(Reference for a preliminary ruling from the Hoge Raad der Nederlanden)

(Reference for a preliminary ruling – Regulation (EEC) No 2658/87 – Common Customs Tariff – Customs duties – Relief – Pharmaceutical substances – Composition – Restrictions)

Summary of the Judgment

Common Customs Tariff – Importation free of customs duties – Medicinal products

(Council Regulation No 2658/87, Annex I, Part One, Section II, C, point 1(i), and Part Three, Annex 3, as amended by Commission Regulations No 2031/2001 and No 1832/2002)

Part One, Section II, C, 1(i) of Annex I to Regulation No 2658/87 on the tariff and statistical nomenclature and on the Common Customs Tariff, as amended by Regulations Nos 2031/2001 and 1832/2002, must be interpreted as meaning that a pharmaceutical substance listed in Annex 3 of Part Three of Annex I, to which other substances have been added, in particular pharmaceutical substances, no longer qualifies for the duty-free treatment which would have applied if such a substance had been in its pure form.

The provision governing the application of duty-free treatment constitutes a derogation from the principle that goods imported into the European Union are, as a general rule, subject to customs duties and, as such, must therefore be interpreted strictly. Consequently, in the absence of an express indication or another factor supporting the conclusion that the legislature of the European Union intended to grant duty-free treatment to the pharmaceutical substances listed in Annex 3 which, subject to possible residual impurities contained in those substances, are not in their pure form, Regulation No 2658/87 cannot be interpreted as meaning that pharmaceutical substances to which other substances have been added qualify for that relief.

In addition, that interpretation is the most appropriate for ensuring a uniform application of the provisions of Regulation No 2658/87 in so far as it leaves only limited discretion to the national customs authorities to determine whether a pharmaceutical substance is in its pure form or not.

(see paras 16-17, 25-26, operative part)

17 February 2011 (*)

(Reference for a preliminary ruling – Regulation (EEC) No 2658/87 – Common Customs Tariff – Customs duties – Relief – Pharmaceutical substances – Composition – Restrictions)

In Case C‑11/10,

REFERENCE for a preliminary ruling under Article 267 TFEU from the Hoge Raad der Nederlanden (Netherlands), made by decision of 18 December 2009, received at the Court on 8 January 2010, in the proceedings

Marishipping and Transport BV,

THE COURT (Fifth Chamber),

composed of J.-J. Kasel (Rapporteur), President of the Chamber, E. Levits and M. Berger, Judges,

Advocate General: P. Mengozzi,

Registrar: A. Calot Escobar,

having regard to the written procedure,

after considering the observations submitted on behalf of:

– the Netherlands Government, by C.M. Wissels and B. Koopman, acting as Agents,

– the European Commission, by M. van Beek and L. Bouyon, acting as Agents,

having decided, after hearing the Advocate General, to proceed to judgment without an Opinion,

gives the following

1This reference for a preliminary ruling concerns the interpretation of Part One, Section II, C, 1(i) of the combined nomenclature of the Common Customs Tariff constituting Annex I to Council 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 by Commission Regulations (EC) Nos 2031/2001 of 6 August 2001 (OJ 2001 L 279, p. 1) and 1832/2002 of 1 August 2002 (OJ 2002 L 290, p. 1) (‘Regulation No 2658/87’).

2The questions were raised in proceedings between the Staatssecretaris van Financiën (State Secretary of Finance) and Marishipping and Transport BV (‘Marishipping’), a company established in the Netherlands, about whether the relief from customs duty provided for pharmaceutical products applies only to goods composed of pure pharmaceutical substances or whether it also applies to products in which other substances have been added.

Legal context

Directive 2011/92

Recitals 7 to 9 of Directive 2011/92 state:

‘(7) Development consent for public and private projects which are likely to have significant effects on the environment should be granted only after an assessment of the likely significant environmental effects of those projects has been carried out. …

(8) Projects belonging to certain types have significant effects on the environment and those projects should, as a rule, be subject to a systematic assessment.

(9) Projects of other types may not have significant effects on the environment in every case and those projects should be assessed where the Member States consider that they are likely to have significant effects on the environment.’

Article 2(1) of that directive provides:

‘Member States shall adopt all measures necessary to ensure that, before development consent is given, projects likely to have significant effects on the environment by virtue, inter alia, of their nature, size or location are made subject to a requirement for development consent and an assessment with regard to their effects on the environment. Those projects are defined in Article 4.’

