Regulation 1170/2009: ensuring safe and effective addition of vitamins to foods
Ensuring the safety and quality of food products is a fundamental concern within the European Union (EU), given the increasing consumption of fortified foods and dietary supplements. With the rise in health-conscious consumers seeking additional nutrients, it became essential to create a standardized framework to regulate the minerals and vitamins in food products.
This is where Regulation (EC) No 1170/2009 steps in, providing clear guidelines and ensuring that consumers can trust the products they purchase. This regulation not only amends previous directives but also incorporates scientific evaluations to keep up with advancements in food technology and nutrition science.
Why is this regulation so important for the vitamins in foods?
Regulation (EC) No 1170/2009 represents a central regulatory framework within the EU. This regulation delineates the types of vitamins and minerals, along with their approved chemical forms, that can be incorporated into food products, including supplements, ensuring a standardized approach across EU Member States.
Lists of minerals and vitamins allowed in foods
Central to Regulation 1170/2009 is the harmonization of lists detailing permissible vitamins and minerals, as well as their specific forms, that can be added to foods and supplements. This harmonization is essential to foster consistency and clarity across the EU, eliminating discrepancies between Member States’ regulations.
The inclusion of minerals and vitamins in the foods of these lists is based on their established health benefits and nutritional importance. Each nutrient on the list is considered essential for maintaining normal physiological functions and overall health, thereby underlying the regulation’s commitment to promoting public health.
Chemical forms of minerals and vitamins allowed in foods
Additionally, the regulation specifies the chemical forms of each vitamin and mineral that are permitted for use. This is a critical aspect as the bioavailability and safety of nutrients can vary significantly depending on their chemical form. For instance, vitamin C can be added as L-ascorbic acid, sodium-L-ascorbate, or calcium-L-ascorbate, among other forms. By specifying the approved forms, Regulation 1170/2009 ensures that only those forms that have been scientifically validated for safety and efficacy are utilized.
The criteria for inclusion of a vitamin or mineral, and its specific form, hinge on two primary factors: safety for human consumption and bioavailability. Only those vitamins and minerals which have undergone rigorous safety assessments are included in the regulation. Moreover, the chemical forms must be bioavailable, meaning they can be efficiently absorbed and utilized by the human body.
In addition, regulation 1170/2009 also incorporates a mechanism for updating the lists of vitamins, minerals, and their forms as new scientific evidence emerges, allowing the regulation to adapt to advances in nutritional science and changes in dietary patterns.
Labeling requirements for minerals and vitamins
The regulation also imposes specific labeling requirements for products containing added vitamins and minerals. These products must be accurately labeled, indicating the type and amount of each nutrient. Moreover, the regulation requires that the labels clearly identify the specific chemical forms of the vitamins and minerals used. Given that different forms of a nutrient can have varying levels of bioavailability and efficacy, this information is crucial for consumers who may have preferences or requirements for certain forms due to health conditions or dietary considerations.
Compliance and labeling requirements of vitamin E and mixed tocopherols in food products
Regulation 1170/2009 includes detailed provisions regarding vitamin E, particularly its various forms such as mixed tocopherols. Vitamin E is an essential nutrient known for its antioxidant properties, which help protect cells from oxidative damage.
The regulation lists several forms of vitamin E that are permitted for use in foods and food supplements, and these include:
- DL-Alpha-Tocopheryl Acetate.
- D-Alpha-Tocopheryl Acetate.
- DL-Alpha-Tocopheryl Acid Succinate.
- D-Alpha-Tocopheryl Acid Succinate.
- Mixed Tocopherols.
Each form of vitamin E has unique characteristics and benefits. For instance, tocopheryl acetate forms are stable and commonly used in dietary supplements and fortified foods. Mixed tocopherols, on the other hand, provide a blend of different tocopherol isomers, enhancing the antioxidant capacity of the product.
Mixed tocopherols as a source of vitamin E in food supplements
The EFSA (European Food Safety Authority) evaluated the safety and bioavailability of mixed tocopherols as a source of vitamin E in food supplements. Mixed tocopherols are commonly derived from natural sources such as soybean oil and are composed of alpha-, beta-, gamma-, and delta-tocopherols. To label tocopherol mixtures as vitamin E in food supplements, manufacturers must adhere to specific criteria outlined in Regulation 1170/2009. These criteria ensure that the mixed tocopherols meet a defined isomer profile:
- Minimum of 20% Alpha-Tocopherol.
- Minimum of 10% Beta-Tocopherol.
- Between 50-70% Gamma-Tocopherol.
- Between 10-30% Delta-Tocopherol.
Use of mixed tocopherols in food supplements
Toxicological data support the safety of mixed tocopherols. Acute toxicity and sub-chronic toxicity studies in animals have demonstrated no adverse effects even at high doses. The No-Observed-Adverse-Effect Level (NOAEL) was determined to be 120 mg/kg body weight per day for male rats and 130 mg/kg body weight per day for female rats. However, the safety evaluations by EFSA focused on their use in food supplements, setting a tolerable upper intake level (UL) of 300 mg/day for adults.
Moreover, research on the bioavailability of mixed tocopherols indicates efficient absorption when ingested, as shown by a 2023 study conducted by Liu and colleagues. This research showed that tocopherols from mixed sources are bioavailable and can lead to higher concentrations of gamma and delta-tocopherols in tissues compared to supplementation with alpha-tocopherol alone [1]. This enhanced uptake and distribution can contribute to the stronger inhibitory effect on lipid peroxidation observed with mixed tocopherols. These points collectively support the assertion that a mixture of tocopherols, due to the higher uptake and distinct functional properties of gamma and delta-tocopherols, provides a stronger inhibitory effect on lipid peroxidation compared to alpha-tocopherol alone.
The antioxidant activity of tocopherols underlay their beneficial effects in food supplements, supporting overall health and well-being. Furthermore, the EU regulation states that the technological function of mixed tocopherols in preserving products from oxidation must not be omitted in the labeling.
Nutrabiol® T: BTSA mixed tocopherols
BTSA’s Nutrabiol® T is a 100 % natural mixed tocopherols concentrate that serves as a powerful technological antioxidant for food and nutraceutical products. In particular, it is highly recommended for stabilizing oils, fats, meat products, snacks, bakery items, nutritional supplements, and dietetic products even at low concentrations.
Furthermore, the extraction processes used for the manufacture of this product ensure the preservation of the natural stereochemistry of the tocopherols, making them identical to their natural counterparts. These characteristics make it a mix of tocopherols that aligns perfectly with Regulation (EC) No 1170/2009, as well as the availability of Nutrabiol® T in both sunflower origin and soybean. Their respective tocopherol concentrations are up to 50 % and 90 %, which correspond to the product with the highest potency as stated by the EU regulation.
References
- Liu, M.; Wallin, R.; Wallmon, A.; Saldeen, T. Mixed Tocopherols Have a Stronger Inhibitory Effect on Lipid Peroxidation than Alpha-Tocopherol Alone. J Cardiovasc Pharmacol 2002, 39, 714–721, doi:10.1097/00005344-200205000-00012.
