On June 4, 2026, the Comprehensive Department of the National Medical Products Administration (NMPA) released the draft for comments of the mandatory national standard "Specifications for Toothpaste Ingredients" (GB 22115-202X, replacing GB 22115-2008). The public comment period runs from June 4 to August 4, 2026.
Background
Toothpaste is not only a daily consumer product but also a health-related product. China is the world's largest producer and consumer of oral care products. As a daily essential for oral hygiene, the quality and safety of toothpaste are closely linked to consumers' oral health. With the continuous enhancement of public oral health awareness, China has become the world's largest toothpaste producer and consumer market.
Article 77 of the "Regulations on the Supervision and Administration of Cosmetics," effective January 1, 2021, stipulates that toothpaste shall be managed by reference to the provisions on ordinary cosmetics under the Regulations. In 2023, China published and implemented the first specialized departmental regulation for toothpaste, the "Measures for the Supervision and Administration of Toothpaste," and the dedicated document "Provisions on the Administration of Toothpaste Filing Materials." These regulatory requirements set forth clear provisions regarding the use of ingredients in toothpaste products.
GB 22115-2008 "Specifications for Toothpaste Ingredients" was published in 2008 and has been in implementation for over fifteen years. With the continuous advancement of innovation and safety research on toothpaste ingredients, relevant domestic and international regulations and standards have been successively issued. This revision aims to implement the requirements of the "Regulations on the Supervision and Administration of Cosmetics" and the "Measures for the Supervision and Administration of Toothpaste," standardize the management of toothpaste ingredients, and ensure toothpaste quality and safety. The content of GB 22115-2008 is no longer coordinated with the current national toothpaste regulatory provisions and cannot meet the needs of the rapidly developing toothpaste industry. The revision of this standard is both necessary and urgent.
Scope
This document specifies the requirements for toothpaste ingredients, including prohibited substances, restricted ingredients, permitted preservatives, and permitted colorants.
This document applies to toothpaste produced and distributed within the People's Republic of China. Furthermore, this document does not apply to toothpaste intended solely for sale outside the People's Republic of China.
Interpretation of Standard Changes
| Inventory | GB 22115-2008 | Draft for Comments | Change |
| Inventory of Prohibited Substances for Toothpaste (Table A.1) | 1,205 | 1,630 | +425 |
| Inventory of Prohibited Plant (Animal) Derived Substances for Toothpaste (Table A.2) | 88 | 120 | +32 |
| Inventory of Prohibited Substances for Toothpaste II (Table A.3) | 173 | 154 | -19 |
| Inventory of Restricted Ingredients for Toothpaste (Table B.1) | 39 | 58 | +19 |
| Inventory of Permitted Preservatives for Toothpaste (Table C.1) | 48 | 42 | -6 |
| Inventory of Permitted Colorants for Toothpaste (Table D.1) | 102 | 103 | +1 |
Overview of Standard Changes
This draft for comments primarily references EC 1223/2009 and its latest amendments, incorporating the relevant provisions of the "Inventory of Prohibited Ingredients for Cosmetics" and the "Inventory of Prohibited Plant (Animal) Derived Ingredients for Cosmetics," as well as the usage history of relevant ingredients and applicable laws, regulations, and mandatory national standards. This document has been technically cross-checked against GB 22115-2008 "Specifications for Toothpaste Ingredients" and the "Safety and Technical Standards for Cosmetics (2015 Edition)," and spelling errors and formatting redundancies in GB 22115-2008 have been corrected.
Inventory of Prohibited Substances for Toothpaste
In this revision, the number of prohibited ingredients for toothpaste has increased from 1,205 to 1,630, an increase of 425 substances.
Key revisions include:
- Reclassifying certain permitted preservatives from the original GB 22115-2008 as prohibited ingredients, including boric acid, formaldehyde, paraformaldehyde, and chloroacetamide;
- Adjusting the English translations and spellings of acetylcholine and its salts, levofacetoperane and its salts, hexachlorophene, etc., to align with the "Inventory of Prohibited Ingredients for Cosmetics";
- Consolidating glucocorticoids (corticosteroids) and similar substances into the category "hormones," consistent with the "Inventory of Prohibited Ingredients for Cosmetics";
- Adding Solanum nigrum, Strophanthus divaricatus, and Sabina vulgaris to the inventory of prohibited plant (animal) derived substances for toothpaste (Table A.2);
- Revising the descriptions of radioactive substances and narcotic drugs in accordance with relevant Chinese laws and regulations;
- Adjusting the descriptions of acrylamide, hydroquinone, zirconium and its compounds, etc., in light of the "Inventory of Prohibited Ingredients for Cosmetics" and Chinese national conditions, such as removing "with the exception of entry 14 in Annex III" from the description of hydroquinone;
- Changing certain conditionally prohibited substances to unconditionally prohibited, such as 1,2,4-trihydroxybenzene, 6-amino-m-cresol, and 6-amino-2-(2,4-dimethylphenyl)-1H-benz[de]isoquinoline-1,3(2H)-dione (Solvent Yellow 44) and their salts. For example, the original entry for 1,2,4-trihydroxybenzene was "1,2,4-Trihydroxybenzene (10) when used as a substance in hair and eyelash dye products" — the restrictive condition regarding "hair and eyelash dye products" has been removed, and the substance is now unconditionally prohibited.
