FSA Interested Parties Letter (CPD/104), 20 August 2009     

PARNUTS - European Commission’s options for revising the ‘parnuts’ framework Directive

Following the publication last year of the European Commission’s reports to the Council and European Parliament on implementation of Article 9 of 89/398/EEC, diabetic foods and the conclusion of an impact assessment the Commission is now considering options for amending the foods for particular nutritional uses (parnuts) framework Directive (2009/39/EC).   Please note that these are preliminary options which have yet to be discussed formally with Member States.

The Agency would welcome your comments on the possible benefits and disadvantages of each of the options outlined below in order to begin informing the UK position.

Background:

A food for a particular nutritional use (a parnuts food) is a food which, owing to its special composition or process of manufacture, is clearly distinguishable from food intended for normal consumption, and is sold in such a way as to indicate its suitability for its claimed nutritional purpose.  A particular nutritional use means the fulfilment of the particular nutritional requirements of certain categories of persons a) whose digestive processes or metabolism are disturbed or b) whose physiological condition renders them able to obtain special benefit from controlled consumption of certain substances in foodstuffs or c) of infants or children in good health.

Parnuts foods include, but are not limited to, infant formulae and follow-on formulae; processed cereal-based foods and baby foods for infants and young children (weaning foods); foods intended for use in energy restricted diets for weight reduction (certain weight reduction products); foods for special medical purposes (including special products such as tube feeds mainly used in a hospital setting) and foods labelled as ‘gluten-free’ or ’very low gluten’.

Foods intended for particular nutritional uses are regulated by framework Directive 2009/39/EC and by specific Directives adopted under that framework. This framework is now nearly 20 years old and a number of issues regarding its scope and interpretation have been highlighted through Commission reports and by the industry, consumer groups and /or regulatory authorities. In addition, food legislation has evolved a great deal since the adoption of the framework Directive and as such the Commission considers that it is a timely opportunity to review the effectiveness of this legislation.

The Commission has identified four general objectives in revising the framework Directive - to maintain a high level of consumer safety; to secure effective functioning of the internal market of the EU; to provide businesses and Member States with simple clear legislation which does not stifle innovation and to facilitate trade with non-EU partners.   In addition, specific objectives are:

1. To clarify the definition of parnuts foods to ensure that the scope of the parnuts legislation is fit for purpose, consistent with newer legislation such as that on supplements, claims and fortification and that Member States are able to interpret and apply the legislation in a uniform manner.
2. To address the inconsistencies in the current application of the notifications system and if possible reduce the administrative burden of this system on both industry and competent authorities.
3. To determine how to deal with each of the categories of parnuts foods which are highlighted in the current legislation and for which no specific decisions have been made (e.g. diabetic foods, sports foods, lactose-free foods).
4. To assess the need for a prior-authorisation procedure for new ingredients in infant formula and follow-on formula as discussed during negotiations on the recent revision of the infant formula and follow-on formula Directive.

Policy options:

The following policy options have been identified by the Commission:

1. No EU action – i.e. maintain the status quo.
2. Amend the framework Directive to replace the notification system (formerly under Article 9 of Directive 89/398/EC) with a pre-authorisation system and maintain the list of product categories currently listed in Annex I of 2009/39/EC, i.e. keep existing specific legislation and make decisions about how to handle listed categories for which no harmonised legislation exists as yet.
3. Reassess the scope of the framework Directive and revise the framework Directive to limit the scope of the legislation and create a positive list of categories of parnuts foods. The definition of a parnuts food could be amended to reflect such revisions. Under this option the current notification system would be removed.
4. Carry out a thorough revision of some or all of the legislation on parnuts foods. This option could include deleting the definition of a parnuts food and creating a series of pieces of legislation which stand alone (e.g. infant formula and follow-on formula) and incooperating other elements of parnuts legislation into other legislation such as that on nutrition and health claims or the new food information regulation.

Are there any other options which should be considered taking into account the purpose of this revision? Please include a rationale and supporting evidence for your view.

Benefits and disadvantages of the options:

In general, there may be benefits associated with each of the options such as simpler legislation which is easier to understand and therefore easier to comply with and enforce. This may also mean that it will be easier for manufacturers to trade across the EU as interpretation and implementation of the rules will be same in all Member States. Consumers could also benefit from updated compositional standards and clearer claims leading to more informed choice.

Similarly there may be disadvantages and/or costs imposed by any of the options above which may arise from mandatory changes to labelling, voluntary reformulation and labelling, possible loss of market share and changes in enforcement requirements.

We would welcome comments on the benefits and disadvantages of each of these options, with supporting evidence, from all interested parties. We would also welcome any cost/benefit analysis, with supporting evidence, which can be provided at this stage.

Next steps:

The Commission will publish its impact assessment in due course. This will be followed by a formal proposal to amend the parnuts legislation, however, this is not expected until 2010. In order to be able to prepare the UK position in response to this the Agency is requesting initial views from all interested parties on all of the proposed options. This is a preliminary stage in the process and we will continue to consult stakeholders throughout the process, including conducting a formal consultation when the Commission proposal is published. 

At this stage, in order to inform the UK position should the Commission hold a Members States’ working group in the autumn, we would be grateful for any comments by 16th September 2009.