China Regulatory News

On the 1st of December 2021, China’sNational Medical Products Administration  (NMPA) published a special label for cosmetics that are intended for use by children under 12 years old. Fro...

On the 1st of December 2021, China’sNational Medical Products Administration  (NMPA) published a special label for cosmetics that are intended for use by children under 12 years old.

From 1 May 2022, newly registered children’s cosmetics must attach the logo. If the cosmetic is already registered or filed when the notification is published, companies must update their labels before 1 May 2023.  

According to the requirements, the label must be at least 1cm wide if the outer surface area of a product is smaller than 100cm2, while if it is larger, then the label must be at least 2cm wide.

Children’s cosmetics are defined as cosmetics made for children under 12 years old. NMPA defines children’s cosmetics as those products that have functions such as cleansing, moisturizing, and sun protection. China’s NMPA announced children's cosmetic working plan in October which is planned to come into force on January 1, 2022. 

For more inquires relating to China REACH and cosmetic regulation, please contact compliance@gpcregulatory.com  

Last update: 2021-12-15

On 27th October, the National Centre for Food Safety Risk Assessment (CFSA) of China published a consultation on the approval of food additives and resins and the ex...

On 27th October, the National Centre for Food Safety Risk Assessment (CFSA) of China published a consultation on the approval of food additives and resins and the expanded use of FCM additives.  

There are three food additives being considered for use in FCMs. They are:  

• acids, aliphatic, monocarboxylic (C10-C22), esters with polyglycerol – for use in plastic at a maximum use level of 0.35%; 
• 2-propenoic acid, 2-methyl-, 1,2-ethanediyl ester, polymer with methyl 2-methyl-2-propenoate – for use in polyethylene (PE) and polypropylene (PP) plastics up to 1%;  
• hexanedioic acid, polymer with N-(2-aminoethyl)-1,3-propanediamine, aziridine, (chloromethyl)oxirane, 1,2-ethanediamine, N,N''-1,2-ethanediylbis[1,3-propanediamine], formic acid and α-hydro-ω-hydroxypoly (oxy-1,2-ethanediyl) – for use in paper and paperboard up to 0.12% (counts as the dry weight*). 

And the food contact resins that are also being considered are: 

• polymer of ethyl acrylate, acrylic acid and styrene – for use in coating and coating film at a maximum use level of 2%; 
• 1,3-benzenedicarboxylic acid, polymer with 2,2-dimethyl-1,3-propanediol, 1,2-ethanediol and hexanedioic acid – for use in coating and coating film up to 10%; 
• 1-isocyanato-3-isocyanatomethyl- 3,5,5,-trimethylcyclohexane homopolymer, methyl ethyl ketone oxime-blocked – for use in coating and coating film up to 15%; 
• 1,3-benzenedicarboxylic acid, polymer with azacyclotridecan-2-one, 1,4-benzenedicarboxylic acid, dodecanedioic acid and 4,4'-methylenebis [2-methylcyclohexanamine] – for use in plastic; and 
• propanoic acid, 3-hydroxy-2-(hydroxymethyl)-2-methyl-, polymer with 1,3-diisocyanatomethylbenzene and α-hydro-ω-hydroxypoly [oxy(methyl-1,2-ethanediyl)] – for use in adhesives with indirect contact with food. 

In addition to the addictives and resins, CFSR is considering the additional uses of the following FCM addictives:  

• C.I. solvent red 52 – for use in in plastic polycyclohexylenedimethylene terephthalate (PCT) at a maximum use level of 0.03%; and 
• C.I. pigment yellow 180 – for use in PCT up to 0.3%.

After the consultation period which ended on November 18, if the substance gets approved, it will be put in the positive list of GB 9685-2016 and must adhere to GB 4806.1 requirements before they can be used in FCMs.  

Last Update: 2021-11-30

On the 30th of September, the National Medical Products Administration of China (NMPA) published the final Regulations on the Supervision and Administration of Children’s Cosm...

On the 30th of September, the National Medical Products Administration of China (NMPA) published the final Regulations on the Supervision and Administration of Children’s Cosmetics which is expected to take effect on the 1st of January 2022.  

Under this regulation, children's cosmetics are defined as cosmetic products intended for children under 12 years old. Specifically, children’s cosmetics must include a warning statement that it shall be used under adult guidance and not have words such as food grade, edible, or even pictures related to food. Regarding data requirements, children's products need to provide both toxicological and safety assessment data. Being different from other products, animal testing is not exempted for such cosmetics.  

According to the requirements, manufacturers who wish to produce or export children cosmetics to China have to take note of the following points:  

• In addition to the labeling requirement, this regulation will come into force on the 1st of January 2022;  

• From May 1, 2022, registration and record filing of children’s cosmetics must have the required labels. For those who registered before this regulation, they have to update their labels and products in alignment with this regulation;  
• The children's cosmetic label is to be announced later.  

For more inquires relating to China REACH and cosmetic regulation, please contact compliance@gpcregulatory.com  

Last Update: 2021-11-03

On the 7th of September, 2021, the Chemical Registration Centre in China upgraded its hazardous chemical substance registration platform based on the module of ’Platform + Applica...

On the 7th of September, 2021, the Chemical Registration Centre in China upgraded its hazardous chemical substance registration platform based on the module of ’Platform + Application’ mentioned in its 2021 working plan. The system was upgraded to enable companies generate Quick Response (QR) codes for hazardous chemicals.

This upgrade is meant to support the supervision of chemicals, create a better information system, and control hazardous chemicals. Therefore, the system now has a ‘one company, one product, one code’ for hazardous chemicals, and companies can now quickly generate QR codes for their hazardous chemicals.

