China Overhauls Toothpaste Ingredient Standards for First Time in 18 Years

For global personal care brands and ingredient suppliers, China's massive oral care market is entering a highly regulated era. This regulatory shift means that any brand selling or manufacturing toothpaste in China must immediately audit their formulations, coordinate with suppliers, and prepare for much stricter compliance hurdles.

For the first time in 18 years, China's oral care industry is facing a massive overhaul of its raw material standards.

The National Medical Products Administration (NMPA)—China's primary cosmetics and drug regulator—recently released the draft of the mandatory national standard, Technical Specifications for Toothpaste Raw Materials (Draft for Comments), open for public feedback until August 4.

Marking the first update since the implementation of the GB 22115-2008 standard, this draft introduces comprehensive upgrades across banned substances, restricted ingredients, preservatives, colorants, and labeling claims. It signals that the toothpaste sector is entering an era of unprecedented regulatory scrutiny.

Five Core Changes: Understanding the New Regulatory Rigor

Compared to the 2008 standard, this revision is not just a minor adjustment of numbers; it represents a systemic upgrade in regulatory philosophy. Here are the five key changes to watch.

1. Massive Expansion of Banned Substances

The draft expands the list of banned chemical substances in toothpaste from 1,205 to 1,630—a net increase of 425. Ingredients previously allowed under the older standard, such as borates, formaldehyde, paraformaldehyde, and chloroacetamide, have now been reclassified as banned.

Banned plant and animal-derived substances increased from 88 to 120. Notably, the new restrictions explicitly cover "extracts and derivatives." Furthermore, if no specific banned part of a plant is specified, the ban applies to the entire plant. This prevents companies from using "non-banned parts" or processed derivatives to bypass the rules. Cannabis sativa seed oil, cannabis sativa leaf extract, and marigold (Tagetes erecta) flower extract are among the newly banned ingredients.

Additionally, the second catalog of banned substances was reduced from 173 to 154. This adjustment incorporates newly banned cosmetic ingredients like cannabidiol (CBD), bimatoprost, and latanoprost. To align with European Union regulations, certain substances like hydroquinone and diethylene glycol have been moved to a unified banned raw materials table.

2. Expanded Restricted Ingredients and Full Regulation of Fluorides

The list of restricted ingredients has grown from 39 to 58. The most concentrated changes target fluorine compounds. Over ten fluorides—including aluminum fluoride, ammonium fluoride, ammonium monofluorophosphate, calcium fluoride, olaflur, and stannous fluoride—are now unified under the restricted list. The draft mandates that when multiple fluorides are blended, the total fluorine concentration must not exceed 0.15%, and each fluoride must be labeled individually.

Retinol (Vitamin A) and its derivatives have also been added to the restricted list, with a maximum allowable concentration of 0.3%. Products containing these ingredients must carry a warning label: "Contains Vitamin A. Consider your daily intake before use."

3. Narrower List of Permitted Preservatives and Strict Formaldehyde Controls

The number of permitted preservatives has been cut from 48 to 42. Isopropylparaben, isobutylparaben, phenylparaben, benzylparaben, pentylparaben, and their salts have been removed from the approved list. The remaining 42 preservatives face stricter conditions. For example, a mixture of methylchloroisothiazolinone (MCI) and methylisothiazolinone (MIT) (3:1) is capped at a maximum concentration of 0.0015% and cannot be used alongside MIT alone.

Formaldehyde-releasing preservatives (such as diazolidinyl urea and DMDM hydantoin) are also heavily regulated. Regardless of the source, if the free formaldehyde concentration in the finished product exceeds 0.05%, the packaging must be labeled "contains formaldehyde."

4. Labeling Claims Tied to Concentration, Usage, and Demographics

Beyond raw material controls, the draft introduces strict rules linking ingredient usage to final product claims. For instance, products with an ammonia concentration of 2% or higher must be labeled "contains ammonia." Products containing hydrogen peroxide or salicylic acid must be labeled accordingly, with salicylic acid products requiring the warning "not to be used for children under three years of age." This raises the bar for packaging and labeling compliance.

5. Nanomaterials and Impurity Limits Defined to Align with Global Standards

Permitted colorants increased from 102 to 103, with "nano-carbon black" being the sole addition, subject to strict limits on polycyclic aromatic hydrocarbons (PAHs). The draft also outlines highly specific physical requirements for nano-hydroxyapatite: at least 95.8% of the particles must be rod-shaped, have an aspect ratio of less than 3, and remain uncoated or unmodified.

