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Approval of Glyphosate Usage Permit in the EU

Date:08 April 2024

By Ömür Kadri SARI, visiting PhD researcher, University of Groningen, k.sari .rug.nl.

Following the court decision regarding Roundup in the United States of America (US), the permissions for the use of agricultural pesticides and their impact on human health should be re-evaluated. How should this recent decision affect the EU’s practices?

Introduction

Since the mid-20th century, chemical-based agricultural pesticides have been used to control plant diseases, prevent pests, and enhance productivity. These synthetic chemicals include insecticides (insect killers), fungicides (fungus killers), herbicides (weed killers), and other chemical substances effective against harmful organisms. Advances in chemistry and the food industry have led to the production of more potent agricultural pesticides. However, there is insufficient data regarding the environmental and human health impacts of these chemicals. Accurate and consistent information about the risks posed by these substances is not always adequately shared with the public. For example, the active ingredient in the agricultural pesticide Roundup was deemed carcinogenic to humans by the International Agency for Research on Cancer in 2015,[1] while the U.S. Environmental Protection Agency published contrary views in 2017.[2]

In the United States, BAYER (the producer of Roundup), has faced numerous lawsuits regarding Roundup, [3] one of the widely used agricultural pesticides. Some of these lawsuits are related to consumers being misled about the environmental effects of the product, while others are related to claims for compensation from individuals who have become ill due to the use of the product. The majority of the lawsuits have been filed for compensation claims. Most recently, a 49-year-old U.S. citizen claimed to have developed lymphoma cancer after using Roundup on his property for 20 years and filed a lawsuit in the Philadelphia County Court.[4] The court determining the agricultural pesticide as the cause of the cancer is of great significance. As a result of the case, on January 26, 2024, Bayer was sentenced to pay a $2.25 billion compensation.[5] The jury verdict determined that the product was defective in terms of consumer expectations, lacked sufficient warnings, and there was a connection found between the plaintiff's cancer disease and the use of the product.[6] As a result of the identified relationship between the plaintiff's illness and the use of the product, a high monetary penalty was imposed.

This lawsuit has led to a reevaluation of the potential effects of agricultural pesticide use on human and environmental health. I think the conclusion has emerged that the risk analysis of the products used should be more transparent. The use of Roundup is also being debated more prominently within the EU society.[7] It should be evaluated, especially in conjunction with the decision by the European Commission to extend the use of (the active ingredient of Roundup) glyphosate for 10 years (28 November 2023) and the U.S. court decision.

Glyphosate and the right to health

The agricultural pesticides used in both animal and plant production affect food at the first level of the food chain. These pesticides used in animals and plants also enter the human body through residues or direct contact. Scientific studies associate the use of glyphosate with health-related risks. For instance, the International Agency for Cancer Research (IARC) has classified glyphosate as ‘probably carcinogenic for humans’ in 2015.[8] According to a recent study by Bloem and Boonstra (2023) in the Lancet on the link between Glyphosate and Parkinson's disease, negative health impacts were also established through research on animals.[9] This study suggests the possibility of this toxic substance causing not only cancer but also various other diseases. Therefore, the rules of law that protect human health should be utilized against this medication.

In Article 12 of the International Covenant on Economic, Social and Cultural Rights(ICESCR), it is recognized that everyone has the right to the highest attainable standard of physical and mental health. According to this article, in order for the right to health to be fully realized, improvement in all aspects of environmental and industrial hygiene, as well as scientific research for the prevention and control of diseases, is necessary.[10]

States are obliged to prevent harm to the health of their citizens due to food processing processes.[11] The risks posed by drugs and additives used in the cultivation of animal and plant-based foods must be thoroughly investigated. There are different opinions on the risks posed by agricultural chemicals used in the cultivation of plant-based foods. The use of glyphosate also adversely affects animal feed, thus compromising animal health. Consequently, human health is again adversely affected.[12] In situations where human health is threatened, the precautionary principle, which is internationally accepted, should be applied.[13]

This has been affirmed by the Committee on Economic Social and Cultural Rights, which has recently recommended on several occasions that ICESCR States parties ‘adopt a regulatory framework that includes the application of the precautionary principle with regard to the use of harmful pesticides and herbicides, in particular those that contain glyphosate, in order to avoid the negative health impacts and environmental degradation that can result from their use.[14] It notes in this respect that the WHO’s IARC has identified glyphostate ‘as a probable carcinogen, and refers to ICESCR General Comment No. 14 (2000) on the right to the highest attainable standard of health.  International and regional standards, particularly UN guidelines and EU regulations on the use of pesticides, should also be followed regarding the use of Roundup. Precaution should be taken in case of risks to human and environmental health and administrative measures should be taken. In case of potential harm to public health, more scientific research is needed to clarify the situation.

