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Additives and excipients

Beta carotene 20% tablet grade

Product code: P02124

This ingredient provides 20% β-carotene on 56% modified food starch and 21% corn starch, with 3% DL-alpha-tocopherol (vitamin E). The microencapsulated beadlets are manufactured with advanced spray and starch-catching drying technology. The individual particles containing Beta-Carotene are finely dispersed in the matrix of modified food starch, coated with corn starch. dl-alpha-tocopherol is added as antioxidant. This product is particularly well suited for tablet applications. β-carotene can be used either as an additive (as an orange colour) or as a nutrient (to provide vitamin A). Beta carotene gets its name from carrots, because it is the orange pigment naturally found in carrots

Beta-Carotene as an additive

Carotenes are authorised as an additive and have the e-number ‘E 160a’. Beta carotene is also known as ‘CI Food Orange 5’. This particular p-code is a diluted and stabilised preparation of ‘E 160a (i); E 160a (i) is the all trans isomer of beta-carotene together with minor amounts of other carotenoids. It is from synthetic source. There are other types of beta carotenes, including E 160a (ii), which is the type that is derived from plant source (such as carrots/vegetable oils/grass/alfalfa/nettle), and E 160a (iii), which is the beta carotene that is derived by fermentation from Blakeslea trispora.

To check usage levels of beta carotene as a food additive, check the food additives regulation (1333/2008) to see permitted usage levels and conditions of use based on the type of product. Carotenes are part of ‘Group II, Colours’.

To find out more information about the safety of beta carotene as an additive, see the following link for the European Food Safety Authority (EFSA) Scientific Opinion: https://efsa.onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2012.2593

Β- Carotene is a red/orange-coloured fat-soluble terpenoid with antioxidant properties. This beadlet is emulsified with modified starch to make it into a beadlet suitable for liquid applications. Carotenoids are susceptible to oxidation and therefore vitamin E has been used in this preparation to make it more stable.

Β-Carotene appears yellow to orange in most applications (depending on the concentration) and is acceptable to use in a wide pH range of 2-14. It generally has good stability to heat (up to 100°C), light and acid.

Beta-Carotene as a source of vitamin A

Beta carotene is a precursor to vitamin A; beta carotene is known as provitamin A because the human body converts beta carotene into vitamin A.

On the basis of available evidence, the EFSA Panel on Dietetic Products, Nutrition and Allergies decided to maintain the conversion factors proposed by the Scientific Committee for Food (SCF) for the European populations:

1 μg Retinol Equivalents equals

  • 1 μg of retinol
  • 6 μg of β-carotene
  • 12 μg of other provitamin A carotenoids

Vitamin A is expressed as ‘retinol equivalents’ for the purpose of food labelling.

Therefore, to obtain 100% of the reference intake for vitamin A (800µg), 6 times this amount of beta-carotene would be required.

Therefore 4.8mg of β-carotene = 800µg Retinol Equivalents (100% Reference Intake)

To obtain this amount from a preparation containing only 20% beta carotene such as this, 5 times this amount of material would be required. Therefore, 24mg of a 20% β-carotene beadlet would provide 4.8mg of β-carotene/800µg retinol equivalents.

Follow the below link to read the Scientific Opinion on Dietary Reference Values for Vitamin A by the EFSA Panel on Dietetic Products, Nutrition and Allergies

https://efsa.onlinelibrary.wiley.com/doi/pdf/10.2903/j.efsa.2015.4028

Safety/Toxicity

The UK Department of Health encourages that food supplements are formulated to less than 7mg/day beta-carotene. Government officials considered that the labels of all food supplements containing beta carotene should carry the advisory statement 'Beta-carotene should not be taken by heavy smokers.' Industry considered that this should only be on products recommending a daily amount > 7mg. The reason for this statement is because intervention studies looking at the supplementation of high doses of beta carotene has demonstrated a higher risk of lung cancer and higher risk of death in smokers, compared with the placebo.

Other member states have made similar recommendations, for example, France, Malta, Poland and Bulgaria also recommend a maximum daily dose of 7mg. For Belgium the recommendation is ≤7.2mg, and for Italy this is ≤7.5mg. Hungary, Cyprus, Ireland and Switzerland all have somewhat higher recommended maximum limits. It is important to check local legislation before putting a product on the market.

Health Claims Relating to 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

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