The background to the complaint

1. The complainant is a member of the Austrian Ombudsman Board.

2. On 2 March 2012, he turned to the European Ombudsman after receiving a complaint from an Austrian citizen concerning the problem of bee mortality related to the use of certain plant protection products known as neonicotinoids. In his complaint to the European Ombudsman, the complainant pointed out that, over the past few years, beekeepers noticed an increasing mortality of bees, which has resulted in the degradation of numerous bee colonies. According to the complainant, scientific evidence demonstrates that neonicotinoids used for the treatment of seeds could be the cause of bee mortality.

3. Regulation 1107/2009[1] concerning the placing of plant protection products on the market lays down rules for, among other things, the approval of active substances used in plant protection products. The Commission has authorised certain neonicotinoids for use as plant protection products[2].

4. Article 21 of Regulation 1107/2009 provides for a review process of authorised substances, in case new scientific and technical evidence indicates that the substance does not fulfil the approval criteria set out in the Regulation. The relevant parts of Article 21 read:

"1. The Commission may review the approval of an active substance at any time. It shall take into account the request of a Member State to review, in the light of new scientific and technical knowledge and monitoring data, the approval of an active substance, including where, after the review of the authorisations pursuant to Article 44(1), there are indications that the achievement of the objectives established in accordance with Article 4(1)(a)(iv) and (b)(i) and Article 7(2) and (3) of Directive 2000/60/EC is compromised.

Where, in the light of new scientific and technical knowledge it considers that there are indications that the substance no longer satisfies the approval criteria provided for in Article 4, or further information required in accordance with Article 6(f) has not been provided, it shall inform the Member States, the Authority and the producer of the active substance, setting a period for the producer to submit its comments. ..."

The subject matter of the inquiry

5. In his complaint, the complainant submitted the following allegation and claim.

Allegation

The Commission failed to take appropriate measures to address the issue of bee mortality linked to the use of certain neonicotinoids, such as clothianidin, thiamethoxam, fipronil, and imidacloprid, despite the availability of new scientific evidence highlighting the risks involved in the use of these substances.

Claim

The Commission should, in light of the new scientific evidence available, take appropriate measures to address the issue of bee mortality linked to the use of neonicotinoids. These measures could include reviewing the approval of the relevant substances pursuant to Article 21 of Regulation 1107/2009.

The inquiry

6. On 28 March 2012, the Ombudsman asked the Commission to submit an opinion on the present complaint. The Commission's opinion was forwarded to the complainant with an invitation to submit observations, which he did on 28 August 2012.

The Ombudsman's analysis and conclusions

Preliminary remarks

7. Given their factual and logical connection, it is appropriate to consider the complainant's allegation and claim together.

A. Allegation of failure to take appropriate action and related claim

Arguments presented to the Ombudsman

8. The complainant expressed doubt whether the Commission had initiated a review procedure under Article 21 of Regulation 1107/2009, as it ought to have done in view of new scientific evidence. He furthermore questioned the reasons for the Commission's lack of action, given that, in his view, clear evidence about grave damages to bee populations exists.

9. In its opinion, the Commission stated that, in recent years, an increase in bee mortality has been reported in several countries in Europe and worldwide. Scientific studies have not been able to determine the exact causes and to quantify the extent of the increase in bee mortality. In order to understand better the reasons underlying high bee mortality and to address the concerns of the European beekeeping sector, the European Commission issued a Communication on Honeybee Health[3] in 2010, which foresees a number of specific actions. These actions include, for instance, the designation of an EU Reference Laboratory for bee health; the preparation of a surveillance study to estimate the extent of bee mortality; training of Member States officials; and an increase in the EU contribution to the financing of national apiculture programmes by almost 25 percent for the period from 2011 to 2013.

10. The Commission argued that no link between the correct use of pesticides, in particular insecticides, and the decline in bee populations has been established so far. According to the Commission, it is evident that insecticides are, by their nature, toxic to bees. However, their use may still be possible if exposure is minimised to levels which do not generate harmful effects.

