China Regulatory News

On 23 March 2023, the State Administration for Market Regulation of China (SAMR) announced the “Toothpaste Supervision Management Measures” will be enforced from 1 Dec. 2023. According to the regu...

On 23 March 2023, the State Administration for Market Regulation of China (SAMR) announced the “Toothpaste Supervision Management Measures” will be enforced from 1 Dec. 2023. According to the regulation, toothpaste is defined as “a paste-like product that is applied to the surface of human teeth in a frictional manner for the main purpose of cleaning”. 

Within “Cosmetic Supervision and Administration Rules” (CSAR), toothpaste was required to be complied according to normal cosmetic products. To enforce this article, Toothpaste regulation was published. It specified the requirements and procedures for toothpaste registration. After the enforcement of this regulation, toothpaste registration should be carried according to it and not the CSAR regulation. 

There were in total 25 articles which regulate the following aspects: 

• General rules which are about definition, classification, and supervision bodies. 

• Labelling and efficacy claim requirements.

• Registration requirements and procedures, relevant technical standards. 

Manufacturing and importing are not allowed until a certificate is granted. For more information regarding toothpaste regulation, please contact GPC via compliance@gpcregulatory.cn.

The National Health Commission of China is consulting on proposed modification to the country’s main standard regulating food contact materials (FCMs), GB 9685-2016. GB 9685-2016, Standard for the U...

The National Health Commission of China is consulting on proposed modification to the country’s main standard regulating food contact materials (FCMs), GB 9685-2016. GB 9685-2016, Standard for the Use of Additives in Food Contact Materials, contains a positive list of additives that is allowed to be used in FCMs and articles conditionally or unconditionally as prescribed in the standard. 

The new modifications lower the migration levels for following substances:

• 4,4'-methylenedianiline – to be amended to 0.002mg/kg. 

• 2-ethylhexanol – to be amended to 30mg/kg. 

• 1,2,4-benzenetricarboxylic acid – to be amended to 5mg/kg.

• eugenol to be introduced as not detected. 

• a polysiloxane with Cas number 156065-00-8 to be introduced as not detected; and 

• m-xylylenediamineto to be introduced at 0.05mg/kg. 

Additionally, companies are still allowed to use the additives currently permitted for use in food. The consultation is open until 20 March. If you would like to know more information about China regulatory requirements, please contact compliance@gpcregulatory.cn, 

National Istitutes for Food and Drug Conrol of China (NIFDC) published notification calling for suggestions on “Cosmetic Safety and Technical Guidelines”. “Cosmetic Safety and Technical Guidelin...

National Istitutes for Food and Drug Conrol of China (NIFDC) published notification calling for suggestions on “Cosmetic Safety and Technical Guidelines”. “Cosmetic Safety and Technical Guidelines” is the main cosmetic safety standard under the “Cosmetic Supervision and Administration Regulation” (CSAR). It was published first in 2015 and modified in 2021. It gives information about the requirements and proceudres for cosmetic ingredient and final product test, risk assessment and toxicology test requirements. 

Currently, the modifications made in last year’s draft has been approved. The main changes in last year’s draft were: 

• Amending the list of ingredients approved and banned for use;
• Introdcuing more test methods for physical and chemcial inspection, , toxicological test methods and human efficacy test methods; and  
• Including new requriments for safety assessment report to keep in line with CSAR. 

All stakeholders can submit suggestion before 17 March. If you want to know more information about China cosmetic and chemical compliance, please contact compliance@gpcregulatory.cn for help. 

On 18th Jan. 2023, National Medical Products Administration of China (NMPA) published a notification on simplifying normal cosmetic products tests requirement for record filling procedure. This notif...

On 18^th Jan. 2023, National Medical Products Administration of China (NMPA) published a notification on simplifying normal cosmetic products tests requirement for record filling procedure. This notification measure is enforced from the date of publication. 

According to the notification, those normal cosmetic products which adopt inspection as quality control measures and the production process has been included in the daily supervision of Provincial Medical Products Departments, the inspection report issued by the cosmetics filing party or the entrusted manufacturer that conducts self-inspection in accordance with the relevant requirements of the cosmetics technical specification can be submitted. Except for one of the following situations: 

• The product claims to be used by infants and children.
• The product uses new cosmetic raw materials that are still under safety monitoring.
• The product claims to have effects such as acne removal, nourishment, repair, anti-wrinkle, dandruff removal, and deodorization.
• Other situations where the product may have relatively high safety risks.

