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Articles 2014

European Commission: two new health claims have been authorized

Two article 14 health claims on calcium and vitamin D have been recently authorized, in relation with seniors’ health.

The first claim is related to calcium and vitamin D and the reduction of bone mineral loss, and the second one is related to vitamin D and the reduction of the risk of falling, both in relation with a reduced risk of bone fractures in the elderly.

The two claims have been authorized by EU regulation n°1228/2014, published on November 17th 2014, after several months of discussion regarding the associated conditions of use. Those have finally been defined as follows:

  • For the claim on bone mineral density : the claim may be used only for food which provides at least 400 mg of calcium per quantified portion or for food supplements which provide at least 400 mg of calcium and 15 μg of vitamin D per daily portion.
  • For the claim on the risk of falling: the claim may be used only for food supplements which provide at least 15 μg of vitamin D per daily portion.

The claim on bone mineral density is specifically intended for women 50 years and older and the claim on the reduced risk of falling is specifically intended for men and women 60 years of age and older. Besides, information shall be given to the consumer that the beneficial effect is obtained with a daily intake of at least 1 200 mg of calcium and/or 20 μg of vitamin D from all sources.

http://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32014R1228&from=FR

Auteur : A Chanson-Rolle. December 2014.

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EFSA guidance on Statistical Reporting

This guidance, published in December 2014, aims to guide EFSA scientists and applicants on how to improve the quality of the reporting of statistical analyses. In particular, it provides guidance on how to report statistical methodology (including design and conduct), analysis methods, results and interpretation in order to allow independent statistical peer review and reproducibility.

Author: A. Chanson-Rollé. December 2014.
Read more: http://www.efsa.europa.eu/en/efsajournal/pub/3908.htm

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Milk consumption, mortality and risk of bone fractures: A new study with provocative conclusions

This study, published in the British Medical Journal on October 28th, suggests that high milk intake may be associated with higher mortality in men and women and with higher fracture incidence in women.

Researchers from the Uppsala University in Sweden examined the association between milk consumption and risk of mortality and fractures in one cohort of women (n=61 433) and in one cohort of men (n=45 339 men), by using multivariable survival models. Intakes of milk and other dairy products were assessed with a validated food frequency questionnaire. Total milk intake was considered for the statistical analyses (by summing intake of all types of milk, independently of fat content). Death occurrence was searched through the Swedish cause of death registry and fracture events were collated through linkage with the Swedish national patient registry, among which hip fractures could be identified.

Mean intake of milk at baseline was 240 g/d in the women cohort and 290 g/d in the male cohort. The reported intake for most nutrients, including energy intake (women & men) and total and saturated fat intake (women only), increased with increasing categories of milk intake, although alcohol intake tended to decrease. In women, the authors observed a significant positive association between milk intake and total mortality as well as fracture, especially hip fracture. Women consuming ≥ 3 glasses of milk /d (~ 680 g/d) had a higher rate for death from all causes as compared to women consuming <1 glass /d (~ 60 g/d) (multivariable adjusted hazard ratio (HR) for total mortality = 1.93 [95% CI: 1.80 to 2.06]). The association was also significant when milk intake was considered as a continuous variable (multivariable adjusted HR = 1.15 [95% CI: 1.13 to 1.17] per 200g of milk). For women who consumed ≥ 3 glasses of milk /d, the multivariable adjusted HR for any fracture was 1.16 [95% CI: 1.08 to 1.25], and 1.60 [95% CI: 1.39 to 1.84] for hip fracture, as compared to women consuming <1 glass /d. In men, a significant positive association was observed between milk intake and total mortality, but the excess risk was less pronounced than in women. Furthermore, there was no association between milk intake and the risk of fracture in men. Adjustments were performed for several covariables, including age, body mass index, energy and alcohol intake, healthy dietary pattern, calcium and vitamin D supplementation, ever use of cortisone, physical activity level and smoking status. Additional analyses showed that associations were in the opposite direction for consumption of cheese and fermented milk products: women with a high intake of cheese or fermented milk products compared with women with low intakes had lower mortality and lower fracture rates (no significant associations were found in men). Analyses of blood samples from two additional cohorts showed that there were positive associations between milk intake and concentrations of markers for oxidative stress (urine 8-iso-PGF2α) and inflammation (serum interleukin 6). According to the authors, the different results observed for milk as compared to other dairy products may be explained by the higher lactose and galactose content of milk.

