THE BACKGROUND TO THE COMPLAINT

1. On 10 July 2006, the complainant, who is the President of an NGO, submitted a "petition" to the President of the European Commission on behalf of 140 other European associations active in the field of animal protection. He asked the Commission to prohibit experiments on animals and to introduce "new" scientific test methods for the assessment of risks to human health, in accordance with the provisions of Regulation (EC) No 1907/2006 ('the REACH Regulation')[1].

2. On 10 October 2006, the Commission replied that, under the Seventh Research Framework Programme, it had supported, and would continue to support, scientific projects aimed at developing and promoting alternative methods to animal testing. In doing so, it would continue validating appropriate methods and consider relevant changes in the current law to ensure their application. A high priority would be given to ensure that the REACH Regulation would be adapted as soon as possible, following the approval of appropriate test methods.

3. A further exchange of correspondence took place between the complainant and the Commission on the matter. However, the complainant was not satisfied with the content of the Commission's replies and turned to the Ombudsman.

THE SUBJECT MATTER OF THE INQUIRY

4. The complainant alleged that the Commission failed to respect the REACH Regulation by not validating alternative test methods for the assessment of hazards of substances and that, in so doing, it misused Community funds.

5. He claimed that the Commission should validate toxicogenomics[2] and carcinogenomics[3] as alternative test methods.

THE INQUIRY

6. On 30 May 2008, the Ombudsman opened an inquiry. On 24 October 2008, the Commission sent its opinion, which was drafted in English. On 4 November 2008, the Commission provided a translation of its opinion into French, which was forwarded to the complainant for his observations. The complainant sent his observations on 16 February 2009.

THE OMBUDSMAN'S ANALYSIS AND CONCLUSIONS

A. Alleged failure to respect the REACH Regulation, alleged misuse of Community funds, and the related claim

Arguments presented to the Ombudsman

7. The complainant alleged that the Commission failed to respect the REACH Regulation by not validating alternative test methods (such as toxicogenomics) for the assessment of hazards of substances and that, in so doing, it misused Community funds.

8. The complainant claimed that the Commission should validate toxicogenomics and carcinogenomics as alternative test methods.

9. In support of his allegation and claim, the complainant argued that the Commission decided to finance project PL037712 Carcinogemics instead of validating and applying all toxicogenomics as alternative test methods designed to discover potential hazards of substances. He argued that there is enough scientific research on carcinogemics. The Commission is therefore wasting Community money by supporting the related project. He also pointed out that toxicogenomics-based methods are already used in the United States and Japan and argued that there is sufficient scientific information for the Commission to validate these methods and legally authorise them in the Community.

10. Moreover, he highlighted that the Commission ignored scientific evidence concerning toxicogenomics-based methods which the complainant had submitted to it. The Commission also failed to take into consideration a recommendation made by its own service, the European Centre for Validation of Alternative Test Methods (ECVAM)[4]. According to the complainant, ECVAM had already in 2006 encouraged the "immediate use of toxicogenomics-based approaches in conjunction with conventional testing approaches".

11. In its opinion, the Commission explained that, before an alternative test method can be used to assess the hazards of substances, it should go through a process of (a) scientific validation and (b) regulatory acceptance.

12. The objective of scientific validation is to verify whether the method in question is relevant and reliable for determining the extent to which a chemical shows a potentially hazardous property. ECVAM carries out such scientific validation.

13. Regulatory acceptance determines whether the test method under scrutiny: (a) would generate data suitable for the purposes of the REACH Regulation; and (b) covers a sufficiently wide spectrum of chemicals. An alternative test method which complies with the above criteria would be included in Council Regulation EC 440/2008 ('the REACH Test Methods Regulation')[5]. If the test method only provides some of the required information, it could be included into guidance material as part of a tiered testing strategy.

14. Although the toxicogenomics field is indeed a well studied discipline, the development of toxicogenomics-based methods has not yet advanced to a stage where these could be used for regulatory purposes, in particular under the REACH Regulation. As soon as these methods are better developed, they must go through the process of scientific validation and regulatory acceptance. In this respect, the Commission is financially supporting several scientific projects, including those in the field of Carcinogemics and Predictomics, which all aim to develop research in toxicogenomics. In particular, the aim of the Carcinogemics project is to develop in vitro methods for assessing the carcinogenic potential of compounds as an alternative to current rodent bioassays for genotoxicity and carcinogenicity.

