Supplements are food in law
Capsules, tablets, powders, gummies and liquids sold as a concentrated source of nutrients are food supplements. They sit under food law, not the general product safety rules. In the European Union that means Directive 2002/46/EC for supplements, Regulation (EU) No 1169/2011 for the label and Regulation (EC) No 1924/2006 for claims. Great Britain kept the same framework, with the Food Supplements (England) Regulations 2003 and their equivalents in Scotland and Wales. Northern Ireland follows the EU rules.
A supplement sold in Great Britain is not automatically right for the EU, or the reverse. Health claims must match the register of the market where you sell. Ingredients with no significant history of consumption before May 1997 can be novel foods, which need an authorisation before sale. And many EU countries ask for a notification with the label before the product goes on sale, each with its own process.
Who the label names
Food law does not use the cosmetics idea of a Responsible Person. It names the food business operator: the business under whose name the product is sold or, where that business is not established in the market, the importer. That business's name and address go on the label.
Part of the review is confirming which business your label names in each market, and whether our named entity can take that role for your products.
What we review
The composition, and the form of each vitamin and mineral. Whether any ingredient is a novel food. The mandatory statements: the name food supplement, the categories of nutrients, the recommended daily portion, a warning not to exceed it, that supplements are not a substitute for a varied diet, and to keep the product out of reach of young children. Nutrient amounts per daily portion, allergens, and every health claim against the register of the market.
Capsules, powders and gummies are usually separate families. Strengths can share a family where the formulation, intended use and requirements are the same, so the underlying work is reviewed and priced once.
What the law asks for, market by market
United Kingdom
The Food Supplements (England) Regulations 2003 and the food law kept after Brexit apply in Great Britain, with equivalent regulations in Scotland and Wales.
- Permitted vitamins and minerals
- Only the vitamins and minerals, and the forms of them, on the permitted lists.
- Food Supplements (England) Regulations 2003
- Mandatory statements
- The name food supplement, the categories of nutrients, the daily portion, a warning not to exceed it, a statement that supplements are not a substitute for a varied diet, and to keep out of reach of young children.
- Food Supplements (England) Regulations 2003
- Nutrient amounts
- Declared per recommended daily portion, with vitamins and minerals also given as a percentage of the reference values.
- Food Supplements (England) Regulations 2003
- Food business operator
- The label names the business under whose name the product is sold or, if it is not established in the UK, the importer, with a UK address.
- Regulation (EU) No 1169/2011 as kept in UK law, Articles 8 and 9
- Allergens
- Allergens from the list of fourteen are emphasised in the ingredient list.
- Article 21 and Annex II
- Language
- The mandatory information is in English.
- Article 15
- Health claims
- Only claims on the GB nutrition and health claims register, used with their conditions of use.
- Regulation (EC) No 1924/2006 as kept in UK law
- Novel foods
- An ingredient without a history of significant consumption before 15 May 1997 needs a GB authorisation first.
- Regulation (EU) 2015/2283 as kept in UK law
Sources
European Union
Directive 2002/46/EC and EU food law apply in every EU country, and in Northern Ireland. Each country can add its own notification.
- Permitted vitamins and minerals
- Only the vitamins and minerals, and the forms of them, on the permitted lists.
- Directive 2002/46/EC, Annexes I and II
- Mandatory statements
- The name food supplement, the categories of nutrients, the daily portion, a warning not to exceed it, a statement that supplements are not a substitute for a varied diet, and to keep out of reach of young children.
- Directive 2002/46/EC, Article 6
- Nutrient amounts
- Declared per recommended daily portion, with vitamins and minerals also given as a percentage of the reference values.
- Directive 2002/46/EC, Articles 8 and 9
- Food business operator
- The label names the business under whose name the product is sold or, if it is not established in the EU, the importer, with its address.
- Regulation (EU) No 1169/2011, Articles 8 and 9
- Allergens
- Allergens from the list of fourteen are emphasised in the ingredient list.
- Article 21 and Annex II
- Language
- The mandatory information is in a language easily understood where the product is sold, as each country sets.
- Article 15
- Health claims
- Only claims on the EU Register, used with their conditions of use. No claim that a food prevents, treats or cures a disease.
- Regulation (EC) No 1924/2006; Regulation (EU) No 1169/2011, Article 7
- Novel foods
- An ingredient not consumed to a significant degree in the EU before 15 May 1997 needs an authorisation first.
- Regulation (EU) 2015/2283
- Notification
- A country may ask for a notification with a model of the label before the product goes on sale.
- Directive 2002/46/EC, Article 10
Sources
What you send us
Send what you have. If a document does not exist, say so. Finding that gap is part of the review.
- The full formulation: every active ingredient and excipient, with the amount per daily dose.
- A certificate of analysis for the finished product, with the actives quantified.
- Supplier certificates of analysis and identity certificates for the active raw materials.
- The evidence behind your claims: studies, literature, or the authorised claim you rely on.
- An allergen declaration, including any cross-contamination risk.
- Shelf-life or stability data that supports the best-before date.
- The GMP certificate for the facility that makes the product.
- The full label artwork, ideally the print files.
- Any notification, approval or correspondence with a health authority in any market.
- For the EU, any check you have already made against the permitted ingredient lists.
Questions
Do food supplements need a Responsible Person?
Not in the sense cosmetics do. A supplement is food, so the label names the food business operator: the business under whose name it is sold or, if that business is not established in the market, the importer. The general product safety rules that require a Responsible Person for many other consumer products do not apply to food. We confirm in the review which business your label names in each market.
Is a supplement that is legal in the UK legal in the EU?
Not automatically. Health claims must be on the register of the market where you sell, the label has to meet each market's rules and language, some ingredients are treated differently, and many EU countries ask for a notification before sale. We review the product for each market you are launching in.
Which health claims can I use on a supplement?
Only claims authorised for the market where you sell, with their conditions of use: the GB nutrition and health claims register for Great Britain, and the EU Register of nutrition and health claims for the EU. A claim that a food prevents, treats or cures a disease is not allowed.
Do I have to notify a supplement before selling it in the EU?
In many EU countries, yes. Article 10 of Directive 2002/46/EC lets each country ask for a notification with a model of the label, and each sets its own process. We tell you which of your launch countries ask for one.
How long does the review take?
Initial reviews are typically completed within 1-2 working days once we have the information we need, subject to product complexity and scope. Representation only becomes active after the required checks, the contractual appointment and regulatory approval are complete. We confirm the activation date for each customer.