Article 1 The following materials shall be submitted when applying for filing domestic cosmetics for non-special purposes:
(1) An application form for filing domestic cosmetics for non-special purposes;
(two) the naming basis of the product name;
(3) product formula (excluding content, except restricted substances);
(four) a brief description and sketch of the production process of the product;
(5) List of product production equipment;
(six) product quality and safety control requirements;
(seven) product design and packaging (including product labels, product manuals);
(eight) the inspection report and related materials issued by the inspection agency designated by the provincial food and drug supervision and management department (hereinafter referred to as the inspection agency);
(nine) the relevant safety assessment data of the safety risk substances that may exist in the product; ?
(ten) a copy of the hygiene license of the production enterprise;
(eleven) a copy of the hygiene license of other clients (if any);
(12) A copy of the production agreement (if any);
(thirteen) other information that may be helpful for the record.
Article 2 To apply for restricting the export of domestic cosmetics for non-special purposes, the following materials shall be submitted:
(1) Application Form for Filing Domestic Cosmetics for Non-Special Use (export products only);
(2) product name;
(3) Enter the name of the country or region;
(4) Name of the entrusting party;
(five) product formula (excluding content, except restricted substances);
(6) Input the product quality and safety control standards and requirements of the country or region;
(seven) product design and packaging (including product labels, product manuals);
(8) Copies of health permits of other consignees (if any);
(nine) a copy of the commissioned production agreement (if any);
(ten) other information that may be helpful for the record.
Article 3 Anyone who applies for filing domestic cosmetics for non-special purposes shall submit relevant materials in accordance with the requirements of these Measures. The filing materials are in duplicate, one kept by the provincial food and drug supervision and administration department and the other kept by the production enterprise. The application information requirements are as follows:
(1) The original application materials shall be stamped with the official seal or riding seal by the applicant page by page; Except inspection reports, notarized documents and third-party certification documents;
(2) Print on A4 paper, use obvious distinguishing marks, arrange them in the prescribed order, and bind them into volumes;
(three) the use of Chinese legal units of measurement;
(four) the contents of the declaration should be complete and clear, and the same item should be filled in consistently;
(five) all foreign languages (except overseas addresses, websites, registered trademarks, patent names, etc.). , must be in a foreign language) should be translated into standardized Chinese, and the translation should be accompanied by corresponding foreign language materials;
(six) the product formula should be submitted to the text version and electronic version;
(seven) the contents of the text version and the electronic version should be consistent.
Article 4 To apply for the filing of domestic non-special cosmetics, the product formula information shall meet the following requirements:
(1) A formula table containing raw material numbers, standard Chinese names, contents of restricted substances, purposes of use, etc. It shall be provided in the same table in the form of a table, and the font size shall not be less than ì 5.
(2) The names of all raw materials shall be provided; The raw materials of compounds must be declared in the form of compounds, and the names of each component must be marked.
If the essence raw material is used in the formula, it is not necessary to declare the type and content of specific perfume components in the essence, and the name of the raw material is "essence".
(3) The Chinese names of formula raw materials (including ingredients in composite raw materials) shall be in accordance with the standard Chinese names in the Catalogue of International Standard Chinese Names of Cosmetic Raw Materials. If there is no international name (INCI name) of cosmetic raw materials or it is not listed in the Catalogue of Chinese Names of International Standards for Cosmetic Raw Materials, the plant names or chemical names or Latin names in China Pharmacopoeia shall be used, and trade names or generic names shall not be used, except for compound raw materials.
(4) The colorant shall provide the colorant index number (CI number for short) specified in the Hygienic Standard for Cosmetics, unless there is no CI number.
(5) If it contains extracts from animal organs and blood products, it shall submit the proof of the source, quality specifications and raw materials allowed to be used in the producing country.
(6) If hydrocarbons derived from petroleum and coal tar (except single component) are used in the product formula, the chemical abstracts index number (CAS number for short) of relevant raw materials shall be indicated in the product formula. ?
(7) If the hygienic standard for cosmetics is limited to the specification of materials and raw materials, the certificate of raw material quality specification issued by the raw material production enterprise shall also be submitted.
(8) If the product claims to be used by pregnant women, lactating women, children or infants, it shall provide information on formula design principles (including overall formula analysis report), raw material selection principles and requirements, production technology, quality control and other contents based on safety considerations.
Article 5 To apply for filing domestic cosmetics for non-special purposes, the requirements for product quality and safety control shall include the following contents:
(1) Sensory indicators such as color, smell and character;
(two) microbial indicators (except those that do not need to be tested) and hygienic chemical indicators;
(3) Products that claim to contain α -hydroxy acid or do not claim to contain α -hydroxy acid, but the total amount is ≥3%(w/w), should have pH index (except water-in-oil (oily products), powder, powder cake and wax-based group) and its detection method.
Article 6 The inspection reports and related materials issued by inspection institutions shall include the following contents:
(a) product description;
(two) health and safety inspection report (microbiology, hygiene chemistry, toxicology);
(3) Human safety inspection report (if any);
(4) Test reports of other new projects (such as asbestos test reports in cosmetics).