ORDER OF THE GENERAL COURT (First Chamber)

19 July 2017 ([\*](#Footnote*))

(Action for annulment — Customs union — Common Customs Tariff — Tariff and statistical nomenclature — Classification in the Combined Nomenclature — Tariff subheadings — Customs duties applicable to goods classified under those tariff subheadings — Regulatory act entailing implementing measures — Lack of individual concern — Inadmissibility)

In Case T‐716/16,

**Pfizer Ltd,** established in Sandwich (United Kingdom),

**Pfizer Santé familiale,** established in Paris (France),

represented by L. Catrain González, lawyer, and E. Wright, Barrister,

applicants,

v

**European Commission,** represented by A. Caeiros and K. Skelly, acting as Agents,

defendant,

ACTION pursuant to Article 263 TFEU seeking partial annulment of Commission Implementing Regulation (EU) No 2016/1140 of 8 July 2016 concerning the classification of certain goods in the Combined Nomenclature (OJ 2016 L 189, p. 1),

THE GENERAL COURT (First Chamber),

composed of I. Pelikánová, President, V. Valančius (Rapporteur) and U. Öberg, Judges,

Registrar: E. Coulon,

makes the following

**Order**

**Background to the dispute**

1        Regulation (EU) No 952/2013 of the European Parliament and of the Council of 9 October 2013 laying down the Union Customs Code (OJ 2013 L 269, p. 1, corrigendum OJ 2013 L 287, p. 90, ‘the Union Customs Code’) lays down the rules and general procedures that must be applied to goods imported to or exported from the European Union. Article 288 of the regulation repealed Regulation (EC) No 450/2008 of the European Parliament and of the Council of 23 April 2008 laying down the Community Customs Code (Modernised Customs Code) (OJ 2008 L 145, p. 1) and is applicable, according to the provisions in question, as of 30 October 2013 or 1 May 2016.

2        For the purposes of applying the Common Customs Tariff and facilitating the establishment of statistics of the EU’s external trade and other EU policies relating to imports and exports of goods, the Council of the European Union, by adopting Regulation (EEC) No 2658/87 of 23 July 1987 on the tariff and statistical nomenclature and on the Common Customs Tariff (OJ 1987 L 256, p. 1), as amended (‘the Combined Nomenclature Regulation’), established a complete nomenclature of goods being imported and exported in the EU (‘the Combined Nomenclature’ or ‘the CN’). The nomenclature is set out in Annex I to that regulation.

3        In order to ensure the uniform application of the Combined Nomenclature in the EU, the European Commission, with the assistance of a committee of representatives of the Member States, the Union Customs Code Committee, may adopt a number of measures which are set out in Article 9 of the Combined Nomenclature Regulation. Among those measures is the possibility for the Commission to adopt tariff classification regulations for particular goods in the Combined Nomenclature.

4        The applicants, Pfizer Ltd (‘Pfizer’) and Pfizer Santé familiale, are companies belonging to Pfizer Inc., a global pharmaceutical company which produces, imports and markets pharmaceutical and healthcare products and medical devices.

5        On 14 September 2012, the United Kingdom customs authorities issued, on Pfizer’s request, a binding tariff information (‘BTI’) to it classifying under CN subheading 3005 1000 the goods imported by the applicants. A BTI is information on the tariff classification of specific goods issued by the customs authorities that is binding on those authorities in respect of the requester and the holder of the BTI. The goods correspond to the following description:

‘Therapeutic heatwraps are medical adhesive patches which are placed on the body to relieve pain from an affected area. They are made of a soft synthetic material conforming to the body’s shape and contain a number of discs which, on exposure to the air, create heat. The discs contain iron, charcoal, salt and water and an exothermic reaction takes place when they are exposed to air’.

