International Standard-Setting Activities

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

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.

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

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.

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.

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.

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.

(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.

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.

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.

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.

(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.

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.

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.

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.

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;

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:

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 Special Dietary Uses

The Committee on Nutrition and Foods for Special Dietary Uses is responsible for studying nutritional problems referred by the Codex Alimentarius Commission. The Committee also drafts provisions on nutritional aspects for all foods and develops guidelines, general principles, and standards for foods for special dietary uses. The reference document for the following matters is ALINORM 97/ 26. The Twentieth Session of the Committee recommended that the following documents be considered by the Twenty-Second Session of the Codex Alimentarius Commission in June 1997: Draft guidelines on the procedure for the Table of Conditions for Claims and Nutrient Contents, to be included in the Draft Guidelines for Use of Health and Nutrition Claims at Step 8; Proposed Draft Standard for Food Grade Sale at Steps 5 and 8; Proposed Draft Amendment to the Standard for Infant Formula; Vitamin B12, at Step 5 of the accelerated procedure; Proposal to amend the Terms of Reference of the Committee; Proposed Draft Revised Standard for Gluten-Free Foods at Step 5; Proposed Draft Guidelines for Vitamin and Mineral Supplements at Step 5; and Proposal to discontinue work on Proposed Draft Guidelines on the Inclusion of Nutrition Provisions on Nutritional Quality in Food Standards. In addition to the above documents being circulated for comment prior to their consideration by the Commission, the following documents are open for comment for consideration at the next Committee meeting in March, 1998: Part B of the Table of Conditions for Claims for nutrient contents, to be included in the Draft Guidelines for Use of Health and Nutrition Claims, at Step 6; Proposed Draft Revised Standard for Cereal-Based Foods for Infants and Young Children at Step 3.

RESPONSIBLE AGENCY: HHS/FDA U.S. PARTICIPATION: Yes

Codex Committee on Fish and Fishery Products

The Fish and Fishery Products Committee is responsible for elaborating standards for fresh and frozen fish, crustaceans, and mollusks. The following draft guideline will be considered for adoption by the Codex Alimentarius Committee at its meeting in June. The guideline is contained in ALINORM 97/18. To be considered at Step 5: Proposed Draft Guidelines for the Sensory Evaluation of Fish and Shellfish The committee is continuing work on draft revised codes of practice for Frozen Fish, Minced Fish, Fresh Fish, Frozen Shrimps and Prawns, Molluscan Shellfish, Salted Fish, and Smoked Fish at Step 3. In addition, it is working on a Proposed Draft Code of Practice for the Products of Aquaculture at Step 3 and a draft section on training for the Proposed Guidelines for the Sensory Evaluation of Fish and Shellfish at Step 3.

RESPONSIBLE AGENCY: HHS/FDA, USDC/NOAA/NMFS U.S. PARTICIPATION: Yes

Codex Committee on Milk and Milk Products

The Codex Committee on Milk and Milk Products is responsible for establishing international codes and standards for milk and milk products. The following revised standards and draft revised codes of principles will be considered for adoption of the Codex Alimentarius Commission in June 1997. The standards listed below are contained in ALINORM 97/11. To be considered at Step 8: Draft Revised Standard for Butter Draft Revised Standard for Milkfat Products Draft Revised Standard for Evaporated Milks Draft Revised Standard for Sweetened Condensed Milk Draft Revised Standard for Milk and Cream Powders Draft Revised Standard for Cheese Draft Revised Standard for Whey Cheese Draft Revised Standard for Cheeses in Brine To be considered at Step 5: Draft Revised Code of Principles Concerning Milk and Milk Products In addition, the committee requested approval to initiate elaboration of standards for Dairy Spreads and Mozzarella Cheese and a Model Export Certificate for Milk Products. It also recommended the withdrawal of Cheese Standards for Danablu, Gruyere, Gudbrandsdalsost, Norvegia, Esrom, certain Blue Veined Cheeses and Cream Cheese (pending the inclusion in the Standard for Unripened Cheese Including Fresh Cheese).

RESPONSIBLE AGENCY: USDA/AMS, HHS/FDA U.S. PARTICIPATION: Yes

Codex Committee on Fats and Oils

The Codex Committee on Fats and Oils is responsible for elaborating standards for fats and oils of animal, vegetable, and marine origin. The reference document is ALINORM 97/17. The Fifteenth Session of the Committee recommended the following be adopted by the Commission in June 1997: Draft Standard for Named Animal Fats at Step 8; Draft Standard for Edible Fats and Oils Not Covered by Individual Standards at Step 8; Draft Revised Code of Practice for the Storage and Transport of Fats and Oils in Bulk at Step 8; In addition, the Commission is invited to consider the decision of the Committee to discontinue work on the revision and revoke the current Standard for Specified Vegetable Fat products and Specified Animal and Vegetable Fat products. The Commission is also invited to consider whether work should proceed in converting the European Regional Standard for mayonnaise into a world-wide standard.

RESPONSIBLE AGENCY: HHS/FDA U.S. PARTICIPATION: Yes

Codex Committee on Cocoa Products and Chocolate

The Codex Committee on Cocoa Products and Chocolate held 15 sessions. The last meeting, at which the original program of work was completed, was held in 1982. The Committee elaborated world-wide standards for cocoa products and chocolate.

The Commission in 1991 decided to embark on a program of work to update and revise all of the standards. The revisions were to include updating of the sections on food hygiene and food labeling and removal from the standards of all non- essential details. The standards, when updated and revised, should contain only those provisions that are necessary to protect consumer health and prevent fraud. Provisions of an advisory nature reflecting quality factors and criteria typically used in trade to define or describe the quality of the product are to be removed from the standard. These guidance provisions are intended to assist users of the Codex standard when making international purchases and are, therefore, not subject to formal acceptance by users of the standard. The Twenty-first Session of the Commission endorsed the recommendation of the forty-second session of the Executive Committee to initiate the revision of the Cocoa Products and Chocolate Standards. The Swiss Secretariat prepared updated versions of the Standards and requested government comments in CL 1995/28 CPC. The technical contents of the standards were not amended and comments were requested from governments on amendments. The amended standards for chocolate and chocolate products were considered at Step 4 by the Sixteenth Session of the Committee, October 1996. The Committee returned the Proposed Draft Revised Standard for Chocolate and Chocolate Products to Step 3 for further consideration. Proposed Draft Revised Standards for Cocoa Butter, Cocoa (Cacao) Nib, Cocoa (Cacao) Mass, Cocoa Press Cake and Cocoa Dust (Cocoa Fines) for use in the manufacture of Cocoa and Chocolate products, and for Cocoa Powders (Cacaos) and Dry Cocoa-Sugar Mixture will be considered at the Seventeenth Session of the Committee tentatively scheduled for the Fall of 1998.

