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More Info-Beijing Alan-China CFDA registration and approval, sanitary license, cosmetics and more
China's CFDA and Beijing Alan Business Solutions, Inc.


Until 1998, China's food regulation and safety management of food, pharmaceuticals and State Food & Drug Administration (SFDA) was governed by the Ministry of Health. In 1999, State Drug Administration (SFDA) became a separate bureau in 1999. This Agency's name was changed in 2003 to the State Food and Drug Administration (SFDA). In July 2007, irregularities within the organization was into question. In March 2008, the SFDA was restructured back into the Ministry of Health.

To deepen government efficiency and transparency, The State Council pressed again for government institutional reform. SFDA was renamed to China Food Drug and Administration (CFDA) on March 14th, 2013. The new CFDA expanded with additional responsibilities and powers, such authority previously assumed by the General Administration of Quality Supervision, Inspection and Quarantine (AQSIQ). CDFA as a ministry organization still directly reporting to and supervised by the State Council. In addition, governments at province, city or county level are consolidating product regulatory and supervision function creating an elevated Food and Drug regulatory agency to exercise centralized and uniform regulation and supervision. In the future, part of the new reform, certain products may also be submitted for approval at province level.

The SFDA is responsible for developing policies and plans for the supervision of drugs, medical devices, cosmetics, and food safety in the consumer contact sector and supervising their implementation. It also participates in drafting relevant laws, regulations, and normative documents.

The Agency conducts international exchanges and cooperation related to food and drug regulation, in addition to overseeing other work assigned by the State Council and the Ministry of Health.

The CFDA requires that all cosmetics, medical device, IVD and pharmaceutical companies with no location in the People's Republic of China appoint a registered Legal Agent and After Sales Service Agent (in-country regulatory representative). Appointed CFDA Legal Agents and After Sales Agents must be residents of China or maintain a place of business in China. Beijing Alan Business Solutions, Inc. can serve you as a Legal Agent and/or After Sales Agent to protect your business interest, in addition to obtaining the import product registration/sanitary license.

Over the past 15 years, as an industry leader, we helped nearly 1,000 companies and processed thousands of products achieving a 97% success rate.

Product Registration: Cosmetics

Market overview

China has one of the world’s oldest civilizations with a history dating back 5,000 years, and is the most populous nation on the planet with over 1.3 billion people. Thanks to its consistently rapid economic development since the late 1970s, it is now the world’s second largest economy in terms of GDP. The World Bank has projected that it will surpass the United States as the world’s largest economy in the coming decades. Given an enormous increase in disposable income, Chinese consumers increasingly desired more sophisticated, premium products in many categories, including beauty and skincare.

Procter & Gamble was the first multinational to enter mainland China’s beauty and skincare market, with Olay in 1989. With the exception of Estee Lauder which waiter until 2002, the other multinationals quickly followed: Shiseido in 1991 with Shiseido, L’Oréal in 1997 with L’Oréal Paris, and Unilever in 1998 with Hazeline. They introduced extensive portfolios of high-quality brands and products, and brought marketing expertise, financial resources and cutting-edge R7D (which were soon localized by establishing local research centers). Initially, they drove out weak local brands, replacing them in the most desirable department stores.

As of 2010, the top five companies in the beauty and skincare market (including personal care) were all multinationals: P&G, L’Oreal, Shiseido, Unilever and Amway. Yet they still only accounted for 40% of the €18 billion market, and now had strong local competition. Firms such as Shanghai Jahwa and Jala had experienced extremely strong local strong growth and their brands were available everywhere, from high-end department stored to local cosmetic stores, presenting a formidable challenge.

Definition of cosmetics

The sanitation supervisory ordinance for cosmetics defines cosmetics as following: Cosmetics means articles intended to be rubbed, poured or sprayed on the human body (skin, hair, nails, lips, etc.) or oral mucosa for cleansing, protection, beautifying or make-up.

CFDA categorizes cosmetics using three criteria:

1. Form: cream, gel, lotion, etc.

2. Area of application: skin, hair, etc.

3. Effect: general cosmetics and cosmetics for special purpose.

*General cosmetics: skin protection, hair control, make-up, fragrance, oral hygiene, etc.

*Cosmetics for special purpose: prevention of hair loss, hair dyeing, hair removal, supple breast, figure management, odor removal, removal of blemish, sun protection.

The criterion first considered during the conformity assessment when applying for the sanitation permit is the effect of cosmetics.For cosmetics containing new ingredients or for special purposes, safety evaluation tests and clinical studies must be conducted together.

