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ANALYSIS
Significant Amendment of Chinese Infant Formula Registration Dossier Requirements
Dec 21, 2016
1. The trial guidelines for infant formula registration have been finalized and detail the requirements and practical elements involved in compiling infant formula registration dossiers. Overall the trial versions have optimized certain procedures and removed some unpractical requirements when compared to the draft version. 2. Outlining the requirements for expounding the scientific rationale for formula development is the major focus. Scientific information relating to formula comparability with natural breast milk or other supporting nutritional research can be used to meet this requirement.
Chinese Mainland
Infant Formula
Labeling
ANALYSIS
China’s New Food Legislative Framework
Nov 15, 2016
1. With the release of the “Food Safety Law Implementation Rules”, the framework of China’s new food legislative framework has been formed. 2. More than 40 administrative regulations have been issued to implement the key articles of the new Food Safety Law. 3. In general, the new food safety legislative framework will increase market access prerequisites, stringency and frequency of inspections and regulatory requirements. 4. At a domestic level we can expect closure of many substandard food enterprises and for importers we can expect more technically demanding barriers to trade.
Chinese Mainland
Infant Formula
Health Supplement
FSMP
ANALYSIS
Interpretation of China’s Revised Food Safety Law Implementation Rules
Nov 09, 2016
1. The revised draft of Implementation Rules of Food Safety Law further detail the requirements laid out in the articles of the Food Safety Law. 2. Allergic labelling becomes mandatory for the first time 3. Supervision on special food will be strengthened and inspections will be conducted by authorized institutions. 4. Every batch of imported infant formula will go through full-inspection at port.
Chinese Mainland
Prepackaged Food
ANALYSIS
Understanding China Food for Special Medical Purposes Clinical Trial Requirements
Oct 10, 2016
1. Clinical trial requirements for FSMPs are similar to pharmaceutical requirements. 2. The government provides 13 broad categories of disorders as examples in which FSMPs may be of therapeutic benefit however products are not limited to these categories. 3. Difficulties in substantiating scientifically significant therapeutic/clinical benefit, trail size requirements and cost are major difficulties for successfully meeting China’s FSMP registration requirements.
Chinese Mainland
FSMP
ANALYSIS
Chinese New Food Contact Material Standard System and the Impact on Industry
Aug 26, 2016
1. China will develop a new food contact regulation system that will focus on risk control of raw materials, processing, storage, transportation and final products. 2. The new food contact material regulatory framework is built on the legal basis of the “Food Safety Law” and 4 categories of national standards.
Chinese Mainland
FCM
Food Packaging
ANALYSIS
Comparative Analysis of Regulations on Health Food and FSMPs in China
Aug 26, 2016
Health food and foods for special medical purpose (FSMP) are both regulated as special food in China in accordance with the new Food Safety Law. As two important food categories of special food, their major differences are compared in the aspects of targeted consumption groups, raw materials, product formula, function claims, etc.
Chinese Mainland
Health Supplement
FSMP
ANALYSIS
China’s Food Additive National Food Safety Standard System
Jul 22, 2016
Chinese Mainland
Food Additives
ANALYSIS
China Health Foods: The Dilemma for Health Foods Traded Through CBEC
Jun 13, 2016
China’s health food industry will be greatly impacted by the new CBEC policies, especially the registration and filing obligations for overseas health food enterprises under the new regulatory environment.
Chinese Mainland
Health Supplement
CBEC
ANALYSIS
Guidance on Registration of Overseas Food Manufacturers with China CNCA
Jun 07, 2016
Chinese Mainland
ANALYSIS
Regulatory Environment for GMO Foods in China
May 30, 2016
GMOs may pose unforeseen risks to the ecosystem and human health and therefore China’s government adopts a precautionary approach to their management as evidence by its careful regulation of this sector. During the past two decades, GMOs have been well developed in China and so has corresponding regulations.
Chinese Mainland
GM Food
Pre
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China Food Additive Standard GB 2760-2024 Standard for Uses of Food Additives
GB 2760-2024 marks a significant chapter in China's regulatory approach to food additives, following the thorough groundwork laid by GB 2760-2014 and informed by drafts in subsequent years. The meticulous refinement process through drafts in 2017, 2021, and 2022 has led to this well-structured standard. Now, the GB 2760-2024 standard is ready for implementation, set to become effective on February 8, 2025, as the authoritative guide for food additive usage in China.
Data and Analysis: Imported Food Rejected by China Customs
For enterprises expand their businesses to the Chinese food market, one of the key challenges is the risk of rejection during customs clearances. ChemLinked collects the latest data of imported food rejected by China customs, and provides related analysis and reports.
Global Halal Certification Requirements and Regulation Dynamics
Halal food refers to food products consistent with the Islamic doctrine, which is one of the most profitable and influential sectors of the global food industry. Currently, there is no unified Halal certification standard used globally. Certain details, such as the processing method, slaughtering procedure, labeling items, etc. are subject to different standards in different countries. To help remove the market access barriers and catch the market opportunities, ChemLinked collects contents related to halal certification and its regulation dynamics around the world.
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