15. ECVAM is actively involved in these projects and is participating in a special working group at the OECD level[6]. This may lead, in the following years, to validation studies on toxicogenomics-based methods.

16. Finally, the Commission explained that the complainant met with representatives from ECVAM on 6 February 2006. On that occasion, he presented the results of his own study on toxicogenomics. However, the presented method was based on a "weak" scientific approach which was not sufficiently developed for scientific validation. ECVAM could therefore not use the results of his study. In addition, the complainant did not submit to ECVAM any sort of "formal" dossier containing the results of his research studies on toxicogenomics that could be used to evaluate the method scientifically.

The Ombudsman's assessment

17. The Ombudsman first points out that, prior to its inclusion in the EU regulatory system of testing substances, each newly proposed test method is first subjected to a validation procedure[7]. As the Commission explained in its opinion, this procedure encompasses two main stages: (a) the scientific validation and (b) the regulatory approval. The Ombudsman understands that a newly proposed alternative test method should undergo the scientific validation before being evaluated for incorporation into the EU legislation.

18. The main issue in dispute is whether toxicogenomics-based methods in general, and those developed by the complainant in particular, could be included in the EU regulatory testing system at present (that is, pass directly to the stage of the regulatory approval) and, therefore, be used to test hazardous properties of chemicals, without undergoing the above scientific validation. In substance, the complainant alleges that the Commission made a manifest error of assessment in deciding not to do so.

19. In its opinion, the Commission appears to agree with the importance of the toxigenomics-based methods. It also appears that its current scientific projects (not only those in the field of Carcinogemics to which the complainant refers, but also Predictomics) may lead to results which could allow scientific validation studies to take place on toxigenomics-based methods in the future. At present, the Commission finds that this would be premature because there are not enough scientific results for such validation to occur and the complainant's own method does not qualify as such.

20. The complainant submitted voluminous documentation along with his complaint to support his view that the toxigenomics-based methods are "mature" enough to be regulated in the Community framework. In its opinion, the Commission provided scientific arguments to prove the contrary. However, the Ombudsman is not in a position to assess the divergence between the Commission's and the complainant's opinions in this respect. The Ombudsman recalls what he stated in his letters to the complainant and Commission opening his inquiry, namely, that his review is necessarily limited in cases involving highly complex scientific assessments. Similarly to the European courts, for cases in which the Commission enjoys a wide discretion when undertaking complex scientific/technical assessments, the Ombudsman can only verify in his inquiry whether the relevant procedural rules have been complied with, whether the facts admitted by the Commission have been accurately stated and whether there has been a manifest error of assessment or a misuse of power[8]. The Ombudsman should therefore not assess the Commission's findings that toxigenomics-based methods in general, and those presented by the complainant in particular, do not qualify for the Community scientific validation and subsequent regulatory process. Instead, the Ombudsman should assess the way in which the Commission arrived at those findings.

21. The Ombudsman also recalls the relevant case-law in this regard, which stipulates that, where a party claims that a competent institution has made a manifest error of assessment, the Community judicature must examine whether that institution has carefully and impartially examined all the relevant facts of the individual case which support the conclusions reached[9]. Moreover, the institution should base its findings on excellent and independent scientific advice[10].

22. After a careful analysis of the documentation submitted by both parties, the Ombudsman does not consider that the complainant succeeded in demonstrating that the Commission's findings in question were not based on excellent and independent scientific advice and that they were vitiated by a manifest error of assessment.

23. First, the scientific validation of test methods is carried out by ECVAM, which is the competent body within the EU REACH institutional system dealing with the scientific validation of the new test methods[11]. ECVAM cooperates on a regular basis with international institutions (with the OECD in particular) dealing with similar issues. One cannot therefore reasonably argue that ECVAM is unaware of the current scientific developments in this field.

