Provisional text

delivered on 24 March 2022 (1)

Case C-4/21

Fédération des entreprises de la beauté

Agence nationale de sécurité du médicament et des produits de santé

(Request for a preliminary ruling from the Conseil d’État (Council of State, France))

( Reference for a preliminary ruling – Approximation of laws – Cosmetic products – Regulation (EC) No 1223/2009 – Article 27 – Safeguard clause in the event of a serious risk to human health – National provisional measure laying down certain labelling requirements in respect of cosmetic products containing phenoxyethanol – E-mail from a Commission official concerning the national measure – Preparatory measure or Commission decision – Concept of cosmetic product for the purposes of the adoption of a provisional measure – Cosmetic products characterised by the fact that they contain a certain substance in their composition – Article 28 – Remedies – Scope of the judicial review of the national provisional measure )

2.Regulation (EC) No 1223/2009 (2) provides as a general rule that Member States must not refuse, prohibit or restrict the making available on the market of cosmetic products which comply with its requirements.

3.However, that regulation contains a ‘safeguard clause’ whereby the authorities of a Member State may adopt provisional measures (such as withdrawal or limitations on availability) in respect of one or more cosmetic products in the event of a serious risk to human health.

4.Where the safeguard clause is activated, the European Commission must indicate as soon as possible whether the provisional measure is justified or not, after consulting, where appropriate, the Scientific Committee on Consumer Safety (‘SCCS’). (3)

5.In France, the Agence nationale de sécurité du médicament et des produits de santé (National Agency for the Safety of Medicinal Products and Health Products; ‘ANSM’) adopted a provisional measure laying down certain requirements in connection with the labelling of products containing phenoxyethanol (4) which are intended for children of three years or less. These requirements differed from those contained in Regulation No 1223/2009, which itself adheres to the requirements recommended in an SCCS opinion. (5)

6.The Fédération des entreprises de la beauté (Federation of Beauty Companies; ‘FEBEA’) made an application for the annulment of the ANSM’s decision to the Conseil d’Etat (Council of State, France), which has submitted to the Court of Justice a request for a preliminary ruling on the interpretation of Regulation No 1223/2009.

Recitals 3 and 4 of Regulation No 1223/2009 are worded as follows:

(3) This Regulation … strengthens certain elements of the regulatory framework for cosmetics, such as in-market control, with a view to ensuring a high level of protection of human health.

(4) This Regulation comprehensively harmonises the rules in the Community in order to achieve an internal market for cosmetic products while ensuring a high level of protection of human health.

…

Article 1 (‘Scope and objective’) states:

This Regulation establishes rules to be complied with by any cosmetic product made available on the market, in order to ensure the functioning of the internal market and a high level of protection of human health.

Article 2 (‘Definitions’) provides:

1. For the purposes of this Regulation, the following definitions shall apply:

(a) “cosmetic product” means any substance or mixture intended to be placed in contact with the external parts of the human body … or with the teeth and the mucous membranes of the oral cavity with a view exclusively or mainly to cleaning them, perfuming them, changing their appearance, protecting them, keeping them in good condition or correcting body odours;

(b) “substance” means a chemical element and its compounds in the natural state or obtained by any manufacturing process, including any additive necessary to preserve its stability and any impurity deriving from the process used but excluding any solvent which may be separated without affecting the stability of the substance or changing its composition;

(c) “mixture” means a mixture or solution composed of two or more substances;

…

Article 3 (‘Safety’) provides:

A cosmetic product made available on the market shall be safe for human health when used under normal or reasonably foreseeable conditions of use ...

Article 10 (‘Safety assessment’) provides:

1. In order to demonstrate that a cosmetic product complies with Article 3, the responsible person shall, prior to placing a cosmetic product on the market, ensure that the cosmetic product has undergone a safety assessment on the basis of the relevant information and that a cosmetic product safety report is set up in accordance with Annex I.

…

Article 11 (‘Product information file’) states:

…

(a) a description of the cosmetic product which enables the product information file to be clearly attributed to the cosmetic product;

(b) the cosmetic product safety report referred to in Article 10(1);

…

Article 13 (‘Notification’) reads:

1. Prior to placing the cosmetic product on the market the responsible person shall submit, by electronic means, the following information to the Commission:

(a) the category of cosmetic product and its name or names, enabling its specific identification;

…

Article 22 (‘In-market control’) states:

‘Member States shall monitor compliance with this Regulation via in-market controls of the cosmetic products made available on the market. They shall perform appropriate checks of cosmetic products and checks on the economic operators on an adequate scale, through the product information file and, where appropriate, physical and laboratory checks on the basis of adequate samples.

…

Article 23 (‘Communication of serious undesirable effects’) states:

1. In the event of serious undesirable effects, the responsible person and distributors shall without delay notify the following to the competent authority of the Member State where the serious undesirable effect occurred:

…

Article 24 (‘Information on substances’) provides:

‘In the event of serious doubt regarding the safety of any substance contained in cosmetic products, the competent authority of a Member State in which a product containing such a substance is made available on the market may by reasoned request require the responsible person to submit a list of all cosmetic products for which he is responsible and which contain this substance. …’

Article 25 (‘Non-compliance by the responsible person’) reads:

1. … competent authorities shall require the responsible person to take all appropriate measures … where there is non-compliance with any of the following:

…

5. The competent authority shall take all appropriate measures to prohibit or restrict the making available on the market of the cosmetic product or to withdraw the product from the market or to recall it in the following cases:

(a) where an immediate action is necessary in the event of serious risk to human health; or

(b) where the responsible person does not take all appropriate measures within the time limit referred to in paragraph 1.