6        On 26 October 2012, the United Kingdom customs authorities issued, on Pfizer’s request, a BTI to it classifying under CN subheading 3005 9050 goods corresponding to the following description:

‘Therapeutic heatwraps for tower back and hip. Designed for single use to be placed on the body to relieve pain from an affected area. They are made of a soft synthetic nonwoven textile material which wraps and fastens around the body and contains a number of discs which, on exposure to the air, create heat. The ends of the wrap have a small area of hook and loop stile fastening. The discs contain iron, charcoal, salt and water and an exothermic reaction takes place when they are exposed to air. Packed in foil wrapper in a cardboard box.’

7        On 29 June and 1 October 2012 and 17 January 2013, the applicants imported into France goods corresponding to the description set out in the BTIs issued by the United Kingdom customs authorities, classifying them, in their customs declaration, under subheading 3005 10.

8        Following an inspection carried out during a clearance of goods on 29 June 2012, the direction régionale des douanes et droits indirects du Havre (Regional Directorate of Customs and Indirect Taxes of Le Havre, France) sent, by letters of 18 December 2012 and of 7 February 2013, the results of the inspection to Pfizer Santé familiale, informing it that the goods inspected should have been declared under CN heading 3824 and not heading 3005.

9        Under Annex I of the Combined Nomenclature Regulation, the majority of goods classified under heading 3824 are subject to a customs duty of 6.5%. Heading 3824 is worded as follows:

‘Prepared binders for foundry moulds or cores; chemical products and preparations of the chemical or allied industries (including those consisting of mixtures of natural products), not elsewhere specified or included.’

10      By letters of 18 January and 8 March 2013, Pfizer Santé familiale objected to the Regional Directorate of Customs and Indirect Taxes of Le Havre’s position expressed in the letters of 18 December 2012 and 7 February 2013.

11      In 2015, the French Republic requested the Commission to clarify the classification of the goods imported by the applicants. The request was referred to the Union Customs Code Committee.

12      The Union Customs Code Committee examined the question during a meeting held from 15 to 17 February 2016 and invited the Commission to prepare a draft tariff classification regulation.

13      On 4 May 2016, the Commission presented to the Union Customs Code Committee a draft implementing regulation classifying self-heating patches and self-heating belts to relieve pain under CN subheading 3824 90 96.

14      On 8 July 2016, the Commission adopted, pursuant to Article 9(1)(a), first indent, of the Combined Nomenclature Regulation, Implementing Regulation (EU) No 2016/1140 concerning the classification of certain goods in the Combined Nomenclature (OJ 2016 L 189, p. 1, ‘the contested regulation’). The annex to the contested regulation consists of a table divided into three columns. Column 1 of the table reproduces the description of the goods at issue, column 2, the classification in the Combined Nomenclature and, column 3, the grounds. The classification of the goods at issue is established in these terms:

| | | |
| --- | --- | --- |
| Description of goods | Classification (CN code) | Grounds |
| (1) | (2) | (3) |
| 1.A product in the form of a self-heating patch to relieve pain. The patch is made of adhesive material intended for attaching to the skin (neck, wrist or shoulder). The product is made of a soft synthetic material conforming to the body’s shape and contains a number of discs which, on exposure to the air, generate heat. The discs contain iron powder, charcoal, salt and water. When the individual packets containing the patch are opened and exposed to air, an exothermic reaction takes place. | 3824 90 96 | Classification is determined by General Rules 1, 3(b) and 6 for the interpretation of the Combined Nomenclature and the wording of CN codes 3824, 3824 90 and 3824 90 96. The discs contained in the product are used as a heat source due to the exothermic reaction. This gives the product the essential character of a preparation of heading 3824. Therefore, the product cannot be considered as bandages and similar articles of heading 3005. Therefore, the product should be classified in CN code 3824 90 96. |
| 2. A product in the form of a self-heating belt to relieve pain. The belt is made of non-adhesive material, which is attached by means of a self-adhesive strip. The product is made of a soft synthetic material conforming to the body’s shape and contains a number of discs which, upon exposure to air, generate heat. The discs contain iron powder, charcoal, salt and water. When the individual packets containing the belt are opened and exposed to air, an exothermic reaction takes place. | 3824 90 96 | Classification is determined by General Rules 1, 3(b) and 6 for the interpretation of the Combined Nomenclature and the wording of CN codes 3824, 3824 90 and 3824 90 96. The discs contained in the product are used as a heat source due to the exothermic reaction. This gives the product the essential character of a preparation of heading 3824. Therefore, the product should be classified in CN code 3824 90 96. |

15      In accordance with Article 3 thereof, the contested regulation entered into force twenty days after its publication in the *Official Journal of the European Union*, namely on 3 August 2016.