Under Article 3(1) of that directive:

‘The environmental impact assessment shall identify, describe and assess in an appropriate manner, in the light of each individual case, the direct and indirect significant effects of a project on the following factors:

…

(b) biodiversity, with particular attention to species and habitats protected under [Council Directive 92/43/EEC of 21 May 1992 on the conservation of natural habitats and of wild fauna and flora (OJ 1992 L 206, p. 7), as amended by Council Directive 2013/17/EU of 13 May 2013 (OJ 2013 L 158, p. 193) (“Directive 92/43”)] and Directive 2009/147/EC [of the European Parliament and of the Council of 30 November 2009 on the conservation of wild birds (OJ 2010 L 20, p. 7)];

…’

Article 4 of Directive 2011/92 provides:

‘1. Subject to Article 2(4), projects listed in Annex I shall be made subject to an assessment in accordance with Articles 5 to 10.

(a) a case-by-case examination;

(b) thresholds or criteria set by the Member State.

Member States may decide to apply both procedures referred to in points (a) and (b).

Where a case-by-case examination is carried out or thresholds or criteria are set for the purpose of paragraph 2, the relevant selection criteria set out in Annex III shall be taken into account. Member States may set thresholds or criteria to determine when projects need not undergo either the determination under paragraphs 4 and 5 or an environmental impact assessment, and/or thresholds or criteria to determine when projects shall in any case be made subject to an environmental impact assessment without undergoing a determination set out under paragraphs 4 and 5.

Where Member States decide to require a determination for projects listed in Annex II, the developer shall provide information on the characteristics of the project and its likely significant effects on the environment. The detailed list of information to be provided is specified in Annex IIA. The developer shall take into account, where relevant, the available results of other relevant assessments of the effects on the environment carried out pursuant to Union legislation other than this Directive. The developer may also provide a description of any features of the project and/or measures envisaged to avoid or prevent what might otherwise have been significant adverse effects on the environment.

The competent authority shall make its determination, on the basis of the information provided by the developer in accordance with paragraph 4 taking into account, where relevant, the results of preliminary verifications or assessments of the effects on the environment carried out pursuant to Union legislation other than this Directive. The determination shall made available to the public and:

(a) where it is decided that an environmental impact assessment is required, state the main reasons for requiring such assessment with reference to the relevant criteria listed in Annex III; or

(b) where it is decided that an environmental impact assessment is not required, state the main reasons for not requiring such assessment with reference to the relevant criteria listed in Annex III, and, where proposed by the developer, state any features of the project and/or measures envisaged to avoid or prevent what might otherwise have been significant adverse effects on the environment.

Member States shall ensure that the competent authority makes its determination as soon as possible and within a period of time not exceeding 90 days from the date on which the developer has submitted all the information required pursuant to paragraph 4. In exceptional cases, for instance relating to the nature, complexity, location or size of the project, the competent authority may extend that deadline to make its determination; in that event, the competent authority shall inform the developer in writing of the reasons justifying the extension and of the date when its determination is expected.’

Annex II.A of that directive contains the list of ‘information to be provided by the developer on the projects listed in Annex II’. That list reads as follows:

‘1. A description of the project, including in particular:

(a) a description of the physical characteristics of the whole project and, where relevant, of demolition works;

(b) a description of the location of the project, with particular regard to the environmental sensitivity of geographical areas likely to be affected.

3. A description of any likely significant effects, to the extent of the information available on such effects, of the project on the environment resulting from:

(a) the expected residues and emissions and the production of waste, where relevant;

(b) the use of natural resources, in particular soil, land, water and biodiversity.

4. The criteria of Annex III shall be taken into account, where relevant, when compiling the information in accordance with points 1 to 3.’

Annex III to that directive sets out the ‘criteria to determine whether the projects listed in Annex II should be subject to an environmental impact assessment’.

Directive 2014/52

Recitals 11 and 29 of Directive 2014/52 state:

‘(11) The measures taken to avoid, prevent, reduce and, if possible, offset significant adverse effects on the environment, in particular on species and habitats protected under [Directive 92/43] and Directive 2009/147 …, should contribute to avoiding any deterioration in the quality of the environment and any net loss of biodiversity, in accordance with the [European] Union’s commitments in the context of the [United Nations Convention on Biological Diversity, signed in Rio de Janeiro on 5 June 1992,] and the objectives and actions of the Union Biodiversity Strategy up to 2020 laid down in the [Communication from the Commission to the European Parliament, the Council, the Economic and Social Committee and the Committee of the Regions] of 3 May 2011 entitled ‘Our life insurance, our natural capital: an EU biodiversity strategy to 2020’ [(COM(2011) 244 final)]

…

(29) When determining whether significant effects on the environment are likely to be caused by a project, the competent authorities should identify the most relevant criteria to be considered and should take into account information that could be available following other assessments required by Union legislation in order to apply the screening procedure effectively and transparently. In this regard, it is appropriate to specify the content of the screening determination, in particular where no environmental impact assessment is required. Moreover, taking into account unsolicited comments that might have been received from other sources, such as members of the public or public authorities, even though no formal consultation is required at the screening stage, constitutes good administrative practice.’

