# The Globalization of Regulatory Science on Pesticides:
## History and Effects on European Law

Annie Martin-Moreno

► To cite this version:

Annie Martin-Moreno. The Globalization of Regulatory Science on Pesticides: History and Effects on European Law. Nataly Botero; Hélène Ledouble; François Allard-Huver. Pesticides. Pluridisciplinary Dialogues in Social and Human Sciences, 4, ISTE; WILEY, pp.73-95, 2025, Communication, Environment, Science and Society, 978-1-78630-950-1. 10.1002/9781394340712.ch4. hal-05513173

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Submitted on 16 Feb 2026

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A. Martin, « The Globalization of Regulatory Science on Pesticides: History and Effects on European Law », in *Pesticides. Pluridisciplinary Dialogues in Social and Human Sciences*. Ed. By N. Botero, H. Ledouble, F. Allard-Huver, ISTE Editions, 2025, pp. 73-97

Introduction

I - Chemical safety ideas and tools promoted worldwide by the OECD

A - Ideas promoted by the OECD in the chemical sector

B - Tools developed by the OECD in the chemical sector

II - The effects of the OECD's promotion of chemical safety ideas and tools in European law

A - The flow of regulatory science from the OECD to the European Union

B - A regulatory science that produces ignorance

Conclusion

References

**Introduction**

This chapter offers a legal and historical perspective on international approaches to the use of pesticides. By answering the questions concerning the tools and ideas which have presided over the constitution of regulatory science on pesticides, including the effects within the European Union, we show that regulatory science is globalized and, as a result, is moving towards European law while concealing certain harmful effects.

From a methodological point of view, the corpus of documents used, whether or not they have a normative purpose, was formed thanks to their online publication. The period studied extends from the late 1960s to the present day. There is a twofold approach. Firstly, it is based on an analysis at both an international and regional level of the formal sources of law and the standards of soft law, which are generic expressions for legally nonbinding tools, some of which nonetheless have real normative power. It also draws on disciplines other than law, for two reasons. The first is the chemical nature of pesticides, whose health and environmental effects call on a number of disciplines from the so-called hard sciences. The case law of the Court of Justice of the European Union (CJEU) on pesticides bears witness, both in the parties' arguments and in the judges' reasoning, to the complex terms of the dialogue between law and these various sciences. This interdisciplinary approach is essential for lawyers wishing to understand, explain and perhaps criticize the legal framework. The second reason, which brings us to the edges of sociology, political science and the history of science, is the fact that nongovernmental organizations (NGOs), the press, scientists and public bodies are regularly highlighting (Jouzel 2019) and denouncing a shift between the regulations that make the marketing of pesticides conditional on the production of science proving that this chemical object has no unacceptable effects on the environment and health, and another science, which would be no less consensual<fnref n="1" /> and would prove that authorized pesticides have harmful effects.

Since 2009, environmental scientists have been arguing that chemical pollution, which interacts with biodiversity and climate change, is one of the nine planetary boundaries that human activity must not transgress, if we are to avoid unacceptable global environmental change (Rockström et al. 2009). Continuing this work, other scientists asserted in 2022 that no regulatory assessment can include all of the possible impacts of the 350,000 chemical products<fnref n="2" /> on the market, in other words, that their

<footnote n="1">¹ The supplementary brief to the petition lodged by several associations against the French state with the Paris Administrative Court on January 10, 2022, refers to “a scientific consensus” that “agrochemical pollution due to the use of plant protection products is one of the main factors in the widespread decline in biodiversity”.</footnote>

<footnote n="2">² The term chemical products is used in the broad sense used in the study, including plant protection products, biocides, cosmetics, etc.</footnote>
production exceeds global assessment and monitoring capacity, and that this constitutes a transgression
that affects the Earth system’s capacity for selfregulation. This recent study concludes that increasing
production is incompatible with maintaining humanity in a safe operating space (Persson et al. 2022).
These scientific publications are echoed at the institutional level. The Organisation for Economic
Cooperation and Development (OECD), a major player in the globalization of pesticide regulatory
science, admits that there is insufficient risk assessment for 20,000–100,000 approved chemical
products (OECD 2015, p. 11). The *Office parlementaire d’évaluation des choix scientifiques et
technologiques* (French Parliamentary Office for the Evaluation of Scientific and Technological
Choices) states that “pesticides present a particularly significant threat to insects due to [...] inadequate
risk assessment regulations” at both the European and national level (OPECST 2021, p. 2). The
*Commission nationale de la déontologie et des alertes en santé publique et environnement* (French
National Commission on Ethics and Alerts in Public Health and the Environment), which commissioned
experts to reflect on improving “the articulation between ‘regulatory science’ and ‘academic science’”
in the consideration of chemical risks, reached the same conclusion (Bonvallot et al. 2021, pp. 3 and
24)<fnref n="3" />. It was along these lines that, in January 2022, five associations<fnref n="4" /> brought action against the French
government for negligence in the assessment and authorization procedures for plant protection products
(PPPs). This action, called “Justice pour le vivant”<fnref n="5" />, points, for example, to the failure to consider several
aspects in the assessment of indirect effects, notably trophic interactions<fnref n="6" /> and cumulative or cocktail
effects, in other words, the interaction between the substances contained in a single complex product,
on the one hand, and the multiple substances and compounds present in the environment, on the other.

