International Standard-Setting Activities

Federal RegisterMay 23, 1997

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DEPARTMENT OF AGRICULTURE

Food Safety and Inspection Service

[Docket No. 97-026N]

International Standard-Setting Activities

AGENCY: Food Safety and Inspection Service, USDA.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: This notice informs the public of the sanitary and

phytosanitary standard-setting activities of the Codex Alimentarius

Commission (Codex), in accordance with section 491 of the Trade

Agreements Act of 1979, as amended by the Uruguay Round Agreements Act,

Pub. L. 103-465, 108 Stat. 4809 (1994), and seeks comments on standards

currently under consideration and recommendations for new standards. It

also lists other standard-setting activities of Codex, including

commodity standards, guidelines, codes of practice, and revised texts.

This notice covers the time periods from June 1, 1996, to May 31, 1997,

and May 31, 1997, to June 1, 1998.

ADDRESSES: Submit written comments to: FSIS Docket Clerk, U.S.

Department of Agriculture, Food Safety and Inspection Service, Room

102, Cotton Annex, Washington, DC 20250-3700. Please state that your

comments refer to Codex and, if your comments relate to specific Codex

committees, please identify those committees in your comments and

submit a copy of your comments to the delegate from that particular

committee. All comments submitted will be available for public

inspection in the Docket Clerk's Office between 8:30 a.m. and 4:30

p.m., Monday through Friday.

FOR FURTHER INFORMATION CONTACT: Patrick J. Clerkin, Director, U.S.

Codex Office, U.S. Department of Agriculture, Food Safety and

Inspection Service, 1255 22nd Street, NW, Room 311, West End Court

Building, Washington, DC 20250-3700; (202) 418-8852. For information

pertaining to particular committees, the delegate of that committee may

be contacted. (A complete list of U.S. delegates and alternate

delegates can be found in Appendix 1 to this notice.)

SUPPLEMENTARY INFORMATION:

Background

The World Trade Organization (WTO) was established on January 1,

1995, as the common international institutional framework for the

conduct of trade relations among its members in matters related to the

Uruguay Round Agreements. The WTO is the successor organization to the

General Agreements on Tariffs and Trade (GATT). U.S. membership in the

WTO was approved by Congress when it enacted the Uruguay Round

Agreements Act, which was signed into law by the President on December

8, 1994. Pursuant to section 491 of the Trade Agreements Act of 1979,

as amended, the President is required to designate an agency to be

responsible for informing the public of the sanitary and phytosanitary

(SPS) standard-setting activities of each international standard-

setting organization, Codex, International Office of Epizootics, and

the International Plant Protection Convention. The President, pursuant

to Proclamation No. 6780 of March 23, 1995 (60 FR 15845), designated

the U.S. Department of Agriculture as the agency responsible for

informing the public of sanitary and phytosanitary standard-setting

activities of each international standard-setting organization. The

Secretary of Agriculture has delegated to the Administrator, Food

Safety and Inspection Service (FSIS), the responsibility to inform the

public of the SPS standard-setting activities of Codex. The FSIS

Administrator has, in turn, assigned the responsibility for informing

the public to the Office of U.S. Codex Alimentarius, located in FSIS.

Codex was created in 1962 by two U.N. organizations, the Food and

Agriculture Organization (FAO) and the World Health Organization (WHO).

Codex is the major international organization for encouraging fair

international trade in food and protecting the health and economic

interests of consumers. Through adoption of food standards, codes of

practice, and other guidelines developed by its committees and by

promoting their adoption and implementation by governments, Codex seeks

to ensure that the world's food supply is sound, wholesome, free from

adulteration, and correctly labeled. In the United States, the United

States Department of Agriculture (USDA); the Food and Drug

Administration (FDA), Department of Health and Human Services (HHS),

and the Environmental Protection Agency (EPA) manage and carry out U.S.

Codex activities.

As the agency responsible for informing the public of the sanitary

and phytosanitary standard-setting activities of Codex, FSIS will

publish this notice in the Federal Register annually, setting forth the

following information:

1. The sanitary or phytosanitary standards under consideration or

planned for consideration; and

2. For each sanitary or phytosanitary standard specified:

a. A description of the consideration or planned consideration of

the standard;

b. Whether the United States is participating or plans to

participate in the consideration of the standard;

The agenda for United States participation, if any; and

d. The agency responsible for representing the United States with

respect to the standard.

To obtain copies of those standards listed in this notice that are

under consideration by Codex, please contact the Codex delegate or the

office of U.S. Codex Alimentarius. This notice also solicits public

comment on those standards that are under consideration and on

recommendations for new standards. The delegate, in conjunction with

the responsible agency, will take the comments received into account in

participating in the consideration of the standards and in proposing

matters to be considered by Codex.

The United States delegate will facilitate public participation in

the United States Government activities relating to Codex Alimentarius.

The United States delegate will maintain a list of individuals, groups,

and organizations that have expressed an interest in the activities of

the Codex committees and will disseminate information regarding United

States

[[Page 28417]]

delegation activities to interested parties. This information will

include the current status of each agenda item, the United States

Government's position or preliminary position on the agenda items, and

the time and place of planning meetings and debriefing meetings

following Codex committee sessions. Please notify the appropriate U.S.

delegate or the Office of U.S. Codex Alimentarius, West End Court

Building, Room 311, Washington, DC 20250-3700, if you would like to

receive information about specific committees.

The information provided below describes the status of Codex

standard-setting activities by the Codex Committees for the two year

period from June 1, 1996 to June 1, 1998. In addition, the following

information is included with this Federal Register notice:

Appendix 1. List of U.S. Codex Officials (includes U.S. delegates and

alternate delegates).

Appendix 2. Timetable of Codex Sessions (June 1996 through June 1998)

Appendix 3. Definitions for the Purpose of Codex Alimentarius

Appendix 4.

(A) Uniform Procedure for the Elaboration of Codex Standards and

Related Texts

(B) Uniform Accelerated Procedure for the Elaboration of Codex

Standards and Related Texts

Appendix 5. Nature of Codex Standards

Done at Washington, DC on: May 15, 1997.

Thomas J. Billy,

Administrator.

Codex Alimentarius Commission and Executive Committee

The Codex Alimentarius Commission will hold its Twenty-second

Session on June 23-28, 1997 in Geneva, Switzerland. At that time it

will consider the standards, codes of practice, and related matters

brought to its attention by the general subject committees,

commodity committees, and member delegations.

Prior to the Commission meeting, the Executive Committee will

meet on June 19-20 in Geneva. It is composed of the chairperson,

vice-chairperson and six further members elected from the

Commission, one from each of the following geographic regions:

Africa, Asia, Europe, Latin America and the Caribbean, North

America, and South-West Pacific. The committee may make proposals to

the Commission regarding the general orientation and program work of

the Commission, study special problems and help implement the

program as approved by the Commission.

Codex Committee on Residues of Veterinary Drugs in Foods

The Codex Committee on Residues of Veterinary Drugs determines

priorities for the consideration of residues of veterinary drugs in

foods and recommends Maximum Residue Limits (MRLs) for veterinary

drugs. A Codex Maximum Limit for Residues of Veterinary Drugs

(MRLVD) is the maximum concentration of residue resulting from the

use of a veterinary drug (expressed in mg/kg or ug/kg on a fresh

weight basis) that is recommended by the Codex Alimentarius

Commission to be legally permitted or recognized as acceptable in or

on a food.

An MRLVD is based on the type and amount of residue considered

to be without any toxicological hazard for human health as expressed

by the Acceptable Daily Intake (ADI)*, or on the basis of a

temporary ADI that utilizes an additional safety factor. An MRLVD

also takes into account other relevant public health risks as well

as food technological aspects.

When establishing an MRLVD, consideration is also given to

residues that occur in food of plant origin and/or the environment.

Furthermore, the MRLVD may be reduced to be consistent with good

practices in the use of veterinary drugs and to the extent that

practical analytical methods are available.

*Acceptable Daily Intake (ADI): An estimate by the Joint FAO/WHO

Expert Committee on Food Additives (JECFA) of the amount of a

veterinary drug, expressed on a body weight basis, that can be

ingested daily over a lifetime without appreciable health risk

(standard man = 60 kg).

Information about committee actions can be found in ALINORMS 97/

31 and 97/31A. Residues of Veterinary Drugs in Foods to be

considered at the Twenty-Second Session of the Codex Alimentarius

Commission include the following:

----------------------------------------------------------------------------------------------------------------

Status of US participation/

Codex committee Standard consideration agenda Responsible agency

----------------------------------------------------------------------------------------------------------------

Residues of Veterinary Drugs Moxidectin....... MRLs Under Yes................... HHS/FDA

in Foods (to be considered at Consideration at

Twenty-second Session of the Step 8 cattle

Codex Alimentarius and sheep.

Commission) (CAC) Ref.

ALINORM 97/31 and 97/31A.

Levamisole....... MRLs Under Yes................... HHS/FDA

Consideration at

Step 8.

Triclabendazole.. MRLs Under Yes................... HHS/FDA

Consideration at

Step 8.

Carazolol........ MRLs Under Yes................... HHS/FDA

Consideration at

Step 8.

Bovine MRLs Under Yes................... HHS/FDA

Somatotropin. Consideration at

Step 8.

Doramectin....... MRLs Under Yes................... HHS/FDA

Consideration at

Step 8.

Spiramycin....... MRLs Under Yes................... HHS/FDA

Consideration at

Step 8.

Moxidectin....... MRLs Under Yes................... HHS/FDA

Consideration at

Step 5/8 deer.

Oxtetracycline... MRLs Under Yes................... HHS/FDA

Consideration at

Step 5/8.

Abamectin........ MRLs Under Yes................... HHS/FDA

Consideration at

Step 5.

Azaperone........ MRLs Under Yes................... HHS/FDA

Consideration at

Step 5.

Chlortetracycline MRLs Under Yes................... HHS/FDA

, Consideration at

oxytetracycline Step 5.

and tetracycline.

Cypermethrin..... MRLs Under Yes................... HHS/FDA

Consideration at

Step 5.

Residues of Veterinary Drugs Cypermethrin..... MRLs Under Yes................... HHS/FDA

in Foods (to be considered at Consideration at

Twenty-second Session of the Step 5.

Codex Alimentarius

Commission) (CAC) Ref.

ALINORM 97/31 and 97/31A.

[[Page 28418]]

Dexamethasone.... MRLs Under Yes................... HHS/FDA

Consideration at

Step 5.

