Definition

Toothpaste refers to solid and semi solid preparations used for the purpose of cleaning, beautifying, and protecting the surface and surrounding tissues of human teeth by friction.

Regulatory Overview

According to regulations, toothpaste is managed in accordance with the provisions of ordinary cosmetics. Before the product is launched, it must be filed in accordance with corresponding procedures and requirements.

After evaluating the efficacy of toothpaste in accordance with national and industrial standards, the toothpaste registrant can claim to have the efficacy of preventing caries, suppressing dental plaque, resisting dentin sensitivity, and alleviating gum problems.

Relevant regulatory basis

"Regulations on the Supervision and Administration of Cosmetics", "Measures for the Supervision and Administration of Toothpaste ", "Toothpaste filing information management regulations (Draft for Comments)", "Measures for the Supervision and Administration of Cosmetic Labels", "Catalogue of Raw Materials Used in Toothpaste (Under Collection)", "Technical Guidelines for the Safety Assessment of Cosmetics (2021 Edition)"

Toothpaste filing process

Filing account application → determining formula and label → sample testing → sorting out other materials → submitting filing materials to the information service platform of the State Drug Administration → uploading a summary of the basis for product efficacy declaration on the website designated by the State Drug Administration → completing the filing → reporting the production situation and compliance with laws and regulations, mandatory national standards, and technical specifications to the drug administration responsible for the filing every year (similar to the annual report of cosmetics).

Information required for filing account applications

（1） Information form of the filing person and resume of the person in charge of quality and safety;

（2） Overview of the quality management system of the registrant;

（3） Overview of adverse reaction monitoring and evaluation system of the registrant;

（4） The overseas filing person shall submit the information form of the domestic responsible person;

（5） The overseas filing person shall submit the original letter of authorization of the domestic responsible person and the original notarial certificate;

（6） If the filing person has independent production or entrusts an overseas production enterprise to produce, it shall submit the production enterprise information form and the resume of the person in charge of quality and safety, and fill in and submit the existing production enterprise and its information at one time. If the production enterprise is overseas, it shall submit the original of the overseas production specification certification materials.

Enterprises in China that are only engaged in entrusted production should submit the production enterprise information form and the resume of the person in charge of quality and safety specified in item (6) in order to associate and confirm the entrusted production relationship.

Those with multiple identities such as domestic registrant, domestic responsible person, production enterprise, or multiple overseas registrants for the same domestic responsible person can submit all relevant materials at once, and obtain corresponding user permissions after passing the review. Existing users can supplement relevant information and increase user permissions based on the situation.

Information required for product filing

（1） "Toothpaste Filing Information Form" and relevant materials;

（2） Product name naming basis;

（3） The product formula contains raw material safety information;

（4） Product implementation standards;

（5） Sample product label;

（6） Product inspection report;

（7） Product safety assessment data;

（8） Certificate of free sales of the product abroad (imported toothpaste).

Other:

（1） Upload a summary of the basis for product efficacy claims on the website designated by the State Drug Administration when filing;

（2） Report the production situation and compliance with laws and regulations, mandatory national standards, and technical specifications to the drug regulatory department responsible for filing management every year.

Professional services that Zoop can provide

In order to meet the needs of manufacturers for testing and filing, relying on the strong support of laboratories authorized by the Food and Drug Administration and the technical team of Comprehensive Education, we provide services including:

（1） Assist in establishing a quality management system and review the qualification of the person in charge of quality and safety;

（2） Coaching in establishing an adverse reaction monitoring and evaluation system;

（3） Pre review of production capacity qualification;

（4） Apply for formula compliance review;

（5） Preparation of product execution standards;

（6） Product label sample compliance review;

（7） Product safety and efficacy testing and evaluation services;

（8） Preparation of product safety assessment materials;

（9） Complete agency service for toothpaste filing.

Service advantages of Zoop

Since its establishment in 2010, Zongpu has focused on product compliance related services. The company's cosmetics business department has audited teachers, all from medium-sized and large cosmetics manufacturers, and have professional backgrounds in biology, medicine, cosmetics, chemistry, and other related fields.

Our strengths lie in:

1. Professional and mature team with periodic service guarantee;

2. Rich experience, with a cumulative record of over 100000 cosmetics, and a high one-time pass rate;

3. Reasonable price, high-quality service throughout the process, and peace of mind;

4. Convenient communication through outlets in Shenzhen, Guangzhou, Shanghai, and Beijing;

5. One-stop service for cosmetics, retail brands, and medical devices, efficient and economical;

6. Focus on compliance services, do not engage in product production and operation, and have no concerns.

Responsible for customers, quality service is the consistent business philosophy of Zoop Company. We hope to serve more quality oriented customers and grow with you!