On the issuance of domestic non-special use cosmetics record management notice


State Food and Drug Administration Xu [2011] No. 181
April 21, 2011 release

Provinces, autonomous regions and municipalities Food and Drug Administration (Drug Administration), the unit:

To strengthen the management of domestic non-special use cosmetics, the State Food and Drug Administration formulated the "domestic non-special use cosmetics record management", is hereby issued, please comply, and on the matter are as follows:

First, the provincial food and drug supervision and management departments of the administrative area designated inspection agencies report to the State Bureau. The number of designated inspection agency, in principle, less than 3, less than 3 to the National Bureau needs to explain the situation.
Certification and accreditation in accordance with relevant provisions of accreditation of inspection has been made in manufacturing enterprises can issue inspection reports of the enterprise product, the enterprises should be the provincial food and drug supervision and management department and submit the appropriate evidence.
Provincial food and drug supervision and management departments should publish the designated inspection agency and have been in the provincial food and drug supervision and management departments for the record with a qualification test report issued by the production company, and in June 30, 2011 submitted to the National Bureau.

Second, the provincial food and drug supervision and management department designated inspection agency should have the following conditions:
(A) an independent legal personality of a third party inspection agency.
(B) health and safety inspection agency shall be in accordance with the provisions of the relevant national certification and accreditation, to obtain accreditation; human safety inspection agency shall obtain the qualification body cosmetic dermatology diagnosis.
(C) have independently assume "administrative licensing cosmetic inspection standard," China-Africa special cosmetics health and safety or human safety test test projects.
(D) has adapted its inspection work, the effective operation of the quality management system, and to maintain its impartiality, independence.

Third, the application of domestic non-special use cosmetics for the record, and can choose by the provincial food and drug supervision and management department designated inspection agency inspection, inspection reports across the country effectively.

Fourth, inspection bodies and inspection requirements:
(A) the inspection agency shall be in accordance with "cosmetic inspection standard administrative licensing" special use cosmetics Africa test items for testing.
(B) the inspection agency shall "Hygienic Standard for Cosmetics," Inspection and test methods to carry out the provisions of the inspection work.
(C) the inspection agency should refer to the "cosmetic inspection standard administrative license" in the style of inspection reports issued reports.

Fifth, since October 1, 2011 the domestic market from the first non-special use cosmetics, it should be in accordance with the "domestic non-special use cosmetics, record management," the relevant requirements of the record. October 1, 2011 has been put on the market but fails to "Cosmetics Health Supervision" and its implementation rules on filing requirements should be December 31, 2012, in accordance with the "domestic non-special use cosmetics record management" of the relevant requirements record. Has been put on the market and have been "cosmetic Health Supervision" and its Implementing Rules of the requirements for the record, do not resubmit the information for the record, but should be December 31, 2012 for "domestic non-special use cosmetics registration certificate."
Since the date of implementation of these measures have been put on the market but no longer in production of domestic non-special use cosmetics, should the provincial food and drug supervision and management department.


Accessories: Domestic non-special use cosmetics filing requests for information


State Food and Drug Administration
April 21, 2011

Domestic non-special use cosmetics record management

In order to strengthen the domestic non-special use cosmetics, record management, according to the "Cosmetics Health Supervision" and the relevant provisions of the development of this approach.

Second approach is applicable to domestic cosmetics manufacturers (hereinafter referred to as manufacturer) production of non-special use cosmetics.

Third of the State Food and Drug Administration should strengthen the domestic non-special use cosmetics for the record management guidance. Provincial food and drug supervision and management department is responsible for the administrative area of ​​the production of domestic non-special use cosmetics, record management, record management should establish a sound system, made according to relevant regulations to carry out the work of non-special use cosmetics for the record.

Article IV of domestic non-special use cosmetics products on the market should be in within 2 months from the manufacturer to the provincial administrative area where the food and drug supervision and management departments for the record, and record information submitted in accordance with the relevant requirements, filing procedures.
Commissioned production by the manufacturer (hereinafter referred to as Principal) to the actual production enterprises (hereinafter referred to as trustees) where the administrative area of ​​the provincial food and drug supervision and management departments for the record.
There are multiple trustees, and by the commissioning party the option to one of the trustees where the administrative area of ​​the provincial food and drug supervision and management departments for the record. The commissioning party shall submit registration certificate copy of the other trustees were administrative area where the provincial food and drug supervision and management departments.
Limited to exports from the actual manufacturer of the provincial administrative area to where the food and drug supervision and management departments for the record.

Article shall record the product manufacturer claims data integrity, standardization, authenticity, and is responsible for the safety of products and bear the corresponding legal responsibility.

Article domestic non-special use cosmetics application filing, should be made in accordance with non-special use cosmetics filings required to submit relevant information.
Limited to the export of cosmetics, the record in accordance with the requirements of these measures and submit relevant information.

Article VII application filed domestic non-special use cosmetics products that may be a security risk substances, there may be cosmetic in accordance with the security risk substances risk assessment guidelines for safety assessment required to submit information.

Article VIII of the provincial food and drug supervision and management department receives the record of domestic non-special use cosmetics after application, and complete information on filing the required form, shall be filed on the spot and sent in registration certificates within five days; filing incomplete or not not filing the required forms and explain the reasons.

Article IX style registration certificate by the State Food and Drug Administration to develop a unified.
Registration certificate number format is: provinces, autonomous regions and municipalities prepare short + G + makeup + 4 digit year number of words +6 bit order of the administrative area of ​​issuing numbers.