Diclazuril....... MRLs Under Yes................... HHS/FDA

Consideration at

Step 5.

Dihydrostreptomyc MRLs Under Yes................... HHS/FDA

in and Consideration at

streptomycin. Step 5.

Febantal/ MRLs Under Yes................... HHS/FDA

Fenbendazole/ Consideration at

Oxfendazole. Step 5.

Gentamicin....... MRLs Under Yes................... HHS/FDA

Consideration at

Step 5.

Neomycin......... MRLs Under Yes................... HHS/FDA

Consideration at

Step 5.

Spectinomycin.... MRLs Under Yes................... HHS/FDA

Consideration at

Step 5.

Thiamphenicol.... MRLs Under Yes................... HHS/FDA

Consideration at

Step 5.

Tilmicosin....... MRLs Under Yes................... HHS/FDA

Consideration at

Step 5.

----------------------------------------------------------------------------------------------------------------

In addition, the following matter will be brought to the

attention of the 22nd Session of the Codex Alimentarius Commission

in June 1997 for adoption:

Amendments to Methods of Analysis for Previously

Adopted Maximum Residue Limits for Veterinary Drugs

Priority List of Veterinary Drugs Requiring Evaluation

or Reevaluation.

Responsible Agency:

HHS/FDA

USDA/FSIS

US Participation: Yes

Food Additives and Contaminants

The Codex Committee on Food Additives and Contaminants (CCFAC)

establishes or endorses permitted maximum or guideline levels for

individual food additives, contaminants, and naturally occurring

toxicants in food and animal feed. The 29th Session of the CCFAC met

March 17-21, 1997, in the Hague, The Netherlands. The 30th Session

of the CCFAC is tentatively scheduled for March 9-13, 1998, in the

Hague, The Netherlands. The following matters contained in ALINORMS

12 and 12A are under consideration by the CCFAC:

Food Additives

Proposed Draft General Standard for Food Additives:

Preamble (forward to Commission at Step 8); Annex A (Guidelines for

the Estimation of Appropriate Levels of Use of Food Additives) to be

revised for consideration at Step 5; additives with nonnumerical

JECFA ADIs (forward to Commission at Step 5 with recommendation to

adopt Step 8); antioxidants, preservatives, stabilizers, thickeners,

sweeteners with numerical JECFA ADIs (forward to Commission at Step

5); colours, colour retention agents, bulking agents, and

emulsifiers (Step 3) (see Table 1, below); and

Specifications for the following food additives are

recommended by the CCFAC for adoption by the Twenty-second Session

of the Codex Commission; acesulfame K, alitame, ammonia solution,

benzoic acid, benzyl alcohol, calcium benzoate, calcium cyclamate,

calcium dihydrogen phosphate, calcium stearoyl-2-lactylate,

carmines, curcumin, cyclohexysulfamic acid, dodecyl gallate, ethyl

acetate, ethyl alcohol, glycerol ester of wood rosin, hydrochloride

acid, isomalt, konjac flour, lactic acid, nitrogen, octyl gallate,

phosphoric acid, polydextrose, potassium benzoate, potassium

bromate, potassium nitrate, propyl gallate, sodium benzoate, sodium

cyclamate, sodium metaphosphate (insoluable), sodium nitrate, sodium

nitrite, sodium polyphosphates (glassy), sodium stearoyl-2-

lactylate, sorbitol syrup, stearyl tartrate, sucrose acetate

isobutyrate, triacetin, and xylitol. Specifications for the

following flavouring agents are recommended by the CCFAC for

adoption by the Twenty-second Session of the Codex Commission: allyl

butyrate, allyl 2-ethylbutyrate, allyl hexanoate, allyl isovalerate,

allyl nonanoate, allyl octanoate, benzaldehyde, benzyl acetate,

benzyl alcohol, benzyl benzoate, ethyl alcohol, ethyl butyrate,

ethyl decanoate, ethyl dodecanoate, ethyl formate, ethyl heptanoate,

ethyl hexadecanoate, ethyl hexanoate, ethyl octadecanoate, ethyl

pentanoate, ethyl propionate, ethyl tetradecanoate, isoamyl alcohol,

isoamyl formate, isoamyl hexanoate, and isoamyl propionate.

Specifications for the following food additives are recommended by

the CCFAC for adoption after changes considered editorial have been

made by the Twenty-second Session of the Codex Commission:

``-cyclodextrin, lactitol, maltitol, mannitol, mineral oil

(high viscosity), sodium thiocyanate, and sorbitol.

Specifications for the following flavouring agents are

recommended by the CCFAC for adoption after changes considered

editorial have been made by the Twenty-second Session of the Codex

Commission: allyl heptanoate, allyl phenoxyacetate, allyl 10-

undecanoate, and ethyl acetate.

Contaminants

Proposed Draft General Standard for Contaminants and

Toxicants in Food Annexes I (Criteria for the Establishment of

Maximum Levels in Foods), II (Procedure for Risk Management

Decisions), and III (Format of the Standard) to be forwarded to the

Twenty-second Session of the Commission at Step 8;

Proposed Draft General Standard for Contaminants and

Toxicants in Food: Introduction section of Annex IV (see attached

list) and the whole of Annex V (Food Categorisation System to be

used in the GSC) to be forwarded to the Twenty-second Session of the

Codex Committee for adoption at Step 8;

Position paper on zearalenone to be prepared for the

30th CCFAC;

Proposed Draft Code of Practice for the Reduction of

Aflatoxins in Raw Materials and Supplementary Feeding stuffs for

Milk-Producing Animals at Step 8;

Position paper on Ochratoxin A to be revised and to

include proposed maximum levels;

The CCFAC decided to discontinue consideration of the

guideline level of 0.5 mg/kg lead in the Draft Guideline Levels for

Cadmium and Lead in Cereals, Pulses and Legumes at Step 7 in view of

its decision to include a level of 0.2 mg/kg in the General Standard

for Contaminants and Toxins. The CCFAC decided to maintain the

guideline level of 0.1 mg/kg cadmium at Step 7;

Responsible Agency: HHS/FDA

U.S. Participation: Yes

Food Additives

For the purposes of Codex, a food additive means any substance

not normally consumed as a food by itself and not normally used as a

typical ingredient in the food, whether or not it has nutritive

value, the intentional addition of which to food for a technological

(including organoleptic) purpose in the manufacture, processing,

preparation, treatment, packing, packaging, transport, or holding of

such food results, or may be reasonably expected to result (directly

or indirectly), in it or its by-products becoming a component of or

otherwise affecting the characteristics of such foods. The food

additive term does not include ``contaminants'' or substances added

to food for maintaining or improving nutritional qualities.

The General Standard for Food Additives (GSFA) will set forth

maximum levels of use of food additives in various foods and food

categories. The maximum levels will be based on the food additive

provisions of previously established Codex commodity

[[Page 28419]]

standards, as well as on the use of the additives in non-

standardized foods.

Only those food additives for which an acceptable daily intake

(ADI) has been established by the Joint FAO/WHO Expert Committee on

Food Additives (JECFA) will be included in the general Standard for

Food Additives (GSFA). The draft GSFA, which is being developed in

stages, currently covers only those JECFA-reviewed food additives

that have non-numerical JECFA ADIs and additives with numerical

JECFA ADIs that are used as antioxidants, preservatives,

stabilizers, thickeners, and sweeteners. All of the additives that

are currently under consideration for inclusion in the draft GFSA

are listed below.

----------------------------------------------------------------------------------------------------------------

Status of US participation/

Codex committee Substance consideration agenda Responsible agency

----------------------------------------------------------------------------------------------------------------

(Food Additives and Acesulfame Maximum Levels Yes................ HHS/FDA

Contaminants) Ref. ALINORM 97/ Potassium. Under

12 and 97/12A. Consideration at

Step 5.

Acetic Acid....... Maximum Levels Yes................ HHS/FDA

Under

Consideration at

Step 5/8.

Acetic and Fatty Maximum Levels Yes................ HHS/FDA

Acid Esters of Under

Glycerol. Consideration at

Step 5/8.

Acetylated Maximum Levels Yes................ HHS/FDA

Distarch Adipate. Under

Consideration at

Step 5/8.

Acetylated Maximum Levels Yes................ HHS/FDA

Distarch Under

Phosphate. Consideration at

Step 5/8.

Acid Treated Maximum Levels Yes................ HHS/FDA

Starch. Under

Consideration at

Step 5/8.

(Food Additives and Agar.............. Maximum Levels Yes................ HHS/FDA

Contaminants) Ref. ALINORM 97/ Under

12 and 97/12A. Consideration at

Step 5/8.

Alginic Acid...... Maximum Levels Yes................ HHS/FDA

Under

Consideration at

Step 5/8.

Alitame........... Maximum Levels Yes................ HHS/FDA

Under

Consideration at

Step 5.

Alkaline Treated Maximum Levels Yes................ HHS/FDA

Starch. Under

Consideration at

Step 5/8.

Allura Red AC..... Maximum Levels Yes................ HHS/FDA

Under

Consideration at

Step 3.

Alpha-Amylase Maximum Levels Yes................ HHS/FDA

(Aspergillus Under

oryzae, var.). Consideration at

Step 3.

Alpha-amylase Maximum Levels Yes................ HHS/FDA

(Bacillus Under

megaterium Consideration at

expressed in Step 5/8.

Bacillus

subtilis).

Alpha-amylase Maximum Levels Yes................ HHS/FDA

(Bacillus Under

stearothermophilu Consideration at

s expressed in Step 5/8.

Bacillus

subtilis).

Alpha-amylase Maximum Levels Yes................ HHS/FDA

(Bacillus Under

stearothermophilu Consideration at

s). Step 5/8.

Alpha-amylase ( Maximum Levels Yes................ HHS/FDA

Bacillus Under

subtilis). Consideration at

Step 5/8.

Alpha-amylase Maximum Levels Yes................ HHS/FDA

(Carbohydrase) Under

(Bacillus Consideration at

lichenforms). Step 5/8.

Aluminum Ammonium Maximum Levels Yes................ HHS/FDA

Sulphate. Under

Consideration at

Step 5.

Aluminum Silicate. Maximum Levels Yes................ HHS/FDA

Under

Consideration at

Step 5/8.

(Food Additives and Amaranth.......... Maximum Levels Yes................ HHS/FDA

Contaminants) Ref. ALINORM 97/ Under

12 and 97/12A. Consideration at

Step 3.