**Procedure and forms of order sought**

16      By application lodged at the Court Registry on 10 October 2016, the applicants brought the present action.

17      By separate document lodged at the Court Registry on 21 December 2016, the Commission raised an objection of inadmissibility under Article 130 of the Rules of Procedure of the General Court. The applicants submitted their observations on that objection of inadmissibility on 17 February 2017.

18      In the application, the applicants claim that the Court should:

–        annul the contested regulation in so far as they are concerned by it;

–        order the Commission to pay the costs.

19      The Commission contends that the Court should:

–        dismiss the action as inadmissible;

–        order the applicants to pay the costs.

20      In their observations on the objection of inadmissibility, the applicants claim that the Court should:

–        dismiss the objection of inadmissibility;

–        order the Commission to pay the costs.

**Law**

21      Pursuant to Article 130(1) of the Rules of Procedure, a defendant can request the Court to rule on admissibility without going into the substance of the case. In accordance with Article 130(6) of those rules, the Court can decide to open the oral part of the procedure on the objection of inadmissibility.

22      In the present case, the Court considers that it has sufficient information from the documents before it and decides to give judgment without opening the oral part of the procedure.

23      In support of its objection of inadmissibility, the Commission raises two pleas of inadmissibility, alleging, respectively, that the contested regulation produces its effects in respect of the applicants only through implementing measures, within the meaning of the fourth paragraph of Article 263 TFEU, and that the regulation does not individually affect the applicants.

24      The applicants dispute the Commission’s arguments and maintain that the contested regulation does not entail implementing measures in their regard and is of direct and individual concern to them.

25      Under the fourth paragraph of Article 263 TFEU, any natural or legal person may, under the conditions laid down in the first and second paragraphs of that article, institute proceedings against an act addressed to that person or which is of direct and individual concern to them, and against a regulatory act which is of direct concern to them and does not entail implementing measures.

26      It should be noted that the applicants are not addressees of the contested regulation. In those circumstances, pursuant to the fourth paragraph of Article 263 TFEU, they may bring an action for annulment of that regulation only in two situations, namely, first, if they are directly and individually concerned by it or, secondly, if the regulation is a regulatory act which is of direct concern to them and which does not entail implementing measures.

27      In the present case, it is common ground that the applicants are directly concerned by the contested regulation.

28      The contested regulation directly affects their legal situation and leaves no discretion to the addressees of that measure who are entrusted with the task of implementing it, such implementation being purely automatic and resulting from EU rules without the application of other intermediate rules (see, to that effect, judgment of 30 September 2003, *Sony Computer Entertainment Europe* v *Commission*, T‐243/01, EU:T:2003:251, paragraph 62).

***The first plea of inadmissibility, alleging that the contested regulation entails implementing measures***

29      The Commission contends, in essence, that the contested regulation produces no immediate and definitive legal effects for the applicants, because it produces such effects only following implementing measures.

30      The applicants dispute the Commission’s arguments and maintain that they have standing, in so far as the contested regulation is a regulatory act which is of direct concern to them and which does not entail implementing measures.

31      According to well-established case-law, in spite of the apparent specificity of the descriptions they contain, tariff classification regulations are nonetheless of entirely general application, since they concern all products of the type described, regardless of their individual characteristics and origin, and they take effect, in the interests of the uniform application of the Common Customs Tariff, in relation to all customs authorities in the EU and all importers (judgments of 14 February 1985, *Casteels* v *Commission*, 40/84, EU:C:1985:77, paragraph 11; of 30 September 2003, *Sony Computer Entertainment Europe* v *Commission*, T‐243/01, EU:T:2003:251, paragraph 58, and of 12 September 2013, *Valeo Vision* v *Commission*, T‐457/11, not published, EU:T:2013:414, paragraph 39).

