COMMISSION IMPLEMENTING REGULATION (EU) 2023/2218

of 16 October 2023

concerning the classification of certain goods in the Combined Nomenclature

THE EUROPEAN COMMISSION,

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

Having regard to Regulation (EU) No 952/2013 of the European Parliament and of the Council of 9 October 2013 laying down the Union Customs Code (1), and in particular Article 57(4) and Article 58(2) thereof,

Whereas:

(1) In order to ensure uniform application of the Combined Nomenclature annexed to Council Regulation (EEC) No 2658/87 (2), it is necessary to adopt measures concerning the classification of the goods referred to in the Annex to this Regulation.

(2) Regulation (EEC) No 2658/87 has laid down the general rules for the interpretation of the Combined Nomenclature. Those rules apply also to any other nomenclature which is wholly or partly based on it or which adds any additional subdivision to it and which is established by specific provisions of the Union, with a view to the application of tariff and other measures relating to trade in goods.

(3) Pursuant to those general rules, the goods described in column (1) of the table set out in the Annex should be classified under the CN code indicated in column (2), by virtue of the reasons set out in column (3) of that table.

(4) It is appropriate to provide that binding tariff information issued in respect of the goods concerned by this Regulation which does not conform to this Regulation may, for a certain period, continue to be invoked by the holder in accordance with Article 34(9) of Regulation (EU) No 952/2013. That period should be set at three months.

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

HAS ADOPTED THIS REGULATION:

Article 1

The goods described in column (1) of the table set out in the Annex shall be classified within the Combined Nomenclature under the CN code indicated in column (2) of that table.

Article 2

Binding tariff information which does not conform to this Regulation may continue to be invoked in accordance with Article 34(9) of Regulation (EU) No 952/2013 for a period of three months from the date of entry into force of this Regulation.

Article 3

This Regulation shall enter into force on the twentieth day following that of its publication in the

Official Journal of the European Union

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels, 16 October 2023.

For the Commission,

On behalf of the President,

Gerassimos THOMAS

Director-General

Directorate-General for Taxation and Customs Union

(1)

OJ L 269, 10.10.2013, p. 1

(2) Council Regulation (EEC) No 2658/87 of 23 July 1987 on the tariff and statistical nomenclature and on the Common Customs Tariff (

OJ L 256, 7.9.1987, p. 1

ANNEX

Description of the goods

Classification

(CN-code)

Reasons

(1)

(2)

(3)

Agarose beads chemically modified with 10 % by weight of protein A. The beads are stored in an aqueous storage buffer, containing 40-60 % by weight of beads.

The product is used as a resin in affinity chromatography. It acts as a selective filtration medium in specific processes to isolate antibodies, for example, monoclonal antibodies.

The agarose polymer chains are highly cross-linked to form a rigid matrix to which recombinant protein A molecules are covalently bound.

The product is packed in 50-litre containers.

3913 90 00

Classification is determined by general rules 1 and 6 for the interpretation of the Combined Nomenclature, Notes 5 and 6 (a) to Chapter 39 and the wording of CN codes 3913 and 3913 90 00 .

The product interacts with antibodies but does not contain antibodies. Protein A is not an immunological product, as it is not directly involved in the regulation of immunological processes as defined by Note 2 to Chapter 30. Classification of agarose chemically modified with protein A in heading 3002 is therefore excluded.

The product is a chemically modified polymer as defined by Note 5 to Chapter 39 and the Harmonized System Explanatory Note (HSEN) to Chapter 39, General, part ‘Polymers’, the third paragraph. Therefore, the product cannot be classified in heading 3504 , as other protein substances and their derivatives not elsewhere specified or included (see also HSEN to heading 3504 , point (B), first paragraph).

The product is in the form of a dispersion (suspension) which is a primary form within the meaning of Note 6 (a) to Chapter 39. It is therefore covered by the wording of heading 3913 as a modified natural polymer in primary forms. Classification in heading 3926 as other articles of plastics and articles of other materials of headings 3901 to 3914 is thus excluded.

Consequently, the product is to be classified under CN code 3913 90 00 as other natural polymers and modified natural polymers, not elsewhere specified or included, in primary forms.

ELI: http://data.europa.eu/eli/reg_impl/2023/2218/oj

ISSN 1977-0677 (electronic edition)