Ammonium Acetate.. Maximum Levels Yes................ HHS/FDA

Under

Consideration at

Step 5/8.

Ammonium Alginate. Maximum Levels Yes................ HHS/FDA

Under

Consideration at

Step 5/8.

Ammonium Carbonate Maximum Levels Yes................ HHS/FDA

Under

Consideration at

Step 5/8.

Ammonium Chloride. Maximum Levels Yes................ HHS/FDA

Under

Consideration at

Step 5/8.

Ammonium Citrate.. Maximum Levels Yes................ HHS/FDA

Under

Consideration at

Step 5/8.

Ammonium Fumarate. Maximum Levels Yes................ HHS/FDA

Under

Consideration at

Step 5/8.

Ammonium Hydrogen Maximum Levels Yes................ HHS/FDA

Carbonate. Under

Consideration at

Step 5/8.

Ammonium Hydroxide Maximum Levels Yes................ HHS/FDA

Under

Consideration at

Step 5/8.

Ammonium Lactate.. Maximum Levels Yes................ HHS/FDA

Under

Consideration at

Step 5/8.

Ammonium Malate, Maximum Levels Yes................ HHS/FDA

D,L-. Under

Consideration at

Step 5/8.

Ammonium Polyphos- Maximum Levels Yes................ HHS/FDA

phate. Under

Consideration at

Step 3.

[[Page 28420]]

Ammonium Sulphate. Maximum Levels Yes................ HHS/FDA

Under

Consideration at

Step 5/8.

Annato Extracts Maximum Levels Yes................ HHS/FDA

(Includes Bixin Under

and Norbixin). Consideration at

Step 3.

Anoxomer.......... Maximum Levels Yes................ HHS/FDA

Under

Consideration at

Step 5.

(Food Additives and Ascorbic Acid..... Maximum Levels Yes................ HHS/FDA

Contaminants) Ref. ALINORM 97/ Under

12 and 97/12A. Consideration at

Step 5/8.

Ascorbyl Palmitate Maximum Levels Yes................ HHS/FDA

Under

Consideration at

Step 5.

Ascorbyl Stearate. Maximum Levels Yes................ HHS/FDA

Under

Consideration at

Step 5.

Aspartame......... Maximum Levels Yes................ HHS/FDA

Under

Consideration at

Step 5.

Azorubin.......... Maximum Levels Yes................ HHS/FDA

Under

Consideration at

Step 3.

Beeswax, White and Maximum Levels Yes................ HHS/FDA

Yellow. Under

Consideration at

Step 3.

Beet Red.......... Maximum Levels Yes................ HHS/FDA

Under

Consideration at

Step 5/8.

Benzoic Acid...... Maximum Levels Yes................ HHS/FDA

Under

Consideration at

Step 5.

BHA............... Maximum Levels Yes................ HHS/FDA

Under

Consideration at

Step 5.

BHT............... Maximum Levels Yes................ HHS/FDA

Under

Consideration at

Step 5.

Bleached Starch... Maximum Levels Yes................ HHS/FDA

Under

Consideration at

Step 5/8.

Bone Phosphate Maximum Levels Yes................ HHS/FDA

(Essentially Under

Calcium Phosphate Consideration at

Tribasic). Step 3.

Brilliant Black PN Maximum Levels Yes................ HHS/FDA

Under

Consideration at

Step 3.

Brilliant Blue FCF Maximum Levels Yes................ HHS/FDA

Under

Consideration at

Step 3.

Bromelain......... Maximum Levels Yes................ HHS/FDA

Under

Consideration at

Step 5/8.

(Food Additives and Brown HT.......... Maximum Levels Yes................ HHS/FDA

Contaminants) Ref. ALINORM 97/ Under

12 and 97/12A. Consideration at

Step 3.

Calcium Acetate... Maximum Levels Yes................ HHS/FDA

Under

Consideration at

Step 5/8.

Calcium Alginate.. Maximum Levels Yes................ HHS/FDA

Under

Consideration at

Step 5/8.

Calcium Aluminum Maximum Levels Yes................ HHS/FDA

Silicate. Under

Consideration at

Step 5/8.

Calcium Ascorbate. Maximum Levels Yes................ HHS/FDA

Under

Consideration at

Step 5/8.

Calcium Benzoate.. Maximum Levels Yes................ HHS/FDA

Under

Consideration at

Step 5.

Calcium Carbonate. Maximum Levels Yes................ HHS/FDA

Under

Consideration at

Step 5/8.

Calcium Chloride.. Maximum Levels Yes................ HHS/FDA

Under

Consideration at

Step 5/8.

Calcium Citrate... Maximum Levels Yes................ HHS/FDA

Under

Consideration at

Step 5/8.

Calcium Dihydrogen Maximum Levels Yes................ HHS/FDA

Diphosphate. Under

Consideration at

Step 3.

Calcium Disodium Maximum Levels Yes................ HHS/FDA

Ethylenediaminete Under

tra-acetate. Consideration at

Step 5.

Calcium Formate... Maximum Levels Yes................ HHS/FDA

Under

Consideration at

Step 5.

Calcium Gluconate. Maximum Levels Yes................ HHS/FDA

Under

Consideration at

Step 5.

Calcium Glutamate, Maximum Levels Yes................ HHS/FDA

DL, L-. Under

Consideration at

Step 5/8.

Calcium Guanylate, Maximum Levels Yes................ HHS/FDA

5'. Under

Consideration at

Step 5/8.

(Food Additives and Calcium Hydrogen Maximum Levels Yes................ HHS/FDA

Contaminants) Ref. ALINORM 97/ Sulphite. Under

12 and 97/12A. Consideration at

Step 5/8.

Calcium Hydroxide. Maximum Levels Yes................ HHS/FDA

Under

Consideration at

Step 5/8.

Calcium Inosinate, Maximum Levels Yes................ HHS/FDA

5'. Under

Consideration at

Step 5/8.

[[Page 28421]]

Calcium Lactate... Maximum Levels Yes................ HHS/FDA

Under

Consideration at

Step 5/8.

Calcium Malate, D, Maximum Levels Yes................ HHS/FDA

L-. Under

Consideration at

Step 5/8.

Calcium Oleyl Maximum Levels Yes................ HHS/FDA

Lactylate. Under

Consideration at

Step 3.

Calcium Oxide..... Maximum Levels Yes................ HHS/FDA

Under

Consideration at

Step 5/8.

Calcium Maximum Levels Yes................ HHS/FDA

Polyphosphate. Under

Consideration at

Step 5.

Calcium Propionate Maximum Levels Yes................ HHS/FDA

Under

Consideration at

Step 5/8.

Calcium Maximum Levels Yes................ HHS/FDA

Ribonucleotides, Under

5'-. Consideration at

Step 5/8.

Calcium Silicate.. Maximum Levels Yes................ HHS/FDA

Under

Consideration at

Step 5/8.

Calcium Sorbate... Maximum Levels Yes................ HHS/FDA

Under

Consideration at

Step 5.

Calcium Stearoyl Maximum Levels Yes................ HHS/FDA

Lactylate. Under

Consideration at

Step 5.

Calcium Sulphate.. Maximum Levels Yes................ HHS/FDA

Under

Consideration at

Step 5/8.

Calcium Sulphite.. Maximum Levels Yes................ HHS/FDA

Under

Consideration at

Step 5.

(Food Additives and Candelilla Wax.... Maximum Levels Yes................ HHS/FDA

Contaminants) Ref. ALINORM 97/ Under

12 and 97/12A. Consideration at

Step 3.

Canthaxanthin..... Maximum Levels Yes................ HHS/FDA

Under

Consideration at

Step 3.

Caramel Colour, Maximum Levels Yes................ HHS/FDA

Class I. Under

Consideration at

Step 5/8.

Caramel Colour, Maximum Levels Yes................ HHS/FDA

Class III. Under

Consideration at

Step 3.

Caramel Colour, Maximum Levels Yes................ HHS/FDA

Class IV. Under

Consideration at

Step 3.

Carbon Dioxide.... Maximum Levels Yes................ HHS/FDA

Under

Consideration at

Step 5/8.

Carmines (Includes Maximum Levels Yes................ HHS/FDA

Aluminum and Under

Calcium Lakes of Consideration at

Carminic Acid). Step 3.

Carnuba Wax....... Maximum Levels Yes................ HHS/FDA

Under

Consideration at

Step 3.

Carob Bean Gum.... Maximum Levels Yes................ HHS/FDA

Under

Consideration at

Step 5/8.

Carotenes, Maximum Levels Yes................ HHS/FDA

Vegetable. Under

Consideration at

Step 3.

Carotene, -(synthetic). Under

Consideration at

Step 3.

Carotene, -apo-8'-. Under

Consideration at

Step 3.

Carotenic Acid, Maximum Levels Yes................ HHS/FDA

-apo-8', Under

methyl or ethyl Consideration at

ester. Step 3.

Carrageenan....... Maximum Levels Yes................ HHS/FDA

Under

Consideration at

Step 5/8.

Chlorophyll s..... Maximum Levels Yes................ HHS/FDA

Under

Consideration at

Step 5/8.

(Food Additives and Chlorophylls, Maximum Levels Yes................ HHS/FDA

Contaminants) Ref. ALINORM 97/ Copper Complex. Under

12 and 97/12A. Consideration at

Step 3.

Chlorophyllin Maximum Levels Yes................ HHS/FDA

Copper Complex, Under

Sodium and Consideration at

Potassium salts. Step 3.

Cholic Acid....... Maximum Levels Yes................ HHS/FDA

Under

Consideration at

Step 3.

Citric Acid....... Maximum Levels Yes................ HHS/FDA

Under

Consideration at

Step 5/8.

Citric and Fatty Maximum Levels Yes................ HHS/FDA

Acid Esters of Under

Glycerol. Consideration at

Step 5/8.

Curcumin.......... Maximum Levels Yes................ HHS/FDA

Under

Consideration at

Step 3.

Cyclamates (acid Maximum Levels Yes................ HHS/FDA

and Na, K, Ca Under

salts). Consideration at

Step 5.

Dextrins, White Maximum Levels Yes................ HHS/FDA

and Yellow, Under

Roasted Starch. Consideration at

Step 5/8.

[[Page 28422]]

Diacetyltartaric Maximum Levels Yes................ HHS/FDA

Acid and Fatty Under

Acid Esters of Consideration at

Glycerol. Step 5.

Dicalcium Maximum Levels Yes................ HHS/FDA

Diphosphate. Under

Consideration at

Step 3.