…

Article 27 (‘Safeguard clause’) states:

1. In the case of products meeting the requirements listed in Article 25(1), where a competent authority ascertains, or has reasonable grounds for concern, that a cosmetic product or products made available on the market present or could present a serious risk to human health, it shall take all appropriate provisional measures in order to ensure that the product or products concerned are withdrawn, recalled or their availability is otherwise restricted.

For the purposes of the first subparagraph, the information exchange system provided for in Article 12(1) of Directive 2001/95/EC shall be used.

Article 12(2), (3) and (4) of Directive 2001/95/EC shall apply.

3. The Commission shall determine, as soon as possible, whether the provisional measures referred to in paragraph 1 are justified or not. For that purpose it shall, whenever possible, consult the interested parties, the Member States and the SCCS.

5. Where the provisional measures are not justified the Commission shall inform the Member States thereof and the competent authority concerned shall repeal the provisional measures in question.

According to Article 28 (‘Good administrative practices’):

1. Any decision taken pursuant to Articles 25 and 27 shall state the exact grounds on which it is based. It shall be notified by the competent authority without delay to the responsible person, who shall at the same time be informed of the remedies available to him under the law of the Member State concerned and of the time limits to which remedies are subject.

…

Article 31 (‘Amendment of the Annexes’) states:

1. Where there is a potential risk to human health, arising from the use of substances in cosmetic products, which needs to be addressed on a Community-wide basis, the Commission may, after consulting the SCCS, amend Annexes II to VI accordingly. …

II. Facts, dispute and the questions referred for a preliminary ruling

In September 2012, the Commission received from the ANSM a risk assessment stating that the maximum authorised concentration (of 1%) of phenoxyethanol for use as a preservative should be reduced to 0.4% in cosmetic products for children aged three years or less, and that phenoxyethanol was not to be used in cosmetic products intended for the nappy area. (6)

On 6 October 2016, the SCCS issued an opinion in which it considered the use of phenoxyethanol as a preservative with a maximum concentration of 1.0% to be safe, regardless of the target age group.

In December 2017, the ANSM convened a temporary specialised scientific committee which endorsed the proposal which that authority had made in September 2012.

On 13 March 2019, the ANSM applied the safeguard clause provided for in Article 27 of Regulation No 1223/2009 by laying down specific conditions for making available on the market in France leave-on cosmetic products containing phenoxyethanol.

In the contested decision, the ANSM laid down a temporary obligation to indicate on the labelling of ‘leave-on cosmetic products’ (7) containing phenoxyethanol – with the exception of deodorants, styling products and make-up – that they are not suitable for use on the buttocks of children aged three years or less. (8)

On 10 May 2019, the ANSM communicated the contested decision to the Commission.

On 27 November 2019, a Commission official (9) sent the Director-General of the ANSM an e-mail (‘letter from the head of unit’) stating, inter alia, (10) that the provisional measure, since it affected a category of products rather than a specific product or specific products, did not fall within the scope of Article 27 of Regulation No 1223/2009.

On 6 December 2019, the Director-General of the ANSM expressed his disagreement with the analysis set out in the letter from the head of unit and informed the head of unit that he would be maintaining the contested decision on a temporary basis until such time as the Commission adopted a measure in accordance with Article 27 of Regulation No 1223/2009.

28.On 8 April 2019, the FEBEA made an application to the Conseil d’Etat (Council of State) seeking the annulment of the contested decision.

29.In the FEBEA’s view, the provisional measure was in breach of Regulation No 1223/2009 because, despite the fact that the conditions for the application of Article 27 thereof were not present, that measure imposed a labelling requirement not provided for in the regulation. It therefore infringed Article 9 thereof on the free movement of cosmetic products.

30.In order to dispose of the aforementioned application, the Conseil d’État (Council of State) considers it essential to establish:

— whether the letter from the head of unit is a Commission decision for the purposes of Article 27(3) of Regulation No 1223/2009, or merely a preparatory measure;

— in the event that the letter from the head of unit is a preparatory measure without legal effects, to what extent the national court has jurisdiction in respect of the contested decision;

— whether Article 27 of Regulation No 1223/2009 allows provisional measures to be adopted in respect of a category of cosmetic products containing the same substance.

31.In order to dispel its doubts, the Conseil d’État (Council of State) referred to the Court of Justice for a preliminary ruling six questions of which I shall, at the Court’s direction, address the first three:

‘(1) Must the letter of 27 November 2019 from the Head of … Unit [at the European Commission] be regarded as a measure which is preparatory to the decision by which the Commission determines whether a provisional measure of a Member State is justified or not on the basis of Article 27(3) of [Regulation No 1223/2009], in view of the wording of that letter and the absence of any evidence showing that authority has been delegated to the member of staff who signed it to take a decision on behalf of the Commission, or must it be regarded as such a decision, expressing the final position of the Commission?