RESPONSIBLE AGENCY: HHS/FDA U.S. PARTICIPATION: Yes

Codex Committee on Processed Fruits and Vegetables

During its eighteen sessions, the United States-hosted Codex Committee on Processed Fruits and Vegetables (CCPFV) elaborated 37 standards for various types of processed fruits and vegetables, including dried products (prunes), canned products (except juices), and jams and jellies. The most recent session of the CCPFV was held in 1986, after which the CCPFV adjourned sine die. In keeping with the Commission's charge to update and revise Codex standards, the United States Secretariat, with assistance from the Codex Secretariat in Rome, has prepared proposed draft revised standards for the 37 standards covered by the CCPFV. These proposed drafts are for circulation for government comment and consideration at the nineteenth session on the CCPFV. This next session is tentatively scheduled for March 1998. The following Proposed Draft Revised Standards are expected to be considered at the 19th Session of the Committee at Step 3 of the Codex process: Proposed Draft Revised Standard for Canned Tomatoes Proposed Draft Revised Standard for Canned Peaches Proposed Draft Revised Standard for Canned Grapefruit Proposed Draft Revised Standard for Canned Green Beans and Wax Beans Proposed Draft Revised Standard for Canned Applesauce Proposed Draft Revised Standard for Canned Sweet Corn Proposed Draft Revised Standard for Edible Fungi and Fungus Products Proposed Draft Revised Standard for Edible Dried Fungi Proposed Draft Revised Standard for Fresh Fungus ``Chanterelle'' Proposed Draft Revised Standard for Canned Pineapple Proposed Draft Revised Standard for Canned Asparagus Proposed Draft Revised Standard for Processed Tomato Concentrates Proposed Draft Revised Standard for Canned Green Peas Proposed Draft Revised Standard for Canned Plums Proposed Draft Revised Standard for Canned Raspberries Proposed Draft Revised Standard for Canned Pears Proposed Draft Revised Standard for Canned Strawberries Proposed Draft Revised Standard for Table Olives Proposed Draft Revised Standard for Raisins Proposed Draft Revised Standard for Canned Mandarin Oranges Proposed Draft Revised Standard for Canned Fruit Cocktail Proposed Draft Revised Standard for Jams (Fruit Preserves) and Jellies Proposed Draft Revised Standard for Citrus Marmalade Proposed Draft Revised Standard for Canned Mature Processed Peas Proposed Draft Revised Standard for Canned Tropical Fruit Salad Proposed Draft Revised Standard for Pickled Cucumbers Proposed Draft Revised Standard for Canned Carrots Proposed Draft Revised Standard for Canned Apricots Proposed Draft Revised Standard for Dried Apricots Proposed Draft Revised Standard for Unshelled Pistachio Nuts Proposed Draft Revised Standard for Dates Proposed Draft Revised Standard for Canned Palmito Proposed Draft Revised Standard for Canned Chestnuts and Chestnut Puree Proposed Draft Revised Standard for Canned Mangoes Proposed Draft Revised Standard for Mango Chutney Proposed Draft Revised Standard for Grated Desiccated Coconut RESPONSIBLE AGENCY: HHS/FDA, USDA/AMS U.S. PARTICIPATION: Yes

Certain Codex Commodity Committees

Several Codex Alimentarius Commodity Committees have adjourned sine die. The following Committees fall into this category: Cereals, Pulses and Legumes* Responsible Agency: HHS/FDA, USDA/GIPSA U.S. Participation: Yes Edible Ices Responsible Agency: HHS/FDA U.S. Participation: Yes Meat Hygiene* Responsible Agency: USDA/FSIS U.S. Participation: Yes Processed Meat and Poultry Products* Responsible Agency: USDA/FSIS U.S. Participation: Yes Sugars Responsible Agency: HHS/FDA U.S. Participation: Yes Soups and Broths* Responsible Agency: USDA/FSIS U.S. Participation: Yes Vegetable Proteins* Responsible Agency: HHS/FDA, USDA/ARS U.S. Participation: Yes *There is no planned activity for these Committees in the next year. A brief report on activities of the Codex Committee on Edible Ices and the Codex Committee on Sugars follows:

Edible Ices

The Committee on Edible Ices is responsible for elaborating standards for all types of edible ices, including mixes and powders used for their manufacture. The Forty-third Session of the Executive Committee in June 1996 recommended that the Codex Standard for Edible Ices and Mixed Ices be revoked. It was reported that there was no need for a standard as there was not a significant international trade. The Executive Committee further recommended that the Codex Committee on Edible Ices be abolished. The Twenty- second Session of the Codex Alimentarius Commission will decide the issues in June 1997.

RESPONSIBLE Agency: HHS/FDA U.S. PARTICIPATION: Yes

Sugars

The Codex Committee on Sugars is responsible for elaborating world-wide standards for all types of sugars and sugar products. The Committee has been adjourned since 1974. At the direction of the Codex Alimentarius Commission, the Secretariat of the Host Government (the United Kingdom) was asked to examine the existing Codex Standards relating to Sugars and the Codex Standard for Honey. During the Nineteenth session of the Codex Alimentarius Commission, the Commission agreed that existing Codex Standards should be reviewed in order to simplify them. Those documents were revised and circulated to member governments (see CL 1995/5-S) for comments. The objective of the revision is to focus the standards only on public health, food safety, and consumer protection. The Twenty-first session of the Commission noted that substantial late comments were received and agreed that further revision of the Draft Standards should be carried out by

correspondence. The Secretariat has prepared revised Draft Standards and circulated them for government comments at Step 6 in document CL 1996/1-S. To be considered at Step 8: Draft Revised Standard for Sugar Draft Revised Standard for Honey

RESPONSIBLE Agency: HHS/FDA U.S. PARTICIPATION: Yes

Joint U.N.E.C.E. Codex Alimentarius Groups of Experts

Two groups of experts dealt with specific commodities much as the Codex Commodity Committees do. The Joint Groups of Experts have completed their main tasks and have adjourned. They could be called to meet again if the Codex Alimentarius Commission so decides. These Groups are: Standardization of Quick Frozen Foods; and Standardization of Fruit Juices. There are no standards from either group being considered by the Twenty-second session of the Commission in June, 1997.

RESPONSIBLE Agency: HHS/FDA U.S. PARTICIPATION: Yes

Codex Committee for Natural Mineral Waters

The Codex Committee for Natural Mineral Waters (CCNMW) is responsible for elaborating standards for natural mineral water products. The following draft standard will be considered by the Codex Alimentarius Commission at its June meeting. Information about the standard and new committee work can be found in ALINORM 97/20. To be considered at Step 8: Draft Revised Standard for Natural Mineral Waters In addition, the committee requested approval to initiate development of a general standard applicable to bottled/packaged waters other than natural mineral waters.

