Opinion of the Advocate-General

1. By its action, the Commission of the European Communities seeks a declaration that, by laying down, for processing aids and foodstuffs whose preparation involved the use of processing aids from other Member States where they are lawfully manufactured and/or marketed, a prior authorisation scheme not complying with the principle of proportionality, the French Republic has failed to fulfil its obligations under Article 28 EC.

I – Legal framework

A – Community law

B – French legislation concerning processing aids

4. The legal regime on processing aids was established by the Decree of 15 April 1912 laying down administrative regulations for implementing the Law of 1 August 1905 to prevent deception in the sale of goods and adulteration of foodstuffs, as amended by Decree No 73‑138 of 12 February 1973, and Decree No 99-242 of 26 March 1999 (‘the 1912 Decree’).

5. The 1912 Decree is based on the system of prior authorisation. That means that the marketing of goods and foodstuffs intended for human consumption is prohibited where chemical products (5) are added to them or where chemical products are used in their preparation. That prohibition does not apply to chemical products whose use has been declared lawful by the orders taken pursuant to the 1912 Decree.

6. A series of orders was adopted pursuant to the 1912 Decree. In general, those orders establish the authorised substance and the use and the foodstuff for which it is authorised. They lay down criteria on purity and other characteristics with which the processing aids must comply, and set, in addition to conditions for the use of the processing aid concerned in the manufacturing process, the maximum residual content of the processing aids used in the final foodstuff. Only four of those orders contain a mutual recognition clause.

7. The 1912 Decree was repealed by Decree No 2001-725 of 31 July 2001 on processing aids which may be used in the manufacture of foodstuffs intended for human consumption (‘the 2001 Decree’). However, that decree did not enter into force until 2 December 2006.

‘any substance not consumed as a food ingredient by itself, intentionally used in the processing of raw materials, foodstuffs or their ingredients, to fulfil a given technological purpose during treatment or processing and which may result in the unintentional but technically unavoidable presence of residues of the substance or its derivatives in the final product, provided that those residues do not present any health risk and do not have any technological effect on the finished product’.

10. Article 3 of the 2001 Decree concerns the possibility of amending the order provided for in Article 2 thereof. It is worded as follows:

‘Applications to amend or add to the provisions of the order referred to in Article 2 can be made by any natural or legal person. They are to be addressed to the Directorate General for Competition Policy, Consumer Affairs and Fraud Control ( Direction générale de la concurrence, de la consommation et de la répression des fraudes ), together with the file necessary for their investigation, with a view to their transmission to the French Food Safety Agency (Agence française de sécurité sanitaire des aliments; “AFFSA”).

An order of the Ministers for Consumer Affairs, Agriculture, Health, and Industry shall determine the rules concerning the preparation and content of files.

When the file is complete, the Directorate General for Competition Policy, Consumer Affairs and Fraud Control shall acknowledge receipt thereof and ensure its transmission to AFFSA. The Agency has a period of four months from receipt of the application to issue an opinion.

The Directorate General for Competition Policy, Consumer Affairs and Fraud Control shall notify the applicant of the opinion of AFFSA and the reasoned decision of the Minister based on that opinion. Such notification shall be made within one month following the adoption of the opinion.’

11. Article 6 of the 2001 Decree provides that it is prohibited to hold, exhibit for sale, offer for sale, sell, or distribute free of charge processing aids which do not meet the provisions of Article 2 of the 2001 Decree and foodstuffs intended for human consumption in the preparation of which processing aids have been used which do not meet the provisions of Article 2 of the 2001 Decree.

12. However, Article 6 of the 2001 Decree sets out a mutual recognition clause which is worded as follows:

‘However, those provisions shall not hinder the principle of the free movement:

(a) of the foodstuffs referred to in paragraph (1) of this article from other Member States of the European Community, or other contracting parties to the agreement on the European Economic Area, where those States have put in place a method for evaluating the risks presented by the use of processing aids, ensuring an equivalent level of safety to that guaranteed by this decree;

(b) of processing aids from other Member States of the European Community, or other contracting parties to the agreement on the European Economic Area, with purity criteria different from those set by the order referred to in Article 2, where those criteria have been fixed by one of those States, or have been subject to a favourable opinion of a competent body in one of those States, officially published.’

