FAQs Vol. 4 | Further Interpretation on China Cosmetic Registration and Notification under New Regulations

It depends on the ingredient quality specification. If the ingredient supplied is of the same quality specification, multiple manufacturer’s information can be filled in; otherwise, the information of each ingredient and its manufacturer shall be provided separately. 

When filling in the formula table, in principle, the same ingredient is not allowed to be repeatedly filled in. However, if the same ingredient has different quality specifications, it can be filled in separately, and the corresponding quality specification must be remarked.

Most vegetable oils come from plant seeds and fruits, and some of them come from plant leaves, barks, roots, petals and stamens, etc. In order to determine the safety of the source of plant extraction, it is recommended to indicate the extraction part when filling in the formula.

Kathon is a common preservative in cosmetics. It is a mixture of methylchloroisothiazolinone and methylisothiazolinone with magnesium chloride and magnesium nitrate, and usually used in cosmetics in the form of aqueous solution. According to the Provisions for Management of Cosmetic Registration and Notification Dossiers, the product formula should provide the names of all ingredients, including the standard Chinese name, the International Nomenclature of Cosmetic Ingredients (INCI name) or the English name. If Kathon contains water or other solvents, corresponding information shall be filled in the formula to ensure that the formula table contains all the ingredients information.

Hydrosol refers to a 100% saturated distilled liquid separated from essential oils during the distillation and extraction process. Plant extract refers to a substance extracted or processed from plant (all or a certain part of plant) using appropriate solvents or methods. These two substances have different definitions, preparation methods, saturation, distribution ratios and contents of the ingredients. Therefore, plant extract cannot be equated to hydrosol, and product containing plant extract shall not be named as ** hydrosol.

The Administrative Measures on Cosmetics Labeling stipulates: "the use of specific ingredient names or vocabularies indicating the types of ingredients shall be consistent with the product formula, and the efficacy of the ingredients in the product shall also be consistent with the product efficacy claims". The claim of "amino acids" is inconsistent with the ingredients (amino acid surfactants) contained in the formula, and their efficacies are also different. 

The Cosmetic Supervision and Administration Regulation clarifies that NMPA encourages and supports enterprises to conduct research and introduce innovation in cosmetics. Moreover, the Administrative Measures on Cosmetics Labeling stipulates that, it is prohibited for enterprises to prove or recommend products by displaying names or images of appointed professionals, state organs, public institutions, medical institutions, public welfare institutions and other units as well as their staff on labels. Enterprises should attach importance to product quality development and devote themselves to brand building, and shall not mislead customers by implying the products have medical efficacy with claims of "medical research and development institutions" and "time-honored pharmaceutical brands".

"Li Shizhen Chinese medicine", "** Pharmacy", etc., as part of the company name of the notifier or the manufacturer, can be marked on the product packaging, but cannot be marked in a deliberately stressed and emphasized manner. Moreover, "Li Shizhen Chinese medicine", "** Pharmacy ", etc. cannot appear in the product name as a registered trademark; otherwise, it violates the regulation against using medical terms in product names or claims.

According to the article 15 of the Standards for Cosmetic Efficacy Claim Evaluation, except for special provisions, priority shall be given to the test method in (I) and (II) for efficacy evaluation test. If no methods are prescribed in (I) and (II), the test methods in (III) and (IV) can be discretionarily selected:

1. Methods prescribed in mandatory national standards and technical norms for cosmetics in China;

2. Methods specified in other relevant regulations, national standards and industry standards in China;

3. Methods prescribed in relevant foreign regulations or technical standards;

4. Methods released by domestic or international authoritative organizations, technical institutions and industry associations, methods published in professional academic journals and magazines, or self-drafted and developed methods. Evaluation institutions shall complete the necessary test method transfer, confirmation or validation before carrying out the evaluation to ensure the scientificity and reliability.

The Technical Guidelines for Cosmetic Safety Assessment (2021) stipulates that, to prove the safety of ingredients, the simplified safety assessment report can adopt the following evidences:

• Requirements listed in Safety and Technical Standards for Cosmetics

• Assessment conclusion published by authoritative organizations

• The ingredient concentration in the enterprise’s marketed product

• The ingredient highest historical use concentration announced by Inventory of Existing Cosmetic Ingredients in China (2021)

The sources of the relevant data cited in the safety assessment report shall be clearly listed in the "References" in accordance with the format requirements. Cosmetic registrants/notifiers should carry out safety assessments on their own or entrust professional institutions to compile safety assessment reports, and be responsible for the authenticity and scientificity.

Non-sunscreen products that use chemical sunscreen in the submitted formula shall be tested for the chemical sunscreens contained. For products with chemical sunscreen content ≥0.5% (w/w) (except for rinse-off products, perfumes, and nail polishes), in addition to the prescribed tests, skin phototoxicity tests, skin sensitization tests and tests on SPF values should be conducted as well. Based on their actual purpose of use, the chemical sunscreens can serve as a "stabilizer" or a "protective agent", but not a "skin conditioning agent".