RESPONSIBLE Agency: HHS/FDA U.S. PARTICIPATION: Yes

FAO/WHO Regional Coordinating Committees

The Codex Alimentarius Commission is made up of an Executive Committee, as well as approximately 25 subsidiary bodies. Included in these subsidiary bodies are several coordinating committees. There are currently five Regional Coordinating Committees:

--Coordinating Committee for Africa --Coordinating Committee for Asia --Coordinating Committee for Europe --Coordinating Committee for Latin America and the Caribbean --Coordinating Committee for North America and the South-West Pacific

The United States participates as an active member of the Coordinating Committee for North America and the South-West Pacific, and is informed of the other coordinating committees through meeting documents, final reports, and representation at meetings. Each regional committee:

--defines the problems and needs of the region concerning food standards and food control; --promotes within the committee contacts for the mutual exchange of information on proposed regulatory initiatives and problems arising from food control and stimulates the strengthening of food control infrastructures; --recommends to the Commission the development of world-wide standards for products of interest to the region, including products considered by the committee to have an international market potential in the future; and --exercises a general coordinating role for the region and such other functions as may be entrusted to it by the Commission.

Codex Coordinating Committee for North America and the South--West Pacific

The Coordinating Committee is responsible for defining problems and needs concerning food standards and food control of all Codex member countries of the regions. The Fourth Session of the Committee addressed the following matters of interest to the Commission. Information about their deliberations can be found in ALINORM 97/32. Suggested that consideration be given to a further consultation on risk communication mechanisms and methodologies; Supported the current alignment of Codex membership of the region and more active collaboration between Codex and APEC; and Agreed to bring concerns regarding the length and procedures of the Codex Alimentarius Commission and the timely distribution of Codex documents to the attention of the Executive Committee. In addition, the Committee identified main objectives and priorities related to the identification of Codex Standards and related texts which have a major impact in the Region and discussed papers on Dietary Modeling and Guidelines for the Development of Agreements Regarding Food Import and Export Inspection and Certification Systems.

AGENCY RESPONSIBLE: USDA/FSIS U.S. PARTICIPATION: Yes

Appendix 1--US. Codex Alimentarius Officials Steering Committee Members

Mr. Thomas J. Billy, Administrator, Food Safety and Inspection Service, U.S. Department of Agriculture, Room 331-E, Jamie L. Whitten Federal Bldg., 1400 Independence Avenue, SW, Washington, DC 20250-3700, Phone: (202) 720-7025, Fax: (202) 205-0158 Mr. Michael V. Dunn, Assistant Secretary, Marketing and Regulatory Programs, U.S. Department of Agriculture, Room 228-W, Jamie L. Whitten Federal Bldg., 1400 Independence Avenue, SW, Washington, DC 20250, Phone #: (202) 720-4256, Fax #: (202) 720-5775 Dr. Lynn R. Goldman, Assistant Administrator, Office of Prevention, Pesticides and Toxic Substances, U.S. Environmental Protection Agency, 401 M Street, SW (7101), 637 East Tower, Washington, DC 20460, Phone #: (202) 260-2902, Fax #: (202) 260-1847 Ms. Penny Fenner-Crisp, Deputy Director, Office of Pesticide Programs, U.S. Environmental Protection Agency, 401 M Street, SW, Washington, DC 20460, Phone #: (202) 260-0947, Fax #: (202) 260-1847 Mr. William Schultz, Deputy Commissioner for Policy, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, Phone #: (301) 827-3360, Fax #: (301) 594-6777 Dr. Fred R. Shank, Director, Center for Food Safety and Applied Nutrition (HFS-1), Food and Drug Administration, Room 6815, 200 C Street, SW, Washington, DC 20204, Phone #: (202) 205-4850, Fax #: (202) 205-5025 Ms. Linda R. Horton, Director, International Policy, Office of the Commissioner, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, Phone #: (301) 827-3344, Fax #: (301) 443-6906 Mr. August Schumacher, Jr., Administrator, Foreign Agricultural Service, U.S. Department of Agriculture, Room 5071, South Agriculture Building, 1400 Independence Avenue, SW, Washington, DC 20250-3700, Phone #: (202) 720-3935, Fax #: (202) 690-2159

Codex Committee Chairpersons

Mr. Steven N. Tanner, Director, Technical Services Division, Grain Inspection, Packers & Stockyards Administration, U.S. Department of Agriculture, 10383 N. Executive Hills Blvd., Kansas City, MO 64153- 1394, Phone #: (816) 891-0401, Fax #: (816) 891-0478--Cereals, Pulses and Legumes (adjourned Sine Die) Dr. I. Kaye Wachsmuth, Acting Deputy Administrator, Office of Public Health and Science, Food Safety and Inspection Service, U.S. Department of Agriculture, Room 341-E, Jamie L. Whitten Federal Building, 1400 Independence Avenue, SW, Washington, DC 20250-3700, Phone #: (202) 720-2644, Fax #: (202) 690-2980--Food Hygiene Mr. James Rodeheaver, Chief, Processed Product Branch, Fruit and Vegetable Division, Agricultural Marketing Service, U.S. Department of Agriculture, Room 0709, South Agriculture Building, 1400 Independence Avenue, SW, Washington, DC 20250-3700, Phone #: (202) 720-4693, Fax #: (202) 690-1527--Processed Fruits and Vegetables Dr. Stephen F. Sundlof, Director, Center for Veterinary Drugs in Foods Medicine, Food and Drug Administration, 7500 Standish Place (HFV-1), Rockville, MD 20855, Phone #: (301) 594-1740, Fax #: (301) 594-1830--Residues of Veterinary Drugs in Food

Listing of U.S. Delegates and Alternate Delegates, Worldwide General Subject Codex Committees

Codex Committee on Residues of Veterinary Drugs in Foods

(Host Government--United States)

U.S. Delegate--Dr. Robert C. Livingston, Director, Office of New Animal Drug Evaluation, Center for Veterinary Medicine (HFV-100), Food and Drug Administration, 7500 Standish Place, Rockville, MD 20855, Phone #: (301) 594-1620, Fax #: (301) 594-2297 Alternate Delegate--Dr. Pat Basu, Director, Chemistry and Toxicology Division, Office

of Public Health and Science, Food Safety and Inspection Service, U.S. Department of Agriculture, 6912 Franklin Court, 1099 14th Street, NW, Washington, DC 20250-3700, Phone #: (202) 501-7319, Fax: (202) 501-7639

Codex Committee on Food Additives and Contaminants

(Host Government--The Netherlands)

U.S. Delegate--Dr. Alan Rulis, Director, Office of Premarket Approval, Center for Food Safety and Applied Nutrition, Food and Drug Administration, 200 C Street, SW, (HFS-200), Washington, DC 20204, Phone #: (202) 418-3100, Fax #: (202) 418-3131 Alternate Delegate--Dr. Terry C. Troxell, Director, Division of Programs and Enforcement Policy, Center for Food Safety and Applied Nutrition, Food and Drug Administration, 200 C Street, SW, (HFS- 456), Washington, DC 20204, Phone #: (202) 205-5321, Fax #: (202) 205-4422

