Agenda Item 7 CX/NFSDU 04/8

September 2004

JOINT FAO/WHO FOOD STANDARDS PROGRAMME

CODEX COMMITTEE ON NUTRITION AND FOODS FOR SPECIAL DIETARY USES

Twenty-sixth Session
Bonn, Germany, 1 - 5 November 2004

Proposed Draft Revision of the Advisory List(s) of Mineral Salts and Vitamin Compounds for the Use in
Foods for Infants and Children
(CAC/GL 10-1979, amended 1983, 1991)

- Comments at Step 3 -

Comments from:

CUBA
SOUTH AFRICA
SWITZERLAND
UNITED STATES OF AMERICA

ISDI – International Special Dietary Foods Industries

CX/NFSDU 04/8 page 2

CUBA
We agree with the inclusion criteria indicated in section 2.1. We suggest that nutrient compounds which do not
meet these requirements be deleted from the lists A, B and C.

SOUTH AFRICA
South Africa proposes to include Ferrous bisglycinate into the above-mentioned List. A hard copy of the dossier
with the following information will be delivered to the meeting on 1 to 5 November 2004:
• Data supporting the safe and appropriate use of ferrous bisglycinate as a source of iron for infants and
young children, including the JECFA toxicology monograph for ferrous bisglycinate
• Data supporting the biological availability of ferrous biglycinate as a source of iron
• Purity requirements of ferrous bisglycinate established by JECFA, including the JECFA specifications for
ferrous bisglycinate
Data supporting the stability of ferrous bisglycinate as an ingredient in foods.

SWITZERLAND
Nutrient Source Purity Requirement .

1.6 L-Cysteine hydrochloride Directive 96/77/EC

(Refer to Annex 1)
2.1 Carnitine EFSA Journal (2003)19, 1-13
2.3 L-Carnitine tartrate EFSA Journal (2003)19, 1-13
(Refer to Annex 2)

Annex 1
L-cysteine hydrochloride

Directive 96/77/EC of 2 December 1996 laying down specific purity criteria on food additives other than colours
and sweeteners (OJ L 339, 30.12.1996).
CX/NFSDU 04/8 page 3
CX/NFSDU 04/8 page 4

Annex 2

The EFSA Journal (2003)19, 1-13

Opinion of the Scientific Panel on Food Additives, Flavourings, Processing Aids and Materials in Contact
with Food (AFC) on a request from the Commission related to L-Carnitine-L-tartrate for use in foods for
particular nutritional uses
(adopted on 3 November 2003 by written procedure)

Specifications
Specifications have been provided by the petitioner (Bioresco, 2003a) and these are shown in Table 1, together
with those for L-carnitine for comparison. The purity criteria correspond to those for L-carnitine in the European
Pharmacopoeia 4th Edition and in the Food Chemicals Codex 4th Edition and to those for L-tartaric acid in
Commission Directive 96/77/EC. A maximum content for D-carnitine has been introduced because D-carnitine
does not fulfil the biochemical function of L-carnitine and is antagonistic to L-carnitine.

Table 1: Specifications for L-carnitine-L-tartrate provided by the petitioner

Analyses of 8 batches said to be representative of L-carnitine-L-tartrate were in compliance with the above
specifications.

UNITED STATES OF AMERICA

I. General Comments
Proposals to add nutrient compounds to this advisory list
The United States recommends that only nutrient compounds with recognized international or national
specifications be included in this list, and all other compounds be removed.
Rationale: The United States strongly supports the Committee’s decision to include criteria for amending the
advisory list of nutrient compounds. We also support the application of these criteria to the Committee’s current
deliberations on revisions to this list. That is, if a country proposes to add a nutrient compound to this list the
country should also provide information to address how the nutrient compound satisfies all of the criteria in Section
2.1. For example, we note that the criteria in 2.1(c) specifies that the purity requirements of the nutrient compounds
listed be established in an internationally recognized specification or if there is no internationally recognized
specification, national purity requirements may be considered. However, as noted in the Circular Letter, no purity
criteria at all could be found for a number of the listed substances.
Identity and Purity Specifications for Nutrient Compounds
The United States recommends that the CCNFSDU ask the Codex Alimentarius Commission to request that the
Joint FAO/WHO Food Standards Programme develop a means to establish identity and purity specifications for
nutrient compounds. JECFA could be used as a model.
CX/NFSDU 04/8 page 5

Rationale: With respect to food additives, it is our understanding that JECFA recommends identity and purity
criteria, which are then forwarded to the Codex Committee on Food Additives and Contaminants for endorsement,
and then to the Codex Alimentarius Commission for adoption as Codex specifications.
The United States is concerned, however, that the Codex Alimentarius Commission has not systematically
established identity and purity specifications for nutrient compounds. As a consequence, it is difficult for the
CCNFSDU to make recommendations about the listing of nutrient compounds for which there are no Codex
specifications. The use of non-Codex specifications for nutrient compounds will only lead to inconsistencies which
do not further the Codex’s purpose of protecting consumer health and promoting fair trade practices.

II. Comments on Specific Sections

2. CRITERIA FOR THE INCLUSION AND DELETION OF NUTRIENT COMPOUNDS FROM THE
ADVISORY LISTS
The United States suggests slightly rewording the criteria in Section 2.1 (c) in order to specifically identify Codex
specifications in addition to other internationally recognized specifications and national references as follows:
2.1 Nutrient compounds that are to be added for nutritional purposes to foods for infants and young children may
be included in the Lists only if:

(c) the purity requirements of the nutrient compounds conform with the applicable Specifications of Identity
and Purity recommended by the Codex Alimentarius Commission, or in the absence of such specifications,
with are established in an another internationally recognized specification. or, If there is no internationally
recognized specification, national requirements may be considered.

