TECHNICAL REPORT
APPROVED: 16 April 2015
PUBLISHED: 20 April 2015
Response to comments on the Scientific Opinion of the
EFSA Panel on Dietetic Products, Nutrition and Allergies
(NDA) on the scientific substantiation of a health claim
related to carbohydrate solutions and maintenance of
physical performance during endurance exercise
pursuant to Article 13(5) of
Regulation (EC) No 1924/2006
European Food Safety Authority
Abstract
Following a request from the European Commission, EFSA was asked to address the scientific
comments received on the Scientific Opinion of the EFSA Panel on Dietetic Products, Nutrition and
Allergies (NDA) on the scientific substantiation of a health claim related to carbohydrate solutions and
maintenance of physical performance during endurance exercise pursuant to Article 13(5) of
Regulation (EC) No 1924/2006. Comments submitted to EFSA via the European Commission Services
originated from the applicant (British Specialist Nutrition Association Ltd). The comments received
were related to the comparative health claim, the scientific assessment of the meta-analyses, and the
outcome measures. EFSA has reviewed the scientific comments and shared them with the chair of the
NDA Panel and the chair of the NDA Working Group on Claims. In its opinion adopted on
18 September 2014, the NDA Panel concluded that a cause and effect relationship has not been
established between the consumption of carbohydrate solutions and maintenance of physical
performance during endurance exercise. The comments received do not require any change to the
conclusions of the NDA Panel.
© European Food Safety Authority, 2015
Key words: carbohydrate solutions, performance, endurance exercise, health claims, comments
Requestor: European Commission
Question number: EFSA-Q-2015-00009
Correspondence: [email protected]
www.efsa.europa.eu/publications
EFSA Supporting publication 2015:EN-797
Response to comments on the Scientific Opinion on the scientific substantiation of a health claim
related to carbohydrate solutions and maintenance of physical performance
Acknowledgements: EFSA wishes to thank: Ambroise Martin and Sean (J.J) Strain for the support
provided to this output.
Suggested citation: EFSA (European Food Safety Authority), 2015. Response to comments on the
Scientific Opinion of the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) on the
scientific substantiation of a health claim related to carbohydrate solutions and maintenance of
physical performance during endurance exercise pursuant to Article 13(5) of Regulation (EC)
No 1924/2006. EFSA supporting publication 2015:EN-797. 6 pp.
© European Food Safety Authority, 2015
www.efsa.europa.eu/publications
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EFSA Supporting publication 2015:EN-797
Response to comments on the Scientific Opinion on the scientific substantiation of a health claim
related to carbohydrate solutions and maintenance of physical performance
Table of contents
Abstract .........................................................................................................................................1
1.
Introduction........................................................................................................................4
1.1.
Background as provided by the European Commission ..........................................................4
1.2.
Terms of Reference as provided by the European Commission ...............................................4
2.
Consideration......................................................................................................................4
2.1.
Comparative health claim ....................................................................................................5
2.2.
Scientific assessment of the meta-analyses ...........................................................................5
2.3.
Outcome measures .............................................................................................................5
3.
Conclusions ........................................................................................................................6
Documentation provided to EFSA ....................................................................................................6
References .....................................................................................................................................6
www.efsa.europa.eu/publications
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EFSA Supporting publication 2015:EN-797
Response to comments on the Scientific Opinion on the scientific substantiation of a health claim
related to carbohydrate solutions and maintenance of physical performance
1.
Introduction
1.1.
Background as provided by the European Commission
Article 16(6) of Regulation (EC) No 1924/2006 on nutrition and health claims states that: “The
Authority, in accordance with Article 38(1) of Regulation (EC) No 178/2002, shall make its opinion
public. The applicant or members of the public may make comments to the Commission within
30 days from such publication”.
The Regulation does not foresee a consultation on the EFSA opinion. It does, however, allow for the
applicant or members of the public to make comments to the Commission relating to the EFSA
opinion. The Commission’s services have established a practice for handling the comments provided
by applicants and members of the public in order to allow their full consideration by the regulators in
the health claims’ authorisation process. More particularly, whenever the comments relate to the
scientific assessment they are transmitted to EFSA for consideration. The Commission and the
Member States await the EFSA response to the comments before proceeding with the final discussion
and the vote in the Standing Committee on the Food Chain and Animal Health on the draft measure
authorising or rejecting the health claims for which comments were made.
The procedure briefly outlined above is in line with the procedure foreseen in Article 31 of
Regulation (EC) No 178/2002, whereby the Authority may be requested by the Commission to provide
scientific or technical assistance in any field within its mission, and when the matter does not require
scientific evaluation by a Scientific Committee or a Scientific Panel.
1.2.