(2) Should the letter of 27 November 2019 have to be regarded as a measure which is preparatory to the decision by which the Commission determines whether a provisional measure of a Member State is justified or not on the basis of Article 27(3) of [Regulation No 1223/2009], when a national court is asked to rule on the legality of a provisional measure taken by a national authority on the basis of Article 27(1) of that regulation, may that court, pending the Commission’s reaching its decision, rule on that provisional measure’s compliance with that article and, if so, to what extent and on which points, or must that court, for as long as the Commission has not declared it to be unjustified, treat the provisional measure as compliant with that article?

(3) If the answer to the preceding question is in the affirmative, must Article 27 of [Regulation No 1223/2009] be interpreted as allowing provisional measures to be taken which apply to a category of products containing the same substance?’

III. Procedure before the Court

32.The request for a preliminary ruling was registered at the Court on 4 January 2021.

33.Written observations have been lodged by the FEBEA, the French and Greek Governments, and the Commission. All of the parties except for the Greek Government attended the hearing held on 20 January 2022.

34.The first question, concerning the legal nature of the letter from the head of unit (that is to say, whether it is a preparatory act or a final decision), must be viewed in the context of Article 27(3) of Regulation No 1223/2009.

35.Considered from that point of view, the question is whether, for the purposes of that article, the letter from the head of unit may be construed as the Commission’s official response or reply to the ANSM’s provisional measure.

36.All of those taking part in these preliminary ruling proceedings (in particular, the two principal interlocutors, namely, the ANSM, represented by the French Government, and the Commission) agree that the letter from the head of unit is not in the nature of a Commission decision.

37.If the ANSM had regarded that letter as a final Commission decision, the French Government could have brought an action for its annulment under Article 263 TFEU. Not only did it fail to do so, but instead, on 6 December 2019, the ANSM informed the Commission that it was maintaining the provisional measure until such time as that institution adopted a decision under Article 27(3) of Regulation No 1223/2009.

38.The Commission, in particular, does not consider that letter to be in the nature of a decision and regards it as being merely a preparatory act. It relies in this regard on a number of arguments with which I agree:

— The letter from the head of unit is not consistent, either in the heading or in the body of that communication, with the format of a decision. Although it comes from a Commission department, it does not state that it is issued pursuant to a decision-making authority held by that institution as part of its powers or by delegation.

— In terms of content, it is made up of the aforementioned official’s opinion on the scope of Article 27(1) of Regulation No 1223/2009, followed by a request to the French authorities to re-examine the provisional measure.

— The letter leaves the door open for the ANSM to present new scientific evidence showing that the use of phenoxyethanol should be restricted, with a view to following the usual procedure.

— The letter from the head of unit goes on to say that, in order for the opinion of the SCCS to be reconsidered, ‘a file containing relevant new data must be sent to the European Commission’.

39.It is clear from the foregoing information that the letter from the head of unit is not equivalent to a decision which the Commission is to adopt under Article 27(3) of Regulation No 1223/2009.

40.I would recall that, under that provision, the Commission must inform the national authority whether its provisional measure is justified or not. The letter from the head of unit, however, does not expressly state that the contested decision is unjustified. Neither does it require the national authority to repeal the provisional measure, as prescribed by Article 27(5) of Regulation No 1223/2009 in the case where a provisional measure is not justified.

41.The letter from the head of unit, as I have said, simply suggests that the national authorities should re-examine the provisional measure and, if they consider it appropriate to do so, send new scientific data on the basis of which to review the SCCS’s opinion on phenoxyethanol.

42.Furthermore, as the French Government notes, since the head of unit does not have the power to take decisions on the Commission’s behalf and his letter does not state the legal basis on which it is adopted, that letter does not satisfy the legal certainty requirement applicable to measures intended to create legal effects. Indeed, the binding force of such a measure derives specifically from a provision of EU law that must be indicated as the legal basis on which the measure is founded.

43.In short, Article 27(3) of Regulation No 1223/2009 must be interpreted as meaning that a letter such as that from the head of unit, which does not formally make clear to the ANSM whether the provisional measure adopted in accordance with Article 27(1) of that regulation is justified or not, cannot be classified as a final Commission decision.

44.The second question starts from the (correct) assumption that the letter from the head of unit does not express the Commission’s decision. On that premiss, the referring court’s uncertainty has to do with the powers of the national court called upon to verify the legality of the provisional measure in the action brought before it.

45.The Conseil d’État (Council of State) wishes to ascertain whether and in what terms it may give a ruling, pending the adoption of a Commission decision on that provisional measure under Article 27(3) of Regulation No 1223/2009.

46.The answer to the first part of that (twofold) question does not present any difficulties. The guarantee of judicial protection for the persons concerned, at national level, is set out in Article 28 of Regulation No 1223/2009. Under that provision, any decision taken pursuant to Articles 25 and 27 must be notified without delay ‘to the responsible person, who shall at the same time be informed of the remedies available to him under the law of the Member State concerned and of the time limits to which remedies are subject’.

47.The term ‘remedies’ in Article 28 of Regulation No 1223/2009 thus means that the national court has the power to review a decision to adopt provisional measures which is taken by the authorities of the country concerned under Article 27(1) of that regulation, if that country’s domestic law authorises it to do so.

48.The second part of the question is focused on a definition of the powers of the national court adjudicating upon the action brought against such provisional measures.

49.The Court has already ruled in similar proceedings, in which a provision of EU law conferred powers on the national authorities to adopt provisional measures and left the final assessment to the EU institutions.

