fertilization containing silicon and potassium on the yield and technological quality of sugar beet roots was assessed. The fertilizer was used in seven combinations, differing in the number and time of application. The best results were obtained by treating plants during drought stress. The better soil moisture for the plants, the smaller the pure sugar yield increase was observed. It is difficult to clearly state which combination of silicon and potassium foliar application is optimal, as their effects do not differ greatly.

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