Food Supplements

Food supplements are foods that intend to supplement a normal diet. Supplements have ingredients that have a nutritional or physiological effect, which means that they create a physical effect in the human body. Examples of food supplements include vitamins, minerals, trace elements, amino acids, fiber, plants or herbal extracts.

EU Requirements: To ensure these products are safe for use, there are many different requirements for their composition and presentation. These additional requirements are laid down in several European laws, the main one being EU Directive 2002/46/EC. This Directive is implemented by national legislation in each member state, so there can be slight differences in approach for each jurisdiction. One example of this relates to what constitutes a food supplement and which ingredients can be contained in a food supplement.

Food Supplements are sold in dosage form as tablets, capsules, coated tablets, or powders and liquids intended to be ingested in small, measured amounts. In contrast to regular foods, food supplements require a recommended dosage along with other mandatory information and warnings for consumers, for example, that they should be stored out of the reach of small children.

UK Requirements: To ensure these products are safe for use, there are many different requirements for their composition and presentation. These additional requirements are laid down in several UK laws, the main one being The Food Supplements (England) Regulations 2003.

Food Supplements are sold in dosage form as tablets, capsules, coated tablets, powders, and liquids intended to be ingested in small, measured amounts. In contrast to regular foods, food supplements require a recommended dosage along with other mandatory information and warnings for consumers, for example, they should be stored out of the reach of small children.

Below is an overview of what is required for the sale and labelling of food supplements. You should also refer to the Food Standards Agency (FSA) brochure on food supplements: https://www.food.gov.uk/sites/default/files/media/document/foodsupplementsenglish_0.pdf

I. EU Requirements

Food Supplement restrictions

Food supplements are a restricted product type on VegaVend. You must obtain approval to sell food supplements. You can apply for approval here.

Additionally, in some marketplaces a national pre-market notification is required before a food supplement can be listed and sold on VegaVend for that jurisdiction.

Requirements to list Food Supplements

• • The products you sell must be new.

• • All products must be intended for sale within the EU and compliant with all laws and regulations of the EU (or of local countries).

• • Each product requires a valid barcode (product identifier) registered and associated with the product.

• • You must list products under the correct “Product Type” within the Health and Personal Care Inventory File Template so that your listings are correctly categorised and display the correct, relevant information to customers.

The list below clarifies the type of products that should be uploaded under Food Supplements, but it is not exhaustive. If you cannot find your product in this list, or if you are unsure which Product Type to list your product under, contact Vendor Support .

• • Nutritional supplements

• • Nutrition bars and drinks

• • Vitamin supplements

• • Sports nutrition and supplements

• • Slimming and weight loss aids (subject to relevant regulatory requirements)

You can also refer to our Help page on Personal Care Appliances Product Types and our list of permitted and prohibited listings for Drugs, Drug Paraphernalia and Dietary Supplements.

Labelling requirements

The following information should be included on the labelling of a Food Supplement, in addition to the information required under Regulation 1169/2011 on food information for consumers:

• • The indication “food supplement”

• • The name(s) of nutrients or substances that characterise the product and have a nutritional and/or physiological effect

• • The portion recommended for daily consumption

• • A warning not to exceed the stated recommended daily dose

• • A statement that food supplements should not be used as a substitute for a varied diet

• • A statement that the product should be stored out of reach of young children

• • The amount of the ingredients with a nutritional or physiological effect present in the product. These must be declared in numerical form and per portion of the product as recommended for daily consumption.

• • The information on vitamins and minerals must also be expressed as a percentage of the reference intake values listed in food information for consumers.

Claims

Only nutrition and health claims that have been approved under EU Regulation (EC) No 1924/2006 on nutrition and health claims made on food (the ‘Regulation’) can be used on the label.

The aim of the Regulation is to protect consumers from misleading and false claims made on products and harmonise the rules across the EU to facilitate trade.

Nutrition claims

A nutrition claim is any claim that states, suggests, or implies that a food has particular beneficial nutritional properties due to the presence, absence, increased or reduced levels of energy, or of a particular nutrient or other substance. Nutrition claims provide factual information about the nutritional composition of the food, for example “source of calcium”, “low fat”, “high fiber”, or “reduced salt”.

Only nutrition claims listed in the Annex to the Regulation can be made on food and only if the product meets with the specific conditions of use for that claim. For example, “low fat” can only be made on products containing no more than 3g of fat per 100g for solids.

Health claims

A health claim is any claim that states, suggests, or implies that a relationship exists between a food category, a food or one of its ingredients, and health. Only health claims that have been authorised by European Food Safety Authority (EFSA) and the Commission are permitted. The EU Register contains a list of specific health claims and the outcome of their assessment, whether authorised or not, as well as their conditions of use. An example of a specific health claim would be “calcium helps maintain normal bones”. More general, non-specific claims, such as “good for you” or “healthy”, may be allowed if they are accompanied by a relevant specific authorised health claim listed in the EU Register, provided they meet the specific conditions of use.