Dicalcium Maximum Levels Yes................ HHS/FDA

Orthophosphate. Under

Consideration at

Step 5.

Dilauryl Maximum Levels Yes................ HHS/FDA

Thiodipropionate. Under

Consideration at

Step 5.

Dimagnesium Maximum Levels Yes................ HHS/FDA

Orthophosphate. Under

Consideration at

Step 3.

Dimethyl Maximum Levels Yes................ HHS/FDA

Dicarbonate. Under

Consideration at

Step 3.

(Food Additives and Dioctyl Sodium Maximum Levels Yes................ HHS/FDA

Contaminants) Ref. ALINORM 97/ Sulfosuccinate. Under

12 and 97/12A. Consideration at

Step 5.

Diphenyl.......... Maximum Levels Yes................ HHS/FDA

Under

Consideration at

Step 5.

Dipotassium Maximum Levels Yes................ HHS/FDA

Diphosphate. Under

Consideration at

Step 5.

Dipotassium Maximum Levels Yes................ HHS/FDA

Guanylate, 5'. Under

Consideration at

Step 5/8.

Dipotassium Maximum Levels Yes................ HHS/FDA

Inosinate, 5'. Under

Consideration at

Step 5/8.

Dipotassium Maximum Levels Yes................ HHS/FDA

Orthophosphate. Under

Consideration at

Step 5.

Dipotassium Maximum Levels Yes................ HHS/FDA

Tartrate. Under

Consideration at

Step 5.

Disodium Maximum Levels Yes................ HHS/FDA

Diphosphate. Under

Consideration at

Step 5.

Disodium Maximum Levels Yes................ HHS/FDA

Ethylenediaminete Under

tra-acetate. Consideration at

Step 5.

Disodium Maximum Levels Yes................ HHS/FDA

Guanylate, 5'. Under

Consideration at

Step 5/8.

Disodium Maximum Levels Yes................ HHS/FDA

Inosinate, 5'. Under

Consideration at

Step 5/8.

Disodium Maximum Levels Yes................ HHS/FDA

Orthophosphate. Under

Consideration at

Step 5.

Disodium Maximum Levels Yes................ HHS/FDA

Ribonucleotides, Under

5'. Consideration at

Step 5/8.

Disodium Tartrate. Maximum Levels Yes................ HHS/FDA

Under

Consideration at

Step 5.

Disodium Phosphate Maximum Levels Yes................ HHS/FDA

Under

Consideration at

Step 5/8.

(Food Additives and Enzyme Treated Maximum Levels Yes................ HHS/FDA

Contaminants) Ref. ALINORM 97/ Starch. Under

12 and 97/12A. Consideration at

Step 5/8.

Erythorbic Acid... Maximum Levels Yes................ HHS/FDA

Under

Consideration at

Step 5/8.

Erythrosine....... Maximum Levels Yes................ HHS/FDA

Under

Consideration at

Step 3.

Ethyl Cellulose... Maximum Levels Yes................ HHS/FDA

Under

Consideration at

Step 5/8.

Ethyl Hydroxyethyl Maximum Levels Yes................ HHS/FDA

Cellulose. Under

Consideration at

Step 5/8.

Ethyl p- Maximum Levels Yes................ HHS/FDA

Hydroxybenzoate. Under

Consideration at

Step 5.

Ethyl Maltol...... Maximum Levels Yes................ HHS/FDA

Under

Consideration at

Step 5.

Fast Green FCF.... Maximum Levels Yes................ HHS/FDA

Under

Consideration at

Step 3.

Ferrous Gluconate. Maximum Levels Yes................ HHS/FDA

Under

Consideration at

Step 5.

Ferrous Lactate... Maximum Levels Yes................ HHS/FDA

Under

Consideration at

Step 3.

Formic Acid....... Maximum Levels Yes................ HHS/FDA

Under

Consideration at

Step 5.

Fumaric Acid...... Maximum Levels Yes................ HHS/FDA

Under

Consideration at

Step 5/8.

Gellan Gum........ Maximum Levels Yes................ HHS/FDA

Under

Consideration at

Step 5/8.

Glucono delta- Maximum Levels Yes................ HHS/FDA

lactone. Under

Consideration at

Step 5/8.

Glucose Oxidase Maximum Levels Yes................ HHS/FDA

(Aspergillus Under

niger, var.). Consideration at

Step 5/8.

[[Page 28423]]

(Food Additives and Glutamic Acid, L-. Maximum Levels Yes................ HHS/FDA

Contaminants) Ref. ALINORM 97/ Under

12 and 97/12A. Consideration at

Step 5/8.

Glycerol.......... Maximum Levels Yes................ HHS/FDA

Under

Consideration at

Step 5/8.

Glycerol Ester of Maximum Levels Yes................ HHS/FDA

Wood Rosin. Under

Consideration at

Step 5.

Grape Skin Extract Maximum Levels Yes................ HHS/FDA

Under

Consideration at

Step 3.

Guaiac Resin...... Maximum Levels Yes................ HHS/FDA

Under

Consideration at

Step 5.

Guanylic Acid, 5'. Maximum Levels Yes................ HHS/FDA

Under

Consideration at

Step 5/8.

Guar Gum.......... Maximum Levels Yes................ HHS/FDA

Under

Consideration at

Step 5/8.

Gum Arabic........ Maximum Levels Yes................ HHS/FDA

Under

Consideration at

Step 5/8.

Hexamethylene Maximum Levels Yes................ HHS/FDA

Tetramine. Under

Consideration at

Step 5.

Hydrochloric Acid. Maximum Levels Yes................ HHS/FDA

Under

Consideration at

Step 5/8.

Hydroxypropyl Maximum Levels Yes................ HHS/FDA

Cellulose. Under

Consideration at

Step 5/8.

Hydroxypropyl Maximum Levels Yes................ HHS/FDA

Distarch Under

Phosphate. Consideration at

Step 5/8.

Hydroxypropyl Maximum Levels Yes................ HHS/FDA

Methyl Cellulose. Under

Consideration at

Step 5/8.

Hydroxypropyl Maximum Levels Yes................ HHS/FDA

Starch. Under

Consideration at

Step 5/8.

Indigotine........ Maximum Levels Yes................ HHS/FDA

Under

Consideration at

Step 3.

(Food Additives and Inosinic Acid, 5'. Maximum Levels Yes................ HHS/FDA

Contaminants) Ref. ALINORM 97/ Under

12 and 97/12A. Consideration at

Step 5/8.

Insoluable Maximum Levels Yes................ HHS/FDA

Polyvinylpyrrolid Under

one. Consideration at

Step 5/8.

Iron Carbonate.... Maximum Levels Yes................ HHS/FDA

Under

Consideration at

Step 5/8.

Iron Oxides Maximum Levels Yes................ HHS/FDA

(Black, Red, & Under

Yellow). Consideration at

Step 3.

Isomalt........... Maximum Levels Yes................ HHS/FDA

Under

Consideration at

Step 5/8.

Isopropyl Citrates Maximum Levels Yes................ HHS/FDA

Under

Consideration at

Step 5.

Karaya Gum........ Maximum Levels Yes................ HHS/FDA

Under

Consideration at

Step 5/8.

Konjac Flour...... Maximum Levels Yes................ HHS/FDA

Under

Consideration at

Step 5/8.

Lactic Acid....... Maximum Levels Yes................ HHS/FDA

Under

Consideration at

Step 5/8.

Lactic and Fatty Maximum Levels Yes................ HHS/FDA

Acid Esters of Under

Glycerol. Consideration at

Step 5/8.

Lactitol.......... Maximum Levels Yes................ HHS/FDA

Under

Consideration at

Step 5/8.

Lethicin.......... Maximum Levels Yes................ HHS/FDA

Under

Consideration at

Step 5/8.

Lipase (Animal Maximum Levels Yes................ HHS/FDA

Sources). Under

Consideration at

Step 5/8.

Lipase Maximum Levels Yes................ HHS/FDA

(Aspergillus Under

oryzae, var.). Consideration at

Step 5/8.

(Food Additives and Lysozyme, Maximum Levels Yes................ HHS/FDA

Contaminants) Ref. ALINORM 97/ Hydrochloride. Under

12 and 97/12A. Consideration at

Step 3.

Magnesium Maximum Levels Yes................ HHS/FDA

Carbonate. Under

Consideration at

Step 5/8.

Magnesium Chloride Maximum Levels Yes................ HHS/FDA

Under

Consideration at

Step 5/8.

Magnesium Maximum Levels Yes................ HHS/FDA

Glutamate, DL, L-. Under

Consideration at

Step 5/8.

Magnesium Hydrogen Maximum Levels Yes................ HHS/FDA

Carbonate. Under

Consideration at

Step 5/8.

Magnesium Maximum Levels Yes................ HHS/FDA

Hydroxide. Under

Consideration at

Step 5/8.

Magnesium Lactate, Maximum Levels Yes................ HHS/FDA

DL, L-. Under

Consideration at

Step 5/8.

[[Page 28424]]

Magnesium Oxide... Maximum Levels Yes................ HHS/FDA

Under

Consideration at

Step 5/8.

Magnesium Silicate Maximum Levels Yes................ HHS/FDA

(Synthetic). Under

Consideration at

Step 5/8.

Magnesium Sulphate Maximum Levels Yes................ HHS/FDA

Under

Consideration at

Step 5/8.

Malic Acid, D, L-. Maximum Levels Yes................ HHS/FDA

Under

Consideration at

Step 5/8.

Malitol (Including Maximum Levels Yes................ HHS/FDA

Malitol Syrup). Under

Consideration at

Step 5/8.

Maltol............ Maximum Levels Yes................ HHS/FDA

Under

Consideration at

Step 5.

Mannitol.......... Maximum Levels Yes................ HHS/FDA

Under

Consideration at

Step 5/8.

Methyl Cellulose.. Maximum Levels Yes................ HHS/FDA

Under

Consideration at

Step 5/8.

(Food Additives and Methyl Ethyl Maximum Levels Yes................ HHS/FDA

Contaminants) Ref. ALINORM 97/ Cellulose. Under

12 and 97/12A. Consideration at

Step 5/8.

Methyl p- Maximum Levels Yes................ HHS/FDA

Hydroxybenzoate. Under

Consideration at

Step 5.

Microcrystalline Maximum Levels Yes................ HHS/FDA

Cellulose. Under

Consideration at

Step 5/8.

