On the draft Commission implementing decision renewing the authorisation for the placing on the market of products containing, consisting of or produced from genetically modified maize MON 88017 (MON-88Ø17-3) pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council

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

A.whereas Commission Decision 2009/814/EC authorised the placing on the market of food and feed containing, consisting of or produced from genetically modified (‘GM’) maize MON 88017; whereas the scope of that authorisation also covers the placing on the market of products, other than food and feed, containing or consisting of GM maize MON 88017 for the same uses as any other maize, with the exception of cultivation;

B.whereas on 10 July 2018, Monsanto Europe N.V. on behalf of the authorisation holder Monsanto Company, United States, submitted to the Commission an application, in accordance with Articles 11 and 23 of Regulation (EC) No 1829/2003, for the renewal of that authorisation;

C.whereas, on 21 April 2009, EFSA adopted a favourable opinion, which was published on 6 May 2009, in relation to the initial authorisation application;

D.whereas, on 29 January 2020, EFSA adopted a favourable opinion, which was published on 11 March 2020, in relation to the renewal application;

E.whereas GM maize MON 88017 has been engineered to produce Cry3Bb1, a synthetic insecticidal protein (also known as a Bt toxin) with enhanced toxicity, compared to the natural bacteria it is derived from, against coleopteran insect pests and the CP4 EPSPS protein providing tolerance to glyphosate;

F.whereas the combination of the two gene constructs was derived from stacking, but no assessment was made of the single parental plants, in contravention of Commission Implementing Regulation (EU) No 503/2013;

G.whereas Regulation (EC) No 1829/2003 states that GM food or feed must not have adverse effects on human health, animal health or the environment, and requires the Commission to take into account any relevant provisions of Union law and other legitimate factors relevant to the matter under consideration when drafting its decision;

Member State concerns about the EFSA opinions

H.whereas, during the consultation period in relation to the initial authorisation application, Member States submitted many critical comments to EFSA’s draft opinion; whereas those critical comments include observations that little significance can be attributed to the acute toxicological tests which were undertaken with isolated proteins (i.e. not with the whole GM plant), that the proposed post-market environmental monitoring is too imprecise for a surveillance plan of unintended effects on human or animal health and the environment, that testing bacterial surrogate proteins should not substitute for testing the plant-expressed proteins, that the number of field seasons and locations is not adequate given the commercial use of the GMO, that further information is required to conclude on the risk assessment and that an increase in allergenic activity due to mCry3Bb1 protein in food and feed from GM maize MON 88017 cannot be excluded; whereas, furthermore, one Member State questioned the independence of the studies carried out for the purpose of the risk assessment, given that they were carried out by the applicant Monsanto;

I.whereas, during the consultation period in relation to the renewal application, Member States again submitted many critical comments to EFSA’s draft opinion; whereas those critical comments include the observation that the monitoring plan based on consent given by Decision 2009/814/EC and the monitoring reports have fundamental shortcomings and are not in in line with Directive 2001/18/EC of the European Parliament and of the Council or with relevant EFSA guidance, that the studies are not sufficient and that further experiments are needed to determine the exposure and subsequent effects and risks for non-target organisms from the exposure to Bt proteins via manure or sewage, and that due to missing information the environmental safety of GM maize MON 88017 cannot be fully assessed;

Complementary herbicides and lack of analysis of residues

J.whereas it has been shown that the cultivation of herbicide-tolerant GM crops results in a higher use of herbicides, which is due in large part to the emergence of herbicide-tolerant weeds; whereas, as a consequence, it has to be expected that crops of the GM maize will be exposed to both higher and repeated doses of glyphosate, which will potentially lead to a higher quantity of residues in the harvest;

K.whereas questions concerning the carcinogenicity of glyphosate remain; whereas EFSA concluded in November 2015 that glyphosate was unlikely to be carcinogenic and the European Chemicals Agency concluded in March 2017 that no classification was warranted; whereas, on the contrary, in 2015, the International Agency for Research on Cancer the specialised cancer agency of the World Health Organization, classified glyphosate as a probable carcinogen for humans; whereas a number of recent scientific peer-reviewed studies confirm the carcinogenic potential of glyphosate;

L.whereas according to an opinion by the EFSA Pesticides Unit data on glyphosate residues on GM maize with EPSPS modifications are insufficient to derive maximum residue levels and risk assessment values;

M.whereas, again according to the EFSA Pesticides Unit, toxicological data allowing a consumer risk assessment to be performed for several break-down products of glyphosate relevant for GM glyphosate-tolerant crops are missing;