The main strengths of this study are its prospective design, the large number of people included and the adjustment for several important covariates. However, because of the observational design, it is not possible to rule out residual confounding and the possibility that results on fractures might be explained by reverse causation (people with a higher predisposition for osteoporosis consuming deliberately higher amounts of milk). Besides, results from this study should not be considered in isolation, but should rather be evaluated in light of other study findings. Comparisons between studies are nevertheless hampered by differences in the considered milk exposure (e.g., differences in range of milk intake and in type of milk products consumed) and in the studied populations (e.g., differences in background dietary pattern). To consider the totality of evidence concerning the role of milk consumption in death and fractures, meta-analyses of observational studies, with meta-regression analyses allowing to account for the whole range of milk intake, should be performed. Furthermore, long term randomized control trials would be needed to confirm a causal association between higher milk intake and higher risk of fractures.

Overall, the results from this study therefore appear as quite provocative since they “may question the validity of recommendations to consume high amounts of milk to prevent fragility fractures”. Medias from around the world will probably echo this conclusion. However, and as acknowledged by the authors themselves, these findings should be “interpreted cautiously given the observational design” of the study and they would “merit independent replication before they can be used for dietary recommendations”.

The full publication is available here: http://www.bmj.com/content/349/bmj.g6015

Author: Aurelie Chanson-Rolle. November 2014

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EFSA scientific opinions on dietary reference values (DRV) for folate

As part of its ongoing work on Dietary Reference Values (DRVs), the EFSA has published its scientific opinion on the DRVs for folate in November. As usual, the opinion was made available for public consultation before being finalised.

DRVs comprise a set of reference values such as average requirements, population reference intakes, adequate intakes, lower threshold intakes and tolerable upper intake levels. Scientific advice on DRVs is an important basis for the policy decisions of the European Union in the field of nutrition.

The full opinion is available here:
http://www.efsa.europa.eu/en/efsajournal/pub/3893.htm

Author: A. Chanson-Rolle. November 2014.

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Antioxydant vitamins & arterial stiffness

Conclusions from a recent meta-analysis suggest that antioxidant vitamin supplementation reduces arterial stiffness in adults.

This systematic review and meta-analysis, published in the Journal of Nutrition, aimed to pool the results of all published randomized controlled trials which assessed the effect of antioxidant vitamins (vitamins C, E, and A and β-carotene) on arterial stiffness in adult participants aged ≥18 y. Comparisons were made with either placebo or no active control. Antioxidant vitamins were administered alone or in combination, irrespective of dose, duration, and route of administration. The meta-analysis showed that antioxidant vitamin supplementation reduced arterial stiffness significantly (standardized mean differences (SMD): −0.17; 95% CI: −0.26, −0.08; P < 0.001), irrespective of age group and duration of intervention. However, antioxidant vitamins were more effective in participants with low baseline plasma concentrations of vitamins C (SMD: −0.35; 95% CI: −0.62, −0.07; P < 0.016) and E (SMD: −0.79; 95% CI: −1.23, −0.33; P < 0.01). This meta-analysis therefore shows that supplementation with antioxidant vitamins has a small, protective effect on arterial stiffness, and that the effect may be higher in individuals with lower baseline plasma concentrations of vitamins E and C.

http://jn.nutrition.org/content/early/2014/08/06/jn.114.195826.abstract
Author: A Chanson-Rolle. October 2014.

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EFSA scientific opinions on dietary reference values (DRV)  for zinc, selenium and chromium

As part of its ongoing work on Dietary Reference Values (DRVs), the EFSA has published in October three scientific opinions on the DRVs for zinc, selenium and chromium.

The opinions were all made available for public consultation before being finalised.

DRVs comprise a set of reference values such as average requirements, population reference intakes, adequate intakes, lower threshold intakes and tolerable upper intake levels. Scientific advice on DRVs is an important basis for the policy decisions of the European Union in the field of nutrition.

The full opinions are available here:
http://www.efsa.europa.eu/en/efsajournal/pub/3844.htm
http://www.efsa.europa.eu/en/efsajournal/pub/3846.htm
http://www.efsa.europa.eu/en/efsajournal/pub/3845.htm

Author: A Chanson-Rolle. October 2014.

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EFSA: electronic submission introduced for health claim applications

Applications for health claims should now be submitted by electronic means by using electronic mediums such as CD ROMs or USB. Hard copies will therefore not be needed any more. According to EFSA, this initiative will cut bureaucracy and streamline the risk assessment process. This new submission procedure also concerns applications for regulated products such as feed additives and food enzymes.

