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INTERPRETATION BY TÜV SÜD TO THE NEW EDITION OF THE COSMETIC SUPERVISION AND ADMINISTRATION REGULATION  

On 29 June 2020, the State Council of the People's Republic of China issued Order No.727, and the Cosmetics Supervision and Administration Regulation was officially promulgated, which will take effect on 1 January 2021. 

The Cosmetics Supervision and Administration Regulation (hereinafter referred to as the New Regulation) can be regarded as the "fundamental law" of the cosmetics industry. It has been under revision for eight years. It was first included in the revision plan by the State Council in 2013, and the Cosmetics Supervision and Administration Regulation (Draft) was reviewed and approved by the 77th executive meeting of the State Council on 3 January 2020, and finally officially promulgated. 

MEMORABILIA OF LAWS AND REGULATIONS CONCERNING COSMETICS

  • In 2013, the Cosmetics Supervision and Administration Regulation was first included in the revised plan by the State Council
  • On 8 November 2014, the former State Food and Drug Administration publicly solicited opinions on the Cosmetics Supervision and Administration Regulation (Draft for Comment)
  • On 20 July 20, 2015, the Legislative Affairs Office of the State Council publicly solicited opinions on the Cosmetics Supervision and Administration Regulation (Draft for Review)
  • On 23 December 2015, the Technical Specifications for Cosmetic Safety (2015 Edition) was released and implemented from December 1, 2016
  • On 18 January 2017, China National Medical Products Administration (NMPA, now China Food and Drug Administration ) issued the "Announcement on the Working Procedures for the Filing and Management of Imported Non-Special Cosmetics in Pudong New Area, Shanghai (Provisional)" 
  • On 12 March 2018, NMPA issued the "Announcement on Piloting the Implementation of the Registration Management of Imported Non-Special Purpose Cosmetics on a Larger Scale"  
  • On 9 November 2018, NMPA issued the "Announcement on Nationwide Implementation of the Record Management of Imported Non-Special Purpose Cosmetics" 
  • On 18 December 2018, the Ministry of Justice officially notified the WTO of the Cosmetics Supervision and Administration Regulation (draft)
  • On 10 September 2019, NMPA issued the "Specifications for the Registration and Filing Inspection of Cosmetics"
  • On 3 January 2020, the State Council executive meeting passed the Cosmetics Supervision and Administration Regulation (Draft)
  • On 29 June 2020, the Cosmetics Supervision and Administration Regulation was officially promulgated

The predecessor of the Cosmetics Supervision and Administration Regulation was the Regulations concerning the Hygiene Supervision over Cosmetics promulgated by the former Ministry of Health in 1989 (hereinafter referred to as the old regulation). The old regulation contains 35 articles in total and 3188 Chinese characters in total after revision. It has been in service for 30 years since 1 January 1990. 

At present, the number of cosmetics production enterprises that have obtained cosmetics production licenses has increased from more than 70 in 1980 to more than 5,000 in 2020. The market has retail sales of about one trillion yuan. The average annual growth rate of the industry as a whole is kept in double digits, and the market has expanded by more than 900 times. At present, China has developed into the second largest consumer market among all countries in the world. With the rapid development of China's economy and cosmetics industry in recent years, the transformation of the cosmetics industry and the increasing demand of cosmetics consumption, all the cosmetics market, relevant persons engaged in cosmetics production, operation, supervision and management, and the vast number of consumer groups are in urgent need of policies and regulations that can adapt to the upgrading of cosmetics industry, standardise the market competition of cosmetics industry, and promote the improvement of cosmetics quality and safety.

Compared with the old regulation, the new one has been increased from the original 35 rules to 72 rules, with a total of 80 articles in 6 chapters and 12,911 Chinese characters. The requirements for reform of "devolution, management and service" have been implemented, and cosmetics products and raw materials have been registered and filed according to the risk level. The management has clarified the main responsibility of enterprises for the quality and safety of cosmetics, increased the intensity of illegal punishment, and standardised the cosmetics production and operation activities and their supervision and management from various aspects. Once the new regulation was issued, it aroused widespread concern in the whole cosmetics industry. Next, let's take a concrete look at the points of revision in the new regulation, which are worthy of attention and discussion. 

