Chat with Us
COLUMN NAVIGATION

Interpretation| Use, Label and Register Substances Belong to Food Fortifiers & Novel Food Ingredients

放大字体  缩小字体 Date:09 Jan 2019  Source:Global Foodmate  Writer:Global Foodmate  Views:123
 novel food

Many substances can be used as food fortifiers also novel food ingredients, sometimes, food enterprises might be confused about it during food production. In fact, the quality specifications and usage requirements of using as food fortifiers and food ingredients are quite different. Therefore, Global Foodmate summarized the substances belong to food fortifiers and novel food ingredients, and their usage and labelling requirements in foods. Global Foodmate also discussed how to apply for approval of a newly occurred substance that meets the abovementioned criteria in China.


1. Substances belong to food fortifiers and novel food ingredients
(1) Docosahexaenoic Acid (DHA)

 

Food fortifiers

Novel food ingredients

Standard

GB 26400-2011 National Food Safety Standard-Food Additive- Docosahexaenoic Acid Oil (Fermentation)

Notice No. 3 of Ministry of Health [2010] (DHA algal oil)

Usage


(1) Formulated milk powder (only for children): ≤ 0.5% (% total fatty acids)


(2) Formulated milk powder (only for pregnant and lactating women): 300 mg/kg-1000 mg/kg

(3) Cereal-based complementary foods for infants and young children: ≤ 1150 mg/kg


Daily consumption: ≤300 mg/d (based on pure DHA)

Usage in infant formula shall comply with relevant standards: ≤ 0.5% (% total fatty acids)


(2) Arachidonic acid (AA or ARA)

 

Food fortifiers

Novel food ingredients

Standard


GB 26401-2011 National Food Safety Standard-Food Additive- Arachidonic Acid Oil (Fermentation)


Notice No. 3 of Ministry of Health [2010] (Arachidonic acid oil)

Usage


(1) Formulated milk powder (only for children): ≤ 1% (% total fatty acids)


(2) Cereal-based complementary foods for infants and young children:  ≤ 2300 mg/kg


Daily consumption: ≤ 600 mg/d (based on pure AA)

 
Usage in infant formula shall comply with relevant standards: ≤ 1% (% total fatty acids)


(3) Galacto-Oligosaccharides (GOS)

 

Food fortifiers

Novel food ingredients

Standard


(1) Notice No. 12 of Ministry of Health [2007] (Origin: lactose, hydrolysed by β-galactosidase)


(2) Notice No. 8 of NHFPC [2016] (Origin: lactose, hydrolysed by β-galactosidase produced by Aspergillus oryzae)


(3) Notice No. 8 of NHFPC [2017] (Origin: whey filtrate, hydrolysed by β-galactosidase produced by Aspergillus oryzae


Notice No. 20 of Ministry of Health [2008] (Origin: lactose, hydrolysed by β-galactosidase)

Usage


Infant formula, Cereal-based complementary foods for infants and young children: as one of the sources of prebiotics, used alone or in combination, the total amount does not exceed 64.5 g/kg.


Daily consumption: ≤ 15 g/d


Application range: infant food, dairy products, beverages, baked products, candy


(4) Polyfructose

 

Food fortifiers

Novel food ingredients

Standard


Notice No. 12 of Ministry of Health [2007] (Origin: Cichorium intybus L.)


Notice No. 5 of Ministry of Health [2010] (Origin: Cichorium intybus var. sativum, Asteraceae)

Usage


Infant formula, Cereal-based complementary foods for infants and young children: as one of the sources of prebiotics, used alone or in combination, the total amount does not exceed 64.5 g/kg.


Daily consumption: ≤ 8.4 g/d


Application range: milk powder for children, milk powder for pregnant and lactating women

 
(5) Yeast β-glucan

 

Food fortifiers

Novel food ingredients

Standard


Notice No. 6 of Ministry of Health [2012]


Notice No. 9 of Ministry of Health [2010]

Usage


Older infants and young children formula (only for young children), formulated milk powder (only for children): 0.21-0.67 g/kg.