Tables A, B, and C (Purity Requirements):

The United States proposes that the CCNFSDU identify those nutrient compounds that conform with the applicable
specifications of identity and purity recommended by Codex rather than listing those evaluated by JECFA. The
United States further proposes that the Committee consider whether it would be helpful to give more prominence to
nutrient compounds that have Codex specifications compared to those that have other references for purity
specifications. For example, the table could include two columns under Purity Requirements: 1) a column labeled
“Codex Specifications” that would include a check mark for all nutrient compounds that have Codex specifications,
and 2) a second column labeled “Other Specifications” that would include other internationally recognized
specifications, and if none, national requirements may be considered.
Rationale: The recommendation to identify nutrient compounds that conform with Codex specifications is
consistent with the proposed revision of the criteria in 2.1 (c ). Moreover, while the purity specifications
recommended by JECFA may often be the same as those adopted by the Codex Alimentarius Commission, this is
not always the case.
Table A (“….Mineral Salts and Trace Elements….” )
Footnote:
In the latest revision of the advisory list, there is the following footnote for calcium lactate, sodium lactate, and
potassium lactate:
“Nutrient compounds that should not be used in infant foods, as proposed by the United States during the 24th
Session of the CCNFSDU.”
The United States recommends that this footnote be removed, and that the advisory list only identify the L- forms
of these compounds, that is:
1.6 Calcium L-Lactate
4.6 Sodium L-Lactate
5.7 Potassium L-Lactate
Comment: We would like to clarify that at the 24th CCNFSDU Session, the United States did not propose that these
nutrient compounds be removed from the advisory list. Rather, the United States pointed out that JECFA has
assigned an ADI for these compounds, but includes in their comments that "Neither D(-)-lactic acid nor (DL)-
lactic acid should be used in infant foods". Thus, the United States recommended that the forms of the above
compounds that may be used in infant foods be clarified in this advisory list, either in the listing of the nutrient
source or in a footnote.
Former Table D: United States Justification for the Recommendation to Delete Table D: “Advisory List of Food
Additives for Special Nutrient Forms” (in CX/NFSDU 03/8, September 2003)

In the introduction to CL 2004/21-NFSDU, Germany noted that it had removed the “Advisory List of Food
Additives for Special Nutrient Forms” based on the proposal made at the 25th CCNFSDU session, but indicated that
this topic may require further discussion.
CX/NFSDU 04/8 page 6

In the event that this topic is reopened for discussion, the United States would like to reemphasize its rationale for
proposing that Table D be removed, and that instead, these substances be listed in the food additive sections of the
applicable standards, either under existing or new functional classes.
Rationale: The scope of this advisory list should be limited to nutrient compounds for use as nutrient sources. The
ingredients listed in Table D appear to serve other purposes (e.g., as carriers of vitamins).
We recognize that the existing advisory list includes a section on “special vitamin forms” that include compounds
that are used as carriers of vitamins. This advisory list was developed in the late 1970’s which was before CCFAC
and CCFL started work on the Codex International Numbering System for Food Additives (CAC/GL 36). Some
Codex members may have supported retaining and expanding this section under the recently proposed title,
“Advisory List of Food Additives for Special Nutrient Forms” because the Codex Alimentarius Commission has
not established an INS food additive functional class for them (e.g., ingredients used as vitamin carriers).
However, rather than retain and expand a list of substances that are not used as nutrient sources in this advisory list,
the United States continues to recommend that CCNFSDU request that CCFAC add an additive functional class for
nutrient carriers (or carriers) and possibly other functional classes to the INS as justified to be able to incorporate
these substances into the food additive provisions of the respective standards. We note that JECFA has a food
additive class for carriers. We further note that the CCFAC is considering a definition for the term “carrier” in
view of the development of a suitable approach for consideration of carriers in the General Standard for Food
Additives. This committee agreed that a working group would prepare a discussion paper that would address the
definition and approaches for the inclusion of carriers in the GSFA, including the use of food additives as “nutrient
carriers” as requested by the 25th CCNFSDU session. (ALINORM 04/27/12, April 2004, para 89)
We continue to believe that food additives for use in foods for infants and young children and their maximum use
levels are most appropriately listed in the respective food standards rather than in this advisory list. We believe
that this will help avoid the potential for inconsistencies (as well as omission and duplication) with this list and the
food additive section of these food standards—such as the listing of the same compound in the advisory list and
respective standard, but with different maximum levels. Also more specificity may be provided in the food
additive provisions in the respective standards. For example, the current version of Table D does not distinguish
between permissible food additives and maximum levels according to the type of food and population group (e.g.,
infant formula, processed cereal based food, etc.). Furthermore, the basis of determining the maximum levels for
Table D is unclear.

