导航菜单
Toothpaste is one of the most universal consumer healthcare products—but also one of the most inconsistently regulated across global markets.
Depending on the jurisdiction, it may be treated as a cosmetic, an OTC drug, or a hybrid category subject to both cosmetic and pharmaceutical controls. These differences go far beyond terminology: they directly shape product formulation strategy, claims design, regulatory timelines, and market entry feasibility.
For international brands, toothpaste compliance is rarely about meeting a single global standard. Instead, it requires navigating distinct regulatory philosophies in different markets.
In China, toothpaste is defined as a product applied to the teeth for cleaning through friction and is regulated as a general cosmetic. It is subject to a mandatory pre-market notification system administered by the National Medical Products Administration (NMPA).
Maximum fluoride concentration: ≤ 0.15% (1500 ppm); Mandatory warning statements required on packaging where applicable
Labels must include core product and compliance information such as:
Notification entity and manufacturer details
Full ingredient listing
Net content and shelf life
Usage instructions and safety warnings
Required regulatory statements
In China, toothpaste may carry claims such as anti-caries, plaque inhibition, anti-dentin hypersensitivity, and whitening or stain removal, provided that supporting evidence is submitted through the regulatory notification system and disclosed in the form of scientific literature, research data, or summaries of efficacy evaluation. Products limited to basic cleansing claims are exempt from submitting efficacy supporting materials.
A distinction is also made for children's toothpaste, where claims are restricted to basic cleaning and anti-caries functions only, and products must clearly display a designated children's toothpaste label on the front of the packaging.
In the EU, toothpaste is regulated as a cosmetic product under Regulation (EC) No 1223/2009. No pre-market approval or registration is required. However, the Responsible Person must ensure that:
a Cosmetic Product Safety Report (CPSR) is completed
a Product Information File (PIF) is established
The product is notified via the Cosmetic Products Notification Portal (CPNP)
Maximum fluoride concentration: ≤ 0.15% (1500 ppm); Mandatory labeling warnings where relevant.
Toothpaste products must comply with EU cosmetic labeling requirements, including the product name, the name and address of the Responsible Person, the list of ingredients (INCI names), nominal content, date of minimum durability or period after opening, directions for use, warning statements, country of origin, and product function.
In the EU, toothpaste may carry claims such as cleaning, fresh breath, anti-caries, sensitivity relief, and plaque control, provided that they are supported by appropriate scientific evidence, including scientific literature, study data, or efficacy evaluation reports.
In the United States, toothpaste may be regulated as either a cosmetic or an over-the-counter (OTC) drug, depending on its ingredients and claims.
Products intended solely for cleansing or breath freshening are regulated as cosmetics. Products making claims related to the prevention or treatment of dental caries or other therapeutic benefits are generally classified as OTC drugs.
If regulated as a cosmetic: Toothpaste products do not require pre-market approval, but facility registration and product listing are required prior to marketing.
If regulated as an OTC drug: Products covered by an applicable FDA OTC monograph (e.g., anticaries toothpaste) may be legally marketed provided they comply with all monograph conditions, and after completing drug establishment registration and drug listing. If no applicable monograph exists or the product does not comply with the monograph requirements, it must obtain pre-market approval through a New Drug Application (NDA) before marketing.
If fluoride is included, permitted fluoride ingredients in toothpaste include sodium fluoride, sodium monofluorophosphate, and stannous fluoride. The total fluoride concentration must be within the range of 850–1150 ppm, and appropriate warning statements must be included on the label. The use of other fluoride compounds, or fluoride levels exceeding 1500 ppm, is subject to regulation as a new drug.
If regulated as a cosmetic: the label must include the product name, name and address of the responsible party, ingredient list, net content, directions for use, warning statements, country of origin, and contact information for adverse event reporting.
If regulated as an OTC drug: the label must include the product name, active ingredients, inactive ingredients, intended use, target user group, directions for use, and warning statements.
If claims are limited to cosmetic functions such as cleaning, whitening, or breath freshening, the product may be regulated as a cosmetic, provided that the claims do not imply any therapeutic effect. All claims must be truthful and substantiated by appropriate evidence, including scientific literature, study data, or efficacy evaluation reports.
If claims include anti-caries or cavity prevention, the product is generally classified as an OTC drug. Such claims must be supported by appropriate scientific evidence, including scientific literature, study data, efficacy evaluation reports, or testing data in accordance with FDA requirements.
In ASEAN markets, toothpaste is regulated as a cosmetic product and is subject to pre-market notification in each Member State.
If fluoride is included, fluoride levels must comply with national limits, such as potassium fluorosilicate, where applicable, with a general maximum total fluoride concentration of ≤ 0.15% (1500 ppm). Appropriate warning statements must be included on the label.
Labels must include the product name, company information, country of origin, full ingredient list (INCI names), net content, batch number, expiry date, directions for use, and required warning statements.
Claims such as cleaning, fresh breath, and plaque reduction are generally permitted for basic oral care functions, provided they are truthful and supported by appropriate scientific evidence, including scientific literature, study data, or efficacy evaluation reports.
Functional claims such as anti-caries, anti-sensitivity, and plaque inhibition may be permitted in certain Member States, but must also be substantiated by scientific evidence and must not imply treatment of disease.
Regulatory requirements for toothpaste vary significantly across jurisdictions. Companies should assess target market requirements in advance and ensure compliance across ingredient requirements, product notification, labeling, and claims substantiation.
For inquiries, please contact us at info@zmuni.com.
