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Monday, 23 June, 2008 OFFICIAL GAZETTE (First Section)

MINISTRY OF HEALTH Draft Mexican Official Standard PROY-NOM-243-SSA1-2005, Goods and Services. Milk, Milk Formula, Combined Milk Product and Milk Derivatives. Health Requirements and Specifications. Test Methods (Continued in Second Section)

In the margin, a seal with the National Coat of Arms, that states: United States of Mexico.- Ministry of Health

DRAFT MEXICAN OFFICIAL STANDARD PROY-NOM-243-SSA1-2005. GOODS AND SERVICES. MILK, MILK FORMULA, COMBINED MILK PRODUCT, AND MILK DERIVATIVES. HEALTH REQUIREMENTS AND SPECIFICATIONS. TEST METHODS.

I, MIGUEL ÁNGEL TOSCANO VELASCO, Federal Commissioner for Protection against Health Risks and Chairman of the National Advisory Committee for Health Regulation Standardisation and Development, under Article 39 of the Organic Law of Federal Public Administration; 4th of the Federal Law on Administrative Procedure; 3rd paragraph XXIV, 13 section A, paragraphs I and II, 17a paragraphs II and III, 194 paragraphs I, 197, 199, 201, 210, 214 and other applicable provisions of the General Health Law; 38 paragraph II, 40 paragraphs I, II, XI and XII, 41, 43, 46, 47 paragraph I and 51 of the Federal Law of Metrology and Standardisation; 28 and 33 of the Regulation of the Federal Law on Metrology and Standardisation; 1st paragraph I, 4th, 8th, 15, 25, 30, 40, 44 and 140 of the Health Control Regulation for Goods and Services; 2nd point C, paragraph X and 36 of the Interior Regulation of the Ministry of Health; 3rd paragraph I subparagraph C, fraction II, 10 fraction IV and VIII, 12 fraction III and other applicable provisions of the Regulation of the Federal Commission for Protection Against Health Risks, hereby order the publication in the Official Gazette of Mexico of the Draft Mexican Official Standard PROY-NOM-243-SSA1-2005, GOODS AND SERVICES. MILK, MILK FORMULA, COMBINED MILK PRODUCT, AND MILK DERIVATIVES. HEALTH REQUIREMENTS AND SPECIFICATIONS. TEST METHODS.

This draft is being published so that interested parties may, within the next 60 calendar days after the publication date, submit their written comments in Spanish and with sufficient technical evidence to the National Advisory Committee of Health Regulation Standardisation and Development, located at Monterrey número 33, planta baja, colonia Roma, postal code 06700, México, D.F., telephone 50-80-52-00 extension 1480, fax 55-11-14-99, E-mail [email protected]

During the period mentioned, the documents used as a basis to prepare the draft shall be made available for public consultation at the committee's address.

DRAFT MEXICAN OFFICIAL STANDARD PROY-NOM-243-SSA1-2005, GOODS AND SERVICES. MILK, MILK FORMULA, COMBINED MILK PRODUCT, AND MILK DERIVATIVES.

HEALTH REQUIREMENTS AND SPECIFICATIONS. TEST METHODS

CONTENTS 1. Purpose and Scope of Application

2. References

3. Definitions

4. Classification

5. Symbols and Abbreviations

6. Health Specifications

7. Sampling

8. Test Methods

9. Labelling

10. Consistency with International Standards

11. References

12. Compliance with the Standard

13. Effective Date

(First Section) OFFICIAL GAZETTE Monday, 23 June, 2008

Regulatory Appendix A. Maximum Limits for Food Additives

Regulatory Appendix B. Test Methods

Information Appendix A. List of Recommended Disinfectant Substances

Information Appendix B Cleaning and Decontamination Procedure for the Glassware and Work Area for the Determination of Aflatoxins

1. Purpose and Scope of Application

1.1 This Official Mexican Standard lays down the health and nutritional specifications for milk, milk formula, combined milk product and milk derivatives.

1.2 This Official Mexican Standard is mandatory in Mexico for natural and legal persons engaged in the processing and import of milk, milk formula, combined milk product and milk derivatives.

2. References

This regulation complements the following or those that substitute them:

NOM-086-SSA1-1994 Goods and Services. Foods and Soft Drinks with Modifications in Their Composition. Nutritional Specifications

NOM-120-SSA1-1994 Goods and Services. Health and Hygiene Practices for the Processing of Food, Soft Drinks and Alcoholic Drinks

NOM-127-SSA1-1994 Environmental Health, Water for Human Use and Consumption-Permissible Quality Limits and Treatments Which Water Must Undergo for Potabilisation

NOM-130-SSA1-1995 Goods and Services. Foods Packaged in Airtight Containers and Exposed to Heat Treatment. Health Requirements and Specifications

3. Definitions

The terms used to define and classify the specific products are not trade names and their application is related exclusively to health control.