These various forms of public and often collective mobilization have one thing in common: they
highlight the inadequacy of regulatory science, an expression whose use is appropriate in the context of
this reflection, even though it is foreign to French-speaking academic legal discourse. Formalized in the
early 1990s, regulatory science is understood as a “set of scientific assessment activities that participate
in taking legal measures aimed at framing industrial activities and products” and whose criteria and
procedures “are formalized in regulatory texts, guidelines” (Demortain and Borraz 2015, p. 279). In
concrete terms, these rules and standards are, for the most part, technical in nature, determining the
scientific protocols that make it possible, for example, to identify the effects of endocrine disruption<fnref n="7" />.
They deal with scientific issues such as the animal species that can be used for testing. The
implementation of these standards results in the production of regulatory knowledge on the effects of
chemical substances. Regulatory science is therefore at the heart of expert decision making, and we can
observe the recent emergence of the expression in the discourse of European institutions<fnref n="8" /> such as the
Council (Council of the European Union 2021, pp. 27 and 31), the Parliament (European Parliament
and Council 2019, p. 60) and the Commission (European Commission 2020a, p. 17). Its use reflects the
coexistence of two sciences: the one enshrined in the rules for the pre-market assessment of pesticides,
which legitimizes both the knowledge produced and the trade in these products, and the one conducted
outside any normative perspective. In social science research, however, regulatory science is criticized
for the influence that industrialists exert on its content through various tools such as lobbying, links and
conflicts of interest, and revolving doors (Demortain 2017). The risk of industrial influence on the fight
against the harmful effects of pesticides can be seen in practice, since the Food and Agriculture
Organization of the United Nations announced its collaboration with the pesticide industry trade
association CropLife International. The event has prompted reactions from scientists and NGOs (Gérard
2020), who condemn a conflict of interest with the UN’s mission and mandate to protect biodiversity,

<footnote n="3">³ The report uses a family of SDHi fungicides, glyphosate and neonicotinoids as examples.</footnote>

<footnote n="4">⁴ Notre affaire à tous, POLLINIS, Biodiversité sous nos pieds, l'Association nationale pour la protection des eaux et rivières Truite-Ombre-Saumon et l'Association pour la protection des animaux sauvages et du patrimoine naturel.</footnote>

<footnote n="5">⁵ “Justice for the living”. See: www.justicepourlevivant.org/ [Accessed January 19, 2023].</footnote>

<footnote n="6">⁶ All of the interactions between living beings in an ecosystem.</footnote>

<footnote n="7">⁷ The term emerged in 1991 and refers to the disruption of the hormonal system, whether human or animal, by chemical substances and products.</footnote>

<footnote n="8">⁸ There are only a few search results for the term *regulatory science* on the European Union's Eurlex site, but they start in 2013 in the drug sector.</footnote>
support the public good, and respect, protect and fulfill human rights. In the same vein, European law
bears witness to the pressure exerted by interest representatives on regulatory science. For example, the
European regulation concerning the placing of PPPs on the market (European Parliament and Council
2009a, hereinafter the PPP Regulation<fnref n="9" />) required the Commission to present scientific criteria for
determining endocrine disrupting properties by December 2013 at the latest. As substances with
endocrine disrupting properties cannot be used in pesticides, industry lobbied so hard that the
Commission failed to meet the deadline and was brought before the European General Court (EGC),
which – exceptionally – ruled against it for failure to act. To justify its delay, the Commission lightly
invoked “criticisms” of the scientific criteria it had proposed in terms of their impact on the internal
market (EGC 2015, paragraph 69). On the other hand, it was more audacious in referring to “interference
by external parties” and “undue pressure” from representatives of interests (EGC 2016, paragraph 27)
to oppose the communication of all documents relating to the draft regulations to an NGO. As the EGC
points out, the Commission preferred to confine itself to “general, vague and imprecise indications”
(EGC 2016, paragraph 32), and it was outside the jurisdiction of the courts that industrial pressure was
documented (Horel 2015). Similarly, the European Ombudsman has criticized the Commission for not
requiring a declaration of interest from academic experts whose research is cofinanced by the chemical
industry, when they take part in training workshops to prepare a method for assessing the environmental
risks of pesticides (European Ombudsman 2021).