No

New regulation

Interpretation

1

The new regulation redefines cosmetics in China thirty years later

Article 3: Cosmetics as mentioned in the Regulation refer to daily used chemical products applied on the surface of any part of the human body (such as skin, hair, nails and lips) by way of smearing, spraying or other similar methods for the purpose of cleaning, protecting, beautifying and make-up.

Compared with the old edition of REGULATIONS CONCERNING THE HYGIENE SUPERVISION OVER COSMETICS, the word "美容 (making up)" was changed to "美化 (beautifying)", and the purpose of " undesirable odor " was removed. These changes are closely related to the redefinition of cosmetics classification, which will be described later.

2

Filing and registration of new raw materials

Cosmetic raw materials are classified into new raw materials and established raw materials. The state implements registration management for new raw materials of cosmetic with high risk, and imposes filing control for other new cosmetic raw materials.

Article 11: The natural or artificial raw materials used in cosmetics for the first time in China are defined as new cosmetic raw materials. New cosmetic raw materials with anti-corrosion, sun protection, coloring, hair dyeing, freckle-removing and whitening functions can only be used after being registered by the supervisory and administrative department under the State Council; other new cosmetic raw materials shall be filed with the drug supervisory and administrative department under the State Council before use. The drug supervisory and administrative department under the State Council may, according to the development of scientific research, adjust the scope of new cosmetic raw materials subject to registration administration, and implement the new rules after approval by the State Council.

Article 14: Within 3 years after the new cosmetics raw materials that have been registered and filed are put into use, the registrants and filing persons of the new raw materials shall report the use and safety condition of the new raw materials to the drug supervisory and administrative department under the State Council every year. For new cosmetic raw materials with safety problems, the drug supervisory and administrative department under the State Council shall cancel the registration or cancel the record of filing. New cosmetic raw materials that have not experienced safety problems after the expiration of the 3 years shall be included in the catalogue of established cosmetic raw materials formulated by the drug supervisory and administrative department under the State Council.

The new regulation clearly stipulates the types of new raw materials that need to be filed and registered, as well as the specific process of filing and registration, materials to be submitted and cycle of review. The detailed and transparent registration and filing process of new raw materials actually reflects, to some extent, the state's support and encouragement for the use of new cosmetic raw materials.

3

Classification of cosmetics

Article 4: The State imposes classified management of cosmetics and cosmetic raw materials according to the degree of risk.Cosmetics are classified into special cosmetics and ordinary cosmetics. The state implements registration management for special cosmetics and filing control for ordinary cosmetics.Cosmetics used for dyeing hair, perming, removing spots and whitening skin, sun-screening and preventing hair loss, and cosmetics claiming new functions are special cosmetics. Cosmetics other than special cosmetics are ordinary cosmetics.

The drug supervisory and administrative department under the State Council shall formulate and publish the classification rules and catalogues of cosmetics according to the efficacy claims, effecting positions, product dosage forms, applicable users and other factors of cosmetics.

Article 17: Special cosmetics can be produced or imported only after being registered by the drug supervisory and administrative department under the State Council. Domestic ordinary cosmetics shall be filed with the drug supervision and administration department of the people's government of the province, autonomous region or municipality directly under the Central Government where the filing person is located before being put on the market. Imported ordinary cosmetics shall be filed with the drug supervisory and administrative department under the State Council before import.

The new regulation replaces the former classification of special-purpose cosmetics/non-special-purpose cosmetics with special cosmetics/ordinary cosmetics. Special cosmetics are defined as cosmetics used for dyeing hair, perming, removing spots and whitening, sun-screening and preventing hair loss; and the cosmetics of "hair growth, hair removal, breast enhancement, body building and deodorization" stipulated in the old regulations are removed. The registered cosmetics have a transition period of 5 years since the implementation of the Regulations, during which they can continue to be produced, imported and sold. After the transition period expires, they are not allowed to be produced, imported or sold.

In addition, Article 77 of the Regulation stipulates that toothpaste shall be subject to management with reference to the provisions of the Regulation on ordinary cosmetics. After evaluating the efficacy of toothpaste according to national and industrial standards, the filing person of toothpaste can claim that toothpaste has the efficacy of preventing caries, inhibiting dental plaque, resisting dentin sensitivity, relieving gum problems, etc. The specific measures for the management of toothpaste shall be drawn up by the drug supervision and administration department under the State Council, and submitted to the market supervision and administration department under the State Council for examination and release.