50.The judgment in Monsanto and Others was delivered in the context of Regulation (EC) No 1829/2003, the scheme of which mirrors that of Regulation No 1223/2009.

51.Article 34 of Regulation No 1829/2003 provides for the adoption of emergency measures where products authorised by that regulation are likely to constitute a serious risk to human health, animal health or the environment. In such a situation (and in the circumstances provided for in Article 54(1) of Regulation (EC) No 178/2002/EC), Member States may take interim protective measures which they must immediately communicate to the other Member States and the Commission.

The Court found as follows, in this regard, in the judgment in Monsanto and Others:

— ‘In the light of the overall scheme provided for by Regulation No 1829/2003 and its objective of avoiding artificial disparities in the treatment of a serious risk, the assessment and management of a serious and evident risk ultimately come under the sole responsibility of the Commission and the Council, subject to review by the European Union Courts.

— ‘At the stage of adoption and implementation by the Member States of the emergency measures referred to in Article 34 of Regulation No 1829/2003, as long as no decision has been adopted in that regard at European Union level, the national courts before which actions have been brought to test the lawfulness of such measures have jurisdiction to assess the lawfulness of those measures having regard to the substantive conditions provided for in Article 34 of Regulation No 1829/2003 and the procedural conditions laid down in Article 54 of Regulation No 178/2002 ...’

— ‘With a view to the adoption of emergency measures, Article 34 of Regulation No 1829/2003 requires Member States to establish, in addition to urgency, the existence of a situation which is likely to constitute a clear and serious risk to human health, animal health or the environment.

— ‘However, where … a decision has been adopted at European Union level, the factual and legal assessments relating to that case and contained in such a decision are binding on all bodies of the Member State which is the addressee of such a decision, in accordance with Article 288 TFEU, including its courts which are called on to assess the lawfulness of measures adopted at national level’.

53.To my mind, those considerations can be transposed to the interpretation of Regulation No 1223/2009, Article 27(1) of which allows the competent authority of the Member State to ‘[ascertain], or [have] reasonable grounds for concern, that a cosmetic product or cosmetic products made available on the market present or could present a serious risk to human health’. In such circumstances, that authority may ‘take all appropriate provisional measures in order to ensure that the product or products concerned are withdrawn, recalled or their availability is otherwise restricted’.

54.Once such a decision has been adopted, the national court before which that decision has been challenged retains full jurisdiction to adjudicate on the action, for as long as the Commission has not taken the decision provided for in Article 27(3) of Regulation No 1223/2009.

55.If, conversely, the Commission has taken that decision, which is binding on all of the authorities of the Member State concerned until such time as it is annulled by the Court, the dispute before the national court will henceforth be devoid of purpose.

56.Thus, for as long as the Commission has not taken the decision referred to above, it will be for the national court to assess whether the authority having adopted the provisional measure complies both with the substantive requirements of Article 27 of Regulation No 1223/2009 and with the procedural requirements laid down in that regulation and, of course, in the applicable national legislation:

— As regards the substantive requirements, the national court may verify whether the provisional measure is sufficiently substantiated, from the point of view of the precautionary purpose it serves, by the existence of a serious risk and whether it is proportionate to meeting the objective of protecting human health against that risk.

— As regards the procedural requirements, it will also fall to the national court to determine how the provisions defining the powers of the administrative body have been applied and the procedure used. In particular, it will have to check whether the administrative body has complied not only with the requirements of national law but also with the procedural provisions of Regulation No 1223/2009 (that is to say, whether the measure has been notified to the Commission and the other Member States (Article 27(2)), and whether the good administrative practices referred to in Article 28 have been observed).

57.In giving its ruling, whether in favour or against, pending the exercise by the Commission of its competence under Article 27(3) of Regulation No 1223/2009, the national court does not interfere in the exercise of the Commission’s exclusive jurisdiction in this regard:

— If it annuls the provisional measure, the legal situation which that measure had altered will be fully restored, and the previous status quo will therefore remain unchanged. The restriction on the movement of cosmetic products that comply with Regulation No 1223/2009 thus ceases to apply.

— If, conversely, the national court confirms that, from the point of view of its precautionary purpose, the provisional measure complied with the substantive and procedural requirements of the applicable legislation (at both national and EU level), the Commission can still decide whether that measure was justified or not.

58.The Commission’s final decision, as I have already pointed out, is binding on all of the bodies of the Member State for as long as it is not annulled by the Court. Prior intervention by the national court is not therefore incompatible with the subsequent intervention of the Commission.

59.Contrary to the Commission’s contention, a national judicial decision annulling a decision to adopt provisional measures does not impede the actions taken by the Commission itself any more than would the withdrawal or repeal of those measures by the competent authority of the Member State on its own initiative.

60.If the national authority, on its own initiative or in implementation of a court judgment, annuls its decision to adopt a provisional measure, the Commission will no longer have to rule on whether that measure is justified (because the measure will have ceased to exist), but this in no way affects its own powers to assess the risks inherent in using a substance in cosmetic products and to act accordingly.

61.In short, for as long as the Commission does not exercise its power under Article 27(3) of Regulation No 1223/2009, the national court may annul or maintain in being, to serve the precautionary purpose for which they were introduced, the provisional measures adopted by the national authority.

62.The referring court wishes to ascertain whether Article 27(1) of Regulation No 1223/2009 permits the adoption of provisional measures in connection with a category of products containing the same substance.

