• No results found

Decision in case 268/2017/MH on how the European Commission dealt with an application to authorise formaldehyde as an additive to animal feed

N/A
N/A
Protected

Academic year: 2021

Share "Decision in case 268/2017/MH on how the European Commission dealt with an application to authorise formaldehyde as an additive to animal feed"

Copied!
7
0
0

Loading.... (view fulltext now)

Full text

(1)

European Ombudsman

Decision in case 268/2017/MH on how the European

Commission dealt with an application to authorise

formaldehyde as an additive to animal feed

Decision

Case 268/2017/MH - Opened on 06/12/2017 - Decision on 04/02/2019 - Institution concerned European Commission ( No maladministration found ) |

The complaint concerned how the European Commission dealt with an application for formaldehyde to be authorised as an additive to animal feed.

The complainant considered that the Commission had lacked objectivity, was politically-motivated and had not sufficiently taken into account scientific opinion in proposing to refuse the authorisation of formaldehyde. The complainant also considered that the Commission had not properly explained the reasons for its proposal.

The Ombudsman found that the Commission had acted on objective grounds and taken into account all the relevant factors, in particular, the scientific opinion of the European Food Safety Authority. She also found that the Commission had provided a satisfactory

explanation as to why the final ‘implementing regulation’, which refused the application to authorise formaldehyde, had changed, compared to earlier drafts.

The Ombudsman therefore closed the inquiry finding no maladministration. Background to the complaint

1. The complainant is a producer of animal feed additives. The complaint concerns its application to the European Commission for formaldehyde to be authorised as an additive to animal feed, in line with EU rules on additives in animal feed (Regulation 1831/2003) [1] .

2. Formaldehyde is a chemical compound naturally present in human and animal organisms. It is also manufactured and used for a range of purposes in the EU, including as a

preservative in cosmetics and a veterinary disinfectant. Until 2013, it was also authorised for use as an additive to animal feed.

3. In 2014, the complainant applied to renew the authorisation for formaldehyde as an additive to poultry and pig feed. Under Regulation 1831/2003, the Commission is required, as the ‘risk manager’, to inform the Member States immediately, and to forward the application to the ‘risk assessor’, the European Food Safety Authority (EFSA), for an opinion. [2]

(2)

could not determine a safe level for formaldehyde in poultry and pig feed. It considered that using formaldehyde as a feed additive would not pose an “ additional” risk to consumers, and that it had the potential to be effective in reducing bacterial growth in already contaminated feed. However, EFSA could not identify a safe level of exposure for a person’s skin, eyes or respiratory system [4] , and therefore recommended protective measures for “ any person handling ” formaldehyde [5] . It also proposed to revisit, at a later stage, whether such measures protect the user effectively.

5. Under Regulation 1831/2003, within three months of EFSA’s opinion, the Commission had to prepare a draft ‘implementing regulation’, granting or denying the authorisation. [6] This draft implementing regulation then had to be voted on [7] in the Standing Committee on Plants, Animals, Food and Feed (the PAFF Committee), which is comprised of national experts representing EU governments and public authorities [8] . The Commission presented a draft implementing regulation to the PAFF Committee in summer 2015, recommending that formaldehyde be authorised for use in animal feed. It presented amended versions to the committee between 2015 and late 2017.

6. In January 2017, the complainant wrote to the Commission to express concern about the authorisation process.

7. In February 2017, the complainant turned to the Ombudsman.

8. On 21 November 2017, the Commission published a revised draft implementing

regulation, refusing the application to authorise formaldehyde as a feed additive. It invited the public to give feedback on this draft by 19 December 2017 [9] .

9. The complainant wrote to the Commission during the consultation period, expressing serious concern about the proposal to deny the authorisation. It referred to a scientific report by the European Centre for Disease Prevention and Control (ECDC) and EFSA (the EFSA/ECDC report) [10] on food-borne outbreaks, which, it claimed, demonstrated the importance of formaldehyde in preventing diseases like salmonella.

10. On 20 December 2017, the Commission submitted its revised draft of the implementing regulation to the PAFF Committee. The PAFF Committee subsequently approved the draft, denying the application to authorise formaldehyde.

11. In early 2018, the complainant raised further concerns with the Ombudsman, referring to the EFSA/ECDC report.

12. On 7 February 2018, the Commission adopted the implementing regulation, which meant that formaldehyde would not be authorised for use as an additive in animal feed in the EU [11] .

The inquiry

13. The Ombudsman opened an inquiry into the complainant’s concerns that the

Commission lacked objectivity, was politically motivated and did not sufficiently take into account scientific evidence, when amending the draft implementing regulation.

(3)

14. The Ombudsman’s inquiry team held a meeting with the Commission to clarify the complainant’s concerns and to inspect the Commission’s file. Following a request from the Ombudsman, the Commission subsequently disclosed to the complainant some of the documents from the file, which the Ombudsman’s inquiry team had seen during the inspection.

