C-230/99

1 — Original language: German. 2 — OJ 1983 L 109, p. 8.

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appropriate, Member States shall simulta- Article 9 neously communicate the text of the basic legislative or regulatory provisions princi- pally and directly concerned, should knowledge of such text be necessary to 1. Without prejudice to paragraphs 2 and assess the implications of the draft techni- 2(a), Member States shall postpone the cal regulation. adoption of a draft technical regulation for six months from the date of the notification referred to in Article 8(1) if the Commis- sion or another Member State delivers a detailed opinion, within three months of that date, to the effect that the measure envisaged must be amended in order to The Commission shall immediately notify eliminate or reduce any barriers which it the other Member States of any draft it has might create to the free movement of received; it may also refer this draft to the goods. The Member State concerned shall Committee referred to in Article 5 and, if report to the Commission on the action it appropriate, to the Committee responsible proposes to take on such detailed opinions. for the field in question for its opinion. The Commission shall comment on this reaction.

2. The Commission and the Member States 2. The period in paragraph 1 shall be 12 may make comments to the Member State months if, within three months following which has forwarded a draft technical the notification referred to in Article 8(1), regulation; that Member State shall take the Commission gives notice of its intention such comments into account as far as of proposing or adopting a Directive on the possible in the subsequent preparation of subject. the technical regulation.

Article 2 — "Polymers" shall mean

3. Paragraphs 1, 2 and 2(a) shall not apply in those cases where, for urgent reasons relating to the protection of public health — dry natural latex and rubber; or safety, the protection of health and life of animals or plants, a Member State is obliged to prepare technical regulations in a very short space of time in order to enact and introduce them immediately without any consultations being possible. The •— dry synthetic latex and rubber, consist- Member State shall give, in the commu- ing of organic homopolymers or copo- nication referred to in Article 8, the reasons lymers. An indicative list of these which warrant the urgency of the measures polymers and of the abbreviations that taken. The Commission shall take appro- can be used in referring to them is priate action in cases where improper use is contained in Table A of Annex I. made of this procedure.'

The synthetic polymers used in manufac- turing the materials and articles listed in Article 1 must be produced only from monomers, base materials and modifying 4. Articles 1, 2, 4, 5 and 7 of the French agents listed in Table B of Annex I. For order of 9 November 1994 concerning some of these monomers and base materi- rubber materials and rubber articles enter- als, a maximum permitted residue ("Qm"

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expressed in milligrams per kilogram of the ing Parties to the Agreement on the Eur- material or article) and/or a specific migra- opean Economic Area. tion limit ("SML", expressed in milligrams per kilogram of foodstuffs or foodstuff simulants shall be set). Adherence to these two types of limit is to be verified in the ready-to-use material or article.

(b) fillable articles where it is not possible specific provisions contained in Article 8 of to assess the surface area coming into this Order. contact with foodstuffs, food products and beverages;

Primary and secondary aromatic amines: SML 1 mg/kg; (c) lids, seals, stoppers or other similar sealing devices.

Formaldehyde: SML s 3 mg/kg. Specific limits:

Peroxides: Finished, ready-to-use materials N-nitrosamines and N-nitrosable sub- and articles must not give a positive stances; reaction to peroxides, according to the method defined in the 10th Edition of the French Pharmacopoeia.'

N-nitrosamines: SML 1 µg/dm2

III — Facts and proceedings

be examined for compliance with Commu- ing of Article 226 EC, and that the nity law. On the basis of Article 9 of response of the French Government would Directive 83/189, the Commission deliv- be regarded as observations within the ered a detailed opinion on 20 February meaning of Article 226 EC. 1994 regarding the draft order. In its introduction, reference was made to the procedure under Directive 83/189 and it expressly gave as its legal basis Article 9(1) and Article 8(2) of Directive 83/189. The Commission alleged that the draft order did 6. By letter of 9 August 1994, the French not include clauses ensuring the application Government replied that the Commission of the principle of mutual recognition. In had itself recognised the need to harmonise order to make the draft conform to Com- the rules on materials coming into contact munity law, it required that specific provi- with foodstuffs. Community legislation in sions be inserted to ensure the recognition this area which had already been adopted of technical regulations, standards and or which was under discussion was not production procedures applied lawfully in characterised by mutual recognition, but by other Member States or in a State party to total harmonisation. Furthermore, the the EEA Agreement. Furthermore, it stated French Government claimed that the draft that provision should be made for specific order submitted did contain a mutual recognition of the results of checks and recognition clause: its wording was identi- tests, as well as in this respect certificates of cal to that used in the order on silicon inspectorates and supervisory authorities of elastomers which the Commission had other Member States or contracting states accepted at the time. This letter did not of the EEA Agreement, or certificates address the legal qualification of the issued by laboratories officially recognised detailed opinion as a letter of formal notice in those countries, offering suitable, ade- or the question of any answer by the French quate guarantees, from the technical and Government being treated as observations specialist point of view and from the point within the meaning of Article 226 EC. of view of their independence. Expressly referring again to Article 9(1) of Directive 83/189, the Commission also pointed out that France was obliged, following delivery of the detailed opinion, to wait six months before adopting the order. A deadline of 7. On 9 November 1994, the French order 19 May 1994 was set. Furthermore, France was adopted without the express recogni- was reminded of its duty to inform the tion clauses requested by the Commission. Commission how it intended to take On 5 January 1995, the French Govern- account of the detailed opinion. The Com- ment communicated the adopted text to the mission concluded the opinion by stating Commission. that, if its objections were not taken into account, the opinion was to be regarded as a letter of formal notice, within the mean-