Codex Committee on Pesticide Residues

(Host Government--The Netherlands)

U.S. Delegate--Dr. Richard Schmitt, Deputy Director, Special Review and Registration Division, Office of Pesticide Programs, U.S. Environmental Protection Agency, 1921 Jefferson Davis Highway, Mail Code (7502C), Room 712, CM-2, Arlington, VA 22204, Phone #: (703) 305-6352, Fax #: (703) 305-5512 Alternate Delegate--Dr. Richard Parry, Jr., Assistant Administrator, Cooperative Interactions, Agricultural Research Service, U.S. Department of Agriculture, Room 358-A, Jamie L. Whitten Federal Bldg., Washington, DC 20250-3700, Phone #: (202) 720-3973, Fax #: (202) 720-5427

Codex Committee on Methods of Analysis and Sampling

(Host Government--Hungary)

U.S. Delegate--Dr. William Horwitz, Scientific Advisor, Center for Food Safety and Applied, Nutrition (HFS-500), Food and Drug Administration, Room 3832, 200 C Street, SW, Washington, DC 20204, Phone #: (202) 205-4346, Fax #: (202) 401-7740 Alternate Delegate--Mr. William Franks, Director, Science and Technology Division, Agricultural Marketing Service, U.S. Department of Agriculture, Room 3507, South Agriculture Building 1400 Independence Avenue, SW, Washington, DC 20250-3700, Phone #: (202) 720-5231, Fax #: (202) 720-6496

Codex Committee on Food Import and Export Certification and Inspection Systems

(Host Government--Australia)

Delegate--Dr. Fred R. Shank, Director, Center for Food Safety and Applied Nutrition (HFS-1), Food and Drug Administration, Room 6815, 200 C Street, SW, Washington, DC 20204, Phone #: (202) 205-4850,Fax #: (202) 205-5025 Alternate Delegate--Mr. Mark Manis, Director, International Policy Development Division, Office of Policy, Program Development, and Evaluation, Food Safety and Inspection Service, U.S. Department of Agriculture, Room 4434, South Agriculture Building, 1400 Independence Avenue, SW, Washington, DC 20250-3700, Phone #: (202) 720-6400, Fax #: (202) 720-7990

Codex Committee on General Principles

(Host Government--France)

Delegate--Note: A member of the Steering Committee heads the delegation to meetings of the General Principles Committee.

Codex Committee on Food Labelling

(Host Government--Canada)

Delegate--Dr. F. Edward Scarbrough, Director, Office of Food Labeling Center for Food Safety and Applied Nutrition (HFS-150), Food and Drug Administration, 200 C Street, SW, Room 1832, Washington, DC 20204, Phone #: (202) 205-4561, Fax #: (202) 205-4594 Alternate Delegate--Mr. Robert Post, Deputy Director, Facilities, Equipment, Labeling & Compounds Review Division, Office of Policy, Program Development, and Evaluation, Food Safety and Inspection Service, U.S. Department of Agriculture, West End Court Building, Room 327, Washington, DC 20250-3700, Phone #: (202) 418-8900, Fax #: (202) 418-8834

Codex Committee on Food Hygiene

(Host Government--United States)

Acting Delegate--Mr. E. Spencer Garrett, Director, National Seafood Inspection Laboratory, National Marine Fisheries, 705 Convent Street, Pascagoulla, MS 39568-1207, Phone #: (601) 769-8964, Fax #: (601) 762-7144 Alternate Delegate--VACANT

Worldwide Commodity Codex Committees

Codex Committee on Fresh Fruits and Vegetables

(Host Government--Mexico)

Delegate--Mr. David Priester, International Standards Coordinator, FPB, Fruit & Vegetable Division, Agricultural Marketing Service, U.S. Department of Agriculture, Room 2069, South Agriculture Building, 1400 Independence Avenue, SW, Washington, DC 20250-3700, Phone #: (202) 720-2184, Fax #: (202) 720-0016 Alternate Delegate--Mr. Larry B. Lace, Branch Chief, Fresh Products Branch, Fruits and Vegetables Division, Agricultural Marketing Service, U.S. Department of Agriculture, Room 2049, South Agriculture Building, 1400 Independence Avenue, SW, Washington, DC 20250-3700, Phone #: (202) 720-5870, Fax #: (202) 720-0393

Codex Committee on Nutrition and Foods for Special Dietary Uses

(Host Government--Germany)

Delegate--Dr. Elizabeth Yetley, Acting Director, Office of Special Nutritionals, Center for Food Safety and Applied Nutrition, FDA, 200 C Street, SW (HFS-450), Washington, DC 20204, Phone #: (202) 205- 4168, Fax #: (202) 205-5295 Alternate Delegate--Dr. Robert J. Moore, Senior Regulatory Scientist, Center for Food Safety and Applied Nutrition, Food and Drug Administration, 200 C Street, SW (HFS-456), Washington, DC 20204, Phone #: (202) 205-4605, Fax #: (202) 260-8957

Codex Committee on Fish and Fishery Products

(Host Government--Norway)

Delegate--Mr. Philip C. Spiller, Director, Office of Seafood (HFS- 400) VERB, Center for Food Safety and Applied Nutrition, Food and Drug Administration, 200 C Street, SW, Washington, DC 20204, Phone #: (202) 418-3133, Fax #: (202) 418-3198 Alternate Delegate--Mr. Samuel W. McKeen, Director, Office of Trade and Industry Services, National Oceanic and Atmospheric Administration, NMFS, 1335 East-West Highway, Room 6490, Silver Spring, MD 20910, Phone #: (301) 713-2351, Fax #: (301) 713-1081

Codex Committee on Cereals, Pulses and Legumes

(Host Government--United States)

Delegate--Mr. Charles W. Cooper, Director, International Activities Staff, Center for Food Safety and Applied Nutrition, Room 5823 (HFS- 585), Food and Drug Administration, 200 C Street, SW, Washington, DC 20204, Phone #: (202) 205-5042, Fax #: (202) 401-7739 Alternate Delegate--Mr. David Shipman, Deputy Administrator, Grain Inspection Packers and Stockyards Administration, U.S. Department of Agriculture, Room 1092, South Agriculture Building, 1400 Independence Avenue, SW, Washington, DC 20250-3700, Phone #: (202) 720-9170, Fax #: (202) 720-1015

Codex Committee on Milk and Milk Products

(Host Government--New Zealand)

Delegate--Mr. Duane Spomer, Chief, Dairy Standardization Branch, U.S. Department of Agriculture, Agricultural Marketing Service, Room 2750, South Agriculture Building, 1400 Independence Avenue, SW, Washington, DC 20250-3700, Phone #: (202) 720-9382, Fax #: (202) 720-2643 Alternate Delegate--Dr. John C. Mowbray, Division of Programs and Enforcement Policy, Center for Food Safety and Applied Nutrition, Food and Drug Administration, 200 C Street, SW, (HFS-306), Washington, DC 20204, Phone #: (202) 205-1731, Fax #: (202) 205-4422