Terms of Reference as provided by the European Commission
The Commission requests EFSA, within the framework of scientific and technical assistance to the
Commission foreseen in Article 31 of Regulation (EC) No 178/2002, to evaluate the comments of a
scientific nature received by the Commission pursuant to Article 16(6) of Regulation (EC)
No 1924/2006 and to provide the Commission with a response.
Relevant actions performed under this mandate will be carried out in good cooperation between the
Commission and EFSA in accordance with the procedure set out in the Annex to the Mandate (to be
found in the EFSA Register of Questions under mandate number M-2011-0063).
2.
Consideration
On 18 September 2014, the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) adopted a
Scientific Opinion on the scientific substantiation of a health claim related to carbohydrate solutions
and maintenance of physical performance during endurance exercise (EFSA NDA Panel, 2014)
pursuant to Article 13(5) of Regulation (EC) No 1924/2006 1 following an application for authorisation
from the British Specialist Nutrition Association Ltd submitted via the Competent Authority of the
United Kingdom (Claim serial number: 0408_UK, Question No EFSA-Q-2014-00058).
In accordance with Article 16 of Regulation (EC) No 1924/2006, the applicants or members of the
public may make comments to the European Commission on opinions published by the Authority
pursuant to Articles 16 and 18 of the Regulation. On 22 December 2014, the European Commission
requested EFSA to respond to the scientific comments received during the commenting period
specified in Article 16 of the Regulation. Comments submitted to EFSA via the European Commission
Services originated from the applicant (British Specialist Nutrition Association Ltd). The comments
received were related to the comparative health claim, the scientific assessment of the meta-analyses,
and the outcome measures. In line with the Terms of Reference as provided by the European
Commission, EFSA addressed the comments which were of a scientific nature.
EFSA has reviewed the scientific comments and shared them with the chair of the NDA Panel,
Professor Ambroise Martin, and the chair of the NDA Working Group on Claims, Professor Sean (J.J.)
Strain.
1
Regulation (EC) No 1924/2006 of the European Parliament and of the Council of 20 December 2006 on
nutrition and health claims made on foods. OJ L 404, 30.12.2006, p. 9–25.
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EFSA Supporting publication 2015:EN-797
Response to comments on the Scientific Opinion on the scientific substantiation of a health claim
related to carbohydrate solutions and maintenance of physical performance
During this commenting period after the publication of the Scientific Opinion, the applicant cited some
additional new references (i.e. not previously submitted), the review of which is out of the scope of
this technical report. It is noted that only scientific comments on the published Scientific Opinion, i.e.
on the studies evaluated in the opinion, are reviewed. New studies (i.e. evidence not previously
submitted for the substantiation of the health claim) require an assessment by the Panel and,
therefore, were not reviewed in this technical report.
2.1.
Comparative health claim
The applicant argued that the claim, which was the subject of the application, was not a
“comparative” claim, as assessed by the Panel, but a claim on “carbohydrate solutions” per se. The
applicant commented that, as the claim was on “carbohydrate solutions” only, no information was
provided on the comparator.
During the scientific assessment, EFSA requested clarifications from the applicant on whether the
claim was a comparative claim (letter from EFSA dated 16 May 2014). In reply, the applicant indicated
that the food/constituent, which was the subject of the health claim, was carbohydrate solutions (i.e.
containing 50–80 g/L or 200 320 kcal/L of carbohydrates that induce high glycaemic responses, e.g.
glucose, glucose polymers, sucrose) and that the comparator was “water” or “water plus electrolytes”
(letter from the applicant dated 28 May 2014).
Considering that for comparative claims the appropriate reference or comparator/food constituent
should be characterised2, EFSA requested the applicant to fully characterise the comparator (i.e.
“water plus electrolytes”) (letter from EFSA dated 16 May 2014). No information was provided on the
comparator, as requested by EFSA during the scientific assessment.
The comments received do not require any change to the conclusions of the NDA Panel.
2.2.
Scientific assessment of the meta-analyses
The applicant argued that, contrary to what it is expressed in the opinion, sufficient information was
provided on the food that is the subject of the health claim in the individual studies included in the
three meta-analyses which were submitted for the substantiation of the claim (Karelis et al. 2010;
Temesi at al. 2011; Vandenbogaerde and Hopkins, 2011). The applicant also argued that a detailed
analysis of the interventions, which were used in the individual studies included in the meta-analysis
by Temesi at al. (2011), could have been provided to the Panel, if required.