13. Pursuant to Article 7 thereof, the 2001 Decree entered into force only on the date on which the order referred to in Article 2 thereof was published. Since that order, namely the order relating to the use of processing aids in the manufacture of certain foodstuffs (‘the 2006 order’), was adopted on 19 October 2006 and published in the Journal officiel de la République française (Official Journal of the French Republic) on 2 December 2006, the 2001 Decree entered into force on 2 December 2006.

II – Pre-litigation procedure and forms of order sought

14. Considering that the French Republic had failed to fulfil its obligations under Article 28 EC by imposing a prior authorisation scheme on processing aids and foodstuffs, where their manufacturing process used processing aids, from other Member States where they were legally manufactured and/or marketed, and, in the alternative, by failing to establish, for the purpose of obtaining authorisations for the use of processing aids, a procedure which was sufficiently clear, easily accessible and transparent, and met the requirements of legal certainty, the Commission sent a letter of formal notice to the French Republic (6) on 18 October 2005 in accordance with Article 226 EC.

15. Not being satisfied with the observations set out by the French Republic in its reply of 16 February 2006, (7) the Commission sent it a reasoned opinion dated 4 July 2006, in which it called on the French authorities to take the necessary measures within a period of two months.

16. Despite the arguments set out by the French authorities in their reply to the reasoned opinion on 8 September 2006, the Commission brought the present action in which it seeks a declaration that, by imposing, in respect of processing aids, and in respect of foodstuffs in the preparation of which processing aids from other Member States where they are lawfully manufactured and/or marketed have been used, a prior authorisation scheme which does not comply with the principle of proportionality, the French Republic has failed to comply with its obligations under Article 28 EC, and an order for costs against the French Republic.

17. On the basis of the arguments set out in its defence and its rejoinder, the French Republic contends that the Court should dismiss the action and order the Commission to pay the costs.

III – Analysis

A – Prior authorisation as a measure having equivalent effect to quantitative restrictions

18. In the present case, it is not disputed that the prior authorisation scheme for processing aids, laid down in both the 1912 Decree and the 2001 Decree, constitutes, in itself, a measure having equivalent effect to quantitative restrictions.

19. The Court has already had the opportunity to consider the prior authorisation scheme established by the 1912 Decree with regard to vitamins and minerals. In the judgment in Commission v France , (8) the Court held that legislation making the marketing of foodstuffs fortified with vitamins and minerals subject to the prior entering of those nutritive substances on a ‘positive list’ rendered the marketing of those foodstuffs more difficult and more expensive, and therefore constituted a measure having equivalent effect to quantitative restrictions within the meaning of Article 30 of the Treaty.

21. That case-law seems to be transposable to this case. Both the 1912 Decree and the 2001 Decree are based on the system of prior authorisation of processing aids which, by requiring that the marketing of processing aids and foodstuff in the preparation of which processing aids have been used be subject to the prior registration of the processing aids on an ‘authorised list’, makes the marketing of processing aids and foodstuffs in the preparation of which processing aids have been used from other Member States where they are lawfully produced and/or marketed, more difficult and more expensive, and therefore hinders trade between the Member States.

22. I am of the opinion that that would not apply were the prior authorisation system to contain a mutual recognition clause eliminating the negative effects of that system, as regards the putting on the market of processing aids and foodstuffs in the preparation of which processing aids from other Member States in which they are lawfully produced and/or marketed have been used. However, that is not the case here.

23. So far as the 1912 Decree is concerned, there was a mutual recognition clause only in four of the orders taken pursuant to that decree. The 2001 Decree, admittedly, does contain a mutual recognition clause. However, as its wording shows, that clause merely safeguards the free movement of processing aids and foodstuffs in the preparation of which processing aids coming only from States which guarantee a level of security equivalent to that guaranteed by the French legislation have been used.

