- Substances that may be added for specific nutritional purposes in Parnuts
- Notification requirements when placing on the market
From the 20th July 2016 Directive 2009/39/EC (PARNUTs) is repealed by Regulation (EU) No 609/2013 of 12 June 2013 on food intended for infants and young children, food for special medical purposes, and total diet replacement for weight control. See New Rules Update.
Directive 2009/39/EC (OJ L124, p21, 20/05/2009) of the European Parliament and of the Council of 6 May 2009 on foodstuffs intended for particular nutritional uses (recast)
Commission Regulation (EC) No 953/2009 (OJ L269, p9, 14/10/2009) of 13 October 2009 on substances that may be added for specific nutritional purposes in foods for particular nutritional uses
- European Union (Foodstuffs Intended for Particular Nutritional Uses) Regulations (S.I. No. 169 of 2012)
Directive 2009/39/EC defines foodstuffs intended for particular nutritional uses (Parnuts) as 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.
A particular nutritional use must fulfil the particular nutritional requirements:
- of certain categories of persons whose digestive processes or metabolism are disturbed; or
- of certain categories of persons who are in a special physiological condition and who are therefore able to obtain special benefit from controlled consumption of certain substances in foodstuffs; or
- of infants or young children in good health.
Conditions for the use of the terms 'dietetic' and 'dietary' are also set out in Directive 2009/39/EC . Foodstuffs intended for particular nutritional uses are only allowed on the retail market in pre-packaged form, and the packaging must completely cover the products.
Commission Regulation (EC) No 953/2009 applies to foods for particular nutritional uses, excluding those covered by Directive 2006/125/EC on processed cereal-based foods and baby foods for infants and young children and Directive 2006/141/EC on infant formulae and follow-on formulae
The Regulation identifies the substances that may be added for specific nutritional purposes in foods for particular nutritional uses. Only those substances listed in the Annex to the Regulation and complying with the relevant specifications as necessary may be added for specific nutritional purposes in the manufacture of foodstuffs for particular nutritional uses covered by Directive 2009/39/EC.
The use of nutritional substances in foods for particular nutritional uses must result in the manufacture of safe products that fulfil the particular nutritional requirements of the persons for whom they are intended as established by generally accepted scientific data. The substances are categorised into the following 6 groups - vitamins, minerals, amino acids, carnitine and taurine, nucleotides, choline and inositol. These chemical substances have been selected on the basis of their safety, their availability for use by humans and their organoleptic and technological properties. The purity criteria generally applied for the manufacture of foods apply to the substances also.
Regulation (EU) 1169/2011 on the provision of food information to consumers applies to 'Parnuts' subject to the following conditions
- The designation under which a product is sold must be accompanied by an indication of its particular nutritional characteristics. However, in the case of the products covered by Article 1(3)(c) of Directive 2009/39/EC i.e. Infants or young children in good health that reference must be replaced by a reference to the purpose for which they are intended.
- The labelling of products for which no specific Directive has been adopted in must also include:
- the particular elements of the qualitative and quantitative composition or the special manufacturing process which gives the product its particular nutritional characteristics;
- the available energy value expressed in kilojoules and kilocalories and the carbohydrate, protein and fat content per 100 grams or 100 millilitres of the product as marketed and, where appropriate, per specified quantity of the product as proposed for consumption.
- If, however, the energy value is less than 50 kilojoules (12 kilocalories) per 100 grams or 100 millilitres of the product as marketed, those particulars may be replaced either by the words ‘energy value less than 50 kilojoules (12 kilocalories) per 100 grams’ or by the words ‘energy value less than 50 kilojoules (12 kilocalories) per 100 millilitres’.
The particular labelling requirements for those products for which a specific Directive has been adopted is laid down in the relevant Directive. For further information on these requirements please refer to the section on
- infant formulae and follow-on formulae
- processed cereal-based foods and baby foods for infants and young children;
- dietary foods for special medical purposes
- foods intended for use in energy restricted diets for weight reduction,
Directive 2009/39/EC concerns foodstuffs intended for particular nutritional uses which owing to their special composition or manufacturing process are intended to satisfy the particular nutritional requirements of specific categories of the population. People with coeliac disease are such a specific group of the population suffering from a permanent intolerance to gluten. Further information on the requirements regarding the labelling of such products can be viewed here
Directive 2009/39/EC requires that Member States are notified of the placing of Parnuts on the market within their State.
The notification requirements for products which fall within the scope of the groups listed in Annex I to Directive 2009/39/EC are set out in the specific Directive for that particular Parnut e.g. Dietary foods for special medical purposes. At present only the following Parnuts belonging to this group require notification and notification forms can be accessed by choosing the relevant link:
Directive 2009/39/EC also sets out specific provisions for foodstuffs intended for a particular nutritional use which do not belong to one of the groups listed in Annex I to the Directive:
- when a product as referred to above is placed on the market for the first time the manufacturer or, where a product is manufactured in a third State, the importer, shall notify the competent authority of the Member State where the product is being marketed by forwarding it a model of the label used for the product;
- where the same product is subsequently placed on the market in another Member State the manufacturer or, where appropriate, the importer, shall provide the competent authority of that Member State with the same information, together with an indication of the recipient of the first notification;
- where necessary, the competent authority can require the manufacturer or, where appropriate, the importer, to produce the scientific work and the data establishing the product's compliance with Article 1(2)and (3) together with the information provided for in Article 9(3)(a) of Directive 2009/39/EC . If such work is contained in a readily available publication, a mere reference to this publication shall suffice.
The Food Safety Authority of Ireland is the competent authority for notification in Ireland. This form may be used to notify us before a food for a particular nutritional use is placed on the Irish market for the first time. The duty to notify falls on the manufacturer if the product is manufactured in Ireland and on the importer if the product is imported into Ireland . A separate form is required for each product and in the case of reformulation (i.e. ingredients/ingredient levels) or changes in claims.