Arguments presented to the Ombudsman

15. The complainant considered that the Commission had failed to act objectively, as it had not taken into account all the relevant factors. The complainant also claimed that the Commission had not sufficiently explained why it had changed the approach taken in the implementing regulation to deny the application to authorise formaldehyde, where earlier drafts had recommended granting authorisation [12] . The complainant took the view that this change was “arbitrary” and “radical”, suggesting that it was politically motivated.

16. According to the complainant, the proposal to deny authorisation lacked a scientific basis.

17. During the inspection meeting, the Commission argued that the amendment of the draft implementing regulation reflected how the debate in the PAFF Committee had evolved.

18. In its comments on the Ombudsman’s report on the inspection meeting, the complainant stated that the Commission appeared unable to advance any concrete explanation (scientific or otherwise) as to why it amended the draft implementing regulation. The complainant also considered that the Commission had disregarded the feedback received during the public consultation, pointing to the fact that the Commission had presented the proposal to the PAFF Committee “less than 12 hours” after the public consultation finished. Finally, it

considered that the Commission had failed to explain how alternative products could replace formaldehyde (as stated in the draft implementing regulation).

19. The complainant also questioned whether the Commission had seriously considered the EFSA/ECDC report.

The Ombudsman's assessment

20. The complainant is essentially concerned that the Commission was either politically motivated or not objective in revising the draft implementing regulation to propose refusing the application to authorise formaldehyde.

21. The various versions of the draft implementing regulation confirm the Commission’s argument that the text had evolved over time. [13] The initial draft presented to the PAFF Committee in summer 2015 proposed that formaldehyde should be authorised for the standard 10 year period, with measures to protect workers.

(4)

22. Later versions provided for authorisation, with similar protective measures, for a non-renewable period of 5 years, and then three years. The final draft proposed to ban formaldehyde as a feed additive.

23. The documents on the Commission’s file (subsequently disclosed to the complainant) demonstrate the reasons for the change of approach in the draft implementing regulation. The Member States in the PAFF Committee had diverging positions on whether

formaldehyde should be authorised. As a result, the draft regulation evolved to a proposal to refuse authorisation, which was ultimately supported by a qualified majority in the PAFF Committee.

24. This is in line with the rules applicable to cases concerning the protection of the health or safety of humans or animals. Where there is a qualified majority [14] in the PAFF Committee for an implementing regulation, the Commission is obliged to follow this opinion [15] . Where there is no qualified majority, the Commission cannot adopt the proposed implementing measure unchanged [16] , as it can in other cases.

25. It is understandable, at first sight, why the complainant characterised the Commission’s change of position as “ radical ”. However, a full understanding of the decision-making procedure in question and, specifically, the role of both the Commission and the Member States allows one to understand how discussions evolved. As the risk manager, the Commission set out by proposing to authorise formaldehyde with protective measures, a course of action it felt, at the time, appropriate to achieve a high level of protection of human and animal health. The Ombudsman’s inspection confirmed that the Commission had made every effort to obtain sufficient Member State support for this course of action. However, given the alternatives to formaldehyde that were subsequently developed [17] and after obtaining input from Member State representatives and other interested parties, the

Commission saw the need to revise its proposal. For as long as its position was underpinned by science and took other relevant factors into account [18] , there was nothing problematic in how the Commission dealt with the matter.

26. The complainant, for its part, considered that there was no scientific basis for proposing to refuse to authorise formaldehyde, since EFSA’s opinion concluded that using

formaldehyde as an additive was safe and effective.

27. However, EFSA’s opinion did not conclude that formaldehyde was safe for humans. EFSA could not identify safe levels of exposure for the skin, eyes and respiratory tract. EFSA’s opinion recommended that people handling formaldehyde should take certain precautions to protect these body parts if using formaldehyde. [19]

28. The complainant claimed that, according to Regulation 1831/2003, decisions on authorising additives have to take into account the benefits to animal health and welfare, and to consumers [20] . However, Regulation 1831/2003 also requires that feed additives do not have an adverse effect on human health. [21]

(5)

29. As the risk manager, the Commission had to consider the risks at stake, if necessary, weighing the risks for workers “ handling ” formaldehyde, against the risks for animals and consumers posed by banning formaldehyde in animal feed [22] . Earlier versions of the draft implementing regulation, which recommended authorising formaldehyde, recognised the risks for workers and the need for protective measures. They also acknowledged the potential negative side effects for animals that consume contaminated feed. The final implementing regulation stated that “ the advantages of formaldehyde do not compensate the health risks ” to workers using the substance, and referred to the ‘precautionary principle’ [23] .

