To implement the upcoming regulatory scheme on toothpaste prescribed in the CSAR and standardize the management of toothpaste ingredients, China NMPA authorized China Oral Care Industry Association (COCIA) to collect existing toothpaste ingredients in the Chinese market and formulate the first draft of Inventory of Existing Toothpaste Ingredients.
On July 29, COCIA released a notice encouraging companies to submit their existing ingredients usage information and specifying the requirements for submission. The collection period will last until August 20. The usage information can be sent to the COCIA by email at [email protected].
Information Required for Submission
According to the notice, the existing toothpaste ingredients specifically refer to the ingredients used in the toothpaste that has been marketed in China before July 31, 2020. Companies shall submit the usage information of eligible ingredients by filling out the existing toothpaste ingredients collection form designated by COCIA and enclose the corresponding proofs of usage as well. Details of the usage information and proofs of usage are shown below:
Collection Form | Proofs of Usage |
1) Required Information l English INCI name l Chinese INCI name l CAS number l The maximum usage amount (%) l Purpose of use l Product name 2) Optional information l Concentration (for plant extract) l Extracting solvent (for plant extract) l Animal name (for animal extract) l Organ (for animal extract) l Mineral name (for mineral substances) l Place of production (for mineral substances) l Category (for microbial fermentation substances, e.g. enzymes) l Starting material (for microbial fermentation substances, e.g. enzymes)
| l For ingredients used in domestic products, their sales packaging (cut-away photos) and corresponding marketed records (including outbound orders, electronic sales records, etc.) must be provided l For ingredients used in imported products, customs clearance certificates must be provided, including the original label and the corresponding Chinese translation (shall contain the foreign product name and sales packaging) |
Note: 1. The product name provided in the collection form shall conform to that in the proofs of usage. 2. The ingredients shall be listed in alphabetical order of their Chinese INCI Name in the collection form. | |
Points for Attention
1. If multiple companies use the same ingredient, the company with the largest use of the ingredient is responsible for providing the product formula and feeding records as proof.
2. If an ingredient has been filled in by one company, other companies do not need to fill it again but need to provide all the proofs of using the ingredient.
3. For compound ingredients composed of several components, the component not included in the full ingredient list of the packaging must be reported together with the compound ingredient. And the packaging of products using the compound ingredient and safety data (MSDS) of the compound ingredient shall be submitted.
4. Substances added to ingredients for ensuring the ingredients quality (e.g. trace stabilizers, preservatives, antioxidants) and not marked on the product packaging must be reported and the certifications of ingredient supplier must be provided.
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