During the scientific assessment, EFSA requested the applicant to clarify how the foods that were
investigated in each of the individual studies included in the three meta-analyses mentioned above,
and the foods which were used as “control” or “placebo” related to the food that is the subject of the
claim and to the food that is proposed as comparator (letter from EFSA dated 16 May 2014). In reply
the applicant did not provide detailed indications on the type of interventions and “control” or
“placebo” used in the individual studies in the three meta-analyses, but only indicated that the
concentration of carbohydrates in the “carbohydrate solutions” used in the studies included in the
meta-analysis by Temesi at al. (2011) was ≤ 8% (letter from the applicant dated 28 May 2014). Also
considering that the comparator for the claim was not sufficiently characterised for a scientific
assessment, the three meta-analyses provided by the applicant could not be used to substantiate the
claim.
The comments received do not require any change to the conclusions of the NDA Panel.
2.3.
Outcome measures
The applicant argued that “time to exhaustion” and “time trials” were appropriate outcome measures
for a claim on “maintenance of performance”. The applicant also indicated that these two outcome
measures were considered appropriate by the Panel in a previously adopted opinion for a claim on
2
EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA), 2011. General guidance for stakeholders on
the evaluation of Article 13.1, 13.5 and 14 health claims. EFSA Journal 2011;9(4):2135, 24 pp.
doi:10.2903/j.efsa.2011.2135. Available online: www.efsa.europa.eu/efsajournal
www.efsa.europa.eu/publications
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EFSA Supporting publication 2015:EN-797
Response to comments on the Scientific Opinion on the scientific substantiation of a health claim
related to carbohydrate solutions and maintenance of physical performance
carbohydrate-electrolyte solutions and maintenance of endurance performance during prolonged
endurance exercise (EFSA NDA Panel, 2011).
As indicated in the guidance for health claims on physical performance3, the ability to complete certain
physical tasks faster or with higher intensity are appropriate outcome measures for claims on physical
performance, whereas “exercise time to fatigue” is an appropriate outcome measure for claims on
endurance capacity.
Thus, in the context of the claimed effect as proposed by the applicant (i.e. “maintenance of
endurance performance during prolonged endurance exercise”), appropriate outcome measures are
obtained from time-limited or task-limited physical activities during endurance exercise (one hour’s
duration or longer).
Likewise, the same outcome measures were indicated by the Panel in the opinion, which has been
cited by the applicant, on maintenance of endurance performance during prolonged endurance
exercise (i.e. ability of completing certain tasks with higher intensity, faster, or with a higher power
output, when performing long-term exercise) (EFSA NDA Panel, 2011).
The comments received do not require any change to the conclusions of the NDA Panel.
3.
Conclusions
In its opinion adopted on 18 September 2014, the EFSA Panel on Dietetic Products, Nutrition and
Allergies (NDA) concluded that a cause and effect relationship has not been established between the
consumption of carbohydrate solutions and maintenance of physical performance during endurance
exercise. The comments received do not require any change to the conclusions of the NDA Panel.
Documentation provided to EFSA
1.
Comments submitted to the European Commission by the British Specialist Nutrition Association
Ltd.
References
EFSA NDA Panel (EFSA Panel on Dietetic Products, Nutrition and Allergies), 2014. Scientific Opinion on
the substantiation of a health claim related to carbohydrate solutions and maintenance of physical
performance during endurance exercise pursuant to Article 13(5) of Regulation (EC)
No 1924/2006. EFSA Journal 2014;12(10):3836, 6 pp. doi:10.2903/j.efsa.2014.3836
EFSA NDA Panel (EFSA Panel on Dietetic Products, Nutrition and Allergies), 2011. Scientific Opinion on
the substantiation of health claims related to carbohydrate-electrolyte solutions and reduction in
rated perceived exertion/effort during exercise (ID 460, 466, 467, 468), enhancement of water
absorption during exercise (ID 314, 315, 316, 317, 319, 322, 325, 332, 408, 465, 473, 1168, 1574,
1593, 1618, 4302, 4309), and maintenance of endurance performance (ID 466, 469) pursuant to
Article 13(1) of Regulation (EC) No 1924/2006. EFSA Journal 2011;9(6):2211, 29 pp.
doi:10.2903/j.efsa.2011.2211
Karelis AD, Smith JW, Passe DH and Peronnet F, 2010. Carbohydrate administration and exercise
performance: what are the potential mechanisms involved? Sports Medicine, 40, 747-763.
Temesi J, Johnson NA, Raymond J, Burdon CA and O'Connor HT, 2011. Carbohydrate ingestion during
endurance exercise improves performance in adults. Journal of Nutrition, 141, 890-897.
Vandenbogaerde TJ and Hopkins WG, 2011. Effects of acute carbohydrate supplementation on
endurance performance: a meta-analysis. Sports Medicine, 41, 773-792.
3
Guidance on the scientific requirements for health claims related to physical performance. EFSA Journal
2012;10(7):2817, 6 pp. doi:10.2903/j.efsa.2012.2817
www.efsa.europa.eu/publications
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