Health claims cannot:

• • Imply that health could be affected by not consuming the food

• • Make reference to the rate or amount of weight loss

• • Make reference to recommendations of individual doctors or health professionals

In general, claims must not be false, ambiguous or misleading, encouraging or condoning excess consumption of a food, or imply that a balanced diet cannot provide the necessary nutrients. Claims cannot give rise to doubt about the safety and/or nutritional adequacy of other foods. They cannot refer to changes in bodily functions that could give rise to or exploit fear in the consumer.

Nutrition and health claims are only permitted if the average consumer can be expected to understand the beneficial effects as expressed in the claim. As above, if general wellbeing claims are used (such as “superfoods”, “antioxidants”, ‘good for you”), then these must be accompanied by a specific health claim, that is they need to explain why it is considered a “superfood”. For example, mackerel as part of a healthy balanced diet can be considered a superfood because it is a source of Omega-3 fatty acids (contains x mg of eicosapentaenoic acid and docosahexaenoic acid per 100 g and per 100 kcal). Omega 3 contributes to normal heart function.

Medicinal claims

Food supplements cannot claim the property of preventing, treating, or curing human disease or refer to such properties. Such medicinal claims are never permitted for food supplements. Only products licensed as medicinal products can bear such claims.

Novel foods and banned ingredients

The Annexes to the Directive 2002/46/EC list the vitamins and minerals and their chemical forms permitted for use in the manufacture of food supplements. For additional vitamins and minerals to be considered for inclusion on this list, they would need to be authorised by the commission following a safety assessment by EFSA.

“Novel Foods” are foods that have not been consumed to a significant degree by humans in the EU before 15 May 1997. A novel food can be newly developed, innovative food, food produced using new technologies and production processes, as well as food that is or has been traditionally eaten outside of the EU. Examples of novel food include new sources of vitamin K (menaquinone) or extracts from existing food (Antarctic krill oil rich in phospholipids from Euphausia superba), agricultural products from third countries (e.g. chia seeds, noni fruit juice), or food derived from new production processes (UV-treated foods such as milk, bread, mushrooms and yeast).

A safety assessment must be conducted and pre-market authorisation must be given before a novel food can be marketed in the EU.

In addition to novel foods, certain other ingredients are also not permitted in food supplements. For example, the following substances are not permitted as ingredients in the manufacture of food supplements:

• • Certain banned and restricted herbal ingredients, particularly those for medicinal use, such as ephedra herb and kava kava,

• • Medicinal ingredients, including ingredients authorised as traditional herbal medicines, and

• • Medicinal levels of otherwise permitted ingredients.

Products for sale on VegaVend cannot contain any unauthorised ingredients (for example, unauthorised vitamins or minerals, additives, or flavourings), novel foods, or banned ingredients.

Safe upper limits

To ensure that food supplements are safe for consumption, the manufacturer must take into account the upper safe levels established by scientific risk assessment and data on vitamin and minerals intake from other foods, while also taking into account what is considered an adequate vitamin and mineral intake for an average person. EFSA has published scientific opinions about upper safe levels for various vitamins, minerals, and other substances. Some member states have legal maximum limits for vitamins and minerals, while others provide only guidance only. For example, the UK provides Guidance on Upper Levels for Vitamins and Minerals from the Expert Group on Minerals and Vitamins.

II. UK Requirements

Food Supplement restrictions

Food supplements are a restricted product type on VegaVend. You must obtain approval to sell food supplements. You can apply for approval here.

Requirements to list Food Supplements

• • The products you sell must be new.

• • All products must be intended for sale within the UK and compliant with all laws and regulations of the UK.

• • Each product requires a valid barcode (product identifier) registered and associated with the product.

• • You must list products under the correct “Product Type” within the Health and Personal Care Inventory File template so that your listings are correctly categorised and displays the correct, relevant information to customers.

The list below clarifies the type of products that should be uploaded under Dietary Supplements, but it is not exhaustive. If you cannot find your product in this list, or if you are unsure which Product Type to list your product under, contact Selling Partner Support.

• • Nutritional supplements

• • Nutrition bars and drinks

• • Vitamin supplements

• • Sports nutrition and supplements

• • Slimming and weight loss aids (subject to relevant regulatory requirements)

You can also refer to our Help page on Personal Care Appliances Product Types and our list of permitted and prohibited listings for Drugs, Drug Paraphernalia, and Dietary Supplements.

Labelling requirements

The following information should be included on the labelling of a Food Supplement, in addition to the information required under UK Regulation on food information for consumers:

• • The indication “food supplement”.

• • The name(s) of nutrients or substances that characterise the product and have a nutritional and/or physiological effect.

• • The portion recommended for daily consumption.

• • A warning not to exceed the stated recommended daily dose.

• • A statement that food supplements should not be used as a substitute for a varied diet.

• • A statement that the product should be stored out of reach of young children.

• • The amount of the ingredients with a nutritional or physiological effect present in the product. These must be declared in numerical form and per portion of the product as recommended for daily consumption.

• • The information on vitamins and minerals must also be expressed as a percentage of the reference intake values listed in food information for consumers.

Claims

Claims on food products must not be false, ambiguous or misleading and should comply with the relevant requirements.

In general, claims for foods must not be false, ambiguous or misleading about:

• • Quality or size.

