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Decision in case 1981/2019/KR on the European Commission’s alleged inaction concerning an application to approve an increase of the maximum residual levels for glyphosate on borage seeds

The complaint to the Commission

1. In 2015, the complainant, Nature’s Crops International, asked the UK authorities to grant it an authorisation to use a glyposate-containing herbicide on corn gromwells (which is a flower used to produce an oil[1]). It is for the UK authority to decide whether to grant such a ‘minor use’ authorisation in accordance with Article 51 of Regulation 1107/2009 on the extension of authorisations for minor uses[2]. This application was notified to the European Commission and the European Food Safety Authority (EFSA).

2. Whereas Member States can grant a ‘minor use’ authorisation, it is for the European Commission to determine what the maximum residue limits (MRLs) are for the use of the pesticide on products[3]. The UK, in this context, made a proposal to the Commission to raise the existing MRL on borage seeds from 0.1 mg/kg to 10 mg/kg.

3. Before the Commission can take a position on a MRL for a specific crop, it must obtain a safety assessment from EFSA and an opinion from the Standing Committee of Plants, Animals, Food and Feed (SCoPAFF). All Member States are member of SCoPAFF. The Commission chairs SCoPAFF.

4. In that context,  the European Food Safety Authority (EFSA) carried out a safety assessment[4], which, in 2016, concluded that the proposed use of glyphosate on borage seeds will not result in a consumer exposure exceeding the toxicological reference values and therefore its use on borage seeds is unlikely to pose a consumer health risk[5].

5. The complainant has, since EFSA adopted that opinion, regularly contacted the Commission asking when the MRL for glyphosate on borage seeds would be voted upon by SCoPAFF. Although the MRL for glyphosate in borage seeds was discussed in SCoPAFF[6], it was never put to a vote.

6. The Commission, in this context, explained to the complainant that the new MRL for glyphosate in borage seeds will only be taken forward when a general review of MRLs for glyphosate has been completed.

7. As regards the general review of MRLs, the Commission stated there is a high level of public interest in the use of glyphosate-containing products, which makes reviewing the related MRLs very sensitive. In this context, the Commission referred to the difficulties in obtaining a qualified majority in SCoPAFF for the renewal of the approval of the active substance, glyphosate.

8. The complainant was not satisfied with the Commission’s response and turned to the Ombudsman.

The European Ombudsman's findings

9. The Commission, as chair of the SCoPAFF, enjoys a wide discretion to set SCoPAFF’s agenda.

10. The Commission presented the requested MRL to the SCoPAFF for discussion during its meeting 18 and 19 September 2018[7].  On 29 November 2018, further discussion took place in SCoPAFF, in the context of the general review of existing MRLs for glyphosate.

11. The Ombudsman notes that the Commission, as the chair of the SCoPAFF, also has discretion as regards setting a time limit for the SCoPAFF to deliver its opinion. It can set the time limit according to the urgency of the matter (there is no set time limit for voting on a proposal included in the EU’s Regulation).

12. The Commission had, in this context, explained to the complainant that the new MRL for glyphosate in borage seeds will only be taken forward when a general review of MRLs for glyphosate has been completed.

13. Specifically, on 17 May 2018, EFSA published a reasoned opinion on the review of all the existing MRLs for glyphosate. Subsequently, on 17 January 2019, the Member State responsible for the file (Germany) submitted an addendum. As a result, on 19 February 2019, the Commission gave EFSA a new mandate to revise its reasoned opinion to reflect these additional studies, and to amend the MRLs where necessary.

14. EFSA adopted the revised reasoned opinion on 29 September 2019 and published on 31 October 2019[8]. The Ombudsman notes that the revised reasoned opinion also deals with the MRL for glyphosate on borage seeds. The Ombudsman notes that the review had just been completed when the complainant submitted its complaint to the Ombudsman on 28 October 2019 (indeed, the revised opinion was not published by EFSA until three days after the complaint was submitted to the Ombudsman). 

15. Now that EFSA has issued its revised reasoned opinion on the setting of MRLs in glyphosate, the Commission must submit that reasoned opinion to the SCoPAFF. As noted above, that revised reasoned opinion also covers the setting of an MRL for glyphosate on borage seeds.

16. In light of the above, the Ombudsman takes the view that the decision not to proceed to a vote on the setting of an MRL for glyphosate on borage seeds until such time as EFSA had completed its general review of MRLs regarding glyphosate was reasonable.

17. In this context, Ombudsman concludes that there was no maladministration by the Commission[9].

 

Fergal Ó Regan

Head of Inquiries - Unit 2

Strasbourg, 28/11/2019

 

[1] Nature’s Crops International is a company that develops specialty oils from crops. The oils are used as dietary supplements, food and personal care products.

[2] Available at https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32009R1107

[3] Maximum residue level (MRL) means the upper legal level of a concentration for a pesticide residue in or on food or feed set in accordance with this Regulation, based on good agricultural practice and the lowest consumer exposure necessary to protect vulnerable consumers.

[4] In line with Article 10 of Regulation (EC) No 396/2005 on maximum residue levels, see: https://eur-lex.europa.eu/legal-content/EN/ALL/?uri=CELEX%3A32005R0396.

[5] EFSA’s reasoned opinion, as first published in the EFSA Journal (2016; 14(4):4468) is available here: https://www.efsa.europa.eu/en/efsajournal/pub/4468.

[6] In the SCoPAFF meeting on 18 and 19 September 2018, see:  https://ec.europa.eu/food/sites/food/files/plant/docs/sc_phyto_20180918_ppr_sum.pdf.

[7] The issue of glyphosate was listed under “Section A. Information and/or discussion”, see: https://ec.europa.eu/food/sites/food/files/plant/docs/sc_phyto_20180918_ppr_agenda.pdf.

[8] EFSA Journal 2019;17(10):5862), see https://efsa.onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2019.5862.

[9] This complaint has been dealt with under delegated case handling, in accordance with Article 11 of the Decision of the European Ombudsman adopting Implementing Provisions.