For the first time, impurity limits are explicitly defined. If diethylene glycol (DEG) and ethylene glycol (EG) are technically unavoidable as impurities, their combined concentration in the toothpaste must not exceed 0.1%. Trace impurities in colorants are also strictly limited—for example, aniline in CI 17200 (D&C Red No. 33) must not exceed 25 mg/kg, and benzidine is capped at 20 μg/kg, aligning China's standards with international benchmarks.

Regulatory Wave: Tightening Supervision Is Inevitable

This major revision of the raw material specifications is not an isolated policy shift, but a critical piece of China's rapidly evolving regulatory framework for oral care.

The landmark Cosmetics Supervision and Administration Regulation (CSAR), implemented in 2021, classified toothpaste under the same regulatory umbrella as ordinary cosmetics, establishing the legal foundation for the industry. In 2023, the Measures for the Supervision and Administration of Toothpaste established a full-chain oversight framework covering product filing, production licensing, efficacy claims, and labeling. On March 30, 2026, the NMPA released the draft of the General Safety Technical Requirements for Toothpaste, the first general safety standard since toothpaste was integrated into cosmetics supervision. The new raw material specifications now fill the most critical gap: ingredient-level control.

Concurrently, the draft of the Toothpaste Classification Catalog is moving forward, classifying toothpaste efficacy claims and defining permitted marketing language to prevent false advertising.

Technical indicators are also being quantified and standardized, from testing methods for toothpaste Relative Dentin Abrasion (RDA) values to laboratory tests for extrinsic stain removal. Efficacy claims can no longer rely on marketing buzzwords; they must be backed by standardized clinical or laboratory data.

Regulation is shifting from post-market random testing to pre-market source control, moving from general principles to highly quantified standards. This comprehensive framework now spans raw materials, safety, efficacy, and labeling. Tightening supervision has become an irreversible trend.

Rising Compliance Barriers to Accelerate Industry Consolidation

For toothpaste manufacturers, the implementation of these new rules will bring multi-dimensional challenges, accelerating the consolidation of the market.

R&D and Formulation: Formula reformulations are now urgent. The combination of 425 newly banned substances, expanded restricted lists, and fewer permitted preservatives means that a vast number of existing formulations must be re-evaluated or completely overhauled. Small and medium-sized enterprises (SMEs) that rely on generic, off-the-shelf formulas will face severe disruptions if their core ingredients are restricted or banned.

Filing and Registration: Filing requirements are becoming much more demanding. Once the new raw material specifications take effect, any changes to existing product formulations will require re-filing or supplementary documentation. For companies with extensive product portfolios, this translates to significant time and financial costs. Furthermore, the strict limits on impurities mean brands must perform rigorous audits on raw material suppliers and conduct in-house testing rather than relying solely on supplier-provided certificates of analysis. To mitigate these risks, brands must build highly resilient supply chains. This is a challenge not unique to oral care; as seen across the broader beauty sector, companies are increasingly auditing and optimizing their beauty supply chain to ensure compliance and quality control.

Labeling Compliance: Labeling is the new compliance battlefield. As mentioned, several ingredients now require specific warning labels based on concentration, usage, and target demographics. Brands must establish precise raw material and label review mechanisms to ensure every batch is fully compliant.

From an industry-wide perspective, SMEs lacking compliance capabilities will be phased out rapidly. Conversely, leading manufacturers and innovative brands with strong R&D, supply chain control, and robust compliance systems will capture greater market share. Additionally, aligning with international standards helps domestic Chinese brands overcome technical barriers to export, though it also means they must meet the same rigorous technical standards at home as global brands.

To ease the transition and address potential issues like raw material stockpiles and formula adjustments, the draft's compiling notes suggest a 12-month transition period. This offers a fair starting line for all players, but those who invest early in compliance will gain a significant head start.

Ultimately, proactive adaptation is far better than reactive compliance. By embedding regulatory compliance into their core competitiveness, brands can secure their position in the upcoming industry shakeup. For consumers, stricter ingredient controls and transparent labeling will ultimately deliver a safer, more trustworthy daily oral care experience.