Le Comité permanent des végétaux, des animaux, des denrées alimentaires et de l’alimentation animale ou SCoPAFF (Standing Committee on Plants, Animals, Food and Feed) doit discuter l’éventualité de renouveler l’autorisation les 12 et 13 octobre même si cela semble moins probable devant les derniers développements.
L’AMLP est signataire de ce communiqué :
BRUSSELS, 9th OCTOBER 2023 To: EU national Ministers for Agriculture, Environment, and Health
Support the non-renewal of pesticide active substance glyphosate due to health and environment concerns
Dear Ministers,
On behalf of public health and environmental groups working together all across Europe, we are writing to you in view of the important Member States’ discussion and potential vote on the renewal process of the pesticide active substance glyphosate due to take place on 12th/13th October [1]. We are asking you to support the non- renewal of the substance due to significant remaining concerns about long-term health and environmental effects.
Significant long-term concerns for health
Glyphosate is the most widely used pesticide active substance in the world. Independent science points to concerning health effects, part of which have already been central to the debates preceding the 2018 renewal of the substance and resulted in a shorter reauthorisation than originally planned – five years instead of the originally proposed 15.
Carcinogenicity
As you are aware, in 2015, the World Health Organization’s International Agency for Research on Cancer (IARC) concluded that glyphosate is a potential carcinogen based on an extensive independent peer-review of all the available scientific evidence for both the active ingredient and glyphosate-based formulations [2]. In 2021, these carcinogenicity concerns were echoed in a review on the health impacts of pesticides carried out by France’s national institute for public health INSERM [3], who also took part in the public consultation about the current substance evaluation.
In 2022, a HEAL report [4] showed that the studies provided by pesticide companies in the renewal dossier indicateclearly a potential for glyphosate’s carcinogenicity. HEAL has raised those concerns during meetings of the Risk Assessment Committee (RAC) at the European Chemical Agency (ECHA) earlier this year [5] and regrets that the carcinogenicity evidence was not reconsidered in the assessment. Finally, a few weeks ago, independent experts warned about the need to reconsider the data specific to oxidative stress in the dossier, showing that it currently still leaves carcinogenicity concerns uncleared [6].
Other health concerns
Leaving aside the carcinogenicity potential, the independent scientific literature accumulated over the last years has associated glyphosate exposure to numerous serious health conditions, including among others kidney disease, potential contributions to the development of Parkinson’s disease, impacts for the human developmental and the reproductive systems, as well as other transgenerational effects [7, 8, 9, 10]. Preliminary results of the Global Glyphosate Study currently carried out by internationally renowned Ramazzini Institute already indicate a range of serious enough human health effects to warrant a cautious approach to a potential renewal of the substance, including endocrine disrupting effects in animals confirmed in human cohorts, effects on the microbiome, on kidney and liver and overall doses across endpoints at doses traditionally considered safe by risk assessors [11].
Significant health-related data gaps in the industry dossier and the EFSA opinion
While the European Food Safety Agency (EFSA) stated that there are no critical areas of concern for human health or the environment when publishing its peer review [12], it highlighted a number of data gaps and remaining outstanding issues, which we consider contradict this statement and should prevent the substance renewal. Issues that could not be finalised include the consumer dietary risk assessment, which is critical when assessing long- term health risks of the population. Among remaining outstanding issues, we are also surprised to see questions regarding potential for neurodevelopmental toxicity and potential long-term impacts on the microbiome, especially in the light of available independent scientific evidence pointing to concerns that need further investigation.
Recent analysis from independent scientists indicates that a developmental neurotoxicity study compliant with existing test guidelines showed a neurobehavioural effect of a specific form of glyphosate on rats at doses previously not known to cause effects. This finding was not communicated by companies to assessing authorities [13]. This omission from the industry dossier is currently the subject of a criminal investigation [14].
Significant uncertainties regarding long-term effects for the environment
According to EFSA, it was also not possible to finalise the risk assessment for biodiversity for representative uses of the substance, in part due to a lack of harmonised methodology to do so [15]. This remains an extremely important data gap in the evaluation, which cannot be left to a guess estimate. Risks for biodiversity and the ecosystems are also relevant for long-term impacts of the substance on human health via indirect exposure.
