Legal Instruments to Protect the Environment from the Effects of Excessive Chemistry in Agriculture on the Example of Plant Protection Products Regulation

Chemical plant protection products used in agricultural production have an impact on human health and life, but also undeniably on the state of individual elements of the environment, including biodiversity. Pollinating insects are representative of the animal world particularly sensitive to modern environmental threats generated by agriculture. The purpose of the article is to analyze and evaluate the legal regulation relating to plant protection products, made in terms of preventing excessive chemisation in agriculture, and consequently ensuring food safety. The subject of the study are the legal conditions for the admission and use of substances that ensure simultaneous benefits for plant production, in the absence of harmful effects on human and animal health and unacceptable effects on the environment. Particular attention has been paid to the authorization, on special terms, of preparations containing neonicotinoids.

Chemical plant protection products used in agricultural production have an impact on human health and life, but also undeniably on the state of individual elements of the environment, including biodiversity. Pollinating insects are representative of the animal world particularly sensitive to modern environmental threats generated by agriculture.
The purpose of the article is to analyze and evaluate the legal regulation relating to plant protection products, made in terms of preventing excessive chemisation in agriculture, and consequently ensuring food safety. The subject of the study are the legal conditions for the admission and use of substances that ensure simultaneous benefits for plant production, in the absence of harmful effects on human and animal health and unacceptable effects on the environment. Particular attention has been paid to the authorization, on special terms, of preparations containing neonicotinoids.
the PRecaUtionaRy PRinciPLe anD the PRinciPLe oF PReVention anD the aUthoRization oF PLant PRotection PRoDUcts on the maRket As indicated in the natural sciences 6 plant protection products, commonly known as pesticides, constitute a group of preparations used in agriculture, horticulture, forestry and veterinary medicine. The name "pesticide", according to the latin origin of the word (pestis 'pestilence', occido 'kill'), means a substance that aims to kill living organisms considered harmful 7 . It is a type of chemical compounds, both natural (from plants) and synthetic, which are used to destroy plant and animal parasites. Toxicity of pesticides results from the presence of biologically active ingredients that may adversely affect the biocenosis of the environment, hence the use of pesticides is associated with environmental and health risks 8 . Chemicals used in the production of pesticides, as biologically active ingredients, are toxic to specific groups of organisms (insecticides, acaricides, bactericides and others) and, therefore, it is important to ensure their selective impact 9 .
analysis and assessment of environmental and health risk is a basic factor in the introduction of pesticide preparations for widespread use. In 2018, 1,325 pesticides were on the list of chemicals regulated by eu food and nutrition legislation, of which 492 as authorized and 833 as prohibited active substances 10 .
there are four main elements in pesticide risk assessment: risk identification, dose relationship assessment, exposure scale, and overall risk characterization 11 . the results of scientific studies must be considered when assessing the acceptability of the product on the market and use.
the need to consider the risk to human health and life and the environment related to the placing of pesticides on the market and use rests on the european Union's decision-making bodies, and then on the eU member states transposing and implementing european law into national systems. the eU legislator must take into account the complex environmental protection principles arising from the Treaty on european union 12 and the treaty on the Functioning of the european Union 13 , among others the principle of sustainable development and ensuring a high level of environmental protection (Article 3 (3) Teu), the principle of integration of environmental protection requirements into eU policies and activities (article 11 tFeU), the principle of prevention or the precautionary principle (article 191 tFeU).
with regard to plant protection products, the principle of prevention (preventive action) indicates the need to prevent negative effects on the environment 14 . The principle of prevention is based on an objective assessment of whether an activity has a negative impact on the environment, which should, however, be supported by an analysis of the activity in question using the expertise in the field 15 .
A further principle is the precautionary principle, as set out in Article 191 (2) tFeU. as emphasized by P. korzeniowski, the precautionary principle raises the requirements bar against the precautionary principle much higher, because the term "foresight" includes a greater degree of precaution than provided for in the principle of prevention 16 .