32      In the present case, Article 1 of the contested regulation provides that the goods with the characteristics described in column 1 of the table set out in the annex to that regulation are to be classified within the Combined Nomenclature under the CN code indicated in column 2 of that table, namely CN code 3824 90 96. The provision applies to all products analogous to, or of, the type described, regardless of their individual characteristics and origin (see, to that effect, order of 3 December 2008, *RSA Security Ireland* v *Commission*, T‐227/06, EU:T:2008:547, paragraph 57, and judgment of 12 September 2013, *Valeo Vision* v *Commission*, T‐457/11, not published, EU:T:2013:414, paragraph 40 and the case-law cited).

33      That provision, being in the form of a measure of general application, applies to an objectively determined situation and produces legal effects with respect to categories of persons envisaged generally and in the abstract, and in particular importers of the product it describes (see, to that effect, order of 3 December 2008, *RSA Security Ireland* v *Commission*, T‐227/06, EU:T:2008:547, paragraph 58, and judgment of 12 September 2013, *Valeo Vision* v *Commission*, T‐457/11, not published, EU:T:2013:414, paragraph 41).

34      Furthermore, the contested regulation does not constitute a legislative act since it was not adopted in accordance with either the ordinary legislative procedure or a special legislative procedure within the meaning of paragraphs 1 to 3 of Article 289 TFEU. The contested regulation is a Commission act adopted in the exercise of its implementing powers, based on Article 9(1)(a) of the Combined Nomenclature Regulation (see paragraph 14 above).

35      Consequently, the contested regulation constitutes a regulatory act within the meaning of the fourth paragraph of Article 263 TFEU.

36      The question whether the contested regulation entails implementing measures should be assessed by reference to the position of the person pleading the right to bring proceedings under the last limb of the fourth paragraph of Article 263 TFEU. It is therefore irrelevant whether the act in question entails implementing measures with regard to other persons (see judgments of 28 April 2015, *T & L Sugars and Sidul Açúcares* v *Commission*, C‐456/13 P, EU:C:2015:284, paragraph 32 and the case‐law cited, and of 10 December 2015, *Canon Europa* v *Commission*, C‐552/14 P, not published, EU:C:2015:804, paragraph 45 and the case-law cited).

37      It is also irrelevant to ascertaining whether or not those measures are mechanical in nature (judgments of 28 April 2015, *T & L Sugars and Sidul Açúcares* v *Commission*, C‐456/13 P, EU:C:2015:284, paragraphs 41 and 42, and of 10 December 2015, *Canon Europa* v *Commission*, C‐552/14 P, not published, EU:C:2015:804, paragraph 47).

38      Moreover, it has been held that, for a tariff classification regulation to produce real and definitive legal effects on the importer at issue, it is always necessary that national measures have been taken beforehand, in particular on submission of the customs declaration by that importer (judgments of 12 September 2013, *Valeo Vision* v *Commission*, T‐457/11, not published, EU:T:2013:414, paragraphs 62 and 72, and of 12 September 2013, *Palirria Souliotis* v *Commission*, T‐380/11, not published, EU:T:2013:420, paragraphs 32 and 42).

39      The customs system, as instituted by the Union Customs Code and of which the contested regulation forms part, in so far as it classifies in the Combined Nomenclature the goods described therein, provides that the receipt of duties fixed by the Combined Nomenclature is carried out, in all cases, on the basis of measures adopted by the national authorities (see, to that effect, judgment of 10 December 2015, *Canon Europa* v *Commission*, C‐552/14 P, not published, EU:C:2015:804, paragraph 50).

40      Consequently, the contested regulation cannot be classified as a regulatory act not entailing implementing measures within the meaning of the fourth paragraph of Article 263 TFEU.

