On 30 March 2023, a Luxembourg administrative appeal Court canceled 8 decisions from the Luxembourg government to ban glyphosate-based herbicides (GBHs). The Court details that the ban of GBHs is possible but it needs to follow EU rules as laid down in Regulation (EU) 1107/2009 (hereafter "the pesticide regulation").
Following this judgment, Bayer (the major producer of glyphosate worldwide) stated that these bans were done in violation of EU law and without any scientific argumentation[1]. This is not true.
With this blog, PAN Europe would like to clarify the legal procedure Member States should follow to ban glyphosate based herbicides or any other synthetic pesticide that harms health and the environment.
1. The legal procedure for authorising or banning pesticide products in EU Member States
Pesticide products are composed of one or more active substances (e.g. glyphosate) and a series of other chemicals (co-formulants, safeners and synergists). Active substances are evaluated and authorised at EU-level while pesticide products are dealt with at national-level.
When a pesticide active substance is approved at EU-level, the pesticide industry then needs to apply for national authorisations for the actual formulation. EU Member States are then required to carry out a risk assessment for these authorisation requests, in line with the pesticide regulation. This aims to ensure that authorised pesticides do not harm human and animal health, and that they do not have an unacceptable effect on the environment. In order to carry out this work, Member States assess the pesticide industry’s application, which contains information about the product and a range of studies including toxicity studies . These studies are carried out according to harmonised rules[2] on data requirements.
In order to reduce the burden for national regulatory authorities, the pesticide regulation foresees a mechanism where EU Member States are grouped in 3 zones, where one Member State, the zonal Rapporteur Member State (zRMS), will carry out the risk assessment for one specific pesticide product
Following the conclusions of the zRMS, Member States are entitled to either accept them or to refuse them (art.36(3)) when justifying specific national conditions that allow them to reject a pesticide authorisation.
When a pesticide is authorised in a Member State, national authorities have the possibility to withdraw the authorisation (art.44) in case it is proven that the pesticide no longer meets the criteria laid down in article 29 of the pesticide regulation. In other words, in case scientific evidence shows a pesticide poses a threat to human health, animal health or the environment, a Member State is entitled to withdraw such authorisation. It needs to notify its intention to the authorisation holder and allow the holder to comment. The ban must then be notified to the European Commission and other Member States.
The entire procedure is underpinned by the precautionary principle (art.1). The case law of the European Court of Justice clarifies that the precautionary principle “is a general principle of Union law requiring the authorities concerned to take, in the specific context of the exercise of the powers conferred on them by the relevant legislation, appropriate measures to prevent certain potential risks to public health, safety and the environment, giving precedence to the requirements the protection of these interests over economic interests, without having to wait for the reality and seriousness of these risks to be fully demonstrated. In particular, where it proves impossible to determine with certainty the existence or extent of the alleged risk because of the insufficient, inconclusive or imprecise nature of the results of the studies carried out, but the likelihood of real damage to public health persists should the risk materialise, this principle justifies the adoption of restrictive and objective measures”[3]. This principle thus allows “institutions, when scientific uncertainties remain as to the existence or extent of risks to human health, to take protective measures without having to wait for the reality and seriousness of these risks to be fully demonstrated or for the adverse health effects to materialise”[4]. The same principle also requires “the competent authorities to take appropriate measures to prevent certain potential risks to public health, safety and the environment, giving precedence to the requirements of the protection of these interests over economic interests”[5].
In other words, when there are indications of harm, EU- and national authorities are obliged to take action to protect health and the environment.
2. The judgment from the Luxembourg Administrative Court in appeal
In its judgment[6], the Administrative Court clarifies that Luxembourg is entitled to ban GBHs but failed to follow the rules from article 44 from the pesticide regulation. Indeed, article 44 clarifies that in order to withdraw the national authorisation of a pesticide, Member States are required to notify their intention to the holder of the authorisation and give them the possibility to comment on their intention. Furthermore, the Luxembourg government failed to justify the ban with new scientific information demonstrating that GBHs do not meet the safety criteria from the pesticide regulation. Indeed, the justification provided to the authorisation holder is that it is an agreement from the governmental coalition. In other words, this is a political argument, which is not foreseen in the pesticide regulation. The Court also refers to article 36, concerning the zonal approach in risk assessment/risk management. The fact that Belgium, as a zonal Rapporteur Member States concluded that GBHs are safe, the Luxembourg state could have refused such conclusions based on specificities from its countries. The Court identifies that such justification is missing in the decision from the ministry.