The precaution applies to all activities whose negative impact on the environment is not yet fully recognized. as indicated by m.m. kenig-witkowska, the lack of scientific evidence as to the possibility of a phenomenon or process occurring is not a reason for not taking action to avoid potentially serious and irreversible damage to the environment 17 . Precaution requires that appropriate action be taken in advance when there is a reasonable probability that an ecological problem will need to be solved, and not only when practice or science confirms its existence 18 . This obliges the union bodies to strive to introduce the most effective actions corresponding to the current level of scientific and technical knowledge. this means that the new legal regulations should lead to an increase in the level of protection in force in the Member States, not to a reduction in it.
referring to the precautionary principle should always be supported by scientific risk assessment and limited to situations where there is a possibility of irreversible changes, when urgent and provisional action must be taken 19 .
the precautionary principle is a principle of the Union's environmental policy 20 . In addition, as A. Jurcewicz points out 21 eU institutions should take it into account in the context of the common agricultural Policy when taking measures to protect public health. this thesis is confirmed by the jurisprudence of the eU court of Justice and the eU court (former court of First instance). in the jurisprudence of these courts, we often find a reference to the precautionary principle in matters related to food safety. the eU General court in its judgements of 2003 in case t-392/02 Solvay Pharmaceuticals BV v. Council of the EU 22 and of 2007 in case T-229/04 Kingdom of Sweden v. EU Commission 23 , examining the allegations regarding the introduction in Community provisions of provisions preventing the use in agriculture of 54 substances that could adversely affect human health, food safety and the environment, he referred to the precautionary principle in order to avoid even a potential threat to health and people or the environment. According to its content, in cases of reasonable suspicion of probable threats, public authorities should take preventive action, even though there is no clear scientific evidence in this respect. however, this does not mean, as the eu Court pointed out in its judgement of 2002 in case T-13/99 Pfizer Animal Health v. Council of the EU 24 and in the aforementioned judgement in the case of the Kingdom of Sweden v. EU Commission, the obligation of the community institutions to assume zero tolerance, to take into account purely theoretical threats, based on unsupported hypotheses.
In the above-mentioned judgement in the case of the Kingdom of Sweden v. EU Commission, the eU General court further stressed that the choice of legal solution applied by the Community authorities must be subject to the rule, and the protection of health, safety and the environment is to prevail over economic interests. Such a position of the court speaks for recognition and interpretation of the extension of the integration principle when it is necessary for the effective implementation of the intended environmental objectives, and the principle set out in article 11 tFeU and specified in article 191 tFeU, gives grounds for the obligation to protect the value of the environment, despite obvious economic losses caused by non-approval of the plant protection product.
otherwise, the Court of Justice in its judgement of 2010 in case C-77/09 Gowan Comércio Internacional e Serviços Lda v. Ministero della Salute 25 examined the legality of the provisions of Commission Directive 2006/134/eC 26 , in which the use of the active substance in a plant protection product (fenarimol) has been temporarily restricted as a precautionary measure. The manufacturer of the indicated product containing a prohibited substance questioned the lawfulness of applying the precautionary principle as a basis for adopting a Commission Directive. The court ruled that since there is some scientific uncertainty about the assessment of the endocrine effects of substances such as fenarimol, the commission's decision to restrict the use of these substances cannot be considered as grossly erroneous application of the precautionary principle. Given the numerous scientific studies that have been invoked to prove the annulment of the commission's decision, the conclusion maintaining the decision by the court's judgement seems to suggest a wide application of the precautionary principle 27 . The precautionary principle applies in the eu approach to food safety, where it is primarily a risk management tool. where there are reasonable grounds for concern and there is scientific uncertainty, this principle may be invoked in the risk management process 28 . It refers to a situation in which: 1) there are reasonable grounds for fearing that an unacceptably high level of health risk has occurred; 2) available information and supporting data are not sufficiently complete to enable a comprehensive risk assessment to be carried out.
In such special circumstances, as emphasized by the european Court of Auditors in 2019 29 , decision-makers or risk managers can apply measures or take other actions based on the precautionary principle while seeking more complete scientific data. such actions must comply with the principles of non-discrimination and proportionality and should be temporary until more comprehensive information on risk is collected and analyzed.