11. The Commission highlighted that the potential impact of active substances belonging to the chemical class of neonicotinoids (clothianidin, thiametoxam, and imidacloprid) and fipronil has recently been of concern. There is consensus within the scientific community that further work is needed to determine contact doses and to evaluate whether they accumulate in hives or within the food chain, and, if so, what behavioural impact they may or may not have on long-term populations for honey bees, bumble bees and other natural pollinators. The Commission also pointed out that accidental releases of neonicotinoids and fipronil in several Member States in recent years have resulted in substantial losses of honey bee colonies. This has led Member States to adopt precautionary measures designed to temporarily suspend the placing on the market of plant protection products containing those substances. As for the Commission, it took measures to avoid further accidents and reinforced the conditions for placing on the market and for using insecticides mostly employed in seed treatment and, in particular, thiametoxam, clothianidin, imidacloprid and fipronil[4].

12. The Commission also stated that it is about to finalise new "data requirements" for pesticide dossiers, including the requirement to assess the impact of pesticides on bees in the framework of Regulation 1107/2009. In March 2011, the Commission asked the European Food Safety Authority (EFSA) to review the existing risk assessment scheme for bees and to address a number of specific questions in this regard. In the given context, the Commission pointed out that the validity and effectiveness of the existing risk assessment scheme had been questioned by several parties, including the European Parliament. EFSA's final opinion is expected in March 2013.

13. The Commission moreover explained that, in January 2012, the Italian authorities officially informed it of the completion of the monitoring and research programme entitled "Apenet"[5], which raises concerns about the use of seeds treated with plant protection products containing clothianidin, thiametoxam, fipronil and imidacloprid. On 22 March 2012, the Commission, following discussions with experts from Member States in the framework of the Standing Committee of the Food Chain and Animal Health, decided to request an opinion from EFSA on the subject. On a general level, the Commission explained that, when it is informed of new reports and/or data concerning negative effects of pesticides on bees, it ensures that this information is assessed by the Member State responsible for the evaluation of the substance concerned (the 'Rapporteur Member State') and discussed with all the Member States in the Standing Committee on the Food Chain and Animal Health. Given that none of the reports received so far revealed any new possible risks, not already taken into account at the time of the initial approval of active substances, no further decisions had been taken.

14. On 30 March 2012, new scientific evidence on the sub-lethal effects of neonicotinoids on bees was published in the scientific journal "Science". On 3 April 2012, the Commission, acting on the basis of Article 21 of Regulation 1107/2009, mandated EFSA to assess this new information and to verify, by 30 April 2012, if the doses reported in the relevant articles are comparable to those occurring in fields sowed with seeds treated with neonicotinoids. As a result of the Commission's request, on 1 June 2012, EFSA published a "Statement on the findings in recent studies investigating sub-lethal effects in bees of some neonicotinoids in consideration of the uses currently authorised in Europe"[6]. Moreover, on 31 May 2012, the French Agency for Food, Environmental and Occupational Health and Safety (ANSES), following a request from the French authorities, published a statement on one of the articles published in "Science"[7].

15. On 25 April 2012, the Commission requested EFSA to perform, according to Article 21 of Regulation (EC) No 1107/2009, "a whole review of the risk assessment of all neonicotinoids to bees, namely thiametoxam, clothianidin, acetamiprid, thiacloprid and imidacloprid". The Commission pointed out that the completion of EFSA's evaluation was foreseen for December 2012.

16. In view of the above, the Commission reassured the Ombudsman as regards the attention it gives to the problems related to bee health. Concerning the complainant's claim, the Commission stated that it has and is adopting appropriate actions in this field. The Commission also stated that the 2010 Communication on Honeybee Health had succeeded in elevating the issue to a high level of visibility and in clarifying many elements. The European Parliament, the Council and many stakeholders largely endorsed the actions related to that Communication. While insisting that there are no easy fixes to the problems encountered, the Commission stated that it is confident that the ongoing actions would deliver science-based data on bee losses and would put the EU in a better position to decide on the best actions and strategies needed to mitigate those problems.