The EU’s Position on Glyphosate           

There have been several court decisions in the US stating that glyphosate, the active ingredient in Roundup, commonly used as a herbicide, causes cancer. Despite being a controversial product and the increasing opposition to the product’s use within the EU, its use continues in the EU. In the process of granting a usage permit for such a product, a detailed scientific examination should be conducted. Recently, the European Commission granted permission for the use of this product in the EU for 10 years.[15] This permission has led to serious criticisms in the EU public opinion.[16]  Specific questions arise regarding whether necessary scientific examinations were conducted before the issuance of the license, and if decisions are based on the latest scientific evidence of effects of glyphosate.[17] The Commission sought a scientific report from EFSA before making its decision.[18] However, civil society and the academic community argue that EFSA's scientific assessment is incomplete and inadequate.[19] This situation regarding Roundup may also damage the credibility of EFSA. Prioritizing human health, the Commission needs to reconsider its decision based on the precautionary principle.

The procedures to be followed in the placing on the market of plant protection products in the EU are provided in Directives 1107/2009 and the renewal process is regulated by Directive 844/2012. In both of these regulations, it is emphasized that the use of plant protection products should be closely monitored for risks to human health and the environment before making usage decisions.[20] Re-evaluation reports are prepared taking into account scientific and technical advancements. Following the decisions made in the United States, comprehensive and detailed reviews should be conducted to create objective, impartial, and transparent reports. EFSA should share scientific reports addressing the concerns of the EU community with the public.

Conclusion

There are undeniable connections between Glyphosate and diseases. Especially from lawsuits in the United States, it is understood that the agricultural pesticide cause cancer, and IARC qualifies it as a substance that is ‘probably carcinogeric to humans’. The scientific findings of the US courts regarding Glyphosate, naturally, do not bind the EU Commission. However, the significant compensations awarded and scientific uncertainties need to be taken into consideration.

Both Article 12 of the ICESCR and the regulation governing the market for plant protection products require comprehensive examination of products before they are placed on the market. In other words, while allowing the use of plant protection products, the highest level of protection for human health must be provided. Affording both human health and the environment a ‘high level of protection’ in EU policy design and implementation is also an obligation under Articles 35 and 37 of the Charter of Fundamental Rights of the EU.[21]

During the preparation stage of the EU Commission decision, EFSA's reports are taken into consideration. In fact, the regulation itself grants EFSA the authority in this regard. EFSA has the duty to submit scientific reports to Member States and the Commission. Therefore, due to new developments, EFSA needs to produce objective and transparent reports that will help address public health concerns regarding Roundup. It needs to conduct further risk analysis and present objective data. Yes, there is uncertainty regarding glyphosate. However, following the decisions in the US, a more detailed examination is necessary. The scientific basis of the decision-making process regarding pesticide (glyphosate) use should be reexamined in light of human rights law and the precautionary principle. From this perspective, it may be wondered if the decision to extend the use of Roundup for another 10 years is justifiable.


[1] ‘IARC Monograph on Glysophate’ (World Health Organization, 19 July 2018) < https://www.thelancet.com/journals/lanplh/article/PIIS2542-5196(23)00255-3/fulltext> accessed 4 March 2024.

[2]  ‘Glyphosate’ (United Stataes Enviromental Protection Agency, 11 September 2023) < Glyphosate – EPA (https://www.epa.gov/ingredients-used-pesticide-products/glyphosate)> accessed 2 March 2024;

[3] Michelle Llamas,’ Roundup Lawsuit’ (Drugwatch, 1 April 2024) <https://www.drugwatch.com/legal/roundup-lawsuit/ > accessed 2 April 2024.

[4] Minyvonne Burke, ‘Bayer ordered to pay $2.25B after jury finds Roundup weed killer caused Pennsylvania man’s cancer’ (NBC NEWS, 30 January 2024) < https://www.nbcnews.com/news/us-news/bayer-ordered-pay-225b-jury-finds-roundup-weed-killer-caused-pennsylva-rcna136338> accessed 4 March 2024.