Codex Committee on Fats and Oils

(Host Government--United Kingdom)

Delegate--Mr. Charles W. Cooper, Director, International Activities, Staff, Center for Food Safety and Applied Nutrition, Room 5823 (HFS- 585), Food and Drug Administration, 200 C Street, SW, Washington, DC 20204, Phone #: (202) 205-5042, Fax #: (202) 401-7739 Alternate Delegate--Dr. Dwayne Buxton, National Program Leader for Oilseeds and Bioscience, Agricultural Research Service, Room 212, Bldg. 005, BARC West, Beltsville, MD 20705, Phone #: (301) 504-5321, Fax #: (301) 504-5467

Codex Committee on Processed Fruits and Vegetables

(Host Government--United States)

U.S. Delegate--Mr. Richard B. Boyd, Senior Marketing Specialist, Fruit and Vegetable Division, Agricultural Marketing Service, U.S. Department of Agriculture, Room 0717, South Agriculture Building, 1400 Independence Avenue, SW, Washington, DC 20250-3700, Phone #: (202) 720-5021, Fax #: (202) 690-1527 Alternate Delegate--Mr. Charles W. Cooper, Director, International Activities Staff, Center for Food Safety and Applied Nutrition, Room 5823 (HFS-585), Food and Drug Administration, 200 C Street, SW, Washington, DC 20204, Phone #: (202) 205-5042, Fax #: (202) 401-7739

Worldwide Commodity Codex Committees

Codex Committee on Cocoa Products and Chocolate

(Host Government--Switzerland)

Delegate--Mr. Charles W. Cooper, Director, International Activities Staff, Center for Food Safety and Applied Nutrition, Room 5823 (HFS- 585), Food and Drug Administration, 200 C Street, SW, Washington, DC 20204, Phone #: (202) 205-5042, Fax #: (202) 401-7739 Alternate Delegate--Dr. Michelle Smith, Food Technologist, Office of Food Labeling, Center for Food Safety and Applied Nutrition (HFS- 158), 200 C Street, SW, Washington, DC 20204, Phone #: (202) 205- 5099, Fax #: (202) 205-4594

Codex Committee on Sugars

(Host Government--United Kingdom)

Delegate--Dr. Thomas J. Army, Area Director, Mid-South Area, USDA/ Agricultural Research Center, P.O. Box 225, Stoneville, MS 38776- 0225, Phone #: (601) 686-5265, Fax #: (601) 626-5259 Alternate Delegate--Dr. Dennis M. Keefe, Office of Premarket Approval, Center for Food Safety and Applied Nutrition, Food and Drug Administration, 200 C Street, SW (HFS-206), Washington, DC 20204, Phone #: (202) 418-3113, Fax #: (202) 418-3131

Codex Committee on Edible Ices \1\

(Host Government--Sweden)

Delegate--Mr. Charles W. Cooper, Director, International Activities Staff, Center for Food Safety and Applied Nutrition, Room 5823 (HFS- 585), Food and Drug Administration 200 C Street, SW, Washington, DC 20204, Phone #: (202) 205-5042, Fax #: (202) 401-7739 Alternate Delegate--VACANT

Codex Committee on Soups and Broths \1\

(Host Government--Switzerland)

Delegate--Mr. Charles Edwards, Director, Facilities, Equipment, Labeling & Compounds Review Division, Office of Policy, Program Development, and Evaluation, Food Safety and Inspection Service, U.S. Department of Agriculture, West End Court Building, Room 329, 1255 22nd Street, NW, Washington, DC 20250-3700, Phone #: (202) 418- 8900, Fax #: (202) 418-8834 Alternate Delegate--Mr. Robert Post, Deputy Director, Facilities, Equipment, Labeling & Compounds Review Division, Office of Policy, Program Development, and Evaluation, Food Safety and Inspection Service, U.S. Department of Agriculture, West End Court Building, Room 327, Washington, DC 20250-3700, Phone #: (202) 418-8900, Fax #: (202) 418-8834

Codex Committee on Vegetable Proteins \1\

(Host Government--Canada)

U.S. Delegate--Dr. Wilda H. Martinez, Associate Deputy Administrator, Aqua Products and Human Nutrition Sciences, U.S. Department of Agriculture, Agricultural Research Service, Room 107, B-005, Beltsville, MD 20705, Phone #: (301) 504-6275, Fax #: (301) 504-6699 Alternate Delegate--Ms. Elizabeth J. Campbell, Director, Division of Programs and Enforcement Policy, Center for Food Safety and Applied Nutrition (HFS-155), Food and Drug Administration, 200 C Street, SW, Washington, DC 20204, Phone #: (202) 205-5229, Fax #: (202) 205-4594

Codex Committee on Meat Hygiene \1\

(Host Government--New Zealand)

Delegate--Dr. John Prucha, Assistant Deputy Administrator, International and Domestic Policy, Food Safety and Inspection Service, U.S. Department of Agriculture, Room 350-E, Jamie L. Whitten Federal Bldg., Washington, DC 20250-3700, Phone #: (202) 720-3473, Fax #: (202) 690-3856 Alternate Delegate--Dr. Richard Mikita, Special Assistant, International Activities, Food Safety and Inspection Service, U.S. Department of Agriculture, Room 344-E, Jamie L. Whitten Federal Bldg., Washington, DC 20250-3700, Phone #: (202) 720-0290, Fax #: (202) 690-0766

Codex Committee on Processed Meat and Poultry Products \1\

(Host Government--Denmark)

U.S. Delegate--Mr. Daniel Engeljohn, Branch Chief, Standards Development Branch, Inspection Methods Development Division, Office of Policy, Program Development, and Evaluation, Food Safety and Inspection Service, U.S. Department of Agriculture, Room 405, Cotton Annex, 300 12th Street, SW., Washington, DC 20250-3700, Phone #: (202) 205-0210, Fax #: (202) 205-0080 Alternate Delegate--Mr. Charles Edwards, Director, Facilities, Equipment, Labeling & Compounds Review Division, Office of Policy, Program Development, and Evaluation, Food Safety and Inspection Service, U.S. Department of Agriculture, West End Court Building, Room 329, 1255 22nd Street, NW., Washington, DC 20250-3700, Phone #: (202) 418-8900, Fax #: (202) 418-8834

Codex Committee on Natural Mineral Waters

(Host Government--Switzerland)

U.S. Delegate--Dr. Terry C. Troxell, Director, Division of Programs and Enforcement Policy, Center for Food Safety & Applied Nutrition (HFS-305), Food and Drug Administration, 200 C Street, SW., Washington, DC 20204, Phone #: (202) 205-5321, Fax #: (202) 205-4422 Alternate Delegate--Ms. Shellee A. Davis, Division of Programs and Enforcement Policy, Center for Food Safety and Applied Nutrition, Food and Drug Administration, 200 C Street, SW (HFS-306), Washington, DC 20204, Phone #: (202) 205-4681, Fax #: (202) 205-4422

