Differences and Similarities in Food Supplement Regulations

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Published in Lex Mundi, 2010

1. What is the definition of a food supplement in your jurisdiction?
In line with the provisions of Directive 2002/46/EC of the European Parliament and of the Council of 10 June 2002 on the approximation of the laws of the Member States relating to food supplements, Romanian legislation defines food supplements as to the foodstuffs the purpose of which is to supplement the normal diet and which are concentrated sources of nutrients or other substances with a nutritional or physiological effect, alone or in combination, marketed in dose form, namely forms such as capsules, pastilles, tablets, pills and other similar forms, sachets of powder, ampoules of liquids, drop dispensing bottles, and other similar forms of liquids and powders designed to be taken in measured small unit quantities (art. 2 letter a) of Order 1069/2007 for the approval of the norms regarding food supplements issued by the Ministry of Health).
The regulations concerning food supplements clearly differentiate such foodstuffs from the medicines, and expressly provide that the labeling, presentation and advertising of food supplements must not attribute such the property of preventing, treating or curing a human disease, or refer to such properties (similar to food products).
In order to ensure clear differentiation between these type of products, when filing the required notification form with the competent authority, the applicant must declare that the respective food supplement has not been authorized / registered in any country as OTC medicinal product.

2. Are the ingredients of food supplements regulated?
Yes. Food supplements may only contain the vitamins and minerals exhaustively listed in Order 1069/2007 or Commission Regulation (EC) no. 1170/2009 of 30 November 2009 amending Directive 2002/46/EC and Council Regulation (EC) no. 1925/2006 of the European Parliament and Council on lists of vitamins and minerals and their forms that can be added to foods, including food supplements.
In addition, the botanicals that may be used as ingredients of food supplements are separately listed in the common Order no. 244/401/2005 on the processing and trading of medicinal and aromatic plants used as such, partially processed or processed as pre-dosed food supplement, issued by the Ministry of Agriculture together with the Ministry of Health. The inclusion as ingredient of a food supplement of a plant which is not listed in the aforementioned piece of legislation is subject to the prior approval of the Foodstuff Bio-Resources Institute.
Other substances (e.g., food additives) may also be added, unless prohibited by applicable legislation and unless such addition may transform the food supplement into a medicinal product.

3. Is there a specific food supplement procedure for launching the product or is it the same procedure which applies to all food products?

The placing on the market of the food supplements
a) including botanicals processed in pre-dosed food supplements or
b) of animal and vegetal origin
is subject to the submission with the Foodstuff Bio-Resources Institute of a notification file, containing data on the respective food supplement and the composition thereof, as well as the standard artwork under which such is going to be sold on the Romanian market. In principle, the authority shall grant a registration number to the notification file and shall issue its approval within 30 days as of the submission of all documents as concerns the food supplements including botanicals or within 10 days as concerns the food supplements of animal and vegetal origin.
For the food supplements which do not contain either vegetal or animal components, the placing on the market is allowed after the notification of the Public Health Ministry, upon the submission of a standard application filled in by the applicant and the standard label. Within 48 hours as of the receipt of all documents, the Public Health Ministry will issue a registration of the notification document, on the basis of which the food supplement may be commercialized.

4. Are there any specific food supplement requirements regarding packaging, labeling and presentation or are they the same for all food products?
General rules concerning food labeling, packaging and presentation apply also to food supplements, save for certain particular requirements applicable only for these types of products. The table below summarizes both the general and particular requirements in the legislation in force:

Source/ origin • For the EU products, the label shall indicate the name or commercial name and the headquarters of the manufacturer, packager or of the distributor registered in the European Union.
For the non-EU products, the label shall include the name and headquarters of the importer or of the distributor registered in Romania.
• Place of origin shall be included on the label insofar the omission thereof may be confusing for the consumers with respect to the actual origin of the product.
Name The name under which the products may be sold is “food supplements”.
The commercial name of the product shall be placed in the same view with the quantity and expiry date information.
Ingredients The ingredients shall be listed on the label in the decreasing order of their quantities. Vitamins and minerals shall be also listed in the ingredients list.
In case of ingredients which are (i) listed together with the name under which the product is sold or which are regularly associated with the name of the product by the consumers; (ii) highlighted in labeling upon words, drawings or graphics or (iii) giving the product special characteristics, differentiating the product, such will be included in the ingredient list jointly with the quantity thereof expressed in percentages.
Amount of the product Net weight
Obligatory information,
warnings or statements
• Name of the product;
• Ingredient list;
• Quantities for certain ingredients, as case may be;
• Net weight;
• Validity term;
• Name or commercial name and the headquarters of the manufacturer, packager or of the distributor registered in the European Union (for EU products) or name and headquarters of the importer or of the distributor registered in Romania (for non-EU products).
• Origin, label insofar the omission thereof may be confusing for the consumers with respect to the actual origin of the product;
• Recommended use instructions;
• Lot number;
• The names of the categories of nutrients or substances that characterize 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 and balanced diet;
• A statement to the effect that the products should be stored out of the reach of young children.
• If applicable, relevant statements regarding sweeteners, liquorices, etc.
• If applicable, storage and use conditions
Optional statements Any statement not mandatory to be included, which represent correct information that might be useful to consumers
Language Romanian language is mandatory. Other language versions may be included as well.
General features of a label The label must include correct, complete and precise information of the product.
Other remarks N/A

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