Total duration for general-purpose cosmetics based on 5 working days.

Industry Average: over 180 days vs. Beijing Alan: 115 to 150 days

Notes:

*No second application shall be filed for any product not approved for any reason involving safety of the product, such as containing any prohibited substance or any out-of-limit restricted substance, failure to pass through the hygiene and safety tests, etc. (Article 13, 25 Dec 2009)

*Import product registration/sanitary license is valid for 4 years. We provide the renewal service at a minimal cost.

*Due to the often-changing policies, this information is subject to change. Contact us for the most current information.

What kind of materials do I need to file for the general-purpose cosmetics?

  • The application form for filing of imported non-special purpose cosmetics
  • The naming basis of the product’s Chinese name
  • Formula of the product
  • The product quality and safety control requirements
  • The original product package (including product label, product description) and, if the package is designed exclusively for China's market, the designed product package (including product label, product description)
  • The testing reports and relevant materials issued by a licensed testing institution recognized by the State Food and Drug Administration
  • Documents relevant to the safety assessment of the potential hazardous substances in the product
  • A copy of the filed letter of authorization for the responsible agency in China and a sealed copy of the said agency’s business license
  • The letter of commitment undertaking that the ingredients used in the product as well as the sources of such ingredients meet the requirements for the prohibited or restricted use of highly risky substances in the mad cow disease infected areas
  • Documents proving that the country (region) where the product is manufactured or processed permits the sale of the product without any restriction
  • Other materials that may support the application

What kind of materials do I need to file for the special-purpose cosmetics?

  • The application form for the administrative license for the imported special-purpose cosmetics
  • The naming basis of the product’s Chinese name
  • Formula of the product
  • The product quality and safety control requirements
  • The original product package (including product label, product description) and, if the package is designed exclusively for China's market, the designed product package (including product label, product description)
  • The testing reports and relevant materials issued by a licensed testing institution recognized by the State Food and Drug Administration
  • Documents relevant to the safety assessment of the potential hazardous substances in the product
  • A copy of the filed letter of authorization for the responsible agency in China and a sealed copy of the said agency’s business license
  • The letter of commitment undertaking that the ingredients used in the product as well as the sources of such ingredients meet the requirements for the prohibited or restricted use of highly risky substances in the mad cow disease infected areas
  • Documents proving that the country (region) where the product is manufactured or processed permits the sale of the product without any restriction
  • Other materials that may support the application

What kind of materials do I need to file for a new cosmetic ingredient?

  • The application form for the administrative license for the new cosmetic ingredient
  • The research report:

    a. The background and process of the research and development of the ingredient as well as the relevant technical materials

    b. Source of the ingredient as well as its physical and chemical features, chemical structure, molecular formula and mass

    c. Purpose of using such ingredient in the product as well as its basis, scope and maximum usage

  • The brief description and simplified drawing of the manufacturing process
  • The ingredient quality and safety control requirements, including its specification, testing method, potential hazardous substances and their control
  • Documents relevant to the toxicological safety assessment, including documents relevant to the safety assessment of the potential hazardous substances in the ingredient
  • A copy of the filed letter of authorization for the responsible agency in China and a sealed copy of the said agency’s business license
  • Other materials that may support the application

What are the important factors in the import product registration/sanitary license process?

The most important items during the process are the accuracy of ingredients, insert sheets and labeling and packaging cosmetics, a total of 494 ingredients indications. CFDA clearly specifies, in the sanitation quality standard for cosmetics announced by the Ministry of Health for the conformity assessment for the safety of cosmetics, the chemical and microbiological sanitation quality standards for cosmetics and the tests for banned chemical substances, color additives, preservatives and uv absorbers. Banned ingredients include: biological products containing drugs and pesticides, hormone, hazardous ingredients of plants, mad cow disease-related raw materials, radioactive materials, etc. as well as 67 chemical substances, 42 preservatives,22 uv absorbers and 157 colorants.

Notes:

*Due to the often-changing policies, this information is subject to change. Contact us for the simplified solution. That was Easy!

We have been providing services for over 13 years for the following categories, please contact us for more details:

  • Health food
  • Water filtered equipment
  • Clinical Research
  • Trademark / Patents

If you are in need of finding distribution channels or consulting service for your products, We can help. For the past 13 years, we have built not only the one of the best networks in the industry, but valuable insights and experiences as well. Let us know what you need and we will give a simplified and customized solution. That was Easy!

 

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