41      That conclusion cannot be called into question by the arguments put forward by the applicants.

42      In the first place, they claim that the contested regulation, in so far as it classifies the goods described therein under CN subheading 3824 90 96, imposes, without the need for any implementing measures, an obligation on all importers of goods corresponding to that description to classify the goods under that subheading and to pay the resulting 6.5% customs duty.

43      Admittedly, the direct consequence of the contested regulation is to require the applicants, like any other importer of goods corresponding to the description set out therein, to adopt for those goods, when they import them in the customs territory of the Union, CN subheading 3824 90 96 in the customs declaration, which, under the Union Customs Code, they must establish for the purposes of placing them under a given customs procedure.

44      However, that obligation in itself produces no real and definitive legal effects on the situation of the importer in question. In particular, contrary to the applicants’ assertions, it does not in itself entail a decision on the tariff classification indicated by the importer in its customs declaration, nor, consequently, on the amount of customs duties which it will potentially have to pay (judgments of 12 September 2013, *Valeo Vision* v *Commission*, T‐457/11, not published, EU:T:2013:414, paragraph 60, and of 12 September 2013, *Palirria Souliotis* v *Commission*, T‐380/11, not published, EU:T:2013:420, paragraph 30).

45      In the second place, the applicants submit that the contested regulation, in itself, pursuant to Article 34(1)(b) of the Union Customs Code, rendered invalid the BTIs that they had been issued by the United Kingdom customs authorities on 14 September and 26 October 2012, without requiring any implementing measures.

46      Article 33(4) of the Union Customs Code, on which the applicants rely, provides that a BTI ceases to be valid before the end of its validity period where it no longer conforms to the law, as a result of, inter alia, the adoption of measures referred to in Article 57(4) of the code, which confers power on the Commission to determine the tariff classification of goods. In that regard, it must be held that the contested regulation constitutes such a measure.

47      Therefore, contrary to what the Commission contends, the adoption of the contested regulation had the effect of invalidating the BTIs which had been issued to the applicants by the United Kingdom customs authorities (see, to that effect, judgment of 30 September 2003, *Sony Computer Entertainment Europe* v *Commission*, T‐243/01, EU:T:2003:251, paragraph 69).

48      However, for a reason similar to that set out in paragraph 44 above, the fact that the BTIs at issue ceased to be valid cannot be considered a real and definitive legal effect of the contested regulation on their situation, within the meaning of the case-law recalled in paragraphs 38 and 44 above.

49      First, that cessation of validity entails, in itself, neither a decision on the tariff classification indicated by the importer in its customs declaration nor, consequently, on the amount of customs duties he will potentially have to pay. Secondly, it is merely a consequence of the classification of the goods at issue in the Combined Nomenclature under the contested regulation, which must, to produce real and definitive legal effects on the importer at issue, always be preceded by national measures, as recalled in paragraph 38 above.

50      In the third place, the applicants claim that the customs authorities have no discretion to classify the goods at issue under another subheading or not to collect the corresponding customs duty.

51      It must be noted that that argument is relevant solely in the context of the assessment of the requirements for direct concern to an applicant. However, the question whether or not the contested regulation leaves a discretion to the national authorities responsible for the implementing measures is irrelevant in ascertaining whether the contested regulation entails implementing measures (see, to that effect, judgments of 12 September 2013, *Valeo Vision* v *Commission*, T‐457/11, not published, EU:T:2013:414, paragraph 74 and the case‐law cited, and of 12 September 2013, *Palirria Souliotis* v *Commission*, T‐380/11, not published, EU:T:2013:420, paragraph 44).

52      In the fourth place, the applicants maintain that, if their action were declared inadmissible, the only way that they could have a court consider the validity of the contested regulation would be if they were to disregard the classification of the goods decided by that regulation and infringe the regulation by continuing to classify the goods under CN subheading 3005 10 and CN subheading 3005 90.

