The major interest for crop protection of agrochemical substances without maximum residue limit (MRL)

Abstract

Description of the subject. The real-time management of residues of plant protection products is a general issue for food producers and/or exporters. Authorized pesticides under European Regulation (EC) No 1107/2009 (Reg. 1107/2009) are granted a maximum residue limit (MRL) defined by the European Chemicals Agency (ECHA). These maximum residue limits are managed by the European Commission and listed in EC Regulation No 396/2005. MRLs for newly approved substances are set for pesticide residues present in products or groups of products covered by Annex I with a default value of 0.01 mg·kg-1, unless they have been considered, elaborated upon on approval and affected in one of the six other Annexes (II to VII). Substances listed in Annex IV are favoured in the selection of substances to be used by producers as it is for substances with very low potential impacts (low-risk substances [Art. 22 of Reg. 1107/2009] which therefore require no MRL; basic substances [Art. 23 of Reg. 1107/2009]; and microorganisms). The number of substances affected by this lack of an MRL (without residues survey requirement) has been steadily increasing since the publication of the SANCO/11188/2013 Guideline. Many biocontrol agents are listed in Annex IV, including microbial insecticides (e.g. Bacillus thuringiensis, Cydia pomonella granulosis virus), semiochemicals used in traps (e.g. ammonium acetate, putrescine) and some natural substances (e.g. sulphur) as well as all the currently listed basic substances. Objectives. To show that plant protection may be achieved with less concern or control (auto + external) than with certain agrochemical pesticides, including those without maximum residue limits (MRL). Method. Analysis of EU Pesticide Database and EU Regulation (EU) No 540/2011. Results. All approved pesticide active substances with no MRL included in Annex IV of Regulation (EC) No 396/2005, listed by substance status type (active, low-risk or basic) and category (microorganism, semiochemical or natural). Conclusions. These results may be used to help achieve plant protection with much less risk of contaminations, while noting the necessity for controls, analytical issues, positive controls, as well as the possibility of downgrading and withdrawal of approval from the market.

Scientific Opinion on the update of the list of QPS‐recommended biological agents intentionally added to food or feed as notified to EFSA (2017–2019)

“…Nevertheless, no adverse effects on pathology or animal health were observed. Charon et al (2019) describe the regulatory framework for agrochemicals (including baculoviruses) and promote the inclusion of baculoviruses as a low risk substance. Nan et al (2019) note the prion-like properties of one gene product (Late Essential Factor 10) related to the insect pathology of baculoviruses.…”

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

“…This can be explained by the small number of low-risk substances and the relatively high number of candidates for substitution [26]. It should be noted that other aspects concerning pesticides are not considered in the calculation of harmonized risk indicator 1 [2,21].…”

“…This coefficient is, therefore, an undeniable means of calculating the overall risk, but in detail, it highlights that this risk has progressed until 2018 and is still high compared to the base 100 in all cases, including the best hypotheses. Another possible notion on pesticides impact like Maximum Residue Limits (MRL) of active substances [2] and specific non-sprayed substances on crops, is that usage [21] is not considered or differentiated for the calculation of harmonized risk indicators.…”

Equisetum arvense (horsetail) Extract: The First Approved Basic Substance Allowed for EU Crop Protection

“…At present, 24 basic substances that have been identified as having neither immediate nor delayed harmful effects on human and animal health nor unacceptable effects on the environment are approved. They are permitted for the protection of conventional crops and granted without maximum residue limits (Charon, 2019), and are likely to be included in Annex I of the Regulation (EC) 2021/1165, most of them (22) in organic production also (Marchand, 2015(Marchand, , 2016(Marchand, , 2017a(Marchand, , 2021.…”