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Domestic non-special use cosmetics record management notice

发布日期:2011-04-21

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 follow the instructions of and informed 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 three of the State Council are required to make the note.
Certification and accreditation in accordance with relevant provisions, accreditation of testing has been made in manufacturing enterprises can issue inspection reports of the enterprise product, the enterprises should be the provincial food and drug administration departments for the record and submit the evidence.
Provincial food and drug supervision and management departments should publish the designated inspection agency and in the provincial food and drug supervision and management department with an inspection report qualified production companies, and in June 30, 2011 submitted to the National Bureau.

Second, the provincial food and drug administration 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 relevant national certification and accreditation requirements to obtain accreditation; human safety inspection agency shall obtain the qualification body cosmetic dermatology diagnosis.
(C) have independently assume "cosmetic inspection standard administrative licensing" special use cosmetics African health and safety or human safety test test projects.
(D) has adapted its inspection work, the effective operation of 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 administration to test the designated inspection agency, 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," under the inspection and test methods to carry out 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 the implementation details of the requirements for the record, should be December 31, 2012, in accordance with the "domestic non-special use cosmetics, record management," the relevant requirements of 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 it 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 ​​domestic production of 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 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 administration 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 of the provincial administrative area where the food and drug administration departments for the record. Principal should be a copy of registration certificate were submitted to the other trustees of the provincial administrative area where the food and drug administration.
Limited to exports from the actual manufacturer of the provincial administrative area to where the food and drug administration departments for the record.

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

Article 6 When applying non-special use cosmetics made the record should be made non-special use cosmetics, according to 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 the assessment of safety data submitted.

Article VIII of the provincial food and drug administration received the record of domestic non-special use cosmetics after application of the information is complete and the required filing forms, filing and should be spot on registration certificate issued 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 digit year number + 6 +4 word bit sequence 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 control department of 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 to submit the product to the production of note; overdue, the original record of the provincial food and drug supervision and management departments shall 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 recipe has not changed, the manufacturer shall not apply to change the original product name (except for violation of relevant laws and regulations). Still using the original formula changed the name, logo on the product packaging should be marked to distinguish them from pre-change product.

Article XII of the provincial food and drug supervision and management departments 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);
(D) production processes and briefly sketch;
(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 administration designated inspection agency (hereinafter referred to as inspection body) inspection reports issued and related information;
(I) the product material may be a security risk assessment of the safety information;
(X) manufacturer health permit;
(11) other trustees of the health copy of the license (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 there are 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 electronic version of the complete 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, the purpose of such use of the content of the recipe table, 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, trade name or common name not be used, but except for compound materials.
(D) coloring agent should provide a "Hygienic Standard for Cosmetics," set forth in the coloring agent index (referred to as CI No.), except no CI number.
(E) containing animal tissues and extracts of 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 numbers).
(G) "Hygienic Standard for Cosmetics" on the restricted substances in raw materials specifications, and should be submitted by the manufacturers of raw materials issued by the specification that the quality of raw materials.
(H) Where a claim for pregnant women, lactating women, children or infants of the product, safety considerations should be based formula design principles (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) of the product should have a pH value indicator (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.).

Schedule:
1. Domestic non-special use cosmetics record application form
2. Domestic non-special use cosmetics record application form (only export)
3. Domestic non-special use cosmetics registration certificate (style)
4. Product Description Table of the original record (pattern)

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