63.The Commission and the FEBEA choose to answer that question in the negative. That article, they submit, authorises the adoption of provisional measures only in respect of a specific product as it has been commercially exploited, that is to say made available on the market. The national authority may take action only in respect of a product presented on the market under a particular trade mark or trade name.

64.The French and Greek Governments take issue with that interpretation by recourse to arguments with which, in essence, I agree. I recognise, however, that there are strong arguments in favour of both propositions.

65.My analysis will look first at the concept of cosmetic product and then turn to the objective pursued by Regulation No 1223/2009. Finally, I shall consider the Commission’s arguments concerning the system for exchanging information with the national authorities.

1. Concept of cosmetic product

66.Article 2(1)(a) of Regulation No 1223/2009 defines ‘cosmetic product’ as ‘any substance or mixture intended to be placed in contact with the external parts of the human body … with a view exclusively or mainly to cleaning them, perfuming them, changing their appearance, protecting them, keeping them in good condition or correcting body odours’.

67.In the words of the Court, that definition ‘is based on three cumulative criteria: (i) the nature of the product in question (substance or mixture); (ii) the part of the human body with which it is intended to be placed in contact; and (iii) the purpose of its use’.

68.Of those criteria, the one most relevant to this dispute is the first. The cosmetic product does indeed consist of a substance or mixture. The association between the cosmetic product and the substances or mixtures that comprise it is therefore undeniable.

69.It would be a different matter if the product were presented on the market through extrinsic elements unconnected with its own essence, such as the signs (trade marks) that distinguish it in trade or the name given to it by its manufacturer.

70.The clear connection between product and substance would therefore, in principle, militate in favour of the proposition put forward by the French and Greek Governments.

71.It is true, however, that certain provisions of Regulation No 1223/2009 appear at first sight to support the interpretation advocated by the FEBEA and the Commission, inasmuch as they suggest that the product is identified by its name:

— Article 13(1), relating to the notification which the responsible person must submit when placing a cosmetic product on the market, mentions ‘the category of cosmetic product and its name or names, enabling its specific identification’.

— Article 23 provides for the notification by the responsible person and the distributor, ‘in the event of serious undesirable effects’, of the ‘name of the cosmetic product concerned, enabling its specific identification’.

72.In my view, an interpretation of those provisions in relation to Article 27 of Regulation No 1223/2009 does not inevitably have the effect of limiting the scope of the latter to single (that is to say, individual) products as they appear on the market under their distinctive signs or their trade name. I shall endeavour to explain that the purpose of that article, in the context of that regulation, supports the other proposition, first and foremost on the basis of the literal definition of the concept of cosmetic product.

73.As the Court has held, ‘it follows from a reading of the provisions of Regulation No 1223/2009 as a whole, in particular its Article 1, read in the light of recitals 3 and 4 thereof, that that regulation has as its objective an exhaustive harmonisation of the rules in force in the European Union which is aimed at establishing an internal market for cosmetic products while, at the same time, ensuring a high level of protection for human health’.

74.In attaining those objectives, ‘Member States shall not … refuse, prohibit or restrict the making available on the market of cosmetic products which comply with the requirements of this Regulation’, but they are permitted to adopt safeguard measures such as those at issue in this dispute.

75.The protection of public health, which operates as a limit to the free movement of products, permeates the whole of Regulation No 1223/2009. A distinction can be drawn between two levels of activity in operation in the regulation:

— The regulation of cosmetic products, which falls exclusively to the Commission, with a view to ensuring market unity and, at the same time, consumer health. At this level, the regulation establishes prospectively which cosmetic products (and, therefore, which substances) are permissible and under what conditions.

— Market surveillance (Chapter VII of the regulation), responsibility for which is borne by the national authorities, in the interests of which provisional measures may be adopted (Chapter VIII of the regulation) in order to protect human health retrospectively against serious risks.

76.It is the national authority which discharges the market supervision functions and it must have the information necessary to be able to do so. The responsible persons and distributors must inform it, in particular, of the existence of serious undesirable effects in a cosmetic product (Articles 22 and 23 of Regulation No 1223/2009).

77.Article 24 of Regulation No 1223/2009 provides that, in the event of serious doubt regarding the safety of any substance contained in a cosmetic product, the authority of the Member State in which that product is made available on the market ‘may … require the responsible person to submit a list of all cosmetic products for which he is responsible and which contain this substance’.

78.The effect of that provision of Regulation No 1223/2009, of course, is that the national authority is in possession of information not only on a single product but on the ‘list’ of products containing the same substance.

79.The extent to which that ‘list’ amounts to a ‘group’ or a ‘category’ of products strikes me as being more a matter of semantics than reality. What matters is that the supervision by the national authority, whether ex officio or by communication from the responsible persons or the distributors, may reveal doubts as to the safety of a substance contained in one or more cosmetic products.

80.In this way, the national authority will be in a position to identify a collection (be it a list, group or category) of cosmetic products which, inasmuch as their composition includes a particular substance, may adversely affect human health. If this is true for Article 24, it will for the same reason be true for Article 27(1) of Regulation No 1223/2009.

81.The response mechanisms which Regulation No 1223/2009 makes available to national authorities cater for two different scenarios:

— In the first, surveillance ensures that the cosmetic product complies with the requirements of Regulation No 1223/2009 as referred to in Article 25(1) thereof. The national authority may require the responsible person to take all appropriate measures or order the withdrawal of the product concerned from the market or its recall of where there is non-compliance with any of the aforementioned requirements.

