Background to the complaint

1. The EU’s Cosmetics Regulation[1] regulates the safety of cosmetics products. It contains a list of prohibited substances, which cannot be used in cosmetics, as well as a list of other substances, the use of which is restricted.

2. The Cosmetics Regulation does not specifically regulate the use in cosmetic products of endocrine disruptors[2], which are substances that alter the functions of the hormonal system[3]. However, the Cosmetics Regulation stipulates that “[w]hen Community or internationally agreed criteria for identifying substances with endocrine-disrupting properties are available, or at the latest on 11 January 2015, the Commission shall review this Regulation with regard to substances with endocrine-disrupting properties”[4].

3. The complainant is the European Consumer Organisation (BEUC), which represents national consumer organisations at European level. It considered that the Commission had failed to carry out this review in good time. Specifically, it considered that the Commission should have completed the review by 11 January 2015.

4. In June 2016, the Commission stated in a ‘Communication’[5] that a review of the Cosmetics Regulation with regard to endocrine disruptors was “overdue”. It said that, to this end, a ‘screening exercise’ of certain cosmetic ingredients was close to completion. The Commission undertook to present the review by the end of 2016. In July 2016, in reply to a question from a Member of the European Parliament, the Commission stated that it would complete the review and communicate the results before the end of 2016[6].

5. However, in March 2017, at a meeting of the Working Group on Cosmetic Products[7], on which the complainant has a representative, the Commission stated that it was still examining a draft report on the review. The report could not be completed before the end of 2016, it said, due to ongoing discussions on the scientific criteria for defining endocrine disruptors in biocides and plant protection products[8].

6. The complainant took the view that these discussions did not justify the Commission’s decision to postpone the review of the Cosmetics Regulation. The complainant pointed out that the EU’s General Court[9] had already found unlawful the Commission’s failure to adopt scientific criteria on endocrine disruptors in biocides by December 2013, the deadline set out in the Biocidal Products Regulation[10]. The complainant considered that the principles underpinning that ruling applied also to the review of the Cosmetics Regulation.

7. Dissatisfied with the time taken by the Commission to complete the review, the complainant turned to the Ombudsman.

The inquiry

8. The Ombudsman opened an inquiry into the complainant’s contention that, despite the Commission’s obligation to review the Regulation “at the latest on 11 January 2015”, the Commission had failed to complete the review .

9. In the course of the inquiry, the Ombudsman received the reply of the Commission on the complaint and, subsequently, the comments of the complainant in response to the Commission’s reply.

Arguments presented to the Ombudsman

10. The complainant argued that the Cosmetics Regulation set an unequivocal deadline for the Commission to carry out the review, even if criteria for identifying endocrine disruptors had not yet been agreed. The complainant contended that the Commission’s decision to postpone the review could not be justified by the ongoing discussions to define the scientific criteria for endocrine disruptors in biocides and plant protection products. In any event, it is unclear whether the criteria for identifying substances with endocrine-disrupting properties in biocides and plant protection products could be applied to other sectors or product groups, such as cosmetics.

11. According to the complainant, the delay was due to political concerns, rather than legitimate technical or scientific considerations.

12. In its reply to the Ombudsman, the Commission contended that the Cosmetics Regulation does not require it to adopt any specific legal act with a defined content. It simply states that the Commission should review the basic regulation with regard to certain substances.

13. The Commission stated that, by 11 January 2015, no ”agreed criteria for identifying substances with endocrine-disrupting properties”[11] were available and that it had been working on defining such criteria for some years, particularly concerning biocides and plant protection products. It had carried out a comprehensive impact assessment to analyse different options for defining the criteria for identifying endocrine disruptors[12], which had included a public consultation. The Commission added that “a screening study analysing which chemicals would be identified as endocrine disruptors under the different options for the criteria was conducted to provide input for the impact assessment”[13].

14. The Commission acknowledged that it had committed to present the review of the Cosmetics Regulation with regard to endocrine disruptors by the end of 2016. It stated that “[a]lthough the preparation of the document was well advanced, further discussions with Member States were necessary in light of the ongoing discussions on the scientific criteria for the definition of endocrine disruptors in the sectors of biocides and plant protection products”. As a result, the Commission had postponed completing the review of the Cosmetics Regulation. 

15. In its response, the complainant argued that the requirement for a review under the Cosmetics Regulation, and the related deadline, were independent of the requirements to develop criteria for identifying substances with endocrine-disrupting properties in other sectors, like biocidal and plant protection products[14].

