Introductory text

THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,

Having regard to Council Regulation (EEC) No 2658/87 of 23 July 1987 on the tariff and statistical nomenclature and on the Common Customs Tariff^f1, and in particular Article 9(1)(e) thereof,

Whereas:

Regulation (EEC) No 2658/87 establishes a goods nomenclature (hereinafter referred to as the ‘Combined Nomenclature’), which is reproduced in Annex I to that Regulation.

In the interest of legal certainty, it is necessary to clarify the classification of orthopaedic appliances of subheading 9021 10 10 of the Combined Nomenclature.

In accordance with the judgment of the Court of Justice in Joined Cases C-260/00 to C-263/00^f2, the Harmonized System Explanatory Notes to heading 9021 and Note 6 to Chapter 90, orthopaedic appliances are defined as products specially designed for a particular orthopaedic purpose.

In that judgment, the Court of Justice explained that orthopaedic appliances have a specific medical purpose in distinction to ordinary (simple) products that are for general use. The criteria for distinguishing orthopaedic appliances from ordinary products also include the method of manufacture, the materials of which they are made, their method of operation, their adjustability to the patient’s specific handicaps.

Note 6 to Chapter 90 provides that orthopaedic appliances serve either to prevent or correct bodily deformities or to support or hold parts of the body following an illness, operation or injury.

Section (I) of the Harmonized System Explanatory Notes to heading 9021 provides examples of a number of orthopaedic appliances covered by the heading together with examples of products that are not covered by heading 9021. The product scope established by these explanatory notes is in line with the new Additional note.

For reasons of legal certainty, it is necessary to provide examples of medical purposes that certain products might serve which distinguish them from orthopaedic appliances that are designed for a particular orthopaedic purpose.

For reasons of legal certainty, explanations should be provided on the method of operation (high degree of precision) of orthopaedic appliances that are meant to prevent further injuries or bodily deformities in distinction to ordinary products that are not considered to be designed with the same high degree of precision and, thus, are not able to prevent completely undesired movements.

A new Additional note should therefore be added to Chapter 90 of Part Two of the Combined Nomenclature to ensure its uniform interpretation.

The new Additional note is in line with Commission Implementing Regulation (EU) 2018/787^f3 classifiying an ankle bandage (so-called ‘lace-orthosis’), with the existing Explanatory Notes to the Combined Nomenclature to subheading 9021 10 10, and reflects the established classification practice of the Member States.

Regulation (EEC) No 2658/87 should therefore be amended accordingly.

The measures provided for in this Regulation are in accordance with the opinion of the Customs Code Committee,

HAS ADOPTED THIS REGULATION: