The EFSA Journal (2008) 718, 1-26 © European Food Safety Authority, 2007
Opinion on certain bisglycinates as sources of copper, zinc, calcium, magnesium and glycinate nicotinate as source of chromium in foods intended
for the general population (including food supplements) and foods for
particular nutritional us 1
Scientific Opinion of the Scientific Panel on Food Additives,
Flavourings, Processing Aids and Materials in Contact with Food
(Question No EFSA-Q-2005-035, EFSA-Q-2005-133, EFSA-Q-2005-034, EFSA-Q-2005-038, EFSA-Q-2005-166, EFSA-Q-2005-033, EFSA-Q-2005-132, EFSA-Q-2005-036, EFSA-
Q-2005-130)量化考核
Adopted on 22 May 2008
兴师问罪什么意思P ANEL M EMBERS
F. Aguilar, H. Autrup, S. Barlow, L. Castle, R. Crebelli, W. Dekant, K.-H. Engel, N. Gontard,
D. Gott, S. Grilli, R. Gürtler, J.-C. Larn, C. Leclercq, J.-C. Leblanc, F. X. Malcata, W. Mennes, M.-R. Milana, I. Pratt, I. Rietjens, P. Tobback, F. Toldrá.为爱付出
S UMMARY
Following a request from the European Commission, the Panel on Food Additives, Flavourings, Processing Aids and Materials in Contact with Food (AFC) was asked to deliver a scientific opinion on the u of copper bisglycinate chelate and chromium glycinate nicotinate as sources for respectively copper and chromium added for nutritional purpos to food supplements, and of calcium bisglycinate chelate and magnesium bisglycinate chelate as sources for respectively calcium and magnesium added for nutritional purpos to foods for particular nutritional us and food supplements, and of zinc bisglycinate chelate when ud as a source for zinc in foods intended
for the general population (including food supplements) and foods for particular nutritional us.
The mineral amino acid chelates considered in this application are intended for u as a direct replacement for the permitted respective mineral forms of copper and chromium for nutritional purpos in food supplements according Council Directive 2002/46/EC, for calcium and magnesium for nutritional purpos in food supplements and the categories of PARNUTS other than for baby foods and infant formula according to Council Directive 89/398/EEC, and for zinc in foods intended for the general population (including food supplements) and foods for particular nutritional us.
1 For citation purpos: Scientific Opinion of the Panel on Food Additives, Flavourings, Processing Aids and Materials in Contact with Food on a request from the Commission on certain bisglycinates and glycinate nicotinate as sources for copper, zinc, calcium, magnesium and chromium. The EFSA Journal (2008) 718, 1-266.
The prent opinion deals only with the safety of bisglycinate chelates of copper, zinc, calcium, magnesium, and of glycinate nicotinate as sources of the nutrient cations of respectively copper, zinc, calcium, magnesium and chromium and with the bioavailability of the nutrient cations from the sources. The safety of the nutrient cations themlves (copper, chromium, zinc, calcium and magnesium), in terms of amounts that may be consumed, is outside the remit of this Panel.
The bisglycinates considered in this opinion consist of a bivalent metal ion, namely Cu+2, Zn+2, Ca+2, and Mg+2, linked to two molecules of glycine. The metal is bound to the carboxyl group and to the α-amino group of glycine with coordinate covalent bonds to form two heterocyclic rings. This 1:2 metal to ligand ratio restricts reaction with dietary inhibitors of the metal absorption and does not participate in oxidation reactions.
Chromium(III) glycinate nicotinate chelate is also considered in this opinion.
No specific u levels for the mineral bisglycinates under consideration in this opinion have been given. However, it is assumed that under the intended conditions of u, the daily intake would not exceed tho levels anticipated through existing supplementation of the listed minerals and would be similar to other forms of copper, zinc, calcium, magnesium and chromium that are already approved for u in foods in the EU.
Regarding the bioavailability of the different cations from their sources, data are provided showing that the minerals are bioavailable after oral administration.
No genetic toxicity studies have been conducted on the compounds; however the Panel has no concern on the genotoxicity aspects of glycine or nicotinic acid.
Due to the similarity in chemical structure between the metal glycinates considered in the prent application and ferrous bisglycinate it is anticipated that the glycine part of the glycinates will exhibit similar toxicological characteristics as their ferrous bisglycinate counterpart, the safety of which was already evaluated and accepted by the AFC Panel in 2006. The Panel agrees that the subchronic studies on ferrous bisglycinate can be ud to asss the subchronic toxicity of the glycinates. From the studies a NOAEL of 500 mg/kg body weight/day for ferrous bisglycinate in rats (the highest do tested) was derived, corresponding to approximately 400 mg glycinate/kg body weight/day.
Specific chronic toxicity or carcinogenicity studies are not available.
Specific reproductive toxicity and developmental toxicity studies on the bisglycinates are also not available. However, in longer-term feeding studies with livestock (female pigs) receiving dietary supplementation with mineral glycinates throughout a period covering multiple litters, no adver effects on reproduction or on the resulting offspring were obrved.
The Panel noted that the longer-term feeding studies are of limited value for the asssment of either chronic toxicity or carcinogenicity of the chelates, due to the relatively short duration of the studies relative to the life span of the pig and the small numbers of animals ud in the studies.
作文我的烦恼A conrvative estimate of the dietary exposure was made bad on a hypothetical intake from all sources (PARNUTS, food supplements and foods intended for the general population) at the tolerable upper intake level for copper (5 mg/day), zinc (25 mg/day), calcium (2500 mg/day) and magnesium (250 mg/day). The equivalent exposure to glycine would be around 12 mg glycine/day for copper bisglycinate, 57 mg glycine/day for zinc bisglycinate, 9239 mg glycine/day for calcium bisglycinate and 1523 mg glycine/day for magnesium bisglycinate. The Panel noted that this estimated exposure is lower than the NOAEL of 400 mg glycinate/kg bw/day, the highest do tested.
