Influence of Cosmetic Supervision Laws and Regulations on Toothpaste Industry

Guangzhou Dental Doctor Oral Nursing Research Institute,China

On June 29,2020,theRegulations on Supervision and Administration of Cosmetics(hereinafter referred to as the Regulations) were officially promulgated and will come into force on January 1,2021.In the Regulations,it is stipulated that toothpaste products shall be managed with reference to ordinary cosmetics,and separate management measures shall be formulated.On November 13,2020,the National Medical Products Administration issued theMeasures for the Supervision and Administration of Toothpaste(Exposure Draft),clarifying the basic principles and requirements of toothpaste supervision and administration.Starting from 2021,for toothpaste products,in addition to the original production license management,new contents,such as product registration administration,raw material record registration management,product declaration term management,product efficacy verification management,safety evaluation management,and adverse reaction management,will be added.All toothpaste enterprises will face a “big test”,and the ecosystem of the toothpaste industry will undergo a major restructuring.At present,people from all walks of life are very concerned about this focus issue.As an industry insider who has been engaged in research work for a long time,I would like to talk about my own cognition for everyone’s reference.

Previous and present lives of toothpaste management

Since the founding of the People’s Republic of China,as consumers have continuously put forward new requirements for toothpaste quality in different periods,the toothpaste industry has been promoted to continuously improve the quality management and develop rapidly.At present,China’s toothpaste output has ranked first in the world with the quality reaching the international advanced level.A certain market size and industrial foundation have laid a solid foundation for the promulgation of the Regulations to adjust toothpaste management measures.

In 1956,the National Toothpaste Industry Technology Exchange Cooperation Group was established in Tianjin,which has done a lot of work for the follow-up promotion of new products,new technologies and new equipment in the toothpaste industry,as well as the revision of quality standards and rating and award decision of product quality.In 1957,the former Ministry of Light Industry began to formulate the standard for soap-based toothpaste,which was passed at the 3rd National Toothpaste Work Conference in 1967,becoming the first Ministry-issued “Interim Standards for Toothpaste”on soap-based toothpaste in China.

Due to technological innovation in the industry,the soap-based toothpaste has gradually been replaced by foaming agent toothpaste.In 1972,the former Ministry of Light Industry began to organize the drafting of the draft standard for foaming agent toothpaste,which was officially approved and issued in 1981,becoming the first standard for detergent toothpaste in China,with the standard number QB 592-81.

In November 1984,with the approval of the former State Economic and Trade Commission,the China Toothpaste Industry Association was established and began to formulate guiding policies for the toothpaste industry,mainly including: the pharmacological and therapeutic research that should be strengthened for toothpaste production is organized according to the standards of the former Ministry of Light Industry,with oral and dental health care as the main objective; the production scale of toothpaste factory should be not less than 30 million standard tubes (65 g/tube is the standard branch);aluminum tube toothpaste gradually transited to aluminum-plastic composite tube toothpaste;paste making,tube making,filling and packaging equipment are introduced to improve the automation level of production equipment.

In January 1987,the national standard Toothpaste (GB 8372-1987) drafted by the former Ministry of Light Industry was approved.On March 1,1988,it was officially approved and implemented,becoming the first national standard for toothpaste products in China.This standard has played a positive role in guiding China’s toothpaste production,promoting technological progress in the toothpaste industry and improving the quality of toothpaste products.With standardized products,there should be also standardized raw materials.Since the 1990s,for the main raw materials of toothpaste,such as natron,dicalcium phosphate dehydrate,silica,sorbitol,glycerin,propylene glycol,polyethylene glycol,sodium lauryl sulfate,sodium carboxymethyl cellulose,xanthan gum,hydroxypropyl guar gum,aluminum-plastic composite tube,and allplastic composite tube,there have been formulated standards,some of which are national standards and some are national industry standards.The formulation of toothpaste raw material standards makes toothpaste raw and auxiliary material enterprises have rules to follow,and the quality of toothpaste products is fundamentally guaranteed.