3. PAN Europe recommendations for future bans
PAN Europe considers that there is a plethora of legal arguments that are more than sufficient to ban GBHs, as well as numerous other pesticides in Member States. In particular regarding glyphosate:
- In 2015, the International Agency for Research on Cancer (IARC) from the World Health Organisation (WHO) has classified glyphosate as being carcinogenic category 1B ("probable carcinogenic"). Their work has been based on data on the active substance itself, as well as data on GBHs. The European Union refused this classification as it uses a different statistical approach compared to the one from IARC. The application of the precautionary principle should lead to considering the results of IARC as valid, as their approach led to the hazard classification of glyphosate as probably carcinogenic. This hazard class is the equivalent to ‘presumed human carcinogen’ (carcinogenic category 1B ) in Europe and such active substances should not be approved according to the pesticide regulation, with minor exceptions. In 2019, the IARC reiterated that their classification remained unchanged, in light of the new scientific information[7]. In 2021, the French Health institute Inserm, published its experts report on pesticides and health and concluded that there is a moderate presumed link of glyphosate exposure and non-Hodgkin lymphoma[8]. A recent scientific peer-review literature further supports the genotoxic potential of glyphosate[9].
- Evaluation of GBHs: a proper evaluation of the toxicity of the full product. In 2019, the Court of Justice of the EU reiterated the obligation for Member States to carry out a full evaluation of the toxicity for human health, and in particular the long term chronic toxicity (carcinogenicity, reprotoxicity…) of the pesticide products[10]. This is currently not the case and the zRMS has not carried out such an evaluation as the chronic toxicity data was not provided by the industry. Member States are supposed to ask for it but, as already acknowledged by the European Commission, they do not. In the absence of such data, these products should not be allowed and Member States are entitled to withdraw their authorisations, especially when there are indications for health concerns. When the risk assessment is not carried out according to the rules explained by the court ruling as it is the case of glyphosate risk assessment carried out by Belgium as zRMS, Luxembourg is entitled to reject their conclusions.
- Pesticide co-formulants: the black box. Co-formulants present in pesticides are chemicals that are added to increase the "efficacy" (i.e. the toxicity) of the active substance. Glyphosate without its co-formulants does not have a herbicidal activity. Conversely, the co-formulants alone have a herbicidal activity. For many co-formulants, there is no available data on their toxicity on health and the environment. On the other hand, in order to authorise pesticides on its territory, an EU Member State needs to ensure that all components of the pesticide product do not pose a risk to health and the environment. Considering the absence of scientific data on co-formulants, a Member State is entitled to withdraw the authorisation of the pesticide. For GBHs in particular, a series of scientific publications point at the fact that their co-formulants strongly increase their toxicity on human health and the environment.
- The scientific literature contains thousands of publications on the toxicity of glyphosate and GBHs on human health and the environment. These studies do not follow regulatory procedures and show harm to the environment in more sensitive tests. Carrying out a review of the available scientific data should lead to an immediate ban on these substances. The pesticide regulation, as well as the case law of the Court of Justice of the EU foresees that non-industry science must be given similar weight. In case of contradictory conclusions between industry studies and independent studies, the precautionary principle must lead to giving precedence on the results of independent studies.
4. Precedents
It is not new that Member States decide to either ban a pesticide for environmental or health reasons, or not to re-authorise it in the frame of the re-authorisation procedures that occur every 10 or 15 years when a pesticide is re-approved at EU-level.
- France and the neonicotinoids. Following the observation of massive bee deaths in France, the French government decided to ban specific uses of neonicotinoids and fipronil, based on the precautionary principle[11]. In order to protect bees, imidacloprid and fipronil were banned on sunflower and maize as early as 1999, while the EU banned these substances only in 2018.
- Since 2018, all neonicotinoids (including the ones still approved at EU-level at the time, namely acetamiprid and thiacloprid) were banned in France, including substances with similar mode of action (flupyradifurone and sulfoxaflor).