B – Justification for the prior authorisation scheme

24. Even if the system of prior authorisation is a measure having equivalent effect, it is settled case-law that a national rule which hinders the free movement of goods is not necessarily contrary to Community law if it may be justified by one of the public-interest grounds set out in Article 30 EC or by one of the overriding requirements.(10)

25. Since the system of prior authorisation for use of processing aids is justified, according to the French Government, by the requirement of the protection of public health, which is expressly set out in Article 30 EC, it is necessary to examine whether the conditions which allow a derogation from the general rule in Article 28 EC are met.

26. In this connection, the Commission submits that the general system of prior authorisation for use of processing aids cannot be justified by the objective of the protection of public health, since it is disproportionate in the light of the potential risks which processing aids may pose for human health. On principle, it does not exclude certain categories of processing aids from being subject to prior authorisation, provided however that the use of such a system is targeted and specifically justified on a scientific basis in respect of each category of processing aid concerned.

27. In its defence, the French Government contends that processing aids may pose potential risks for public health, linked to the presence of residues of the processing aids themselves and/or neoformed products in the finished products. In support of its contention, it refers, first, to a note from the French Food Safety Agency (‘AFSSA’) of 13 August 2004 in which that agency summarised its report of eight years of assessment of applications for authorisation for the use of processing aids used in the agro-alimentary industry and, secondly, to AFSSA’s study on the impact of the manufacturing processes of foodstuffs in the formation of neoformed products of April 2007.

29. In this connection, the Commission does not dispute that the system of prior authorisation is appropriate for safeguarding public health. The question at issue is whether such a safeguard to health is necessary or, in other words, whether processing aids as a whole pose such a risk to public health that it is necessary to ensure its protection by means of a prior authorisation scheme.

31. It must also be noted that the Commission’s application does not concern decisions taken under the prior authorisation system whose purpose is to prohibit the marketing of a specific product. On the contrary, it concerns only the prior authorisation system itself.

32. In accordance with the Court’s case-law, it is for the Member States, in the absence of harmonisation and to the extent that uncertainties continue to exist in the current state of scientific research, to decide on the level of protection of human health and life they wish to ensure and on whether to require prior authorisation for the marketing of foodstuffs, always taking into account the requirements of the free movement of goods within the Community. (12)

34. It may appear that there is a conflict between the principles derived from the case-law set out above. Whereas, on the one hand, for the purposes of the examination of an authorisation prior to placing foodstuffs on the market, it is sufficient to show the uncertainties which continue to exist in the current state of scientific research, it is necessary, on the other hand, to show in each individual case, having regard to the results of international scientific research, that the marketing of the goods at issue poses a real risk for public health.

35. In that context it is necessary to distinguish between the system of prior authorisation and the specific decisions prohibiting the marketing of goods adopted pursuant to that system. In my opinion, in the case of a prior authorisation system, it is sufficient to demonstrate the uncertainties which continue to exist in the current state of scientific research, whereas, in the case of the specific decisions prohibiting the marketing of goods, it is necessary to demonstrate in each individual case, taking into account the results of international scientific research, that the marketing of the goods at issue poses a real risk for public health.

36.Consequently, I consider the French Government to have satisfied the burden of proof required. An AFSSA note of 13 August 2008 and the AFSSA study of April 2007 constitute sufficient evidence. They demonstrate that, as the current state of scientific research now stands, it is not certain that processing aids are harmless to public health.

37.As regards the Commission’s argument that only certain categories of processing aids may be subject to prior authorisation, on condition that the use of such a system is targeted and specifically justified on a scientific basis in respect of each category of processing aids concerned, I concur with the French Government’s argument that, having regard to the continuous development in manufacturing processes, it is difficult to predict what substances may be used as processing aids and to identify in advance the categories of processing aids which are harmless.

