Bezwaar­motie tegen de verlenging van de goed­keuring van glyfosaat

DRAFT MOTION FOR A RESOLUTION

pursuant to Rule 112(2) and (3) of the Rules of Procedure

on the draft Commission implementing regulation renewing the approval of the active substance glyphosate in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council and amending Commission Implementing Regulation (EU) No 540/2011

(D092073/02 – 2023/2896(RSP))

Committee on the Environment, Public Health and Food Safety

Members responsible:

Maria Arena
On behalf of the S&D Group
Marie Toussaint
On behalf of the Greens/EFA Group
Anja Hazekamp
On behalf of The Left Group

B9‑0000/2023

European Parliament resolution on the draft Commission implementing regulation renewing the approval of the active substance glyphosate in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council and amending Commission Implementing Regulation (EU) No 540/2011

(D092073/02 – 2023/2896 (RSP))

The European Parliament,

– having regard to the draft Commission implementing regulation renewing the approval of the active substance glyphosate in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council and amending Commission Implementing Regulation (EU) No 540/2011 (D092073/02),

– having regard to Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC^[1], and in particular Article 20(1) thereof,

– having regard to the vote of the Standing Committee on Plants, Animals, Food and Feed referred to in Article 79(1) of Regulation (EC) No 1107/2009, on 13 October 2023, at which no opinion was delivered,

– having regard to Articles 11 and 13 of Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 laying down the rules and general principles concerning mechanisms for control by Member States of the Commission’s exercise of implementing powers^[2],

– having regard to Article 7 of Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety^[3],

– having regard to the European Food Safety Authority (EFSA) conclusion of 6 July 2023 on the peer review of the pesticide risk assessment of the active substance glyphosate^[4],

– having regard to Rule 112(2) and (3) of its Rules of Procedure,

– having regard to the motion for a resolution of the Committee on the Environment, Public Health and Food Safety,

Background information on glyphosate

A. whereas the systemic herbicide glyphosate currently has the highest global production volume of all herbicides; whereas its global use has increased dramatically, by a factor of 260, in the last 40 years, that is from 3 200 tonnes in 1974 to 825 000 tonnes in 2014^[5];

B. whereas, in 2017, glyphosate represented 33 % of the total herbicide market in the Union[6];

C. whereas 76 % of the use of glyphosate worldwide is in agriculture; whereas it is also widely used in forestry, urban and garden applications;

D. whereas glyphosate and its residues and metabolites have been detected in water, soil, food and drinks and non-comestible goods, as well as in the human body, e.g. in urine and maternal milk;

E. whereas the general population is exposed primarily through residence near sprayed areas, through home use, and through diet; whereas exposure to glyphosate is on the rise owing to the increase in the total volume of glyphosate used;

F. whereas several Member States have already taken precautionary measures to protect public health and the environment from exposure to glyphosate, but many others have not done so; whereas, in order to achieve the same level of protection in all Member States, in the case of renewal of the approval of the active substance glyphosate, clear and legally binding conditions, including risk mitigation measures, for its use should be set at Union level;

Draft renewal of the approval and legal basis

G. whereas, in its resolution of 24 October 2017[7], the European Parliament called on the Commission to adopt necessary measures to phase out the active substance glyphosate in the Union no later than 15 December 2022, ensuring that no use of glyphosate is authorised after that date; whereas the European Parliament called on the Commission to restrict the use of glyphosate during the phase-out period between 2017 and 2022, inter alia by not approving the use of glyphosate for pre-harvest desiccations and by allowing no glyphosate use where integrated pest management systems are sufficient for the necessary weed control; whereas the Commission did not take into account those restrictions requested by the European Parliament in its renewal of the approval of the active substance glyphosate in Commission Implementing Regulation (EU) 2017/2324[8];

H. whereas the draft Commission implementing regulation proposes to authorise glyphosate until 15 December 2033 for any use as herbicide;