Directive 92/43

Article 6(3) of Directive 92/43 provides:

‘Any plan or project not directly connected with or necessary to the management of the site but likely to have a significant effect thereon, either individually or in combination with other plans or projects, shall be subject to appropriate assessment of its implications for the site in view of the site’s conservation objectives. In the light of the conclusions of the assessment of the implications for the site and subject to the provisions of paragraph 4, the competent national authorities shall agree to the plan or project only after having ascertained that it will not adversely affect the integrity of the site concerned and, if appropriate, after having obtained the opinion of the general public.’

Article 12(1) of that directive provides:

‘Member States shall take the requisite measures to establish a system of strict protection for the animal species listed in Annex IV(a) in their natural range, prohibiting:

(a) all forms of deliberate capture or killing of specimens of these species in the wild;

(b) deliberate disturbance of these species, particularly during the period of breeding, rearing, hibernation and migration;

(c) deliberate destruction or taking of eggs from the wild;

(d) deterioration or destruction of breeding sites or resting places.’

Point (a) of Annex IV to that directive mentions ‘all species’ of bats belonging to the suborder of ‘microchiroptera’.

Irish law

In the present case, it is apparent from the file that the INN attributed to chitosan does not cover the goods since they contain too high a proportion of other substances.

22As regards the CAS numbers which are also referred to in Part One, Section II, C, 1(i) of Annex I to Regulation No 2658/87, it must be pointed out that it is also established, as the Netherlands Government and the Commission have noted, that chitosan (CAS 9012-76-4), ascorbic acid (CAS 5081-7) and tartaric acid (CAS 8769-4) all have their own CAS identification number and that a mixture of those substances cannot be identified by a single CAS number.

23Next, the interpretation given in paragraph 19 above is consistent with the principle that provisions on suspensions of, and relief from, customs duties must correspond to the requirements of legal certainty and take account of the difficulties confronting national customs administrations owing to the wide range and complexity of the tasks which they must carry out (see, to that effect, Ethicon, paragraph 12, and Case C‑247/97 Schoonbroodt [1998] ECR I‑8095, paragraph 23).

24Although the requirement that, in order to qualify for the duty-free treatment provided for in Part One, Section II, C, 1(i) of Annex I to Regulation No 2658/87, pharmaceutical substances must as a rule be in their pure form does not, admittedly, relieve customs authorities of their task of carrying out, where necessary, a chemical analysis of a sample of imported goods, the fact none the less remains that, in carrying out such an analysis, those authorities can limit themselves to researching whether those goods are actually composed exclusively of a substance on the list of pharmaceutical substances which qualify for the relief at issue, without being required to identify the other substances contained in those goods or to determine their proportions in the composition of those goods.

25Finally, that interpretation is the most appropriate for ensuring a uniform application of the provisions of Regulation No 2658/87 in so far as it leaves only limited discretion to the national customs authorities to determine whether a pharmaceutical substance is in its pure form or not.

26Having regard to the foregoing considerations, the answer to the first question is that Part One, Section II, C, 1(i) of Annex I to Regulation No 2658/87 must be interpreted as meaning that a pharmaceutical substance listed in Annex 3 of Part Three of Annex I, to which other substances have been added, in particular pharmaceutical substances, no longer qualifies for the duty-free treatment which would have applied if such a substance had been in its pure form.

The second question

27Having regard to the answer to the first question, it is not necessary to answer the second question.

Costs

28Since these proceedings are, for the parties to the main proceedings, a step in the action pending before the national court, the decision on costs is a matter for that court. Costs incurred in submitting observations to the Court, other than the costs of those parties, are not recoverable.

On those grounds, the Court (Fifth Chamber) hereby rules:

Part One, Section II, C, 1(i) of Annex I to Council Regulation (EEC) No 2658/87 of 23 July 1987 on the tariff and statistical nomenclature and on the Common Customs Tariff, as amended by Commission Regulations (EC) Nos 2031/2001 of 6 August 2001 and 1832/2002 of 1 August 2002, must be interpreted as meaning that a pharmaceutical substance listed in Annex 3 of Part Three of Annex I, to which other substances have been added, in particular pharmaceutical substances, no longer qualifies for the duty-free treatment which would have applied if such a substance had been in its pure form.

[Signatures]

*

Language of the case: Dutch.