ISDI - International Special Dietary Foods Industries

Title of the list
ISDI supports the proposal from Germany to change the title of the list into: “Advisory list of nutrient compounds
for use in foods for special dietary uses intended for use by infants and young children
General remark on the requested substances
In the table below, the substances ISDI wishes to be included in the advisory list are, for the great majority, defined
and authorised already in supranational or national legislation specification.
Most of these substances are sources of nutrients that are mandatory in infant formulae, follow-on-formulae,
processed cereal-based foods for infants and young children canned baby foods and Foods for Special Medical
Purposes.
They have been shown to have good technological and nutritional characteristics. They allow flexibility in the
formulation of the variety of foods specifically designed for infants and young children.
Specific remark on Foods for Special Medical Purposes
FSMPs play a vital part in the dietary management of those infants and young children who have special nutritional
requirements. Products intended for infants and young children not in good health are highly specific and are
designed to meet the particular nutritional requirements resulting from a disease, disorder or medical condition.
They are designed to be used for the dietary management of infants suffering from a particular disease e.g.
pheylketonuria, galactosemia and other inborn errors of metabolism, malabsorption, allergies.
In some medical conditions, protein requirements cannot be met using whole protein due to an intolerance, inability
to metabolise etc. To supply the protein requirements to such patients, a range of amino acids must be used, to
provide the body protein in its simplest form, while satisfying the specific daily requirements.
In many cases, the products are used as the only source of nutrition and are, in fact, substitutes for normal food.
Thus a full complement of nutrition in the form of carbohydrate, protein, fat, vitamins, minerals and trace elements
must be supplied. It is vital that the vitamins and minerals requested by ISDI for use in FSMPs are accepted, to
allow the formulation of these much needed products.
 A: ADVISORY LIST OF MINERAL SALTS AND TRACE ELEMENTS FOR USE IN FOODS FOR SPECIAL DIETARY USES
INTENDED FOR USE BY INFANTS AND YOUNG CHILDREN
Use in Food Categories for
Nutrient Source Purity Requirements Infants and Young Children Comments
IF FUF PCBF CBFFSMP
1.Source of Calcium (Ca)
1.1 Calcium carbonate Ph Eur (2002), USP/NF, FCC
√ √ √ √ [√ ]
IV, DAB, BP, JECFA (1973)
1.2 Calcium chloride Ph Eur (2002), USP, FCC IV,
√ √ √ √ [√ ]
DAB, JP, BP, JECFA (1975)
1.3 Tricalcium dicitrate USP, FCC IV, DAC, JECFA
√ √ √ √ [√ ]
(Calcium citrate) (1975)
Remove [ ]
1.4 Calcium gluconate Ph Eur (2002), USP, FCC IV,
√ √ √ √ [√ ] Authorised in EU for these
DAB, BP, JECFA (1998)
products.
[1.5 Calcium glycerophosphate] [Ph Eur (2002), FCC IV, Ph
[√ ] [√ ] [√ ] [√ ] [√ ]
Franc]
1.6 Calcium lactate* Ph Eur (2002) (Tri- and
Pentahydrate), USP, FCC √ √ √ √ [√ ]
IV, BP, DAB, JECFA (1974)
1.7 Calcium hydroxide Ph Eur (2002), USP, FCC IV,
√ √ √ √ [√ ]
BP, JECFA(1975)
1.8 Calcium oxide FCC IV, DAC, JECFA(1975) Requested for use in FSMP, as
- - √ √
it is authorised in EU
1.9 Calcium dihydrogen FCC IV, JECFA (1996)
phosphate (Calcium √ √ √ √
phosphate, monobasic) Remove [ ]
1.10 Calcium hydrogen Ph Eur (2002), USP, FCC IV, Authorised in EU for these
phosphate (Calcium BP, DAB, JECFA (1975) √ √ √ √ [√ ] products.
phosphate, dibasic)
1.11 Tricalcium diphosphate BP, FCC IV, JECFA (1973)
√ √ √ √ [√ ]
(Calcium phosphate, tribasic)
Other calcium compounds proposed for inclusion:
[1.13 Calcium enriched yeast] ? - - - - [√ ] Delete this section
Malaysia: FCC IV, JECFA (1980)
? ? ? ? ?
1.15 Calcium pyrophosphate
Neuseeland, Malaysia, Ph Eur (2002) (dihydrate),
FCC IV, DAB, JECFA (1975) Remove [ ]
ISDI: - - - - [√ ]
Authorised in EU for FSMP
1.16 Calcium sulphate

2. Source of Iron (Fe)

[2.1 Ferrous carbonate, Remove [ ]
- - [√ ] [√ ] [√ ]
stabilised with saccharose] Authorised in EU for these
 CX/NFSDU 04/8 page 8

[2.2 Ferrous fumarate] [Ph Eur (2002), BP, USP, products.

[√ ] [√ ] [√ ] [√ ] [√ ]
FCC IV]
2.3 Ferrous gluconate Ph Eur (2002), USP, FCC IV,
√ √ √ √ [√ ]
DAB, BP, JECFA (1999)
2.4 Ferrous lactate NF, FCC IV, JECFA(1989) √ √ √ √ [√ ]
2.5 Ferrous sulphate Ph Eur (2002), USP, FCC IV,
√ √ √ √ [√ ]
DAB, BP, JECFA (1999)
2.6 Ferric ammonium citrate DAC, FCC IV, JECFA (1984) √ √ √ √ [√ ]
[2.7 Ferric citrate] [FCC IV] [√ ] [√ ] [√ ] [√ ] [√ ]
[2.8 Ferric diphosphate [FCC IV]
[√ ] [√ ] [√ ] [√ ] [√ ]
(pyrophosphate)]
[2.9 Hydrogen reduced iron] [FCC IV, DAB]
- - [√ ] [√ ] [√ ]

[2.10 Electrolytic iron] [FCC IV]

- - [√ ] [√ ] [√ ]

[2.11 Carbonyl iron] [FCC IV] - - [√ ] [√ ] [√ ]

[2.12 Ferric saccharate]
- - [√ ] [√ ] [√ ]

Other iron compounds proposed for inclusion:

EU, ISDI: [FCC IV]
[2.14 Sodium ferric - - [√ ] [√ ] [√ ] Remove [ ]
diphosphate] Authorised in EU for these
ISDI: [FCC IV] products
[√ ] [√ ] [√ ] [√ ] [√ ]
[2.15 Ferrous citrate]
New Zealand: Remove [ ]
[√ ] [√ ] [√ ] [√ ] [√ ]
[2.16 Ferrous succinate]

3. Source of Magnesium (Mg)

3.1 Magnesium hydroxide BP, USP, DAB, Remove [ ]
√ √ √ √ [√ ]
carbonate JECFA(1983)
3.2 Magnesium chloride Ph Eur (2002) (-4,5 hydrate), Remove [ ]
USP, FCC IV, DAB, BP, √ √ √ √ [√ ] Authorised in EU for these
JECFA (1983) products
[3.3 Trimagnesium dicitrate [DAC]
[√ ] [√ ] [√ ] [√ ] [√ ]
(Magnesium citrate)]
3.4 Magnesium gluconate FCC IV, DAC, JECFA (1999) √ √ √ √ [√ ]
[3.5 Magnesium [Ph Eur (2002), BPC]
- - [√ ] [√ ] [√ ]
glycerophosphate]
3.6 Magnesium hydroxide Ph Eur (2002), USP FCC IV,
√ √ √ √ [√ ]
DAB, BP, JECFA (1975)
 CX/NFSDU 04/8 page 9

3.7 Magnesium lactate JECFA (Mg-DL-Lactat, Mg-

√ √ [√ ]
L-Lactat: 1983)
3.8 Magnesium oxide Ph Eur (2002), USP, FCC IV,
√ √ √ √ [√ ]
DAB, BP, JECFA (1973)
3.9 Magnesium hydrogen FCC IV, DAB, JECFA (1982)
phosphate (Magnesium √ √ √ √ [√ ]
phosphate, dibasic)
3.10 Trimagnesium FCC IV, JECFA (1973)
diphosphate (Magnesium √ √ √ √ [√ ]
phosphate, tribasic)
[3.11 Magnesium sulphate] [Ph Eur (2002)
(Heptahydrate), BP, USP,, [√ ] [√ ] [√ ] [√ ] [√ ]
JP, FCC IV, DAB, DAC]
[3.12 Magnesium acetate] [DAC] - - - - [√ ]
[3.13 Magnesium salts of citric
[√ ] [√ ] [√ ] [√ ] [√ ]
acid]
Other magnesium compounds proposed for inclusion:
3.14 Magnesium carbonate DAB, Ph Eur (2002), BP,
√ √ √ √ [√ ]
USP, FCC IV, JECFA (1973)

4. Source of Sodium (Na)

4.1 Sodium carbonate Ph Eur (2002), BP, NF, FCC
√ √ - - [√ ]
IV, DAB, USP, JECFA (1975)
4.2 Sodium hydrogen Ph Eur (2002), USP, FCC IV,
carbonate (Sodium DAB, BP, JECFA (1975) √ √ - - [√ ]
bicarbonate)
[4.3 Sodium chloride] [Ph Eur (2002), BP, JP,
[√ ] [√ ] - - [√ ]
USP/NF, FCC IV, DAB]
4.4 Trisodium citrate (Sodium Ph Eur (2002), USP, FCC IV,
√ √ - - [√ ]
citrate) BP, DAB, JECFA (1975)
4.5 Sodium gluconate USP, FCC IV, DAC, JECFA
√ √ - - [√ ]
(1998)
Remove [ ]
4.6 Sodium lactate* Ph Eur (2002), BP, USP,
FCC IV, DAB, JECFA (1974) √ √ - - [√ ] Authorised in EU for these
products
4.7 Sodium dihydrogen (Ph Eur (2002) Dihydrate),
phosphate (Sodium USP, FCC IV, JECFA (1963) √ √ - - [√ ]
phosphate, monobasic)
4.8 Disodium hydrogen USP, FCC IV, BP, JECFA
phosphate (Sodium (1975) √ √ - - [√ ]
phosphate, dibasic)
4.9 Trisodium phosphate FCC IV, DAC, JECFA (1975)
√ √ - - [√ ]
(Sodium phosphate, tribasic)
4.10 Sodium hydroxide Ph Eur (2002), DAB, NF, JP,
BP, USP, FCC IV, JECFA √ √ - - [√ ]
(1975)
 CX/NFSDU 04/8 page 10

Other sodium compounds proposed for inclusion:

New Zealand: [Ph Eur (2002), BP, JP, USP] Delete this section
[4.11 Sodium chloride (iodised)] Iodine levels in foods for special
dietary should be tightly
? ? ? ? ?
controlled and should therefore
be added specifically rather than
through iodised salt.
4.12 Sodium sulphate Ph Eur (2002), DAB, BP,
? ? ? ? ?
FCC IV, USP, JECFA (2000)
4.13 Sodium tartrate JECFA (1963) ? ? ? ? ? .

5. Source of Potassium (K)

5.1 Potassium carbonate Ph Eur (2002), USP, FCC IV,
DAC, JECFA (1975) Remove [ ]
√ √ - - [√ ] Authorised in EU for these
products

5.2 Potassium hydrogen Ph Eur (2002), USP, FCC IV,

carbonate (Potassium DAB, BP, JECFA (1975) √ √ - - [√ ]
bicarbonate)
5.3 Potassium chloride Ph Eur (2002), USP, FCC IV,
√ √ √ √ [√ ]
BP, DAB, JECFA (1979)
5.4 Tripotassium citrate Ph Eur (2002), USP, FCC IV,
√ √ √ √ [√ ]
(Potassium citrate) DAB, BP, JECFA (1975)
5.5 Potassium gluconate USP, FCC IV, DAC, JECFA
√ √ √ √ [√ ]
(1998)
[5.6 Potassium [FCC IV]
glycerophosphate]

- - [√ ] [√ ] [√ ]

5.7 Potassium lactate*1 FCC IV, DAB, JECFA (1974) √ √ √ √ [√ ]

5.8 Potassium dihydrogen Ph Eur (2002), FCC IV, NF,
phosphate (Potassium BP, DAB, JECFA (1976) √ √ - - [√ ]
phosphate, monobasic)
5.9 Dipotassium hydrogen FCC IV, BP, JECFA (1975)
phosphate (Potassium √ √ - - [√ ]
phosphate, dibasic)

1
Nutrient compounds that should not be used in infant foods, as proposed by the United States during the 24th session of the CCNSFDU.
 CX/NFSDU 04/8 page 11

5.10 Potassium phosphate, JECFA (1975)

√ √ - - [√ ]
tribasic
5.11 Potassium hydroxide Ph Eur (2002), BP, JP, NF,
√ √ - - [√ ]
FCC IV, DAC, JECFA (1975)

6. Source of Copper (Cu)

[6.1 Cupric carbonate] ? [√ ] [√ ] [√ ] [√ ] [√ ]
[6.2 Cupric citrate] [FCC IV] [√ ] [√ ] [√ ] [√ ] [√ ]
[6.3 Cupric gluconate [FCC IV] Remove [ ]
[√ ] [√ ] [√ ] [√ ] [√ ]
(Copper gluconate)] Authorised in EU for these
[6.4 Copper-lysine-complex] ? [√ ] [√ ] [√ ] [√ ] [√ ] products.
6.5 Cupric sulphate Ph Eur (2002), USP, FCC
√ √ √ √ [√ ]
(Copper sulphate) IV, DAB, JECFA (1973)

7. Source of Iodine (I)

[7.1 Potassium iodide] [Ph Eur (2002), BP, USP,
[√ ] [√ ] [√ ] [√ ] [√ ]
FCC IV, DAB]
Remove [ ]
[7.2 Sodium iodide] [Ph Eur (2002), USP, BP,
[√ ] [√ ] [√ ] [√ ] [√ ] Authorised in EU for these
DAB] products.
7.3 Potassium iodate FCC IV, JECFA (1988) √ √ √ √ [√ ]
[7.4 Sodium iodate] - - [√ ] [√ ] [√ ]

8. Source of Zinc (Zn)

[8.1 Zinc acetate] [Ph Eur (2002)
[√ ] [√ ] [√ ] [√ ] [√ ]
(Dihydrate), USP]
[8.2 Zinc chloride] [Ph Eur (2002), USP, BP,
[√ ] [√ ] [√ ] [√ ] [√ ]
JP, DAB]
[8.3 Zinc citrate] [FCC IV] [√ ] [√ ] [√ ] [√ ] [√ ]
[8.4 Zinc gluconate] [USP, FCC IV, DAC] [√ ] [√ ] [√ ] [√ ] [√ ]
Remove [ ]
[8.5 Zinc lactate] ? [√ ] [√ ] [√ ] [√ ] [√ ]
Authorised in EU for these
[8.6 Zinc oxide] [Ph Eur (2002), BP, USP,
[√ ] [√ ] [√ ] [√ ] [√ ] products.
FCC IV, DAB]
[8.7 Zinc sulphate] [Ph Eur (2002), BP, USP,
[√ ] [√ ] [√ ] [√ ] [√ ]
FCC IV]
Other zinc compounds proposed for inclusion:
EU, ISDI: ?
- - - - [√ ]
[8.8 Zinc carbonate]

9. Source of Manganese (Mn)

[9.1 Manganese(II) Remove [ ]
[√ ] [√ ] [√ ] [√ ] [√ ]
carbonate] Authorised in EU for these
 CX/NFSDU 04/8 page 12

[9.2 Manganese(II) chloride] [FCC IV] [√ ] [√ ] [√ ] [√ ] [√ ] products.

[9.3 Manganese(II) citrate] [FCC IV] [√ ] [√ ] [√ ] [√ ] [√ ]
[9.4 Manganese(II) [FCC IV]
- - [√ ] [√ ] [√ ]
glycerophosphate]
[9.5 Manganese(II) [Ph Eur (2002)
sulphate] (Monohydrate), USP, FCC [√ ] [√ ] [√ ] [√ ] [√ ]
IV]
[9.6 Manganese(II) [FCC IV]
[√ ] [√ ] [√ ] [√ ] [√ ]
gluconate]

10. Source of Selenium (Se)

[10.1 Sodium selenate] New
[√ ] [√ ] Zealand - [√ ] Remove [ ]
[√ ]
New
Authorised in EU for these
[10.2 Sodium selenite] [DAC] products.
[√ ] [√ ] Zealand - [√ ]
[√ ]
[10.3 Sodium hydrogen ISDI ISDI
ISDI: ISDI:
selenite] : [√ : [√ [√ ] Authorised in EU for FSMP.
[√ ] [√ ]
] ]
Other selenium compounds proposed for inclusion:
ISDI: [10.4 Selenium ?
- - - - [√ ] Delete this section
enriched yeast]

11. Chromium (Cr III)

[11.1 Chromium (III) Remove [ ]
sulphate and its USP (24) - - - - [√ ] Authorised in EU for FSMP.
hexahydrate] Add purity crit
[11.2 Chromium (III) chloride Remove [ ]
- - - - [√ ]
and its hexahydrate] Authorised in EU for FSMP.
Other chromium compounds proposed for inclusion:
ISDI: [11.3 Chromium
- - - - [√ ] Delete this section
enriched yeast]

12. Molybdenum (Mo VI)

[12.1 Sodium molybdate] [Ph Eur (2002) (dihydrate),
- - - - [√ ]
BP, DAB] Remove [ ]
[12.2 Ammonium [USP, FCC IV] Authorised in EU for FSMPs
- - - - [√ ]
molybdate]

13. Fluoride (F)

[13.1 Potassium fluoride] - - - - [√ ] Remove [ ]
 CX/NFSDU 04/8 page 13

[13.2 Sodium fluoride] [Ph Eur (2002), BP, USP, Authorised in EU for FSMPs
- - - - [√ ]
DAB, FCC IV]
Other fluoride compounds proposed for inclusion:

B: ADVISORY LIST OF VITAMIN COMPOUNDS FOR USE IN FOODS FOR INFANTS AND YOUNG CHILDREN
Use in Food Categories for
Nutrient Source Purity Requirements Infants and Young Children Comments
IF FUF PCBF CBFFSMP
1. Vitamin A
[1.1 all trans Retinol] [Ph Eur (2002) (vitamin A),
[√ ] [√ ] [√ ] [√ ] [√ ]
USP, FCC IV(vitamin A)]
[1.2 Retinyl acetate] [Ph Eur (2002) (vitamin A),
USP, FCC IV (vitamin A), [√ ] [√ ] [√ ] [√ ] [√ ]
Jap Food Stan]
Remove [ ]
[1.3 Retinyl palmitate] [Ph Eur (2002) (vitamin A),
Authorised in EU for these
USP, FCC IV (vitamin A), [√ ] [√ ] [√ ] [√ ] [√ ]
products.
Jap Food Stan]
2. Provitamin A
2.1 Beta-Carotene Ph Eur (2002), USP, FCC
IV, Jap Food Stan, √ √ √ √ [√ ]
JECFA (1987)
Other provitamin A carotenoids proposed for inclusion:
3. Vitamin D
[3.1 Vitamin D2= [Int.Pharm, Ph Eur (2002),
Ergocalciferol] USP, FCC IV, Jap Food [√ ] [√ ] [√ ] [√ ] [√ ]
Remove [ ]
Stan, DAB]
Authorised in EU for these
[3.2 Vitamin D3 [BP, USP, Int.Pharm,
products
= Cholecalciferol] FCC IV, Jap Food Stan, [√ ] [√ ] [√ ] [√ ] [√ ]
DAB]
Other vitamin D compounds proposed for inclusion:
New Zealand:
[3.3 Cholecalciferol ? ? ? ? ? ?
cholesterol]
4. Vitamin E
4.1 D-alpha-Tocopherol Ph Eur (2002), USP,
√ √ √ √ [√ ]
FCC IV, JECFA (2000)
4.2 DL-alpha-Tocopherol Ph Eur (2002), USP,
FCC IV, Jap Food Stan, √ √ √ √ [√ ] Remove [ ]
JECFA (1986) Authorised in EU for these
 CX/NFSDU 04/8 page 14