In 2001,China Toothpaste Industry Association organized the drafting of Production Management Standard for Toothpaste Enterprises,which was issued as a self-discipline document for the industry.

In 2005,China Toothpaste Industry Association was renamed China Oral Care Industry Association,with other oral cleaning and care products enterprises such as mouthwash and toothbrush also joining the Association.

In 2006,the China Oral Care Industry Association organized the drafting of the Detailed Rules for the Implementation of Toothpaste Product Production License,which was approved and issued by the former General Administration of Quality Supervision.Toothpaste products were officially listed in the state production license management and the National Industrial Product Production License(Toothpaste) was issued to toothpaste manufacturers.

In 2007,the former General Administration of Quality Supervision issued the Regulations on the Administration of Cosmetic Labels to include the administration of toothpaste product labels in the scope of cosmetics.

In 2008,in order to meet the needs of safety management of toothpaste products and the development of functional toothpaste products in China,China Oral Care Industry Association drafted and issued the national standard General Requirements on Raw Materials of Toothpastes(GB 22115-2008) and the national light industry standard Functional Toothpastes (QB 2966-2008),playing an important guiding role in the standardized development of toothpaste industry,especially in the management of functional toothpastes.

In December 2010,the former Ministry of Health issued the national health industry standard Toothpaste Efficacy Evaluation (WS/T 326-2010),standardizing the principles,methods and standards of toothpaste efficacy evaluation.The implementation of this Standard is of great significance to guide the scientific consumption of the public,guide the scientific production of enterprises,prevent false propaganda and ultimately promote the oral health of the public.

In 2012,China Oral Care Industry Association established an industry safety research group;In 2013,a product safety evaluation system and mechanism were established in the whole industry,with the Association setting up the safety evaluation committee and enterprises setting up the safety evaluation team to track the safety evaluation of products throughout the process and to conduct many special trainings for safety evaluation personnel to fully ensure the safety of the whole process of product production.

In 2013,the former National Medical Products Administration assumed the supervision function of cosmetics and made it clear that toothpaste was included in the supervision scope.

In 2016,the former National Medical Products Administration formulated the Code for Cosmetics Production License to bring the toothpaste production management into the scope of cosmetics and issue the Cosmetic Production License to toothpaste production enterprises.

In 2018,after a new round of institutional reform,the new National Medical Products was established to continue the former National Medical Products Administration's regulatory function on toothpaste.

Supervision principles of new laws and regulations on toothpaste

According to the drafting instructions of theMeasures for the Supervision and Administration of Toothpaste(Exposure Draft),there are five principles for the supervision of toothpaste products in the future:

Adhere to the principle of centering on the people’s heath.Strictly implement the “four strictest” requirements,requiring that toothpaste raw materials and products must be registered and filed,toothpaste filed must pass the inspection,and functional toothpaste must pass the efficacy evaluation,so as to effectively safeguard the health rights and interests of consumers.

Give prominence to the key points.Formulate separate toothpaste management regulations,clarify the differences between cosmetics and toothpaste,and refer to the relevant regulations on ordinary cosmetics for other matters that are not clear.Therefore,the enterprises in toothpaste industry should not only seriously study the toothpaste supervision laws and regulations,but also seriously study the cosmetics supervision laws and regulations.

Highlight the principle of problem orientation.Compared with cosmetics,toothpaste formula and production process are relatively simple and the overall safety risk is not high.At present,the main problem in the market is the confusion of efficacy claims,and some claims are blurred with those of drugs and medical devices.It is expected that the National Medical Products Administration will implement a positive list management of toothpaste efficacy claim terms to curb the occurrence of illegal toothpaste claim.Toothpaste,known as “Disinfection Product Number” and “Equipment Product Number”,will be severely hit.

