Food Supplements Directive 2002/46/EC of the European Parliament came into force on the 12th of July 2002. This directive was amended by the Directive 2006/37/EEC and Regulation (EC) 1170/2009 to include additional substances and establish additional rules on vitamins and minerals in food supplements.
Parnuts DIRECTIVE 2009/39/EC of the European Parliament and of the Council came into force on the 6th of May 2009.
The aim of both Directives is to establish harmonized rules for the labeling of food supplements and Parnuts. The main purpose of the Food Supplements and Parnuts Directives is to harmonize the laws of the Member States relating to Food Supplements and Parnuts and to ensure that these products are safe and properly labeled, allowing the consumers to make informed choices.
What is a Food Supplement?
“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.”(FSD Article 2.1(a))
What is a Parnut?
“Foodstuffs for particular nutritional uses are foodstuffs which, owing to their special composition or manufacturing process, are clearly distinguishable from foodstuffs for normal consumption, which are suitable for their claimed nutritional purposes and which are marketed in such a way as to indicate such suitability.” (2009/39/EC Article 1.2)
The framework Directive 2009/39/EC specifies that specific provisions applicable to certain groups of foods for particular nutritional uses shall be laid down in specific Directives. These categories are as follows:
• infant formulae and follow-on formulae
• dietary foods for special medical purposes
• foods intended for use in energy restricted diets for weight reduction
• food intended to meet the expenditure of intense muscular effort, especially for sportspeople
• foods for persons suffering from carbohydrate-metabolism disorders (diabetes).
In order to comply with the Food Supplements and Parnuts Directives, non-EU manufacturers are required to appoint an Authorized Representative with a permanent office within the European Community.
As a Responsible Person, GiDoS offers the following Food Supplements and Parnuts services:
• Classification & Identification of Proper Regulation
• European Authorized Representative & Vigilance Contact Point
• Pre-market Notification :
• Food Supplement Directive 2002/46/EC – Article 10
• Parnut Directive 2009/39/EC – Article 11 (a)
• Justification documentation keeping & updating
• Labeling & Language Requirements
• Labeling, presentation and advertising of foodstuffs Directive 2000/13/EC
• Permitted Claims & Regulatory Advice
• Guidance on national requirements
• Regulatory Strategy
• Regulatory Study services
• Support on sampling and analysis
• Guidance on Post-marketing Surveillance
• EU Trade Mark submission
To receive more information about GiDoS Food Supplement & PARNUT Services or our offer, please contact: firstname.lastname@example.org