First, clear definition of toothpaste

Article 3 The term "toothpaste" as mentioned in these Measures refers to solid and semi-solid preparations used on the surface and surrounding tissues of human teeth by means of friction for the purpose of cleaning, beautifying and protecting them.

Lawyer's interpretation:

The method clearly defines the scope of toothpaste from four aspects: product use method, use part, product use and product form. From the legislative point of view, the definition is the basis of the rules, and clarifying the definition of toothpaste is a great legislative progress, but there are also shortcomings. Do mouthwash, powder, stickers, whitening gel and other oral cleaning products derived from toothpaste currently available in the market fall under the category of toothpaste? Does the toothpaste control system apply? The definition of toothpaste is not covered, and the specific regulations are not clear. In the case that the above oral cleaning products do not belong to the category of cosmetics, if the toothpaste regulatory standards are not applied, it is obviously inappropriate from the point of view of consumer safety, leaving a regulatory blind area to be improved.

Second, define the regulatory body

Article 4 The drug regulatory department under The State Council shall be responsible for the supervision and administration of toothpaste throughout the country. The provincial drug supervision and administration department is responsible for the supervision and administration of toothpaste in its administrative region, and undertakes the production license and filing management of toothpaste manufacturers in its jurisdiction. The department responsible for drug supervision and administration under the local people's government at or above the county level shall be responsible for the supervision and administration of toothpaste within its administrative area.

Lawyer's interpretation:

In the process of the development of China's toothpaste industry, on the one hand, the toothpaste manufacturer issued a cosmetic production license, but the toothpaste products were not included in the cosmetics management. On the other hand, at any time The State Council adjusts, the toothpaste regulatory body has also been in an unclear state. After the institutional reform of The State Council in 2013, the former Food and Drug Administration assumed the unified supervision function of cosmetics. In 2018, The State Council was reformed again, the State Drug Administration was established, and the responsibility for cosmetics supervision was assigned to the drug administration. Based on the above industry status quo, the "Measures" clearly stipulates that the drug regulatory department of The State Council is responsible for the supervision and administration of toothpaste in the country. Clear toothpaste authorities, that is, the implementation of regulatory measures favorable to the toothpaste industry, more conducive to the development of the industry.

Third, establish the product recordholder system

Article 5 The recordholder of toothpaste shall be responsible for the claim of quality safety and efficacy of toothpaste. Toothpaste manufacturers and operators shall engage in production and business activities in accordance with laws, regulations, mandatory national standards and technical norms, strengthen management, integrity and self-discipline, and ensure the quality and safety of toothpaste products.

Lawyer's interpretation:

The production and operation process of toothpaste, product manufacturers, producers and other concepts are not clearly defined, and there is no uniform standard for product labeling; In the toothpaste consignment processing mode, there are also entrusted producers, entrusted producers and other management subjects, which are complex. In the above operator identity, how to divide the responsibility of each operator? There have long been differences in practice over who consumers should claim their rights to after a product has gone wrong. Drawing on the supervision experience of drugs and cosmetics, the "Measures" established the toothpaste filing system, and clarified that the toothpaste filing person is responsible for the quality safety and efficacy claims of toothpaste, and effectively protected the health rights and interests of consumers, which is a major legislative progress.

Fourth, establish a product filing system

Article 7 The State shall administer toothpaste for filing purposes. A product may be put on the market for sale or imported only after it has been filed in accordance with the provisions of the drug regulatory department under The State Council.

Lawyer's interpretation:

In the long-term practice of toothpaste business, the supervision department only implemented the production license system for toothpaste manufacturers, but there was no specific prior supervision measures for toothpaste products. Considering that toothpaste is a product closely related to the health of the people, the Measures refer to the management requirements of cosmetics, establish a product filing system, and the product can be listed for sale or imported after product filing, through the product filing system, protect the consumer's right to know, clarify the product responsible party, and effectively safeguard the health rights and interests of consumers. At the same time, it is also stipulated that the filing person shall submit the following information for filing: (1) the name, address and contact information of the filing person; (2) Name, address and contact information of the manufacturer; (3) Product name; (4) Product formula; (5) Standards of product execution; (6) Product labels; (7) Product inspection report; (8) Product safety assessment data. The product filing system not only strengthens the supervision of toothpaste in advance, but also fully guarantees the consumer's right to know. In view of the current status of toothpaste products are not filed, toothpaste operators should make overall preparations for product filing in advance.

