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China,Active Ingredient,Health Food,Raw Material,SAMR,Food,Filing

On April 1^st, 2019, the State Administration for Market Regulation (SAMR) issued 5 Health Food Raw Materials Directories for Coenzyme Q10, Melatonin, Fish oil, Broken Ganoderma lucidum spore powder and Spirulina and related Technical Requirements (Draft for public comments, hereinafter referred to as “the Draft”), the deadline for comments and opinions is April 30, 2019, via bjspba@bjsp.gov.cn.

Meanwhile, the SAMR is soliciting opinions and comments on adjusting the health functions of health food (Please click here for further information). The related functions in the Draft are linked with the health function adjustment work.

Information of the 5 raw material directory is listed below:

S.N.	Name	Daily Intake			Functions	Recommend Dosage Form
S.N.	Name	Daily Intake	Suitable Crowds	Unsuitable Crowds	Functions	Recommend Dosage Form
1	Coenzyme Q10	30-50mg	Adults	Children, Adolescent, Pregnant women, Lactating women, People who are prone to allergy	Improving immunity; Anti-oxidation	Tablet, Granule, Hard capsule, Soft capsule
2	Melatonin	1-3mg	Adults	Children, Adolescent, Pregnant women, Lactating women	Sleep improvement	Tablet, Granule, Hard capsule, Soft capsule
3	Fish oil	≤4.0g (in which，EPA+DHA≥1.0g)	People with high blood lipids	Children, Adolescent, Pregnant women, Lactating women, People with bleeding tendencies and hemorrhagic disease patients, Patients with liver dysfunctions	Assisting blood lipid reduction	Soft capsule
4	Broken Ganoderma lucidum spore powder	1-4g	People with low immunity	Children, Adolescent, Pregnant women, Lactating women	Improving immunity	Tablet, Granule, Hard capsule
5	Spirulina	3-4g	People with low immunity	Infant, Pregnant women, Lactating women, People who are prone to allergy	Improving immunity	Tablet, Granule, Hard capsule

Further information: Subject Research on Health Food Raw Material Directory

The Center for Food Evaluation under SAMR has issued 2 subject researches on health food raw material directory, the related active ingredients which could be included into the filing list have been listed as follows:

The active ingredients which could be included into the filing list (1)

Hippophae rhamnoides L. (oil), Ginseng Radix ET rhizome (Ginseng Radix ET rhizome rubra), Panacis quinauefolii radix, Gastrodiae rhizoma, Notoginseng radix ET rhizome, Ganoderma, Ganoderma spore powder, Lycii fructus, Spirulina, Ginkgo folium (extract), Carthami flos, Astragali radix, Dendrobii caulis, Rhodiolae crenulatae radix ET rhizome, Fish oil, Seal oil, Cod liver oil, Garlic oil, Bovine colostrum, Royal jelly, Phytosterols (Phytosterol esters), Lycopene, Coenzyme Q10, Melatonin + Vitamin B6, Squalene, Cistanches herba.

The active ingredients which could be included into the filing list (2)

Crataegi Fructus, Polygonati Rhizoma, Polygonati Odorati Rhizoma, Asini Corii Colla, Lonicerae Japonicae Flos, Corni Fructus, Rehmanniax Radix, Propolis, Broadleaf Holly Leaf, Coicis Semen, Schisandrae Chinensis Frucius, Mori Folium, Dunaliella Salina (Extract), PINI POLLEN, DHA and DHA Algal Oil, Conjugated Linoleic Acid, Cordyceps Militaris (Cordyceps Militaris Fruiting Bodies), Soybean Protein, Whey Protein, Hydrolyzed Amino Acids of Silkworm Chrysalis, Casein Phosphopeptide + Calcium, Bifidobacterium, Bifidobacterium longum, Bifidobacterium brevis, Bifidobacterium adolescentis, Bifidobacterium animalis, Lactobacillus acidophilus, Lactobacillus plantarum, Lactobacillus royi, Lactobacillus rhamnosus, IMO, FOS, GOS, XOS, oligofructose , soy oligosaccharides, Inulin, Combination of Probiotic and Prebiotics.

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SAMR Issued the Draft on Health Food Raw Material Directory of 5 Active Ingredients