1. Definition
According to the Act Governing Food Safety and Sanitation “food additives” are defined as any single substance or combination of substances that are added to or brought into contact with foods for the purpose of coloring, seasoning, preserving, bleaching, emulsifying, flavoring, stabilizing quality, enhancing fermentation, increasing viscosity, enriching nutritional value, preventing oxidation or other necessary purpose. Contents of the food additive combinations shall be limited to food additives approved by the central competent authority. A single food additive shall be issued with an approval number by the central competent authority.
2. Standards for Specification, Scope of Application and Limitation of Food Additives
In Taiwan, China, the use of food additives shall comply with the Standards for Specification, Scope of Application and Limitation of Food Additives, which introduces several positive lists detailing all the permitted food additives as well as their specifications, scope of application and limits. 800 substances have been included in the Standards as of 25 Nov 2015. In the Standards food additives are classified into 17 categories:
Preservative
Bactericide
Antioxidant
Bleaching agent
Color fasting agent
Leavening agent
Quality improvement, distillery and foodstuff processing agent
Nutritional enriching agent
Coloring agent
Flavoring agent
Seasoning agent
Pasting (Binding) agent
Coagulating agent
Chemicals for food industry
Solvent
Emulsifier
Other
The first draft of “Standards for Scope of Application and Limitation of Food Additives” was issued in Apr 2015. In the draft a food numbering system is established, and the Standards will replace the current Standard once finalized and implemented.
3. Permission of Food Additives
As per the Act Governing Food Safety and Sanitation, food additives shall be manufactured, processed, prepared, repacked, imported or exported with a valid registration certificate and a permit document from TFDA.
In practice, according to the TFDA Announcement on 24 Apr 2014, some rules have been adjusted to different types of food additives including single food additives, compounded food additives and food flavorings.
For single food additives in “the Standards”, registration with TFDA shall be completed before they are manufactured, processed, prepared, repacked, imported or exported into Taiwan.
Compounded additives shall be physically composed of single additives listed in “the Standards” with valid permissions issued by TFDA or other raw materials. The registration for a compounded additive is not required at this stage.
Food flavorings are exempted from mandatory registration.
Spontaneous filing for compounded additives and food flavorings is encouraged.
Both the permit document for single food additives and the filing document for compounded additives/food flavorings will be valid for 5 years.
4. Labeling of Food Additives
The container or external packaging of food additives and their raw materials shall conspicuously indicate in Chinese and common symbols the following matters:
product name;
printed words “Food Additive” or “Food Additive Raw Material”;
name of food additives or, in the case of a mixture of two or more ingredients, each of the ingredients shall be indicated separately. The labeling of the name of food additives shall be handled in accordance with the food additive items prescribed in Paragraph 1 of Article 18 or the names commonly known prescribed by the central competent agency in a public announcement;
net weight, volume or quantity;
name, telephone number and address of the manufacturer or that of the responsible domestic company;
expiry date;
scope of use, maximum allowance and limitation of use of food additives;
country of origin;
genetically modified food raw materials;
other matters designated by the central competent authority in a public announcement.
For food additives to be added in the food products, specifications are as follow:
The name of food additives shall be labeled in accordance with the Standards for Scope, Application and Limitation of Food additives or the general names.
Sweeteners, preservatives and antioxidants shall indicate the names of their respective functions as well as the names/general names.
Flavoring agents (exclusive of sweeteners, caffeine), emulsifier, leavening agent, enzyme, coagulating agent for bean curd and luster agent shall be labeled with respective functions. Flavorings shall be labeled as “flavoring” while natural ones shall be labeled as “natural flavoring”.
5. Approval of New Food Additives
The application of scope, limitation and specification of a new food additive shall be approved and announced by TFDA before being used in Taiwan. Applications could be submitted by individuals.
Several items will be considered:
Safety assessment
Intakes of the target food categories
Assessment of the necessity of introducing the new food additive
Relevant International standards
* Global Food Compliance Service
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Covered Countries
China, Thailand, Vietnam, Singapore, Malaysia, Philippines, Indonesia, Japan, South Korea, United States, European Union, Australia, New Zealand etc.
Our Services
Food Ingredient Review
Label Review
Product Registration
Regulatory Consultation
Monitoring, Training and customized report
Please feel free to contact us via food@chemlinked.com if you need any help.