More information at : http://www.efsa.europa.eu/fr/press/news/140924.htm

Author: A. Chanson-Rolle. October 2014.

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EFSA - Health claims : two new positive opinions for non-digestible carbohydrates and reduction of post-prandial glycaemic responses

The EFSA has published new favourable opinions for two article 13.5 health claims related to the consumption of foods/beverages containing non-digestible carbohydrates and reduction of post-prandial glycaemic responses. The concerned products are Nutriose®06 from Roquette and AlphaGOS® from Olygose, which will be able to bear the lower glycaemic response claim when used to replace glycaemic carbohydrates in foods or beverages.

These two positive opinions echoed a previous positive opinion published by the EFSA on January 2014 (EFSA Journal 2014;12(1):)3513), which was on the replacement of sugars with non-digestible carbohydrates. The EFSA is now considering that the positive evaluation applies to the replacement of all glycaemic carbohydrates (and not just “sugars”) with non-digestible carbohydrates. The conditions of use are the same as those described in the previous evaluation, i.e., that in order to bear the claim, glycaemic carbohydrates in foods or beverages should be replaced by non-digestible carbohydrates “so that foods or beverages contain reduced amounts of sugars as per Annex of Regulation (EC) No 1924/2006 and in accordance with the Guidance on the implementation of Regulation (EC) No 1924/2006 of the Standing Committee on the Food Chain and Animal Health for comparative nutrition claims made on foods”. The proposed claim wording is also the same as for the previous claim, except that the word “sugars” has been replaced by the word “glycaemic carbohydrates”:  “Consumption of foods/drinks containing non-digestible carbohydrates instead of glycaemic carbohydrates induces a lower blood glucose rise after meals compared to foods/drinks containing glycaemic carbohydrates”.

However, the EFSA Panel noted that the product characteristic needed to bear the claim was not unique to Nutriose®06 and AlphaGOS®, but was common to other non-digestible carbohydrates (e.g. non-starch polysaccharides and resistant oligosaccharides). The important point of the Nutriose®06 and AlphaGOS® applications was therefore to prove that the two ingredients could be considered as non-digestible carbohydrates.

These series of positive opinions seem to suggest that the lower glycaemic response claim could be used by any ingredient which can be defined as a non-digestible carbohydrate.

The two new opinions are available at:

http://www.efsa.europa.eu/en/efsajournal/pub/3839.htm?utm_source=newsletter&utm_medium=email&utm_content=pub&utm_campaign=20141008
http://www.efsa.europa.eu/en/efsajournal/pub/3838.htm?utm_source=newsletter&utm_medium=email&utm_content=pub&utm_campaign=20141008

The previous opinion published in January 2014 is available at:
http://www.efsa.europa.eu/en/efsajournal/doc/3513.pdf

 Author: A. Chanson-Rolle. October 2014.

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EFSA published Dietary Reference Values for intakes of biotin and pantothenic acid

As part of its ongoing work on Dietary Reference Values (DRVs), the EFSA has published in February two scientific opinions on the DRVs for intakes of biotin and pantothenic acid.

The EFSA considered that that there was insufficient evidence available to derive an Average Requirement and a Population Reference Intake for those two vitamins, and proposed therefore Adequate Intakes (AIs) instead. The setting of AIs was based on observed biotin and pantothenic acid intakes with a mixed diet and the apparent absence of signs of deficiency in the EU.

Biotin: The AI for adults and pregnant women has been set at 40 µg/day (for lactating women, an additional 5 µg biotin/day has been proposed to compensate for biotin losses through breast milk). The AI for infants aged 6 months to 1 year has been set at 6 µg/day. The AIs for children aged 1–3 and 4–10 years have been set at 20 and 25 µg/day, respectively, and for adolescents at 35 µg/day.

Pantothenic acid: The AI for adults and pregnant women has been set at 5 mg/day (for lactating women, an AI of 7 mg/day has been proposed, to compensate for pantothenic acid losses through breast milk). The AI for infants aged 6 months to 1 year has been set at 3 mg/day. The AIs for children and adolescents have been set at 4 and 5 mg/day, respectively.