30. The Ombudsman therefore considers that, throughout the authorisation process, the Commission examined the risks at stake and took these into account in the drafts of the implementing regulation.

31. Contrary to the complainant’s view, the implementing regulation provides sufficient details on the available alternatives to formaldehyde for addressing the risk of bacterial pathogens, which do not pose the same safety concerns for humans. [24]

32. Regarding the complainant’s doubts as to whether the Commission had taken into account the EFSA/ECDC report, the complainant has not identified any particular findings to support its view that formaldehyde should be authorised as a feed additive. The EFSA/ECDC report does not, in fact, refer to formaldehyde.

33. Based on publicly available information, the Ombudsman has confirmed that, contrary to what the complainant contended, the Commission did, in fact, take into account feedback received during the public consultation in revising the draft implementing regulation. The Commission provided an overview to the PAFF Committee of the comments received during the consultation, and explained how these had been taken into account in the draft

implementing regulation [25] .

34. In light of the above, the Ombudsman finds that there was no maladministration by the Commission.

Conclusion

Based on the inquiry, the Ombudsman closes this case with the following conclusion :

There was no maladministration in how the European Commission dealt with the application to authorise formaldehyde for use as an additive in animal feed.

The Ombudsman will inform the complainant and the Commission of this decision.

Emily O'Reilly

(6)

Strasbourg, 04/02/2019

[1] Regulation (EC) No 1831/2003 of the European Parliament and of the Council of 22 September 2003

on additives for use in animal nutrition,

https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A32003R1831 . [2] Articles 7 and 8 of Regulation 1831/2003.

[3] See: https://efsa.onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2014.3790 . [4] Formaldehyde is a toxic substance and, if inhaled, is carcinogenic. See: https://efsa.onlinelibrary.wiley.com/doi/pdf/10.2903/j.efsa.2014.3561 .

[5] Another study, published in 2016 by the Scientific Committee on Occupational Exposure Limits (SCOEL) demonstrated that formaldehyde is a hazardous chemical agent, but noted that its hazardous impact could be prevented at lower concentration levels. See

https://circabc.europa.eu/sd/a/2882e9bc-d52e-4944-ac08-974b43957ed2/REC-125%20Formaldehyde.pdf .

[6] Article 9 of Regulation 1831/2003. [7] Article 22 of Regulation 1831/2003.

[8] Standing committees deliver opinions on draft implementing measures, proposed by the Commission on the basis of secondary EU law that has already been adopted. For more information on the PAFF Committee, see: https://ec.europa.eu/food/committees/paff_en . [9] More information:

https://ec.europa.eu/info/law/better-regulation/initiatives/ares-2017-5676888_en . [10] Available at: https://efsa.onlinelibrary.wiley.com/doi/10.2903/j.efsa.2017.5077 .

[11] Commission Implementing Regulation (EU) 2018/183 of 7 February 2018 concerning the denial of authorisation of formaldehyde as a feed additive belonging to the functional groups of preservatives and hygiene condition enhancers,

https://eur-lex.europa.eu/legal-content/EN/TXT/?toc=OJ:L:2018:034:TOC&uri=uriserv:OJ.L_.2018.034.01.0006.01.ENG .

[12] Article 9(1), second indent, of Regulation 1831/2003 requires the Commission to provide an explanation of the reason for the differences, where its draft is not in accordance with EFSA’s opinion.

(7)

[13] The complainant subsequently received copies of these documents.

[14] That is to say, 55% of EU countries representing at least 65% of the total EU population. [15] Articles 5(2) and (3) 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, https://eur-lex.europa.eu/legal-content/EN/ALL/?uri=CELEX:32011R0182 .

[16] Article 5(4)(a) of Regulation 182/2011.

[17] Formic acid, which is now authorised for use in animal feed under Implementing Regulation (EU) 2017/940.

[18] Recital 17 of Regulation 1831/2018 says “ It is recognised that scientific risk assessment alone cannot, in some cases, provide all the information on which a risk management decision should be based, and that other factors relevant to the matter under consideration should legitimately be taken into account, including societal, economic or environmental factors, feasibility of controls and the benefit for the animal or for the consumer of animal products.”

[19] The Commission’s approach also took into account the findings of SCOEL (above), see Recital 8 of the final Implementing Regulation 2018/183.

[20] Article 9(1), first indent, of Regulation 1831/2003. [21] Articles 5(2)(a) and 3(2) of Regulation 1831/2003.

[22] Recital 9 of the final Implementing Regulation 2018/183. [23] Recital 15 of the final Implementing Regulation 2018/183.

[24] Recital 13 and footnote 17 of Implementing Regulation 2018/183 identify as an alternative formic acid, which is authorised for use in animal feed under Implementing Regulation (EU) 2017/940.

[25] See Point B1 available at

References

Related documents