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Guidance on Vitamin E and tocopherols

Shervin Bahmaninia, our regulatory and compliance specialist deep dives into what Vitamin E is, its main functions, and its regulation on the UK and EU markets.

What is Vitamin E and its main function?

Vitamin E is a fat-soluble vitamin essential for human health. The most common and biologically active form of Vitamin E is α-tocopherols, however, there are many other types of tocopherols and tocotrienols which can be used for their properties as an antioxidant for a technological function in food. Through the mechanisms of protecting cells against oxidative stress, Vitamin E has a positive impact on maintaining healthy skin, eyes and the immune system.

Vitamin E in foods and food supplements

When adding a source of Vitamin E to fortified foods or food supplements certain permitted forms are allowed depending on the category and we have listed these below. To declare the amount of Vitamin E each form must be converted to its d-alpha-tocopherol equivalents (a-TE) in mg. 

Vitamin E forms which can be added to foods (fortified foods)  - Regulation (EC) No 1925/2006

(a) D-alpha-tocopherol

(b) DL-alpha-tocopherol

(c ) D-alpha-tocopheryl acetate

(d) DL-alpha-tocopheryl acetate

(e ) D-alpha-tocopheryl acid succinate

 

Vitamin E forms which can be added to food supplements – food supplements directiveUK list

(a) D-alpha-tocopherol

(b) DL-alpha-tocopherol

(c) D-alpha-tocopheryl acetate

(d) DL-alpha-tocopheryl acetate

(e) D-alpha-tocopheryl acid succinate

(f) mixed tocopherols

(g) tocotrienol tocopherol

 

Vitamin E and other tocopherols as food additives

Tocopherols can be used as food additives. Food additives are substances that are intentionally added for a technological purpose. In the case of tocopherols, these are used as antioxidants.

Antioxidants are defined by the EU Food Additives Regulation (EU Regulation 1333/2008) as “substances which prolong the shelf-life of foods by protecting them against deterioration caused by oxidation, such as fat rancidity and colour changes;

Tocopherols are used as antioxidants in oily foods (because they are fat-soluble; water-soluble antioxidants such as vitamin C would be used in non-fatty foods) to prevent the foods from oxidizing and going rancid. Tocopherols have been assigned the e-numbers below:

  • E 306 Tocopherol-rich extract
  • E 307 Alpha-tocopherol
  • E 308 Gamma-tocopherol
  • E 309 Delta-tocopherol

The EU Food Additives Regulation (EU Regulation 1333/2008) provides the conditions of use for each food additive, which is specific to the category of the product. EU Regulation 231/2012 describes the specifications for each E number.

E 306 Tocopherol-rich extract

Tocopherol-rich extract is sometimes referred to as ‘natural’ because it is derived from plant oils (usually either refined soybean oil or sunflower oil). E 306 differs from the other tocopherols (E 307, E 308 and E 309) because it is a mixture of alpha, beta, gamma and delta tocopherols, but only contains the d-stereoisomer.

There is a slight difference in the numbering system between E-numbers (Europe) and The International Numbering System (Codex). Under The International Naming System (INS) for food additives, 307b is the number given to ‘Mixed Tocopherol Concentrate/ Vitamin E Concentrate’. Mixed tocopherol concentrate contains tocopherols such as d-alpha-, d-beta-, d-gamma- and d-delta- tocopherols. In the US it is often called ‘mixed tocopherols’.

E 307 Alpha-tocopherol

E 307 is made synthetically from petroleum products. Because it is produced synthetically, it is all-racemic (a mixture of D- and L- stereoisomers).

Vitamin E Reference intake and upper limits

Regulation (EU) No 1169/2011 of the European Parliament and of the Council of 25 October 2011 on the provision of food information to consumers lists the nutrient reference value of Vitamin E as 12mg per day, as per the below:

For further information on the intake and upper limit recommendations for different ages and genders please refer to the EFSA DRV finder interactive tool.

According to the Expert Group on Vitamins and Minerals (EVM) report from 2003, a Safe Upper Level of supplemental Vitamin E intake is recommended to be 800 IU/day, which is equivalent to 540 mg of d-α-tocopherol daily. This recommendation is based on the careful evaluation of available scientific evidence on the safety and efficacy of Vitamin E supplementation.

Based on the scientific knowledge and recommendations from EFSA/SCF, the Tolerable Upper Intake Levels (UL) for Vitamin E are as follows:

  • 300 mg/day for adults over 18 and pregnant or breastfeeding women.
  • 260 mg/day for adolescents aged 15-17 years.
  • 220 mg/day for children aged 11-14 years.
  • 160 mg/day for children aged 7-10 years.
  • 120 mg/day for children aged 4-6 years.
  • 100 mg/day for children aged 1-3 years.

To ensure the compliance of your product please check if the region you are selling in has any specific requirements about the maximum permitted levels as these do vary between member states.

Authorised health claims 

 

 

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