Article producers no longer have the record production of products, should take the initiative to inform the original record of the provincial food and drug supervision and management departments, the original record of the provincial food and drug supervision and management departments inform the cases to be filed.
Manufacturers of the products have been filed, shall record the date, every 4 years ago, within four months of the original record of the provincial food and drug supervision and management departments on whether to continue production of the product information note; overdue, the original record of the provincial food and drug supervision and management departments should cancel the product record.

Article XI of the product has been filed, the original record content is changed, change the contents of the response to re-record.
The product has been filed, the formula has not changed, the original manufacturer may not apply to change the product name (except for violation of relevant laws and regulations). After the change still using the original recipe name, logo on product packaging should be in the state, as distinct from pre-change product.

Article XII of the provincial food and drug supervision and administration department should strengthen the filing records and information management products, the timely disclosure of domestic non-special use cosmetics record information.

XIII of this approach since October 1, 2011 shall come into force.


Attachment:
Domestic non-special use cosmetics filing requests for information

The first application of domestic non-special use cosmetics for the record, should submit the following information:
(A) domestic non-special use cosmetics record application form;
(B) the name based on the product name;
(C) the product formulation (not including content, except for restricted substances);
(4) The product description and diagram of the production process;
(E) production equipment list;
(F) product quality and safety control requirements;
(G) packaging design (including product labels, product brochures);
(H) by the provincial food and drug supervision and management department designated inspection agency (hereinafter referred to as inspection body) inspection reports issued and related information;
(Ix) product safety may exist in the material safety risk assessment information;
(X) manufacturer health permit;
(11) other trustees of the health permit copies (if there are production);
(Xii) contract manufacturing agreement copy (if there are production);
(XIII) may help to record other information.

The second application is limited to the export of domestic non-special use cosmetics for the record, should submit the following information:
(A) domestic non-special use cosmetics record application form (only export products);
(B) the product name;
(C) the name of the importing country or region;
(D) the name of the commissioning party;
(E) products recipes (not including content, except for restricted substances);
(F) the importing country or region control product quality and safety standards and requirements;
(G) packaging design (including product labels, product brochures);
(Viii) other copies of trustees of the health permit (if commissioned production);
(I) contract manufacturing agreement copy (if there are production);
(X) may help to record other information.

Article domestic non-special use cosmetics application filed in accordance with this approach required to submit relevant information, record data in duplicate, a cross-provincial food and drug supervision and management department, a production company to stay archive. Disclosure of information requirements are as follows:
(A) the original disclosure of information by the applicant with official seal by page or Jifeng Zhang; inspection reports, and third-party documents notarized documents, except;
(B) the use of A4 size paper to print, use the clear distinguishing mark, according to the provisions of the order, and bound into books;
(C) the use of Chinese legal units of measurement;
(D) to declare the content should be complete, clear, complete the same project should be consistent;
(E) All foreign language (foreign address, website, registered trademarks, patents, names, etc., except in foreign languages ​​must be used) should be translated into standard Chinese, and foreign language translation attached to the corresponding data before;
(F) product formulations should be submitted text and electronic versions;
(G) the text version and fill in the electronic version of the content should be consistent.

Article IV of domestic non-special use cosmetics application filing, product formula information should meet the following requirements:
(A) should be in table form is provided in a table containing the same number of raw materials, the standard Chinese name, restricted substances, and other content with the purpose of the formula sheet, Times New Roman font size no smaller than a small V.
(B) the name of all raw materials should be provided; compound to compound in the form of raw materials must be declared, and shall indicate the name of each component.
Such as the formula used in the flavor of raw materials, not required to report the specific flavors and spices in the type and content of components, raw materials, the name of the "flavor" name.
(C) the formulation of raw materials (including compound ingredients in each component) of the Chinese name should be "international standard Chinese name cosmetics raw materials directory" using a standard Chinese name, without naming the international cosmetic ingredients (INCI name) or not included in the "International cosmetic raw material standards of the Chinese name directory "should be used" Chinese Pharmacopoeia "in the chemical name or plant name or Latin name, common name or trade name not be used, but except for compound materials.
(D) coloring agent should provide a "Hygienic Standard for Cosmetics" in the coloring agent contained in the index number (referred to as CI No.), except no CI number.
(E) contain animal organ extracts of tissue and blood products, should be submitted to the source of raw materials, quality specifications and allows the use of raw materials to produce proof of the country.
(F) Where the use of the product formulations derived from petroleum, coal tar hydrocarbons (except for a single component), should be indicated in the product formulation of the Chemical Abstracts index of raw materials (referred to as CAS number).
(G) "Hygienic Standard for Cosmetics" on the restricted substances in raw materials specifications, the materials should be submitted by the manufacturer issued specifications that the quality of raw materials.
(H) Where a claim for pregnant women, breastfeeding women, infants or children's products, should provide security considerations based on the principles of formulation (including the overall analysis formula), the choice of the principles and requirements of raw materials, production processes, quality control, etc. content information.

Article 5 When applying non-special use cosmetics made the record, product quality and safety control requirements should include the following:
(A) the color, odor, character and other sensory indicators;
(B) microbial indicators (except without testing), chemical health indicators;
(C) the claim or with α-hydroxy acid, while not containing α-hydroxy acid claim, but its total ≥ 3% (w / w) should have a pH value of the product indicators (water in oil (oil-like product), powder, powder type, the wax base class) and their detection methods.

Article inspection agency issued the inspection report and related information should include the following information:
(A) Product description;
(B) health and safety inspection reports (microbiological, chemical hygiene, toxicology);
(C) human safety inspection report (if any human trial report);
(D) Other new projects test report (if asbestos inspection report in cosmetics, etc.).

  

Beijing Tong Rui Lian Technology Co., Ltd.
Tel: 86-10-64284605   86-10-84366465
Fax: 86-10-84366465
E-mail:  bj500@126.com      bj2180@gmail.com