16. The complainant claimed that the implication of the Commission’s position is that the criteria applying to different products are separate[15]. If, as the Commission maintains, the criteria for endocrine disruptors in plant protection and biocidal products are specific to those sectors, then the Commission had no reason to await the conclusion of the discussions on those criteria before completing the review of the Cosmetics Regulation, since this covered a separate type of product.

17. The complainant stated that the review report[16], which was finally published on 8 November 2018, indicated that the criteria for endocrine disruptors in biocidal and plant protection products should be taken into account for the purposes of the review[17]. However, according to the complainant, the report did not explain how this had been done in practice.

The Ombudsman's assessment

18. Article 15(4) of the Cosmetics Regulation lends itself to different interpretations. While the complainant takes the view that the review should have been completed by 11 January 2015, the Ombudsman’s view is that the Cosmetics Regulation obliged the Commission to commence its review by no later than 11 January 2015[18].

19. As the Commission has now completed the review, and as the complainant’s desired outcome was for the review to be completed, this matter is no longer of the essence. However, given that the purpose of the review is to ensure that public health and the environment are protected, it was clearly in the public interest for the review to be completed as quickly as possible. Where there are question marks over the potential safety of products, these should be resolved without undue delay. As the Commission itself points out in its review report, “cosmetic products are consumer products used by every citizen every day”.

20. As noted above, the Commission completed the review almost two years after the deadline to which it had publicly committed. It is regrettable, both in terms of public credibility and good administrative practice, for an administration to set and then miss deadlines.

21. As regards whether the time taken by the Commission to complete the review was reasonable, the Ombudsman acknowledges that the subject of endocrine disruptors is a complex one. She further notes that the Commission has explained why the review was finally completed two years after the deadline to which it had publicly committed.

22. The complainant disputes the soundness of the Commission’s decision to link its work on the review of the Cosmetics Regulation with the discussions on the adoption of the criteria for defining endocrine disruptors in biocides and plant protection products. The Commission’s argument as to why this link was made is essentially scientific in nature, and the Ombudsman does not have the scientific or technical expertise to question this approach. The importance of ensuring “coherence throughout the sectors” (see footnote 13) also seems reasonable.

23. The Ombudsman notes, however, that the Commission had been obliged to present draft measures (with regard to pesticides) and to adopt delegated acts (with regard to biocides) setting out scientific criteria for determining endocrine disruptors, by mid-December 2013[19]. The Commission failed to do so in time. The General Court of the EU deemed the Commission’s failure to meet the deadline for adopting delegated acts set in the Biocidal Products Regulation to be unlawful[20].  

24. It is at least arguable that this delay impacted on the review of the Cosmetics Regulation. According to the Commission itself, by the end of 2016, although the preparation of the review document was well advanced, its adoption was postponed because further discussions with Member States were necessary in view of the (then) ongoing discussions on the criteria for defining endocrine disruptors in biocides and plant protection products.

25. It is also relevant that the very (Community or internationally agreed) criteria the legislature referred to in Article 15(4) of the Cosmetics Regulation are not yet available. The Commission is obliged to use the criteria for identifying substances with endocrine-disrupting properties as soon as these criteria become available. The fact that these criteria are still not available is itself a cause for concern.

26. The Commission has acknowledged that it is important to “step up the EU’s efforts” in this area[21]. In the review presented in November 2018, it made a commitment to draw up a priority list of potential endocrine disruptors by the first quarter of 2019, and to ensure that substances are evaluated with a view to banning or restricting their use in cosmetics without delay.

27. The Ombudsman urges the Commission to respect this self-imposed deadline and invites it to inform her as soon as it has drawn up the priority list. Given the subsequent involvement of Member States, stakeholders and academia, as well as the Scientific Committee on Consumer Safety, she invites the Commission to report back, within one year, on the further steps that have been completed in this area.

Conclusion

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

As the Commission has now presented its review of the Cosmetics Regulation with regard to substances with endocrine disrupting properties, no further inquiries into the complaint are justified. Given that the purpose of the review is to ensure that public health and the environment are protected, the Ombudsman regrets that the Commission completed this review, almost two years after the deadline to which it had publicly committed.

The Commission should inform the Ombudsman as soon as it has drawn up the priority list mentioned in its review and, within one year, on the further steps that have been completed in this area.