Microcrystalline Maximum Levels Yes................ HHS/FDA

Wax, Synthetic. Under

Consideration at

Step 3.

Mineral Oil....... Maximum Levels Yes................ HHS/FDA

Under

Consideration at

Step 5.

Mono-and Maximum Levels Yes................ HHS/FDA

Diglycerides. Under

Consideration at

Step 5/8.

Monoammonium Maximum Levels Yes................ HHS/FDA

Glutamate, L-. Under

Consideration at

Step 5/8.

Monocalcium Maximum Levels Yes................ HHS/FDA

Orthophosphate. Under

Consideration at

Step 5.

Monopotassium Maximum Levels Yes................ HHS/FDA

Glutamate, L-. Under

Consideration at

Step 5/8.

Monopotassium Maximum Levels Yes................ HHS/FDA

Orthophosphate. Under

Consideration at

Step 5.

Monopotassium Maximum Levels Yes................ HHS/FDA

Tartrate. Under

Consideration at

Step 5.

Monosodium Maximum Levels Yes................ HHS/FDA

Glutamate, L-. Under

Consideration at

Step 5/8.

Monosodium Maximum Levels Yes................ HHS/FDA

Orthophosphate. Under

Consideration at

Step 5.

Monosodium Maximum Levels Yes................ HHS/FDA

Tartrate. Under

Consideration at

Step 5.

Monosodium Maximum Levels Yes................ HHS/FDA

Phosphate. Under

Consideration at

Step 5/8.

(Food Additives and Nisin............. Maximum Levels Yes................ HHS/FDA

Contaminants) Ref. ALINORM 97/ Under

12 and 97/12A. Consideration at

Step 5.

Nitrogen.......... Maximum Levels Yes................ HHS/FDA

Under

Consideration at

Step 5/8.

Orthophenylphenol. Maximum Levels Yes................ HHS/FDA

Under

Consideration at

Step 5.

Orthophosphoric Maximum Levels Yes................ HHS/FDA

Acid. Under

Consideration at

Step 5.

Oxidized Starch... Maximum Levels Yes................ HHS/FDA

Under

Consideration at

Step 5/8.

Papain............ Maximum Levels Yes................ HHS/FDA

Under

Consideration at

Step 5/8.

Pectins (Amidated Maximum Levels Yes................ HHS/FDA

and non-Amidated). Under

Consideration at

Step 5/8.

Pentapotassium Maximum Levels Yes................ HHS/FDA

Triphosphate. Under

Consideration at

Step 5.

Pentasodium Maximum Levels Yes................ HHS/FDA

Triphosphate. Under

Consideration at

Step 5.

Phosphated Maximum Levels Yes................ HHS/FDA

Distarch Under

Phosphate. Consideration at

Step 5/8.

Pimaricin......... Maximum Levels Yes................ HHS/FDA

Under

Consideration at

Step 5.

Polydextroses..... Maximum Levels Yes................ HHS/FDA

Under

Consideration at

Step 5/8.

Polyethylene Maximum Levels Yes................ HHS/FDA

Glycol. Under

Consideration at

Step 5.

[[Page 28425]]

Polyglycerol Maximum Levels Yes................ HHS/FDA

Esters of Fatty Under

Acids. Consideration at

Step 5.

(Food Additives and Polyglycerol Maximum Levels Yes................ HHS/FDA

Contaminants) Ref. ALINORM 97/ Esters of Under

12 and 97/12A. Interesterified Consideration at

Ricinoleic Acid. Step 5.

Polyoxyethylene Maximum Levels Yes................ HHS/FDA

(8) Stearate. Under

Consideration at

Step 5.

Polysorbates 20, Maximum Levels Yes................ HHS/FDA

40, 60, 65, and Under

80. Consideration at

Step 5.

Polyvinylpyrrolido Maximum Levels Yes................ HHS/FDA

ne. Under

Consideration at

Step 5.

Ponceau 4R........ Maximum Levels Yes................ HHS/FDA

Under

Consideration at

Step 3.

Potassium Acetate. Maximum Levels Yes................ HHS/FDA

Under

Consideration at

Step 5/8.

Potassium Benzoate Maximum Levels Yes................ HHS/FDA

Under

Consideration at

Step 5.

Potassium Alginate Maximum Levels Yes................ HHS/FDA

Under

Consideration at

Step 5/8.

Potassium Maximum Levels Yes................ HHS/FDA

Ascorbate. Under

Consideration at

Step 5/8.

Potassium Maximum Levels Yes................ HHS/FDA

Bisulphate. Under

Consideration at

Step 5.

Potassium Maximum Levels Yes................ HHS/FDA

Carbonate. Under

Consideration at

Step 5/8.

Potassium Chloride Maximum Levels Yes................ HHS/FDA

Under

Consideration at

Step 5/8.

Potassium Maximum Levels Yes................ HHS/FDA

Dihydrogen Under

Citrate. Consideration at

Step 5/8.

Potassium Hydrogen Maximum Levels Yes................ HHS/FDA

Carbonate. Under

Consideration at

Step 5/8.

(Food Additives and Potassium Hydrogen Maximum Levels Yes................ HHS/FDA

Contaminants) Ref. ALINORM 97/ Malate, D, L-. Under

12 and 97/12A. Consideration at

Step 5/8.

Potassium Maximum Levels Yes................ HHS/FDA

Hydroxide. Under

Consideration at

Step 5/8.

Potassium Lactate Maximum Levels Yes................ HHS/FDA

(Solution). Under

Consideration at

Step 5/8.

Potassium Malate, Maximum Levels Yes................ HHS/FDA

D, L-. Under

Consideration at

Step 5/8.

Potassium Maximum Levels Yes................ HHS/FDA

Metabisul- phate. Under

Consideration at

Step 5.

Potassium Nitrate. Maximum Levels Yes................ HHS/FDA

Under

Consideration at

Step 5.

Potassium Polyphos- Maximum Levels Yes................ HHS/FDA

phate. Under

Consideration at

Step 5.

Potassium Maximum Levels Yes................ HHS/FDA

Propiniate. Under

Consideration at

Step 5/8.

Potassium Silicate Maximum Levels Yes................ HHS/FDA

Under

Consideration at

Step 5/8.

Potassium Sodium Maximum Levels Yes................ HHS/FDA

Tartrate. Under

Consideration at

Step 5.

Potassium Sorbate. Maximum Levels Yes................ HHS/FDA

Under

Consideration at

Step 5.

Potassium Sulphate Maximum Levels Yes................ HHS/FDA

Under

Consideration at

Step 5/8.

Potassium Sulphite Maximum Levels Yes................ HHS/FDA

Under

Consideration at

Step 5.

Powdered Cellulose Maximum Levels Yes................ HHS/FDA

Under

Consideration at

Step 5/8.

(Food Additives and Processed Eucheuma Maximum Levels Yes................ HHS/FDA

Contaminants) Ref. ALINORM 97/ Seaweed. Under

12 and 97/12A. Consideration at

Step 5.

Propane........... Maximum Levels Yes................ HHS/FDA

Under

Consideration at

Step 5/8.

Propionic Acid.... Maximum Levels Yes................ HHS/FDA

Under

Consideration at

Step 5/8.

Propyl Gallate.... Maximum Levels Yes................ HHS/FDA

Under

Consideration at

Step 5.

Propyl p-Hydroxy- Maximum Levels Yes................ HHS/FDA

benzoate. Under

Consideration at

Step 5.

Propylene Glycol.. Maximum Levels Yes................ HHS/FDA

Under

Consideration at

Step 5.

Propylene Glycol Maximum Levels Yes................ HHS/FDA

Alginate. Under

Consideration at

Step 5.

[[Page 28426]]

Propylene Glycol Maximum Levels Yes................ HHS/FDA

Esters of Fatty Under

Acids. Consideration at

Step 5.

Quinoline Yellow.. Maximum Levels Yes................ HHS/FDA

Under

Consideration at

Step 3.

Red 2G............ Maximum Levels Yes................ HHS/FDA

Under

Consideration at

Step 3.

Riboflavin........ Maximum Levels Yes................ HHS/FDA

Under

Consideration at

Step 3.

Riboflavin 5'- Maximum Levels Yes................ HHS/FDA

Phosphate, Sodium. Under

Consideration at

Step 3.

Saccharin (and Na, Maximum Levels Yes................ HHS/FDA

K, Ca, salts). Under

Consideration at

Step 5.

Salts of Fatty Maximum Levels Yes................ HHS/FDA

Acids (Ammonium, Under

Calcium, Consideration at

Potassium, Step 5/8.

Sodium).

(Food Additives and Silicon Dioxide Maximum Levels Yes................ HHS/FDA

Contaminants) Ref. ALINORM 97/ (Amorphous). Under

12 and 97/12A. Consideration at

Step 5/8.

Sodium Acetate.... Maximum Levels Yes................ HHS/FDA

Under

Consideration at

Step 5/8.

Sodium Alginate... Maximum Levels Yes................ HHS/FDA

Under

Consideration at

Step 5/8.

Sodium Maximum Levels Yes................ HHS/FDA

Aluminosilicate. Under

Consideration at

Step 5/8.

Sodium Aluminum Maximum Levels Yes................ HHS/FDA

Phosphate-Acidic. Under

Consideration at

Step 3.

Sodium Aluminum Maximum Levels Yes................ HHS/FDA

Phosphate-Basic. Under

Consideration at

Step 3.

Sodium Ascorbate.. Maximum Levels Yes................ HHS/FDA

Under

Consideration at

Step 5/8.

Sodium Benzoate... Maximum Levels Yes................ HHS/FDA

Under

Consideration at

Step 5.

Sodium Calcium Maximum Levels Yes................ HHS/FDA

Polyphosphate. Under

Consideration at

Step 3.

Sodium Carbonate.. Maximum Levels Yes................ HHS/FDA

Under

Consideration at

Step 5/8.

Sodium Maximum Levels Yes................ HHS/FDA

Carboxymethyl Under

Cellulose. Consideration at

Step 5/8.

Sodium Diacetate.. Maximum Levels Yes................ HHS/FDA

Under

Consideration at

Step 5.

Sodium Dihydrogen Maximum Levels Yes................ HHS/FDA

Citrate. Under

Consideration at

Step 5/8.

Sodium Ethyl p- Maximum Levels Yes................ HHS/FDA

Hydroxybenzoate. Under

Consideration at

Step 5.

(Food Additives and Sodium Erythorbate Maximum Levels Yes................ HHS/FDA

Contaminants) Ref. ALINORM 97/ Under

12 and 97/12A. Consideration at

Step 5/8.