thReats FRom PLant PRotection PRoDUcts FoR PoLLinatinG insects
Agriculture is one of the major sources of threat to the environment, directly through soil, groundwater and indirectly through surface water and marine pollution 30 . The literature on the subject lists many factors related to agricultural activity that cause the degradation of natural values and at the same time cause the impoverishment of biological diversity 31 . Among the greatest threats are the intensification of technologies used in agriculture, including excessive chemisation (the use of mineral fertilizers, pesticides), the degradation of so-called buffer zones (copper, mid-field forestation). these factors, inherent in the intensification of agriculture, caused the destruction of many biocoenoses and vegetation refuges Pollinating insects, which include bees, hymenoptera, butterflies, flies, beetles and many more, are particularly sensitive to the progressive degradation of the environment 33 . Alarming is, in particular, the example of bees, whose progressive decline in numbers, referred to as so-called Colony Collapse Disorder 34 , which in effect led to the listing of these insects on the european red list of endangered species by the International union for Conservation of nature (IuCn) 35 . The result of the massive disappearance of honeybee families are huge economic losses in the production of oilseeds, fruits and vegetables, as well as a threat to beekeeping 36 .
Pesticides are one of the main factors affecting the weakening of health and the disappearance of pollinating insects 37 . when examining the impact of "pesticides" on the environment, the interaction of up to several hundred active substances of plant protection products and carriers, stabilizers and auxiliary substances present in these preparations is primarily considered. Plant protection products, depending on what they are supposed to fight, are divided among others for insecticides (insecticides), fungicides (fungicides) and herbicides (herbicides)  Pobrane z czasopisma Studia Iuridica Lublinensia http://studiaiuridica.umcs.pl Data: 16/07/2020 03:28:40 U M C S Legal instruments to Protect the environment from the effects of excessive chemistry… 57 central nervous system of pests, but also bees and other pollinating insects 40 , but there is scientific evidence for the impact of these measures on animal and human health 41 .

neonicotinoiDs in the LeGaL ReGULation oF PLant PRotection PRoDUcts in the eURoPean Union
In relation to the instruments of the Common Agricultural Policy, a broader interpretation of the precautionary principle is justified by legislation regarding the authorization and placing on the market of plant protection products. already in the 1990s in the provisions of Council Directive 91/414/eeC of 15 July 1991 concerning the placing of plant protection products on the market 42 it was pointed out that the achievement of the goal of improving plant production should not be at the expense of protecting human health and the environment. For this reason, the procedural provisions authorizing the marketing measures were to provide a high level of protection, and in particular had to prevent the introduction of substances posing a risk to human health and the environment.
As a consequence, the implementation of these regulations into national legal systems has contributed to the unification of regulations, however, the form of the directive, despite the undeniable consolidation function, has also left an active role for the eu Member States. This role became apparent through the transfer of many competences to committees consisting of representatives of individual countries and the possibility of derogations due to regional differences. This thesis can be confirmed by the provision of article 6 of Directive 91/414/eec, pursuant to which the standing committee on Plant health 43 decision-making was entrusted in many issues crucial for a given regulation, including on the admission of a specific chemical substance and the removal of a substance from the list of authorized substances if, in the light of the current state of knowledge, it no longer meets the safety requirements for human, animal and environmental health 44 . 40 s.G. Potts, s.P.m. Roberts, R. Dean [et al.], Declines of Managed Honey Bees and Beekeepers in Europe, "Journal of agricultural Research" 2010, no. 49, pp. 20-22. 41 studies show the harmfulness of nicotinoids for birds, aquatic invertebrates and even -through research done on rats -for humans. see m. Grotowska, k. Janda, k. Jakubczyk, Wpływ pestycydów na zdrowie człowieka, "Pomeranian Journal Life sciences" 2018, t. 64 (2) 340, 9.12.1978, p. 25). 