I. whereas, pursuant to Article 1(3) of Regulation (EC) No 1107/2009, its purpose is ‘to ensure a high level of protection of both human and animal health and the environment and to improve the functioning of the internal market through the harmonisation of the rules on the placing on the market of plant protection products, while improving agricultural production’;

J. whereas, pursuant to Article 1(4) of Regulation (EC) No 1107/2009, its provisions are ‘underpinned by the precautionary principle in order to ensure that active substances or products placed on the market do not adversely affect human or animal health or the environment’; whereas that Article further provides that ‘[i]n particular, Member States shall not be prevented from applying the precautionary principle where there is scientific uncertainty as to the risks with regard to human or animal health or the environment posed by the plant protection products to be authorised in their territory’;

K. whereas, pursuant to Article 13(2) of Regulation (EC) No 1107/2009, any decision regarding the approval, non-approval or conditional approval of an active substance shall be based on the Commission’s review report and on ‘other factors legitimate to the matter under consideration and the precautionary principle where the conditions laid down in Article 7(1) of Regulation (EC) No 178/2002 are relevant’;

L. whereas Article 7(1) of Regulation (EC) No 178/2002 stipulates that ‘[i]n specific circumstances where, following an assessment of available information, the possibility of harmful effects on health is identified but scientific uncertainty persists, provisional risk management measures necessary to ensure the high level of health protection chosen in the Community may be adopted, pending further scientific information for a more comprehensive risk assessment’;

M. whereas the conditions of recourse to the precautionary principle as laid down in Regulation (EC) No 178/2002 are clearly unfulfilled in light of the unresolved controversy about the carcinogenic properties of glyphosate (see dedicated section below);

N. whereas, in her decision in case 12/2013/MDC of 18 February 2016 on the practices of the European Commission regarding the authorisation and placing on the market of plant protection products (pesticides), the European Ombudsman called on the Commission to review its approach to the definition and implementation of mitigation measures (conditions and restrictions), so as to include further requirements aimed at ensuring that the Commission does not evade its responsibility to ensure the effective protection of human health, animal health and the environment by allowing Member States almost absolute discretion as regards the definition of mitigation measures for potentially unsafe substances, given that standard formulations are very open-ended and it can be doubted whether they can be legally described as requiring mitigation measures at all;

O. whereas the Commission has, however, not reviewed its approach in the context of the renewal of the approval of glyphosate; whereas the draft Commission implementing regulation includes only very limited restrictions of use, and instead passes the responsibility to deal with the concerns and data gaps found by EFSA during the peer review in a mostly non-binding manner on to the competent authorities of the Member States, in the context of the subsequent authorisation of glyphosate-based plant protection products;

Co-formulants

P. whereas Article 4(5) of Regulation (EC) No 1107/2009 provides that the approval criteria for an active substance shall be deemed to be satisfied where compliance with the requirements of Article 4(1), (2) and (3) of that Regulation has been established with respect to one or more representative uses of at least one plant protection product containing that active substance; whereas an active substance therefore need to be assessed not only in isolation but also as part of one plant protection product, in combination with the other co-formulants of that plant protection product;

Q. whereas, in its judgment in Case C-616/17[9], the European Court of Justice recalled that a plant protection product ‘can be authorised only if it is established that it has no immediate or delayed harmful effect on human health’; whereas the Court moreover clarified that ‘[a] plant protection product cannot be considered to satisfy that condition [the approval conditions in Article 4(3), point (b), and Article 29(1) of Regulation (EC) No 1107/2009] where it exhibits any long-term carcinogenicity and toxicity’;

R. whereas that judgment confirms that the competent authorities are required to thoroughly examine any immediate or delayed harmful effect on human health that plant protection products may have; whereas according to the Court, to that end, they are obliged to take into account the cumulative and synergistic effects of all the constituents of a given plant protection product and only accept reliable scientific data[10];

S. whereas the Court specified that those requirements also bind EFSA where it adopts, in the light of current scientific and technical knowledge, conclusions in which it states whether the active substance can be expected to meet the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009[11];

