Regulatory Services for Chemical Products & Mixtures
in China

Overview

Cleaning and disinfectant products are identified and regulated very differently across various countries and regions. It makes very challenging for the industry to place the products in different markets.

In China, disinfectant products are regulated by the National Health and Family Planning Commission (MOH) under the regulation measures on the administration of disinfection products where detergent products should be in compliance with China’s national standard (GB), like GBT 26396-2011 (technical specifications for safety of soaps and detergents)

Furthermore, active and other non-active chemicals used in the product formulation/ mixture are subject to other additional regulations like:

GB 38850-2020 (List for materials and restricted substances in disinfectants), which specifies the list of ingredients and the scope of application of disinfectants for different disinfection objects along with the prohibited and restricted substances in disinfectant formulations, and China REACH/inventory of existing chemical substances produced or imported in China.

Registration/Notification Process in China

Hazardous chemical registration where companies must fulfil all the Regulatory requirements.

For daily chemical products, the disinfectant products shall be registered or notified before sale or import. Only new disinfectants (new materials, new processes and technologies, and new sterilization principles) shall be registered; other products should be managed under three (03) categories depending on the risk. Category 1 (High Risk) and category 2 (Medium Risk) products shall be notified before sale or import.  For the category 3 (Low Risk) products, under regular supervision, the enterprises should guarantee product compliance before sale or import.

Product Classification

 

Categories

Biocide/ Disinfectant

Detergents

/Cleaning products

General consumer Products

Chemicals

Regulation

  • Measures on Disinfectant Administration issued by the Ministry of Health (MOH) in 2002
  • Regulations on Sanitary and Safety Evaluation of Disinfection Products
  • Regulations on Administrative License of New Disinfection and Aquatic Products
  • GB 38598-2020 General requirement for label and instruction book of disinfection products
  • Administration for Market Regulation (SAMR)  
  • GB China standard (GBT 26396-2011-Technical specification for the safety of soap and detergent, detergents/cleaners and GB/T 36970-2018 Instruction for use of consumer products-Labeling for detergents)
  • Product quality law of the People's Republic of China.
  • Order No. 12 of the Ministry of Ecology and Environment (MEE Order No. 12) - Measures on the Environmental Management of New Chemical Substances
  • China REACH (MEP Decree No.7)
  • Global harmonized system

Registration Requirement

Yes

No

No

Yes

Process brief

Online

N/A

N/A

Online

Local representative

Yes

N/A

N/A

Yes

Key data requirements

R&D report (efficacy and other testing), Quality standards, Proof of allowance of local sale by authority, Draft product label artworks, and Safety Datasheet.

 

Safety Information about the product (skin sensitization/ irritation), PH, Biodegradability, phosphate content, stability etc.

Safety Information about the product related Use

New hazard information, Assessment certificates, SDS, physicochemical properties, health toxicology and ecotoxicological properties.

 

Timeline

6-12 months

N/A

N/A

Depends on the type of  registration.

H.S. Code

38089400

Multiple HS codes: 3401 and 3402

Multiple

Multiple

Examples:

3903, 29, 38

GHS is implemented on chemicals and mixtures through China National standards like “General Rule for Classification and Hazard Communication of Chemicals,” where SN/T 3083.1-2012 specified definitions and specifications.

Important Validities

In China, validity depends on product class; for example, Class I products are valid for four (04) years, whereas for Class II products, no validity is required until there is no change in product notification. There is no registration required for Class III products.

Local Representation in China

A local representative in China is required for biocides, disinfectants, and chemical products.

As a proven Regulatory Expert, Freyr assists market entrants with chemical Regulatory services in China. Consult Freyr for Regulatory services such as chemical product registration in China, document renewals, preparing technical dossiers, etc.

 

 

Expertise

Freyr Expertise

  • Product classification and Regulatory guidance
  • Regulatory strategies for market access/product launch
  • Develop product notification/registration strategies.
  • Chemical product Registration in China
  • Regulatory applicability review and interpretation
  • Prepare technical data files (Specification, MSDS, etc.), including registration/ notification dossiers
  • Application preparation and submission of relevant introductions and renewals
  • Sustainability and packaging solutions
  • Regulatory intelligence
Freyr Advantages
Advantages

Freyr Advantages

  • Local presence in the market with relevant expertise and experience
  • End-to-end Regulatory consultation
  • Easily navigate complexities of Regulatory Authorities
  • Support for region-specific Regulatory complexities
  • A structured and cost-effective approach to ensure compliance in multi-market scenario
  • Quick turnaround and faster time-to-market