Select Sector :
Select pages :

China - Regulation

In 2003, Chinese Ministry of Ecology and Environment (MEE) introduced the regulation on the registration of New Chemical Substances (MEP Order No.7). In 2010, this regulation was revised for the first time and the Inventory (IECSC) was introduced under Order No.7.

After 9 years’ implementation of Order No.7, MEE called for the second revision of Measures for the Environmental Management Registration of New Chemical Substances, which was finally approved on February 12, 2020 (MEE Order No.12). This new regulation has come into force on January 1, 2021 and replaced the previous regulation (Order No.7).

Under the provisions of this regulation, companies shall submit registration application if manufactured/imported substance is not listed in the Inventory. All activities including research, production, importation and processing have to comply with the regulation requirements as long as the chemical substances are under the scope of this regulation. Business activities are not allowed until a certificate is granted.

Apart from the points discussed above there are some specific points/things that need to be present while the labelling of the article

  • Name of the Food
  • Specific List of Ingredients
    • Stated as the descending order of the composition of that particle chemical/substance.
    • List of Compound Ingredients (i.e. when two or more ingredients make up an ingredient) must be declared if any and if >5%.
    • Added water; except in cases where water is in fact a part of the ingredient and does not evaporate during the manufacturing process.
    • If the package contains a mixture of substances; clear labelling must be done for all the basic as well as compound ingredients if any.
  • Nutritional Information (i.e. nutritional facts per serving/ per 100mg)
    • It must include energy value(kcal).
  • Fat Declaration
    • Presence of hydrogenated vegetable fats or bakery shortening should be declared as they contain trans fat
  • Food Additive Declaration
    • The following class titles shall be used in conjunction with the specific names or accepted international numerical identifications for food additives falling into the appropriate classes and appearing in lists of food additives approved for use in foods generally:
      • Acidity Regulator
      • Acids
      • Anticaking Agent
      • Antifoaming Agent
      • Antioxidant
    • Unnecessary extra colouring materials that must be noted on the label – When an extraneous colouring matter has been introduced to any food product, one of the following phrases in capital letters must be shown.

CONTAINS PERMITTED NATURAL COLOUR(S) OR CONTAINS PERMITTED SYNTHETIC FOOD COLOUR(S). Similarly, for added flavours the label must contain:

  • CONTAINS ADDED FLAVOUR
    • In case the article contains both colour and added flavours then both the points stated above must be declared on it.
  • Name and Complete Address of the manufacturer
  • Net Quantity
  • Lot/Code/Batch Identification
  • Date of Manufacture or packing
  • Best Before and Use by Date
  • Instructions for Use

  1. The use of raw materials in food-contact materials and articles shall be in accordance with the provisions of applicable national food safety regulations and public announcements.
  2. The use of additives in food-contact materials and articles must adhere to the requirements of GB 9685 and any related public notices.
  3. Food-contact materials and articles should adhere to the provisions of relevant national food safety standards.

  • Identification of compliance requirements under various guidelines including all data requirements.
  • Data gap analysis and pre-assessment support
  • Technical documentation support
  • Pre and post submission support and technical liaison with authorities.

 

 

 

  • National Level
    • The Ministry of Health (MOH); is responsible for food hygiene, chemical contamination, food borne disease control, permission and inspection for new food, new food contact articles and food contacts additives notification approval, preparation/revision of food standards.
    • State Administration of Food and Drug (SFDA)  is responsible for monitoring and supervision of the actual implementation of food safety regulation which also includes coordination.
    • Administration of Quality Supervision, Inspection and Quarantine of the People’s Republic of China (AQSIQ) is responsible for granting the permission for production of food and food packaging products; and imported food contact material compliance verification.
  • Province Level
    • MOH Local Departments: responsible for supervision and inspection. No FDA involvement

Also in Shanghai, The FDA has the main responsibility to ensure that China MOH food contact material requirements and AQSIQ’s food contact material requirements are implemented

  1. The level of substance migrated from the FCM into foods should not be harmful to human health under the recommended use conditions.
  2. When FCM comes in contact with food particles under the recommended conditions, they should not cause changes in food composition, structure or attributes such as colour, odour or taste; they should not have any technical effect on the food particles.
  3. On the assumption that the desired objectives may be accomplished, the quantity of chemicals utilised in food contact materials and articles should be limited.
  4. Non-intentionally added chemicals in goods must be monitored by producers of food-contact materials and articles to ensure that the migrating quantity satisfies the stipulated requirements.
  5. For substances that do not contact foods and have an effective resistant/proofing layer between such substance and the foods, or for substances that are not listed in the appropriate national food safety standards, producers of food-contact materials and articles should conduct safety assessments and control measures to ensure that the migrating quantity of such substances does not exceed 0.01mg/kg. Nanomaterials, as well as carcinogenic, teratogenic, and mutagenic substances, are exempt from the aforementioned principles, but must follow all applicable laws, rules, and norms.
  6. Producers must establish Traceability systems for FCM’s from production to distribution.

When food contact products are sold, they must be accompanied by sufficient product information. This comprises the product name, material, declaration of conformance to applicable laws, regulations, and standards; the producer's and/or dealer's names, addresses, and contact information; the production date, warranty duration (if applicable), instruction for use, and qualification certificate.

Request for Quote

Top