The European regulation 1924/2006 foresees that any nutrition or health claim should be assessed by EFSA and authorised by the European Commission and the Member States (with scrutiny by the European ...Parliament and the Council), the outcomes of which are published in the EU Register of Nutrition and Health Claims. Since 2007, EFSA has evaluated 230 dossiers submitted under Article 13.5 or Article 14. In addition, out of the 44,000 ‘general function claims’, defined under Article 13.1, proposed by Member States, a list of 4,637 claims was compiled, EFSA completed evaluation of 2,849 of them, and published the results in 365 opinions, providing the basis for a list of 229 permitted health claims. For maintaining consistency over time and scientific areas, EFSA developed a systematic approach (for food characterisation, effect characterisation and scientific substantiation). Pertinent human studies of sufficient quality are central for the substantiation; any other study type can be used as supportive. This approach is summarized in 6 guidance documents. These guidance documents are revised progressively, which includes systematic submission to public consultation.
Following a request from the European Commission, the EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA) derived dietary reference values (DRVs) for sodium. Evidence from balance studies ...on sodium and on the relationship between sodium intake and health outcomes, in particular cardiovascular disease (CVD)‐related endpoints and bone health, was reviewed. The data were not sufficient to enable an average requirement (AR) or population reference intake (PRI) to be derived. However, by integrating the available evidence and associated uncertainties, the Panel considers that a sodium intake of 2.0 g/day represents a level of sodium for which there is sufficient confidence in a reduced risk of CVD in the general adult population. In addition, a sodium intake of 2.0 g/day is likely to allow most of the general adult population to maintain sodium balance. Therefore, the Panel considers that 2.0 g sodium/day is a safe and adequate intake for the general EU population of adults. The same value applies to pregnant and lactating women. Sodium intakes that are considered safe and adequate for children are extrapolated from the value for adults, adjusting for their respective energy requirement and including a growth factor, and are as follows: 1.1 g/day for children aged 1–3 years, 1.3 g/day for children aged 4–6 years, 1.7 g/day for children aged 7–10 years and 2.0 g/day for children aged 11–17 years, respectively. For infants aged 7–11 months, an Adequate Intake (AI) of 0.2 g/day is proposed based on upwards extrapolation of the estimated sodium intake in exclusively breast‐fed infants aged 0–6 months.
This publication is linked to the following EFSA Supporting Publications articles: http://onlinelibrary.wiley.com/doi/10.2903/sp.efsa.2019.EN-1679/full, http://onlinelibrary.wiley.com/doi/10.2903/sp.efsa.2017.e15121/full
This publication is linked to the following EFSA Journal article: http://onlinelibrary.wiley.com/doi/10.2903/j.efsa.2019.5779/full
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EFSA asked the Panel on Dietetic Products, Nutrition and Allergies (NDA) to update the guidance on the scientific requirements for health claims related to antioxidants, oxidative damage and ...cardiovascular health published in 2011. The update takes into accounts experiences gained with evaluation of additional health claim applications related to antioxidants, oxidative damage and cardiovascular health, and the information collected from a Grant launched in 2014. This guidance is intended to assist applicants in preparing applications for the authorisation of health claims related to the antioxidants, oxidative damage and cardiovascular health. The document was subject to public consultation (from 12 July to 3 September 2017). This document supersedes the guidance on the scientific requirements for health claims related to antioxidants, oxidative damage and cardiovascular health published in 2011. It is intended that the guidance will be further updated as appropriate in the light of experience gained from the evaluation of health claims.
This publication is linked to the following EFSA Supporting Publications articles: http://onlinelibrary.wiley.com/doi/10.2903/sp.efsa.2018.EN-1364/full, http://onlinelibrary.wiley.com/doi/10.2903/sp.efsa.2018.EN-1272/full
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Background
Agroforestry systems have enhanced diversity of cultivated plants compared to monocultures, and are expected to affect associated biodiversity. Despite a growing body of literature on the ...importance of soil fauna, the known effects of different agroforestry types on soil fauna communities and functions have not yet been synthesized.