[4.3 D-alpha-Tocopheryl [Ph Eur (2002), USP, FCC products

[√ ] [√ ] [√ ] [√ ] [√ ]
acetate] IV]
[4.4 DL-alpha-Tocopheryl [Ph Eur (2002), USP, FCC
[√ ] [√ ] [√ ] [√ ] [√ ]
acetate] IV; NF, BP]
Other tocopheryl compounds proposed for inclusion:
ISDI, EU, New Zealand: [NF, FCC IV]
[4.5 D-alpha-Tocopheryl - - - - [√ ]
acid succinate]
4.6 DL-alpha-Tocopheryl
- - - - [√ ]
acid succinate]
4.7 DL-alpha-Tocopheryl Add “DL-alpha-Tocopheryl
polyethylene glycol 1000 polyethylene glycol 1000
succinate succinate” for FSMPs.
Water soluble source of vitamin
√ E particularly useful in
conditions where there is
insufficient amount of bile
secreted e.g. cholestatic liver
disease.
5. Vitamin C
5.1 L-Ascorbic acid Ph Eur (2002), BP, USP,
JP, FCC IV, Int.
√ √ √ √ [√ ]
Pharm, Jap Food Stan,
DAB, JECFA (1973)
5.2 Calcium-L-ascorbate Ph Eur (2002), USP,
√ √ √ √ [√ ]
FCC IV, JECFA (1981)
[5.3 Potassium-L-ascorbate] [√ ] [√ ] [√ ] [√ ] [√ ] Remove [ ]
5.4 6-Palmitoyl-L-ascorbic Ph Eur (2002), BP, NF, Authorised in EU for these
acid FCC IV, USP/NF, Jap products
√ √ √ √ [√ ]
(Ascorbyl palmitate) Food Stan, DAB, JECFA
(1973)
5.5 Sodium-L-ascorbate DAC, Ph Franc, USP,
FCC IV, Ph Eur (2002),
√ √ √ √ [√ ]
Jap Food Stan,
JECFA (1973)
6. Vitamin B1
[6.1 Thiaminchloride [Int. Pharm, Ph Eur
hydrochloride] (2002), USP, FCC IV, [√ ] [√ ] [√ ] [√ ] [√ ] Remove [ ]
Jap Food Stan, DAB] Authorised in EU for these
[6.2 Thiamin mononitrate] [Int. Pharm, Ph Eur products
[√ ] [√ ] [√ ] [√ ] [√ ]
(2002), USP, FCC IV,
 CX/NFSDU 04/8 page 15

Jap Food Stan, DAB]

7.Vitamin B2
7.1 Ph Eur (2002), BP, JP,
Riboflavin USP, Int. Pharm, FCC
√ √ √ √ [√ ]
IV, Jap Food Stan, Remove [ ]
DAB, JECFA (1987) Authorised in EU for these
7.2 Ph Eur (2002), BP, JP, products
Riboflavin-5’-phosphate USP, Jap Food Stan, √ √ √ √ [√ ]
sodium DAB, JECFA (1987)
8. Niacin
[8.1 [Ph Eur (2002), BP, USP,
Nicotinic acid amide FCC IV, Int. Pharm, Jap [√ ] [√ ] [√ ] [√ ] [√ ]
Remove [ ]
(Nicotinamide)] Food Stan, DAB]
Authorised in EU for these
[8.2 Nicotinic acid] [Ph Eur (2002), BP, USP,
products
Int. Pharm, FCC IV, Jap [√ ] [√ ] [√ ] [√ ] [√ ]
Food Stan, DAB]
9.Vitamin B6
[9.1 [Int. Pharm, Ph Eur
Pyridoxine hydrochloride] (2002), USP, FCC IV, [√ ] [√ ] [√ ] [√ ] [√ ]
Jap Food Stan, DAB] Remove [ ]
[9.2 Authorised in EU for these
[√ ] [√ ] [√ ] [√ ] [√ ]
Pyridoxal 5-phosphate] products
[9.3
[√ ] [√ ] [√ ] [√ ] [√ ]
Pyridoxal dipalmitate]
Other pyridoxine compounds proposed for inclusion:
Malaysia:
? ? ? ? ?
[9.4 Pyridoxamine]
10. Folic acid
[10.1 N-Pteroyl-L-glutamic [Ph Eur (2002), USP, Remove [ ]
acid] FCC IV, Jap Food Stan] [√ ] [√ ] [√ ] [√ ] [√ ] Authorised in EU for these
products
11.Pantothenic acid
[11.1 Calcium-D- [Ph Eur (2002), USP,
pantothenate] FCC IV, Jap Food Stan, [√ ] [√ ] [√ ] [√ ] [√ ]
DAB] Remove [ ]
[11.2 Sodium-D- [Jap Food Stan, DAB] Authorised in EU for these
[√ ] [√ ] [√ ] [√ ] [√ ]
pantothenate] products
[11.3 D-Panthenol/ [Ph Eur (2002), USP,
[√ ] [√ ] [√ ] [√ ] [√ ]
DL-Panthenol] FCC IV]
12. Vitamin B12
[12.1 Cyanocobalamin] [Ph Eur (2002), BP, USP, Remove [ ]
[√ ] [√ ] [√ ] [√ ] [√ ]
 CX/NFSDU 04/8 page 16