With these clarifications in mind, it is now time to define pesticides in European law. The term,
in use since the late 1960s, was not defined until 1978 in a sense that was close to its Latin etymology,
in other words, as mixtures intended alternatively to “destroy” “organisms harmful to plants”,
“undesired plants”, “parts of plants”, “promote [...] plant production” and “preserve plant products”
(Council of the European Union 1978a, Article 2). In the same year, the term “pesticide” coexisted with
the term “plant protection product”, which was used to denote similar effects (Council of the European
Union 1978b, Article 2) with a preference to mean that these products aim to “protect plants [...] against
[...] harmful organisms” (Council of the European Union 1991, Article 2; European Parliament and
Council 2009a, Article 2.a). In 2009, the term pesticide became generic, with European law (European
Parliament and Council 2009b, Article 3) expressly stating that pesticides cover two categories of
products governed by different texts: PPPs for agricultural use and biocides for other uses, the main
ones being disinfection of people, animals and things (water, surfaces, materials, etc.), antimicrobial
protection and pest control<fnref n="10" />. The PPPs covered in this chapter are defined as “products, [...] consisting
of or containing [...] active substances, safeners or synergists [...]” (European Parliament and Council
2009a, Article 2). A PPP is therefore a complex product, a mixture generally composed of several
chemical objects, which are either individual substances or mixtures of several substances. Roundup,
for example, is a PPP composed of an active substance, glyphosate, and other substances or mixtures of
substances.

In simple terms, PPP Regulation makes market access for PPPs subject to a two-stage procedure.
Active substances, safeners and synergists are subject to a European approval procedure carried out by
Rapporteur Member States, the European Food Safety Authority (EFSA) and the Commission, which
grants or withholds approval, and may or may not renew it. The PPP, or finished product, which may
only contain active substances, PPPs and synergists<fnref n="11" /> approved by the Commission, is subject to a
national but harmonized marketing authorization procedure. In the light of “current scientific and
technical knowledge” (Article 4.1 and Article 29.1.e), these two levels consist of an assessment to ensure

<footnote n="9">⁹ Current text.</footnote>

<footnote n="10">¹⁰ The European Chemicals Agency (ECHA) distinguishes 22 types of biocides in four main groups. See: www.echa.europa.eu/fr/regulations/biocidal-products-regulation/product-types [Accessed November 8, 2022].</footnote>

<footnote n="11">¹¹ A PPP may also contain co-formulants as defined in Article 2.3.c of the PPP Regulation, provided they are not on the list of prohibited co-formulants. However, co-formulants are not subject to the approval procedure established by this regulation. They are solely governed by the REACH regulation (European Parliament and Council 2006, Article 14) which, unlike the PPP Regulation, only requires the production of certain knowledge for substances produced in quantities exceeding 10 tons.</footnote>
that PPP residues have no harmful effect on human health and no unacceptable effect on the environment (Article 4.2), and that the PPP is sufficiently effective, has no immediate or delayed harmful effects on human health and has no unacceptable effects on plants or the environment (Article 4.3).

This expert system and the current state of scientific and technical knowledge targeted by the PPP Regulation are specifically influenced by one international organization (IO) in particular, the OECD, which globalizes the regulatory science it develops. In the general field of the environment, with which chemical safety is linked at the OECD, the latter has adopted 97 tools that illustrate its normative power, or at least a capacity to influence or persuade (SFDI 2013). The polluter-pays economic principle formalized by the OECD, which is now incorporated into international environmental law, is a striking example of this power and of the translation of an economic principle into the legal system at international and national levels. The OECD has been a pioneer in formulating and integrating an economic aspect into environmental policies and, in its words, in "the definition of effective and efficient environmental policies [...]" (OECD 2011a, p. 9). Since the 1970s, acting as a lever to propose a harmonized model, the OECD has globalized ideas and tools containing scientific methods for producing knowledge on the health and environmental effects of chemical products used in PPPs. The dissemination of these methods to member states and other IOs leads to the harmonization of knowledge. It is surprising that the OECD has taken on the task of drawing up standards in this field. It is not a scientific organization, and its primary objective is not to protect health and the environment, but to promote economic growth. To this end, it has sought to build trust in knowledge about the effects of chemical products, thereby helping to facilitate the flow of trade in these products. To do this, however, it had to build trust in the way knowledge is produced. This aspect is at the heart of the rules and standards we will examine in section 4.2, before looking at their effects on European law in section 4.3.

# I - Chemical safety ideas and tools promoted worldwide by the OECD

According to the first article of its founding Convention, the OECD, which groups together 38 countries committed to market economy principles, has the objective of promoting policies particularly designed “to achieve the highest sustainable economic growth [...], and thus to contribute to the development of the world economy” (OECD 1960). In the chemical sector, the promotion of world trade has underpinned the OECD’s work from the outset. According to the organization, the tools it has adopted have contributed to the expansion<fnref n="12" /> of the global chemical industry, which has become the second largest industry in the world (UNEP 2019, p. 24). The rapid growth of the chemical market has benefited OECD member countries, where 83% of world production was concentrated when it began publishing its work on chemical trade in 1970 (OECD 2011b, p. 4)<fnref n="13" />.