Sodium Formate.... Maximum Levels Yes................ HHS/FDA

Under

Consideration at

Step 5.

Sodium Fumarate... Maximum Levels Yes................ HHS/FDA

Under

Consideration at

Step 5/8.

Sodium Hydrogen Maximum Levels Yes................ HHS/FDA

Carbonate. Under

Consideration at

Step 5/8.

Sodium Hydrogen Maximum Levels Yes................ HHS/FDA

Malate, D, L-. Under

Consideration at

Step 5/8.

Sodium Hydrogen Maximum Levels Yes................ HHS/FDA

Sulphite. Under

Consideration at

Step 5.

Sodium Hydroxide.. Maximum Levels Yes................ HHS/FDA

Under

Consideration at

Step 5/8.

Sodium Lactate Maximum Levels Yes................ HHS/FDA

(Solution). Under

Consideration at

Step 5/8.

Sodium Malate, D, Maximum Levels Yes................ HHS/FDA

L-. Under

Consideration at

Step 5/8.

Sodium Maximum Levels Yes................ HHS/FDA

Metabisulphite. Under

Consideration at

Step 5.

Sodium Methyl p- Maximum Levels Yes................ HHS/FDA

Hydroxybenzoate. Under

Consideration at

Step 5.

Sodium Nitrate.... Maximum Levels Yes................ HHS/FDA

Under

Consideration at

Step 5.

Sodium Nitrite.... Maximum Levels Yes................ HHS/FDA

Under

Consideration at

Step 5.

Sodium Oleyl Maximum Levels Yes................ HHS/FDA

Lactylate. Under

Consideration at

Step 5.

[[Page 28427]]

(Food Additives and Sodium o- Maximum Levels Yes................ HHS/FDA

Contaminants) Ref. ALINORM 97/ Phenylphenol. Under

12 and 97/12A. Consideration at

Step 5.

Sodium Maximum Levels Yes................ HHS/FDA

Polyphosphate. Under

Consideration at

Step 5.

Sodium Propionate. Maximum Levels Yes................ HHS/FDA

Under

Consideration at

Step 5.

Sodium Propyl p- Maximum Levels Yes................ HHS/FDA

Hydroxybenzoate. Under

Consideration at

Step 5.

Sodium Maximum Levels Yes................ HHS/FDA

Sesquicarbonate. Under

Consideration at

Step 5/8.

Sodium Silicate... Maximum Levels Yes................ HHS/FDA

Under

Consideration at

Step 5/8.

Sodium Sorbate.... Maximum Levels Yes................ HHS/FDA

Under

Consideration at

Step 5.

Sodium Sulphite... Maximum Levels Yes................ HHS/FDA

Under

Consideration at

Step 5.

Sodium Stearoyl Maximum Levels Yes................ HHS/FDA

Lactylate. Under

Consideration at

Step 5.

Sodium Sulphate... Maximum Levels Yes................ HHS/FDA

Under

Consideration at

Step 5/8.

Sodium Sulphite... Maximum Levels Yes................ HHS/FDA

Under

Consideration at

Step 5.

Sorbic Acid....... Maximum Levels Yes................ HHS/FDA

Under

Consideration at

Step 5.

Sorbitan Maximum Levels Yes................ HHS/FDA

Monolaurate. Under

Consideration at

Step 5.

Sorbitan Maximum Levels Yes................ HHS/FDA

Monooleate. Under

Consideration at

Step 5.

(Food Additives and Sorbitan Maximum Levels Yes................ HHS/FDA

Contaminants) Ref. ALINORM 97/ Monpalmitate. Under

12 and 97/12A. Consideration at

Step 5.

Sorbitan Maximum Levels Yes................ HHS/FDA

Monostearate. Under

Consideration at

Step 5.

Sorbitan Trioleate Maximum Levels Yes................ HHS/FDA

Under

Consideration at

Step 5.

Sorbitan Maximum Levels Yes................ HHS/FDA

Triesterate. Under

Consideration at

Step 5.

Sorbitol Maximum Levels Yes................ HHS/FDA

(Including Under

Sorbitol Syrup). Consideration at

Step 5/8.

Stannous Chloride. Maximum Levels Yes................ HHS/FDA

Under

Consideration at

Step 5.

Starch Acetate.... Maximum Levels Yes................ HHS/FDA

Under

Consideration at

Step 5/8.

Starch Sodium Maximum Levels Yes................ HHS/FDA

Octenylsuccinate. Under

Consideration at

Step 5/8.

Stearyl Citrate... Maximum Levels Yes................ HHS/FDA

Under

Consideration at

Step 3.

Stearyl Tartrate.. Maximum Levels Yes................ HHS/FDA

Under

Consideration at

Step 3.

Sucralose......... Maximum Levels Yes................ HHS/FDA

Under

Consideration at

Step 5.

Sucroglycerides... Maximum Levels Yes................ HHS/FDA

Under

Consideration at

Step 5.

Sucrose Acetate Maximum Levels Yes................ HHS/FDA

Isobutyrate. Under

Consideration at

Step 5.

Sucrose Fatty Acid Maximum Levels Yes................ HHS/FDA

Esters. Under

Consideration at

Step 5.

(Food Additives and Sulphur Dioxide... Maximum Levels Yes................ HHS/FDA

Contaminants) Ref. ALINORM 97/ Under

12 and 97/12A. Consideration at

Step 5.

Sunset Yellow FCF. Maximum Levels Yes................ HHS/FDA

Under

Consideration at

Step 3.

Talc.............. Maximum Levels Yes................ HHS/FDA

Under

Consideration at

Step 5/8.

Tara Gum.......... Maximum Levels Yes................ HHS/FDA

Under

Consideration at

Step 5/8.

Tartaric, Acetic Maximum Levels Yes................ HHS/FDA

and Fatty Acid Under

Esters of Consideration at

Glycerol (Mixed). Step 5/8.

Tartaric Acid Maximum Levels Yes................ HHS/FDA

(L(+)-). Under

Consideration at

Step 5.

tert- Maximum Levels Yes................ HHS/FDA

Butylhydroquinone Under

(TBHQ). Consideration at

Step 5.

Tetrapotassium Maximum Levels Yes................ HHS/FDA

Diphos- phate. Under

Consideration at

Step 5.

[[Page 28428]]

Tetrasodium Diphos- Maximum Levels Yes................ HHS/FDA

phate. Under

Consideration at

Step 5.

Thaumatin......... Maximum Levels Yes................ HHS/FDA

Under

Consideration at

Step 5/8.

Thiodipropi- onic Maximum Levels Yes................ HHS/FDA

Acid. Under

Consideration at

Step 5/8.

Titanium Oxide.... Maximum Levels Yes................ HHS/FDA

Under

Consideration at

Step 5/8.

Tocopherols Maximum Levels Yes................ HHS/FDA

(Mixed, Under

Concentrate). Consideration at

Step 5.

(Food Additives and Tocopheral, alpha- Maximum Levels Yes................ HHS/FDA

Contaminants) Ref. ALINORM 97/ Under

12 and 97/12A. Consideration at

Step 5.

Tocopherals, Delta- Maximum Levels Yes................ HHS/FDA

, Synthetic. Under

Consideration at

Step 5.

Tocopherals, Gamma- Maximum Levels Yes................ HHS/FDA

, Synthetic. Under

Consideration at

Step 5.

Tragacanth Gum.... Maximum Levels Yes................ HHS/FDA

Under

Consideration at

Step 5/8.

Triacetin......... Maximum Levels Yes................ HHS/FDA

Under

Consideration at

Step 5/8.

Triammonium Maximum Levels Yes................ HHS/FDA

Citrate. Under

Consideration at

Step 5/8.

Tricalcium Maximum Levels Yes................ HHS/FDA

Orthophosphate. Under

Consideration at

Step 5.

Triethyl Citrate.. Maximum Levels Yes................ HHS/FDA

Under

Consideration at

Step 5.

Tripotassium Maximum Levels Yes................ HHS/FDA

Citrate. Under

Consideration at

Step 5/8.

Tripotassium Maximum Levels Yes................ HHS/FDA

Orthophosphate. Under

Consideration at

Step 5.

Trisodium Citrate. Maximum Levels Yes................ HHS/FDA

Under

Consideration at

Step 5/8.

Trisodium Diphos- Maximum Levels Yes................ HHS/FDA

phate. Under

Consideration at

Step 3.

Trisodium Maximum Levels Yes................ HHS/FDA

Orthophosphate. Under

Consideration at

Step 5.

Xanthan Gum....... Maximum Levels Yes................ HHS/FDA

Under

Consideration at

Step 5/8.

(Food Additives and Xylitol........... Maximum Levels Yes................ HHS/FDA

Contaminants) Ref. ALINORM 97/ Under

12 and 97/12A. Consideration at

Step 5/8.

----------------------------------------------------------------------------------------------------------------

Contaminants

A contaminant means any substance not intentionally added to

food, which is present in such food as a result of the production

(including operations carried out in crop husbandry, animal

husbandry and veterinary medicine), manufacture, processing,

preparation, treatment, packing, packaging, transport, or holding of

such food or as a result of environmental contamination. The term

contaminant does not include insect fragments, rodent hairs, and

other extraneous matter.

The Codex maximum level (ML) for a contaminant or naturally

occurring toxicant in a food or feed commodity is the maximum

concentration of that substance recommended by the Codex

Alimentarius Commission to be legally permitted in that commodity.

The ML is intended to ensure free movement of food in international

trade while protecting the health of the consumer.

The General Standard for Contaminants and Toxins in Foods will

establish maximum levels for contaminants in foods based on the

following considerations: toxicological data, human exposure

estimates, availability of analytical procedures, fair trade and

technological implications, regional variations, risk assessment,

and risk management.

The criteria for inclusion of a maximum level for a contaminant

in a food are: (a) consumption of the contaminated food presents a

significant risk to consumers; and (b) the existence of actual

problems in trade of food. The contaminants currently being examined

to determine whether they meet these criteria for inclusion in the

Codex General Standard for Contaminants and Toxins are listed below.

----------------------------------------------------------------------------------------------------------------

Status of U.S. participation/

Codex committee Standard consideration agenda Responsible agency

----------------------------------------------------------------------------------------------------------------

(CCFAC) Ref. ALINORM 97/12.... Arsenic.......... Position Paper to Yes................... HHS/FDA

be revised for

discussion

during the 1998

CCFAC.