44 For more on this topic, see m.a. król, Przejawy europeizacji w prawie rolnym, "studia iuridica agraria" 2009, t. 7, pp. 78-79. on this basis, in 2013 the Commission seriously restricted the use of three pesticides from the group of neonicotinoids (clothianidin, imidacloprid and thiamethoxam) approved as active substances in plant protection products. The european Commission, in accordance with one of the basic principles of eu environmental law, which is the principle of prevention and the precautionary principle, decided to act in this matter, making her decisions dependent on the results of the verification of scientific reports. Commission Implementing regulation (eu) no. 485/2013 47 introduces in Article 2 a ban on placing on the market of seeds grown with the mentioned substances, except for seeds used in greenhouses. At the same time, Member States were required to submit "confirmatory information" regarding the risk assessment of these substances (including for bees) in situations that substances were still permitted. The european Food safety authority (eFsa), which has been conducting studies on the effects of substances contained in plant protection products used in field crops for several years, has confirmed the high risk of using several authorized substances for bee welfare, and research has also indicated that neonicotinoids leak out to soil and water, and from  org/10.2903/j.efsa.2019.5633, p. 5633. 49 Peer review of the pesticide risk assessment for bees for the active substance imidacloprid considering the uses as seed treatments and granules, "eFsa Journal" 2018, Vol. 16(2), Doi: https:// doi.org/10. 2903/j.efsa.2018.5178, p. 5178. 50 the ban was supported by austria, cyprus, estonia, France, Greece, spain, the netherlands, ireland, Luxembourg, malta, Germany, Portugal, slovenia, sweden, the United kingdom, italy (countries representing 74% of the eU population). the czech Republic, Denmark, Romania and hungary were opposed to the ban. apart from Poland, Belgium, Bulgaria, croatia, Finland, Lithuania, Latvia and slovakia abstained from voting. Pobrane z czasopisma Studia Iuridica Lublinensia http://studiaiuridica.umcs.pl Data: 16/07/2020 03:28:40 U M C S use of seed products and mortars containing one or more active substances of the neonicotinoid family is prohibited from 1 September 2018. Derogations may be granted until 1 July 2020 pursuant to a regulation issued jointly by the ministers responsible for agriculture, environment and health. The above regulation may be issued on the basis of an assessment prepared by the national agency for Food safety, environment and Labour, after assessing the benefits and risks of using plant protection products containing active substances from the family of neonicotinoids authorized in France, with substances related to the use of substitutes or available alternative methods (so-called "comparative assessment"). Impact on the environment, including pollinating insects, public health and agricultural activities was indicated as the primary assessment criteria 55 .

neonicotinoiDs in LeGaL instRUments oF PLant PRotection
ProDuCTS In PolAnD The rules for the prevention of environmental pollution through the use of plant protection products are governed by two legal acts in Poland: the Act of Pobrane z czasopisma Studia Iuridica Lublinensia http://studiaiuridica.umcs.pl Data: 16/07/2020 03:28:40 U M C S the right to enter the land, make an inventory of these resources, carry out compliance inspections, access to facilities where these resources are stored, for free of charge sampling for testing. Basic rules for the safe use of plant protection products for bees have also been introduced (e.g. compliance with the bee prevention period), not using not recommended and untested mixtures of plant protection products, because the mixture may have a different effect on bees than a single product 59 , non-use of pesticides on flowering weeds and slips attracting bees and pollinators. Pursuant to article 73 (2) of the Act on Plant Protection Products, the competent authority collects information on poisoning bees with plant protection products.
In accordance with the provisions of the Commission Implementing regulation (eu) no. 485/2013, in Poland the ban on the use of neonicotinoid seed dressing has been in force since 2013.
however, the provision of article 53 (1) of Regulation 1107/2009 creates extraordinary situations in plant protection, giving the possibility of temporary derogation from the established rules in special circumstances. A Member State may authorize, for a period not exceeding 120 days, the placing of plant protection products on the market, for the purpose of limited and controlled use, where such action proves necessary because of a risk which cannot be prevented by other reasonable measures. As an exception to the established rule, it should be, in my opinion, used in extraordinary circumstances, after fulfilling the condition of earlier application of funds admitted to trading in the eu, their ineffectiveness and clearly endangered socio-economic interests, the breakdown of crop production. The Member State concerned is required to inform the other Member States and the commission of the action taken, providing detailed information on the situation and any measures taken to ensure consumer safety.
In in 2019, modesto 480 Fs mortar was granted a permit for the period from 20 may to 17 september 2019, and cruiser osR 322 Fs mortar obtained a temporary permit for the period from 1 June to 28 September 2019, both in the cultivation of winter colza. it should also be stressed that the 120-day permit covers a sufficient period. This means using the exception of an emergency twice and allowing two prohibited neonicotinoids from 2013 in field crops in the eU.