— In the second scenario, which is dealt with in Article 27 of Regulation No 1223/2009, a ‘cosmetic product or products made available on the market’ meet the requirements of that regulation, but the national authorities take the view that they nonetheless pose a serious risk to human health and for that reason decide to restrict their distribution or attach conditions to their use.

82.In that second scenario (which is the one of relevance here), the national authority that identifies a serious risk to health in one or more cosmetic products, notwithstanding that these comply with the requirements of Regulation No 1223/2009, is implicitly highlighting a possible anomaly in the regulation itself (in particular, in the annexes thereto). That alleged anomaly thus acquires a Community dimension and the national authority cooperates loyally with the Commission when alerting the latter to its existence.

83.It follows that the national authority’s intervention may only be temporary, pending confirmation by the Commission that the allegedly inappropriate requirement in Regulation No 1223/2009 remains sound (in which case, the national authority must repeal its unjustified provisional measure) or, conversely, must be changed (in which case, the Commission confirms that the provisional measure was justified and the steps set out in Article 31 of the Regulation itself must be followed).

84.The rationale informing the cooperation between the national authority and the Commission that is inherent in Regulation No 1223/2009 explains why, if the provisional measures are justified, Article 27(4) refers to Article 31(1), on account of the link to the existence of ‘a potential risk to human health, arising from the use of substances in cosmetic products, which needs to be addressed on a Community-wide basis’.

85.If all of the foregoing is correct, what the national authority may bring to the Commission’s attention, so that the latter may make a final decision on the matter, is the risk to human health arising from the use of certain substances in cosmetic products. It is therefore more consistent with the purpose of Regulation No 1223/2009 for provisional measures authorised by Article 27(1) thereof to be capable of being extended not only to a single product identified by its trade mark and trade name but also to a number of products grouped together on the basis of the substance they contain. If those products pose risks to health, it is precisely because they contain that substance.

86.That interpretation, as I have already said, is consistent with the methodology of the process for reviewing the annexes which the Commission must set in motion, in accordance with Article 31 of Regulation No 1223/2009, if it considers the provisional measure to be justified.

87.Where that review process has been initiated following action by the national authority which is deemed justified and is aimed at avoiding risks arising from the ‘use of substances in cosmetic products’ (in the plural), it is reasonable that that authority should have been able to assess the risks associated with a category of products all of which contain the same substance that is allegedly harmful to human health.

88.Articles 27 and 31 of Regulation No 1223/2009 refer to the cosmetic product, which, as I have recalled, Article 2(1)(a) defines as a substance or mixture. There is, therefore, no reason not to characterise a category of products by the presence of a particular substance in them.

89.That approach, as I have said, seems to me to be more consistent with attainment of the objectives pursued by the regulation and with its schematic interpretation. The application of a provisional measure to a category of cosmetic products containing elements in common is conducive to the more effective achievement of an appropriate level of protection of human health. In the conflict between the various interests represented in the text of Regulation No 1223/2009, that intention takes precedence.

90.The foregoing proposition is borne out, in my opinion, by three further arguments:

—First, this approach avoids any discrimination that would follow from selecting certain commercial formats as being alone subject to the effects of the restrictive measure. The fact that the latter is based on the presence of a substance in the composition of a number of products also rules out the potential for distortion of competition on the market, because the criterion is objective and applies in the same way to all manufacturers and distributors. (41)

—Secondly, as the French Government submits, since cosmetic products (unlike medicines) are not subject to authorisation prior to being placed on the market, national authorities cannot identify every single one that contains a particular substance. It was stated at the hearing that neither the frame formulation provided for in Article 13 of Regulation No 1223/2009 nor the manufacturer’s file referred to in Article 11 thereof is an effective mechanism for ensuring that the national authority has detailed knowledge, at any given time, of what substances are contained in products made available on the market, and in what proportion.

—Finally, it is important that the interpretation of a provision of law should not lead to absurdity. From that point of view, moreover, the adoption of a safeguard measure for a group or category of products characterised by the presence of a substance common to all of them avoids the need to identify all of the individual products in that situation. Acceptance of the proposition put forward by the FEBEA and the Commission would make it necessary to refer to the Commission as many decisions as there are individual products affected (which may be in the hundreds), (42) containing the same substance but differentiated only by their trade mark or trade name. (43)

91.It is true that a safeguard measure adopted on the basis of the presence of a substance in a category of cosmetic products might affect the free movement of those products more significantly than a safeguard measure applied to a single specific product. The Commission’s concern to avoid a fragmentation of the internal market and to protect the full harmonisation of this sector is therefore legitimate.

92.However, my proposed interpretation of Article 27(3) of Regulation No 1223/2009 does not disregard the requirements of harmonisation, compliance with which is ensured both by the remedies provided for in Article 28 thereof and, in particular, by the Commission’s power to declare the national measure unjustified, if it is appropriate to do so.

93.Finally, the safeguard measures available to the national authorities are compatible with the possibility open to the Commission of availing itself of the third subparagraph of Article 31(1) of Regulation No 1223/2009 when it considers there to be ‘imperative grounds of urgency’ in connection with a substance authorised by the annexes to that regulation.

