If you are a UK importer and plan to import a batch of toothpaste from China, then the regulations regarding the import of toothpaste into the UK will be very important to you.
You will find below the commodity code, tax, duty, classification, labeling, and claims for toothpaste in the UK.
Commodity code, tax, and duty
- The commodity code for toothpaste in the UK is 3306 1000 00,
- Kinds of toothpaste are subject to Value added tax (20.00%),
- Importing from outside the UK is subject to a third-country duty of 0.00% unless subject to other measures.
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Classification of Toothpaste
In the UK, depending on the ingredients, mode of action, and presentation of the product, toothpaste can potentially be classified as:
- a cosmetic,
- a medicinal product,
- a medical device.
Cosmetic Definition
Article 2(1)(a) of the Cosmetics Regulation (EC) 1223/2009 as amended defines a ‘Cosmetic Product’ as: “any substance or mixture intended to be placed in contact with the external parts of the human body (epidermis, hair system, nails, lips, and external genital organs) or with the teeth and the mucous membranes of the oral cavity with a view exclusively or mainly to cleaning them, perfuming them, changing their appearance, protecting them, keeping them in good condition or correcting body odours;”.
The Cosmetics Regulation (EC) N° 1223/2009 allows the use of fluoride compounds in oral care products with a maximum concentration of 0.15% calculated as fluoride or 1500 ppm fluoride ion.
Medical Product Definition
Article 1 of Directive 2001/83/EC as amended defines a ‘medicinal product’ as: “Any substance or combination of substances presented as having properties for treating or preventing disease in human beings; [the first/presentational limb] Any substance or combination of substances which may be used in, or administered to, human beings, either with a view to restoring, correcting or modifying physiological functions by exerting a pharmacological, immunological or metabolic action or to making a medical diagnosis” [the second/functional limb]
Medical Device Definition
Under Directive 93/42/EEC on medical devices, medical device means “any instrument, apparatus, appliance, software, material or another article, whether used alone or in combination, including the software intended by its manufacturer to be used specifically for diagnostic and/or therapeutic purposes and necessary for its proper application, intended by the manufacturer to be used for human beings for the purpose of— diagnosis, prevention, monitoring, treatment or alleviation of disease,— diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap,— investigation, replacement or modification of the anatomy or of a physiological process,— control of conception, and which does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means.”
In practice, kinds of toothpaste are most often classified and regulated as cosmetics.
Labeling of Toothpaste
Cosmetic Labeling must be in English and include:
- Product identity,
- Net content (weight or volume),
- INCI list, in decreasing order of weight of the ingredients,
- Directions,
- Warnings/cautions,
- Bar code
- Expiry date,
- Batch number,
- Name & address of manufacturer or distributor,
- Country of origin
- Icons, such as PAO (period after opening), Der grüne punkt, etc.
Before cosmetic products can be sold in the UK, the person responsible must submit information about them to the OPSS (Office for Product Safety and Standards). This process is called notification.
Classification of Toothpaste Claims
Toothpaste has different claims and is regulated by different classifications, so we must be very careful.
Cosmetics claims
A toothpaste that is marketed with the purpose of
- cleaning (e.g. helping remove and prevent plaque),
- perfuming (e.g. fresh breath or freshens breath),
- protecting (e.g. helps protects against tooth decay)
- and keeping teeth and the oral cavity in good condition (e.g. maintaining healthy teeth and gums) fulfills the cosmetics definition.
Medical claims
Medical claims are usually
- “fights”
- “protects”
- “prevents”
- “problem(s)”
- “repairs” (e.g. “repair enamel”)
- “re-mineralize”
- “health maintenance”
Exceptional specific statements or phrases
Cosmetic claims are also
- “fight against plaque formation”
- “protect against tartar”
- “prevent bad breath” or ‘bad breath problems”
- “anti-bacterial agents”
- “help to maintain” or “support’ health or a healthy lifestyle
- “sensitive formula” or “(also) suitable for sensitive teeth”
Borderline products
If a product falls within the definition of a cosmetic and within the definition of a medicinal product, it will be classified as a medicinal product (Delattre 1991, C369/88).
The MHRA (Medicines and Healthcare products Regulatory Agency), as the UK Competent Authority, will make a final decision on the classification of the product.
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Hope this may help you.