T. whereas EFSA found in its conclusion of 6 July 2023 a lack of key short- and long-term toxicology data on a co-formulant that was present in ‘significant amount’ in the formulation assessed for the approval of glyphosate; whereas the use of the term ‘significant’ in that context means more than 10 % in line with the common use of that term by EFSA;

U. whereas EFSA stated that in order to allow a final conclusion on the risk assessment of the representative formulation, repeated dose toxicity data for this component (short- and long- term) should be assessed;

V. whereas, due to that data gap, it is not possible to assess whether glyphosate meets the approval criteria pursuant to Article 4(5) of Regulation (EC) No 1107/2009; whereas the Commission cannot therefore be considered to have fulfilled its duty to take into account the potential effects of a combination of the various constituents of a plant protection product for the approval of glyphosate as an active substance by simply requiring Member States to pay particular attention to the co-formulants present in glyphosate-containing plant protection products as a risk mitigation measure;

W. whereas renewing the approval of glyphosate despite the lack of such information would therefore be contrary to Article 4(5) of Regulation (EC) No 1107/2009 as confirmed by the Court in Case C-616/17;

Biodiversity

X. whereas glyphosate is a non-selective herbicide which kills all herbage; whereas it acts by interfering with the so-called shikimate pathway, a pathway that is also present in algae, fungi and bacteria; whereas sub-lethal exposures of Escherichia coli and Salmonella enterica serovar Typhimurium to commercial formulations of glyphosate have been found to induce a changed response to antibiotics;

Y. whereas EFSA found in its conclusion of 6 July 2023 that insufficient information was provided to draw a firm conclusion on the impact to biodiversity via indirect effects and trophic interactions for the representative uses;

Z. whereas, in particular, EFSA concluded that “[r]egarding the data collection [on the indirect effects of glyphosate on biodiversity], it was noted that a specific systematic literature search was not available, although requested to the applicants during the peer review process following the public consultation’ and that ‘the data presented [was] of questionable scientific quality and of limited use to address the topic’;

AA. whereas EFSA concluded that the risk assessment for aquatic macrophytes due to contact exposure via spray drift could not be finalised, and that further information to investigate the risk for aquatic macrophytes due to contact exposure via spray drift is needed, including an assessment of the toxicity of the active substance and the formulation to standard macrophytes species via this route of exposure for all representative uses;

AB. whereas the draft Commission implementing regulation provides that, as a risk mitigation measure, Member States should pay particular attention to the protection of non-target terrestrial and aquatic plants from exposure from spray drift, and to indirect effects on biodiversity via trophic interactions once relevant methods and guidance to identify such effects are agreed at Union level, and may apply interim measures in the meantime;

AC. whereas such risk mitigation measures, which are not legally binding, cannot be considered sufficient to address the respective risk, and cannot be considered as a palliative for the lack of proper conclusion by EFSA on the impact to biodiversity of glyphosate via indirect effects;

AD. whereas renewing the approval of the non-selective herbicide glyphosate in light of its mode of action affecting plants, algae, fungi and bacteria would therefore create an unacceptable effect on the environment due to its adverse effects on biodiversity and therefore does not meet the approval criteria set out in Article 4(3), point (e)(iii), of Regulation (EC) No 1107/2009;

High long-term risk to mammals

AE. whereas EFSA found in its conclusion of 6 July 2023 that with respect to ecotoxicology for the representative uses assessed, a high long-term risk to mammals was concluded for 12 of the 23 representative uses based on tier 1 assumptions, and that suitable data was lacking to refine the risk assessment;

AF. whereas the Commission tries to deal with this by leaving it to Member States, ‘where necessary’ to limit the timing of use, the number of applications or the maximum dose rate, and by establishing maximum application rates for different uses (agricultural, use to control invasive species, use in non-agricultural areas), unless the outcome of the risk assessment undertaken for the specific uses for which authorisation is applied for demonstrates that a higher rate does not lead to any unacceptable effects on small herbivores;