38.In conclusion, I consider that the system for the prior authorisation of processing aids is justified on the grounds of the protection of public health.

C – Procedure for amending the authorised list of processing aids

39.The Commission criticises the prior authorisation scheme for the use of processing aids for not meeting the requirements set by the Court’s case-law on that issue, which provide that a procedure allowing economic operators to obtain registration of processing aids on the national list of authorised processing aids must be easily accessible, able to be completed within a reasonable time and, if it culminates in a refusal, there must be a judicial remedy available.

40.In this connection, it is the Court’s settled-case law that legislation that requires the marketing of certain goods to be subject to their prior registration on an ‘authorised list’ complies with Community law only if a number of conditions are met. (14) One of those conditions is that such legislation must provide for a procedure enabling economic operators to have goods included in the national list of authorised goods. The procedure must be readily accessible, which presupposes that it is expressly provided for in a measure of general application, must be capable of being completed within a reasonable time, and, if it leads to a refusal of registration, reasons for which must be given, that refusal must be open to challenge before the courts. (15)

41.I am of the opinion that the conditions above are criteria which allow the proportionality of the national legislation concerned to be evaluated.

42.As I have already observed in point 19 of this Opinion, the Court has already had the opportunity to examine the system of prior authorisation established by the 1912 Decree. In the judgment in Case C-24/00 Commission v France , (16) the Court held that, as regards the 1912 Decree, the procedure allowing economic operators to obtain registration of goods on the national list of authorised goods did not meet the conditions set out in point 35 of this Opinion.

43.So far as the system of prior authorisation established by the 2001 Decree is concerned, the Commission stresses that, even if it provides for a procedure allowing the list of authorised processing aids to be amended or supplemented, the procedure at issue does not meet the requirements set by the Court’s case-law on that subject for several reasons.

44.First, the Commission states that the applications for registration of new substances on the list of authorised processing aids are treated in the same manner, without taking into account whether the substance is a national substance which is not yet authorised or a substance lawfully manufactured and/or marketed as a processing aid in another Member State. That information was not challenged by the French Government. However, it submitted that the fact that a substance was marketed in another Member State cannot dispense it from an examination by AFSSA and the competent French authorities.

45.I do not think that the preferential treatment of new substances lawfully manufactured and/or marketed as processing aids in another Member State under the authorisation procedure is one of the conditions to be observed in order to ensure that legislation under which the marketing of certain goods is subject to prior authorisation complies with Community law. If the opposite were true, that would run counter to the sense of the prior authorisation system itself.

46.Secondly, (17) the Commission draws attention to the fact that, contrary to the requirement that the authorisation procedure be accessible, the ministerial order specifying the contents of the files of the requests for registration has not yet been adopted. The French Government contends in reply that, on 2 July 2003, AFSSA published on its internet site a document entitled ‘ Lignes directrices pour la constitution d’un dossier relatif à l’emploi d’un auxiliaire technologique en alimentation humaine ’ (Guidelines for the contents of a file relating to the use of a processing aid in human food), which constitute a guide for the purposes of submitting authorisation request files.

47.I fully agree with the analysis that the possibility of having access to information on the content of authorisation request files has an effect on the accessibility of the authorisation procedure. Furthermore, the time-limits laid down by the 2001 Decree for the purposes of ruling on an application to register a substance on the list of authorised processing aids start to run from the day on which the application file is complete.

48.Without it being necessary to analyse the content of the ‘Guidelines for the contents of a file relating to the use of a processing aid in human food’, I agree with the Commission that that document cannot, in any event, replace the Ministerial Order provided for in Article 3 of the 2001 Decree to fix the rules relating to the composition of application files.

49.The person requesting the registration of a substance on the list of authorised processing aids does not have a relationship with AFSSA, which is the author of the ‘Guidelines for the contents of a file relating to the use of a processing aid in human food’. According to Article 3 of the 2001 Decree, the applicant submits his application to the General Directorate for Competition Policy, Consumer Affairs and Fraud Control which rules definitively on that application. From the applicant’s point of view, AFSSA is merely an advisory body. For that reason, AFSSA’s document does not and cannot be of binding effect on persons requesting the registration of a substance on the list of authorised processing aids.