Fifth, the establishment of raw material classification management system

Article 8 The natural or artificial raw materials first used in toothpaste within the territory of the People's Republic of China shall be the new raw materials of toothpaste. According to the historical use of toothpaste raw materials, the drug regulatory department under The State Council shall formulate and publish the Catalogue of Used Raw Materials of Toothpaste as the basis for the judgment of new raw materials of toothpaste.

Lawyer's interpretation:

Although toothpaste and cosmetics have more in common, they also have their special features. As far as raw materials are concerned, toothpaste raw materials only involve the oral route, and do not involve percutaneous absorption and skin phototoxicity. The Measures refer to the classification management system of cosmetics raw materials, based on the actual situation and technical risks of toothpaste raw materials, and establish a classification management system of toothpaste raw materials for the first time in accordance with the concept of tube service, on the one hand, strengthen the management of toothpaste raw materials, implement the catalog management of used raw materials, and do not use or add new toothpaste raw materials at will; On the other hand, give toothpaste enterprises innovation space and encourage raw material technology innovation. The "Measures" stipulate that the raw materials that have been included in the "Toothpaste has been used raw materials Catalog" shall be used reasonably by toothpaste manufacturers and operators according to the corresponding standards. If a new raw material of toothpaste is to be used for the production of toothpaste, a project proposal for the formulation of safety technical standards for the raw material shall be put forward, which shall be incorporated into the national mandatory standards and technical specifications before it can be used.

6. Use the production license system

Article 10 An application shall be submitted to the drug regulatory department of the province, autonomous region or municipality directly under the Central Government where he intends to engage in the production of toothpaste. After data review and on-site verification by the drug regulatory department of the province, autonomous region and municipality directly under the Central Government, cosmetics can be produced only after meeting the conditions and obtaining the production license. The production of toothpaste should meet the environmental requirements of the production workshop of the cosmetic production quality management code.

Lawyer's interpretation:

Production license system is a pre-supervision measure. China has always carried out the production license system for toothpaste production. In 2005, the former General Administration of Quality Supervision, Inspection and Quarantine issued the "Regulations of the People's Republic of China on the Administration of Industrial Product Production Licenses", which stipulates that the production license management of toothpaste manufacturers is implemented and the production license of cosmetics is issued. The Measures continue the production license supervision system, providing producer thresholds through prior supervision to ensure product safety. As far as the toothpaste production license is concerned, it is specifically responsible for the drug supervision and administration department of the province, autonomous region and municipality directly under the Central Government.

Vii. Establish a positive list system of efficacy

Article 13 The drug regulatory department under The State Council shall, according to the efficacy of toothpaste, formulate the efficacy classification catalogue, and the terms used for the efficacy declaration of toothpaste shall not exceed the permissible scope of claim determined by the efficacy classification catalogue. According to the suggestions of industry enterprises and associations and the actual situation of the development of the toothpaste industry, the drug regulatory department under The State Council shall update and adjust the toothpaste efficacy classification catalogue in a timely manner.

Lawyer's interpretation:

Toothpaste is a fast-moving consumer goods, the product life cycle is short, product replacement is fast, product functional publicity is especially important. The uniqueness, pertinence and innovation of product efficacy claims directly determine the brand image and product sales. Due to the relatively simple formulation and production process of toothpaste, the overall safety risk is not high, and the main problem in the current market is the confusion of efficacy claims. Based on the current chaos of toothpaste efficacy claims, the "Measures" draws on the management experience of Japan and other countries, and implements positive list management of toothpaste efficacy claims through the mode of efficacy classification catalogue, so as to curb the chaotic status quo of toothpaste illegal claims, regulate cosmetics claims, and protect the interests of consumers. The toothpaste efficacy claim classification catalogue delineates a red line for the toothpaste efficacy claim, and toothpaste operators can only carry out moderate marketing within the scope of the efficacy classification catalogue, and the efficacy claim can no longer be unrestrained.