## A - Ideas promoted by the OECD in the chemical sector

Collective awareness of the environmental and health hazards posed by chemical products dates back to the publication of Silent Spring (Carson 1962). At the time, the Council of Europe was a pioneer in environmental matters (Meyer 2017, p. 7), and as early as 1968, adopted various texts for its protection, including in the chemical sector. At the same time, the increase in product safety regulations in the US (Jones and Benrubi 2013, p. 802) threatened to create trade barriers in the chemical sector. Concerned about the economic impact of emerging environmental policies, and in particular about the creation of non-tariff barriers to trade that divergent national laws would foster (OECD 1977a), the OECD quickly responded by creating the Committee on the Environment in 1970 (now called the Environment Policy Committee). From the outset, the Secretary General's speech emphasized the cost of pollution control programs for companies, which had measurable consequences on their profitability and economic performance. He advocated the introduction of measures that did not have a negative impact on trade and economic growth (Meyer 2017, p. 2). Two years after the creation of the United Nations Environment Program (UNEP) and the US ban on DDT, this committee, which worked with

<footnote n="12">¹² Its value increased sevenfold between 1978 and 2008, from $520 billion to $3,697 billion (OECD 2010, p. 12).</footnote>

<footnote n="13">¹³ Chemical production in OECD countries still accounts for almost 60% of the world total (OECD 2019, p. 13).</footnote>
the Chemicals Committee under the aegis of the OECD's Environment Directorate, developed (OECD 1974) the two ideas pursued by the tools that are currently in effect.

The first idea, which was the need to assess the health and environmental effects of chemicals before they are marketed, emerged outside the OECD, at the United Nations Conference on the Human Environment in Stockholm, in 1972¹⁴. However, this idea became secondary to another relating to the mutual acceptance of data, according to which each OECD member state must trust the results of the pre-market assessment of chemical substances carried out by any other member country. This idea has an economic rationale.

Indeed, the OECD has chosen an economic direction, citing the 1972 Guiding Principles concerning International Economic Aspects of Environmental Policies in the first citation of the text adopted in 1974. It was in this guiding principle that the OECD first enunciated the polluter-pays economic principle, designed in particular to maintain the environment in an “acceptable state” (OECD 1972, Appendix, A.a. points 3 and 4). At the time, the OECD stated that, “in many circumstances [...] the reduction of pollution beyond a certain level will not be practical or even necessary in view of the costs involved”. From this economic perspective, the OECD also stated that “measures taken to protect the environment should be framed [...] to avoid the creation of non-tariff barriers to trade”. In the chemical sector, the OECD recommended that the governments of member countries consider “in particular” the “financial resources” required for pre-assessment and select “those chemicals that require a full-scale assessment” (OECD 1974).

The idea of mutual acceptance of data is also explained by the principle of efficient use of economic resources enshrined in Article 2.a of the OECD Convention. Assessing the toxicity of chemicals requires time, as well as technical and financial resources, which are all the more important given that the OECD's objective was the growth of this market. The efficient use of these resources justified the introduction of the system of trust between states, since it avoids the need for governments and companies to incur the expenses required by the evaluation, when it has already been carried out by an OECD member state.

The consequence of this economic reasoning was endorsed in 1977 in a recommendation (OECD 1977a) aimed at preparing a hard law text. While the Council recognized the desirability of evaluating all chemical products, it chose, in view of the resources available, to limit control to new chemical substances and to certain existing substances, with the exception of products made from these substances. This may well be the point of origin of the lack of knowledge about the cocktail effects of chemicals that is being denounced today (Rockström et al. 2009; UNEP 2019, p. 163; OPECST 2021, p. 3). The OECD itself points out in its latest Environmental Outlook that, in OECD member countries, “the health impacts of chemicals [...] in the environment – and in particular effects from combined exposure to mixtures of chemicals – is still limited” (OECD 2012, p. 26).

## B - Tools developed by the OECD in the chemical sector

Still in effect today, the Council Decision on Mutual Acceptance of Data in the Assessment of Chemicals (hereinafter MAD) was adopted in 1981 (OECD 1981). The MAD is a hard law tool with a legal scope that is equivalent to that of an international treaty. In the typology of acts provided for by the OECD Convention, a decision is, in principle, adopted by common agreement by all members and is binding, subject to compliance with the constitutional procedure in effect in each country (OECD 1960, Article 6.1, Article 5a and Article 6.3). The choice of this tool is all the more significant given

<footnote n="14">¹⁴ The Conference agreed on the need to “raise awareness and give advance warning of the harmful effects of man-made pollutants on human health and well-being” (Recommendation 74).</footnote>
that the OECD, whose action is based on persuading members to pursue certain types of policy, favors nonbinding measures<fnref n="15" />.

The MAD is divided into two very short parts and two appendices. The body of the decision contains certain omissions. It does not transform the idea of assessing the health and environmental effects of chemicals before they are marketed into a rule of substantive law. This idea is still conveyed by soft law, namely the 1974 Recommendation (OECD 1974), to which the MAD decision refers. More significantly, the MAD mentions virtually no minimum or systematic obligation to assess chemical substances and does not require the assessment of new or existing substances. On this point, the OECD subsequently adopted a binding decision, requiring member states to implement or strengthen national programs for the systematic examination of existing chemicals (OECD 1987). The MAD does not distinguish between products and substances, the former being generally considered a combination of the latter. Other IOs and individual states are therefore free to introduce rules on these issues. Lastly, the MAD does not say whether it is up to governments or industry to provide evidence of the effects of chemicals. We have to look at the preparatory work of the Environment Committee to find out that it is up to the manufacturer to carry out the initial assessment of a substance (OECD 1977b).

