Documents considered by the Committee on 23 May 2012 - European Scrutiny Committee Contents

7 Food for particular nutritional uses



+ ADDs 1-2

COM(11) 353

Draft Regulation on food intended for infants and young children and on food for special medical purposes

Legal baseArticle 114 TFEU; co-decision; QMV
Basis of considerationMinister's letter of 17 May 2012
Previous Committee ReportsHC 428-xxxiv (2010-12) chapter 5 (19 July 2011) and HC 428-li (2010-12) chapter 6 (22 February 2012)
Discussion in CouncilSee para 7.8 below
Committee's assessmentPolitically important
Committee's decisionNot cleared; further information requested; waiver granted under paragraph (3)(b) of the Scrutiny Reserve Resolution


7.1 EU legislation governing foodstuffs which are specially manufactured to satisfy particular nutritional requirements was recently consolidated by Directive 2009/39/EC (the "Framework Directive on dietetic foods"). This enables the Commission to adopt detailed provisions governing the composition, labelling, presentation and advertising of five groups of foodstuff,[36] and it also enables it to propose measures relating to food for those with diabetes.[37] Where no specific provisions are laid down for products regarded as being for particular nutritional uses, the Directive says that, before being placed on the market of any Member State, the manufacturer should notify the Member State in question.

7.2 The Commission believes that an overall revision of these measures is now necessary, in that the broad concept of foodstuffs for particular nutritional uses has led to considerable problems, with different interpretations by Member States of what constitutes such a foodstuff. As a result, it says that an increasing number of different foodstuffs are being marketed as suitable for particular nutritional uses, thereby undermining the functioning of the internal market and creating legal uncertainty.

7.3 It therefore put forward in June 2011 this draft Regulation, which would abolish the concept of dietetic food, and lay down general rules regarding the composition and labelling applicable to three established and well-defined categories of food identified as essential for certain vulnerable groups with specific needs — infant formulae and follow-on formulae, processed cereal-based foods and baby foods for infants and young children, and food for special medical purposes. The measure would not, however, apply to foods marketed as suitable for use by diabetics, slimming foods, sports food and gluten-free foods, which the Commission says are more appropriately covered by other relevant EU legislation. The proposal would enable the Commission to maintain a single consolidated list of substances[38] which can be added to the foods covered by it; and it would also replace the current notification procedure involving all 27 Member States with a prior authorisation system at EU level.

7.4 As we noted in our Report of 19 July 2011, the Government welcomed the clarification and simplification which the proposal would bring, pointed out that it has been broadly welcomed by consumer organisations, but said that the industry was concerned about the exclusion of some foods, particularly those for slimming, and has also pressed for the inclusion of sports foods. It added that it had not yet produced a comprehensive UK Impact Assessment, but would do so following a public consultation in September 2011. In the meantime, it noted that overall the proposal would "significantly" change the current situation, and in particular that the need for manufacturers wishing to market specialist foods to obtain prior authorisation at EU level could result in large administrative burdens.

7.5 We commented that this was a highly technical and complex area, which had made it difficult to identify the precise nature of the changes or their significance. We therefore said that we would await the Government's Impact Assessment before seeking to take a further view, and would in the meantime hold the document under scrutiny.

7.6 As we reported to the House on 22 February 2012, we subsequently received from the Parliamentary Under-Secretary at the Department of Health (Anne Milton) a letter of 8 February 2012, enclosing the promised Impact Assessment. She said that respondents broadly welcomed the proposal to restrict the scope of the measure, and to drop the concept of dietetic foods, though some felt that the scope was too narrow and might not allow innovative foods in certain areas. She added that this and other technical aspects of the proposal would need to be addressed in ongoing discussions, where, in order to minimise the burden on businesses, the Government would negotiate sufficient transitional periods for any necessary changes, for example in relation to the information provided on labels. In the meantime, the Impact Assessment had suggested that the proposals were unlikely to have a major impact on either manufacturers or consumers, with a positive effect on competition and growth, and dietetic foods no longer covered by specific legislation continuing to be sold under more general legal frameworks.

