Compliance Guidelines for Oral Antibacterial Products

In today's market saturated with toothpaste, mouthwash, and oral sprays, many brands, vying for market share, have launched eye-catching slogans such as "anti-Helicobacter pylori," "cure oral ulcers," and "mucosal repair." However, these seemingly professional efficacy claims often conceal significant compliance risks.

In fact, most oral care products on the market fall under the categories of "disinfectants" or "cosmetics," not "pharmaceuticals." So, how can we accurately distinguish the regulatory categories of oral care products? Which promotional terms might cross regulatory red lines? What compliance points should oral antibacterial products pay attention to when promoting them in the market? We will now provide a comprehensive overview.

Oral care products within the cosmetics category

Ordinary toothpaste, mouthwash, and other oral hygiene products that only claim to have cleaning, fragrance, or whitening effects are generally categorized as "cosmetics" and regulated accordingly. Since 2021, the "Cosmetics Supervision and Management Regulations" have officially included toothpaste within the scope of cosmetics regulation, requiring its efficacy claims to be supported by sufficient scientific evidence and to be registered with the NMPA (National Medical Products Administration).

In addition to meeting the routine requirements for microorganisms and heavy metals as outlined in the *Cosmetic Safety Technical Specifications*, toothpaste products must undergo multiple tests based on their specific characteristics, including but not limited to: pH value, safety evaluation of oral hard tissues, hard particles, total fluoride, soluble fluoride, free fluoride, diethylene glycol, ethylene glycol, methanol, dioxane, and free formaldehyde.

If a product claims effects beyond cleaning, human efficacy evaluations or other scientific verifications must be conducted. The registrant must prepare and publish a *Summary of Efficacy Claim Evaluation* based on the evaluation results. Specifically, products claiming effects such as preventing tooth decay, inhibiting plaque, reducing dentin hypersensitivity, or alleviating gum problems must undergo human efficacy evaluations.

Oral care products falling under the category of disinfection products:

According to the definition in the "Hygienic Requirements for Disposable Sanitary Products," antibacterial (bacteriostatic) agents refer to preparations that come into direct contact with intact human skin or mucous membranes, possessing a certain bactericidal (bacterial and yeast-inhibiting) effect, but not intended to treat diseases or improve skin or mucous membrane symptoms.

If an oral care product claims to have antibacterial and disinfection functions such as "reducing oral bacteria," it may be classified as a "disinfection product" and managed accordingly. The effective bacteriostatic or bactericidal components of such products must comply with the requirements of relevant regulations such as the "Disinfection Management Measures." Common antibacterial and disinfection components include chlorhexidine (Hibitane), cetylpyridinium chloride (CPC), triclosan, etc. Products must clearly label their ingredients and content, and pass antibacterial rate testing.

Antibacterial/bacteriostatic effect claim standards:

A bactericidal rate ≥90% can be described as having antibacterial effect; a bactericidal rate ≥99% can be described as having strong antibacterial effect. An inhibition rate of ≥50%–90% can be described as having antibacterial effect; an inhibition rate of ≥90% can be described as having a relatively strong antibacterial effect.

Antimicrobial (bacteriostatic) agents must also meet relevant microbiological indicators and toxicological safety requirements.

Microbiological requirements for antimicrobial (bacteriostatic) agents:

Toxicological and safety requirements for antimicrobial (bacteriostatic) agents:

In addition, oral care products containing disinfectants must comply with the "Regulations on the Management of Labels and Instructions for Disinfectant Products," paying particular attention to the following compliance points in efficacy claims:

❑ Prohibition of Claims Regarding Disease Treatment

Non-pharmaceutical oral care products must not explicitly or implicitly claim to have therapeutic effects on diseases. For example, claims such as "treating oral ulcers," "curing gingival bleeding," "preventing periodontal disease," and "anti-Helicobacter pylori" are all illegal advertising.

❑ Prohibition of False or Exaggerated Advertising

False or misleading advertising is prohibited, such as "whitening in one brush," "complete whitening in 7 days," and "100% antibacterial."

❑ The instructions for antibacterial (antimicrobial) preparations should clearly indicate the following:

• product name;

• specifications and dosage form;

• main active ingredients and content (for plant-based ingredients, the main plant's Latin name must be indicated);

• type of microorganisms inhibited or killed;

• manufacturer information (name, address, contact number, postal code);

• manufacturer's hygiene license number (except for imported products);

• country or region of origin (except for domestically produced products);

• scope of use and method of use;

• precautions;

• implementation standards;

• production date and shelf life/batch number and expiration date.

Oral Care Products in the Category of Medical Devices/Pharmaceuticals

Medical device mouthwashes (such as oral ulcer mouthwash) typically work through physical means. If classified as a Class II medical device, such products should not contain any drug ingredients and cannot claim therapeutic functions. For example, some products relieve pain by forming a protective layer on the wound or add soothing ingredients to reduce inflammation, but these still fall under the category of physical effects.

If a product claims to have therapeutic effects such as "treating oral ulcers," "anti-infection," or "repairing oral mucosa," it must be managed as a drug and obtain the corresponding approval number. Its ingredients may include antibacterial drugs or hormones. Making unauthorized claims of therapeutic effects without approval is a serious violation of the law.

If you have any questions related to China disinfectant products registration and filing, please contact us via info@enter-co.com.

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