Joint U.N.E.C.E. Codex Alimentarius Groups of Experts

Joint ECE/Codex Alimentarius Group of Experts on Standardization of Quick Frozen Foods \1\

U.S. Delegate--Mr. Richard B. Boyd, Senior Marketing Specialist, Fruit and Vegetable Division, Agricultural Marketing Service, U.S. Department of Agriculture, Room 0717, South Agriculture Building, 1400 Independence Avenue, SW., Washington, DC 20250-3700, Phone #: (202) 720-5021, Fax #: (202) 690-1527 Alternate Delegate--Mr. Charles W. Cooper, Director, International Activities Staff, Center for Food Safety and Applied Nutrition, Room 5823 (HFS-585), Food and Drug Administration, 200 C Street, SW., Washington, DC 20204, Phone #: (202) 205-5042, Fax #: (202) 401-7739

Joint ECE/Codex Alimentarius Group of Experts on Standardization of Fruit Juices \1\

U.S. Delegate--Mr. Charles W. Cooper, Director, International Activities, Staff, Center for Food Safety and Applied Nutrition, Room 5823 (HFS-585), Food and Drug Administration, 200 C Street, SW., Washington, DC 20204, Phone #: (202) 205-5042, Fax #: (202) 401-7739 Alternate Delegate--Mr. Richard B. Boyd, Senior Marketing Specialist, Fruit and Vegetable Division, Agricultural Marketing Service, U.S. Department of Agriculture, Room 0717, Agriculture South Building, 1400 Independence Avenue, SW., Washington, DC 20250- 3700, Phone #: (202) 720-5021, Fax #: (202) 690-1527

Subsidiary Bodies of the Codex Alimentarius

There are five regional coordinating committees:

Coordinating Committee for Africa Coordinating Committee for Asia Coordinating Committee for Europe Coordinating Committee for Latin America and the Caribbean, and Coordinating Committee for North America and the South-West Pacific

Contact--Ms. Rhonda Bond, Executive Officer for Codex Alimentarius, Food Safety and Inspection Service, U.S. Department of Agriculture, West End Court, Room 311, 1255 22nd Street, NW., Washington, DC 20250-3700, Phone #: (202) 418-8841, Fax #: (202) 418-8865.

\1\ Adjourned sine die. The main tasks of these Committees are completed. However, the committees may be called to meet again if required.

Appendix 2.--Timetable of Codex Sessions [June 1996 through June 1998] ---------------------------------------------------------------------------------------------------------------- ---------------------------------------------------------------------------------------------------------------- 1996: CX 702-43 Executive Committee of 4-7 June............................... Geneva. the Codex Alimentarius Commission (43rd Session). CX 708-16 Codex Committee on 30 Sept.-2 Oct......................... Thun, Switzerland. Cocoa Products and Chocolate (16th Session). CX 719-5 Codex Committee on 3-5 October............................ Thun, Switzerland. Natural Mineral Waters (5th Session). CX 707-12 Codex Regional TBA.................................... Harare. Coordinating Committee for Africa (12th Session). CX 720-2 Codex Committee on 7-11 October........................... Bonn Bad-Godesberg. Nutrition and Food for Special Dietary Uses (20th Session). CX-712-29 Codex Committee on 21-25 October.......................... Washington, DC. Food Hygiene (29th Session). CX-730-10 Codex Committee on 20 October-1 November.................. San Jose, Costa Rica. Residues of Veterinary Drugs in Foods (10th Session). CX-709-11 Codex Committee on 4-8 November........................... London. Fats and Oils (15th Session). CX-716-12 Codex Committee on 25-28 November......................... Paris. General Principles Principles (12th Session). 1997: CX 713-19 Codex Committee on 3-7 February........................... Washington, DC. Processed Fruits and Vegetables (19th Session). CX 733-5 Codex Committee on Food 17-21 February......................... Sydney. Import and Export Inspection and Certification Systems (5th Session). CX 725-10 Codex Regional 25-28 February......................... Montevideo. Coordinating Committee for Latin America and the Caribbean (10th Session). CX 715-21 Codex Committee on 10-14 March............................ Budapest. Methods of Analysis and Sampling (21st Session). CX 711-29 Codex Committee on 17-21 March............................ The Hague. Food Additives and Contaminants (29th Session). CX 718-29 Codex Committee on 7-12 April............................. The Hague. Pesticide Residues (29th Session). CX 714-25 Codex Committee on 15-18 April............................ Ottawa. Food Labelling (25th Session). CX 702-44 Executive Committee of 19-20 June............................. Geneva. the Codex Alimentarius Commission (44th Session). CX 701-22 CODEX ALIMENTARIUS 23-28 June............................. Geneva. COMMISSION (44th Session). CX 731-7 Codex Committee on 8-12 September......................... Mexico City. Fresh Fruits and Vegetables (7th Session). CX 712-30 Codex Committee on 20-24 October.......................... Washington, DC. Food Hygiene (30th Session). CX 727-11 Codex Regional 16-19 December......................... Chiang Rai. Coordinating Committee for Asia (11th Session). 1998: CX 711-30 Codex Committee on 9-13 March............................. The Hague. Food Additives and Contaminants (30th Session). CX 733-6 Codex Committee on Food 16-21 March............................ TBA. Import and Export Certification and Inspection (6th Session). CX 713-20 Codex Committee on 16-20 March............................ Washington, DC. Processed Fruits and Vegetables (19th Session). CX 722-23 Codex Committee on 30-3 April............................. Bergen. Fish and Fishery Products (23rd Session). CX 718-30 Codex Committee on 20-25 April............................ The Hague. Pesticide Residues (30th Session). CX-730-11 Codex Committee on 27 April-1 May......................... Washington, DC. Residues of Veterinary Drugs in Foods (11th Session). CX 719-21 Codex Regional 5-8 May................................ TBA. Coordinating Committee for Europe (21st Session). CX 714-26 Codex Committee on May-98-May-98.......................... Ottawa. Food Labelling (26th Session). CX 703-3 Codex Committee on Milk 25-29 May.............................. TBA. and Milk Products (3rd Session). CX 702-45 Executive Committee of 3-5 June............................... Rome. the Codex Alimentarius Commission (45th Session). ----------------------------------------------------------------------------------------------------------------