Scope
We scanned publications on soil fauna in agroforestry systems. Our aim was to give an overview of strengths and weaknesses of the existing data, in terms of spatial coverage and representation of diverse agroforestry types and soil fauna groups and functions.
Conclusions
Our database includes sixty-seven articles, mostly focusing on tropical regions and perennial crop agroforestry systems. Soil macrofauna are the most studied fauna group. The most common question addressed is the comparison of the effect of land use types on communities. Effects on fauna abundance and diversity are mainly positive when agroforestry is compared to cropland, and neutral or negative when compared to forests. Few publications actually measure soil fauna functions, or characterize their interactions and evolution in time and space depending on system design and management. Further work on soil fauna in agroforestry should harness ecological theory and address questions of spatial structure and scale, temporal dynamics and ecological interaction networks and how they determine ecosystem functioning.
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BFBNIB, DOBA, EMUNI, FIS, FZAB, GEOZS, GIS, IJS, IMTLJ, IZUM, KILJ, KISLJ, MFDPS, NLZOH, NMLJ, NUK, OBVAL, OILJ, PILJ, PNG, SAZU, SBCE, SBJE, SBMB, SBNM, UILJ, UKNU, UL, UM, UPUK, VKSCE, ZAGLJ
Following a request from the European Commission, the EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA) has derived dietary reference values (DRVs) for chloride. There are no appropriate ...biomarkers of chloride status, no balance studies and no adequate evidence on the relationship between chloride intake and health outcomes that can be used to set DRVs for chloride. There is a close relationship between sodium and chloride balances in the body. Sodium chloride is the main source of both electrolytes in European diets and similar urinary excretion levels of sodium and chloride (on a molar basis) are typically observed in Western populations. Hence, the Panel considered that reference values for chloride can be set at values equimolar to the reference values for sodium for all population groups, and are as follows: 1.7 g/day for children aged 1–3 years, 2.0 g/day for children aged 4–6 years, 2.6 g/day for children aged 7–10 years, 3.1 g/day for children aged 11–17 years and 3.1 g/day for adults including pregnant and lactating women. Consistent with the reference values for sodium, these levels of chloride intake are considered to be safe and adequate for the general EU population, under the consideration that the main dietary source of chloride intake is sodium chloride. For infants aged 7–11 months, an adequate intake of 0.3 g/day is set.
This publication is linked to the following EFSA Supporting Publications articles: http://onlinelibrary.wiley.com/doi/10.2903/sp.efsa.2019.EN-1679/full, http://onlinelibrary.wiley.com/doi/10.2903/sp.efsa.2017.e15121/full
This publication is linked to the following EFSA Journal article: http://onlinelibrary.wiley.com/doi/10.2903/j.efsa.2019.5778/full
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EFSA asked the Panel on Dietetic Products, Nutrition and Allergies (NDA) to update the scientific and technical guidance for the preparation and presentation of an application for authorisation of a ...health claim published in 2011. Since then, the NDA Panel has gained considerable experience in the evaluation of health claims. Lessons learnt from these experiences have been translated into a new General scientific guidance for stakeholders on health claim applications (published in January 2016). In this context, it is noted the need to adapt the existing guidance to the new scientific and technical developments in this area. This guidance document presents a common format for the organisation of information for the preparation of a well‐structured application for authorisation of health claims which fall under Articles 13(5), 14 and 19 of Regulation (EC) No 1924/2006. This guidance outlines the information and scientific data which must be included in the application, the hierarchy of different types of data and study designs, and the key issues which should be addressed in the application to substantiate the health claim.
This publication is linked to the following EFSA Supporting Publications article: http://onlinelibrary.wiley.com/doi/10.2903/sp.efsa.2017.EN-1159/full
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EFSA has asked the Panel on Nutrition, Novel Foods and Food Allergens (NDA) to update the guidance on the scientific requirements for health claims related to physical performance published in 2012. ...The update takes into account the experience gained by the NDA Panel with the evaluation of additional health claim applications, changes introduced to the general scientific guidance for stakeholders for health claims applications and information collected from a grant launched in 2014 which aimed at gathering information in relation to claimed effects, outcome variables and methods of measurement in the context of the scientific substantiation of health claims. The guidance is intended to assist applicants in preparing applications for the authorisation of health claims related to muscle function and physical performance. The draft guidance was subject to public consultation from 16 July to 2 September 2018. This document supersedes the guidance on the scientific requirements for health claims related to physical performance published in 2012. It is intended that the guidance will be further updated as appropriate in the light of experience gained from the evaluation of health claims.