94.The possibility thus available to the Commission does not, as I have said, exclude initiatives on the part of the national authorities, which are able to identify and respond more quickly to any serious risk to human health represented by a medicine made available on the market in their territory. The added value of the mechanism provided for in Article 27 of the regulation, which supplements the mechanism under Article 31(1), lies in the very fact that it provides those authorities with effective (and immediately enforceable) provisional instruments, while safeguarding the unity of the internal market in cosmetic products, and leaves the final word to the Commission.

3. Information exchange system

95.The second subparagraph of Article 27(2) of Regulation No 1223/2009 provides that, ‘for the purposes of the first subparagraph, the information exchange system provided for in Article 12(1) of Directive [2001/95] (44) shall be used’.

96.The Commission observes that the exchange of information through that system (known as ‘RAPEX’) is confined to individual measures for a specific product and is not suited to general measures for one or more categories of products.

97.In support of that proposition, the Commission cites Implementing Decision (EU) 2019/417, (45) in particular paragraph 4.4 of Part I of the annex thereto, which states that ‘generally applicable acts adopted at national level and aimed at preventing or restricting the marketing and use of (a) generally described category(ies) of consumer products … should not be notified to the Commission through the RAPEX application’.

98.That same provision goes on to say, however, that ‘all such national measures that apply to only generally defined categories of products, such as all products in general or all products serving the same purpose – and not to (categories of) products specifically identified by their brand, specific look, producer, trader, model name or number, etc. – are notified to the Commission under Directive (EU) 2015/1535 … (46)’.

99.Now, when the ANSM issued the contested decision, which it communicated to the Commission via the RAPEX application, it did not introduce restrictions that were applicable to ‘only generally defined categories of products’ but rather to a precise typology of products specifically identified as containing phenoxyethanol.

100.In the light of the foregoing, I suggest that the first three questions referred for a preliminary ruling by the Conseil d’État (Council of State, France) be answered as follows:

(1)Article 27(3) of Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products must be interpreted as meaning that a letter from a Commission official that is sent to a national authority which has adopted a provisional measure under Article 27(1) of that regulation does not constitute a Commission ‘decision’ as provided for in Article 27(3) of Regulation No 1223/2009 if, among other factors, it does not expressly state whether the provisional measure in question is justified or not.

(2)For as long as the Commission has not adopted the decision provided for in Article 27(3) of Regulation No 1223/2009, the court before which an action is brought against the provisional measures adopted by the competent national authority under Article 27(1) may assess the compliance of those measures with the substantive and procedural provisions of both EU and national law.

(3)Article 27(1) of Regulation No 1223/2009 allows the competent national authority to adopt provisional measures applicable to a category of cosmetic products containing the same substance.

* * *

(1) Original language: Spanish.

(2) Regulation of the European Parliament and of the Council of 30 November 2009 on cosmetic products (OJ 2009 L 342, p. 59).

(3) The SCCS was established under Commission Decision 2008/721/EC of 5 August 2008 setting up an advisory structure of Scientific Committees and experts in the field of consumer safety, public health and the environment and repealing Decision 2004/210/EC (OJ 2008 L 241, p. 21).

(4) ‘Phenoxyethanol is a broad spectrum preservative which has excellent activity against a wide range of … bacteria, yeast and mould. It is also used as a solvent and, because of its properties as a solvent, it is used in many blends and mixtures with other preservatives’, according to Opinion SCCS/1575/16, which I cite in the following footnote.

(5) Opinion SCCS/1575/16 on phenoxyethanol of 6 October 2016, paragraph 3.2, at https://ec.europa.eu/health/scientific_committees/consumer_safety/docs/sccs_o_195.pdf.

(6) Since 26 November 2012, the ANSM has been recommending on its website that phenoxyethanol not be used in cosmetic products intended for use on the buttocks of children aged three years or less.

(7) The preamble to Annexes II to VI of Regulation No 1223/2009 states that, ‘for the purposes of Annexes II to VI: … “Leave-on product” means a cosmetic product which is intended to stay in prolonged contact with the skin, the hair or the mucous membranes’.

(8) That obligation was to be complied with no later than nine months from the date of publication of the measure on the ANSM website.

(9) This was the head of the ‘Consumer, Environmental and Health Technologies’ unit of the Directorate-General for Internal Market, Industry, Entrepreneurship and SMEs.

(10) See point 38 et seq. of this Opinion.

(11) Paragraphs 35 and 36 of its written observations, which cite the judgment of 25 October 2017, Commission v Council (WRC-15) (C‑687/15, EU:C:2017:803, paragraph 55): ‘such explicit reference [to a provision of the Treaties] is … indispensable where, in its absence, the parties concerned and the Court are left uncertain as to the specific legal basis’.

(12) Emphasis added. The ‘responsible person’ is determined in accordance with Article 4 of Regulation No 1223/2009.

(13) Judgment of 8 September 2011 (C‑58/10 to C‑68/10, EU:C:2011:553; ‘the judgment in Monsanto and Others’).

(14) Regulation of the European Parliament and of the Council of 22 September 2003 on genetically modified food and feed (OJ 2003 L 268, p. 1).

(15) Regulation of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety (OJ 2002 L 31, p. 1).

(16) Judgment in Monsanto and Others, paragraph 78.

(17) Ibid, paragraph 79.

(18) Ibid, operative part, paragraph 3.

(19) Ibid, paragraph 80.