3.1 Additive or food additive, substances added directly to products, during their manufacture, to provide or enhance aroma, colour or flavour, to improve their stability or for their preservation, among other functions.

3.2 Ice cream bases or blends, emulsion of which the composition is adjusted to the ice creams and which may be a liquid, concentrate or powder as appropriate.

3.3 Log or record, controlled document providing objective, auditable evidence of the activities performed or results obtained during the product process and analysis.

3.4 Good manufacturing practices, for the case of additives in particular, refers to the minimal quantity essential to achieve the desired effect.

3.5 Freezing, physical storage method employed using special equipment to reduce the product temperature until its thermal core is frozen.

3.6 Contaminants, undesirable physical, chemical, or biological entities found in the product above the permissible limits.

3.7 Cream, product in which a certain fraction of fat and non-fatty milk solids has been collected, whether by settling, centrifuging, or reconstitution.

3.8 Milk derivatives, products obtained from milk or its components and other ingredients functionally necessary for their preparation, including products with vegetable fat.

3.9 Dehydration, treatment consisting of the elimination of water from a product.

3.10 Milk-based sweets, products prepared by heat treatment of milk and sweeteners, in which optional additives and ingredients may be added.

3.11 Aseptic packaging, process that meets the conditions of commercial sterility to prevent the presence of microorganisms in the product during packaging.

Monday, 23 June, 2008 OFFICIAL GAZETTE (First Section) 3.12 Combo pack, container or wrapping that contains two or more different units of pre-packaged products, intended for sale to the consumer in such presentation.

3.13 Multipack, container or wrapping that contains two or more equal units of pre-packaged products, intended for sale to the consumer in such presentation.

3.14 Package or primary package, container intended to contain a product and that comes into contact with such product.

3.15 Commercial sterilisation, heat treatment applied to the product to kill all viable microorganisms of importance in public health and those capable of reproducing in the food under normal storage and distribution conditions, without refrigeration.

3.16 Label, means the tag, sticker, inscription, brand, graphic image, or other descriptive form that has been written, printed, stencilled, marked, in relief or in intaglio, embossed, affixed, sealed, or attached to the product pack or package.

3.17 Expiry date, deadline at which a pre-packaged product stored under the conditions established by the manufacturer maintains the health characteristics it should meet for consumption. After this date, it may not be sold or used.

3.18 Best before date, date on which, under certain storage conditions, the period expires during which the pre-packaged product is marketable and maintains any specific qualities attributed to it tacitly or expressly, but after which the pre-packaged product may be consumed, provided that it does not exceed the expiry date.

3.19 Milk formula, product prepared from the inherent ingredients of milk, such as casein, fat, whey and water for human consumption, at quantities in accordance with the provisions of the respective trade name standard.

3.20 Ice cream, food produced by freezing with or without stirring, of a pasteurised mixture composed of a combination of dairy ingredients that may contain vegetable fats, fruit, eggs and egg derivatives, flavourings, sweeteners and other additives; when on a stick, it shall be known as an ice lolly.

3.21 Optional ingredients, ingredients that can be added to products, such as: hot peppers, condiments, spices, among others.

3.22 Milk, product intended for human consumption, originating from the natural secretion of the mammary glands of healthy cows or other domesticated animal species. The product is excluded when it contains colostrum, which if present in milk, can wait a reference period between 15 days before and 5 after parturition.

3.23 Maximum limit, established quantity of additives, microorganisms, parasites, foreign matter, pesticides, heavy metals and metalloids, among others, that should not be exceeded in a food, drink, or raw material.

3.24 Cleaning, set of procedures intended to eliminate soil, residue, grime, dirt, fat, or other objectionable substances.

3.25 Batch, quantity of a product, prepared in a single cycle, composed of homogeneous units.

3.26 Butter, product obtained from milk fat or cream fat, which has been pasteurised, ripened, fermented or acidified, whipped or kneaded, with or without added salt.

3.27 Foreign matter, any substance, residue, waste, or material present in the product, but not forming the normal composition thereof

3.28 Heavy metal, chemical elements that cause undesirable effects on the metabolism, even at low concentrations. Their toxicity depends on the intake dose, as well as accumulation in the body.

3.29 Test method, analytical procedure used to verify that a product meets the specifications established by the standard.

