Food Supplements
Introduction
Food supplements are considered as common foodstuffs, despite being marketed in dose form. Therefore, as with all foodstuffs, pursuant to Decree-Law No. 560/99 and Decree-Law No. 136/2003, food supplements may not claim to have the property of preventing, treating or curing a human disease, or refer to such properties, unlike medicinal products that must have one of those therapeutic functions.
Definitions
Decree-Law No. 136/2003 defines food supplements as foodstuffs that can only be delivered to the ultimate consumer in a pre-packaged form.
Their purpose is to supplement the normal diet and they should not be used as a substitute for a varied diet. They are concentrated sources of nutrients or other substances with a nutritional or physiological effect, alone or in combination, and they may contain a wide range of nutrients and other ingredients, including vitamins, minerals, amino acids, essential fatty acids, fibre and various plant and herbal extracts.
Only vitamins and minerals listed in Annex I of Decree-Law No. 136/2003, in the forms listed in its Annex II, may be used for the manufacture of food supplements. However, until 31 December 2009, only for those substances whose dossier was submitted to the European Union before 31 May 2005 and provided that there is not an unfavourable opinion by the European Food Safety Authority (EFSA), the use of vitamins and minerals not included in the list in Annex I or in the forms not listed in Annex II may be allowed.
In order to use substances other than vitamins and minerals as ingredients in food supplements, they must have a significant food use in the European Union prior to 15 May 1997. Otherwise, they will be considered as novel ingredients and they can only be marketed after an assessment is made pursuant to the novel foods regulation (Regulation (EC) No. 258/97). It is incumbent on the business operator to ensure that the ingredients contained in food supplements are not novel ingredients.
Further guidance can be found in this European Union webpage where some substances are classified in terms of novel food ingredients.
If you wish to use a novel ingredient, it must be previously assessed under the novel foods regulation. Such ingredient may be used only if an authorisation is granted, according to the procedure laid down in Article 4 thereof.
Please refer to this EU webpage to look up the Commission Decisions accepting or rejecting products as novel foods or food ingredients.
The European Commission, in accordance with the provisions of Regulation (EC) No. 1925/2006, may decide to include a substance or ingredient in a list of banned substances, of substances subject to restrictions or in a list of substances under Community scrutiny.
Food supplements are marketed in dose form, such as capsules, pastilles, tablets, pills, sachets of powder, ampoules of liquids, drop dispensing bottles, and other similar forms of liquids and powders. They are designed to be taken in measured small unit quantities
Products classified as medicinal products for human use as defined by Decree-Law No. 72/91 of 8 February, as last amended by Decree-Law No. 242/2000 of 26 September, are not food supplements.
Labelling
In order to be marketed, food supplements must comply with the general food labelling rules laid down in Decree-Law No. 560/99 and the labelling provisions included in the specific legislation on food supplements (Decree-Law No. 136/2003).
Specific labelling of food supplements requires the following particulars:
- the names of the categories of nutrients or substances that characterise the product or an indication of their nature;
- the portion of the product recommended for daily consumption;
- the amount of the nutrients or substances with a nutritional or physiological effect present in the product shall be declared on the labelling in numerical form and it refers to the daily consumption recommended by the manufacturer on the labelling. The units to be used for vitamins and minerals shall be those specified in Annex I of Decree-Law No. 136/2003.
- information on vitamins and minerals shall also be expressed as a percentage of the reference values mentioned, namely those listed in Annex I of the legislation on food nutritional labelling (Decree-Law No. 167/2004).
- 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 reach of children.
Nutrition and Health Claims
The labelling of food supplements may include nutrition and health claims that meet the provisions of Regulation (EC) No. 1924/2006.
Notification of Marketing
To facilitate efficient monitoring of food supplements, the Decree-Law No. 136/2003 requires the manufacturer or the person responsible for placing the product on the national market to notify the competent authority of that fact, by sending it a model of the label used for the product.
Since the notification procedure is not a prior marketing approval, the products may be marketed as soon as they are notified, but in accordance with the principles laid down in Regulation (EC) No. 178/2002, it is the responsibility of the business operator to ensure compliance with the requirements contained in the applicable law.
A food supplement that has already been notified, but has been changed (change in ingredients or in their amounts) since then must be notified as if it was a new product.
How to notify
The notification is made by sending the model of the product label together with a letter with the data of the person responsible for it (name, tax number, postal address, telephone and fax number, and e-mail address) to:
Office of Planning and Agri-food Policy (GPP)
Rua Padre António Vieira, nº 1
1099-073 LISBOA
Portugal
Contacts
Tel: 00 351 21 381 93 00
Fax: 00 351 21 386 66 50
E-mails:
suplementosGPP@gpp.pt (notifications)
dsnsa@gpp.pt (other subjects concerning food supplements)
Last update: 7 January 2011