Companies can either place their QR codes on the outer packaging and containers or on the

Globally Harmonized System of Classification and Labelling of Chemicals (GHS). The new updated system has the following two achievements:  

• The new platform has integrated certain functions for enterprise-end  

The functions integrated are safety data sheet registration, printing function for relevant documents, and regulation check.  

• Guangdong was elected for a pilot test of the new system  

To identify the steadiness and reliability of this system, the Emergency Department of Guangdong Province cooperated with the Chemical Substances Registration Center to conduct a pilot. Since July 20, 2021, 1,329 companies have used the platform, which is 85.03% of the total chemical companies in Guangdong. The number of registered companies for hazardous chemicals has also increased from 229 to 495.

The use of the new system is not yet mandatory for all chemical producers, importers, and exporters. Chinese manufacturers and importers can use the new system while foreigners are required to facilitate Chinese importers with documents’ submission. However, it is predicted to become mandatorily promoted, and related regulations will be formulated in the near future.

Last Update: 2021-10-27

On the 15th of September 2021, Chinese authorities approved a list of chlorofluorocarbons (CFCs) and hydrofluorocarbons (HFCs) in agreement and under the control of the Kigali Amendment. This is an am...

On the 15th of September 2021, Chinese authorities approved a list of chlorofluorocarbons (CFCs) and hydrofluorocarbons (HFCs) in agreement and under the control of the Kigali Amendment. This is an amendment to the UN’s Montreal protocol calling on developed countries to gradually phase out HCFs to reduce emissions and protect the ozone layer.

The final list, same as the draft revised list published in August, contains more than 100 CFCs and HFCs and companies have to start phasing them out. This came into force immediately after its publication.

These substances are used as refrigerants, solvents, fire suppressants, foam blowing agents, aerosols, and propellants. HFCs are widely used alternatives for HCFCs and CFCs, ozone-depleting substances which are controlled under the Montreal Protocol. HFCs have high global warming potential, hence the reason for the Kigali Amendment aiming to reduce the use of HFCs as well.

The revised list (in Chinese) can be accessed here.

Last Update: 2021-10-21

On the 26th of July, the National Health Commission of China (NHC) announced that 9 food additives and 19 food reactants were approved, according to China Food Safety Law. The above mentioned 28 su...

On the 26th of July, the National Health Commission of China (NHC) announced that 9 food additives and 19 food reactants were approved, according to China Food Safety Law.

The above mentioned 28 substances are the following:

9 food additives:

• 4-α-glycosyltransferase
• alpha-amylase
• Polygalacturonase
• Pectin esterase
• Phosphoinositide Phospholipase C
• Phospholipase C
• Xylanase
• Glucoamylase
• Lipase

19 food-related reactants and new contacts

• The reaction product of sodium silicate with trimethylchlorosilane and isopropanol
• Dodecylguanidine hydrochloride
• Poly-1,4-butanediol adipate
• talcum powder
• The reaction product of phosphorus trichloride with biphenyl and 2,4-di-tert-butylphenol
• C.I. Solvent Red 135
• C.I. Pigment Violet 15
• Zinc phosphate (2:3)
• Ethanolamine
• 2-[4,6-bis(2,4-dimethylphenyl)-1,3,5-triazin-2-yl]-5-(octyloxy)phenol
• 2-methyl-2-acrylic acid-2-ethyl-2-[[(2-methyl-1-oxo-2-propenyl)oxy]methyl]-1,3-propanediol ester
• Polymer of 2-acrylic acid and 2-ethylhexyl-2-acrylate
• (E) Polymer of -2-butenedioic acid, 1,3-isobenzofurandione and tricyclodecane dimethanol
• 1,4-phthalic acid and 1,3-phthalic acid, 2,2,4,4-tetramethyl-1,3-cyclobutanediol, 1,4-cyclohexanedimethanol and 1,6 -Hexanediol polymer
• Polymer of 2-methyl-2-acrylic acid and N-(butoxymethyl)-2-acrylamide, styrene and ethyl 2-acrylate
• 2,6-Dimethyl 2,6-naphthalenedicarboxylate and 1,4-cyclohexanedimethanol, 1,2-ethylene glycol, 2,2'-oxybis[ethanol] and β3, β3, β9 ,β9-tetramethyl-2,4,8,10-tetraoxaspiro[5.5]undecane-3,9-diethanol polymer
• Poly[imino-1,4-butanediylimino (1,10-dioxo-1,10-decanediyl)]
• Polymers of 2-acrylic acid with 2-butyl acrylate, vinyl acetate, 2-ethylhexyl 2-acrylate and ethyl 2-acrylate
• Esterification of 2,5-furandione and ethylene polymer and vinyl alcohol homopolymer

For more inquires about the application scope and limitations of the above-mentioned new contacts and additives, please contact compliance@gpcregulatory.com.

Last update: 2021-08-31

On the 6th of August, the National Medical Products Administration (NMPA) enacted “Measures for Cosmetics Supervision and Administration” which will come into force from the first day of 2...

On the 6th of August, the National Medical Products Administration (NMPA) enacted “Measures for Cosmetics Supervision and Administration” which will come into force from the first day of 2022. This is the first regulation that focuses on cosmetic production and management in China, according to NMPA.

There are seven chapters and sixty-six articles which outline the license, manufacture, supervision, liability, and management rules, including the following: 

• Certificate holders, agents and entrusted factories must establish a system that can guarantee the quality management process.
• The storage spots are not allowed to store any products that might affect the quality of cosmetics.
• Recording the sources of incoming raw materials and cosmetics to ensure that products are traceable. All the records are subjected to inspection.

In addition, the 5-years certificate validity period can be re-counted under certain circumstances, which lessen producers’ burden. The rules on children's cosmetics are stricter as a special label must be made on the children’s products.

For more inquires on cosmetic regulation in China, please contact compliance@gpcregulatory.com