In the first part, the MAD expressly lays down the principle of sharing test data as a legally binding rule:

> Data generated in the testing of chemicals in an OECD Member country in accordance with OECD Test Guidelines and OECD Principles of Good Laboratory Practice shall be accepted in other Member countries for the purpose of assessment and other uses relating to the protection of man and the environment.

To ensure that the obligation to accept data is effective, the MAD makes the production of such data subject to two conditions: testing must be carried out in accordance with what the OECD calls “test guidelines” and “principles of good laboratory practice” (GLP). In essence, these guidelines and GLP constitute OECD regulatory science and the key to mutual trust between states, a prerequisite for growth in the chemical product trade.

The second part of the MAD does not contain any obligations, but rather a recommendation inviting states to apply the guidelines and GLP contained in the two appendices. The term “recommendation” suggests that the guidelines and GLP are soft law, whereas they are contained in a legally binding decision and form the cornerstone of the system. In practical terms, Appendix I of the decision lists five series of guidelines adopted or revised since 1981¹⁶. For example, guideline 234 for the Fish Sexual Development Test, which concerns endocrine disruption, indicates which fish species are selected for testing, the reasons for these choices and which indicators, including the evolution of the male/female ratio, are evidence of an endocrine disruption effect. The guideline details the test protocol (method, duration, diet, etc.).

While this regulatory science is intended to assess risk and inform the normative decisions of regulatory agencies, the explanatory reports that accompany the guidelines highlight the innumerable difficulties and constraints of this assessment. These include the nonexistence of a “reliable model for overall environmental description”, which leads to the provision of “rough estimates”, even for the study of highly persistent compounds (OECD 2006a, p. 3); difficulties in extrapolating animal tests to humans; disagreements over the appropriate experimental model; the choice of exposure routes for testing a substance that does not correspond to actual human exposure to a combination of substances through more than one route (OECD 2006b, p. 2); and the impossibility of providing normative guidance (OECD 2013, p. 9).

<footnote n="15">¹⁵ In the chemical sector, 20 OECD texts are in effect, including 11 Recommendations, eight Decisions or Decisions–Recommendations, and one Declaration.</footnote>

<footnote n="16">¹⁶ A list of current and draft guidelines is available on the OECD website.</footnote>
Appendix II contains GLP, in other words, the standards that testing laboratories must apply for all nonclinical tests required by national regulations, for the registration or authorization of several products: pharmaceuticals, pesticides, food the regulation of industrial chemicals. The aim is to harmonize standards that apply to testing laboratories, so as to ensure the quality of test results. The OECD has subsequently supplemented these principles to ensure that test results are covered by a presumption of conformity to GLP principles.

Numerous other pesticide-specific tools complement the MAD. These include guidance documents, dossiers and reports on PPP authorization, residues, biopesticides, risk reduction, minor pesticide use, testing and assessment<fnref n="17" />. These documents are not legally binding, but this does not mean that they are not used by regulatory agencies and industry.

Regulatory science as described has been and continues to be developed by experts, not by the Council. They may be employed in both the public and industrial sectors. Among the references cited by the group of experts who prepared the MAD is a publication by the European Center for Ecotoxicology and Toxicology of Chemicals, a professional organization funded by the chemical industry. An OECD guideline document for conducting tests on occupational exposure to pesticides during their application (OECD 1997) was entirely written by an employee of Zeneca Agrochemicals<fnref n="18" /> (Jouzel 2019, p. 157), which is worrying in terms of impartiality in the development of test methods. In reality, the entire body of regulatory science developed by the OECD since the 1970s needs to be investigated, in order to find out the extent of industrial participation in its development and the bias it may be affected by.

Today, the MAD is the equivalent of a multilateral agreement applicable in 45 countries<fnref n="19" />. Initially only applicable to OECD members, a decision taken in consideration of Chapter 19 of Agenda 21 (UNCED 1992) extended the MAD to nonmember countries in 1997. In view of the global goal of sustainable development set in Rio in 1992, the extension of the MAD has the aim of strengthening the ability of non-OECD countries that develop their own chemical industries to exchange information, ensuring that their chemical management systems do not lead to regulatory incompatibilities and the creation of trade barriers. With OECD members having to assess over 5,000 substances in large volumes, this expansion contributes to the objective of reducing the costs of chemical product management, as the number of states sharing responsibility for testing increases. This is why the OECD has implemented a “proactive outreach strategy” (OECD 2010, p. 8).