In addition the normal (mean) intake of glycine in proteins from both food of animal origin, and vegetable origin was calculated to be about 26 mg/kg bw/day for adults (>15 years) and to about 43 mg/kg bw/day for children (< 15 years).
Glycine (synthetic or natural) is already permitted in the EU for u in foods under Directive 2001/15/EC on substances that may be added for specific nutritional purpos in foods for particular nutritional us (PARNUTS). Glycine and its salts (E640) have an ADI not specified and are permitted as food additives in the EU under Directive 95/2/EC on food additives other than colours and sweeteners.
The Panel concludes that the u of copper bisglycinate chelate as a source for copper added for nutritional purpos to food supplements, and of calcium bisglycinate chelate and magnesium bisglycinate chelate as sources for respectively calcium and magnesium added for nutritional purpos to foods for particular nutritional us and food supplements, and of zinc bisglycinate chelate when ud as a source for zinc in foods intended for the general population (including food supplements) and foods for particular nutritional us, is not of safety concern As regards chromium glycinate nicotinate complex, due to lack of information on the specific identity of its components, the Panel is unable to reach a conclusion on the safety of this source and on the bioavailability of chromium from this source.
Keywords:
Copper bisglycinate chelate, CAS N° 13479-54-4; Zinc bisglycinate chelate, CAS N° 14281-83-5; Zinc Glycinate, CAS N° 14281-83-5; Calcium bisglycinate chelate; CAS N° 56960-17-9; Magnesium bisglycinate chelate, CAS N° 14738-68-7; Chromium glycinate nicotinate hydrochloride.
T ABLE OF C ONTENTS
Panel Members (1)
Summary (1)
Table of Contents (4)
Background as provided by the European Commission (5)
Terms of reference as provided by the european Commission (5)
Acknowledgements (5)
Asssment (6)
1.Introduction (6)
2.Chemistry (6)
2.1Identity of the substances (7)
2.1.1.Copper bis(glycinate-N,O), CAS Number 13479-54-4 (7)
2.1.2.Zinc bisglycinate, CAS number, 14281-83-5, (8)
2.1.3.Calcium bis(glycinate-N,O), CAS Number 56960-17-9 (8)
圉怎么读音2.1.4.Magnesium bis(glycinate-N,O), CAS Number 14783-68-7 (9)
2.1.5.Chromium glycinate nicotinate chelate hydrochloride, CAS Number: None established (10)
2.2Manufacturing process (11)
2.2.1.Introduction (11)
2.2.2.Methods of Manufacturing (11)
2.3Methods of analysis (11)
2.4Reaction and fate in foods (11)
3.Ca of Need and Propod Us (12)
4.Exposure (12)
5.Information on Existing Authorisations and Evaluations (13)
6.Biological and toxicological data (13)
6.1Biological data (13)
6.1.1.Bioavailability of the mineral-bisglycinates following oral consumption (13)
6.1.1.1. Copper bisglycinate (13)
6.1.1.2. Zinc bisglycinate (14)
6.1.1.3. Calcium bisglycinate (16)
6.1.1.4. Magnesium bisglycinate (16)
6.1.1.5. Chromium glycinate nicotinate chelate (16)
6.2Toxicological data (17)
6.2.1.Subchronic toxicity (17)
6.2.2.Genotoxicity (18)
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6.2.3Longer-term feeding studies (18)
6.2.4Reproductive and Developmental Toxicity (19)
Conclusion (20)
Documentation provided to EFSA (21)
References (21)
Glossary / Abbreviations (26)
B ACKGROUND AS PROVIDED BY THE E UROPEAN
C OMMISSION
The European Community legislation lists nutritional substances that may be ud for nutritional purpos in certain categories of foods as sources of certain nutrients. The Commission has received a request for the evaluation of certain amino acid chelates as sources of certain minerals in foods for particular nutritional us and in foods for the general population (including food supplements).
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The relevant European legislative measures identified by the petitioner are:
•Commission Directive 2001/15/EC on substances that may be added for specific nutritional purpos in foods for particular nutritional us2.
•Directive 2002/46/EC of the European Parliament and of the Council on the approximation of the laws of the Member States relating to food supplements3.
•Regulation EC 1925/2006 on the addition of vitamins and minerals and of certain other substances to foods4.
T ERMS OF REFERENCE AS PROVIDED BY THE EUROPEAN C OMMISSION
In accordance with Article 29 (1) (a) of Regulation (EC) No 178/2002, the European Commission asks the European Food Safety Authority to provide scientific opinions, bad on its consideration of the safety and bioavailability of:
•copper bisglycinate and chromium glycinate nicotinate hydrochloride when added to food supplements,
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•calcium bisglycinate and magnesium bisglycinate when added for nutritional purpos in foods for particular nutritional us and food supplements,
•zinc bisglycinate when ud as a source for zinc in foods intended for the general population (including food supplements) and foods for particular nutritional us.
A CKNOWLEDGEMENTS
The European Food Safety Authority wishes to thank the members of the Working Group for the preparation of this opinion:
F. Aguilar, D. Boskou, D. Gott, S. Grilli, R. Guertler, K. Hulshof, J.C. Larn, J.C. Leblanc, C. Leclercq, A. Mortenn, D. Parent-Massin, I. Pratt, I. Rietjens, P. Tobback,
G. Speijers, F. Toldra.
2 OJ No L 52, 22.2.2001, p.19.
3 OJ No L 183, 12.7.2002, p. 51.
4 OJ No L 404, 30.12.2006, p. 26.