Cadmium.......... Position Paper to Yes................... HHS/FDA

be revised for

discussion

during the 1998

CCFAC.

(CCFAC) Ref. ALINORM 97/12.... Lead............. Forwarded draft Yes................... HHS/FDA

maximum levels

to the

Commission at

Step 5 with

recommendation

for adoption.

[[Page 28429]]

Patulin.......... 29th CCFAC Yes................... HHS/FDA

requested

additional

information.

Position Paper

will be revised

for discussion

during 1998 CFAC.

Tin.............. 29th CCFAC Yes................... HHS/FDA

requested

additional

information.

Position Paper

will be revised

for discussion

during 1998

CCCAC.

Aflatoxin M1..... 29th CCFAC Yes................... HHS/FDA

maintained draft

maximum levels

in milk at Step

7.

Aflatoxins in Raw Draft Codex Yes................... HHS/FDA

Peanuts. Guideline Levels

and Sampling

Plans for Total

Aflatoxins in

raw shelled

peanuts at Step

7.

----------------------------------------------------------------------------------------------------------------

Codex Committee on Pesticide Residues

The Codex Committee on Pesticide Residues recommends to the

Codex Alimentarius Commission establishment of maximum limits for

pesticide residues for specific food items or in groups of food. A

Codex Maximum Limit for Pesticide Residues (MRLP) is the maximum

concentration of a pesticide residue (expressed as mg/kg),

recommended by the Codex Alimentarius Commission to be legally

permitted in or on food commodities and animal feeds. Foods derived

from commodities that comply with the respective MRLPs are intended

to be toxicologically acceptable, that is, consideration of the

various dietary residue intake estimates and determinations both at

the national and international level in comparison with the ADI*,

should indicate that foods complying with Codex MRLPs are safe for

human consumption.

Codex MRLPs are primarily intended to apply in international

trade and are derived from reviews conducted by the Joint Meeting on

Pesticide Residues (JMPR) following:

(a) Review of residue data from supervised trials and supervised

uses including those reflecting national good agricultural practices

(GAP). Data from supervised trials conducted at the highest

nationally recommended, authorized, or registered uses are included

in the review. In order to accommodate variations in national pest

control requirements, Codex MRLPs take into account the higher

levels shown to arise in such supervised trials, which are

considered to represent effective pest control practices, and

(b) Toxicological assessment of the pesticide and its residue.

MRLs recommended for advancement to steps 5 or 8 by the 28th and

29th CCPRs will be considered by the 22nd Session of the Codex

Alimentarius Commission in June 1997.

*Acceptable Daily Intake (ADI) of a chemical is the daily intake

which, during an entire lifetime, appears to be without appreciable

risk to the health of the consumer on the basis of all the known

facts at the time of the evaluation of the chemical by the Joint

FAO/WHO Meeting on Pesticide Residues. It is expressed in milligrams

of the chemical per kilogram of body weight.

----------------------------------------------------------------------------------------------------------------

Status of US Participation/

Codex committee Standard consideration agenda Responsible agency

----------------------------------------------------------------------------------------------------------------

Pesticide Residues (considered Aldicarb......... MRLs under Yes................... EPA

at the 28th and 29th CCPRs consideration at

(Annex II to ALINORMS 97/42 Steps 5 and 5/8

and 97/42A). and CXL

deletions.

Aldrin/dieldrin.. EMRLs at Step 8.. Yes................... EPA

Azinphos-methyl.. MRLs under Yes................... EPA

consideration at

Steps 5/8 and 8

and CXL

deletions.

Pesticide Residues (considered Bentazone........ MRLs under Yes................... EPA

at the 28th and 29th Session consideration at

of the Codex Committee on Step 8.

Pesticide Residues (Annex II

to ALINORMS 97/24 and 97/24A).

Bifenthrin....... MRLs under Yes................... EPA

consideration at

Step 8.

Bromide Ion...... MRLs under Yes................... EPA

consideration at

Step 8 and CXL

deletions.

Bromopropylate... MRLs under Yes................... EPA

consideration at

Step 8 and CXL

deletions.

Buprofezin....... MRLs under Yes................... EPA

consideration at

Step 8.

Captan........... Temporary CXLs Yes................... EPA

deleted.

Cartap........... CXL deletions Yes................... EPA

(all).

Chlormequat...... CXL deletions.... Yes................... EPA

Chlorothalonil... MRLs under Yes................... EPA

consideration at

Step 8 and CXL

deletions.

Chlorpyrifosmethy MRLs under Yes................... EPA

l. consideration at

Step 5.

[[Page 28430]]

Clethodim........ MRLs under Yes................... EPA

consideration at

Step 5.

Cycloxydim....... MRLs under Yes................... EPA

consideration at

Step 8.

DDT.............. MRLs under Yes................... EPA

consideration at

Step 8 and CXL

deletion.

Pesticide Residues (considered Diazinon......... MRLs under Yes................... EPA

at the 28th and 29th Session consideration at

of the Codex Committee on Steps 5/8 and 8

Pesticide Residues (Annex II and CXL

to ALINORMS 97/24 and 97/24A). deletions.

Dichlorvos....... MRLs under Yes................... EPA

consideration at

Step 8 and CXL

deletions.

Dicloran......... CXL deletions.... Yes................... EPA

Dicofol.......... MRLs under Yes................... EPA

consideration at

Step 8 and CXL

deletions.

Dimethoate....... MRLs under Yes................... EPA

consideration at

Step 8.

Diquat........... MRLs under Yes................... EPA

consideration at

Step 5 and CXL

deletions.

Dithianon........ MRLs under Yes................... EPA

consideration at

Step 8.

Dithiocarbamates. MRLs under Yes................... EPA

consideration at

Step 5 and CXL

deletions.

Endrin........... EMRLs under Yes................... EPA

consideration at

Step 8 and CXL

deletions.

Ethephon......... MRLs under Yes................... EPA

consideration at

Steps 5, 5/8 and

8.

Ethion........... MRLs under Yes................... EPA

consideration at

Step 8 and CXL

deletions.

Pesticide Residues (considered Ethofenprox...... MRLs under Yes................... PA

at the 28th and 29th Sesssion consideration at

of the Codex Committee on Step 8.

Pesticide Residues (Annex II

to ALINORMS 97/24 and 97/24A).

Ethoxyquin....... CXL deletion..... Yes................... EPA

Etrimfos......... CXL deletions Yes................... EPA

(all).

Fenarimol........ MRLs under Yes................... EPA

consideration at

Step 5 and 5/8.

Fenbutatin Oxide. MRLs under Yes................... EPA

consideration at

Step 8 and CXL

deletions.

Fenpropathrin.... MRLs under Yes................... EPA

consideration at

Step 8.

Fenpropimorph.... MRLs under Yes................... EPA

consideration at

Step 5.

Fenthion......... MRLs under Yes................... EPA

consideration at

Steps 5 and 5/8

and CXL

deletions.

Fentin........... CXL deletion..... Yes................... EPA

Flucythrinate.... CXL deletion..... Yes................... EPA

Flusilazole...... MRLs under Yes................... EPA

consideration at

Step 8.

Folpet........... MRLs under Yes................... EPA

consideration at

Step 8 and CXL

deletion.

Glufosinate- MRLs under Yes................... EPA

ammonium. consideration at

Steps 5/8 and 8.

Pesticide Residues (considered Glyphosate....... MRLs under Yes................... EPA

at the 28th and 29th Session consideration at

of the Codex Committee on Step 5/8 and CXL

Pesticide Residues (Annex II deletions.

to ALINORMS 97/24 and 97/24A).

Hexythiazox...... MRLs under Yes................... EPA

consideration at

Step 8.

Imazalil......... MRL under Yes................... EPA

consideration at

Step 5/8.

[[Page 28431]]

Iprodione........ MRLs under Yes................... EPA

consideration at

Step 5, 5/8 and

8 and CXL

deletions.

Isofenphos....... CXL deletions Yes................... EPA

(all).

Methacrifos...... CXL deletions Yes................... EPA

(all).

Methamidophos.... MRLs under Yes................... EPA

consideration at

Steps 5 and 8

and CXL deletion.

Methidathion..... MRLs under Yes................... EPA

consideration at

Step 8 and CXL

deletion.

Monocrotophos.... MRLs under Yes................... EPA

consideration at

Step 8 and CXL

deletions.

Myclobutanil..... MRL under Yes................... EPA

consideration at

Step 8.

Parathion........ MRLs under Yes................... EPA

consideration at

Step 8 and CXL

deletion.

Parathion-methyl. MRLs under Yes................... EPA

consideration at

Steps 5/8 and

CXL deletion.

Pesticide Residues Penconazole...... MRLs under Yes................... EPA

(considered at the 28th and consideration at

29th Session of the Codex Step 5/8 and 8.

Committee on Pesticide

Residues (Annex II to

ALINORMS 97/24 and 97/24A)

Phosalone........ CXL deletions.... Yes................... EPA

Pirimiphosmethyl. MRLs under Yes................... EPA

consideration at

Step 8.

Profenofos....... MRLs under Yes................... EPA

consideration at

Steps 5/8 and 8.

Propiconazole.... MRLs under Yes................... EPA

consideration at

Steps 5/8 and 8

and CXL deletion.

Pyrazophos....... MRLs under Yes................... EPA

consideration at

step 8.

Quintozene....... CXL deletion..... Yes................... EPA

Tebuconazole..... MRLs under Yes................... EPA

consideration at

Step 5/8.

Tolclofos-methyl. MRLs under Yes................... EPA

consideration at

Step 5/8.

Tecnazene........ MRLs under Yes................... EPA

consideration at

Step 8 and CXL

deletions.

Triadimefon...... MRLs under Yes................... EPA

consideration at

Step 8 and CXL

deletions.

Triadimenol...... MRLs under Yes................... EPA

consideration at

Step 8.

Triazophos....... MRL under Yes................... EPA

consideration at

Step 8.

Trichlorfon...... CXL deletions Yes................... EPA

(all).