The two scientific opinions can be consulted at the following links:
http://www.efsa.europa.eu/en/efsajournal/pub/3580.htm?utm_source=newsletter&utm_medium=email&utm_content=pub&utm_campaign=20140226
http://www.efsa.europa.eu/en/efsajournal/pub/3581.htm?utm_source=newsletter&utm_medium=email&utm_content=hl&utm_campaign=20140226

Author: A. Chanson-Rolle. March 2014.

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Findings from a new longitudinal study highlight the importance of establishing healthy eating habits in childhood for the prevention of hypertension in the long run

Results from a longitudinal study in healthy children and adolescents with blood pressure (BP) in the low-normal range showed that both salt intake and fruit and vegetable intake may already start to influence BP, although at a small magnitude. The intra-individual change in salt intake was almost significantly associated with the change in systolic blood pressure (SBP, P= 0.06) and marginally (P= 0.09) with that in diastolic blood pressure (DBP) in puberty, but not in pre-puberty. A 1 g/d increase in salt intake was associated with a 0.2 mmHg increase in SBP. In pre-puberty, but not in puberty, differences in fruit and vegetable intakes between children predicted between-person variations in SBP and DBP (P= 0.03).

This study was performed in 435 healthy subjects, for whom at least three repeated measurements of BP had been taken and who had provided 24 h urine samples and 3 d weighed dietary records between 4 and 18 years of age.

Author: A. Chanson-Rolle. March 2014.
Source : http://www.ncbi.nlm.nih.gov/pubmed/24326147

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Health claims for children:
EFSA has published a series of positive opinions in January and February

Several claims related to children health (article 14 dossiers) received a favourable opinion from the EFSA since the beginning of the year:

  • Vitamin C and increasing non haem iron absorption
  • Iron and contribution to normal formation of haemoglobin and red blood cells
  • Iodine and contribution to normal cognitive development
  • Iodine and contribution to normal thyroid function
  • Vitamin D and contribution to normal bone and tooth development

The target population for these claims is infants and children up to three years, and all had been submitted by Specialised Nutrition Europe (formerly IDACE1). 

These claims now have to appear on the EU Register of health claims and be formally authorized within the EU.

1 European Dietetic Food Industry Association

Author: A. Chanson-Rolle. February 2014.
Source :
http://www.efsa.europa.eu/en/efsajournal/pub/3514.htm?utm_source=newsletter&utm_medium=email&utm_content=pub&utm_campaign=20140117
http://www.efsa.europa.eu/en/efsajournal/pub/3515.htm?utm_source=newsletter&utm_medium=email&utm_content=pub&utm_campaign=20140117

http://www.efsa.europa.eu/en/efsajournal/pub/3517.htm?utm_source=newsletter&utm_medium=email&utm_content=pub&utm_campaign=20140117

http://www.efsa.europa.eu/en/efsajournal/pub/3516.htm?utm_source=newsletter&utm_medium=email&utm_content=pub&utm_campaign=20140117

http://www.efsa.europa.eu/en/efsajournal/pub/3579.htm?utm_source=newsletter&utm_medium=email&utm_content=pub&utm_campaign=20140226

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Health claim: EFSA has published a positive opinion for a health claim related to non-digestible carbohydrates and reduction of post prandial glycaemic responses

The exact wording of the approved claim is “Consumption of foods/drinks containing non-digestible carbohydrates instead of sugars induces a lower blood glucose rise after meals compared to sugar-containing foods/drinks”.

The article 13(5) dossier had been submitted by Beneo-Orafti, Sensus and Cosucra, who initially focused the application on fructo-oligosaccharides (FOS) from inulin. But the Panel considered that the characteristic which was most relevant to the claimed effect was not unique to FOS but common to other non-digestible carbohydrates (e.g. non-starch polysaccharides, resistant oligosaccharides, resistant starch), and therefore extend the opinion to “non-digestible carbohydrates which should replace sugars in foods or beverages”.

The condition of use of this claim is that non-digestible carbohydrates should replace sugars in foods or drinks so that they contain reduced amounts of sugars as per Annex of Regulation (EC) No 1924/2006 and in accordance with the Guidance for comparative nutrition claims made on foods. The target population is individuals who wish to reduce their post-prandial blood glucose responses.

This claim now has to appear on the EU Register of health claims and be formally authorized within the EU.

Author: A Chanson-Rolle. February 2014.
Source: http://www.efsa.europa.eu/en/efsajournal/pub/3513.htm?utm_source=newsletter&utm_medium=email&utm_content=pub&utm_campaign=2014011

 

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