European commitments regarding health protection and zero pollution
Through the EU Green Deal, the European Commission and Member States committed to increased health and environment protection through notably a reduced use of and dependency on harmful pesticides as part of an overall reduction of use of chemicals. With the recently agreed WHO Budapest declaration [16], Member States also promised to step up action to reduce the health impacts of pollution, through addressing both established and emerging environmental risk factors.
The decision you are about to take regarding the renewal of glyphosate provides you with the opportunity to show European citizens that you are able to keep your word and to honour the state of science. We therefore urge you to show your leadership for improved health and environment protection by not prolonging market license of the substance.
Yours sincerely,
Genon K. Jensen (She/her)
Executive Director
Health and Environment Alliance (HEAL)
On behalf of the signatories:
Alerte des Médecins sur les Pesticides
Caring Doctors
Générations Futures
Health and Environment Justice Support (HEJ Support) International Society of Doctors for Environment (ISDE) Italy Réseau Environnement Santé
Stichting Ecobaby
Women Engage for a Common Future (WECF) France
Contact:
Natacha Cingotti, Programme Lead, Health and Chemicals,
Health and Environment Alliance (HEAL), natacha@env-health.org
Notes:
[1] https://food.ec.europa.eu/system/files/2023-09/sc_phyto_20231012_ppl_agenda.pdf
[2] https://www.iarc.who.int/wp-content/uploads/2018/07/MonographVolume112-1.pdf
[3] https://presse.inserm.fr/en/inserm-publishes-its-latest-collective-expert-review-on-the-health-effects- of-pesticides/60325/
[4] https://www.env-health.org/wp-content/uploads/2022/06/HEAL-How-the-EU-risks-greenlighting-a- pesticide-linked-to-cancer-2022.pdf [5]https://www.env-health.org/health-and-environmental-groups-raise-alarms-over-eu-chemicals-agencys- failure-to-classify-glyphosate-as-a-carcinogen-for-human-health/
[6] https://www.pan-europe.info/press-releases/2023/09/eu-glyphosate-evaluation-fails-acknowledge- key-mechanism-can-lead-cancer
[7] https://www.env-health.org/new-scientific-study-confirms-health-concerns-about-glyphosate-based- herbicides/
[8] https://www.sciencedirect.com/science/article/abs/pii/S0013935121011051?via%3Dihub
[9] https://www.mdpi.com/1422-0067/23/9/4605
[10] https://www.env-health.org/health-effects-of-glyphosate-can-be-passed-down-to-other-generations- shows-new-study-on-rodents/
[11] Presentation Ramazzini, European Parliament, 18 September 2023, https://www.pan- europe.info/sites/pan-europe.info/files/public/resources/Webinars/Daniele%20Mandrioli%20- Global%20Glyphosate%20Study.pdf
[12] https://www.efsa.europa.eu/en/news/glyphosate-no-critical-areas-concern-data-gaps-identified [13] https://ehjournal.biomedcentral.com/articles/10.1186/s12940-022-00891-7 ; https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6425996/
[14] https://www.pan-europe.info/press-releases/2023/09/criminal-complaint-against-bayer-concealing- glyphosate-risks-pregnant-women
[15] https://www.efsa.europa.eu/en/news/glyphosate-no-critical-areas-concern-data-gaps-identified [16] https://www.env-health.org/the-who-europe-ministerial-conference-on-environment-and-health- addressing-the-triple-crisis-of-climate-change-biodiversity-loss-and-environmental-pollution-on-health/
The Health and Environment Alliance (HEAL) is the leading not-for-profit organisation addressing how the environment affects human health in the European Union (EU) and beyond. HEAL works to shape laws and policies that promote planetary and human health and protect those most affected by pollution, and raise awareness on the benefits of environmental action for health.
HEAL’s over 90 member organisations include international, European, national and local groups of health professionals, not-for-profit health insurers, patients, citizens, women, youth, and environmental experts representing over 200 million people across the 53 countries of the WHO European Region.
As an alliance, HEAL brings independent and expert evidence from the health community to EU and global decision-making processes to inspire disease prevention and to promote a toxic-free, low-carbon, fair and healthy future.