8. Medical efficacy propaganda is prohibited

Article 15 In addition to the part of the efficacy claim shall conform to the allowable claim scope determined by the classification catalogue, other parts of the toothpaste label shall not be marked with the following contents: (1) express or implied medical content; (2) False or misleading content; (3) Content that violates social public order and good customs; (4) Other contents prohibited by laws, administrative regulations and mandatory national standards.

Lawyer's interpretation:

The supervision system of cosmeceuticals separation is implemented in the field of cosmetics supervision in China. The main problem in the current toothpaste market is that the efficacy claims are confused, especially the claims of "anti-inflammatory, analgesic, hemostatic", and the boundaries of drugs and medical devices are blurred. After the "Regulations" included toothpaste in the supervision of cosmetics, the "Measures" continued the supervision system of cosmetics and drug classification management, and clearly stipulated that toothpaste should not express or imply the content of medical effects. Under the new regulatory system, many toothpaste products claim that they will face compliance challenges, and toothpaste operators should pay attention to this problem. At the same time, toothpaste operators should also pay attention to brand compliance issues, such as Yunnan Baiyao and other brands, also face compliance problems.

9. Strengthen product efficacy evaluation

Article 16 The efficacy claims of toothpaste shall have sufficient scientific basis. In addition to the basic cleaning type, other efficacy toothpastes should be evaluated in accordance with the requirements of the regulations. After the efficacy evaluation has been carried out in accordance with national standards and industry standards, the toothpaste can be claimed to have the effect of preventing caries, suppressing dental plaque, anti-dentin sensitivity, reducing gum problems and so on. The toothpaste recordholder can handle the filing only after completing the product efficacy evaluation. The summary of the efficacy evaluation basis should be submitted to the special website designated by the State Drug Administration when handling the record, and actively open to the public.

Lawyer's interpretation:

In the face of the current situation of the toothpaste market, strengthening the supervision of toothpaste efficacy claims is one of the important contents of the "Measures". On the basis of positive list management of toothpaste efficacy, the Measures put forward more specific requirements for toothpaste efficacy evaluation and evaluation institutions. According to the new rules, claims about the efficacy of toothpaste should be based on sufficient scientific evidence; In addition to the basic cleaning type, other efficacy toothpastes should be evaluated in accordance with the requirements of the regulations. Different from cosmetics, the efficacy evaluation of toothpaste only includes clinical evaluation and laboratory evaluation, but does not include literature research, research data analysis, consumer testing and so on. In addition to the efficacy evaluation, the summary of the basis for the efficacy evaluation of toothpaste should be submitted to the special website designated by the State Drug Administration when handling the record. At present, in the operation practice of toothpaste, products rarely carry out efficacy evaluation reports. After the implementation of the new regulation, the operating cost of efficacy evaluation and efficacy compliance cost of operators will be greatly increased, and toothpaste operators should pay attention to it.

10. The undefined content shall be implemented in accordance with ordinary cosmetics

Article 22 Other matters not specified in these measures shall be implemented in accordance with the relevant provisions on the management of ordinary cosmetics.

Lawyer's interpretation:

From the perspective of product characteristics and international regulatory experience, toothpaste and cosmetics have a lot in common in management. In order to avoid meaningless duplication, no comprehensive supervision and management measures have been formulated for the supervision of toothpaste, and the difference between the management of toothpaste and cosmetics has been clarified, and the remaining unspecified matters have been implemented in accordance with the relevant provisions of ordinary cosmetics. The Measures provide that other matters not clearly defined shall be implemented in accordance with the relevant provisions for the management of ordinary cosmetics. Although the regulation is not specific, it can be said to have the greatest impact on the toothpaste industry, because it means that toothpaste labels, illegal responsibilities and other contents are implemented in accordance with ordinary cosmetics management regulations. Incorporating toothpaste into the scope of cosmetics supervision and establishing systematic supervision measures will bring fundamental changes to the toothpaste industry, which is currently in the extensive stage of operation.