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Information Details
On the disclosure of the results of the simple application and approval of the 11th batch of new chemical substance environmental management registration certificates in 2019
Release time:
2019-09-27 16:59
Introduction to 1. Project
1. Background introduction
a. In the global cosmetics sales ranking, China is second only to Japan and the United States, ranking third. With the upgrading of China's economic structure, the cosmetics market has a bright future.
B. Chinese regulations require that cosmetics listed in China must go to the relevant CFDA departments for filing or administrative licensing procedures.
c. As drugs and health foods have been licensed for a relatively long time in China, while cosmetics can be legally listed in China in a relatively short period of time, cosmetics have become the preferred health products for foreign manufacturers, domestic and foreign trading companies and other companies interested in exploring the Chinese market.
d. According to the requirements of laws and regulations, imported non-special-purpose cosmetics entering the Chinese market must be filed with the drug regulatory department and obtain the "Imported Non-Special-purpose Cosmetics Filing Certificate"; imported special-purpose cosmetics must complete the administrative license application at the drug regulatory department and obtain "Approval for Administrative License for Imported Special-purpose Cosmetics".
2. Project objectives
The goal of this project is to help customers obtain the record certificate of imported non-special-purpose cosmetics or the approval of the administrative license for imported special-purpose cosmetics.
2. Project Process
1. Main processes include:
a. Filing of reporting responsible units in China (imported cosmetics)
B. preparation of application sample inspection data
C. determine the testing mechanism and send samples for inspection
d. Preparation of application materials for cosmetics filing/administrative licensing
E. submit application materials for cosmetics filing/administrative license application
f. Obtain the filing certificate/administrative license approval for imported non-special purpose cosmetics
g. Flow diagram
Imported cosmetics registration, filing process
2. Application materials
To apply for the filing of imported cosmetics for non-special purposes, the following materials shall be submitted:
Application form of administrative license for (I) import of non-special-purpose cosmetics;
Naming basis for Chinese name of (II) product;
(III) product formula;
(IV) product quality and safety control requirements;
(V) the original packaging of the product (including product label and product manual); if the packaging is to be specially designed for the Chinese market, the product design packaging (including product label and product manual) shall be submitted at the same time;
(VI) inspection reports and relevant materials issued by licensed inspection institutions recognized by the State Food and Drug Administration;
Safety assessment materials related to substances that may have safety risks in (VII) products;
(VIII) a copy of the power of attorney of the administrative license reporting responsible unit in China and a copy of the business license of the administrative license reporting responsible unit in China and affix the official seal;
(IX) that the raw materials used in cosmetics and the sources of raw materials meet the requirements for the prohibition and restriction of high-risk substances in the mad cow disease epidemic area;
Documents certifying that the (X) product is produced and sold in the producing country (region) or the country (region) of origin;
(11) Other information that may be helpful for filing.
Attached is a commercially available sample that has not been unsealed by the licensed inspection agency.
To apply for an administrative license to import cosmetics for special purposes, the following materials shall be submitted:
Application form of administrative license for (I) import of cosmetics for special purposes;
Naming basis for Chinese name of (II) product;
(III) product formula;
Brief description and sketch of (IV) production process;
(V) product quality and safety control requirements;
(VI) the original packaging of the product (including product label and product manual); if the packaging is to be specially designed for the Chinese market, the product design packaging (including product label and product manual) shall be submitted at the same time;
(VII) inspection reports and relevant materials issued by licensed inspection institutions recognized by the State Food and Drug Administration;
Relevant safety assessment data of substances in (VIII) products that may have safety risks;
(IX) application for hair, bodybuilding, beauty milk products, should be submitted to the efficacy of ingredients and its use based on scientific literature;
(X) a copy of the power of attorney of the administrative license reporting responsible unit in China and a copy of the business license of the administrative license reporting responsible unit in China and affix the official seal;
(11) A letter of commitment that the raw materials and sources of raw materials used in cosmetics meet the requirements for the prohibition and restriction of high-risk substances in the mad cow disease epidemic area;
(12) documents certifying that the product is produced and sold in the producing country (region) or the country (region) of origin;
(13) Other materials that may contribute to the administrative license.
Attached is a commercially available sample that has not been unsealed by the licensed inspection agency.
