Coenzyme Q10 (ubidecarenone (INN))

Subheading 291462 of the Combined Nomenclature covers coenzyme Q10 - ubidecarenone (INN: ubidecarenone), a lipophilic quinone compound with molecular formula C59H90O4 and CAS number 303-98-0. Ubidecarenone is a naturally occurring molecule synthesised by living organisms, playing an essential role in the mitochondrial electron transport chain as a redox carrier. CN 291462 was carved out from the broader quinones group (previously classified under 291469) as a dedicated subheading owing to the growing commercial and pharmaceutical importance of this compound. In trade, ubidecarenone typically appears as a yellow to orange crystalline powder of pharmaceutical or nutraceutical purity grade. Classification is governed by the Notes to Chapter 29 and the General Rules for Interpretation of the CN. It is essential to distinguish coenzyme Q10 as a chemical substance (CN 291462) from finished preparations for human consumption, which may fall under Chapter 21 or Chapter 30, depending on their formulation and intended use. In cases of doubt Binding Tariff Information (BTI) ruling is advisable.

Coenzyme Q10 classified under subheading 291462 is imported primarily as an active or auxiliary substance for the manufacture of dietary supplements and pharmaceutical products. In medicine, ubidecarenone is investigated and used as an active ingredient in preparations supporting the treatment of heart failure and neurodegenerative conditions. As a dietary supplement ingredient it is regulated in the EU by Directive 2002/46/EC on food supplements - the finished product must comply with labelling and safety requirements established under EU food law and applicable national regulations of the member state of marketing. Importers of the bulk substance intended for supplement manufacture are advised to verify that the manufacturer operates under Good Manufacturing Practice (GMP) principles. In the cosmetics industry, ubidecarenone is a widely used antioxidant active in anti-ageing face creams. Regardless of downstream use, the substance imported under CN 291462 is a chemical substance and is subject to REACH and CLP; finished consumer products are additionally governed by sector-specific legislation covering pharmaceuticals, food or cosmetics.

Importing goods under CN code 291462 into the European Union requires an electronic customs declaration submitted via the relevant national import system in accordance with the Union Customs Code (UCC, Regulation (EU) No 952/2013). The importer must hold a valid EORI number and provide: a commercial invoice specifying CAS 303-98-0 and the INN designation, a transport document, a Certificate of Analysis (CoA) confirming purity and identity, a REACH-compliant Safety Data Sheet (SDS), and - when claiming a preferential tariff rate - a valid proof of origin. As a chemical substance, coenzyme Q10 is subject to REACH Regulation (EC No 1907/2006): importers bringing in more than 1 tonne per year must hold a valid registration or be covered by an Only Representative (OR) registration. Labelling and packaging must comply with CLP Regulation (EC No 1272/2008). Where the substance is destined for dietary supplement or pharmaceutical manufacturing, the customs authority or competent national body may require additional notifications or permits. MFN and preferential duty rates, as well as any applicable trade measures, must be verified in the current EU TARIC database.

Organic substances under CN code 2914 62 (Coenzyme Q10) require detailed chemical documentation for customs clearance. The Safety Data Sheet must comply with REACH Annex II. Substances classified as hazardous under CLP require GHS pictogram labelling. Transport follows ADR (road) or IMDG (maritime) regulations. Some organic substances may be subject to export controls as dual-use goods. Importers should verify whether the substance requires REACH authorisation (Annex XIV) or is subject to restrictions (Annex XVII). A Certificate of Analysis confirming purity and composition is recommended.