Daily consumption: ≤ 250 mg/d


Application range: excluding infant food


2. How to use and label:

For substances that belong to both food fortifiers and novel food ingredients, they should be used and labelled according to the actual function in the finished product.

Quoted from the Q&As concerning the Standard for the usage of Food Fortifiers GB 14880-2012, “For some substances that belong to both food fortifiers and novel food ingredients, such as DHA, AA, GOS and polyfructose, if the purpose of adding is nutrition fortification, usage of the substance shall comply with this standard. If the substance is used as a food ingredient, it shall meet the requirements of relevant notices of novel food ingredients.”

When the substance is used as food fortifiers, the content and NRV% (NRV% is optionally labelled in Foods for Special Uses) of the fortified nutrients shall be labelled in the nutrition facts. The labelling, including name, order, expression unit, rounding level, etc., shall comply with Table 1 of GB28050-2011 General Standard for Nutritional Labelling of Prepackaged Foods. For nutrients that are not listed in Table 1 but are allowed by GB 14880, the labeling order shall be located after the nutrients listed in Table 1.

When the substance is used as food ingredients, the daily consumption and application range of it shall be labelled.


3. How to
register a novel food ingredient that can be used as both food fortifier and food ingredient in China:
 
When registering a substance that belongs to both food fortifier and food ingredient, the purpose of adding, applicable population, application range and daily consumption shall be taken into consideration.

‘Food Fortifier’ is defined by GB 14880 as a natural or synthetic nutrient that is added into food in order to increase the nutritional value of the food. In China, food fortifiers belong to food additives, therefore, they shall be applied for approval as novel food additives.

Administrative Measures for the Safety Review of Novel Food Ingredients 
(2013) and Regulation of Declaration and Acceptance Requirements for Novel Food Ingredients defined the ‘Novel Food Ingredients’ as the following items that are not been traditionally eaten in China: Animals, plants and microorganisms; Components separated from animals, plants and microorganisms; Components with altered original structures; Other newly developed food ingredients. Substances meet the abovementioned requirements shall be applied for registration if the substances are intended to be used in food production.

If a substance is intended to be used in general foods, with varied applicable population (e.g., only excluding infants, pregnant and lactating women or without limitation), with a wide range of application (suitable for multiple types of foods) and the daily consumption is not low, it is generally to be registered as novel food ingredient. While, the allowed dosage of food fortifiers is generally small and the application range is relatively narrow. Also, the approval requires the demonstration of the necessities, effects and others of using certain food fortifier.

Additionally, if a substance has been registered as food fortifier, it cannot be approved as novel food ingredient according to the Regulation of Declaration and Acceptance Requirements for Novel Food Ingredients issued in 2013. On the contrary, if a substance is firstly registered as novel food ingredient to be used in general foods, it is also possible to be approved as food fortifier afterwards, taking Yeast β-glucan as an example.

Enterprises shall choose to declare, according to their own needs. Global Foodmate provide registration services of novel food ingredients and novel food additives for domestic and overseas enterprises, please feel free to contact Global Foodmate.  
 

Please note: Original article of Global Foodmate of Information Service and Business Department, please indicate the source from the Global Foodmate if reprint.
 

Need help or have a question?

 
 
COMMEND NEWS & REGULATIONS UPDATES

Contacts

CHINA(Beijing)

TEL:010-68869850
Email:global-service@foodmate.net
ADD: W. 4th Ring Road North No.160 Haidian Beijing China

 

CHINA(Yantai)

TEL: 0535-2129301
Email:hanking@foodmate.net
ADD: West area, Donghe Technology Park, No. 229 Tongshi South Road, Zhifu District, Yantai City, Shandong Province

 

SWIZERLAND

Tel: +41 784034643
Email: EUoffice@foodmate.net
ADD: Churerstrasse 92i, CH-8808, Pfaeffikon SZ, Switzerland

Support
Global Foodmate Social
TOP