Chemical Registration in China

Chemical Registration in China - Overview

Chemical products used for cleaning and disinfecting purpose are called/identified and regulated very differently across countries and regions, making it very challenging for the industry to place these products in different markets.

Chemical products, being an integral part of the general consumer portfolio, must ensure the quality, efficacy, and safety of the product while being placed in the market. Different Regulatory bodies around the globe enforce regulations w.r.to registration, conformity assessment, standard compliance, sustainability, etc., for chemical products' safety.

In China, disinfectant products are regulated by National Health and Family Planning Commission (NHFPC) under the regulation - Measures on Administration of Disinfection Products. Daily chemical products and 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 and should be managed under the following three (03) categories depending on the risk:

  • Category 1 (High Risk)
  • Category 2 (Medium Risk)
  • Category 3 (Low Risk)

Category 1 and Category 2 products shall be notified before sale or import. Category 3 products shall be under regular supervision by the manufacturers/companies. They should guarantee product compliance before sale or import.

On the other hand, detergent products should comply with China’s National Standard (GB) such as GB/T 26396-2011 (Technical specifications for safety of soaps and detergents).

Further, active and non-active chemicals used in the product formulation/mixture are subjected to other additional regulations such as GB 38850-2020 (List for materials and restricted substances in disinfectant). It specifies:

  • The list of ingredients.
  • The scope of application for different disinfection objects along with prohibited and restricted substances in disinfectant formulations.
  • China REACH/Inventory of existing chemical substances produced or imported in China.

Table 1: Chemical Regulations in China

 

Chemical Regulation

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)
  • 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 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

Sustainability

In China, the primary Regulatory body responsible for environmental protection and sustainable development is the Ministry of Ecology and Environment of China (MEE). The MEE has implemented various regulations and standards to promote sustainable practices in consumer products. However, it's important to note that specific regulations for sustainability and environmental logos can vary depending on the type of product and industry.

  • China Environmental Labeling Program (CELP): The China Environmental Labeling Program, also known as the China Eco-label or the Green Logo, is a voluntary certification program initiated by the Chinese government. It aims to promote products that meet specific environmental standards throughout their life cycle. The program covers various product categories, including household appliances, electronics, paper products, textiles, and more. Products that meet the required standards can display the Green Logo on their packaging.
  • Hazardous Substance Control: China has regulations in place to control the use of hazardous substances in consumer products. For example, the China Restriction of Hazardous Substances (RoHS) restricts the use of certain hazardous substances in electrical and electronic products. Compliance with these regulations ensures that products meet specific environmental and health standards.
  • Packaging Waste Management: China has also implemented regulations to manage packaging waste. These regulations aim to reduce the environmental impact of packaging materials by promoting recycling and waste reduction. The specific requirements for packaging waste management can vary depending on the region and the type of product.

It's important to note that compliance with these chemical regulations and obtaining the necessary certifications often requires interpretive skills. With experience in sustainability challenges, Freyr is well-positioned to support various sustainability-related services and has been supporting some of the leading global firms with food contact material compliance, consumer product packaging Regulatory services, and ecolabeling requirements. 

Pet Food

Any pet food company willing to export pet snacks and supplements to China must comply with a series of regulations, laws, and registrations. The Chinese authorities involved are the General Administration of China Customs (GACC) and the Ministry of Agriculture and Rural Affairs (MARA). GACC authorizes a foreign company's production facility to export goods to China and MARA authorizes the product for its importation, sale, and use in China. Pet food must be packaged and labeled with Chinese labels that comply with the Pet Food Labeling Regulations, and the product's hygienic indicators must comply with the "Pet Feed Hygiene Regulations."

Table 1: Pet Food Regulatory Snapshot

Classification

Pet Food.

Authority

General Administration of Customs of China (GACC).

Ministry of Agriculture and Rural Affairs (MoARA).

Registration/Notification

Before selling pet food to China, manufacturers shall get registered with the GACC.

Imported pet food shall get registered with MoARA.

Active Substance Supplier Requirements

Suppliers should follow Good Manufacturing Practices (GMPs) for Pet Feed.

Requirements

Labeling:

Comply with the Provisions on the Labeling of Pet Foods in China.

Import:

Follow “Measures for Inspection and Quarantine of Import and Export Feed and Feed Additives.”

GMO:

Comply with the “Agricultural Genetically Modified Organism (GMO) Labeling Administrative Rule.”

Standards/Regulations

Management Measures for Pet Feed.

Administrative Measures for Registration of Imported Feed and Feed Additives.

Timelines

Three (03) – six (06) months for Registration.

 

Freyr provides services in a broad spectrum in the China market from chemical products to pet food. Product regulations vary depending on a market-to-market basis, where the following table in each area summarizes Regulatory classification and associate details required to drive market access in China.

Expertise

Chemical Registration in China - Freyr Expertise

  • Product Classification and Regulatory Guidance.
  • Regulatory Strategies for Market Access/Product Launch.
  • Develop Product Notification/Registration Strategies.
  • Regulatory Applicability Review and Interpretation.
  • Prepare Technical Data Files (Specification, MSDS, etc.) including Chemical Registration/Notification Dossiers.
  • Application Preparation and Submission for Relevant Introductions and Renewals.
  • Regulatory Intelligence (RI) Services.
  • Literature Search and Data Collection.
  • Formula Compliance Support.
  • Claim Substantiation Support.
  • Sustainability and Packaging Solutions.
  • Ecolabelling-related Services.
  • Packaging Material Compliance Support.
  • Advice on Migration Testing (Identify Leachable Chemicals migrating from the Contact Materials).
Freyr Advantages
Advantages

Chemical Registration in China - Freyr Advantages

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