(First Section) OFFICIAL GAZETTE Monday, 23 June, 2008 3.30 Sample, all product units originating from a batch and that represent the characteristics and conditions thereof.

3.31 Pasteurisation, heat treatment to which the products are exposed, consisting of a temperature and time relationship that ensures the destruction of pathogenic organisms and the inactivation of some enzymes of the foods.

3.32 Process, set of activities related to the obtaining, elaboration, manufacturing, preparation, preservation, mixing, conditioning, packaging, handling, transportation, distribution, storage and sale or supply to the public of the products covered by this standard.

3.33 Acidified milk product, product basically obtained by acidification of pasteurised milk with acidifying agents.

3.34 Combined milk product, product prepared from milk solids or other ingredients not obtained from milk at quantities that comply with the provisions established in the respective trade name standard.

3.35 Sweetened condensed milk product, product obtained by rehydration, partial evaporation, or reduced pressure of milk, in which sweeteners, additives and optional ingredients have been mixed.

3.36 Fermented milk product, product obtained from fermentation of milk by the action of specific microorganisms with the result of reducing the pH, regardless of whether additives and optional ingredients are added or not.

3.37 Commercial sterility test, temporary retention of representative samples of the products under established time and temperature conditions to verify the commercial sterility of the product.

3.38 Fresh cheeses, cheeses prepared by the action of coagulating agents such as rennet, lactic cultures, or acidifiers and characterised by their high moisture content, without rind or with a very fine rind.

3.39 Ripened cheeses, cheeses prepared by the action of coagulating agents such as rennet, lactic cultures or acidifiers, exposed to a ripening process by addition of microorganisms, under controlled time, temperature and humidity conditions; characterised as hard, semi-hard or soft; may or may not have rind.

3.40 Processed cheeses, cheeses characterised by being prepared by grinding, blending of cheeses, melting, or emulsifying with emulsifiers or by heating, with or without the addition of milk or its components.

3.41 Refrigeration, physical storage method used in food to inhibit the development of most microorganisms, reduce biochemical reactions and inherent deterioration of the food.

3.42 Rehydration, procedure whereby water is restored to dehydrated products covered by this standard.

3.43 Sorbet, product that complies with the definition of ice creams, except that its content in terms of fat, non-fatty solids and total solids is less than those of ice cream.

3.44 Whey, liquid obtained by milk casein coagulation, through the action of coagulating agent enzymes of animal, plant, or microbial origin, by adding food-grade organic or mineral acids; ion exchange acidification until the isoelectric point of casein is reached.

3.45 Heat treatment, physical method consisting of exposing the product to a source of sufficient heat for an appropriate time, before or after packaging, in order to achieve biological stability and ensure that pathogenic microorganisms are killed.

3.46 Ultrapasteurisation, process whereby the product is exposed to an adequate temperature and time relationship and aseptically packaged to ensure commercial sterility.

4. Classification

The products covered in this standard by virtue of their processing are classified into:

4.1 Milk

4.1.1 Pasteurised


4.1.2 Ultrapasteurised

4.1.3 Sterilised

4.1.4 Dehydrated

4.2 Milk formula

4.2.1 Pasteurised


4.2.3 Sterilised

4.2.4 Dehydrated

4.3 Combined milk product

4.3.1 Pasteurised


4.3.3 Sterilised

4.3.4 Dehydrated

4.4 Cheeses

4.4.1 Fresh

4.4.1.1 Soft: Panela, Canasto, Sierra, Ranchero, Fresco, Blanco, Enchilado, Adobado

4.4.1.2 Cooked: Oaxaca, Asadero, Mozzarella, Del Morral, Adobera

4.4.1.3 Acidified: Cottage, Cream, Double Cream, Petit Suisse, Neufchatel

4.4.1.4 Whey cheeses: Broccio, Broccotle, Cerrase, Geitmysost, Gyetost, Mejetle, Mysost, Recuit, Requesón, Ricotta, Picotón, Schottenezinger, Zinder

4.4.2 Ripened

4.4.2.1 Hard, pressed, ripened: Mature, Parmesan, Cotija, Reggianito

4.4.2.2 Pressed, ripened: Cheddar, Chester, Chihuahua, Manchego, Brick, Edam, Gouda, Gruyere, Emmental, Cheshire, Holandés, Amsterdam, Butterkase, Coulomiers, Dambo, Erom, Friese, Fynbo, Havarti, Harzer-Kase, Herrgardsost, Huskallsost, Leidse, Maribo, Norvergia, Provolone, Port Salut, Romadur, Saint Paulin, Samsoe, Svecia, Tilsiter, Bola, Jack