HEAL’s EU Transparency Register Number: 00723343929-96
Le Comité permanent des végétaux, des animaux, des denrées alimentaires et de l’alimentation animale ou SCoPAFF (Standing Committee on Plants, Animals, Food and Feed) doit discuter l’éventualité de renouveler l’autorisation les 12 et 13 octobre même si cela semble moins probable devant les derniers développements.
L’AMLP est signataire de ce communiqué :
BRUSSELS, 9th OCTOBER 2023 To: EU national Ministers for Agriculture, Environment, and Health
Support the non-renewal of pesticide active substance glyphosate due to health and environment concerns
Dear Ministers,
On behalf of public health and environmental groups working together all across Europe, we are writing to you in view of the important Member States’ discussion and potential vote on the renewal process of the pesticide active substance glyphosate due to take place on 12th/13th October [1]. We are asking you to support the non- renewal of the substance due to significant remaining concerns about long-term health and environmental effects.
Significant long-term concerns for health
Glyphosate is the most widely used pesticide active substance in the world. Independent science points to concerning health effects, part of which have already been central to the debates preceding the 2018 renewal of the substance and resulted in a shorter reauthorisation than originally planned – five years instead of the originally proposed 15.
Carcinogenicity
As you are aware, in 2015, the World Health Organization’s International Agency for Research on Cancer (IARC) concluded that glyphosate is a potential carcinogen based on an extensive independent peer-review of all the available scientific evidence for both the active ingredient and glyphosate-based formulations [2]. In 2021, these carcinogenicity concerns were echoed in a review on the health impacts of pesticides carried out by France’s national institute for public health INSERM [3], who also took part in the public consultation about the current substance evaluation.
In 2022, a HEAL report [4] showed that the studies provided by pesticide companies in the renewal dossier indicateclearly a potential for glyphosate’s carcinogenicity. HEAL has raised those concerns during meetings of the Risk Assessment Committee (RAC) at the European Chemical Agency (ECHA) earlier this year [5] and regrets that the carcinogenicity evidence was not reconsidered in the assessment. Finally, a few weeks ago, independent experts warned about the need to reconsider the data specific to oxidative stress in the dossier, showing that it currently still leaves carcinogenicity concerns uncleared [6].
Other health concerns
Leaving aside the carcinogenicity potential, the independent scientific literature accumulated over the last years has associated glyphosate exposure to numerous serious health conditions, including among others kidney disease, potential contributions to the development of Parkinson’s disease, impacts for the human developmental and the reproductive systems, as well as other transgenerational effects [7, 8, 9, 10]. Preliminary results of the Global Glyphosate Study currently carried out by internationally renowned Ramazzini Institute already indicate a range of serious enough human health effects to warrant a cautious approach to a potential renewal of the substance, including endocrine disrupting effects in animals confirmed in human cohorts, effects on the microbiome, on kidney and liver and overall doses across endpoints at doses traditionally considered safe by risk assessors [11].
Significant health-related data gaps in the industry dossier and the EFSA opinion
While the European Food Safety Agency (EFSA) stated that there are no critical areas of concern for human health or the environment when publishing its peer review [12], it highlighted a number of data gaps and remaining outstanding issues, which we consider contradict this statement and should prevent the substance renewal. Issues that could not be finalised include the consumer dietary risk assessment, which is critical when assessing long- term health risks of the population. Among remaining outstanding issues, we are also surprised to see questions regarding potential for neurodevelopmental toxicity and potential long-term impacts on the microbiome, especially in the light of available independent scientific evidence pointing to concerns that need further investigation.
Recent analysis from independent scientists indicates that a developmental neurotoxicity study compliant with existing test guidelines showed a neurobehavioural effect of a specific form of glyphosate on rats at doses previously not known to cause effects. This finding was not communicated by companies to assessing authorities [13]. This omission from the industry dossier is currently the subject of a criminal investigation [14].
Significant uncertainties regarding long-term effects for the environment
According to EFSA, it was also not possible to finalise the risk assessment for biodiversity for representative uses of the substance, in part due to a lack of harmonised methodology to do so [15]. This remains an extremely important data gap in the evaluation, which cannot be left to a guess estimate. Risks for biodiversity and the ecosystems are also relevant for long-term impacts of the substance on human health via indirect exposure.
