EFSA Journal 2012;10(7):2805
Suggested citation: EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA); Scientific Opinion on the substantiation of a health claim related to Rhodiola roa L. extract and reduction of mental fatigue pursuant to Article 13(5) of Regulation (EC) No 1924/2006. EFSA Journal 2012;10(7):2805. [7 pp.]. doi:10.2903/j.efsa.2012.2805. Available online: www.efsa.europa.eu/efsajournal
SCIENTIFIC OPINION
Scientific Opinion on the substantiation of a health claim related to
Rhodiola roa L. extract and reduction of mental fatigue pursuant to
浙江二日游最佳地方Article 13(5) of Regulation (EC) No 1924/20061
EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA)2, 3
European Food Safety Authority (EFSA), Parma, Italy
A BSTRACT
Following an application from Nutrilinks Sarl, submitted pursuant to Article 13(5) of Regulation (EC) No 1924/2006 via the Competent Authority of Belgium, the Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to deliver an opinion on the scientific substantiation of a health claim related to Rhodiola roa L. extract and reduction of mental fatigue. The food constituent that is the subject of the health claim is a dry powder extract of Rhodiola roa L., which is standardid for its content of rosavins and salidroside. The Panel considers that Rhodiola roa L. extract is sufficiently characterid. The claimed effect is “helps to stimulate intellectual functions in situation of stress after the first intake”. Upon request by EFSA, the applicant clarified that the claimed effect related to the reduction of tiredness and fatigue in situation of stress. The target population propod by the applicant is healthy adults in situations of fatigue and stress. The Panel considers that reduction of mental fatigue is a beneficial physiological effect. The applicant identified two published human intervention studies as pertinent to the health claim. The studies were carried out with a Rhodiola roa L. extract which was standardid only for its salidroside content and not for its content of rosavins. The Panel notes that the studies were not undertaken with the food constituent, Rhodiol护士进修
a roa L. extract, which is the subject of the health claim and which is standardid for both its rosavins and salidroside content. The Panel considers that no conclusions can be drawn from the studies for the scientific substantiation of the health claim. The Panel concludes that a cau and effect relationship has not been established between the consumption of Rhodiola roa L. extract and reduction of mental fatigue. © European Food Safety Authority, 2012
K EY WORDS
Rhodiola roa L., mental fatigue, health claims
1 On request from the Competent Authority of Belgium following an application by Nutrilinks Sarl, Question No EFSA-Q-2012-00336, adopted on 27 June 2012.
2 Panel members: Carlo Agostoni, Jean-Louis Bresson, Susan Fairweather-Tait, Albert Flynn, Ines Golly, Hannu Korhonen, Pagona Lagiou, Martinus Løvik, Rosangela Marchelli, Ambroi Martin, Bevan Moley, Monika Neuhäur-Berthold, Hildegard Przyrembel, Seppo Salminen, Yolanda Sanz, Sean (J.J.) Strain, Stephan Strobel, Inge Tetens, Daniel Tomé, Hendrik van Loveren and Hans Verhagen. Correspondence: nda@efsa.europa.eu
3 Acknowledgement: The Panel wishes to thank the members of the Working Group on Claims: Carlo Agostoni, Jean-Louis Bresson, Susan Fairweather-Tait, Albert Flynn, Ines Golly, Marina Heinonen, Hannu Korhonen, Martinus Løvik, Ambroi Martin, Hildegard Przyrembel, Seppo Salminen, Yolanda Sanz, Sean (J.J.) Strain, Inge Tetens, Hendrik van Loveren and Hans Verhagen for the preparatory work on this scientific opinion.
S UMMARY
Following an application from Nutrilinks Sarl, submitted pursuant to Article 13(5) of Regulation (EC) No 1924/2006 via the Competent Authority of Belgium, the Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to deliver an opinion on the scientific substantiation of a health claim related to Rhodiola act and reduction of mental fatigue.
The scope of the application was propod to fall under a health claim bad on newly developed scientific evidence.
The food constituent that is the subject of the health claim is a dry powder extract of Rhodiola roa L., which is standardid for its content of rosavins and salidroside. The Panel considers that Rhodiola act is sufficiently characterid.
The claimed effect is “helps to stim ulate intellectual functions in situation of stress after the first intake”. Upon request by EFSA, the applicant clarified that the claimed effect related to the reduction of tiredness and fatigue in situations of stress. The target population propod by the applicant is healthy adults in situations of fatigue and stress. The Panel considers that reduction of mental fatigue is a beneficial physiological effect.
The applicant identified two published human intervention studies as pertinent to the health claim. The studies were carried out with a Rhodiola roa L. extract which was standardid only for its salidroside content and not for its content of rosavins. The Panel notes that the studies were not undertaken with the food constituent, Rhodiola act, which is the subject of the health claim and which is standardid for both its rosavins and salidroside content. The Panel considers that no conclusions can be drawn from the studies for the scientific substantiation of the health claim. The Panel concludes that a cau and effect relationship has not been established between the consumption of Rhodiola act and reduction of mental fatigue.
