Agenda Item 6 CX/FAC 04/36/5

February 2004
JOINT FAO/WHO FOOD STANDARDS PROGRAMME
CODEX COMMITTEE ON FOOD ADDITIVES AND CONTAMINANTS
Thirty-sixth Session
Rotterdam, The Netherlands, 22 – 26 March 2003
ENDORSEMENT AND/OR REVISION OF MAXIMUM LEVELS FOR
FOOD ADDITIVES AND PROCESSING AIDS IN CODEX STANDARDS
BACKGROUND
1. In accordance with the section concerning Relations between Commodity Committees and General
Committees of the Codex Alimentarius Commission Procedural Manual (Thirteenth Edition, pages 95 - 96),
“All provisions in respect of food additives (including processing aids)...contained in Codex commodity
standards should be referred...and will require to be endorsed by the Codex Committee on Food Additives
and Contaminants”.
2. In consideration of the above and other provisions of the Codex Alimentarius Commission Procedural
Manual, the attached food additive (Part I) and processing aids (Part II) provisions are being submitted to the
Codex Committee on Food Additives and Contaminants for endorsement. It is suggested that those food
additives and corresponding use levels endorsed by the Committee be incorporated into the Codex General
Standard for Food Additives. It is also suggested that those processing aids and corresponding maximum
levels endorsed by the Committee be incorporated into the Inventory of Processing Aids.
3. The following food additive and processing aids provisions of Codex standards have been submitted
for endorsement since the 35th Session of the Codex Committee on Food Additives and Contaminants and
are listed by:
(i) Technological function, INS number and food additive name;
(ii) Proposed level;
(iii) ADI (mg additive/kg body weight per day), and;
(iv) Notes.
4. The following abbreviations have been used in the preparation of this paper:
INS International Numbering System for food additives. The INS has been prepared by the
Codex Committee on Food Additives and Contaminants for the purpose of providing an
agreed international numerical system for identifying food additives in ingredient lists as an
alternative to the declaration of the specific name1.
ADI Acceptable Daily Intake. An estimate of the amount of a substance in food or drinking-
water, expressed on a body-weight basis, that can be ingested daily over a lifetime without
appreciable risk (standard human = 60 kg)2.

1
Class Names and the International Numbering System for Food Additives (CAC/GL 36-2001).
2
Summary of Evaluations Performed by the Joint FAO/WHO Expert Committee on Food Additives (JECFA
1956-2002), Section 5 - Explanation of Terms used in this Summary: http://jecfa.ilsi.org/.
CX/FAC 04/36/5 2
NS ADI “Not Specified”. A term applicable to a food substance of very low toxicity which,
on the basis of the available data (chemical, biochemical, toxicological, and other), the total
dietary intake of the substance arising from its use at the levels necessary to achieve the
desired effect and from its acceptable background in food does not, in the opinion of
JECFA, represent a hazard to health. For that reason, and for reasons stated in individual
evaluations, the establishment of an acceptable daily intake expressed in numerical form is
not deemed necessary. An additive meeting this criterion must be used within the bounds
of good manufacturing practice, i.e., it should be technologically efficacious and should be
used at the lowest level necessary to achieve this effect, it should not conceal inferior food
quality or adulteration, and it should not create a nutritional imbalance2.
NL ADI “Not Limited”. A term no longer used by JECFA that has the same meaning as ADI
"not specified"2.
TE Temporary ADI. Used by JECFA when data are sufficient to conclude that use of the
substance is safe over the relatively short period of time required to generate and evaluate
further safety data, but are insufficient to conclude that use of the substance is safe over a
lifetime. A higher-than-normal safety factor is used when establishing a temporary ADI
and an expiration date is established by which time appropriate data to resolve the safety
issue should be submitted to JECFA. The temporary ADI is listed in units of mg per kg of
body weight2.
CO Conditional ADI. A term no longer used by JECFA to signify a range above the
"unconditional ADI" which may signify an acceptable intake when special problems,
different patterns of dietary intake, and special groups of the population that may require
consideration are taken into account2.
NO No ADI allocated. There are various reasons for not allocating an ADI, ranging from a
lack of information to data on adverse effects that call for advice that a food additive or
veterinary drug should not be used at all. The report should be consulted to learn the
reasons that an ADI was not allocated2.
AC Acceptable2.
Flavouring agents: Used to describe flavouring agents that are of no safety concern at current
levels of intake and subsequent reports of meetings on food additives). If an ADI has been
allocated to the agent, it is maintained unless otherwise indicated.
Enzyme preparations: Used to describe enzymes that are obtained from edible tissues of
animals or plants commonly used as foods or are derived from microorganisms that are
traditionally accepted as constituents of foods or are normally used in the preparation of
foods. Such enzyme preparations are considered to be acceptable provided that satisfactory
chemical and microbiological specifications can be established.
Food additives: Used on some occasions when present uses are not of toxicological concern
or when intake is self-limiting for technological or organoleptic reasons.
Acceptable Level of Treatment. ADIs are expressed in terms of mg per kg of body weight per day.
In certain cases, however, food additives are more appropriately limited by their levels of treatment.
This situation occurs most frequently with flour treatment agents. It should be noted that the
acceptable level of treatment is expressed as mg/kg of the commodity. This should not be confused
with an ADI2.
(L)GMP (Limited by) Good Manufacturing Practice. This statement refers to the limitation of a
food additive in specified foods. It means that the additive in question is self-limiting in food
for technological, organoleptic, or other reasons2, 3.