Introduction to the 3. New Deal
1. Domestic cosmetics for non-special purposes shall be filed online from June 30, 2014.
2. Whitening products have been classified into special-purpose cosmetics freckle removal management since June 2014.
3. If the risk assessment data of domestic non-special purpose cosmetics can fully confirm their safety, the relevant toxicology test can be exempted.
4. Toothpaste products are included in the regulatory scope of cosmetics.
4. FAQ
1 Definition of Cosmetics
In November 1989, the regulations on hygienic supervision of cosmetics were issued, which defined cosmetics for the first time. The regulations stipulate that cosmetics refer to daily chemical industrial products that are spread on any part of the human body surface (skin, hair, nails, lips, etc.) by rubbing, spraying or other similar methods to achieve the purpose of cleaning, eliminating bad odors, skin care, beauty and grooming.
Some products belong to the category of cosmetics in foreign countries, but they need to be declared as drugs when entering the country, such as nursing products to promote wound healing. Whether the product can be declared according to cosmetics needs to be analyzed according to regulations.
2. Classification of Cosmetics
In my country, cosmetics declarations are mainly divided into two categories: special-purpose cosmetics and non-special-purpose cosmetics, which are divided into domestic and imported (including Taiwan, Hong Kong, and Macau).
Special purpose cosmetics are: hair, sunscreen, bodybuilding, deodorant, beauty milk, freckle, hair dye, hair removal, perm.
Non-special-purpose cosmetics refer to cosmetics that are not used for special purposes.
Cosmetics for special purposes shall be subject to a registration system, and cosmetics for non-special purposes shall be subject to a filing system.
3. Which institutions are mainly involved in cosmetics declaration?
The declaration of cosmetics mainly involves four types of institutions: notarization institutions; testing institutions; Food and Drug Administration (CFDA);
Reception hall; review committee; administrative examination and approval department.
a. Notary public: notarize the materials required by the government to be notarized;
B. Testing agencies: CFDA designated a number of testing agencies, commissioned by the enterprise, responsible for the technical inspection of products, and issued inspection reports.
c. Food and Drug Administration:
D. CFDA acceptance hall: responsible for the preliminary examination of the enterprise's application materials, materials meet the requirements of the acceptance and is responsible for arranging to participate in the review meeting; Notify the enterprise of the review opinions; Report the products to be approved to the State Food and Drug Administration; Issue certificates, etc.
e. CFDA Health Food Review Center: responsible for the technical review of the declared products, issued technical review conclusions.
F. Drug and Cosmetic Registration Management Department: administrative review, and according to the law to make a decision on whether to approve the administrative license.
g. Provincial Food and Drug Administration: responsible for the audit of the production capacity of enterprises with domestic special products and issuing audit opinions; responsible for the filing of domestic non-special products.
4. Cosmetics declaration cycle
The declaration cycle of cosmetics varies according to the product category, the preparation of data, the selection of testing items and testing institutions.
The cycle consists of: data preparation cycle, detection cycle, review and approval cycle
A. data preparation cycle: depends on the speed of the customer's basic data preparation and the proficiency of the reporting material writers.
B. testing cycle: cosmetics according to the different categories of testing may include line microbiological testing, health chemical testing, toxicity testing, human safety and functional testing. According to the different inspection items, the inspection time is generally 2-4 months, special purpose cosmetics due to the need to do human body test,
time is relatively long.
C. review and approval cycle: depends on whether the application documents meet the requirements of laws and regulations, the detailed requirements of the review experts on the data, and the review policy.
A good consulting agency can reasonably arrange time in accordance with the requirements of laws and regulations, guide enterprises to prepare materials in stages in detail, and prepare mature declaration documents for them, so as to complete the declaration work efficiently and smoothly.
5. Cosmetic declaration fee
Fees consist of: notarization fee/translation fee, testing fee, consulting service fee
Our company is entrusted by the customer to charge consulting service fees for the declaration work. The specific fees are agreed according to the customer's product situation. Other fees are charged by a third party. Different fees of selected institutions are different and there is no unified pricing. Our company will advise customers to choose suitable third-party institutions such as notarization institutions and testing institutions according to the product situation, so as to maximize cost savings under the premise of ensuring quality.
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