Respect the supervision regularity of toothpaste.For example,as new raw materials for toothpaste only involve peroral approaches,in view of the fact that the food additives or food raw materials approved by the state have a history of eating with low risk level,when such raw materials are first used for toothpaste product filing,they are not managed as new toothpaste raw materials and equated used raw materials,but a safety assessment report for the use of such raw materials in toothpaste products needs to be provided.

Adhere to the working principle of seeking progress while maintaining stability.In consideration of the current situation that only license management is implemented for toothpaste production and no filing management is implemented for toothpaste,the National Medical Products Administration will reduce the impact of the new policy on the toothpaste industry by setting a reasonable transition period,following the existing standards and simplifying the filing content according to the difficulty of officiallyissued documents.

Toothpaste manufacturers focus on 3 major issues

Under the framework of the new laws and regulations,toothpaste manufacturers should pay attention to the following 3 issues:

Raw material management

At present,toothpaste raw materials are divided into used raw materials,equated used raw materials and new raw materials.For new toothpaste products using“equated used raw materials”,enterprises should do a good job in the safety evaluation of raw materials.For new toothpaste products using new raw materials,sufficient materials must first be prepared for raw material filing and registration,and the product filing can only be carried out after success.This requirement is very strict and cannot be treated lightly.Scientific research,production,testing and safety rating shall be conducted at a high level.

Product management

Enterprises should do the following work well:to fully understand the procedures and contents of product filing,and comprehensively sort out the existing toothpaste products of enterprises; to control the existing product packaging inventory to avoid unnecessary waste; to carry out the quality inspections in the national recognized inspection agency for all toothpaste products; to carry out efficacy tests in the efficacy verification institution that meets the national regulations for all functional toothpastes; to make safety evaluation reports for all toothpaste products,which can be made by enterprises themselves or by third-party organizations.

Efficacy claims

Efficacy claims are the focus of future supervision.Enterprises should pay attention to the following issues: to consciously check the contents of labels such as registered trademarks and product names,and avoid using medical terms,false propaganda or exaggerated propaganda; not to claim efficacy other than the basic functions of toothpaste for products that have not been verified in efficacy; to pay attention to the translation for products packaged in minority languages.

Impact faced

Raw material enterprises

Cosmetic raw materials that have not been used in toothpaste before must be fully demonstrated before commercial promotion,which must be registered and filed with the toothpaste raw material system of the National Medical Products Administration in time after being sure.Only after obtaining the registration certificate or filing number can they be officially sold.

Consigned processing enterprises

According to the requirements of the National Medical Products Administration,the consigned processing enterprise,as the product filing person,should firstly establish a quality and safety management system,formulate various management systems,and be equipped with the person in charge of quality and safety and other relevant personnel;should secondly master all the technical data of the toothpaste products filed to successfully file the toothpaste products and supervise the consigned production enterprises to ensure the product quality.

Imported toothpaste sales enterprises

The requirements of the new laws and regulations for imported toothpaste are basically the same as those for domestic toothpaste.As the domestic responsible person,the imported toothpaste sales enterprises need to make all preparations in advance so as to successfully complete the filing of imported toothpaste products;In addition,attention should also be paid to label translation and notarization.

Inspection organization

After the implementation of the new laws and regulations,toothpaste inspection agencies shall,in accordance with the requirements of relevant documents of the National Medical Products Administration,carry out the institution fillings as soon as possible.

Trade associations

In the face of brand-new legal requirements,trade associations need to carry out in-depth legal publicity and operational training,provide consulting services to various enterprises and institutions,and act as a bridge to communicate and feedback with the National Medical Products Administration and local drug administration departments in a timely manner.

The above contents only represent personal views.At present,the supporting documents of the Regulations on Supervision and Administration of Cosmetics are being solicited or revised,and all are subject to the official documents issued by the National Medical Products Administration and the interpretation of laws and regulations.I would like to share this article with my colleagues in the toothpaste industry to promote China’s toothpaste industry to move towards high-quality development with new laws and regulations.