24. Moreover, in the present case, ECVAM's representatives met the complainant and discussed his proposal concerning toxicogenomics-based methods. There was also an abundant exchange of correspondence in which the Commission and the complainant debated the scientific arguments. This certainly indicates the Commission's efforts to become aware of all the expert knowledge available. It also indicates the Commission's fair approach when dealing with scientific experts. The Ombudsman however regrets the comments made by the Commission in its opinion[12] regarding the complainant's involvement in promoting alternative test methods. He trusts that such remarks concerning the complainant's scientific work merely represent a clumsy criticism which may occur during a scientific debate. The Ombudsman therefore considers that no further inquiry is necessary in this respect.

25. Second, all applicants who wish to validate a new alternative test method should submit a reasoned application to ECVAM containing the results of their research on the new test method proposed[13]. The complainant did not however follow the validation procedure and he did not submit a "formal" proposal for scientific validation of his toxicogenomics-based methods, in accordance with ECVAM's standard practice.

26. Finally, the Ombudsman points out that the Commission has an unquestionable discretion when making its policy decisions to finance certain scientific projects rather than others. As regards the choice made by the Commission to finance the Carcinogemics project rather than the method put forward by the complainant, the Ombudsman finds that the complainant did not succeed in demonstrating that the Commission exceeded its discretionary powers in doing so. According to the Commission, the Carcinogemics project involves in vitro methods for testing the carcinogenic properties of compounds. It should help to speed up the process of identifying potentially harmful substances while reducing the need for animal testing, which is what the complainant claims 'his' method could also do. The Ombudsman notes that the Commission's choice complies with the provisions of the REACH Regulation, which stipulates that the "Community's strategy to promote alternative test methods is a priority and the Commission should ensure that within its future Research Framework Programmes ... this remains a priority topic"[14].

27. In his observations, the complainant made a new suggestion, namely, that toxigenomics could be used as part of the initial test strategies to distinguish the main risks of chemicals.

28. According to the Commission, the Carcinogemics project is, in sum, preparatory to future scientific validations of toxicogenomics-based methods. This fact could, in the Ombudsman's view, satisfy the complainant's above suggestion. Nevertheless, if the complainant considers otherwise, he is free to approach the Commission in this respect and come back to the Ombudsman if he is not content with the Commission's stance on his suggestion.

29. In light of the above, the Ombudsman does not find an instance of maladministration as regards the complainant's allegation. Consequently, the complainant's claim cannot be sustained.

B. Conclusion

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

There has been no instance of maladministration in relation to the present complaint.

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

 

P. Nikiforos DIAMANDOUROS

Done in Strasbourg on 29 May 2009

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[1] Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC, OJ 2006 L 396, p. 1.

[2] Toxicogenomics-based methods use an analysis by which the effect of a particular toxin or chemical substance on living tissue can be identified by profiling its known effects on genetic material (in vitro methodology).

[3] The Ombudsman understands that carcinogenomics is a scientific in vitro method for assessing the carcinogenic potential of compounds.

[4] The European Centre for Validation of Alternative Test Methods is a specific unit within the Joint Research Centre.

[5] Regulation (EC) 440/2008 of 30 May 2008 laying down test methods pursuant to Regulation 1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH).

[6] Organisation for Economic Cooperation and Development.

[7] Communication from the Commission to the Council and the European Parliament of 29 October 1991 - Establishment of the European Centre for Validation of Alternative Test Methods (ECVAM), SEC (91)1794 final.

[8] Case T-75/06, Bayer CropScience e.a. v Commission, [2008] ECR I-5469, paragraph 83; Case C-98/78 Racke [1979] ECR 69, paragraph 5; and Case C-16/90 Nölle [1991] ECR I-5163, paragraph 12.

[9] Case C-269/90, Technische Universität München v Hauptzollamt München-Mitte [1991] ECR I-5469, paragraph 14.

[10] Case T- 13/99 Pfizer Animal Health SA v Council [2002] ECR II-3305, paragraphs 170-172.

[11] See footnote 6.

[12] In this respect, the Commission stated that "for years, [the complainant] has been heavily promoting his own proposal for toxicogenomics-based methods on a weak scientific basis".

[13] 'General Guidelines for submitting a proposal to ECVAM for the evaluation of the readiness of a test method to enter the ECVAM prevalidation and/or validation process', available on ECVAM's website.

[14] Paragraph 40 of the REACH Regulation.