N.whereas assessment of herbicide residues, and herbicide break-down products, found on GM plants, along with their interaction with Bt toxins, is considered outside the remit of the EFSA GMO Panel and is therefore not undertaken as part of the authorisation process for GMOs; whereas this is problematic, since the way in which complementary herbicides are broken down by the GM plant concerned, and the composition and thus toxicity of the break-down products (‘metabolites’), can be driven by the genetic modification itself;

Invalid toxicity studies

O.whereas for the studies on acute toxicity and degradation in digestive fluids, the Cry3Bb1 and CP4 EPSPS proteins produced in a recombinant E. coli strain were used;

P.whereas, in general, little significance can be attributed to toxicological tests conducted with proteins in isolation, due to the fact that the effects of the protein in combination with the plant itself are not considered;

Q.whereas, for example, some plants, including maize, naturally produce proteinase inhibitors (PI) which have been shown to slow down the degradation of Bt toxins; whereas this results in much higher toxicity of the Bt toxin, if it is ingested together with the plant tissue, compared to the toxin in isolation; whereas a 1990 study, conducted by scientists at Monsanto, showed that even the presence of extremely low levels of PI enhanced the insecticidal activity of Bt toxins up to 20-fold; whereas this interaction has never been assessed, or mentioned, by EFSA in its risk assessments of GM Bt plants;

R.whereas it has been shown that factors which enhance the toxicity of the Bt toxins can also impact their selectivity: if efficacy of the Bt toxin on target organisms is increased, its selectivity may also be decreased and a wider range of non-target organisms may become susceptible; whereas, whilst no systematic research has been undertaken to date, several studies indicate the effects of PI combined with Bt toxins on non-target insects;

S.whereas the risk of higher toxicity to humans and mammals due to interaction between PI and Bt toxins in GM plants, is not known;

Questions of Bt adjuvanticity

T.whereas a number of studies show that side effects have been observed that may affect the immune system following exposure to Bt toxins and that some Bt toxins may have adjuvant properties, meaning that they can increase the allergenicity of other proteins with which they come into contact;

U.whereas the risk assessment performed by EFSA does not take into account the fact that maize produces PI and therefore a much slower degradation of the Bt toxin has to be assumed if it is ingested with the plant material, compared to its isolated form; whereas this difference can also enhance its adjuvanticity and renders studies using isolated proteins invalid; whereas no empirical studies were performed to investigate the actual immunogenicity of the Bt toxin produced by the GM plant; whereas, the degradation in digestive fluids, which can be relevant for toxicity and adjuvanticity, was tested by using the Bt toxin in isolation;

Bt crops: effects on non-target organisms and increased resistance

V.whereas, unlike the use of insecticides, where exposure is at the time of spraying and for a limited time afterwards, the use of Bt crops leads to continuous exposure of the target and non target organisms to Bt toxins;

W.whereas the assumption that Bt toxins exhibit a single target specific mode-of-action can no longer be considered correct and effects on non-target organisms cannot be excluded; whereas an increasing number of non-target organisms are reported to be affected in many ways; whereas 39 peer-reviewed publications that report significant adverse effects of Bt toxins on many ‘out-of-range’ species are mentioned in a recent overview;

X.whereas combinatorial effects such as combination with PI may significantly contribute to the toxicity of Bt toxins; whereas the question of selectivity is especially relevant for synthetic Bt toxins, such as Cry3Bb1, which may show lower selectivity in combination with higher toxicity; whereas EFSA still considers that Bt toxins only affect a narrow range of non-target organisms, not taking into account any combinatorial effects; whereas a wider range of non-target organisms might be exposed to Bt toxins via spillage, waste and manure;

Y.whereas the risk assessment did not consider the development of resistance in the target pests to Bt toxins, possibly resulting in the use of less environmentally safe pesticides or increased doses and the number of applications to the GM crop in the country of cultivation; whereas, the US Environmental Protection Agency is proposing to phase out many current Bt corn hybrids, as well as some Bt cotton varieties, in the next three to five years, due to the growth in insect resistance to these crops;

Z.whereas, whilst it has been claimed that the use of Bt crops leads to a decrease in the use of insecticides, a recent study published in the United States, found that ‘several analyses on the influence of Bt crops on pesticide-use patterns do not seem to have considered seed treatments and so may have overstated reductions in insecticide use (especially ‘area treated’) associated with Bt crops’; whereas the same study finds that neonicotinoid seed treatments are often used in conjunction with Bt maize and soybean crops, that ‘[t]his pattern of use may have unintended consequences, namely resistance in target pests, outbreaks of non-target pests, and pollution with detrimental effects cascading to wildlife.’ The study also found that ‘some of these effects have already emerged’; whereas the Union has banned the outdoor use of three neonicotinoids, including as seed coatings, because of their impact on honeybees and other pollinators;