Inventory of Prohibited Plant (Animal) Derived Substances for Toothpaste
In this revision, prohibited plant (animal) derived substances have increased from 88 to 120, an increase of 32 substances.
Key revisions include:
- Adding the latest prohibited substances in Chinese cosmetics, such as Cannabis Sativa (hemp) nut, Cannabis Sativa leaf extract, Cannabis Sativa seed oil, Atropa belladonna (deadly nightshade), Amorphophallus kiusianus (East Asian konjac), and Amorphophallus rivieri (konjac);
- Standardizing the Chinese and English descriptions of certain ingredients, referring to the "Inventory of Prohibited Plant (Animal) Derived Ingredients for Cosmetics," including Angelica dahurica (Baizhi), Clematis chinensis (Weilingxian), Daphne genkwa (Yuanhua), and Pharbitis nil (Qianniuhua);
- Relocating certain plant ingredients from Table A.1 (Table 1 in the 2008 edition) to Table A.2 (Table 2 in the 2008 edition) based on ingredient characteristics.
Inventory of Prohibited Substances for Toothpaste II
In this revision, the prohibited substances inventory II (Table 3 in the 2008 edition) has decreased from 173 to 154, a reduction of 19 substances.
Key revisions include:
- Adding certain newly prohibited ingredients from the "Inventory of Prohibited Ingredients for Cosmetics," including propoxyphene, diphenoxylate, methanol, methyl eugenol, bovine-derived materials, chlorophene, methyldibromo glutaronitrile, phenacetin, cannabidiol, bimatoprost, latanoprost, tafluprost, taflutamide, travoprost, nitromethane, and methenamine, totaling 20 substances;
- Standardizing certain ingredient names, such as 4-chlororesorcinol, 2-methylresorcinol, p-phenylenediamine sulfate, p-phenylenediamine HCl, and m-aminophenol HCl;
- Consolidating certain ingredients to align with the "Safety and Technical Standards for Cosmetics," such as merging "N,N-dimethyl-p-phenylenediamine" and "N,N-dimethyl-p-phenylenediamine sulfate" into "N,N-dimethyl-p-phenylenediamine and its salts";
- Moving 30 ingredients, including CI 21100, CI 45190, CI 51319, CI 10020, CI 12010, CI 15800, CI 21230, CI 42045, CI 47000, CI 44045, CI 42510, CI 12370, CI 73900, zinc pyrithione, hydroquinone, diethylene glycol, 6-amino-m-cresol, and 6-amino-o-cresol and their salts, into Table A.1 (Table 1 in the 2008 edition) to facilitate cross-referencing with EU regulations;
- Correcting and removing the entry for "inorganic sulfites and bisulfites."
Inventory of Restricted Ingredients for Toothpaste
In this revision, the restricted ingredients inventory has increased from 39 to 58, an increase of 19 substances.
Key revisions include:
- Adding ingredients with established safety assessment conclusions or those already listed in EC 1223/2009 as restricted substances, including retinol, retinol acetate, retinol palmitate, and hydroxyapatite (nano).
Inventory of Permitted Preservatives for Toothpaste
In this revision, permitted preservatives for toothpaste have decreased from 48 to 42, a reduction of 6 substances.
Key revisions include:
- Reclassifying chlorophene, formaldehyde and paraformaldehyde, and sodium iodate as prohibited ingredients;
- Excluding climbazole from the permitted preservative inventory due to its acute oral toxicity Category 4 classification (harmful if swallowed) and rare industry use;
- Merging piroctone and piroctone olamine, as well as salicylic acid, into their respective ingredient categories.
Inventory of Permitted Colorants for Toothpaste
In this revision, permitted colorants for toothpaste have increased from 102 to 103, an increase of 1 substance.
Key revisions include:
- Adding CI 77266 (nano) as a new permitted ingredient.
Note: EC 1223/2009 permits 26 colorants such as CI 10006, CI 11725, and CI 18130 for rinse-off products. However, since none of these ingredients have been used as toothpaste ingredients in registered toothpaste products in China, they remain prohibited for toothpaste in China.
Relationship with Relevant Laws, Administrative Regulations, and Other Mandatory Standards
Toothpaste ingredients and cosmetic ingredients are both related and significantly different:
- Commonality: Both reference relevant international regulatory requirements such as EC 1223/2009;
- Difference: Ingredients that only have temporary skin contact in cosmetics and are not permitted for mucosal contact should be strictly prohibited in toothpaste; Certain toothpaste-specific ingredients, such as fluorides, are not specifically regulated in other domains.