AG. whereas it is not appropriate to pass the responsibility to Member States to deal with high-long term risks to mammals, especially not with such qualifiers, let alone for non-agricultural uses, for which it is impossible to set meaningful maximum application rates as those cannot be enforced;

AH. whereas renewing the approval of glyphosate for uses for which a high long-term risk to mammals was concluded would create an unacceptable effect on non-target organisms and therefore does not meet the approval criteria set out in to Article 4(3), point (e)(ii), of Regulation (EC) No 1107/2009 for such uses;

Consumer dietary risk assessment

AI. whereas EFSA concluded that the consumer dietary risk assessment could not be finalised since the data set on the magnitude of residues in rotational crops, such as carrots, lettuce and wheat, is not complete;

AJ. whereas it is therefore not possible to assess for such uses whether glyphosate meets the approval criteria set out in Article 4(2) of Regulation (EC) No 1107/2009 according to which residues shall not have any harmful effects on human health;

AK. whereas the risk mitigation measures provided in the draft Commission implementing regulation foresee that Member States shall pay particular attention to the consumer exposure with regard to residues that may be present in succeeding crops grown; whereas, apart from the fact that this is not legally binding, it is difficult to see how Members States should be able to do this in the absence of such information;

AL. whereas the Commission cannot be considered to have fulfilled its responsibility to take into account the risk of exposure to residues for consumers by passing on its responsibility to Member States in such a manner;

AM. whereas renewing the approval of glyphosate for uses in rotational crops in the absence of a complete consumer dietary risk assessment would therefore be contrary to Article 4(2) of Regulation (EC) No 1107/2009;

Pre-harvest uses and desiccation

AN. whereas a significant use of glyphosate is for ‘desiccation’, the killing of the actual crop plant prior to harvest in order to accelerate its ripening and facilitate its harvesting; whereas this practice not only has significant adverse effects on biodiversity, but also typically results in much higher residue levels in the final harvested products, and thus leads to increased human dietary exposure[12]; whereas it is unacceptable, both for the protection of human health and for the environment, to use a non-selective herbicide for such purposes;

AO. whereas, based on Article 55 of Regulation (EC) No 1107/2009, the draft Commission implementing regulation requires that ‘‘[u]ses for desiccation to control the time point of harvest or to optimise threshing shall not be authorised’; ;

AP. whereas a non-authorisation requirement related to the specific use of ‘desiccation”’ could be circumvented by requesting authorisation for e.g. pre-harvest weed control; whereas the use of glyphosate-based formulations for any pre-harvest application creates similar risks as the use for desiccation;

AQ. whereas the use of glyphosate-based formulations for any pre-harvest application, not just desiccation, should be considered an unsafe use and should therefore be prohibited based on Article 55 of Regulation (EC) No 1107/2009,

Controversy over the carcinogenicity of glyphosate and concerns about mutagenicity

AR.whereas, according to Regulation (EC) No 1107/2009, an active substance may only be approved if it is not or has not to be classified, inter alia, as a carcinogen category 1A or 1B or a mutagen category 1A or 1B in accordance with Regulation (EC) No 1272/2008 of the European Parliament and of the Council[13], unless the exposure of humans to the active substance concerned is negligible or there is a serious danger to plant health that cannot be contained by other available means;

AS. whereas, in March 2015, the International Agency for Research on Cancer (IARC) classified glyphosate as ‘probably carcinogenic to humans’ (group 2A) with a positive association observed for non-Hodgkin lymphoma, on the basis of ‘limited evidence’ of cancer in humans (from cases of real-world exposure that actually occurred), ‘sufficient evidence’ of cancer in laboratory animals (from studies of ‘pure’ glyphosate), and ‘strong evidence’ of mechanistic information related to carcinogenicity (for genotoxicity and oxidative stress) for both ‘pure’ glyphosate and glyphosate formulations;

AT. whereas the criteria used by IARC for group 2A are comparable to those for category 1B in Regulation (EC) No 1272/2008;