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

 

Emily O'Reilly

European Ombudsman

Strasbourg, 07/02/2019

 

Annex: Interpretation of Article 15(4)

28. Article 15(4) of the Cosmetics Regulation states that “[w]hen Community or internationally agreed criteria for identifying substances with endocrine-disrupting properties are available, or at the latest on 11 January 2015, the Commission shall review this Regulation with regard to substances with endocrine-disrupting properties”.

29. Article 15(4) of the Cosmetics Regulation can be divided into two parts. First, an obligation to review the Regulation arises once the criteria for identifying substances with endocrine-disrupting properties are available. This is the primary trigger mechanism which launches the review process. Second, as a fall back trigger mechanism, should no criteria for identifying substances with endocrine-disrupting properties become available by 11 January 2015, the obligation to review the Regulation arises by no later than 11 January 2015. It is important to note that the obligation “to review” the Regulation applies to both circumstances in an identical manner (this is evidenced by the fact that both trigger mechanisms are contained in the very same sentence in Article 15(4) of the Cosmetics Regulation).  The reference to an obligation to review the Cosmetics Regulation cannot have one meaning for situations where criteria for identifying substances with endocrine-disrupting properties have become available before 11 January 2015, and another altogether different meaning for situations where the criteria have not become available by 11 January 2015.

30. The purpose of first part of Article 15(4) of the Cosmetics Regulation is that the Commission is obliged to use the criteria for identifying substances with endocrine-disrupting properties as soon as these criteria become available. As such, when Article 15(4) of the Cosmetics Regulation refers to the obligation on the Commission “to review the Regulation”, this obligation “to review” cannot be understood as an obligation to have completed the review, since that would mean that the review referred to had to be completed, using the criteria, at the precise time the criteria first became available, which is impossible. The only meaning that can be given to this provision is that the obligation “to review the Regulation” is an obligation to commence reviewing the Regulation, using the criteria, once the criteria have become available.

31. As such, the obligation to review the Regulation by 11 January 2015 must mean that the Commission was required to have commenced its review of the Regulation by no later than 11 January 2015[22].

 

[1] Regulation (EC) No 1223/2009 on cosmetic products: https://eur-lex.europa.eu/legal-content/EN/ALL/?uri=CELEX%3A32009R1223.

[2] Endocrine disruptors can cause health problems, which studies suggest may include cancer, birth defects, and other developmental disorders.

[3] The current regime to address the safety concerns related to the use of endocrine disruptors in cosmetics is based on a scientific risk assessment of cosmetic ingredients carried out by the EU’s Scientific Committee on Consumer Safety (SCCS). The SCCS is an independent scientific committee that carries out a scientific risk assessment of substances before their inclusion in the Annexes to the Cosmetics Regulation. Substances identified as endocrine disruptors are subject to case-by-case regulatory action.

[4] Article 15(4) of the Regulation.

[5] Communication from the Commission to the European Parliament and the Council on endocrine disruptors and the draft Commission acts setting out scientific criteria for their determination in the context of the EU legislation on plant protection products and biocidal products, COM/2016/0350 final, available at: http://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:52016DC0350&qid=1512988202902&from=EN

[6] See: http://www.europarl.europa.eu/doceo/document/E-8-2016-003989-ASW_EN.html?redirect

[7] The Working Group on Cosmetics Products provides advice to the Commission on issues related to cosmetic product ingredients. Its members include national authorities, as well as industry and civil society. More information: ec.europa.eu/transparency/regexpert/index.cfm?do=groupDetail.groupDetail&groupID=1302&news=1

[8] See the minutes of the Meeting of the Working Group (WG) on Cosmetic Products, 14 March 2017, available at: http://ec.europa.eu/transparency/regexpert/index.cfm?do=groupDetail.groupDetailDoc&id=34018&no=2.  

[9] See the judgment of the General Court of 16 December 2015 in Case T-521/14, Sweden v European Commission, ECLI:EU:T:2015:976. Sweden was supported by the European Parliament, the Council and a number of Member States.

[10] Regulation (EU) No 528/2012 concerning the making available on the market and use of biocidal products https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=celex%3A32012R0528.

[11] Article 15(4) of the Regulation.

[12] The impact assessment was published in June 2016: https://ec.europa.eu/health/sites/health/files/endocrine_disruptors/docs/2016_impact_assessment_en.pdf.

