From now on, compliance requirements for oral care products have become a challenge for cross-border e-commerce sellers. Modern consumers are not only concerned about the aesthetic effect of oral cleaning, but also the long-term health effects. How can Taiwanese manufacturers meet these growing demands while ensuring the safety of their products? SGS Taiwan's experts have compiled a list of key compliance points for cross-border brand owners of oral care products:
Compliance standards for oral hygiene products (e.g. toothpaste, tooth powder, mouthwash, etc.):
- Product additives are subject to strict safety regulations in Taiwan, please refer to the Cosmetic Hygiene and Safety Administration Act, Article 3, Section 2 and Health Authorized Food No. 1071610115 for more details.
- Did you know? Heavy metal testing must cover the four heavy metals arsenic, lead, cadmium and mercury.
- Microbial control is another key area, with standardized tests for aerobic counts, Escherichia coli, Staphylococcus aureus, Pseudomonas aeruginosa and Candida albicans.
- Whether the amount of preservatives added is within the standard range is also a key point of scrutiny.
- Ingredients that should never be included in the product include formaldehyde, western drugs, estrogen, steroids and other harmful substances.
- In addition, experts also recommend evaluating "diethylene glycol, triclosan, pH, effective fluorine content, and product stability," which are key factors that can affect the experience of using the product.
The most unexpected thing is that "Denture Cleansing Lozenges" is categorized as a Class I medical device, with FDA Medical Device Classification Code F3520, and its Chinese and English names are "OTC dental appliance Cleanser without prescription". The product packaging must be labeled with a "Medical Device License" and the sales channel must have a "Drug Dealer License".
Compliance points for oral cleaning aids such as toothbrushes, dental floss and interdental brushes:
- Toothbrush products must comply with Taiwan's CNS 964 and ISO 20126 commodity standards and pass a number of performance tests, including bristle firmness and handle durability.
- In addition to the basic quality requirements, electric toothbrushes need to pay more attention to electrical safety and must pass international standard tests and regularly update the relevant quality reports.
- Floss and floss sticks must comply with the ISO international standard, assessing the overall material, shape and strength, and ensuring that they do not contain perfluoroalkyl compounds such as PFOS/PFOA.
- For example, the smoothness of use, the firmness of the bristles, the durability of the brush handle and the service life of an interdental brush are all determined by clear test methods in accordance with ISO international standards.
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# Amazon Global Store # Oral Care Products # Cross-border E-commerce # Compliance Policy # Taiwan Manufacturers # Brand Protection # International Brands # E-commerce Platforms
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