When submitting a self-inspection report when the product is filed, the filing party should also submit a statement of the corresponding inspection capabilities for the cosmetics filing inspection stipulated in the "Cosmetics Registration and Filing Inspection Work Specification", and provide the corresponding inspection personnel, equipment, facilities, and site environment for self-inspection.

For more China REACH and cosmetic compliance information, please contact GPC via compliance@gpcregulatory.cn.

On 12 Jan. 2023, National Medical Products Administration of China (NMPA) published the final Measures for the Administration of Sampling and Testing of Cosmetics. This new rule will come into force f...

On 12 Jan. 2023, National Medical Products Administration of China (NMPA) published the final Measures for the Administration of Sampling and Testing of Cosmetics. This new rule will come into force from 1 Mar. 2023. 

According to the new rule, the following cosmetic products will be the key products of sampling and testing: 

(1) Children's cosmetics and special cosmetics.

(2) Cosmetics using new raw materials.

(3) Many problems are found in supervision and inspection, case investigation, adverse reaction monitoring, safety risk monitoring, complaints and reporting, and public opinion monitoring process.

(4) The unqualified rate of previous sampling inspections was relatively high.

(5) Those with a wide range of circulation and high frequency of use.

(6) Other products with relatively high safety risks.

But if cosmetic products meet the following situations, then it can be exempted from sampling and testing requirement: 

(1) The product is only for export.

(2) The product has been opened, damaged or contaminated, which may affect the inspection results.

(3) The remaining validity period of the product is less than 6 months, except for products with a validity period less than 6 months.

Overseas manufactures who exported their cosmetic products to China shall ask their Chinese agent to help them with the sampling and testing requirement which will be enforced from 1 Mar 2023. For more cosmetic and REACH compliance in China, please contact GPC via compliance@gpcregulatory.cn or zhengmin@cn.gpcregulatory.com. 

On 23 and 26 Dec. 2022, National Medical and Pharmaceutical Administration of China (NMPA) released two tests, BJH 202204 and BJH 202205, to detect six hazardous chemicals in cosmetic products. Both o...

On 23 and 26 Dec. 2022, National Medical and Pharmaceutical Administration of China (NMPA) released two tests, BJH 202204 and BJH 202205, to detect six hazardous chemicals in cosmetic products. Both of the test methods use qualitative and quantitative methods to determine the hazardous substance contained in cosmetic products. 

Test BJH 202204 is for detecting the presence of the following hazardous chemicals in cream, liquid, gel and wax-based cosmetics:

• tetrahydroimidazoline;  
• naphazoline;
• oxymetazoline;  
• antazoline; and  
• xylometazoline.  

Test BJH 202205 is for cream, liquid, gel and film cosmetics to detect the presence of dehydroandrographolide succinate half ester.

Both test methods are created to strengthen the conventional testing methods through targeting prohibited ingredient. Entities who wish to submit a supplementary test themselves can do so via the NMPA Technical Guidance for Research and Drafting Cosmetics Supplementary Testing Methods. 

For more information regarding China cosmetic regulation and REACH compliance, please contact GPC via compliance@gpcregulatory.cn or zhengmin@cn.gpcregulatory.com. 

On 23 November 2022, the National Medical Products Administration (NMPA) in China released a new supplementary test method ‘BHJ 202203 Determination of 16alpha-hydroxiprednisolone in Cosmetics’. T...

On 23 November 2022, the National Medical Products Administration (NMPA) in China released a new supplementary test method ‘BHJ 202203 Determination of 16alpha-hydroxiprednisolone in Cosmetics’. The test specifies the qualitative and quantitative determination method of the ingredient 16alpha-hydroxyprednisolone in creams, lotions, and liquid cosmetics.

16alpha-hydroxyprednisolone (CAS number of 13951-70-7), is used in the production of steroids such as budesonide and ciclesonide.  According to the EU classification, prolonged or repeated exposure to the substance can cause skin sensitization reactions, impair the fertility of unborn babies, and cause harm to breastfed children. It is banned for use in cosmetics in China.

BJH 202203 is a supplementary test that is a supplement to the conventional test methods specified in the national cosmetic standards and technical specifications. The supplementary tests are established for banned ingredients in cosmetics that lack testing methods and are used in adulterated products. Supplementary testing methods are important for regulators and law enforcement inspecting cosmetics post-market especially when combatting illegal additions.

For further information about the NMPA supplementary tests check the following links:.

• NMPA supplementary tests, 2021 (in English)
• NMPA supplementary test method for 16α-hydroxyprednisolone in cosmetic products (Mandarin)

For more information regarding China regulatory compliance solutions, please contact us at compliance@cn.gpcregulatory.com