50.Thirdly, the Commission takes the view that the duration of the procedure, which is approximately five months minimum, should be significantly reduced with regard to substances from other Member States where they are already authorised as processing aids. In any event, the duration of the examination of the file by the administration is unjustified. According to the French Government, a procedure which lasts approximately five months, four of which are reserved for AFSSA’s assessment, does not appear to be excessive.

51.In my view, the requirement to reduce the duration of the authorisation procedure in the case of new substances lawfully manufactured and/or marketed as processing aids in another Member State is, like the requirement to give preferential treatment to such substances, unfounded.

52.It is however necessary to examine whether the duration of the authorisation procedure can be regarded as a ‘reasonable time’ within the meaning of the Court’s case-law. (18)

53.Pursuant to Article 3 of the 2001 Decree, the authorisation procedure may at best be completed within a period of five months. However, the wording of that article and above all the method for calculating the period do not preclude that period from being exceeded.

54.Moreover, the period starts to run from the day on which the file of the authorisation application is complete. Having regard to the uncertainty relating to the contents of that file, the moment from which the time-limit starts to run seems to be uncertain.

55.Fourthly, the Commission points out that the legal remedies in the event of a refusal of registration are not provided for in the 2001 Decree. That is not disputed by the French Government. However, it contends that the refusal of registration can be subject to an appeal even if the legal remedies against such a decision are not stated in the 2001 Decree. Furthermore, in French law there is a general obligation to provide information to individuals as regards the available legal remedies, and the conditions of their use.

56.On that issue, I agree with the French Government’s argument that the requirement that a legal remedy must be available against the decision refusing registration does not mean that the legal remedies against such a decision should have been provided for in the 2001 Decree. The French Government has established that there are general rules, namely the Code of Administrative Justice, which ensure that in general it is possible to appeal against any administrative decision.

57.In conclusion, I therefore hold that, by failing to provide an easily accessible procedure allowing economic operators to obtain the registration of processing aids on the national authorised list of goods which may be completed within a reasonable time, the 2001 Decree, which requires that the marketing of processing aids be subject to prior authorisation, does not comply with Community law.

58.In the light of the fact that neither the 1912 Decree nor the 2001 Decree are, in my opinion, accompanied by a procedure which complies with the principle of proportionality, it is not important to establish which decree was applicable at the relevant date, namely on completion of the period prescribed in the reasoned opinion. However, I take the view that a notice addressed by the French authorities to undertakings in the food sector, published in the Journal officiel de la République française on 19 January 2002, stating that, from the time of its publication, there was no barrier to the application of the provisions of the 2001 Decree relating to the lodging of files and the principle of free movement, is not binding on third parties. Were that not the case, the principle of legal certainty which forms part of the principle of the rule of law would be infringed.

D – System of prior authorisation and mutual recognition clause

59.This action has raised the issue of whether Community law requires the inclusion in national legislation of mutual recognition clauses.

60.In Commission v Italy , (19) the Court reiterated that Article 28 EC reflects the obligation to respect the principles of non‑discrimination and of mutual recognition of products lawfully manufactured and marketed in other Member States, as well as the principle of ensuring free access of Community products to national markets. It follows that a mutual recognition clause is one of the means of satisfying the obligation under Article 28 EC.

61.However, Article 30 EC authorises certain derogations to the obligation under Article 28 EC. That means that the national legislation which constitutes a measure having equivalent effect need not contain a mutual recognition clause if that barrier may be justified on one of the grounds of public interest listed in Article 30 EC. If the legislation concerned contains a mutual recognition clause, it does not constitute a measure having equivalent effect.