[13] The Commission went on to state that its Joint Research Centre was tasked with developing a ‘screening methodology’, which was then applied to screen the available evidence for approximately 600 chemicals. The screening started in May 2015 and covered active substances used in plant protection and biocidal products, as well as a selection of substances falling under the REACH Regulation, the Cosmetics Regulation and the Water Framework Directive. The Commission contended that cosmetics “were considered in the broader context of this work and due to the ongoing impact assessment, it was decided that ensuring coherence throughout the sectors was important, without creating unnecessary risk for consumers and without lowering the level of protection of human health”.

[14] The complainant argued that the Cosmetics Regulation and the Plant Protection Products Regulation were adopted around the same time (in November and October 2009 respectively). While the Plant Protection Products Regulation obliges the Commission to develop criteria by 14 December 2013, there is no reference to this obligation in the Cosmetics Regulation. Instead, the legislature’s intention was that the Commission should complete the review of the Cosmetics Regulation no later than 5 years after its entry into force, that is, 11 January 2015.

[15] The complainant argued that it is unclear if the criteria for plant protection or biocidal products can be applied to other sectors or product groups, such as cosmetics. It referred to the summary records of the Standing Committee on Plants, Animals, Food and Feed and the Expert Group for Biocidal Products between June 2016 and July 2017, at which, it claimed, the Commission repeatedly acknowledged that the criteria are not directly applicable to other sectors, including cosmetics.

[16] Available at: http://ec.europa.eu/transparency/regdoc/rep/1/2018/EN/COM-2018-739-F1-EN-MAIN-PART-1.PDF.  

[17] The complainant also referred to the Strategy on endocrine disruptors in a Communication entitled “Towards a comprehensive European Union framework on endocrine disruptors”, which the Commission published on 7 November 2018: http://ec.europa.eu/transparency/regdoc/rep/1/2018/EN/COM-2018-734-F1-EN-MAIN-PART-1.PDF. The Communication states that “[t]he Commission will launch a Fitness Check to assess whether relevant EU legislation on endocrine disruptors delivers its overall objective to protect human health and the environment by minimising exposure to these substances. ... It will pay particular attention to those areas where legislation does not contain specific provisions for endocrine disruptors, such as toys, cosmetics and food contact materials”.

[18] The Ombudsman’s reasoning on how Article 15(4) of the Cosmetics Regulation should be interpreted can be found in the Annex. However, the Ombudsman points out that solely the Court of Justice of the European Union may provide an authoritative interpretation of EU law.

[19] Point 3.6.5 of Annex II to the Plant Protection Products Regulation states: “[b]y 14 December 2013, the Commission shall present to the Standing Committee on the Food Chain and Animal Health a draft of the measures concerning specific scientific criteria for the determination of endocrine disrupting properties to be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 79(4)”.

Article 5(3) of the Biocidal Products Regulation states: “[n]o later than 13 December 2013, the Commission shall adopt delegated acts in accordance with Article 83 specifying scientific criteria for the determination of endocrine-disrupting properties”.

[20]In the above-mentioned judgment of 16 December 2015 in Case T-521/14, Sweden v European Commission (ECLI:EU:T:2015:976). It was not until September 2017 that the Commission actually adopted the delegated acts envisaged by the Biocidal Products Regulation (and it presented draft measures setting out scientific criteria for determining endocrine disruptors with regard to pesticides in June 2016).

[21] In its Communication: ‘Towards a comprehensive European Union framework on endocrine disruptors’ the Commission states that “[a]lmost twenty years after the Community Strategy for endocrine disruptors of 1999, endocrine disruption remains a global challenge and a source of concern for many EU citizens. While significant progress has been achieved over the past two decades to better understand and manage endocrine disruptors, it is important to step up the EU's efforts”.

[22] The complainant makes reference to a ruling of the General Court (in Case T-521/14 Sweden v Commission) to argue that the Commission was under an obligation to have completed its review by no later than 11 January 2015. The General Court in that case interpreted the first paragraph of Article 5(3) of the Biocidal Products Regulation as laying down a “clear, precise and unconditional” obligation to adopt delegated acts by no later than 13 December 2013. This case cannot be used to interpret Article 15(4) of Cosmetics Regulation, since the wording of the relevant provision in the Biocidal Products Regulation and the relevant provision in the Cosmetics Regulation is different. The duty to adopt a delegated act by a certain date is unequivocal - the obligation can only be understood as meaning that the act in question must be adopted by the date a question. In contrast, an obligation to review a Regulation by a certain date is not unequivocal.