Consent to the use of mortars by Polish producers of rape is therefore not an isolated case. on 21 June 2010, eFsa published a study commissioned by the european Commission to assess the legitimacy of issuing by seven eu countries (Bulgaria, estonia, Finland, Lithuania, Latvia, Romania, hungary) temporary emergency permits for mortars from the neonicotinoid group.
For example, the Bulgarian 62 report identified information that is not in line with the eFsa methodology proposed in the eFsa insecticide protocol developed under article 4 (7) of Regulation 1107/2009. therefore, eFsa could not assess whether the granting of emergency permits was scientifically substantiated and whether it was necessary because of a danger which could not be stopped by other reasonable measures.
In romania 63 , control of six extraordinary permits granted, pursuant to Article 53 of regulation 1107/2009, showed, in the absence of alternative measures, justified use of neonicotinoid containing agents in three cases, while in the other three urgent authorization was not justified. a similar situation was found for two permits granted in lithuania 64 and nine in hungary 65 .
In estonia 66 two extraordinary authorizations were granted, none of which were justified because there were alternative insecticides for the uses described, a wide range of non-insecticidal methods was available, mainly methods of cultural Finland has granted two permits in the absence of alternative insecticides. in the eFsa assessment 67 , three insecticidal culture control methods were available, but Finland considered them ineffective or moderately effective (depending on the weather when the plant or crop was changed) and no information was available on their specific use. Finland stated that there was no practical, acceptable, established program effective in combating the identified threat. similarly in the case of two permits granted in latvia 68 the lack of sufficient alternative modes of action permitted in this country was found, although some non-insecticidal methods are available here, but not as effective as chemical methods.
The analysis of the discussed cases shows that provided for in Article 53 (1) of regulation 1107/2009, the exception, giving the possibility of a temporary derogation from the established rules in plant protection in emergencies, has become a common form for evading the ban on the use of neonicotinoids in the Member States, and most in cases where there were other alternative methods of combating threats.
ConCluSIonS the use of chemical compounds in pest management has already taken place in antiquity, and the first chemicals to protect plants began to be produced in the 19 th century. Modern, effective agriculture is not possible today without the use of soil enriching substances with nutrients and agents protecting plants from harmful organisms. high efficiency in regulating growth and other biological processes in arable crops must be achieved while maintaining safety for human health and life and environmental protection.
Modern agricultural activity, especially the multiplication of agricultural chemisation, causes numerous threats to biodiversity. Particular attention has been paid in recent years to pesticides due to the presence of residues of these substances in food, as well as disclosed scientific results confirming their negative impact on human and animal health, including pollinating insects.
the legislator's role is to create the conditions for the marketing and use of substances that ensure simultaneous benefits for plant production, in the absence Pobrane z czasopisma Studia Iuridica Lublinensia http://studiaiuridica.umcs.pl Data: 16/07/2020 03:28:40 U M C S of harmful effects on human and animal health and unacceptable effects on the environment. In this respect, in the european union, the basic criterion for admitting a product to trading and use is based on the results of scientific research, and the limitation on the precautionary principle, when the negative impact on the environment has not yet been recognized. An analysis of the jurisprudence of the eu Court of Justice and the eu Court has shown that the courts repeatedly, referring to the principle of prevention and the precautionary principle, in matters related to food safety or environmental protection, examining allegations against non-use of agricultural chemicals, including pesticides, have recognized compliance with the law on restrictive measures to avoid even a potential threat.
Particular attention was paid to insecticides containing chemicals from the neonicotinoid group, which were to be withdrawn from the market in 2018 based on the provisions of the Commission implementing regulations. Several old eu countries have completely banned the use of neonicotinoids in national regulation.
As research has shown, established in Article 53 (1) of regulation 1107/2009, the extraordinary procedure allowing a temporary derogation for marketing, on the basis of specific measures containing neonicotinoids, is becoming more and more common, especially in the new eu Member States, including Poland. This also creates the danger of opening a legal path for future concessions to the chemical industry and allowing further harmful chemisation of agriculture, to the detriment of food safety and the environment. For this reason, it should be postulated at the level of the provisions of regulation 1107/2009 or the eu implementing rules for permissible exceptions to the application of this mode allowing for a temporary derogation.