AU. whereas, nevertheless, on 6 July 2023 EFSA finalised its peer review of glyphosate and concluded that glyphosate is unlikely to be carcinogenic for humans based on the opinion of 30 May 2022 of the Committee for Risk Assessment (RAC) of the European Chemicals Agency (ECHA)[14];

AV. whereas the conclusions of RAC have been strongly criticised by NGO scientists, which illustrates that the conclusions by RAC remain controversial[15];

AW. whereas the French Pesticide Victims Compensation Fund, a fund established under national law in France, has established a direct link between the exposure to glyphosate and birth defects[16]; whereas this raises serious concerns about the possible mutagenic nature of glyphosate;

Studies on genotoxicity

AX. whereas, in it opinion of 30 May 2022, RAC concluded that ‘the genotoxicity observed for glyphosate in some studies is likely to be caused by indirect mechanisms’; whereas RAC further stated that ‘“[n]oting the absence of a Comet assay conducted according to OECD TG 489 in relevant tissues as well as a TGR somatic and germ cell gene mutation assay conducted according to OECD TG 488, the biological importance of such DNA lesions in relation to mutagenicity is equivocal’;

AY. whereas those studies were never requested either by ECHA nor by EFSA, which ECHA justified by stating that ‘the CLH process assesses available data – there is no mechanism to generate additional information’^[17] and that ‘the biological importance of such DNA lesions (i.e., as identified from these assays) in relation to mutagenicity is equivocal, therefore the fact that some studies of this type were not included is not crucial for the conclusion’;

AZ. whereas the absence of two genotoxicity studies conducted in line with the OECD test guidelines and showing DNA lesions in laboratory animals and humans following glyphosate exposure represents a clear violation of the requirements of Regulation (EC) No 1107/2009 and leads to a data gap in the assessment of the capacity of glyphosate to cause DNA damage to specific organs;

BA. whereas it is therefore not possible to assess whether glyphosate has a genotoxic effect and whether it does not have any harmful effects on human health and therefore whether it meets the approval criteria set out in Article 4(3), point (b), of Regulation (EC) No 1107/2009;

Neurotoxicity

BB. whereas a systematic literature review on the effects of glyphosate on the nervous system of various animal species and humans published in 2022 confirmed that ‘it is unequivocal that exposure to glyphosate produces important alterations in the structure and function of the nervous system of humans, rodents, fish, and invertebrates’[18];

BC. whereas, in particular, human clinical reports on the effects of intoxication with glyphosate formulations have described harmful effects on the nervous system, including parkinsonism[19];

BD. whereas there is a consensus among experts that exposure to plant protection products poses a risk of Parkinson’s disease and other neurodegenerative diseases such as Alzheimer’s; whereas EFSA acknowledges that there is a ‘statistically significant association’^[20],

BE. whereas there is no developmental neurotoxicity (DNT) study in the glyphosate application dossier for renewal;

BF. whereas, in its conclusion of 6 July 2023, EFSA identified a data gap for the applicants to clarify the cause of the DNT effects seen in the public literature studies with glyphosate-based herbicides and in the study with glyphosate-trimesium;

BG. whereas it is therefore not possible to assess whether glyphosate has a developmental neurotoxicity effect and whether it does not have a harmful effect on human health and therefore whether it meets the approval criteria set out in Article 4(3), point (b), of Regulation (EC) No 1107/2009;

BH. whereas the Dutch research institute RIVM indicates that farmers have an increased risk of contracting Parkinson’s disease^[21]; whereas, already in 2020, the Dutch Ministry of Agriculture sent a letter to the Commission^[22] requesting new tests for plant protection products to be imposed on the industry to determine the risk of Parkinson’s disease and to identify the products responsible for it;

BI. whereas, in September 2022, EFSA organised a workshop on new approach methodologies (NAMs) on environmental neurotoxicants, where scientists expressed their concern over the increase of patients with Parkinson’s disease and pleaded for better risk assessment methods[23];