(20) There is nothing to stop the national court, if it is in any doubt as to the interpretation of EU law, from approaching the Court of Justice in the course of the proceedings for review of the provisional measures in question, as the Court states in paragraph 79 of the judgment in Monsanto and Others. Indeed, that is what has happened in this case.

(21) At the hearing, the FEBEA reiterated that no serious risk is present in this case, as is demonstrated by the chronology of the decisions adopted by the French authorities. That will be a matter for the referring court to resolve.

(22) Competence in respect of the final decision is reserved to the Commission, as is the case in Regulation No 1829/2003, which provides for a dual mechanism for the adoption of precautionary measures (Article 34), but gives the Commission exclusive competence (Article 10) to modify or revoke authorisations.

(23) Paragraphs 36 and 37 of its written observations.

(24) Judgment of 3 September 2015, Colena (C‑321/14, EU:C:2015:540, paragraph 19), cited in the judgment of 17 December 2020, A.M. (Labelling of cosmetic products) (C‑667/19, EU:C:2020:1039, paragraph 24).

(25) The second criterion is less significant here, since the provisional measure adopted by the ANSM expressly relates to one body area (the buttocks) in children aged three years or less.

(26) Article 2(1)(b) defines ‘substance’ as ‘a chemical element and its compounds in the natural state or obtained by any manufacturing process’, subject to certain clarifications.

(27) Article 2(1)(c) defines ‘mixture’ as ‘a mixture or solution composed of two or more substances’. The language versions I have consulted (Spanish, French, English, German, Italian, Portuguese and Romanian) corroborate that partly tautological definition.

(28) Similarly, albeit in connection with the distributor, paragraphs 3 and 4, concerning certain cosmetics already placed on the market on 11 July 2013, also refer to such ‘specific identification’.

(29) Judgment of 17 December 2020, A.M. (Labelling of cosmetic products)

(C‑667/19, EU:C:2020:1039, paragraph 27), which refers to the judgment of 12 April 2018, <i>Fédération des entreprises de la beauté</i> (C‑13/17, EU:C:2018:246, paragraphs 23 to 25 and the case-law cited).

30Article 9 of Regulation No 1223/2009.

31The reference to human health and safety is repeated in the preamble to Regulation No 1223/2009.

32Those rules are of course constantly evolving, as evidenced by the frequent changes to the annexes to Regulation No 1223/2009. Under Article 31 of that regulation, the Commission may amend the annexes where (a) ‘there is a potential risk to human health, arising from the use of substances in cosmetic products, which needs to be addressed on a Community-wide basis’; (b) it is necessary to adapt those annexes ‘to technical and scientific progress’; and (c) ‘it appears necessary in order to ensure the safety of cosmetic products placed on the market’.

33Emphasis added.

34Article 22 provides for supervision ‘through the product information file’. That file is dealt with in Article 11, which details the required content that must be made available to the competent authority of the Member State in which it is kept.

35Article 25(5) of Regulation No 1223/2009 authorises the national authority to take ‘all appropriate measures to prohibit or restrict the making available on the market of the cosmetic product or to withdraw the product from the market or to recall it’ in two scenarios: (a) ‘where the responsible person does not take all appropriate measures within the time limit referred to in paragraph 1’; and (b) ‘where an immediate action is necessary in the event of serious risk to human health’.

36The list of these requirements (Article 25(1)(a) to (l) of Regulation No 1223/2009) is very detailed.

37Recital 58 of Regulation No 1223/2009: ‘In order to address cosmetic products which, despite complying with the provisions of this Regulation, might endanger human health, a safeguard procedure should be introduced’.

38Emphasis added.

39The French Government emphasises that Article 27 of Regulation No 1223/2009 refers to the term in the plural (‘product or products’), in place of the reference to the singular contained in Article 12(1) of Council Directive 76/768/EEC of 27 July 1976 on the approximation of the laws of the Member States relating to cosmetic products (OJ 1976 L 262, p. 169). In its reply to the Commission of 6 December 2019, the ANSM had already pointed out the change in the wording of the provision.

40Article 31(1) of Regulation No 1223/2009.

41In the same vein, the ANSM had told the Commission, in its letter of 6 December 2019 (paragraph 2.1.), that it would be ‘materially impracticable’ from an operational point of view to ‘notify as many provisional measures as there are products affected by the presence of the contested substance’.

42This was emphasised at the hearing: the Commission, when presented with the fact that, in a given Member State, the number of forms of cosmetic products for a single type of use present on the market may run into the hundreds, had no solution to offer other than that of issuing hundreds of simultaneous safeguard measures (an approach which is unnecessarily costly both for it and for the national authorities). The administration of hundreds of files for products containing the same substance when a single file would be sufficient to achieve the objective pursued is an example of an <i>ad absurdum</i> interpretation of a provision of law.

43Directive of the European Parliament and of the Council of 3 December 2001 on general product safety (OJ 2002 L 11, p. 4).

44Commission Implementing Decision of 8 November 2018 laying down guidelines for the management of the European Union Rapid Information System ‘RAPEX’ established under Article 12 of Directive 2001/95/EC on general product safety and its notification system (OJ 2019 L 73, p. 121).

45Directive of the European Parliament and of the Council of 9 September 2015 laying down a procedure for the provision of information in the field of technical regulations and of rules on Information Society services (OJ 2015 L 241, p. 1).