French authorities without agreement being referred in particular to Article 5 of the reached between the parties. order, which it said contained a recognition clause in relation to the purity criteria governed by Annex II of the order. The mutual recognition of checks and tests, as well as of certificates issued in relation to them, was guaranteed by the reference, in Annex III of the order, to the order of 9. On 3 December 1997, the Commission 14 September 1992. Finally, as to the sent to the French Republic a reasoned mutual recognition of technical regulations, opinion pursuant to Article 226 EC. In this, standards, etc., the French Government it alleged, as in its letter of 20 February proposed to include in the order a new 1994, that Articles 2, 4, 5 and 7 of the Article 4a, incorporating a clause used in French order were incompatible with Com- another order and accepted by the Com- munity law, in particular with the principle mission. The inclusion of a provision of free movement of goods (Article 28 EC). concerning the mutual recognition of stan- The order only permitted the use of the dards and production procedures was, products listed in the specified provisions. however, considered by the French Govern- There was no clause ensuring the mutual ment to be neither justified nor opportune. recognition of goods lawfully marketed in It concluded its letter by expressing a desire other Member States or in States parties to for early harmonisation of the relevant the EEA Agreement and of the checks and regulations and by pointing out that the tests carried out in those other Member Member States were entitled, under Arti- States or countries. Furthermore, the Com- cles 7(2) and 11 of Council Directive mission considered that the prior approval 89/109/EEC of 21 December 1988 on the procedures were a disproportionate restric- approximation of the laws of the Member tion of the free movement of goods, in States relating to materials and articles particular since the time of the entry into intended to come into contact with food- force of Council Directive 89/397/EEC of stuffs, to continue to apply their national 14 June 1989 on the official control of provisions. 5 The letter also did not com- foodstuffs 3and Council Directive 93/43/ ment on the legal qualification of the EEC of 14 June 1993 on the hygiene of various documents exchanged. foodstuffs. 4Referring to Article 226 EC, it set France a deadline of two months to align its legislation with Community law.

12. By document of 8 June 1999, received cle 28 EC. In the absence of Community on 15 June, the Commission brought an law harmonisation in the field of elastomer action against the French Republic. and rubber products which may come into contact with foodstuffs, the Member States do have competence to adopt provisions concerning the production and marketing of those articles. However, the national provisions must adhere to Community law. The order in question infringes Community law in that it prohibits the marketing in IV — Arguments of the parties France of rubber products lawfully pro- duced in other Member States if they do not satisfy the provisions of the order. The requirement of prior approval provided for 13. The Commission takes the view that its in the order is compatible with the principle action is admissible. It states that the pre- of free movement of goods only if provision litigation procedure had been properly is made for a simple, fast procedure carried out before the action was brought. enabling market operators to have Annex- Article 226 EC merely provides that the es I and II of the order amended. For this Member State should be first of all afforded reason, a mutual recognition clause is the opportunity to submit observations needed. A simple administrative practice regarding the alleged infringement of its under which recognition could be granted obligations under the Treaty, and that, at a in individual cases, as proposed by the second stage, it may comply with the terms French Government, does not meet these of the reasoned opinion. Article 226 EC requirements. does not determine the form in which the Commission is to formulate its letters. The provision does not therefore preclude a detailed opinion from serving as a letter of formal notice. All that matters is that the Member State should be informed of the subject-matter of the infringement proceed- ings with sufficient precision to enable it to defend itself against the charge. There is no uncertainty for the French Republic. The Commission clearly expressed its view of the directive, and it was solely up to the French Government to decide whether or not the condition under which the detailed opinion would become a letter of formal 15. Whilst Article 5 of the order contains a notice would come about. certain flexibility as to the purity criteria for the materials named in Annex II, the list of monomers, base materials and modify- ing agents (agents modificateurs) contained in Table B of Annex I of the order is, however, presented in the order as exhaus- 14. Substantively, the Commission alleges tive, and the list of additives contained in an infringement of the principle of the free Annex II is also set out as an exhaustive movement of goods guaranteed by Arti- list.