The geographical coverage of the MAD, which contributes to its globalization, is also aided by the interplay of competition and cooperation between IOs. Since the 1970s, a number of IOs have taken up environmental issues, contributing to the fragmentation of international environmental law without, however, excluding circulation and permeability<fnref n="20" />, particularly in the chemical sector. For example, the latest version of the International Code of Conduct on Pesticide Management refers to OECD GLP and some of its guidance documents (FAO and OMS 2014). In 1980, while the OECD presented itself as the “authority that was best placed” to harmonize chemical safety standards (OECD 1980, p. 13), three UN organizations created the first inter-agency cooperation program in the chemical sector, whose implementing agency, the World Health Organization (WHO), published documents for the assessment of chemical substances. This competitive situation was followed in 1995 by broader IO cooperation, with the OECD joining the Inter-Organization Program for the Sound Management of Chemicals. It was in this context that the Strategic Approach to International Chemicals Management (SAICM) was adopted in 2006, a nonbinding global policy initiative to minimize the adverse effects of chemicals. The

<footnote n="17">¹⁷ See: www.oecd.org/fr/securitechimique/pesticides-biocides/series-pesticides.htm [Accessed May 10, 2022].</footnote>

<footnote n="18">¹⁸ In 1995, when Zeneca Agrochemicals employee G. Chester proposed the test method, the Anglo-Swedish company was producing chemicals including herbicides, fungicides and insecticides. In 2001, after Novartis and Monsanto, the company was the world's third-largest producer of agrochemicals.</footnote>

<footnote n="19">¹⁹ In addition to OECD member countries bound by the MAD, other countries have joined the system: Argentina, Brazil, India, Malaysia, Singapore, South Africa and Thailand.</footnote>

<footnote n="20">²⁰ On these issues, see Maljean-Dubois (2017).</footnote>
SAICM, whose Global Action Plan contains measures to be achieved by 2020, calls for collaboration between the WHO and the OECD to develop and use new harmonized risk assessment methods, and to develop more effective methods and criteria for determining the impact of chemicals on human health. The nonbinding text refers to test guidelines, without mentioning OECD tools. Nevertheless, the OECD, which is responsible for more than 40% of the activities cited in the SAICM Global Action Plan (OECD 2010, p. 16), appears to be one of the main players in the measure in question. Ultimately, in the context of this international cooperation, the guidelines developed by the OECD are considered the most comprehensive set of international standards for the assessment of chemicals for regulatory purposes (UNEP 2019, p. 386). This inter-organizational cooperation is, of course, having an impact on the OECD, having adopted a binding decision for states to develop assessment methods together, without, however, obliging them to consider the risks arising from simultaneous exposure to several chemicals, which are the subject of a simple recommendation (OECD 2018).

## II - The effects of the OECD's promotion of chemical safety ideas and tools in European law

The OECD's promotion of chemical safety ideas and tools has had at least two observable effects on European law. On the one hand, OECD regulatory science has flowed into European law and, on the other, it has helped to generate ignorance<fnref n="21" /> about the harmful effects of pesticides.

### A - The flow of regulatory science from the OECD to the European Union

Under the terms of the first additional protocol to the OECD Convention, the European Communities established by the Treaties of Paris and Rome are represented at the OECD by the Commission. European texts concerning the MAD show that the EU adopts them in accordance with this OECD decision, without reference to any transposition into European law (Council of the European Union 1989; European Parliament and Council 2004). As a result of the EU's representation at the OECD and the legally binding nature of the first part of the MAD, the EU is bound by this text. However, the EU has clarified the nature of imported OECD texts: while the OECD guidelines are soft law for the EU, GLP is both soft and hard laws.

No general European act has been adopted to give legally binding power to the OECD guidelines as a whole. The first explicit reference in European law to the OECD guidelines appeared in 1984, in a text on the classification and labeling of hazardous substances (European Commission 1984). In 1994, a directive amending the one that was then applicable to the marketing of pesticides for agricultural use introduced three OECD guidelines into European law (European Commission 1994). It was not until 2009, in recital 58 of the PPP Regulation, that the EU affirmed the nonbinding nature of these guidelines. The text not only covers the OECD guidelines, but all “technical guidelines”, since other institutions issue guidelines that are transposed into European law through an advisory procedure.

Two regulations implementing the PPP Regulation adopted in 2013 specify that “the list of test methods and guidance documents” are published in the Official Journal for “information” and “harmonization” purposes (European Commission 2013a, 2013b). There are two Commission communications that publish the specific lists of test methods to be implemented (European Commission 2013c, 2013d), including those of the OECD. In the typology of EU acts, these communications are non legislative acts implementing regulations. Consequently, the OECD guidelines did not acquire a legally binding nature when they were imported into European law. This means that the EU can disregard the OECD guidelines.

Over time, there have been numerous imports from the OECD, both in the general field of chemicals and in that of pesticides<fnref n="22" />. The communications issued for the implementation of the PPP Regulation mark a turning point in the introduction of OECD standards into the European expert system,

<footnote n="21">²¹ At the heart of contemporary work in the social sciences, see Jouzel (2019).</footnote>

<footnote n="22">²² The same applies to European regulations on cosmetics and animal feed additives.</footnote>
since they import them on a massive scale: 105 OECD guidelines have been Europeanized. In
quantitative terms, OECD standards are the most numerous in European law<sup>23</sup>, which supports the idea
that OECD guidelines constitute the most comprehensive set of standards in the world. The Commission
admits that this is due to a lack of expertise in Europe in the field of risk assessment regulation (European
Commission 2001). There is no doubt that the European Economic Community, then the EU, shared the
OECD's idea of developing world trade in chemical products in an economically efficient way, i.e. by
limiting the cost of assessment. Perhaps, current European regulatory projects also reflect a genuine
desire, on the one hand, to reduce the presence of chemical products, including pesticides, in our
environment (European Commission 2020b), and, on the other, to develop the EU's capacity to develop
and disseminate pesticide testing methods (European Commission 2022a).

