MOTION FOR A 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 concerning the placing of plant protection products on the market, and amending the Annex to Implementing Regulation (EU) No 540/2011

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 concerning the placing of plant protection products on the market, and amending the Annex to Implementing Regulation (EU) No 540/2011 (D044281-01),

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

–  having regard to Rule 106(2), (3) and (4)(c) of its Rules of Procedure,

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 (from 3 200 tonnes in 1974 to 825 000 tonnes in 2014)[4];

B.  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, bacteria and fungi; 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;

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/or its residues 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 dramatic increase in the total volume of glyphosate used; whereas the impact of glyphosate on human health must not be underestimated;

F.  whereas according to Regulation (EC) No 1107/2009, an active substance may only be approved if it is not or is not to be classified as a carcinogen category 1A or 1B in accordance with the provisions of Regulation (EC) No 1272/2008, 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;

G.  whereas in March 2015 the International Agency for Research on Cancer (IARC) classified glyphosate as ‘probably carcinogenic to humans’ (Group 2A), 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;

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

I.  whereas, nevertheless, in November 2015 the European Food Safety Authority (EFSA) finalised a peer review of glyphosate and concluded that ‘glyphosate is unlikely to pose a carcinogenic hazard to humans and the evidence does not support classification with regard to its carcinogenic potential according to Regulation (EC) No 1272/2008’;

J.  whereas Commission Implementing Regulation (EU) …/... of XXX 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 (hereinafter the ‘draft implementing regulation’) proposes to authorise glyphosate until 30 June 2031, i.e. for the maximum period possible, for any use, without any restrictions (except for one out of over 500 co‑formulants), without any legally binding conditions on its use, and subject only to confirmatory information on endocrine-disrupting properties;

K.  whereas the stated purpose of Regulation (EC) No 1107/2009 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’;

L.  whereas it is stated in the text of Regulation (EC) No 1107/2009 that 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 the text further states that ‘in 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’;

M.  whereas pursuant to Article 13(2) of Regulation (EC) No 1107/2009, any decision regarding the approval/non-approval/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’;

N.  whereas Article 7(1) of Regulation (EC) No 178/2002 stipulates that ‘in 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’,

O.  whereas the conditions of recourse to the precautionary principle as laid down in Regulation (EC) No 178/2002 are clearly fulfilled in light of the ongoing controversy about the carcinogenic properties of glyphosate;

P.  whereas according to Article 14(2) of Regulation (EC) No 1107/2009, the maximum possible period for renewal of approval for active substances is 15 years; whereas in the interests of safety, the approval period should be proportionate to the possible risks inherent in the use of such substances, while experience gained from the actual use of plant protection products containing the substances concerned and any developments in science and technology should be taken into account when any decision regarding the renewal of an approval is taken;

Q.  whereas the European Ombudsman, 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), 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;

R.  whereas the draft implementing regulation does not, however, contain any legally binding risk mitigation measures, despite a high long-term risk found for almost all uses of glyphosate for non-target terrestrial vertebrates, including mammals and birds; whereas use of the non-selective herbicide glyphosate kills not only unwanted weeds, but all plants, as well as algae, bacteria and fungi, thereby having an unacceptable impact on biodiversity and the ecosystem; whereas as such, glyphosate fails to comply with point (e)(iii) of Article 4(3) of Regulation (EC) No 1107/2009;

S.  whereas several Member States have already taken precautionary measures to protect public health and the environment; whereas in order to achieve the same level of protection in all Member States, in case of approval of an active substance clear and legally binding conditions for its use should be set at Union level;

T.  whereas EFSA, at the request of the Commission, considered in its assessment the report published by the International Agency for Research on Cancer (IARC), which classified glyphosate as probably carcinogenic to humans; whereas EFSA’s evaluation was based on a large body of evidence, including a number of studies not assessed by the IARC, and according to EFSA this is one of the reasons why it reached different conclusions;

U.  whereas the head of EFSA’s Pesticides Unit, which was in charge of the assessment, described certain studies not assessed by the IARC as ‘key’ and ‘pivotal’; whereas EFSA has so far refused to make these studies publicly available, as the applicants have claimed that disclosure would harm their commercial interests; whereas non-publication of studies makes independent scientific scrutiny impossible; whereas EFSA did not provide verifiable proof that disclosure would harm the industry in accordance with its legal obligation under Article 63 of Regulation (EC) No 1107/2009;

V.  whereas according to Article 4(2) of Regulation (EC) No 1049/2001 of the European Parliament and of the Council of 30 May 2001 regarding public access to European Parliament, Council and Commission documents[5], the institutions shall refuse access to a document where disclosure would undermine the protection of commercial interests unless there is an overriding public interest in disclosure; whereas in light of the ongoing controversy between IARC and EFSA on an issue as publicly relevant as cancer and the global relevance of the decision regarding the reapproval/conditional reapproval or non-reapproval of glyphosate, there is clearly an overriding interest in disclosing these studies;

W.  whereas there are not only serious concerns about the carcinogenicity of glyphosate, but also doubts as regards a possible mode of action in relation to its endocrine-disruptive properties; whereas glyphosate-based formulations have been found to be endocrine disruptors in human cell lines and, in the absence of the proper scientific horizontal criteria, an endocrine-mediated mode of action cannot be ruled out;

X.  whereas in July 2015 the rapporteur Member State indicated its intention to submit a dossier concerning the harmonised classification of glyphosate under Regulation (EC) No 1272/2008 to the European Chemicals Agency, which is the relevant scientific authority with regard to the harmonised classification of chemical substances; whereas the application was expected for the end of March 2016; whereas the decision-making process is expected to last 18 months;

Y.  whereas in March 2016 the vote in the Standing Committee on Phytopharmaceuticals on the draft implementing regulation renewing the approval of the active substance glyphosate was postponed;

Z.  whereas the US Government Accountability Office (GAO) recently issued a recommendation to the United States Food and Drug Administration to assess risk and disclose information with regard to glyphosate residues in relation to public health;

1.  Considers that the Commission’s draft implementing regulation fails to ensure a high level of protection of both human and animal health and the environment, fails to apply the precautionary principle, and exceeds the implementing powers provided for in Regulation (EC) No 1107/2009;

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

3.  Calls on the Commission not to renew the approval of glyphosate and to set up a clear time-frame for establishing a list of co-formulants not accepted for inclusion in plant protection products;

4.  Calls on the Commission to rapidly ensure an independent review of the classification of glyphosate based on all available scientific evidence relating to carcinogenicity of glyphosate, as well as possible endocrine-disruptive properties under the expected scientific horizontal criteria for endocrine disruptors;

5.  Calls on the Commission and on EFSA to disclose immediately all the scientific evidence that has been the basis for the positive classification of glyphosate and the proposed re-authorisation, given the overriding public interest in disclosure;

6.  Calls on the Commission to mandate its Food and Veterinary Office to test and monitor glyphosate residues in foods and drinks produced in the Union, as well as in imported produce;

7.  Is of the opinion that an appropriate follow-up of this resolution and thus the submission of a thoroughly amended new draft by the Commission will be crucial for trust in and between the institutions of the European Union;

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