7.7 We were also told that the negotiations were still at an early stage, but that, as the Danish Presidency was hoping to secure a first reading deal in the European Parliament, it would be necessary to be prepared for a potential vote in April. We commented that, although the Impact Assessment had allayed some of our earlier concerns, a number of issues were still under discussion, and that the scope of the proposals could change as the negotiations move forward. We therefore said that it would be prudent to hold the document under scrutiny pending any further developments, stressing that, if there was to be a vote in April, we needed to have time to consider the proposals further.

Minister's letter of 17 May 2012

7.8 We have now received from the Minister a further letter of 17 May, in which she says that her original intention had been to provide an update on discussions following informal trilogues scheduled for early June, but that the European Parliament informed the Council last week that it would be progressing this proposal to a second reading following a vote in June. As a result, the Danish Presidency had asked Member States to agree a general approach, with a vote in the Council expected on either 7 or 11 June. In view of the forthcoming recess, she has asked for clearance (or a scrutiny waiver) in advance of those dates.

7.9 The Minister recalls that the Commission's original proposal was based on a better regulation approach, and would result in fewer products being regulated under this legislation, and an opening of the market to a more innovative approach. She says that the Council mandate now proposed represents a balanced solution, which the UK is likely to support subject to further discussion to ensure that suitable transitional periods are provided for businesses to adjust to the new requirements. In particular, she says that, if the proposed compromise were to be adopted following further negotiation, it would resolve the current confusion in defining a particular nutritional purpose food, clarify labelling rules for low-gluten and gluten-free products (including foods sold loose), and reduce the regulatory burden on businesses, with more categories of foods being regulated under existing, more general food law.

7.10 At the same time, she notes that there would be areas of compromise from the UK's original support for the proposal, relating to additional controls on foods intended to replace the total daily diet for weight control and reports on milk-based drinks and similar products intended for young children and sports foods, with a further recommendation on the desirability of specific legislation. However, she says it is clear that the proposed general approach represents the best achievable position at this point, and she is content that the burdens on business have been mitigated as far as possible.

7.11 The Minister also says that this review accords well with Government policy on Better Regulation in that it aims to repeal existing regulations on slimming foods, gluten-free foods and the export of infant and follow-on formula to third countries, and to simplify the regulation of slimming foods, growing-up milks and sports foods. In particular, limiting the scope of the proposal would reduce the administrative burden for industry, and, although there may be costs to businesses insofar as some label changes may be necessary, the majority of products are unlikely to need any change of labelling (and any such costs would be reduced if there were to be an extension to the proposed two-year transition period).


7.12 We are grateful to the Minister for this further information, which suggests that many of the UK's earlier concerns over this proposal are now likely to be met, and we note that the Government supports the overall deregulatory approach embodied in it. We have therefore considered carefully the Minister's request that we should now clear the proposal, or grant a scrutiny waiver in advance of the Council meeting scheduled for early June.

7.13 Given that there are one or two outstanding issues, such as the length of the transitional period, we hesitate to release the document from scrutiny entirely, but we are also conscious that this is a complex and technical proposal, which has been the subject of detailed negotiations, and where what is now on the table incorporates an essentially deregulatory approach, whilst maintaining certain controls. In view of this, we would not wish to prevent the Government from agreeing to whatever may be before the Council, if it judges it in the UK interest to do so. We therefore agree to the Minister's request for a waiver under paragraph (3)(b) of the Scrutiny Reserve Resolution. The document remains under scrutiny and we would be grateful if the Minister could inform us of the outcome of that meeting.

36   As a result, Commission Directives have been adopted 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; and the composition and labelling of foodstuffs suitable for people intolerant to gluten foods. However, compositional criteria have not been agreed for a range of other dietetic foods covered by Directive 2009/39/EC, including very low calorie diets and sports foods. Back

37   A Commission report in 2008 concluded that diabetics should eat as healthily as possible from a variety of food for normal consumption, and that there was no scientific basis on which to develop specific compositional requirements for this category of food. Back

38   Such as vitamins and minerals. Back

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