BJ. whereas the minutes of that workshop[24] note that ‘there was broad consensus that the currently existing procedures, that are part of existing regulatory actions, are likely to give us an inadequate insight into the actual neurotoxic actions of specific pesticides for the substantia nigra, and consequently, offer an inadequate assessment of the risk of developing Parkinson's disease in case of human exposure. Additionally, there are clear ideas on how to perform experiments that will inform an improved screening procedure; this involves both improved in vivo experiments and the search for reliable in vitro alternatives’;

BK. whereas renewing the approval of glyphosate despite the lack of such information would therefore be contrary to Article 4(3) of Regulation (EC) No 1107/2009;

1. Considers that the draft Commission implementing regulation exceeds the implementing powers provided for in Regulation (EC) No 1107/2009;

2. Considers that the draft Commission implementing regulation is not consistent with Union law, in that it fails to ensure a high level of protection of both human and animal health and the environment and fails to apply the precautionary principle, insofar as it proposes to renew the approval of glyphosate contrary to Regulation (EC) No 1107/2009;

3. Calls on the Commission to withdraw its draft implementing regulation and to submit a new draft to the committee;

4. Calls on the Commission to propose not to renew the approval of glyphosate, as renewing the approval of glyphosate despite the lack of information on a co-formulant present in concentrations above 10 % in the formulation used for the approval of glyphosate would be contrary to Article 4(5) of Regulation (EC) No 1107/2009 as confirmed by case law;

5. Calls on the Commission to propose not to renew the approval of glyphosate, as it creates an unacceptable effect on the environment due to its adverse effects on biodiversity and therefore does not meet the approval criteria set out in Article 4(3), point (e)(iii), of Regulation (EC) No 1107/2009,

6. Calls on the Commission, without prejudice to paragraphs 4 and 5, not to renew the approval of glyphosate for the uses for which a high long-term risk to mammals was identified,

7. Calls on the Commission, without prejudice to paragraphs 4 and 5, not to renew the approval of glyphosate for any uses for which the consumer dietary risk assessment is incomplete;

8. Calls on the Commission, without prejudice to paragraphs 4 and 5, to ban all pre-harvest uses of glyphosate based on Article 55 of Regulation (EC) No 1107/2009,

9 Calls on the Commission, without prejudice to paragraphs 4 and 5, not to approve any non-professional uses of glyphosate based on Article 55 of Regulation (EC) No 1107/2009;

10. Calls on the Commission, without prejudice to paragraphs 4 and 5, not to approve any uses of glyphosate in or close to homes, public parks and gardens, playgrounds, schools, hospitals and other places frequented by people as this leads to unacceptable risks to human health;

11. Calls on the Commission and Member States to finance research and innovation with regard to alternative sustainable and cost-efficient solutions for plant protection products to ensure a high level of protection of human and animal health and the environment;

12. Is of the opinion that it is important for trust in and between the institutions of the Union that the Commission follow up on the calls by the European Parliament in this resolution in an appropriate manner, and expects that the Commission does so within two weeks of the adoption of this resolution;

13. Instructs its President to forward this resolution to the Council and the Commission, and to the governments and parliaments of the Member States.

[1] OJ L 309, 24.11.2009, p. 1.

[2] OJ L 55, 28.2.2011, p. 13.

[3] OJ L 31, 1.2.2002, p. 1.

[4] EFSA Journal 2023;21(7):8164, https://www.efsa.europa.eu/en/efsajournal/pub/8164

[5] Benbrook, C.M., ‘Trends in glyphosate herbicide use in the United States and globally’, Environmental Sciences Europe 28, 3 (2016), http://enveurope.springeropen.com/articles/10.1186/s12302-016-0070-0

[6] Antier, C., Kudsk, P., Reboud, X., Ulber, L., Baret, P.V., Messéan, A., ‘Glyphosate Use in the European Agricultural Sector and a Framework for Its Further Monitoring’, Sustainability 2020, 12, 5682, https://www.mdpi.com/2071-1050/12/14/5682

[7] European Parliament resolution of 24 October 2017 on the draft Commission implementing regulation renewing the approval of the active substance glyphosate in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Implementing Regulation (EU) No 540/2011 (OJ C 346, 27.9.2018, p. 117).