----------------------------------------------------------------------------------------------------------------

Codex Committee on Methods of Analysis and Sampling

The Codex Committee on Methods of Analysis and Sampling:

(a) Defines the criteria appropriate to Codex Methods of

Analysis and Sampling;

(b) Serves as a coordinating body for Codex with other

international groups working in methods of analysis and sampling and

quality assurance systems for laboratories;

(c) Specifies, on the basis of final recommendations submitted

to it by the other bodies referred to in (b) above, Reference

Methods of Analysis and Sampling appropriate to Codex Standards

which are generally applicable to a number of foods;

(d) Considers, amends, if necessary, and endorses, as

appropriate, methods of analysis and sampling proposed by Codex

(Commodity) Committees, except that methods of analysis and sampling

for residues of pesticides or veterinary drugs in food, the

assessment of micro-biological quality and safety in food, and the

assessment of specifications for food additives do not fall within

the terms of reference of this Committee;

(e) Elaborates sampling plans and procedures, as may be

required;

(f) Considers specific sampling and analysis problems submitted

to it by the Commission or any of its Committees; and

(g) Defines procedures, protocols, guidelines or related texts

for the assessment of food laboratory proficiency, as well as

quality assurance systems for laboratories.

The following matters will be brought to the attention of the

22nd Session of the Codex Alimentarius Commission in June 1997, for

adoption:

Analytical Terminology for Codex Use;

Guidelines for the Assessment of the Competence of

Testing Laboratories Involved in the Import and Export Control of

Food; and

Revised Terms of Reference for the

Committee.*

---------------------------------------------------------------------------

\*\ Not in Step procedure.

---------------------------------------------------------------------------

The Committee is continuing work on:

Proposed Draft Codex General Guidelines on Sampling;

Criteria for evaluating acceptable methods of

analysis for Codex purposes;

[[Page 28432]]

Harmonization of test results corrected for recovery

factors;

Harmonization of analytical terminology in

accordance with international standards;--Report of Inter-Agency

Meeting on ``limits;''

Measurement uncertainty; and

Report of the Inter-Agency Meeting; and

Endorsement of methods of analysis for Codex

purposes.

The Committee agreed to propose the following new work:

In-house method validation.

The reference documents are ALINORM 97/23 and 97/23a.

RESPONSIBLE AGENCY: HHS/FDA USDA/AMS

U.S. PARTICIPATION: Yes

Codex Committee on Food Import and Export Inspection and

Certification Systems

The Codex Committee on Food Import and Export Certification and

Inspection Systems is charged with developing principles and

guidelines for food import and export inspection and certification

systems. Included in the charge are application of measures by

competent authorities to provide assurance that foods comply with

essential food safety and quality requirements. Recognition of

quality assurance systems through the development of guidelines will

help ensure that foods conform to the essential requirements. Draft

guidelines to be considered by the Codex Alimentarius Commission at

its Twenty-second session in June can be found in ALINORMS 97.30 and

30A.

To be considered at Step 8:

Guidelines for the Exchange of Information Between

Countries on Rejections of Imported Food

Draft Guidelines for the Design, Operation,

Assessment and Accreditation of Food Import and Export Inspection

and Certification Systems

In addition, the Committee agreed:

to append the Criteria for a Generic Certificate for

the Export of Food and Food Products and the Model Certificate to

its report in order to facilitate Commission discussions as to the

need for further consideration by CCFICS of this matter from the

different perspectives of Codex commodity committees.

that a discussion paper on issues relating to the

process of judgment of equivalence be prepared for circulation and

comment prior to its next session.

with regard to elaboration of guidelines on Food

Import Control Systems that the delegations of Mexico and the United

States should further develop a discussion paper for review at the

Committee's next session.

that the United States should revise the proposed

Draft Guidelines for the Development of Agreements Regarding Food

Import and Export Inspection and Certification Systems for

circulation and comment at Step 3 prior to the Committee's Sixth

Session based on discussion and comments received.

RESPONSIBLE AGENCY: HHS/FDA, USDA/FSIS

U.S. PARTICIPATION: Yes

Codex Committee on General Principles

The Codex Committee on General Principles deals with rules and

procedures referred to it by the Codex Alimentarius Commission. None

of the following recommendations for changing the rules of procedure

for Codex are in the Step Procedure. The reference document is

ALINORM 97/33.

The Committee recommended the following matters for adoption by

the 22nd Session of the Codex Alimentarius Commission:

Amendment to the Rules of Procedure (Rules II and IX

to provide for the appointment of Members of the Commission as

Coordinators and to confirm their attendance as observers at

sessions of the Executive Committee.)

Addition of an Appendix to the Procedural Manual

entitled ``General Decisions of the Commission.'' The proposed

Appendix to the Procedural Manual to include: Four Statements of

Principle on the Role of Science in the Codex Decision-Making

Process and the extent to which other factors are taken into account

and Four Statements of Principle relating to the Role of Food Safety

Risk Assessment

Revision of the following sections of the Procedural

Manual:

Definitions

Guidelines for Codex Committees

Guidelines for the Inclusion of Specific Provisions in Codex

Standards

Criteria for the Establishment of Work Priorities

Relations between Commodity Committees and General Subject

Committees--Section K

Proposed specific recommendations in order to

clarify the status of ``advisory'' codes, Guidelines and related

texts

The committee also recommended that the Code of Principles

concerning Milk and Milk Products be redrafted as a standard and

recommended that the Draft Guidelines for Codex Contact Points and

National Codex Committees prepared by CCASIA be circulated to other

Regional Coordinating Committees.

RESPONSIBLE AGENCY: USDA/FSIS, HHS/FDA

U.S. PARTICIPATION: Yes

Codex Committee on Food Labelling

The Codex Committee on Food Labelling is responsible for

drafting provisions on labelling applicable to all foods and to

address issues assigned by the Codex Alimentarius Commission. The

following draft guidelines are being considered by the Codex

Alimentarius Commission at their June 1997 meeting. The guidelines

and other documents listed below are located in ALINORMS 97/22 and

92/22A.

To be considered at Step 8:

Draft Guidelines for Use of Nutrition Claims

Draft General Guidelines for Use of the term

``Halal'' (foods permitted under Islamic Law).

To be considered at Step 5 of the Accelerated Procedure:

Proposed Draft Amendment to the Labelling Section of

the Standard for Quick Frozen Fish Sticks, Fish Portions and Fish

Fillets--Breaded or in Batter

To be considered at Step 5:

Draft Guidelines for Labelling Foods that can cause

Hypersensitivity (Proposed Draft Amendment to the General Standard

for the Labelling of Prepackaged Foods)

The committee is continuing to work on:

Draft Guidelines for the Production, Processing,

Labelling and Marketing of Organically Produced Foods at Step 6

Draft Recommendations for the Labelling of Foods

Obtained through Biotechnology at Step 3

Review of General Guidelines for Nutrition Labelling

including consideration of expanding the list of nutrients required

to be declared to include saturated fat, sodium, sugars, and fiber

whenever nutrition labelling is used.

Review of Guidelines for Use of Health Claims

including circulating for government comment the sections on health

claims previously removed form the guidelines.

RESPONSIBLE AGENCY: HHS/FDA, USDA/FSIS

U.S. PARTICIPATION: Yes

Codex Committee on Food Hygiene

The Food Hygiene Committee drafts basic provisions on food

hygiene for all foods. The term ``hygiene'' also includes, where

applicable, microbiological specifications for food and associated

methodology.

The following matters will be considered by the Codex

Alimentarius Commission at its Twenty-second session in June 1997.

Information about the Codes and Guidelines can be found in ALINORMS

97/13 and 13A.

To be considered at Step 8:

Draft Revised International Code of Practice--

General Principles of Food Hygiene

Draft Revised Guidelines for the Application of the

Hazard Analysis Critical Control Point (HACCP) System

Draft Revised Principles for the Establishment and

Application of Microbiological Criteria for Foods

In addition, the committee requested approval to initiate

development of the following when necessary:

Code of Hygienic Practice for Milk and Milk Products

Guidance on the hygienic recycling of processing

water in food processing plants

Guidance on the application of microbiological risk

evaluation to international trade

Revision of the standard wording for Food Hygiene

Provisions (Procedural Manual)

Risk-based guidance for the use of HACCP-like

systems in small business, with special reference to developing

countries

Recommendations for the management of

microbiological hazards for foods in international trade

The Commission is invited to advise FAO and WHO to consider the

establishment of an international advisory body addressing the

microbiological aspects of food safety and provide scientific advice

in the form of formal microbiological risk assessments.

Other matters to be discussed at the 30th Committee Session in

October 1997 include:

[[Page 28433]]

Proposed Draft Code of Practice for Refrigerated

Packaged Foods with Extended Shelf-Life

Principles and Guidelines for the Conduct of

Microbiological Risk Assessment

Recommendations for the Control of Listeria

monocytogenes in Foods

Code of Hygienic Practice for Uncured/Unripened

Cheese and Ripened Soft Cheese

Code of Hygienic Practice for the Transport of Foods

in Bulk

Code of Hygienic Practice for Bottled Waters (other

than Mineral Water)

Consideration of a technical paper (to be prepared

by CCFFP) on residual chlorine in frozen shrimp and prawns

RESPONSIBLE AGENCY: USDA/FSIS, USDC/NOAA, HHS/FDA

U.S. PARTICIPATION: Yes

Codex Committee on Fresh Fruits and Vegetables

The Codex Committee on Fresh Fruits and Vegetables was

established in June 1988. The Committee is responsible for

elaborating world-wide standards and codes of practice for fresh

fruits and vegetables. Several of the standards listed below are

contained in ALINORM 97/35.

The sixth session of the Committee recommended that the

following standards and codes of practice be considered for adoption

by the Twenty-second Session of the Codex Alimentarius Commission in

June, 1997, at Step 8:

Draft Standard for Banana; and

Draft Standard for Mangosteen

The Committee also recommended initiation or continuation of

work in the following areas:

Draft Standard for Limes (at Step 5);

Draft Standard for Pummelo (at Step 5);

Draft Standard for Guava (at Step 5);

Draft Standard for Chayote (at Step 5);

Code of Practice for the Quality Inspection and

Certification of Fresh Fruits and Vegetables (at Step 5);

Draft Standard for Oranges (at Step 3);

Draft Standard for Asparagus (at Step 3);

Draft Revised Standard for Pineapple (at Step 3);

Draft Standard for Mexican Limes (at Step 1);

Draft Standard for Grapefruit (at Step 1);

Draft Standard for Longan (at Step 1);

Draft Standard for Ginger (at Step 1);

Preparation of a paper on the Objective Indices of

Maturity in Commercial Transactions of Fruits and Vegetables (at

Step 1); and,

Document concerning the Application of Quality

Tolerances at Import (at Step 1)

RESPONSIBLE AGENCY: USDA/AMS

U.S. PARTICIPATION: Yes

Codex Committee on Nutrition and Foods for Speci

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