People often use the term "personal care products" to refer to a wide variety of items that we commonly find in the health and beauty departments of drug and department stores. These products may fall into a number of different categories under the law.

US-If Cosmetics are not FDA-approved, How are They Regulated?

FDA-regulated does not mean FDA-approved. FDA does not have the legal authority to approve cosmetics before they go on the market, although we do approve color additives used in them (except coal tar hair dyes). However, under the law, cosmetics must not be "adulterated" or "misbranded." For example, they must be safe for consumers when used according to directions on the label, or in the customary or expected way, and they must be properly labeled. Companies and individuals who market cosmetics have a legal responsibility for the safety and labeling of their products.

China-How to Understand the Relationship Between Product Label Claims and the Efficacy Claims in Classification Codes?

The efficacy claims stated on the product label must fall within the scope of efficacy claims specified in the classification code reported in the Cosmetic Registration and Notification Dossier. The claims on the label cannot exceed the efficacy scope covered by the classification code. For example, if the reported efficacy claim under the classification code is solely "moisturizing," the product label draft may include claims related to moisturizing functions, such as "moisturizing," "reducing moisture loss," or "relieving skin dryness." However, claims beyond the scope of moisturizing, such as "firming" or "soothing," are not permitted.

China-Do "Microcrystal" or "Microneedle" Products Fall Within the Definition of Cosmetics?

If a product claimed to be a "microcrystal" or "microneedle" product is comprehensively determined—based on its formulation, manufacturing process, method of use, and the physical form of its contents—to be not applied to the surface of the skin, then such a product falls outside the scope of the definition of cosmetics as stipulated in the Cosmetics Supervision and Administration Regulations.

China-How to Assess the Phototoxicity and Photoallergenicity of Cosmetic Ingredients?

The registrant/filer may apply the seven types of evidence outlined in the Guidelines for the Use of Cosmetic Ingredient Data to conduct safety assessments for most ingredients listed in the Inventory of Existing Cosmetic Ingredients in China (IECIC) . For a small number of ingredients where the above evidence types cannot be applied, the registrant/filer should follow the requirements of the Technical Guidelines for Cosmetic Safety Assessment to determine potential health hazard effects, including phototoxicity and photoallergenicity, based on factors such as product usage and exposure routes. If a comprehensive analysis or testing of the ingredient’s structural characteristics demonstrates that it does not have UV absorption properties or that it has no potential for outdoor strong UV exposure (e.g., ingredients used in rinse-off products or cosmetics intended for nighttime use), the assessment of skin phototoxicity and photoallergenicity may be exempted.

China-How to Determine the Toxicological Endpoints that Need to be Assessed for Ingredients?

The registrant/filer should follow the requirements of the Technical Guidelines for Cosmetics Safety Assessment to determine potential health hazard effects of ingredients based on factors such as product usage, exposure routes, and actual exposure levels. Additionally, depending on the physicochemical properties of the ingredient, quantitative structure-activity relationships, toxicological data, usage history, clinical studies, epidemiological investigations, and toxicity data of similar compounds, certain toxicological endpoints may be added or exempted from assessment. For example, if sufficient evidence confirms that a certain ingredient has a history of safe consumption, the assessment of systemic toxicity as a toxicological endpoint may be exempted.

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