FCC IV, DAB]

[12.2 Hydroxocobalamin] [Ph Eur (2002) Authorised in EU for these
(Hydrochloride), USP, [√ ] [√ ] [√ ] [√ ] [√ ] products
NF]
13. Vitamin K1
[13.1 Phytomenadione [Ph Eur (2002), BP, USP, Remove [ ]
(2-Methyl-3-phytyl-1,4- FCC IV (vitamin K)] Authorised in EU for these
naphthoquinone/ products.
[√ ] [√ ] [√ ] [√ ] [√ ]
Phylloquinone/
phytonadione)] Add the name
“phytonadione”
14. Biotin
[14.1 D-Biotin] [Ph Eur (2002), USP, Remove [ ]
FCC IV] [√ ] [√ ] [√ ] [√ ] [√ ] Authorised in EU for these
products

C: ADVISORY LIST OF AMINO ACIDS AND OTHER NUTRIENTS FOR USE IN FOODS FOR SPECIAL
DIETARY USES FOR USE BY INFANTS AND CHILDREN

Use in Food Categories for

Nutrient Source Purity Requirements Infants and Young Children Comments
IF FUF PCBF CBF FSMP
1. Amino acids
1.1 L-Arginine] [Ph Eur (2002), BP, Remove [ ].
[√ ]
USP, FCC IV, DAB] Are authorised in EU for these
1.2 L-Arginine [Ph Eur (2002), BP, [√ ] products.
hydrochloride] USP, FCC IV, DAB]
1.3 L-Cystine] [Ph Eur (2002), USP, FCC only for improving [√ ] Add: “As far as it is
IV] the nutritional applicable, also the sodium,
1.4 L-Cystine quality of the [√ ] potassium, calcium and
? protein (when the magnesium salts as well as
dihydrochloride]
1.5 L-Cysteine] [DAB] protein is [√ ] their hydrochlorides may be
1.6 L-Cysteine [Ph Eur (2002), FCC] nutritionally [√ ] used”, as it is the case in EU
hydrochloride] inadequate for its legislation
1.7 L- Histidine] [Ph Eur (2002), USP, FCC intended use) [√ ]
IV, DAB]
1.8 L- Histidine [Ph Eur (2002), FCC IV, [√ ]
hydrochloride] DAB]
 CX/NFSDU 04/8 page 17

1.9 L-Isoleucine] [Ph Eur (2002), USP, [√ ]

FCC IV, DAB]
1.10 L-Isoleucine [√ ]
?
hydrochloride]
1.11 L-Leucine] [Ph Eur (2002), USP, FCC [√ ]
IV, DAB]
1.12 L-Leucine [√ ]
? only for improving
hydrochloride]
1.13 L-Lysine] [USP] the nutritional [√ ]
1.14 L-Lysine [Ph Eur (2002), USP, quality of the [√ ]
monohydrochloride] FCC IV, DAB] protein (when the
protein is [√ ]
1.15 L-Methionine] [Ph Eur (2002), USP, FCC nutritionally [√ ]
IV, DAB] inadequate for its
1.16 L-Phenylalanine] [Ph Eur (2002), USP, intended use) [√ ]
FCC IV]
1.17 L-Threonine] [Ph Eur (2002), USP, [√ ]
FCC IV, DAB]
1.18 L-Tryptophan] [Ph Eur (2002), USP, [√ ]
FCC IV, DAB]
1.19 L-Tyrosine] [Ph Eur (2002), USP, [√ ]
FCC IV, DAB]
1.20 L-Valine] [Ph Eur (2002), USP, [√ ]
FCC IV, DAB]
Other amino acids and their derivatives proposed for inclusion:
ISDI: [Ph Eur (2002), USP, - Remove [ ].
[√ ]
[1.21 L-Alanine] FCC IV, DAB] Is authorised in EU for FSMP.
[1.22 L-Arginine L-aspartate] FP10 - Remove [ ].
Is authorised in EU for FSMP.
[√ ]
Add Purity criteria FP 10
[1.23 L-Aspartic acid] [Ph Eur (2002), USP, -
[√ ]
FCC IV] Remove [ ].
[1.24 L-Citrulline] [USP, DAC] Are authorised in EU for FSMP
[√ ]
1.25 L- Glutamic acid Ph Eur (2002), USP, ISDI ISDI: Present in breast milk.
[√ ]
FCC IV, JECFA (1987) [√ ] [√ ] Authorised in IF and FOF in
[1.26 L-Glutamine] [USP, FCC IV, DAB] ISDI ISDI: Hong Kong.
[√ ]
[√ ] [√ ] Authorised in EU for FSMP
[1.27 Glycine] [Ph Eur (2002), USP, - [√ ] Remove [ ].
FCC IV] Authorised in EU for FSMP
 CX/NFSDU 04/8 page 18

[1.28 L-Lysine acetate] ISDI [√ ] ISDI: ISDI:

[√ ]
: [√ ] [√ ] [√ ]
[1.29 L-Lysine L-Aspartate] - [√ ]
[1.30 L-Lysine L-Glutamate [√ ]
-
dihydrate]
[1.31 L-Ornithine] - [√ ]
[1.32 L-Proline] [Ph Eur (2002), USP, [√ ]
-
FCC IV, DAB]
[1.33 L-Serine] [PH Eur (2002), USP, [√ ]
-
DAB]
[1.34 N-Acetyl-L-cysteine] [Ph Eur (2002), USP,
- [√ ]
DAB]
[1.35 N-Acetyl-L-methionine] [FCC IV] [√ ]
- except
infant
2. Carnitine
[2.1 L-Carnitine] ISDI: ISDI:
[√ ] [√ ] [√ ] Remove [ ]
[USP, FCC IV] [√ ] [√ ]
Authorised in EU for these
[2.2 L-Carnitine ISDI: ISDI:
[√ ] [√ ] [√ ] products.
hydrochloride] [√ ] [√ ]
Other carnitine compounds proposed for inclusion:
ISDI: Remove [ ]
- - - - [√ ]
[2.3 L-Carnitine tartrate] Authorised in EU for FSMP
3. Taurine
[3.1 Taurine] [USP, JP] Remove [ ]
ISDI:
[√ ] - - [√ ] Authorised in EU for these
[√ ]
products.
4. Choline
[4.1 Choline] [√ ] [√ ] [√ ] [√ ] [√ ] Remove [ ]
[4.2 Choline chloride] [DAB 1996, FCC IV, DAC] [√ ] [√ ] [√ ] [√ ] [√ ] Authorised in EU for these
[4.3 Choline citrate] [NF] [√ ] [√ ] [√ ] [√ ] [√ ] products
[4.4 Choline hydrogen [DAB 1996]
[√ ] [√ ] [√ ] [√ ] [√ ]
tartrate]
[4.5 Choline bitartrate] [DAB 1996, FCC IV, Remove [ ]
NF] [√ ] [√ ] [√ ] [√ ] [√ ] Authorised in EU for these
products
4.6 Lecithin FCC, JECFA Requested for all the
products as source of
phosphatidyl choline.
 CX/NFSDU 04/8 page 19

[5. Myo-Inositol [DAC, FCC IV] Remove [ ]

(=meso-Inositol)] [√ ] [√ ] [√ ] [√ ] [√ ] Authorised in EU for these
products
5.2 Lecithin FCC, JECFA Requested for all the
products as source of
phosphatidyl inositol.
6. Nucleotides
[6.1 Cytidine 5- ISDI:
[√ ] - - [√ ]
monophosphate(CMP)] [√ ]
[6.2 Cytidine 5-
ISDI:
monophosphate [√ ] - - [√ ]
[√ ]
sodium salt]
[6.3 Uridine 5-
ISDI:
monophosphate [√ ] - - [√ ]
[√ ]
(UMP)]
[6.4 Uridine 5-
ISDI:
monophosphate [√ ] - - [√ ]
[√ ]
sodium salt]
[6.5 Adenosine 5- ISDI:
[√ ] - - [√ ]
monophosphate (AMP)] [√ ] Remove [ ]
[6.6 Adenosine 5- Authorised in EU for these
ISDI:
monophosphate sodium [√ ] - - [√ ] products
[√ ]
salt]
6.7 Guanosine 5- JECFA (1985) ISDI:
√ - - [√ ]
monophosphate (GMP) [√ ]
[6.8 Guanosine 5-
ISDI:
monophosphate sodium [√ ] - - [√ ]
[√ ]
salt]
6.9 Inosine 5- JECFA (1974)
ISDI:
monophosphate √ - - [√ ]
[√ ]
(IMP)
[6.10 Inosine 5-
ISDI:
monophosphate sodium [√ ] - - [√ ]
[√ ]
salt]
ISDI: Remove [ ]
[7. Creatine monohydrate] [√ ] Positive opinion from EFSA
17 Feb 2004
D: ADVISORY LIST OF FOOD ADDITIVES FOR SPECIAL VITAMIN FORMS
It is proposed to delete the section.
ISDI is strongly opposed to the deletion of this section until an alternative means of listing these substances is
adopted at Codex. . Upon the request of the 25th Session of CCNFSDU, CCFAC is considering the establishment
of a category "carrier" including the use of food additives as “nutrient carriers” in the General Standard for Food
Additives. However, ISDI has reservation on the approach since:
ƒ CCFAC has only started to consider the issue of carriers and nutrient carriers and it is most improbable that
CCFAC will have completed their discussions on this issue in time with the newly updated version of the
"Advisory Lists" . We recommend that a footnote is added to this section of the Advisory Lists stating that
if/once CCFAC has adopted an alternative solution the information can be transferred to the newly made
category and this section can then be removed from this document.
ƒ Contrary to most food covered by Codex Standards, the carry over principle does not apply for Infant
formula. Thus if nutrient carriers are not specified somewhere in the Codex framework, it will not be
possible to manufacture infant formula according to compositional and nutritional safety requirements of
the Codex Standard on Infant formula.
ƒ The GSFA includes only food additives while a nutrient carrier can also be food ingredients (e.g. dextrin).
This will need to be taken into consideration so that allowed use of this ingredient as a nutrient carrier is
not lost.
JUSTIFICATION for the requested uses
¾ For nutritional substances authorised in the EU, provision can be found under the following legislation:
- For Infant and Follow-on formula: Annex III of Commission Directive 91/321/EEC on infant formula and
follow-on formula as amended.
- For processed cereal based food cereal-based foods and canned baby foods: Annex IV of Directive 96/5/EC
on processed cereal-based foods and baby foods for infants and young children as amended.
- For Foods for Special Medical Purposes: Annex of Directive 2001/15/EC on substances that may be added
for specific nutritional purposes in foods for particular nutritional uses as amended.
¾ For nutritional substances requested by ISDI and not yet authorised in the EU: complete file are available upon
request, which are currently under evaluation by the European Food Safety Authority

Abbreviations:

IF = infant formula
FUF = follow-up formula
PCBF = processed cereal based food
CBF = canned baby food
[FSMP] = food for special medical purposes

BP = British Pharmacopoeia
BPC = British Pharmaceutical Codex
DAB = Deutsches Arzneibuch
DAC = Deutscher Arzneimittel-Codex
FCC = Food Chemicals Codex
FU = Farmacopoea Ufficiale della Republica Italiana
JP = The Pharmacopeia of Japan
Jap Food Stan = Japanese Food Standard
NF = The National Formulary/USA
Ph Eur = Pharmacopoeia Europaea
Ph Franç = Pharmacopée Française
Ph Helv = Pharmacopoea Helvetica
Ph Int = International Pharmacopeia
USP = The United States Pharmacopeia