GLP is now included in a European directive adopted in 2004 (European Parliament and Council 2004). The third article states that the Commission has the power to modify the principles of GLP, on "non-essential elements", in order to adapt them to technical progress. Measures adopted in this way constitute non legislative delegated acts within the meaning of Article 290 of the Treaty on the Functioning of the European Union. It follows that, under European law, GLP technical standards are not legally binding. On the other hand, other provisions relating to GLP are legally binding. For example, Article 1 of the Directive stipulates that member states must take measures to ensure that testing laboratories comply with the OECD principles of GLP appended to the Directive. Similarly, Article 3 of the Directive requires member states to adopt measures to monitor compliance with GLP principles, including "inspections and study checks in accordance with the recommendations of the OECD in this area".

B - A regulatory science that produces ignorance

The problem of assessing cumulative or cocktail effects is emblematic of the consequences of ideas and tools developed by the OECD but shared by the EU. The problem is not new. It was “an important shortcoming” of European law before the PPP Regulation was adopted (European Commission 2002, p. 15), and has been known about in the US since 1980 (Sprinkle and Payne-Sturges 2021).

According to the PPP Regulation, chemical objects containing more than one substance are
PPPs that are composed of “active substances, safeners or synergists” (Article 2.1), “preparations”
defined as mixtures composed of two or more substances (Article 3.3), safeners, synergists, co-
formulants and adjuvants, when they take the form of preparations (Article 2.3). Although the PPP
Regulation expressly provides for synergists and safeners to be subject to the approval procedure, and
stipulates that “data requirements [...] shall be defined” for these two categories of products (Article
25), the EU has still not adopted a regulation on testing methods specific to synergists and safeners that
are not covered by the implementing regulations (European Commission 2013a, 2013b)<sup>24</sup> of the PPP
Regulation, which were not updated until 2022 to take account of the inclusion of microorganisms in
PPPs (European Commission 2022b, 2022c). This failure to act, which we emphasize has been going
on for 13 years, may be explained by the fact that synergists and safeners can be mixtures or preparations
for which the question of cumulative effects arises. The Commission acknowledges its inaction, which
it justifies in two ways. In its view, as far as safeners are concerned, “serious adverse effects [...] seem
unlikely”, which sounds very much like a presumption of the absence of harmfulness that the CJEU
unambiguously condemns (CJEU 2019, paragraph 80). The Commission goes on to explain that it has
given priority to the inventory of unacceptable co-formulants, in view of resource constraints (European

<footnote n="23">²³ Other guidelines for the assessment of PPPs in European law originate from the EU, including those issued by EFSA and the European Chemicals Agency, FAO, WHO, the European and Mediterranean Plant Protection Organization, the United Nations, the US Environmental Protection Agency and the Pest Management Regulatory Agency. Some test methods come from professional organizations, private entities such as ATSM, the European Seed Association, CropLife International and bodies whose members and laboratories are subsidiaries of world leaders in the agrochemical industry.</footnote>

<footnote n="24">²⁴ They only concern active substances and PPPs.</footnote>
Commission 2020c, p. 3). In fact, it did not adopt the list of co-formulants that could not be used in PPPs until 2021, even though some member states had “identified” unacceptable co-formulants in PPPs authorized under the pre-PPP rules, in other words, between 1991 and 2009 (European Commission 2021, p. 8). The Commission also notes that the authorization procedures for adjuvants, for which Article 58 of the PPP Regulation lays down data requirements, have still not been adopted (European Commission 2021, p. 8). Contrary to the letter of the PPP Regulation, synergists, safeners and adjuvants are therefore included in the composition of PPPs placed on the market without any prior European assessment of each of these three chemical categories, whether they come in the form of a single substance or a mixture of substances, and this was also the case for co-formulants until 2021.