17. By way of conclusion, the Commission highlighted that (i) where necessary, it took measures in the framework of the legislation concerning the placing of pesticides on the market; (ii) it is carefully monitoring new scientific developments; (iii) it is currently evaluating, following discussions within the Standing Committee of Food Chain and Animal Health, whether there is a need to take measures in light of the statements published by EFSA and ANSES; and (iv) it has launched a whole review of the risk assessment of all neonicotinoids to bees, namely thiametoxam, clothianidin, acetamiprid, thiacloprid and imidacloprid, which is expected to be finalised by 31 December 2012.

18. In his observations, the complainant welcomed the steps the Commission had in the meanwhile taken to review the approval of the relevant substances pursuant to Article 21 of Regulation 1107/2009. In the given context, the complainant expressed his hope that the most recent scientific studies would be taken into account in the course of the review, so that a positive outcome regarding the serious issue of bee mortality could be achieved. Against this background, the complainant asked the Ombudsman to inform him of the outcome of the review procedure pursuant to Article 21 of Regulation 1107/2009, which was expected at the beginning of 2013. The complainant thanked the Ombudsman and his team for their efforts in the present case.

The Ombudsman's assessment

19. The Ombudsman is pleased to note that the Commission provided him with extensive information concerning the measures which it has taken in the light of new scientific evidence concerning the effects of neonicotinoids on bee health. Most importantly, it emerges from the Commission's opinion that, based on Article 21 of Regulation 1107/2009, it launched, on 25 April 2012, a review of the risk assessment of all neonicotinoids (thiametoxam, clothianidin, acetamiprid, thiacloprid and imidacloprid). It further emerges from the Commission's opinion that this review is currently being carried out by EFSA.

20. In his complaint, the complainant claimed that the Commission should take appropriate measures to address the issue of bee mortality linked to the use of neonicotinoids. He argued that such measures could include a review of the approval of the relevant substances pursuant to Article 21 of Regulation 1107/2009. In view of the measures taken by the Commission, which include launching a review of relevant risk assessments pursuant to Article 21 of Regulation 1107/2009, and in light of the observations submitted by the complainant, the Ombudsman considers that the Commission has settled the complaint to the complainant's satisfaction.

21. The review concerning the neonicotinoids here at issue is currently ongoing. The Ombudsman notes that, according to the Commission, EFSA's evaluation in this regard is foreseen to be completed by December 2012. The Ombudsman would therefore appreciate it if the Commission could inform him, by 31 March 2013, of the outcome of its review. This would enable him to inform the complainant accordingly.

B. Conclusion

On the basis of his inquiry into this complaint, the Ombudsman closes it with the following conclusion:

Following the Ombudsman's intervention, the Commission has settled the case to the complainant's satisfaction.

The complainant and the Commission will be informed of this decision.

 

P. Nikiforos Diamandouros

Done in Strasbourg on 2 October 2012

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[1] Regulation 1107/2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC, OJ 2009 L 309, p.1.

[2] Annex I of Implementing Regulation (EU) 540/2011 implementing Regulation (EC) No 1107/2009 of the European Parliament and of the Council as regards the list of approved active substances (OJ 2011 L 153, p.1) lists clothianidin (Nr 121), thiamethoxam (Nr 140), fipronil (Nr 157) and imidacloprid (Nr 216) as authorised pesticides.

[3] COM(2010) 714 final. The Communication is available online at: http://ec.europa.eu/food/animal/liveanimals/bees/docs/honeybee_health_communication_en.pdf

[4] Commission Directive 2010/21/EU of 12 March 2010 amending Annex I to Council Directive 91/414/EEC as regards the specific provisions relating to clothianidin, thiamethoxam, fipronil and imidacloprid, OJ 2010 L 65, p. 27.

[5] For further information, see http://www.reterurale.it/apenet

[6] Available online at http://www.efsa.europa.eu/efsajournal

[7] Available online at http://www.anses.fr/Documents/DPR2012sa0092.pdf