Food Supplement Guidelines for CBD Products

EFSA Food Supplement Guidelines

Food Supplement Guidelines for CBD Products

If you are selling CBD products as food supplements you need to meet the regulatory requirements in your country

EFSA (European Food Safety Authority).

“EFSA has not developed Guidance for CBD supplements.  Regulation EU 2015/2283  lays down rules for the placing of novel foods on the market of the European Union. The European Commission is the Institution responsible for authorising a novel food and updating the Union list of novel foods authorised. The Commission may request EFSA to give its opinion on the effects on human health. Hence, in its opinion EFSA shall assess the characteristics of the novel food that may pose a safety risk to human health, including considering possible effects on vulnerable groups of the population. Therefore, in order to sell a product on the EU market, an application dossier must be first authorised by the European Commission, as set out by Regulation EU 2015/2283.

 EFSA is  an agency of the European Union competent for assessing direct or indirect risks related to the safety pf the food chain. The tasks of risk assessment and risk management concerning food safety in the European Union (EU) are separated between different institutions. Pursuant to Article 22 of Regulation (EC) No 178/2002 (EFSA’s Founding Regulation) , EFSA, as a risk assessor, is responsible for delivering independent, objective and transparent scientific advice to the risk managers, which are the European Commission, Member State authorities and the European Parliament. Based on EFSA’s scientific opinions, risk managers are the one managing the risks related to food and feed safety, animal health and welfare and plant health, by developing policies, authorising products and making laws. Besides some scientific work carried out on its own initiative in the area of emerging issues and new hazards, EFSA’s work is therefore undertaken in response to requests for scientific advice from the risk managers in the areas falling within its mission.” 

Avoid Medical Claims

You must avoid Medical Claims (unless you product specifically allows this – read more about our CBD product range that can include certain claims)

https://www.efsa.europa.eu/en/topics/topic/nutrition-and-health-claims

Directive 2000/13/EC generally prohibits the use of information that would mislead the purchaser or attribute medicinal properties to food.

Food Supplement

The EFSA explains on their website that:

“Food supplements are intended to correct nutritional deficiencies, maintain an adequate intake of certain nutrients, or to support specific physiological functions. They are not medicinal products and as such cannot claim to exert a pharmacological, immunological or metabolic action. Therefore their use is not intended to treat or prevent diseases in humans or to modify physiological functions.”

https://www.efsa.europa.eu/en/topics/topic/food-supplements

Food supplements are regulated as food, and must therefore adhere to all other legislation that is applicable to foodstuffs. This has consequences for labelling and for the ingredients that are allowed.

Labeling Requirements

Directive 2002/46/EC sets out specific labelling requirements for food supplements.

  • the names of the categories of nutrients or substances that characterise the product or an indication of the nature of those nutrients or substances;
  • the portion of the product recommended for daily consumption;
  • a warning not to exceed the stated recommended daily dose;
  • a statement to the effect that food supplements should not be used as a substitute for a varied diet;
  • a statement to the effect that the products should be stored out of the reach of young children.

Your packaging is required by law to contain the words “Food Supplement” and can also contain more words to make it more precise eg “Food Supplement – containing vitamins and minerals”

Nutrients and other ingredients

A wide range of nutrients and other ingredients might be present in food supplements, including, but not limited to, vitamins, minerals, amino acids, essential fatty acids, fibre and various plants and herbal extracts.

The Term CBD or Cannabidiol can be included on the label. Other phyto-cannabinoids like CBDA or CBG can also be listed.

Cannabis can be referred to as Cannabis, Cannabis Sativa L. or Hemp.

We advise to clearly state the amount of Cannabidiol in mg and the botanical source i.e. cannabis/hemp.

Recommended Daily Dose

Include the recommended daily dose eg. take 1-3 drops twice a day or do not exceed 20 drops in 24 hours. Adjust the recommended daily dose according to the strength of your CBD product.

Since cbd is being marketed as a food supplement you can include individual servings in mg

Warning not to exceed recommended daily dose

Include a warning that tells consumers not to exceed the recommended daily dose.

For example – Do not exceed the stated recommended daily dose, or

Do not exceed 200mg of cbd per 24 hour period.

Include a statement about about a food supplements not be used instead of a healthy varied diet

Food supplements should not be used as a substitute for a varied diet, and a statement to this effect must be included on the label.

Child Safety Warning

Include a statement explaining that the products should be stored out of the reach of young children. eg. “Keep out of the reach of young children”

Product Name

Avoid any product names that contain direct medical claims, or can otherwise be seen as misleading for the consumer.

List of Ingredients

A list of all ingredients contained in the product must be included on the label.

The amount of ingredients used

Include the amount in mg or ml or grams. Include the amount of mg of cannabidiol

Date mark

Include best before date or use by – for most CBD products 12 months is adequate. However, alcohol based tincture can have a much longer shelf life.

Storage conditions

Keep refrigerated or store in a cool dark place.

Name and address of manufacturer

Include the name and address of the manufacturer or producer. The address needs to be a physical address within the EU where your business can be contacted by mail. You can’t use an e-mail address or phone number.

Instructions for use

For CBD oil drops – Place drops sublingually under the tongue and hold for at least 60 seconds before swallowing.

Place of origin

Include the place of origin in your labeling and packaging.

  1. product of the EU, Manufactured in Holland

Organic ingredients

If the raw materials are organic in origin there must be certification evidence provided to support this. In order to make an organic claim on a label, a food manufacturer must be registered with a recognized organic control body.

https://ec.europa.eu/agriculture/organic/organic-farming/what-is-organic-farming/organic-certification_en

The code number of the national certification authority should also be on the label next to the EU organic logo.

Certified Organic Logo - Rules for use in Europe copy

AB – ISO code as specified in Article 58(1)(a) for the country where the controls take place CDE – three letters term that establishes a link with the organic production method as specified in Article 58(1)(b) such as “öko”, “org”, “eko”, “bio”, etc.

999 – reference number, indicated in maximum three digits, to be attributed, as specified in Article 58(1)(c)

https://ec.europa.eu/agriculture/organic/downloads/logo_en

 

 

Disclaimer

CBD OIL EUROPE HAS NO AFFILIATION OR RELATIONSHIP WITH THE EFSA. ALL INFORMATION ON THIS PAGE IS FOR INFORMATION PURPOSES ONLY AND SHOULD NOT BE CONSIDERED LEGAL ADVICE. 

7 thoughts on “Food Supplement Guidelines for CBD Products

    • Adriaan says:

      Hi Raquel,

      we are still deliberating on the impact of the new listing,

      we hope to publish a new article about that in the coming weeks,

      a lot now depends on how member states’ governments will decide to interpret / implement the guidelines.

      Thanks for publishing your question,

    • Adriaan says:

      dear mr Rasmussen,

      we don’t have a lot of experience shipping to Norway. I have asked my colleague to study the status of CBD products in Norway. We will update you as soon as we have more information,

      thanks for reaching out,

  1. Bojski says:

    Dear CBDOILEUROPE,
    What about importing CBD (concentrates) from verified source from China and than wholesale to EU. Which requirements Chinese company should have? (EU GMP?)

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