3
See also Codex Alimentarius Commission Procedural Manual, 13th Edition, page 96.
CX/FAC 04/36/5 3
5. This document does not include previously endorsed food additives provisions at the same levels of
use as specified in draft Codex standards recently considered by the Committee.
6. This document should be read in conjunction with the relevant sections of document CX/FAC
04/36/2-Part II – Matters referred to the Committee by the Codex Alimentarius Commission and Other
Codex Committees and Task Forces.
CX/FAC 04/36/5-Part I: Food Additives 4
PART I
ENDORSEMENT AND/OR REVISION OF MAXIMUM LEVELS FOR FOOD ADDITIVES
IN CODEX COMMODITY STANDARDS
26TH SESSION OF THE
CODEX COMMITTEE ON FISH AND FISHERY PRODUCTS
DRAFT STANDARD FOR SALTED ATLANTIC HERRING
1
AND SALTED SPRAT

(At Step 8)

INS Food Maximum ADI

Notes
No. additive level (mg/kg body weight)
Antioxidants
310 Propyl 100 mg/kg 0-1.4 mg/kg bw This additive was endorsed by the 35th
gallate Session of the Codex Committee on
Food Additives and Contaminants
(March 2003).
The 26th Session of Codex Committee
on Fish and Fishery Products (October
2003) agreed to delete this additive
from the endorsed list of permitted
additives as its use was not
technologically justified in salted
Atlantic herring and salted sprat.
The Committee agreed to forward this
amendment to the Codex Committee
on Food Additives and Contaminants
for endorsement (e.g. to delete this
additive from the previous endorsed
list of permitted additives for Atlantic
herring and salted sprat).
See CX/FAC 04/36/2-Part II paras.
75-76 for further details.

1
ALINORM 04/18, Appendix II.
CX/FAC 04/36/5- Part I: Food Additives 5
3RD SESSION OF THE
AD HOC CODEX INTERGOVERNMENTAL TASK FORCE ON
FRUIT AND VEGETABLE JUICES
DRAFT CODEX GENERAL STANDARD FOR FRUIT JUICES AND NECTARS1
(At Step 7)
ADI
Maximum
INS No. Food additive (mg/kg Notes
level2
body weight)
Acidity Regulators
330 Citric acid 3 g/l3 NL
330 Citric acid 5 g/l NL for fruit nectars
296 Malic acid GMP NS only for pineapple juice and fruit
nectars
334 Tartaric acid 4 g/l 0-30 mg/kg bw only for grape juice and fruit
nectars
Antioxidants
300-303 Ascorbic acid and GMP NS
its salts
220-225, 227, Sulphites 50 mg/l3,4 0-0.7 mg/kg bw as residual SO2
228, 539
Carbonating Agents
290 Carbon dioxide GMP NS
3
Preservatives
210-213 Benzoic acid and 1 g/l 0-5 mg/kg bw5 single or in combination
its salts
200-203 Sorbic acid and its 1 g/l 0-25 mg/kg bw6 single or in combination
salts
Sequestrants3
451(i) Sodium 1 g/l 70 mg/kg bw7 only to enhance the effectiveness
tripolyphosphate of benzoates and sorbates
Stabilizers
440 Pectins GMP NS only for cloudy juices and fruit
nectars

