CFSA is Collecting Public Comments on Three New Food Raw Materials - Regulatory News - Food & Food Contact Materials

On August 28, 2023, China National Center for Food Safety Risk Assessment (CFSA) issued three new food raw materials for public comment, namely (3R,3'S)-β,β-carotene-3,3'-Diol, Pichia kluyveri, and Bacillus subtilis DE111. The deadline for public comments is September 28, 2023. Details are as follows:

1. (3R,3'S)-β,β-carotene-3,3'-Diol

Name	(3R,3'S)-β,β-carotene-3,3'-Diol
Basic information	Source: Tagetes Erecta L. CAS number: 31272-50-1 Molecular formula: C40H56O2 Molecular weight: 568.88 Structure:
Brief introduction of the production process	Prepared through dehydration, crushing, extraction, isomerization, purification, drying processes, and other processes by using Tagetes Erecta L as raw materials.
Recommended intake	≤ 8 milligram per day (mg/day) (calculated as the (3R,3'S)-β,β-carotene-3,3'-Diol)
Quality requirements	Property:	Reddish orange powder
	(3R,3'S)-β,β-carotene-3,3'-Diol, g/100 g	≥ 54.0 (see Appendix A for the test methods)
	Moisture, g/100 g	≤ 5.0
Other information	Application scope and maximum usage: Milk and dairy products – 10 milligrams per kilogram (mg/kg); beverages – 160 mg/kg for liquid beverages ≤ 50 mL, 16 mg/kg for liquid beverages of 51-500 mL; solid beverages are converted according to the mass of liquid after preparation; bakery food – 20 mg/kg; candy 3 grams per kilogram (g/kg); ready-to-eat cereals – 15 mg/kg; frozen beverages – 30 mg/kg, excluding food for infants and young children. Food safety indicators must meet the following requirements:
	n-hexane, mg/kg	≤ 10.0 (see Appendix B for the test methods)
	Methanol, mg/kg	≤ 10.0 (see Appendix B for the test methods)
	Lead (Pb), mg/kg	≤ 1.0
	Arsenic (As), mg/kg	≤ 1.0
	Benzo[a]pyrene (BaP), microgram per kilogram (μg/kg)	≤ 2.0
	Total plate count, colony forming unit per gram (CFU/g)	≤ 1000
	Coliforms, CFU/g	≤ 10
	Mould, CFU/g	≤ 50
	Salmonella, /25g	0
	Staphylococcus aureus, /25g	0

2. Pichia kluyveri

Name	Pichia kluyveri
Other information	1. Being included in the List of Strains that Can Be Used in Food and approved for the use in fermentation processing of fermented wine, fruit and vegetable juices, and tea drinks (excluding food for infants and young children). The labels and instructions must bear a statement of the scope of use. Food safety indicators must meet the following requirements:
	Pb (on dry basis), mg/kg	≤ 1.0
	As (on dry basis), mg/kg	≤ 1.5
	Salmonella, /25 g (mL)	0
	Staphylococcus aureus, /25 g (mL)	0
	Listeria monocytogenes, /25 g (mL)	0

3. Bacillus subtilis DE111

Name	Bacillus subtilis DE111
Other information	Being included in the List of Strains that Can Be Used in Food. Food safety indicators must meet the following requirements:
	Pb (on dry basis), mg/kg	≤ 1.0
	As (on dry basis), mg/kg	≤ 1.5
	Salmonella, /25 g (mL)	0
	Staphylococcus aureus, /25 g (mL)	0
	Listeria monocytogenes, /25 g (mL)	0

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