This publication is linked to the following EFSA Supporting Publications article: http://onlinelibrary.wiley.com/doi/10.2903/sp.efsa.2018.EN-1495/full
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Following an application from Lonza Ltd., submitted for authorisation of a health claim pursuant to Article 13(5) of Regulation (EC) No 1924/2006 via the Competent Authority of Germany, the EFSA ...Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to deliver an opinion on the scientific substantiation of a health claim related to L‐carnitine and normal lipid metabolism. The food that is proposed as the subject of the health claim is L‐carnitine. The Panel considers that L‐carnitine is sufficiently characterised. The claimed effect proposed by the applicant is ‘normal lipid metabolism’. The target population proposed by the applicant is the general population. The Panel considers that contribution to normal lipid metabolism is a beneficial physiological effect. The applicant proposes that the claim submitted with this application is based on the essentiality of a nutrient. The Panel considers that the evidence provided does not establish that dietary L‐carnitine is required to maintain normal lipid metabolism in the target population, for which the claim is intended. The Panel concludes that a cause and effect relationship has not been established between the consumption of L‐carnitine and contribution to normal lipid metabolism in the target population.
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Following an application from Specialised Nutrition Europe (SNE), submitted for authorisation of a health claim pursuant to Article 13(5) of Regulation (EC) No 1924/2006 via the Competent Authority ...of France, the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to deliver an opinion on the scientific substantiation of a health claim related to carbohydrate solutions and contribute to the improvement of physical performance during a high‐intensity and long‐lasting physical exercise. The scope of the application was proposed to fall under a health claim based on newly developed scientific evidence. The food proposed by the applicant as the subject of the health claim is carbohydrate solutions containing glucose, mixtures of glucose and fructose, sucrose and/or maltodextrins. The Panel considers that carbohydrate solutions are sufficiently characterised in relation to the claimed effect. The claimed effect proposed by the applicant is ‘contribute to the improvement of physical performance during a high‐intensity and long‐lasting physical exercise’, which is considered by the Panel as a beneficial physiological effect. The Panel concludes that a cause and effect relationship has been established between the consumption of carbohydrate solutions and the improvement of physical performance during high‐intensity and long‐lasting physical exercise. The target population is healthy trained adults performing high‐intensity (at least at 65% of the VO2max) and long‐lasting (at least 60 min) physical exercise.
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Following an application from Newtricious R&D B.V., submitted for authorisation of a health claim pursuant to Article 13(5) of Regulation (EC) No 1924/2006 via the Competent Authority of the ...Netherlands, the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to deliver an opinion on the scientific substantiation of a health claim related to NWT‐02 and a reduction of the loss of vision. The food proposed by the applicant as the subject of the health claim is NWT‐02. NWT‐02 is standardised by its content in lutein (≥ 1.10 mg), zeaxanthin (≥ 0.20 mg) and docosahexaenoic acid (DHA) (≥ 170 mg). The Panel considers that the food/constituent that is the subject of the health claim, NWT‐02, a fixed combination of lutein, zeaxanthin and docosahexaenoic acid in egg yolk, is sufficiently characterised. The claimed effect proposed by the applicant is ‘reduces loss of vision’. The target population proposed by the applicant is ‘healthy adults over 50 years of age’. The Panel considers that a reduction of the loss of vision is a beneficial physiological effect. The applicant provided two human intervention studies for the scientific substantiation of the claim. The Panel considers that the only study from which conclusions can be drawn for the scientific substantiation of the claim did not show an effect of NWT‐02 on vision. The Panel concludes that a cause and effect relationship has not been established between the consumption of NWT‐02, a fixed combination of lutein, zeaxanthin and docosahexaenoic acid in egg yolk, and a reduction of the loss of vision.
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