- France and glyphosate. In 2019, France withdrew the national authorisation of 36 GBHs representing 75% of the volumes of GBHs used in the country, due to a lack of safety regarding their potential for genotoxicity.
- Chlorpyrifos, a brain-damaging insecticide, has been banned from the EU in 2019. But a series of Member States (Germany, Denmark, Finland, Ireland, Latvia, Lithuania, Slovenia and Sweden) decided far before to not authorise it at national-level, to better protect their citizens.
- Sweden and the soil fumigants. In the EU, some pesticides are used as soil fumigants (e.g. Asulam sodium): they destroy all forms of life in the top layer of the soil, allowing for monocultures. Sweden has decided to not allow these pesticides on its territory, favouring alternatives to these toxic chemicals (such as crop rotation)[12].
5. Conclusion
EU citizens regularly express their demand for a reduction of pesticide use in order to protect their health and the environment. The recent successful European Citizens Initiative Save Bees and Farmers[13] has collected more than 1 million signatures throughout the EU and was declared successful by the European Commission in 2022. This ECI is already the second successful anti-pesticides ECI, out of only 8 successful ECIs in the EU. It asks for a phase out of all synthetic pesticides until 2035 and a restoration of biodiversity.
In the same vein, the recent Conference on the Future of Europe[14] gathered random panels of citizens who also asked for a significant reduction in pesticides and a restoration of biodiversity.
A plethora of legal arguments exist to ban pesticides based on political decisions. On one hand, scientific knowledge is available on the toxicity of many active substances to phase them out. On the other hand, the national risk assessment of the pesticide product is made impossible by the lack of data produced by the industry on their long-term toxicity.
PAN Europe thus considers that Member States should listen to the will of their citizens and gradually ban or not re-authorise pesticides. They should start in priority with the ones for which their toxicity is well document such as glyphosate or Candidates for Substitution[15].
Notes:
[1] https://www.novethic.fr/actualite/environnement/agriculture/isr-rse/le-l...
[2] Regulation (EU) 284/2013
[3] Amongst a many of case law, cf. e.g. C-477/14, Pillbox 38, 4 May 2016, EU:C:2016:324, pt. 55; T- 817/14 Zoofachhandel Züpke and Others v. Commission, 17 March 2016, EU:T:2016:157, pt. 51; T-333/10, ATC and Others v. Commission, 16 September 2013, EU:T:2013:451, pt. 81.
[4] See e.g. T-257/07, France v. Commission, 9 September 2011, EU:T:2011:444, pt. 68.
[5] Cf. T-74/00 e.a., Artedogan e.a. c. Commission, 26 novembre 2002, EU:T:2002:283, pt. 184.
[6] https://justice.public.lu/dam-assets/fr/actualites/2023/47873c.pdf
[7] https://videos.iarc.fr/videos/?video=MEDIA190315141153862 at 1:32 and 2:00
[8] Inserm Communication https://presse.inserm.fr/en/inserm-publishes-its-latest-collective-exper...
[9] Chang et al. Glyphosate Exposure and Urinary Oxidative Stress Biomarkers in the Agricultural Health Study. J Natl Cancer Inst. 2023 https://pubmed.ncbi.nlm.nih.gov/36629488/
[10] https://eur-lex.europa.eu/legal-content/EN/ALL/?uri=CELEX:62017CJ0616
[11] https://www.lemonde.fr/archives/article/2004/05/26/l-insecticide-gaucho-...
[12] https://food.ec.europa.eu/system/files/2019-06/pesticides_sup_nap_swe-re...
"A ban on killing harmful nematodes in the soil when cultivating crops intended for the production of food or feedstuffs. Growers in Sweden are already using alternative methods to treatment with chemical plant protection products in this area. The ban means that chemicals cannot start being used again on the relevant areas, pursuant to Chapter 2, Section 39a, paragraph 2 of the Swedish Pesticides Ordinance. The ban on their use came into force in July 2015."
[13] www.savebeesandfarmers.eu
[14] https://cor.europa.eu/en/Documents/CoFE_Report_with_annexes_EN.pdf
[15] www.toxic12.eu