53      That argument cannot be accepted. Without first having to infringe the contested regulation, the applicants may, in principle, challenge the national measures implementing the contested regulation and, in that context, plead its illegality before the national courts, which may use, before giving judgment, the provisions of Article 267 TFEU (see, to that effect, judgments of 28 April 2015, *T & L Sugars and Sidul Açúcares* v *Commission*, C‐456/13 P, EU:C:2015:284, paragraph 29 and the case‐law cited, and of 12 September 2013, *Valeo Vision* v *Commission*, T‐457/11, not published, EU:T:2013:414, paragraph 75 and the case‐law cited).

54      In that regard, it should be recalled that secondary EU law has expressly prescribed the remedy available to import duty debtors who consider that such duties have been wrongly imposed on them by the customs authorities. That remedy is exercisable at national level, in accordance with the appeals procedure implemented by the Member State in question in compliance with the principles set out in Articles 43 to 45 of the Union Customs Code (see, to that effect, judgment of 12 September 2013, *Valeo Vision* v *Commission*, T‐457/11, not published, EU:T:2013:414, paragraph 75 and the case-law cited).

55      It follows from the foregoing that, since the contested regulation entails implementing measures, the applicants have standing to bring proceedings against the regulation only if they are individually concerned by it, within the meaning of the fourth paragraph of Article 263 TFEU.

***The second plea of inadmissibility, alleging that the applicants are not individually concerned***

56      The Commission contends that the applicants are not individually concerned by the contested regulation. According to the Commission, they are affected by the regulation only in their objective capacity as importers of goods corresponding to the description of the goods contained in that regulation, in the same way as any other operator actually or potentially in the same situation. The regulation does not affect the applicants because of certain attributes which are peculiar to them or circumstances which differentiate them from all other persons. The Commission adds that none of the exceptional circumstances of the case giving rise to the judgment of 30 September 2003, *Sony Computer Entertainment Europe* v *Commission* (T‐243/01, EU:T:2003:251), which is the only case in which an operator has been considered individually concerned by a tariff classification regulation, exist in the present case.

57      The applicants dispute the Commission’s arguments and consider themselves individually concerned by the contested regulation, because of circumstances which differentiate them from all other operators, like the applicant in the case giving rise to the judgment of 30 September 2003, *Sony Computer Entertainment Europe* v *Commission* (T‐243/01, EU:T:2003:251).

58      As stated in paragraphs 32 and 33 above, Article 1 of the contested regulation, the purpose of which is to classify within the Combined Nomenclature the goods described in column 1 of the table set out in the annex to that regulation, is a measure of general application that applies to an objectively determined situation and produces legal effects with respect to categories of persons envisaged generally and in the abstract, and in particular importers of such goods.

59      However, even a measure of general application may, in certain circumstances, be of individual concern to some economic operators. Such is the case where the measure at issue affects them by virtue of certain attributes which are peculiar to them or by reason of circumstances in which they are differentiated from all other persons and thus distinguishes them individually just as in the case of the person to whom a decision is addressed (judgment of 15 July 1963, *Plaumann* v *Commission*, 25/62, EU:C:1963:17, p. 223; see also judgment of 12 September 2013, *Valeo Vision* v *Commission*, T‐457/11, not published, EU:T:2013:414, paragraph 42 and the case-law cited).

60      In that regard, the sole fact that a measure of general application may have specific effects which differ according to the various persons to whom it applies is not such as to differentiate them from all the other persons concerned, where that measure is applied on the basis of an objectively determined situation (see order of 3 December 2008, *RSA Security Ireland* v *Commission*, T‐227/06, EU:T:2008:547, paragraph 59 and the case-law cited).

61      Furthermore, according to settled case-law, the possibility of determining more or less precisely the number or even the identity of the persons to whom a measure applies does not mean that that measure must be regarded as being of individual concern to them, where it applies to them by virtue of an objective legal or factual situation defined by the measure in question (see order of 3 December 2008, *RSA Security Ireland* v *Commission*, T‐227/06, EU:T:2008:547, paragraph 60 and the case-law cited, and judgment of 12 September 2013, *Valeo Vision* v *Commission*, T‐457/11, not published, EU:T:2013:414, paragraph 43).