Appendix 3--Definitions for the Purpose of Codex Alimentarius

Words and phrases have specific meanings when used by the Codex Alimentarius. For the purposes of Codex, the following definitions apply: 1. Food means any substance, whether processed, semi-processed or raw, which is intended for human consumption, and includes drink, chewing gum, and any substance which has been used in the manufacture, preparation or treatment of ``food'' but does not include cosmetics or tobacco or substances used only as drugs. 2. Food hygiene comprises conditions and measures necessary for the production, processing, storage and distribution of food designed to ensure a safe, sound, wholesome product fit for human consumption. 3. Food additive means any substance not normally consumed as a food by itself and not normally used as a typical ingredient of 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. 4. 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 does not include insect fragments, rodent hairs and other extraneous matters. 5. Pesticide means any substance intended for preventing, destroying, attracting, repelling, or controlling any pest including unwanted species of plants or animals during the production, storage, transport, distribution and processing of food, agricultural commodities, or animal feeds or which may be administered to animals for the control of ectoparasites. The term includes substances intended for use as a plant-growth regulator, defoliant, desiccant, fruit thinning agent, or sprouting inhibitor and substances applied to crops either before of after harvest to protect the commodity from deterioration during storage and transport. The term pesticides excludes fertilizers, plant and animal nutrients, food additives, and animal drugs. 6. Pesticide residue means any specified substance in food, agricultural commodities, or animal feed resulting from the use of a pesticide. The term includes any derivatives of a pesticide, such as conversion products, metabolites, reaction products, and impurities considered to be of toxological significance. 7. Good Agricultural Practice in the Use of Pesticides (GAP) includes the nationally authorized safe uses of pesticides under actual conditions necessary for effective and reliable pest control. It encompasses a range of levels of pesticide applications up to the highest authorized use, applied in a manner

which leaves a residue which is the smallest amount practicable. Authorized safe uses are determined at the national level and include nationally registered or recommended uses, which take into account public and occupational health and environmental safety considerations. Actual conditions include any stage in the production, storage, transport, distribution and processing of food commodities and animal feed. 8. 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. MRLPs are based on their toxological affects and on GAP data and foods derived from commodities that comply with the respective MRLPs are intended to be toxologically acceptable. Codex MRLPs, which are primarily intended to apply in international trade, are derived from reviews conducted by the JMPR following: (a) toxological assessment of the pesticide and its residue, and (b) review of residue data from supervised trials and supervised uses including those reflecting national good agricultural practices. 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. 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. 9. Veterinary Drug means any substance applied or administered to any food-producing animal, such as meat or milk-producing animals, poultry, fish or bees, whether used for therapeutic, prophylactic or diagnostic purposes or for modification of physiological functions or behavior. 10. Residues of Veterinary Drugs include the parent compounds and/or their metabolites in any edible portion of the animal product, and include residues of associated impurities of the veterinary drug concerned. 11. 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 g/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 food. An MRLVD is based on the type and amount of residue considered to be without any toxological 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 and analytical methods are available. 12. Good Practice in the Use of Veterinary Drugs (GPVD) is the official recommended or authorized usage including withdrawal periods approved by national authorities, of veterinary drugs under practicable conditions. 13. Processing Aid means any substance or material, not including apparatus or utensils, not consumed as a food ingredient by itself, intentionally used in the processing of raw materials, foods or its ingredients, to fulfill a certain technological purpose during treatment or processing and which may result in the non- intentional but unavoidable presence of residues or derivatives in the final product.

Appendix 4--Uniform Procedure for the Elaboration of Codex Standards and Related Texts

Part 1

Steps 1, 2 and 3

(1) The Commission decides, taking into account the ``Criteria for the Establishment of Work Priorities and for the Establishment of Subsidiary Bodies,'' to elaborate a Worldwide Codex Standard and also decides which subsidiary body or other body should undertake the work. A decision to elaborate a Worldwide Codex Standard may also be taken by subsidiary bodies of the Commission in accordance with the above-mentioned criteria, subject to subsequent approval by the Commission or its Executive Committee at the earliest possible opportunity. In the case of Codex Regional Standards, the Commission shall base its decision on the proposal of the majority of members belonging to a given region or group of countries submitted at a session of the Codex Alimentarius Commission. (2) The Secretariat arranges for the preparation of a proposed draft standard. In the case of Maximum Limits for Residues of Pesticides or Veterinary Drugs, the Secretariat distributes the recommendations for maximum limits, when available from the Joint Meetings of the FAO Panel of Experts on Pesticide Residues in Food and the Environment and the WHO Panel of Experts on Pesticide Residues (JMPR), or the Joint FAO/WHO Expert Committee on Food Additives (JECFA). In the cases of milk and milk products or individual standards for cheeses, the Secretariat distributes the recommendations of the International Dairy Federation (IDF). (3) The proposed draft standard is sent to members of the Commission and interested international organizations for comment on all aspects including possible implications of the proposed draft standard for their economic interests.

Step 4

The comments received are sent by the Secretariat to the subsidiary body or other body concerned which has the power to consider such comments and to amend the proposed draft standard.

Step 5 1 ---------------------------------------------------------------------------

\1\ Without prejudice to any decision that may be taken by the Commission at Step 5, the proposed draft standard may be sent by the Secretariat for government comment prior to its consideration at Step 5, when, in the opinion of the subsidiary body or other body concerned, the time between the relevant session of the Commission and the subsequent session of the subsidiary or other body concerned requires such actions in order to advance the work. ---------------------------------------------------------------------------

The proposed draft standard is submitted through the Secretariat to the Commission or to the Executive Committee with a view to its adoption as a draft standard. When making any decision at this step, the Commission or the Executive Committee will give due consideration to any comments that may be submitted by any of its members regarding the implications which the proposed draft standard or any provisions of the standard may have for their economic interests. In the case of Regional Standards, all members of the Commission may present their comments, take part in the debate and propose amendments, but only the majority of the Members of the region or group of countries concerned attending the session can decide to amend or adopt the draft. When making any decisions at this step, the members of the region or group of countries concerned will give due consideration to any comments that may be submitted by any of the members of the Commission regarding the implications which the proposed draft standard or any provisions of the proposed draft standard may have for their economic interests.

Step 6

The draft standard is sent by the Secretariat to all members and interested international organizations for comment on all aspects, including possible implications of the draft standard for their economic interests.

Step 7

The comments received are sent by the Secretariat to the subsidiary body or other body concerned, which has the power to consider such comments and amend the draft standard.

Step 8

The draft standard is submitted through the Secretariat to the Commission together with any written proposals received from members and interested international organizations for amendments at Step 8 with a view to its adoption as a Codex Standard. In the case of Regional standards, all members and interested international organizations may present their comments, take part in the debate and propose amendments but only the majority of members of the region or group of countries concerned attending the session can decide to amend and adopt the draft.