The Regulation is not applicable for soap, but applicable to those claiming to have special cosmetic effects.

There is so far no specific regulation on the product type of mouthwash.

4

The refinement of the identity related to product liability

Article 17 Special cosmetics can be produced or imported only after being registered by the drug supervisory and administrative department under the State Council. Domestic ordinary cosmetics shall be filed with the drug supervision and administration department of the people's government of the province, autonomous region or municipality directly under the Central Government where the filing person is located before being put on the market. Imported ordinary cosmetics shall be filed with the drug supervisory and administrative department under the State Council before import.

Article 18: The applicant for cosmetics registration and the filing person shall meet the following conditions:

  1. It is an enterprise or other organisation established according to law
  2. There is a quality management system that is suitable for the products that apply for registration and filing
  3. Have the ability to monitor and evaluate the adverse effects of cosmetics

Article 32: Cosmetic registrants, filing persons, and entrusted production enterprises shall assign quality and safety supervisors to undertake the duties of quality and safety management and product release for the corresponding product.

The quality and safety supervisors shall have professional knowledge related to cosmetics quality and safety, and have more than 5 years experience in cosmetics production or quality and safety management.

The identities of product-related persons-in-charge, such as registrants, filing persons and quality and safety supervisors, are clearly defined and required in the new regulation. Further clarify the responsibilities and obligations of relevant personnel, and more accurately correspond to the specific provisions in Chapter V Legal Liability, so as to put the supervision of cosmetics safety into practice.

5

Efficacy declaration and safety evaluation of cosmetics

Article 22: There should be sufficient scientific basis for declaring the efficacy of cosmetics. Cosmetic registrants and filing persons shall publish the abstracts of documents, research data or product efficacy evaluation data, on which efficacy claims are based, on the special website prescribed by the drug regulatory department under the State Council, and accept supervision of the public.

Article 21: For new cosmetic raw materials and cosmetics before registration and filing, the registration applicant and filing person shall carry out safety assessment by themselves or entrust professional institutions to perform the assessment.Personnel engaged in safety assessment should have professional knowledge related to cosmetics quality and safety, and have more than 5 years of relevant professional experience.

In the past cosmetic supervision process, China's requirements for efficacy declaration were relatively loose - those who apply for hair-raising, body-building and chest beautifying products should submit scientific documents on efficacy ingredients and their use basis. However, in the new regulation, it is clearly stipulated that the research data and literature or efficacy evaluation data on which efficacy claims are based should be published and subject to supervision by the public. Compared with the previous data of functional ingredients, the new regulation puts forward requirements for the actual effect of functional ingredients in product formula, and puts forward higher expectations for the management of production enterprises and product R&D and innovation.

In addition, in Article 21, cosmetics safety assessment is mentioned at the height of the regulatory level for the first time.

6

Article 5: For legal liabilities, the rules concerning legal liabilities and punishment are refined

 

In the old regulation, the rules of punishment in Chapter V were made in 998 Chinese characters in total. In the new regulation, the chapter concerning legal liabilities was made in as many as 4,193 Chinese characters. From the production of raw materials and cosmetics to the sales and inspection of cosmetics, we should increase the intensity of punishment for illegal acts, drive serious offenders out of the market, and create a good market environment for law-abiding operators.

7

Matters related to imported cosmetics

Article 17: Special cosmetics can be produced or imported only after being registered by the drug supervisory and administrative department under the State Council. Domestic ordinary cosmetics shall be filed with the drug supervision and administration department of the people's government of the province, autonomous region or municipality directly under the Central Government where the filing person is located before being put on the market. Imported ordinary cosmetics shall be filed with the drug supervisory and administrative department under the State Council before import.