AA.whereas the Union is party to the UN Convention of Biological Diversity (‘UN CBD’), which obliges both importing and exporting countries to take biodiversity into account;

Undemocratic decision-making

AB.whereas the vote on 26 October 2020 of the Standing Committee on the Food Chain and Animal Health referred to in Article 35 of Regulation (EC) No 1829/2003 delivered no opinion, meaning that the authorisation was not supported by a qualified majority of Member States;

AC.whereas the Commission recognises that the fact that GMO authorisation decisions continue to be adopted by the Commission without a qualified majority of Member States in favour, which is very much the exception for product authorisations as a whole but which has become the norm for decision-making on GM food and feed authorisations, is problematic;

AD.whereas, in its eighth term, Parliament adopted a total of 36 resolutions objecting to the placing on the market of GMOs for food and feed (33 resolutions) and to the cultivation of GMOs in the Union (three resolutions); whereas, to date, Parliament has adopted eleven objections in its ninth term; whereas there was not a qualified majority of Member States in favour of authorising any of those GMOs; whereas despite its own acknowledgement of the democratic shortcomings, the lack of support from Member States and the objections of Parliament, the Commission continues to authorise GMOs;

AE.whereas, under Regulation (EU) No 182/2011, the Commission may decide not to authorise a GMO when there is no qualified majority of Member States in favour in the Appeal Committee; whereas no change of law is required in this respect;

1.Considers that the draft Commission implementing decision exceeds the implementing powers provided for in Regulation (EC) No 1829/2003;

2.Considers that the draft Commission implementing decision is not consistent with Union law, in that it is not compatible with the aim of Regulation (EC) No 1829/2003, which is, in accordance with the general principles laid down in Regulation (EC) No 178/2002 of the European Parliament and of the Council, to provide the basis for ensuring a high level of protection of human life and health, animal health and welfare, and environmental and consumer interests, in relation to GM food and feed, while ensuring the effective functioning of the internal market;

3.Calls on the Commission to withdraw its draft implementing decision;

4.Welcomes the fact that the Commission finally recognised, in a letter of 11 September 2020 to Members, the need to take sustainability into account when it comes to authorisation decisions on GMOs; expresses its strong disappointment, however, that, on 28 September 2020, the Commission authorised another GM soybean for import despite an objection by Parliament and a majority of Member States voting against;

5.Calls on the Commission to move forward with the utmost urgency concerning the development of sustainability criteria, with full involvement of Parliament; calls on the Commission to provide information on how this process will be undertaken and in what timeframe;

6.Urges the Commission, again, to take into account the Union’s obligations under international agreements, such as the Paris Climate Agreement, the UN CBD and the UN Sustainable Development Goals, in the authorisation process;

7.Reiterates its call on the Commission to stop authorising GMOs, whether for cultivation or for food and feed uses, when no opinion is delivered by Member States in the Appeal Committee, in accordance with Article 6(3) of Regulation (EU) No 182/2011;

8.Reiterates its call on the Commission not to authorise herbicide-tolerant GM crops until the health risks associated with the residues have been comprehensively investigated on a case-by-case basis, which requires a full assessment of the residues from spraying such GM crops with complementary herbicides, an assessment of the herbicide break-down products and any combinatorial effects, including with the GM plant itself;

9.Calls on EFSA to finally accept the substantial differences between native Bt toxins and those expressed by synthetic transgenes in GM crop plants, and to widen its risk assessment in order to fully take into account all interactions and combinatorial effects between Bt toxins, GM plants and their constituents, residues from spraying with the complementary herbicides, the environment as well as impacts on health and food safety;

10.Calls on EFSA to no longer accept toxicity studies based on isolated proteins which are likely to be different in structure and biological effects compared to those produced by the plant itself, and to require that all tests are carried out with tissue from the GM plant;

11.Calls on EFSA to make sure that data from field trials or green houses cover a sufficiently broad range of agronomic and environmental conditions to assess the impact of all stress factors which have to be expected during cultivation on gene expression and plant composition;

12.Calls on EFSA to make sure that the data from field trials or green houses cover a sufficiently broad range of different varieties to assess the impact of various genetic backgrounds on gene expression and plant composition;

13.Calls on EFSA to request data on the impact of the consumption of food and feed derived from GM plants on the intestinal microbiome;

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