62.Some uncertainties may be raised by the comparison of the judgment in Case C-184/96 Commission v France (20) with the judgment in Case C-24/00 Commission v France . (21) In both cases, the Commission alleged that the French Republic had failed to insert a mutual recognition clause in its legislation, so hindering the free movement of goods. Whereas, in the first case, the Court found there was a failure to fulfil obligations, in the second case it dismissed that allegation of failure to fulfil obligations. However, those cases may be distinguished by the fact that whilst, in the second case, the French Republic proved that its legislation hindering the free movement of goods was justified by the protection of public health, in the first case, no consideration relating to the protection of public health was put forward.

IV – Costs

63.Under the first subparagraph of Article 69(2) of the Rules of Procedure, the unsuccessful party is to be ordered to pay the costs if they have been applied for in the successful party’s pleadings. Since the Commission has applied for a costs order against the French Republic and the latter has been unsuccessful, I am of the opinion that the French Republic must be ordered to pay the costs.

V – Conclusion

64.Having regard to the foregoing, I propose that the Court should:

– Declare that, by laying down, for processing aids and foodstuffs whose preparation involved the use of processing aids from other Member States where they are lawfully manufactured and/or marketed, a prior authorisation scheme which is not accompanied by a procedure allowing economic operators to obtain the registration of processing aids from other Member States, where they are lawfully manufactured and/or marketed, on the national positive list of authorised processing aids, complying with the principle of proportionality, the French Republic has failed to fulfil its obligations under Article 28 EC;

– Order the French Republic to pay the costs.

(1) .

(2) – For example, extraction solvents which are harmonised by Council Directive 88/344/EEC of 13 June 1988 on the approximation of the laws of the Member States on extraction solvents used in the production of foodstuffs and food ingredients (OJ 1988 L 157, p. 28).

(3) – For example, wines which are covered by Council Regulation (EC) No 1493/1999 of 17 May 1999 on the common organisation of the market in wine (OJ 1999 L 179, p. 1).

(4) OJ 2002 L 31, p. 1.

(5) The terms ‘chemical products’ used in the 1912 Decree cover the terms ‘processing aids’ which were not known in 1912.

(6) This was a supplementary letter of formal notice which annulled and replaced the letter of formal notice of 3 July 1996 and the reasoned opinion of 27 March 1998.

(7) In accordance with the request by the French authorities, the Commission agreed to extend the period prescribed for replying to the letter of formal notice.

(8) – Case C-24/00 [2004] ECR I-1277, paragraph 23.

(9) – Case C-219/07 [2008] ECR I-4475, paragraph 23.

(10) – See Case 120/78 Rewe-Zentral [1979] ECR I-649, paragraph 8; Case C-420/01 Commission v Italy [2003] ECR I-6445, paragraph 29; Case C-270/02 Commission v Italy [2004] I-1559, paragraph 21; and Case C-366/04 Schwarz [2005] ECR I-10139, paragraph 30.

(11) – Cited in footnote 8, paragraphs 49 to 75.

(12) – See Case C-88/07 Commission v Spain [2009] ECR I-0000, paragraph 86 and the case-law cited.

(13) – See judgment in Commission v Spain (cited in footnote 12, paragraph 89 and the case-law cited).

(14) – See Case C-344/90 Commission v France [1992] ECR I-4719, paragraphs 8 to 10 and the case-law cited; Commission v France (cited in footnote 8, paragraph 25); and Nationale Raad van Dierenkwekers en Liefhebbers and Andibel (cited in footnote 9, paragraphs 33 to 36).

(15) – See Nationale Raad van Dierenkwekers en Liefhebbers and Andibel (cited in footnote 9, paragraph 35 and the case-law cited).

(16) – Cited in footnote 8, paragraphs 36 to 42.

(17) – For clarity, I have changed the order of the Commission’s arguments.

(18) – See the case-law cited in footnote 15.

(19) – Case C-110/05 [2009] ECR I-0000, paragraph 34 and the case-law cited.

(20) – Case C-184/96 [1998] ECR I-6197.

(21) – Cited in footnote 8.