In view of the launch of the automated food supplement (FS) notification system on Monday 2nd October 2023, please refer to the below updates which will be implemented when completing the FS notification form.
Label of the product
The PDF document is to be named as 'LABEL', when uploading the product labelling. Please note that unless the product labelling is uploaded in this section, the FS notification form will not be submitted to MCCAA.
The PDF document is to be named as 'PAYMENT', when uploading the proof of payment [copy of bank transfer or cheque] of the FS notification fee. Please note that unless the proof of payment is uploaded in this section, the FS notification form will not be submitted to MCCAA.
If the Botanical Ingredients (Part 1) or Botanical Ingredients (Part 2) sections under the Checklist are marked as 'Yes', the Determination Letter is to be uploaded along with this form in the 'Other Documents' section. [The Determination Letter is sent by the Borderline Classification Committee of the Medicines Authority. This letter must declare that the product is non-medicinal, so as to proceed with the notification of the product.]
Please note that unless the determination letter is uploaded in this section, the FS notification form will not be submitted to MCCAA.
Food supplements are concentrated sources of nutrients or other substances with a nutritional or physiological effect whose purpose is to supplement the normal diet. Most importantly, they are marketed 'in dose' form i.e. as pills, tablets, capsules, liquids in measured doses etc. since these are to be consumed according to a maximum recommended daily dose, as indicated on product packaging.
Supplements may be used to correct nutritional deficiencies or maintain an adequate intake of certain nutrients. However, in some cases excessive intake of vitamins and minerals may be harmful or cause unwanted side effects; therefore, maximum levels are necessary to ensure their safe use in food supplements.
Are food supplements covered by a specific piece of legislation?
At European Union level, food supplements are covered by Directive 2002/46/EC relating to food supplements and which sets out harmonized rules for the labelling of food supplements, and introduces specific rules on vitamins and minerals in food supplements.
The ultimate aim is to harmonise the legislation across European Union Member State markets as well as to ensure that products are safe and labelled in such a way that consumers can make informed choices.
At national level, food supplements are covered by the Food Supplements Regulations (Subsidiary Legislation 449.36). This regulation is a reflection of Directive 2002/46/EC. It however includes also specific rules for the Maltese market, such as the Third Schedule which sets out the maximum allowed doses for vitamins and minerals. These were worked out taking into consideration Maltese nutritional habits and requirements.
Food supplements are also covered by the Labelling, Presentation & Advertising of Foodstuffs Regulations (Subsidiary Legislation 449.46) with respect to aspects such as:-
A list of ingredients;
The amount of certain ingredients used;
A date mark;
Any special storage conditions or conditions of use;
The name and address of the manufacturer, packer or seller in the European Community;
Instructions for use;
The place of origin of the food; if failure to give it might mislead.
What kind of information should a food supplement label provide?
Food supplements have their own specific labelling requirements and a food supplement product label must include the following indications, as set out by regulation 6.4 of Subsidiary Legislation 449.36:
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.
Moreover, the labelling, presentation and advertising of food supplements shall not include any mention stating or implying that a balanced and varied diet cannot provide appropriate quantities of nutrients in general.
Very importantly, the labelling, presentation, and advertising must not attribute to food supplements the property of preventing, treating, or curing a human disease or refer to such properties.
Notification of food supplements
In order to place a food supplement (for sale) on the Maltese market, the manufacturer or importer is required by law to notify the Food Safety Commission by forwarding a model of the label used for the product, as set out by regulation 8.1 of Subsidiary Legislation 449.36.
The notification form is self-explanatory and it is structured in such a way so as to guide the notifier as they are completing the form.
The notification form must be filled in and submitted online. The product label and proof of payment must be attached to the form.
Payment is by bank transfer or by cheque. The notification fee is 10 Euros per product. Products that have different package sizes and/or flavours are still considered as one product.
How can I be sure that the food supplement I am buying has been checked by the local authorities?
When purchasing food supplements, consumers may question the seller on whether or not a particular food supplement has been notified with the Malta Competition and Consumer Affairs Authority.
What about herbal products? Can herbal products be used safely by everyone?
Food supplements containing herbs and/or botanicals (parts of plants which may include even bark or roots) are becoming very popular these days due to the purported safety of use. Consumers may be told that such products are safe because they are ‘natural’. Notwithstanding, one must exercise caution when dealing with such products since their effects may cause undesired interactions in persons who are already taking prescribed medication. Therefore, one is to always consult with their physician prior to consuming such products.
List of Herbal Botanical Substances:
Green Category - Botanicals in the Green Category may be safely consumed in food supplements.
Amber Category - Botanicals in the Amber Category may be used in food supplements. However, this depends on certain conditions e.g. plant part from which botanical is extracted; level of certain chemicals present in botanical per recommended daily dose, etc. If the botanical does not fall within the criteria/levels specified in the Amber Category, the notifier must contact the Borderline Classification Committee of the Medicines Authority to determine if the product is medicinal or non-medicinal.
Red Category - If the botanical falls under the Red Category, the notifier must contact the Borderline Classification Committee of the Medicines Authority to determine if the product is medicinal or non-medicinal.