Statement on the conditions of use for health claims related to meal replacements for weight control

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Article
Panel on Dietetic Products, Nutrition and Allergies
EFSA Journal
EFSA Journal 2015;13(11):4287 [11 pp.].
doi
10.2903/j.efsa.2015.4287
Panel members at the time of adoption
Jean Louis Bresson, Barbara Burlingame, Tara Dean, Susan Fairweather-Tait, Marina Heinonen, Karen Ildico Hirsch-Ernst, Inge Mangelsdorf, Harry McArdle, Androniki Naska, Monika Neuhäuser-Berthold, Grażyna Nowicka, Kristina Pentieva, Yolanda Sanz, Alfonso Siani, Anders Sjödin, Martin Stern, Daniel Tomé, Dominique Turck, Hendrik Van Loveren, Marco Vinceti and Peter Willatts.
Acknowledgements

The Panel wishes to thank EFSA staff member Silvia Valtueña Martínez for the support provided to this scientific output. 

Contact
Type
Opinion of the Scientific Committee/Scientific Panel
On request from
European Commission
Question Number
EFSA-Q-2015-00579
Adopted
28 October 2015
Published
13 November 2015
Affiliation
European Food Safety Authority (EFSA), Parma, Italy
Note
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Abstract

Following a request from the European Commission, the Panel on Dietetic Products, Nutrition and Allergies (NDA Panel) was asked to provide a scientific opinion on the conditions of use for health claims related to meal replacements for weight control, and in particular to advise on whether a change in the conditions of use for claims on meal replacements for weight control regarding their micronutrient composition (i.e. referring to 30% of the Nutrient Reference Values (NRVs) laid down in Part A of Annex XIII of Regulation (EU) 1169/2011 instead of the 30% of NRVs laid down in Annex I of Directive 96/8/EC) would affect the conclusions reached by the NDA Panel on its Scientific Opinion with respect to the scientific substantiation of health claims related to meal replacement for weight control (as defined in Directive 96/8/EC on energy restricted diets for weight loss) and reduction in body weight (ID 1417) and maintenance of body weight after weight loss (ID1418) pursuant to Article 13(1) of Regulation (EC) No 1924/2006. Taking into account that the mechanisms by which meal replacements could exert the claimed effects were mostly related to their controlled energy content and the relatively high protein/low fat content, the Panel concludes that the differences in the micronutrient composition of meal replacements which would derive from changing the conditions of use from Directive 96/8/EC to Regulation (EU) 1169/2011 do not affect the scientific substantiation of health claims related to meal replacements for weight control and reduction in body weight (ID 1417), and maintenance of body weight after weight loss (ID 1418) pursuant to Article 13(1) of Regulation (EC) No 1924/2006, as assessed by the Panel in 2010.

Summary

Following a request from the European Commission, the Panel on Dietetic Products, Nutrition and Allergies (NDA Panel) was asked to provide a scientific opinion on the conditions of use for health claims related to meal replacements for weight control, and in particular to advise on whether a change in the conditions of use for claims on meal replacements for weight control regarding their micronutrient composition (i.e. referring to 30% of the Nutrient Reference Values (NRVs) laid down in Part A of Annex XIII of Regulation (EU) 1169/2011 instead of the 30% of NRVs laid down in Annex I of Directive 96/8/EC) would affect the conclusions reached by the NDA Panel on its Scientific Opinion with respect to the scientific substantiation of health claims related to meal replacement for weight control (as defined in Directive 96/8/EC on energy restricted diets for weight loss) and reduction in body weight (ID 1417) and maintenance of body weight after weight loss (ID 1418) pursuant to Article 13(1) of Regulation (EC) No 1924/2006.  

The NDA Panel interpreted this mandate as a request for scientific advice on whether or not the conclusions reached by the Panel on the scientific substantiation of health claims related to meal replacement for weight control could be affected by a modification of the conditions of use which is limited to the micronutrient composition of meal replacements.

It is out of the scope of this mandate to advise on whether or not the conclusions reached by the Panel on the scientific substantiation of the above-mentioned claims could be affected by:

  • changes in the energy content per serving as specified in EFSA’s Scientific Opinion (i.e. a maximum of 250 kcal/serving).
  • changes in the macronutrient composition of meal replacements as described in Annex I of Directive 96/8/EC;
  • changes in target population(s) for the claims;
  • new evidence on the relationship between the use of meal replacements and changes in body weight, e.g. human intervention (efficacy) studies which were not considered by the Panel for the scientific substantiation of such claims and which may have become available after the publication of EFSA’s Scientific Opinion.

Switching from Directive 96/8/EC to Regulation (EU) 1169/2011 will imply some changes (increases or decreases) in the micronutrient content of meal replacements. These changes would be small (up to 13%) or absent for many micronutrients (i.e. vitamin D, thiamin, riboflavin, niacin, vitamin B6, folate, iron, zinc, copper, selenium). The content of the remaining micronutrients (i.e. vitamin A, vitamin E vitamin K, vitamin C, vitamin B12, biotin, pantothenic acid, chloride, calcium, phosphorus, iodine, magnesium, manganese, fluoride, chromium, molybdenum) would always be higher except for sodium, for which there are no NRVs in Regulation (EU) 1169/2011.

Taking into account that the mechanisms by which meal replacements could exert the claimed effects were mostly related to their controlled energy content and the relatively high protein/low fat content, the Panel considers that the differences in the micronutrient composition of meal replacements which would derive from changing the conditions of use from Directive 96/8/EC to Regulation (EU) 1169/2011 do not affect the scientific substantiation of health claims related to meal replacements for weight control and reduction in body weight (ID 1417), and maintenance of body weight after weight loss (ID 1418) pursuant to Article 13(1) of Regulation (EC) No 1924/2006 as assessed by the Panel in 2010. 

Keywords
meal replacements, weight control, health claims, conditions of use, micronutrients
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Number of Pages
11