T ABLE OF CONTENTS
Abstract (1)
Summary (2)
Table of contents (3)
Background (4)
Terms of reference (4)
EFSA Disclaimer (4)
职业决策选择Information provided by the applicant (5)
Asssment (5)
1.Characterisation of the food/constituent (5)
2.Relevance of the claimed effect to human health (6)
3.Scientific substantiation of the claimed effect (6)
Conclusions (6)
Documentation provided to EFSA (7)
References (7)
B ACKGROUND
Regulation (EC) No 1924/20064 harmonis the provisions that relate to nutrition and health claims, and establishes rules governing the Community authorisation of health claims made on foods. As a rule, health claims are prohibited unless they comply with the general and specific requirements of th
is Regulation, are authorid in accordance with this Regulation, and are included in the lists of authorid claims provided for in Articles 13 and 14 thereof. In particular, Article 13(5) of this Regulation lays down provisions for the addition of claims (other than tho referring to the reduction of dia risk and to chi ldren’s development and health)which are bad on newly developed scientific evidence, or which include a request for the protection of proprietary data, to the Community list of permitted claims referred to in Article 13(3).
According to Article 18 of this Regulation, an application for inclusion in the Community list of permitted claims referred to in Article 13(3) shall be submitted by the applicant to the national competent authority of a Member State, which will make the application and any supplementary information supplied by the applicant available to the European Food Safety Authority (EFSA).
S TEPS TAKEN BY EFSA
The application was received on 24/02/2012.
The scope of the application was propod to fall under a health claim bad on newly
developed scientific evidence.
On 28/03/2012, during the validation process of the application, EFSA nt a request to the applicant to provide missing information.
The applicant provided the missing information on 30/04/2012.
The scientific evaluation procedure started on 04/05/2012.
During its meeting on 27/06/2012, the NDA Panel, having evaluated the data submitted,
adopted an opinion on the scientific substantiation of a health claim related to Rhodiola act and reduction of mental fatigue.
螳螂习性
T ERMS OF REFERENCE
EFSA is requested to evaluate the scientific data submitted by the applicant in accordance with Article 16(3) of Regulation (EC) No 1924/2006. On the basis of that evaluation, EFSA will issue an opinion on the scientific substantiation of a health claim related to: Rhodiola act and reduction of mental fatigue.
EFSA D ISCLAIMER
The prent opinion does not constitute, and cannot be construed as, an authorisation for the marketing of Rhodiola act, a positive asssment of its safety,nor a decision on whether Rhodiola act is, or is not, classified as a foodstuff. It should be noted that such an asssment is not foreen in the framework of Regulation (EC) No 1924/2006.
It should also be highlighted that the scope, the propod wording of the claim, and the conditions of u as propod by the applicant may be subject to changes, pending the outcome of the authorisation procedure foreen in Article 18(4) of Regulation (EC) No 1924/2006.
4Regulation (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.
春节音乐I NFORMATION PROVIDED BY THE APPLICANT
Applicant’s name and address: Nutrilinks Sarl - Chemin de Beau-rivage 7 – Post code 96 CH-1000 Lausanne 21 - Switzerland.
Food/constituent as stated by the applicant
According to the applicant, 550-580 mg of a Rhodiola roa extract contained in a food supplement.
Health relationship as claimed by the applicant
回家的英语怎么写
According to the applicant, the claimed effect is “helps to reduce tiredness in ca of stress”. According to the applicant, “Rhodiola roa may help to stimulate intellectual functions in situation of stress. In fact, Rhodiola roa is known as an adaptogen, i.e. a herbal preparation ud to increa
attention and endurance in fatigue and prevent/mitigate/reduce stress-induced impairments and disorders related to neuro-endocrine and immune system”.
Wording of the health claim as propod by the applicant
The applicant has propod the following wording for the health claim: “helps to reduce tiredness in ca of stress”. Alternative wordings propod by the applicant: “results after the first intake”, “helps to stimulate attention and memory in situation of stress after the first intake”, “helps to manage/control/ to cope with stress after the first intake”, “helps to manage/control/ to cope with stress”.
Specific conditions of u as propod by the applicant
According to the applicant, the target population is healthy adults in situations of fatigue and stress. The applicant has propod an intake of three tablets per day providing 550 to 580 mg/day of Rhodiola roa extract.
显示分辨率A SSESSMENT
1.Characterisation of the food/constituent
有风不动无风动The food constituent that is the subject of the health claim is a dry powder extract of Rhodiola roa L.
Rhodiola roa L. is a perennial plant of the Rhodiola genus in the Crassulaceae family. The dry powder extract of Rhodiola roa L. is obtained by maceration of the roots of Rhodiola roa L.with a water/ethanol (50-50 V/V) extracting solvent, and a subquent filtration and spray-drying process on an inert support (potato maltodextrin). The dry powder extract of Rhodiola roa L.is standardid to contain at least 3 % of rosavins (rosarin, rosavin, rosin) and at least 1 % of salidroside (rhodioloside). The constituents can be analyd in foods by established methods.
Information pertaining to the manufacturing process, control specifications, batch-to-batch variability and stability data has been provided by the applicant.
The dry powder extract of Rhodiola roa L. is propod to be ud in tablets which contain 192 mg of Rhodiola act.