62      Moreover, the fact that certain operators are economically more affected by a measure than the other operators in the same sector is not sufficient for them to be regarded as individually concerned by that measure (see order of 3 December 2008, *RSA Security Ireland* v *Commission*, T‐227/06, EU:T:2008:547, paragraph 61 and the case-law cited).

63      It must be held that the arguments put forward by the applicants demonstrate neither an attribute peculiar to them, nor a situation of fact that differentiates and thereby distinguishes them from all other economic operators potentially concerned by the contested regulation.

64      Thus, in the first place, while it is true that, as the applicants claim, the procedure for adopting the contested regulation was initiated because the goods imported by the applicants were classified by the French and United Kingdom customs authorities under different subheadings, it should be observed that a procedure for adopting a tariff regulation is always triggered by difficulties in the classification of a specific product. Nevertheless, the application of such a regulation extends, in principle, to all goods similar to or meeting the type described, regardless of their individual characteristics and their origin (see judgment of 12 September 2013, *Valeo Vision* v *Commission*, T‐457/11, not published, EU:T:2013:414, paragraph 46 and the case-law cited).

65      In the second place, the applicants submit that the procedure which led to the adoption of the contested regulation was specifically pursued concerning the goods they import, namely ThermaCare ‘self-heating patches’ and ‘self-heating belts’. The description of the goods at issue in the contested regulation corresponds precisely to that which the applicants had provided to the United Kingdom customs authorities and which is contained in the BTIs delivered to them. Moreover, the content of that description cannot apply to the other goods already imported by other importers in the EU identified by the Commission, as those goods do not have the same characteristics.

66      In that regard, it must be observed that it is inevitable that discussions taking place within the Union Customs Code Committee in the context of a tariff classification procedure specifically concern one or several particular products, since the Member State requesting the committee to determine the tariff classification of that or those products is generally invited by the committee to provide samples of them in order to be able to proceed with an assessment of its or their objective characteristics and properties (judgment of 12 September 2013, *Valeo Vision* v *Commission*, T‐457/11, not published, EU:T:2013:414, paragraph 47).

67      However, as has previously been stated in paragraph 64 above, the tariff classification regulation which is adopted following that procedure is nevertheless of general application, in that it applies to all goods which are of the same type as that or those examined by the committee.

68      Furthermore, as the Commission rightly contends, contrary to what the applicants claim, the description of the goods in column 1 of the table annexed to the contested regulation is not so precise that it excludes its application to goods other than the ThermaCare ‘self-heating patches’ and ‘self-heating belts’. On the contrary, that description, which is based on the technical characteristics and properties of the goods and must be read in conjunction with the reasons for the classification in column 3 of the table, must be considered generic.

69      In the third place, as regards the judgment of 30 September 2003, *Sony Computer Entertainment Europe* v *Commission* (T‐243/01, EU:T:2003:251) relied on by the applicants, it should be recalled that, as the General Court stated in paragraph 77 of that judgment, it was only in the exceptional circumstances of that case that the applicant had been considered individually concerned.

70      In the present case, two similarities between the case giving rise to the judgment of 30 September 2003, *Sony Computer Entertainment Europe* v *Commission* (T‐243/01, EU:T:2003:251) and the present case may be noted. The first lies in the fact that, in both cases, contacts took place between the importers concerned and the competent Commission services and a presentation of the product was made during a meeting of the Union Customs Code Committee. The second lies in the fact that the BTIs issued beforehand by the national customs authorities classifying the goods at issue under another subheading ceased to be valid because of the adoption of the regulation at issue.

71      However, while similar circumstances were taken into account to declare the action brought in the context of the case giving rise to the judgment of 30 September 2003, *Sony Computer Entertainment Europe* v *Commission* (T‐243/01, EU:T:2003:251) admissible, they could not have been the decisive factor (order of 19 February 2008, *Apple Computer International* v *Commission*, T‐82/06, EU:T:2008:46, paragraphs 51 and 52).