Meanwhile, the usage limits for certain restricted ingredients differ significantly between toothpaste and cosmetics. Therefore, the provisions on ingredients in the "Safety and Technical Standards for Cosmetics" are not applicable to toothpaste.
This standard is coordinated and consistent with current relevant laws, regulations, rules, and standards, including the "Measures for the Supervision and Administration of Toothpaste," the "Provisions on the Administration of Toothpaste Filing Materials," the "Inventory of Prohibited Ingredients for Cosmetics," and the "Inventory of Prohibited Plant (Animal) Derived Ingredients for Cosmetics."
The prohibited ingredients covered in this document encompass all ingredients listed in the "Inventory of Prohibited Ingredients for Cosmetics" and the "Inventory of Prohibited Plant (Animal) Derived Ingredients for Cosmetics," with additional ingredients that should be prohibited in the toothpaste industry. The usage principles for restricted ingredients, permitted preservatives, and colorants are coordinated with the relevant provisions of the "Measures for the Supervision and Administration of Toothpaste" and the "Provisions on the Administration of Toothpaste Filing Materials."
Supporting recommended standards include:
- Current national standard: Toothpaste (GB/T 8372-2017)
- Current industry standard: Efficacy Toothpaste (QB/T 2966-2025)
Comparison with International Standards and Foreign Regulations
This document does not adopt international standards. During the development of this standard, reference was made to EC 1223/2009 and its amendments. The main differences between the technical requirements of this document and EC 1223/2009 are as follows:
- Certain acts or bases cited in EC 1223/2009 do not conform to Chinese national conditions;
- The management requirements for certain ingredients in EC 1223/2009 are inconsistent with Chinese management requirements;
- China has special regulations on the use of certain ingredients that are not covered by the scope of EC 1223/2009.
Therefore, during the development of this document, reference was made to the existing ingredient safety assessment conclusions in EC 1223/2009, while fully incorporating Chinese national conditions and relevant management requirements. The relationship between this document and EC 1223/2009 is one of non-equivalent correspondence.
During the development of this standard, full reference was made to foreign regulations, directives, international standards, and advanced foreign standards, combined with China's actual conditions. This approach facilitates China's timely alignment with international standards, while fully considering China's industry realities and striving to maintain consistency with international requirements in terms of technical specifications.
Recommendation on WTO Notification
It is recommended to notify this standard externally. EU Regulation EC 1223/2009 and its amendments have been published, and the ingredient use management requirements therein are inconsistent with Chinese regulatory requirements; therefore, international standards were not adopted during the revision of this document. Given the significant export volume of Chinese toothpaste products, the publication of this standard may have a major impact on the trade of other World Trade Organization (WTO) members. In accordance with the relevant provisions of the "Measures for the Administration of Mandatory National Standards," it is recommended to notify the WTO as required.
Implementation Date
It is recommended that this document be implemented 12 months after its approval and publication.
CIRS Reminder
This draft for comments strengthens the control of toothpaste ingredients, expands the scope of prohibited and restricted ingredients, adjusts the inventories of preservatives and plant/animal-derived ingredients, and aligns closely with EU regulations while accommodating China's specific toothpaste regulatory requirements. CIRS Group recommends that toothpaste and cosmetics-related enterprises take advantage of the comment period and the 12-month implementation transition period:
1. Focus on ingredient regulatory changes: Pay attention to preservatives previously permitted but now reclassified as prohibited (e.g., boric acid, formaldehyde, paraformaldehyde, chloroacetamide), the usage limit requirements for newly added restricted ingredients (e.g., retinol and its derivatives, hydroxyapatite (nano)), and newly added prohibited plant (animal) derived substances.
2. Note the differences between toothpaste and cosmetics ingredient management: Although toothpaste and cosmetics ingredients are related, there are significant differences. Some ingredients permitted in cosmetics may be prohibited or restricted in toothpaste due to oral mucosal contact. Companies engaged in both cosmetics and toothpaste production should separately verify compliance against the "Safety and Technical Standards for Cosmetics" and this standard — they should not be used interchangeably.
3. Plan ahead for the transition period: The draft for comments recommends implementation 12 months after the standard is formally published. After official publication, companies will need to complete formulation adjustments and filing amendments for existing products within the transition period. Given that formulation adjustments may involve safety assessments, efficacy verification, stability testing, and other processes, enterprises are advised to initiate compliance assessments early and allow sufficient time.
CIRS Group will continue to monitor changes in Chinese toothpaste regulations and standards and publish the latest updates promptly.
If you need any assistance or have any questions, please get in touch with us via service@cirs-group.com.
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