[8] Commission Implementing Regulation (EU) 2017/2324 of 12 December 2017 renewing the approval of the active substance glyphosate in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011 (OJ L 333, 15.12.2017, p. 10).

[9] Judgment of the Court (Grand Chamber) of 1 October 2019, Criminal proceedings against Mathieu Blaise and Others, C-616/17, ECLI:EU:C:2019:800, paragraphs 114 and 115.

[10] Ibid., paragraph 71

[11] Ibid., paragraph 69.

[12]Myers, J.P., Antoniou, M.N., Blumberg, B. et al., ‘Concerns over use of glyphosate-based herbicides and risks associated with exposures: a consensus statement’, Environmental Health 15, 19 (2016), http://ehjournal.biomedcentral.com/articles/10.1186/s12940-016-0117-0

[13] Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006 (OJ L 353 31.12.2008, p. 1).

[14] Committee for Risk Assessment opinion of 30 May 2022 proposing harmonised classification and labelling at EU level of glyphosate (ISO); N-(phosphonomethyl)glycine, https://echa.europa.eu/registry-of-clh-intentions-until-outcome/-/dislist/details/0b0236e185e41a77, https://echa.europa.eu/documents/10162/5702e99d-d503-f154-226f-d8ab070ac47a

[15] HEAL Health and Environment Alliance, ‘How the EU risks greenlighting a pesticide linked to cancer - Zooming in on the glyphosate renewal dossier’, June 2022, https://www.env-health.org/wp-content/uploads/2022/06/HEAL-How-the-EU-risks-greenlighting-a-pesticide-linked-to-cancer-2022.pdf

[16]https://www.lemonde.fr/planete/article/2023/10/09/glyphosate-theo-grataloup-porteur-de-graves-malformations-apres-une-exposition-prenatale-sera-indemnise_6193378_3244.html

[17] ECHA and EFSA letter of October 2023, https://echa.europa.eu/documents/10162/11035849/ECHA_EFSA_reply_NGOs.pdf/7e7b03bc-b2f1-8949-b6f6-da9feb1f7292?t=1696573111452

[18] Costas-Ferreira, C., Durán, R., Faro, L.R.F., ‘Toxic Effects of Glyphosate on the Nervous System: A Systematic Review’, International Journal of Molecular Sciences 2022, Apr 21;23(9):4605, https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9101768/

[19] Barbosa, E.R., Leiros da Costa, M.D., Bacheschi, L.A., Scaff, M., Leite, C.C., ‘Parkinsonism after glycine-derivate exposure’, Movement Disordorders 2001, May;16(3):565-8, https://pubmed.ncbi.nlm.nih.gov/11391760

[20] Ntzani, E.E., Chondrogiorgi, M., Ntritsos, G., Evangelou, E., Tzoulaki, I., ‘Literature review on epidemiological studies linking exposure to pesticides and health effects’, EFSA supporting publication 2013:EN-497, 159 pp. A statistical significant association was observed through fixed and random effect metaanalysis between pesticide exposure and a number of health outcomes, in particular Parkinson’s disease and childhood leukaemia.

[21] Heusinkveld, H., et al., ‘Gewasbeschermingsmiddelen en neurodegeneratieve ziekten: mogelijkheden om de toelatingsvereisten te verbeteren’, RIVM-briefrapport 2021-0153.

[22] Letter from the Ministry of Agriculture of 9 March 2020 (reference DGA-PAV / 20063866) to the European Commission, Ms Julicher, Director for Food and Feed Safety, Innovation.

[23] https://www.groene.nl/artikel/de-gezondheidsrisico-s-van-glyfosaat

[24]https://www.pan-europe.info/sites/pan-europe.info/files/public/resources/other/Agreed%20minutes%207-8%20September%202022.pdf