21. On the substance, the French Govern- ment submits that Directive 89/109 makes provision for the harmonisation of rules relating to materials coming into contact 18. The French Republic takes the view with foodstuffs. On the basis of this frame- that the action is inadmissible. So far as the work directive, a directive on rubber should Commission merges the procedure for the have been adopted, amongst other things. provision of information under Directive Since, however, this has not yet occurred, 83/189 with the procedure under Arti- the French Government was prompted to cle 226 EC for establishing infringement issue regulations on this matter itself, for of a Member State's obligations, it infringes reasons of health protection. It was also in the hierarchy of legal rules. The Commis- order to accelerate harmonisation in this

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26. That decision must be approved. Under 1. Admissibility of the action Article 226 EC, the Treaty infringement procedure is divided into three stages. First of all, the Member State must be given an

24. The first question to be considered is whether the action of the Commission is 6 — See paragraphs 18 to 20 of the order.

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opportunity to submit its observations; this restore observance of the Community legal is done by a letter of formal notice; the order. Commission then draws up a reasoned opinion and only then may an action be brought.

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30. However, as far as the second function 32. The situation is also unclear if a long of the letter of formal notice is concerned, period of time elapses between the detailed that of the subject-matter of the dispute, opinion and the adoption of the national the Commission's course of action gives rise legal text. During that time, Community to legal reservations. Whilst it has been law, or indeed national law, could change, consistently held that no excessive require- so that the draft might then be judged ments should be made of letters of formal differently by the Commission. In such notice, they must contain a first, brief cases, too, it may not be sufficiently certain summary of the Commission's allegations. 8 whether or not an infringement of obliga- The reasoned opinion to be submitted at a tions under the Treaty has taken place. second stage on the basis of the facts set out in the letter of formal notice must clearly define the subject-matter of potential future infringement proceedings. It must contain a detailed, coherent description of the rea- sons forming the basis of the Commission's conviction that the Member State in ques- 33. The amalgamation by the Commission tion has violated an obligation incumbent of the procedure for the provision of upon it under the Treaty.9 information with the Treaty infringement procedure may therefore lead to uncer- tainty in relation to the assessment of the legal situation by the Commission and thus to uncertainty as to the subject-matter of any legal proceedings.

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35. The solution proposed here should not 38. It must therefore be found that the be treated as pure formalism if, in addition Commission did not conduct the pre-litiga- to the detailed opinion, the sending of a tion procedure in accordance with Arti- letter of formal notice having broadly the cle 226 EC, so that its action must be same content as the detailed opinion were dismissed as inadmissible. required. It is necessary to distinguish between these two documents, for the reasons of legal certainty mentioned above, and for the following substantive reason: when the information procedure is being conducted, there is still no Treaty infringe- ment: there is only a potential infringe- ment. When the letter of formal notice is 2. In the alternative: the merits of the sent, on the other hand, a Treaty infringe- Commission 's application ment has already taken place, always assuming the Commission's analysis to be correct. 39. Only in the alternative, in the event of the Court not accepting the argument set forth above but considering the action to be admissible, are its merits now considered.

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procedures for goods that are to be mar- 43. The effect of the order in question is keted on their territory. 10 The authorities that each rubber product that may come of the Member States are, however, obliged into contact with foodstuffs, irrespective of to contribute towards alleviating checks in whether or not it has already been subject intra-Community trade and to take into to inspection in another Member State, consideration any technical or chemical must be subjected to an approval proce- analyses as well as laboratory tests already dure. If it emerges that the product contains carried out in another Member State. 11 a basic material within the meaning of The checks carried out by the Member Article 2 that is not listed in Annex I, States must not go beyond what is neces- approval must be refused under Article 1 sary. It is for the Member State concerned of the order. Only for additives within the to provide evidence that the measures meaning of Article 4 does the order also selected are necessary to protect human provide in Article 5 for the recognition of health. 12 other substances if they have already been tested in other Member States.

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45. France's willingness to take into con- tion of the free movement of goods. It sideration the results of tests in individual would therefore be in breach of Article 28 cases cannot shake that conclusion. Firstly, EC. the wording of the order provides no guarantee that the French authorities will carry out an examination in an individual case. Operators cannot therefore see imme- diately whether authorisation will be granted in an individual case. Furthermore, the result of an individual examination would also lead to an amendment of the VI — Costs lists contained in Annexes I and II of the order. This way of gaining approval in individual cases would be likely to inhibit interstate trade unnecessarily and is there- fore disproportionate. 47. In accordance with Article 69(2) of the Rules of Procedure, the unsuccessful party is to be ordered to pay the costs of the proceedings if they have been applied for. France has not asked for the Commission 46. For these reasons, the French order to be ordered to pay the costs. Both parties would constitute a disproportionate restric- must therefore bear their own costs.

V I I— Conclusion

48. On the basis of the foregoing, I therefore propose that the Court should rule as follows:

(1) The action is dismissed as inadmissible.