Article 19: The following materials shall be submitted when applying for registration of special cosmetics or filing of ordinary cosmetics:

  1. name, address and contact information of the registration applicant and the filing person
  2. name, address and contact information of the producer;
  3. product name
  4. product formula or all components of the product
  5. standards implemented for the product
  6. sample draft of product label
  7. product inspection report
  8. product safety assessment data

If a registration applicant applies for the registration of special cosmetics for the first time, or if the registrant files ordinary cosmetics for the first time, he shall submit the certification materials that meet the conditions stipulated in Article 18 of the Regulation. When applying for registration of imported special cosmetics or filing of imported ordinary cosmetics, the certification documents that the products have been put into market for sales in the producing countries (regions) and the certification materials that the overseas production enterprises meet the cosmetics production quality management standards shall be submitted at the same time; if the cosmetic products are designed for export to China, for which the certification documents that the products have been put into market for sales in the producing country (region) are not available, the applicant shall submit the relevant research and test data targeting at Chinese consumers. Article 35 The smallest salable unit of cosmetics shall be labelled. Labels shall comply with relevant laws, administrative regulations and mandatory national standards, and the contents shall be true, complete and accurate.

Imported cosmetics can be labelled in Chinese directly, or attached with Chinese label on the original label. For Chinese labels being attached, the contents of Chinese labels shall be consistent with the contents of the original labels.

Article 45: Entry-exit inspection and quarantine organizations shall inspect imported cosmetics in accordance with the provisions of the Import and Export Commodity Inspection Law of the People's Republic of China; the products failing to pass the inspection shall not be imported.

The importer shall examine whether the cosmetics to be imported have been registered or filed and whether they conform to these regulations and mandatory national standards and technical specifications; and the products unqualified in the examination shall not be imported. Importers shall truthfully record the information of imported cosmetics, and the retention period of the records shall comply with the provisions of the first paragraph of Article 31 of the Regulation.

In 2017 and 2018, NMPA issued the announcement on pilot filing of imported non-special cosmetics, and put the imported ordinary cosmetic products subject to pilot filing and approval into 11 pilot free trade zones. The new regulation stipulates that they should be filed with the drug supervisory and administrative department of the State Council. Can the subsequent imported ordinary cosmetics be filed in pilot free trade zones of Shanghai Pudong New Area, Tianjin, Liaoning, Zhejiang, Fujian, Henan, Hubei, Guangdong, Chongqing, Sichuan and Shaanxi?

Imported cosmetics labels can be attached to the original foreign language package by means of affixing, and the contents of the attached Chinese labels should correspond to those of the original labels.

After seven years, the Cosmetics Supervision and Administration Regulation, which was jointly formulated by the effort of the whole industry, will be officially implemented on 1 January 2021. It is believed that the new regulation will standardise the production and sales process of cosmetics, clarify the responsibilities and obligations of each identity, and improve the efficiency of supervision and management. At the same time, the more transparent and detailed registration process of raw materials and products encourages and supports the research and innovation of cosmetics, meets the needs of consumers, and protects the legitimate rights and interests of organisations and individuals in carrying out research and innovation of cosmetics. Such a policy will inject new vigour into the cosmetics market. 

At the same time, the new regulation still brings us new questions. For example, the specific details of efficacy and safety assessment need more implementation rules to be issued by the state.  The drug supervisory and administrative department under the State Council shall formulate and publish the classification rules and catalogues of cosmetics according to the efficacy claims, effecting positions, product dosage forms, applicable users and other factors of cosmetics. Can different companies repeatedly file/register the same new raw material of plant extract? It is not clearly stipulated in the Regulation whether the subject of registration and filing of new raw materials is the cosmetics production enterprise or the new raw material production enterprise. 

For another example, in comparison, tailor-made cosmetics are sold in foreign countries, yet the cosmetics brands that customise products for consumers are rarely seen in China, probably because different laws and regulations in different countries affect the public’s recognition of customised cosmetics. The Chinese market stipulates that all cosmetic products must have the inspection report of the designated organisation and be filed with the NMPA (now State Food and Drug Administration). Special cosmetics can only be produced after obtaining the special certificate. The preparatory process usually takes a long time, which limits the promotion of customised cosmetics in the Chinese market at the regulatory level. Article 38 of the new regulation stipulates that cosmetics dealers shall not prepare cosmetic products by themselves. It is not clear whether the customised cosmetics belong to the situation stipulated in the new regulation. 

All in all, more discussions bring about the expectation of the whole industry for the new regulation, and we hope that the cosmetics industry will flourish under the guidance of the new regulation. 

Refer to the original text of the Regulation here.

 

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