72      As regards the first similarity, it should be recalled that the fact that a person is involved in the procedure leading to the adoption of a measure is capable of distinguishing that person individually in relation to that measure only if the applicable EU legislation grants him certain procedural guarantees (order of 19 February 2008, *Apple Computer International* v *Commission*, T‐82/06, EU:T:2008:46, point 50). However, such is not the case for the applicants.

73      As regards the second similarity, it should be recalled, first, that, by virtue of the case-law referred to in paragraph 61 above, the possibility of determining that the contested regulation applies to the applicants does not in any way have the effect that they must be considered individually concerned by the regulation, provided that it applies, as in the present case, by virtue of an objective legal or factual situation defined by the regulation, namely importing goods corresponding to the description set out in column 1 annexed to that regulation.

74      Secondly, a BTI enjoys limited validity. The aim of a BTI is to enable the economic operator to proceed with certainty where there are doubts as to the classification of goods in the existing customs nomenclature, thereby protecting him against any subsequent change in the position adopted by the customs authorities with regard to the classification of the goods. However, a BTI is not aimed at, nor can it have the effect of, guaranteeing that the tariff heading to which the operator refers will not subsequently be amended by a measure adopted by the EU legislature, since the limited validity of BTI is set by Article 12 of the Union Customs Code itself (judgment of 29 January 1998, *Lopex Export*, C‐315/96, EU:C:1998:31, paragraph 28, and order of 3 December 2008, *RSA Security Ireland* v *Commission*, T‐227/06, EU:T:2008:547, paragraph 64).

75      Moreover, there are significant differences between the present case and the case giving rise to the judgment of 30 September 2003, *Sony Computer Entertainment Europe* v *Commission* (T‐243/01, EU:T:2003:251).

76      In that case, the Commission not only described the way in which the PlayStation®2 video games console at issue was presented for retail sale, but also the various parts of which it was composed and to which it could be connected, as well as its main functions. The applicant therefore succeeded in establishing that such a description corresponded exactly to the technical specifications of its product communicated to the Commission and that it was so specific that it was excluded that, at least at the time the regulation at issue entered into force, it could apply to devices other than its games console. Moreover, the regulation at issue in that case displayed a photograph of the product upon which the logo PS2 was clearly visible.

77      However, in the present case, as stated in paragraph 68 above, the applicants have not established that the description of the goods set out in column 1 of the table annexed to the contested regulation contained any element whatsoever relating specifically and solely to the ThermaCare ‘self-heating patches’ and ‘self-heating belts’ it imports. Furthermore, it should be noted that the contested regulation contains no photograph, logo or other sign enabling those goods specifically and solely to be identified.

78      It follows that the applicants’ argument that they are, like the applicant in the case giving rise to the judgment of 30 September 2003, *Sony Computer Entertainment Europe* v *Commission* (T‐243/01, EU:T:2003:251), the only authorised importers of ThermaCare ‘self‐heating patches’ and ‘self-heating belts’ is, even if it were established, ineffective.

79      Those points do not permit the view that exceptional circumstances specific to the present case, like those identified in the judgment of 30 September 2003, *Sony Computer Entertainment Europe* v *Commission* (T‐243/01, EU:T:2003:251), support the conclusion that the applicants are individually concerned by the contested regulation.

80      On the contrary, it is clear from all the foregoing that the applicants are affected by the contested regulation only in their objective capacity as importers of goods corresponding to the description of the goods set out in column 1 of the table annexed to the contested regulation, in the same way as any other operator actually or potentially in the same situation.

81      It follows from all of the foregoing considerations that the action must be dismissed as inadmissible.

**Costs**

82      Under Article 134(1) 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. As the applicants have been unsuccessful, they must be ordered to pay the costs, in accordance with the form of order sought by the Commission.

On those grounds,

THE GENERAL COURT (First Chamber)

hereby orders:

1.      **The action is dismissed as inadmissible.**

2.      **Pfizer Ltd and Pfizer Santé familiale shall pay the costs.**

Luxembourg, 20 July 2017.

| | | |
| --- | --- | --- |
| E. Coulon | | I. Pelikánová |

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[\*](#Footref*)      Language of the case: English.