Technical Guidance for the Identification of New Cosmetic Ingredients (Draft for Comments)

   

On 19 January 2023, the National Institutes for Food and Drug Control released Technical Guidance for the Identification of New Cosmetic Ingredients (Draft for Comments). This helps applicants identify and classify their ingredients correctly, thus to submit a well-prepared dossier. This article is the translation of Annex 2 - the rationale for this draft, which encompasses the background, necessity for this draft, main contents, and notes.

Rationale

To standardize the safety assessment of new cosmetic ingredients, the National Institutes for Food and Drug Control under the instruction of the National Medical Products Administration(NMPA) drafts Technical Guidance for the Identification of New Cosmetic Ingredients (Draft for Comments) (hereinafter referred to as Technical Guidance (Draft for Comments)) following Regulations on the Supervision and Administration of Cosmetics, Administrative Measures for the Registration and Notification of Cosmetics, Rules for the Registration and Notification Dossier of Cosmetics, relevant laws and regulations, and mandatory requirements of national standards and specifications. The following is the rationale for this Technical Guidance (Draft for Comments).

 

I. The Necessity for This Draft

Since the promulgation of Regulations on the Supervision and Administration of Cosmetics and related regulations on 1 May 2021, new cosmetic ingredients are subject to registration and notification in accordance with their risk levels. Up to today, over 40 new cosmetic ingredients have been approved. This facilitates the application of new ingredients in cosmetics. However, in the process of registration and notification, some applicants misunderstand the identification, classification, categories etc. of cosmetics or submit with insufficient dossiers. This gives rise to the issues of confusion between new ingredients and already existing ingredients, claimed efficacy beyond the scope of cosmetics, the wrong choice of categories of cosmetics, etc. Therefore, the National Institutes of Food and Drug Control drafts this Technical Guidance (Draft for Comments) and specifies the identification of cosmetics from different dimensions, so as to expedite the development of the cosmetic industry and standardize supervision and administration of cosmetics under the new cosmetic regulations.

 

 

II. The Main Content of This Draft

The main content of Technical Guidance (Draft for Comments) encompasses the background, regulatory basis, applied scope, general principles, identification principles for new cosmetic ingredients, classification principles for the composition, origin and trait, manufacturing process and actual efficacy of new cosmetic ingredients, and naming principles of new cosmetic ingredients.

 

 

III. Notes for This Draft

1. To help applicants determine whether their ingredients are new ingredients or not, this Technical Guidance (Draft for Comments)specifies the identification of ingredients from four dimensions: composition, origin and trait, manufacturing process, and actual efficacy. The draft of this guidance is based on the current Chinese regulation system on cosmetics and related international regulations.

 

2. With reference to the identification principles for single-component and compound-components in REACH and CLP, in line with the current cosmetic industry in China, Technical Guidance (Draft for Comments)specifies that a component can only be defined as a ‘new single-component' when it has a clear chemical structure and its concentration is equal or above 80%, while a component is defined as a ‘non-single-component’ when it has no clear chemical structure.