European commitments regarding health protection and zero pollution
Through the EU Green Deal, the European Commission and Member States committed to increased health and environment protection through notably a reduced use of and dependency on harmful pesticides as part of an overall reduction of use of chemicals. With the recently agreed WHO Budapest declaration [16], Member States also promised to step up action to reduce the health impacts of pollution, through addressing both established and emerging environmental risk factors.
The decision you are about to take regarding the renewal of glyphosate provides you with the opportunity to show European citizens that you are able to keep your word and to honour the state of science. We therefore urge you to show your leadership for improved health and environment protection by not prolonging market license of the substance.
Yours sincerely,
Genon K. Jensen (She/her)
Executive Director
Health and Environment Alliance (HEAL)
On behalf of the signatories:
Alerte des Médecins sur les Pesticides
Caring Doctors
Générations Futures
Health and Environment Justice Support (HEJ Support) International Society of Doctors for Environment (ISDE) Italy Réseau Environnement Santé
Stichting Ecobaby
Women Engage for a Common Future (WECF) France
Contact:
Natacha Cingotti, Programme Lead, Health and Chemicals,
Health and Environment Alliance (HEAL), natacha@env-health.org
Notes:
[1] https://food.ec.europa.eu/system/files/2023-09/sc_phyto_20231012_ppl_agenda.pdf
[2] https://www.iarc.who.int/wp-content/uploads/2018/07/MonographVolume112-1.pdf
[3] https://presse.inserm.fr/en/inserm-publishes-its-latest-collective-expert-review-on-the-health-effects- of-pesticides/60325/
[4] https://www.env-health.org/wp-content/uploads/2022/06/HEAL-How-the-EU-risks-greenlighting-a- pesticide-linked-to-cancer-2022.pdf [5]https://www.env-health.org/health-and-environmental-groups-raise-alarms-over-eu-chemicals-agencys- failure-to-classify-glyphosate-as-a-carcinogen-for-human-health/
[6] https://www.pan-europe.info/press-releases/2023/09/eu-glyphosate-evaluation-fails-acknowledge- key-mechanism-can-lead-cancer
[7] https://www.env-health.org/new-scientific-study-confirms-health-concerns-about-glyphosate-based- herbicides/
[8] https://www.sciencedirect.com/science/article/abs/pii/S0013935121011051?via%3Dihub
[9] https://www.mdpi.com/1422-0067/23/9/4605
[10] https://www.env-health.org/health-effects-of-glyphosate-can-be-passed-down-to-other-generations- shows-new-study-on-rodents/
[11] Presentation Ramazzini, European Parliament, 18 September 2023, https://www.pan- europe.info/sites/pan-europe.info/files/public/resources/Webinars/Daniele%20Mandrioli%20- Global%20Glyphosate%20Study.pdf
[12] https://www.efsa.europa.eu/en/news/glyphosate-no-critical-areas-concern-data-gaps-identified [13] https://ehjournal.biomedcentral.com/articles/10.1186/s12940-022-00891-7 ; https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6425996/
[14] https://www.pan-europe.info/press-releases/2023/09/criminal-complaint-against-bayer-concealing- glyphosate-risks-pregnant-women
[15] https://www.efsa.europa.eu/en/news/glyphosate-no-critical-areas-concern-data-gaps-identified [16] https://www.env-health.org/the-who-europe-ministerial-conference-on-environment-and-health- addressing-the-triple-crisis-of-climate-change-biodiversity-loss-and-environmental-pollution-on-health/
The Health and Environment Alliance (HEAL) is the leading not-for-profit organisation addressing how the environment affects human health in the European Union (EU) and beyond. HEAL works to shape laws and policies that promote planetary and human health and protect those most affected by pollution, and raise awareness on the benefits of environmental action for health.
HEAL’s over 90 member organisations include international, European, national and local groups of health professionals, not-for-profit health insurers, patients, citizens, women, youth, and environmental experts representing over 200 million people across the 53 countries of the WHO European Region.
As an alliance, HEAL brings independent and expert evidence from the health community to EU and global decision-making processes to inspire disease prevention and to promote a toxic-free, low-carbon, fair and healthy future.
HEAL’s EU Transparency Register Number: 00723343929-96