With regard to PPPs, the PPP Regulation stipulates that an active substance is approved at the European level “in the light of current scientific and technical knowledge”, if it is foreseeable that the PPP containing this substance has no harmful effect on human or animal health, “taking into account known cumulative and synergistic effects” (Article 4). Other provisions reinforce the obligation to assess cocktail effects, such as Article 29.6 of the PPP Regulation, which states that the “interaction between the active substance, safeners, synergists and co-formulants shall be taken into account during the evaluation”. A regulation implementing the PPP Regulation specifies that the information to be produced by manufacturers so as to enable the PPP to be assessed must include information on the “potentially harmful effects” of the PPP on human and animal health, groundwater, the “potentially unacceptable effects [...] on the environment, on plants and plant products”, “as well as known and expected cumulative and synergistic effects” (European Commission 2013b, Appendix, paragraphs 1.1–1.3). Lastly, Article 4 of the PPP Regulation states that the active substance is approved at the European level if, “having regard to realistic conditions of use”, the residues of the PPP containing it and the PPP itself have no harmful effect on health or the environment. This means that the cocktail effect on the environment, in other words, where the PPP is actually used, must first be assessed when the active substance is approved by the European authorities. Nevertheless, Article 4 of the PPP Regulation contains a precautionary wording in its requirement to assess cumulative effects, since it specifies that they are taken into account “where the scientific methods accepted by” EFSA “to assess such effects are available”. This is precisely the flaw in European law, since EFSA has still not agreed on a method for this purpose, even though the problem has been known since at least 2002, i.e. 20 years of exposure of human and animal populations to chemical cocktails. Once again, the Commission justifies this inaction, this time on the grounds of greater complexity than initially envisaged, and announces the development of an assessment method, an action plan to set priorities for ongoing work, and calls for research projects on methods for assessing cumulative risks to ecosystems (Commission 2020c, p. 9 and p. 11). It is true that the European Parliament, NGOs and scientists are denouncing this situation and sometimes proposing solutions, but for the time being and despite a longstanding knowledge of the issue, European regulatory science is conspicuous by its ignorance of these effects. Although the CJEU, questioned by Tribunal correctionnel de Foix (the Foix criminal court), ruled that the assessment of an active substance “cannot be carried out in an objective fashion while failing to take into account the effects deriving from a possible combination of various constituents” of a PPP, adding that this requirement applies to both EFSA and the Member States, it disregarded EFSA’s failure to accept the assessment method, concluding that the PPP Regulation was not tainted by an evident error of assessment (CJEU 2019, paragraphs 62–76). Perhaps, the Court should be asked about the lack of a regulatory method for assessing cumulative effects, and the possibility of taking account, at least on a transitional basis, of such methods proposed in academic publications, particularly in light of Article 4.1 of the PPP Regulation, which does not require the assessment to be carried out on the basis of a regulatory science, but solely with regard to the “current state of scientific and technical knowledge”, in order to ensure that the cumulative effect in a complex product and in the environment does not meet any of the exclusion criteria for the approval of a substance, in other words, an effect that it is neither mutagenic, carcinogenic, toxic for reproduction, nor endocrine disruptive. However, the observation of cocktail effects in the environment presupposes that the latter is carefully monitored. However, as the European Court of Auditors points out, this monitoring, which is a complementary warning system to the assessment, has many shortcomings, partly due to the inadequacy of texts on statistics and the sustainable use of pesticides (Council of the European Union 2020, pp. 28–35).
As for the OECD, it is working to develop methods for testing cocktail effects, drawing on those developed by the US Environmental Protection Agency (EPA) between 1999 and 2006 (OECD 2017). Unsurprisingly, the EPA's 2003 definition of cumulative effects has been circulated to EFSA (2020a, p. 7; 2020b, p. 6), whose relevance is contested for various reasons: because it is based on the assessment of dose additivity, with a common mechanism of toxicity rather than on the interaction, synergism and antagonism between substances, without considering the community vulnerability, the multiplicity of exposure routes and other available methods, including epidemiological models (Sprinkle and Payne-Sturges 2021). Moreover, such a definition goes against the PPP Regulation, which expressly determines the assessment of “cumulative and synergistic effects” (Article 4).

## Conclusion

As European law currently stands, the obligation to assess cocktail effects exists, but the EU's inaction on synergists, safeners, adjuvants and PPPs renders it ineffective, confirming scientists' observation that the production of chemical products is outstripping the world's capacity for assessment and monitoring. Numerous other examples that cannot be discussed here illustrate the gray areas created by the European expert system. The European Parliament has noted this and emphasized the need to take account of non-regulatory scientific literature, which should have the same “probative value” in assessment as studies based on GLP (European Parliament and Council 2019). In addition to this, the European Ombudsman, who was twice called upon to assess certain substance approval practices by the Commission, supports this observation (European Ombudsman 2016, 2020).

As an epilogue, the OECD wrote the following half a century ago:

> The presence of a chemical in the environment may adversely affect man by chronically exposing him to the chemical or by causing the deterioration of materials and biological systems which are beneficial to his survival. Contamination of the environment by cumulative pollutants is of particular concern due to the insidious nature of the process and the difficulty of correcting any damage that may have occurred (OECD 1974, explanatory note, point 4).

In spite of this, the choice has been made to commit to a deadly path by placing the law at the service of chemical market development, and the current observation of regulatory inability to prevent the destruction of the common home does not prevent chemical production from growing until 2060 (OECD 2019, p. 6; UNEP 2019, p. 27).

MAD: Mutual Acceptance of Data in the Assessment of Chemicals

GLP: Good Laboratory Practice

CJEU: Court of Justice of the European Union

OECD: Organisation for Economic Cooperation and Development

IO: international organization

OPECST: Office parlementaire d'évaluation des choix scientifiques et technologiques (French Parliamentary Office for the Evaluation of Scientific and Technological Choices)

SFDI: Société française pour le droit international (French Society for International Law)

EGC: European General Court

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