Appendix 4--Uniform Accelerated Procedure for the Elaboration of Codex Standards and Related Texts

Part 2

Steps 1, 2 and 3

(1) The Commission or the Executive Committee between Commission sessions, on the basis of a two-thirds majority of votes cast, taking into account the ``Criteria for the Establishment of Work Priorities and for the Establishment of Subsidiary Bodies'', shall identify those standards which shall be the subject of an accelerated elaboration process. The identification of such standards may also be made by subsidiary bodies of the Commission, on the basis of a two-thirds majority of votes cast, subject to confirmation at the earliest opportunity by the Commission or its Executive Committee by a two-thirds majority of votes cast. (2) The Secretariat arranges for the preparation of a proposed draft standard. In the case of Maximum Limits for Residues of Pesticides or Veterinary Drugs, the Secretariat distributes the recommendations for maximum limits, when available from the Joint Meetings of the FAO Panel of Experts on Pesticide Residues in Food and the Environment and the WHO Panel of Experts on Pesticide Residues (JMPR), or the Joint FAO/WHO Expert Committee on Food Additives (JECFA). In the cases of milk and milk products or individual standards for cheeses, the Secretariat distributes the recommendations of the International Dairy Federation (IDF). (3) The proposed draft standard is sent to Members of the Commission and interested international organizations for comment on all aspects including possible implications of the proposed draft standard for their economic interests. When standards are subject to an accelerated procedure, this fact shall be notified to the Members of the Commission and the interested international organizations.

Step 4

The comments received are sent by the Secretariat to the subsidiary body or other body concerned which has the power to consider such comments and to amend the proposed draft standard.

Step 5

In the case of standards identified as being subject to an accelerated elaboration procedure, the draft standard is submitted through the Secretariat to the Commission together with any written proposals received from Members and interested international organizations for amendments with a view to its adoption as a Codex standard. In taking any decision at this step, the Commission will give due consideration to any comments that may be submitted by any of its Members regarding the implications which the proposed draft standard or any provisions thereof may have for their economic interests.

Appendix 5--Nature of Codex Standards

Codex standards contain requirements for food aimed at ensuring for the consumer a sound, wholesome food product free from adulteration, and correctly labelled. A Codex standard for any food or foods should be drawn up in accordance with the Format for Codex Commodity Standards and contain, as appropriate, the criteria listed therein.

Format For Codex Commodity Standards Including Standards Elaborated Under the Code of Principles Concerning Milk and Milk Products

Introduction

The format is also intended for use as a guide by the subsidiary bodies of the Codex Alimentarius Commission in presenting their standards, with the object of achieving, as far as possible, a uniform presentation of commodity standards. The format also indicates the statements which should be included in standards as appropriate under the relevant headings of the standard. The sections of the format required to be completed for a standard are only those provisions that are appropriate to an international standard for the food in question. Name of the Standard Scope Description Essential Composition and Quality Factors Food Additives Contaminants Hygiene Weights and Measures Labelling Methods of Analysis and Sampling

Format for Codex Standards

Name of the Standard

The name of the standard should be clear and as concise as possible. It should usually be the common name by which the food covered by the standard is known or, if more than one food is dealt with in the standard, by a generic name covering them all. If a fully informative title is inordinately long, a subtitle could be added.

Scope

This section should contain a clear, concise statement as to the food or foods to which the standard is applicable unless the name of the standard clearly and concisely identifies the food or foods. A generic standard covering more than one specific product should clearly identify the specific products to which the standard applies.

Description

This section should contain a definition of the product or products with an indication, where appropriate, of the raw materials from which the product or products are derived and any necessary references to processes of manufacture. The description may also include references to types and styles of product and to type of pack. The description may also include additional definitions when these additional definitions are required to clarify the meaning of the standard.

Essential Composition and Quality Factors

This section should contain all quantitative and other requirements as to composition including, where necessary, identity characteristics, provisions on packing media and requirements as to compulsory and optional ingredients. It should also include quality factors which are essential for the designation, definition, or composition of the product concerned. Such factors could include the quality of the raw material, with the object of protecting the health of the consumer, provisions on taste, odor, color, and texture which may be apprehended by the senses, and basic quality criteria for the finished products, with the object of preventing fraud. This section may refer to tolerances for defects, such as blemishes or imperfect material, but this information should be contained in appendix to the standard or in another advisory text.

Food Additives

This section should contain the names of the additives permitted and, where appropriate, the maximum amount permitted in the food. It should be prepared in accordance with guidance given on pages 93 to 96 of the Codex Procedural Manual and may take the following form: ``The following provisions in respect of food additives and their specifications as contained in section ________ of the Codex Alimentarius are subject to endorsement [have been endorsed] by the Codex Committee on Food Additives and Contaminants.'' A tabulation should then follow, viz.: ``Name of additive, maximum level (in percentage or mg/kg).''

Contaminants

(a) Pesticide Residues: This section should include, by reference, any levels for pesticide residues that have been established by the Codex Committee on Pesticide Residues for the product concerned. (b) Other Contaminants: In addition, this section should contain the names of other contaminants and where appropriate the maximum level permitted in the food, and the text to appear in the standard may take the following form: ``The following provisions in respect of contaminants, other than pesticide residues, are subject to endorsement [have been endorsed] by the Codex Committee on Food Additives and Contaminants.'' A tabulation should then follow, viz.: ``Name of contaminant, maximum level (in percentage or mg/kg).''

Hygiene

Any specific mandatory hygiene provisions considered necessary should be included in this section. They should be prepared in accordance with the guidance given on pages 96 to 98 of the Codex Procedural Manual. Reference should also be made to applicable codes of hygienic practice. Any parts of such codes, including in particular any end-product specifications, should be set out in the standard, if it is considered necessary that they should be made mandatory. The following statement should also appear: ``The following provisions in respect of the food hygiene of the product are subject to endorsement [have been endorsed] by the Codex Committee on Food Hygiene.''

Weights and Measures

This section should include all provisions, other than labelling provisions, relating to

weights and measures, e.g. where appropriate, fill of container, weight, measure or count of units determined by an appropriate method of sampling and analysis. Weights and measures should be expressed in S.I. units. In the case of standards which include provisions for the sale of products in standardized amounts, e.g. multiples of 100 grams, S.I. units should be used, but this would not preclude additional statements in the standards of these standardized amounts in approximately similar amounts in other systems of weights and measures.

Labelling

This section should include all the labelling provisions contained in the standard and should be prepared in accordance with the guidance given on pages 91 to 93 of the Codex Procedural Manual. Provisions should be included by reference to the General Standard for the Labelling of Prepackaged Foods. The section may also contain provisions which are exemptions from, additions to, or which are necessary for the interpretation of the General Standard in respect of the product concerned provided that these can be justified fully. The following statement should also appear: ``The following provisions in respect of the labelling of this product are subject to endorsement [have been endorsed] by the Codex Committee on Food Labelling.''

Methods of Analysis and Sampling

This section should include, either specifically or by reference, all methods of analysis and sampling considered necessary and should be prepared in accordance with the guidance given on pages 99 to 102 of the Codex Procedural Manual. If two or more methods have been proved to be equivalent by the Codex Committee on Methods of Analysis and Sampling, these could be regarded as alternative and included in this section either specifically or by reference. The following statement should also appear: ``The methods of analysis and sampling described hereunder are to be endorsed [have been endorsed] by the Codex Committee on Methods of Analysis and Sampling.''

[FR Doc. 97-13410 Filed 5-22-97; 8:45 am] BILLING CODE 3410-DM-P