1
ALINORM 03/39A, Appendix II.
2
Calculated as served to the customer.
3
Subject to national legislation of the importing country.
4
Sulphites should be used where there is a technological necessity.
5
Expressed as benzoic acid equivalents.
6
Expressed as sorbic acid.
7
Maximum tolerable daily intake (MTDI) of 70 mg/kg bw for phosphorus from all sources, expressed as P.
CX/FAC 04/36/5- Part I: Food Additives 6
ADI
Maximum
INS No. Food additive (mg/kg Notes
level2
body weight)
Sweeteners
950 Acesulfame 350 mg/l 0-15 mg/kg bw only for fruit nectars
potassium
951 Aspartame 600 mg/l 0-40 mg/kg bw only for fruit nectars
3
952 Cyclamic acid and 400 mg/l 0-11 mg/kg bw8 only for fruit nectars
its salts
954 Saccharin and its 80 mg/l 0-5 mg/kg bw only for fruit nectars
salts
955 Sucralose 300 mg/l 0-15 mg/kg bw only for fruit nectars

8
Cyclamates ADI expressed as cyclamic acid.
CX/FAC 04/36/5- Part II: Processing Aids 7
PART II
ENDORSEMENT AND/OR REVISION OF MAXIMUM LEVELS FOR PROCESSING AIDS
IN CODEX COMMODITY STANDARDS
3RD SESSION OF THE
AD HOC CODEX INTERGOVERNMENTAL TASK FORCE ON
FRUIT AND VEGETABLE JUICES
DRAFT CODEX GENERAL STANDARD FOR FRUIT JUICES AND NECTARS1
(At Step 7)

ADI
Maximum
Function Substance (mg/kg body Notes
level2
weight)
Antifoaming Polydimethylsiloxane 10 mg/l 0-1.5 mg/kg bw Polydimethylsiloxane is
Agent listed as an antifoaming
agent at 10 mg/kg for fruit
and vegetable juices in the
General Standard for
Food Additives and also
as an antifoaming agent in
the Inventory List for
Processing Aids of the
Codex Alimentarius.
The 4th Session of the Ad
Hoc Codex
Intergovernmental Task
Force on Fruit and
Vegetable Juices (May
2003) agreed to request
the Codex Committee on
Food Additives and
Contaminants to withdraw
polydymethylsiloxane
from the General
Standard for Food
Additives and to consider
it as a processing aid for
the products covered by
the Standard for fruit
juices and nectars.
See CX/FAC 04/36/2-Part
II paras. 77-78 for further
details.

1
ALINORM 03/39A, Appendix II.
2
Calculated as served to the customer.
CX/FAC 04/36/5- Part II: Processing Aids 8
ADI
Maximum
Function Substance (mg/kg body Notes
level2
weight)
Clarifying Adsorbent clays - (bleaching, natural, or
Agents activated earths)
Filtration Aids Adsorbent resins -
Activated carbon NL only from plants
Flocculating
Agents Bentonite NO
Calcium hydroxide GMP NL only in grape juice
Cellulose -
Chitosan -
Colloidal silica NS
Diatomaceous earth Decision
postponed
Gelatin NL (from skin collagen)
Ion exchange resins -
(cation and anion)
Isinglass -
Kaolin NS
Perlite -
Polyvinylpolypyrrolidone NS
Potassium tartrate GMP 0-30 mg/kg bw only in grape juice
Precipitated calcium GMP NL only in grape juice
carbonate
Rice hulls -
Silicasol -
Sulphur dioxide 10 mg/l 0-0.7 mg/kg bw as residual SO2; only in
grape juice
Tannin NS3

3
Gallotannins from certain natural sources.
CX/FAC 04/36/5- Part II: Processing Aids 9
ADI
Maximum
Function Substance (mg/kg body Notes
level2
weight)
Enzyme Pectinases NS4 Enzyme preparations may
Preparations (for breakdown of NO5 be used as processing aids
pectins) provided these
Proteinases - preparations do not result
(for breakdown of in a total liquefaction and
proteins) do not substantially affect
Amylases AC6 the cellulose content of
(for breakdown of NS7 the processed fruit.
starch)
Cellulases NO8
(limited use to facilitate NS9
disruption of cell walls)
Packing Gas10 Nitrogen (INS 941) GMP No ADI
necessary
Carbon dioxide GMP NS

4
Pectinases from Aspergillus niger.
5
Pectinase from Aspergillus alliaceus.
6 alpha-Amylase from Aspergillus oryzae, var.
7 alpha-Amylase from Bacillus megaterium expressed in Bacillus subtilis; alpha-amylase from Bacillus
stearothermophilus; alpha-amylase from Bacillus stearothermophilus expressed in Bacillus subtilis; alpha-
amylase from Bacillus subtilis; carbohydrase (alpha-amylase) from Bacillus licheniformis; amyloglucosidase
from Aspergillus niger, var.
8
Cellulase from Penicillium funiculosum.
9
Cellulase from Trichoderma longibrachiatum.
10
May also be used e.g., for preservation.