Product code: P2203
Retinol acetate is one of our most popular sources of vitamin A. Retinol acetate is permitted in the following categories of foods:
• Food supplements (as per Directive 2002/46/EC)
• Fortified foods (as per Regulation 1925/2006)
• Infant formulae and follow on formulae (as per Directive 2006/141/EC)
• Processed cereal-based foods and baby foods for infants and young children (as per Directive 2006/125/EC, Regulation 609/2013)
• Foods for Special Medical Purposes & Total Diet Replacements for Weight Control (as per Regulation 609/2013)
This ingredient is made by carrying retinol acetate on carriers and stabilisers (vegetable oils, gum arabic, sucrose, maltodextrin) with a small amount of antioxidant (vitamin E) and anti-caking agent (silicon dioxide) added so that the preparation is cold water soluble. The preparation is vegetarian and vegan suitable.
Purity & Conversion into Retinol Equivalents
This preparation contains 325,000 International Units (IU) per gram. In Europe, vitamin A would usually be found on a label written in ‘retinol equivalents’. To convert into retinol equivalents, the IU should be divided by 3.33.
Therefore 1 gram of this 325,000IU/g preparation would therefore provide 97597.5976µg/g (9.75976g/100g) of retinol equivalents.
The reference intake for vitamin A is 800µg; to get 800µg of retinol equivalents, 8.1969mg of ‘P2203 Retinol Acetate 325,000IU/g preparation’ would be required.
To get 120µg of retinol equivalents (15% of the Reference Intake), 1.2295mg of ‘P2203 Retinol Acetate 325,000IU/g preparation’ would be required.
To get 240µg of retinol equivalents (30% of the Reference Intake), 2.4591mg of ‘P2203 Retinol Acetate 325,000IU/g preparation’ would be required.
Care should be taken when dosing fat-soluble vitamins and they are less readily excreted as the water-soluble vitamins.
The upper limit for vitamin A (adults) is 3000µmg/day. The upper limit applies to vitamin A as retinol or retinyl esters. The upper limit for adults does not apply to post-menopausal women.
Depending on the member state you intend to sell your product into, there may be local maximum limits to take into consideration.
Recommended warning: "For pregnant and lactating women and women of childbearing age, a daily dose of 1500μg retinol (corresponding to 5000 IU of retinol) can not be exceeded because of the risk of childhood malformations"
Maximum values laid out in the Royal Decree of 3 March 1992 concerning the marketing of nutrients and foodstuffs to which nutrients have been added, stipulates a maximum daily dose of ≤1200µg.
Bulgaria, Croatia and Malta
Bulgaria’s Decree N°47 28 December 2004 stipulates a maximum daily limit of 1500µg retinol equivalents; similarly, Croatia states a maximum daily limit of 1500µg Official Journal 160/13
Malta provides a guidance upper daily dose of ≤1500 µg
The Scientific Committee on Consumer Safety Opinion on Vitamin A ((Retinol, Retinyl Acetate, Retinyl Palmitate) can be found here: https://ec.europa.eu/health/scientific_committees/consumer_safety/docs/sccs_o_199.pdf
EFSA Health Claims for Vitamin A
Vitamin A contributes to normal iron metabolism
Vitamin A contributes to the maintenance of normal mucous membranes
Vitamin A contributes to the maintenance of normal skin
Vitamin A contributes to the maintenance of normal vision
Vitamin A contributes to the normal function of the immune system
Vitamin A has a role in the process of cell specialisation