Overview
Cleaning and disinfectant products are identified and regulated very differently across various countries and regions. It becomes 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 comply 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 formulations/mixtures are subject to other additional chemical regulations like GB 38850-2020 (List for materials and restricted chemical 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 chemical substances in disinfectant formulations, and China REACH/inventory of existing chemical substances produced or imported in China.
Registration/Notification Process in China
Companies must fulfill all the chemical Regulatory requirements for Hazardous chemical registration.
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
|
Chemical Regulation |
Biocide/ Disinfectant |
Detergents /Cleaning products |
General consumer Products |
Chemicals |
|
Regulation |
|
|
|
|
|
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 Artwork, 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 Chemical 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.
Freyr Expertise
- Product Classification and Chemical 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
- 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