[5] Minyvonne Burke, ‘Bayer ordered to pay $2.25B after jury finds Roundup weed killer caused Pennsylvania man’s cancer’ (NBC NEWS, 30 January 2024) <  https://www.nbcnews.com/news/us-news/bayer-ordered-pay-225b-jury-finds-roundup-weed-killer-caused-pennsylva-rcna136338> accessed 4 March 2024.

[6] Zenebou Sylla and Elizabeth Wolfe, ‘Roundup lawsuit: Bayer ordered to pay Pa. man $2.25B after jury finds weed killer caused cancer’ (CNNWire, 30 January 2024) https://6abc.com/bayer-roundup-cancer-weed-killer-lawsuit-john-mckivison/14371967/> accessed 1 March 2024.

[7] ‘Geen meerderheid in EU voor verbod op onkruidverdelger glyfosaat’(AD, 13 October 2023) <  https://www.ad.nl/politiek/geen-meerderheid-in-eu-voor-verbod-op-onkruidverdelger-glyfosaat~ae0b9f76/?referrer=https%3A%2F%2Fwww.google.com%2F> accessed 4 March 2024.

[8] ‘IARC Monograph on Glysophate’ (World Health Organization, 19 July 2018) < https://www.thelancet.com/journals/lanplh/article/PIIS2542-5196(23)00255-3/fulltext> accessed 4 March 2024.

[9] BR Bloem and TA Boonstra, ‘The inadequacy of current pesticide regulations for protecting brain health: the case of glyphosate and Parkinson’s disease’ (2023) 7 Lancet E948.

[10] International Covenant on Economic, Social and Cultural Rights (adopted 19 December 1966, entered into force 3 January 1976) 993 UNTS 3 [ICESCR], Arts. 12 and 15.

[11] Note that the EU is not a Party to the ICESCR, but all its Member States are.

[12] ‘Glyfosaat toelating terwijl wetenschap (en burgers) buitenspel worden gezet?’ (Educatiecentrum, 19 July 2023) < https://bijenstichting.nl/glyfosaat-toelating-terwijl-wetenschap-en-burgers-buitenspel-worden-gezet/> accessed 1 March 2024.

[13] ‘The General Principles of Food Law in the European Union and The European Food Safety Authority’ (FAO nad WHO, 30 January 2002) < https://www.fao.org/3/ab508e/ab508e.htm#:~:text=Precautionary%20Principle&text=Such%20measures%20have%20to%20comply,can%20be%20gathered%20and%20analysed> accessed 2 March 2024.

[14] ‘Report of the Special Rapporteur on the right to food’ (UN, 24 January 2017) < https://reliefweb.int/report/world/report-special-rapporteur-right-food-ahrc3448> accessed 2 March 2024.

[15] ‘Glyphosate’ (European Union, 13 October 2023) < https://food.ec.europa.eu/plants/pesticides/approval-active-substances/renewal-approval/glyphosate_en> accessed 5 March 2024.

[16] Bartosz Brzezıńskı, ‘Glyphosate: Raft of legal challenges launched against EU approval’ (Politico, 25 January 2024) < https://www.politico.eu/article/glyphosate-legal-launched-against-eu-approval-pan-europe/> accessed 5 March 2024. 

[17] Greenpeace European Unit , ‘EU must withdraw licence for toxic glyphosate considering flawed EU approval system for pesticides’ (Greenpeace, 14 December 2023)  < https://www.greenpeace.org/eu-unit/issues/nature-food/46824/eu-must-withdraw-licence-for-toxic-glyphosate-considering-flawed-eu-approval-system-for-pesticides/> accessed 5 March 2024. 

[18] ‘Glyphosate’ (EFSA, 11 September 2023) <https://www.efsa.europa.eu/en/topics/topic/glyphosate> accessed 2 March 2024.

[19] Greenpeace European Unit , ‘EU must withdraw licence for toxic glyphosate considering flawed EU approval system for pesticides’ (Greenpeace, 14 December 2023)  < https://www.greenpeace.org/eu-unit/issues/nature-food/46824/eu-must-withdraw-licence-for-toxic-glyphosate-considering-flawed-eu-approval-system-for-pesticides/> accessed 5 March 2024. 

[20] Regulation No 1107/2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC [2009] OJ L309/1; Commission Implementing Regulation No 844/2012 setting out the provisions necessary for the implementation of the renewal procedure for active

substances, as provided for in Regulation (EC) No 1107/2009 of the European Parliament and of the

Council concerning the placing of plant protection products on the market [2012] OJ L252/26.

[21] Charter of Fundamental Rights of the European Union [2012] OJ 326/391, Arts. 35 and 37.