• • Price.

• • Ingredients.

• • Date, place, and method of manufacture.

• • Efficiency (what you say the food can do).

• • The people or organisations that endorse it.

It is also prohibited to make claims that food or its ingredient can help treat, prevent or cure a disease or adverse condition. In addition, only nutrition and health claims that have been approved under EU Regulation (EC) No 1924/2006 (as retained and amended by UK legislation via the Nutrition (Amendment etc.) (EU Exit) Regulations 2019/651) on nutrition and health, claims made on food can be used on the label and detail page.

Nutrition claims

A nutrition claim is any claim that states, suggests or implies that a food has particular beneficial nutritional properties due to the presence, absence, increased or reduced levels of energy or of a particular nutrient or other substance. Nutrition claims provide information about the nutritional composition of the food. For example, ‘source of calcium’, ‘low fat’, ‘high fibre’ and ‘reduced salt’.

Only nutrition claims listed in the Annex to the EU Regulation (EC) No. 1924/2006 (as retained and amended by UK law) can be made in relation to food and only if the product meets the specific conditions of use for that claim. For example, ‘low fat’ can only be made on products containing no more than 3g of fat per 100g for solids. Click here for more information.

Health claims

A health claim is any claim that states, suggests or implies that a relationship exists between a food category, a food or one of its ingredients and health. Only health claims authorised by the relevant authority as listed below are permitted:

• • England: Secretary of State for Health and Social Care

• • Scotland: Scottish Ministers

• • Wales: Welsh Ministers

• • Northern Ireland: the Department of Health

Until December 31, 2020, the EU Register contains a list of specific health claims and the outcome of their assessment (whether authorised or not) as well as their conditions of use.

After December 31, 2020, a register will be maintained by the UK authorities containing a list of specific health claims and the outcome of their assessment (whether authorised or not) as well as their conditions of use.

Health claims cannot:

• • Be false, ambiguous or misleading

• • Imply that not consuming the food could affect the health.

• • Refer to the rate or amount of weight loss.

• • Refer to recommendations of individual doctors or health professionals.

• • Encourage or condone excess consumption of a food.

• • Imply that a balanced diet cannot provide the necessary nutrients.

• • Induce doubt around the safety and/or nutritional adequacy of other foods.

• • Refer to changes in bodily functions, which could give rise to or exploit fear in the consumer.

Nutrition and health claims are only permitted if the average consumer can be expected to understand the beneficial effects as expressed in the claim. As mentioned above, if general wellbeing claims are used (such as ‘superfoods’, ‘good for you’), then these must be accompanied by a specific health claim, i.e. you need to explain why it is considered a ‘superfood’. For example, Mackerel, as part of a healthy balanced diet, can be considered a superfood because it is a source of Omega-3 fatty acids. The claim could therefore state: ‘Omega 3 fatty acids EPA and DHA contribute to normal heart function’. This should be accompanied with the explanation for where Omega 3 comes from and that it contains x mg of eicosapentaenoic acid and docosahexaenoic acid per 100 g. To use this health claim, you also need to tell the customer that the beneficial effect is obtained with a daily intake of 250mg EPA and DHA.

Medicinal claims

Food supplements cannot claim the property of preventing, treating, or curing human disease or refer to such properties. Such medicinal claims are never permitted for food supplements. Only products licensed as medicinal products can bear such claims.

Novel foods and banned ingredients

The Annexes to the Directive 2002/46/EC (as incorporated and amended by UK law) list the vitamins and minerals and their chemical forms permitted for use in the manufacture of food supplements.

“Novel Foods” for the purposes of UK law are foods that have not been consumed to a significant degree by humans in the EU before 15 May, 1997. A novel food can be newly developed, innovative food, food produced using new technologies and production processes, as well as food that is or has been traditionally eaten outside of the EU. Examples of novel food include new sources of vitamin K (menaquinone) or extracts from existing food (Antarctic krill oil rich in phospholipids from Euphausia superba), agricultural products from third countries (e.g. chia seeds, noni fruit juice), or food derived from new production processes (UV-treated foods such as milk, bread, mushrooms and yeast). A safety assessment must be conducted and pre-market authorisation must be given before a novel food can be marketed in the EU.

In addition to novel foods, certain other ingredients are also not permitted in food supplements. For example, the following substances are not permitted as ingredients in the manufacture of food supplements:

• • Certain banned and restricted herbal ingredients, particularly those for medicinal use, such as ephedra herb and kava kava.

• • Medicinal ingredients, including ingredients authorised as traditional herbal medicines.

• • Medicinal levels of otherwise permitted ingredients.

Products for sale on VegaVend cannot contain any unauthorised ingredients (for example, unauthorised vitamins or minerals, additives, or flavourings), novel foods, or banned ingredients.

Safe upper limits

To ensure that food supplements are safe for consumption, the manufacturer must take into account the upper safe levels established by scientific risk assessment and data on vitamin and minerals intake from other foods, while taking into account what is considered an adequate vitamin and mineral intake for an average person.

The UK provides Guidance on Upper Levels for Vitamins and Minerals from the Expert Group on Minerals and Vitamins.