4.4.2.3 Mould-ripened: Blue, Cabrales, Camembert, Roquefort, Danablu, Limburgo, Brie

4.4.3 Processed

4.4.3.1 Melted

4.4.3.2 Melted for spreading

4.5 Butter

4.6 Creams

4.6.1 Pasteurised


4.6.3 Sterilised

4.6.4 Dehydrated

4.6.5 Acidified

4.6.6 Fermented

4.6.7 Whipping

4.7 Sweetened condensed milk product

4.8 Fermented or acidified milk products


4.9 Milk-based sweets

4.9.1 Low-moisture (less than 12%) or hardened sweets: candies, gummies, jamoncillos [Mexican caramels], etc.

4.9.2 Medium-moisture (12-20%) sweets processed by evaporation: glorias, caramel topping and wafers with caramel topping, etc.

4.9.3 High-moisture (more than 20%) sweets, processed by coagulation, aeration and enzymatic processes: flans, gelatine, chongos, mousse, rice pudding, etc.

4.10 Ice creams and sorbets

4.11 Other milk products not considered shall comply with the provisions laid down in this code.

5. Symbols and Abbreviations

AFM1 aflatoxin M1

GMP good manufacturing practices

cm centimetre

cm2 square centimetre

Cl colour index

conc. concentration

HPLC high-performance liquid chromatography

ºC degrees Celsius

g gram

xg gravity (in centrifuging)

h hour

= equal

RDA Recommended Daily Allowance

1/d reciprocal dilution

kcal kilocalorie

kg kilogram

kJ kilojoules

Ib pound

L litre

+ more than

m mass

± plus or minus

Max. maximum

> greater than

< less than

µ micron

µg microgram

µL microlitre

mg milligram

µn micrometre

mL millilitre

min minutes

mm millimetre

Monday, 23 June, 2008 OFFICIAL GAZETTE (First Section) mM millimole

M Molar

m/v mass to volume

ng nanogram

nm nanometre

N normal

No. number

/ per

% per cent

pH hydrogen potential

in inch

rpm revolutions per minute

s seconds

X multiplication sign

PU phenol units

CFU colony-forming units

IU international units

UV ultraviolet

v Volume

v/v volume to volume

When this standard mentions:

• Agreement, it should be understood to mean the agreement that determines allowed substances such as additives and coadjuvants and its modifications.

• Regulation, it should be understood to mean the Health Control Regulation for Goods and Services.

• CICOPLAFEST, it should be understood to mean the Intersecretariate Commission for Process and Usage Control of Pesticides, Fertilisers and Toxic Substances.

• COFEPRIS, it should be understood to mean the Federal Commission for Protection Against Health Risks.

6. Health Specifications

6.1 General information

The products covered by this standard, in addition to complying with the provisions of the Regulation, shall comply with the following provisions:

6.1.1 Establishments engaged in the processing and import of the products covered by this standard shall comply with the provisions of NOM-120-SSA1-1994, listed in the reference section.

6.1.2 All ingredients used shall comply with the provisions of the Regulation and the respective standards.

6.1.3 The raw material supplier and the establishments where such raw materials are processed or sold, each within the scope of their responsibility, shall monitor that the substances used to kill pests at any part of the process are fitted with a certificate issued by COFEPRIS or, where applicable, by CICOPLAFEST.

6.1.4 Products for which the composition has been modified shall comply with the provisions of NOM-086-SSA1-1994, listed in the reference section.


6.1.5 Products exposed to heat treatment and packaged in airtight containers, in addition to complying with the provisions of this code, shall comply with NOM-130-SSA1-1995, listed in the reference section.

6.1.6 In the preparation of the products, water suitable for human consumption shall be used, in accordance with the provisions of NOM-127-SSA1-1994, cited in the reference section.

6.1.7 The milk, milk formula, or combined milk product sold or used as a raw material for the preparation of milk products shall comply with the following:

6.1.7.1 Contain no foreign matter, preservatives, or neutralising substances.

6.1.7.2 Not curdle when boiled.

6.1.7.3 Have a negative 68% alcohol test.

6.1.7.4 Have a negative bacterial inhibitor test; detected by physicochemical and microbiological methods, in accordance with Table 1 of this code.

Table 1. Bacterial Inhibitors in Milk

PRODUCT Chlorinated Derivatives

Quaternary Ammonium Salts

Oxidants Formaldehyde Antibiotics

Pasteurised Negative Negative Negative Negative Negative

Ultrapasteurised Negative Negative Negative Negative Negative

Sterilised Negative Negative Negative Negative Negative

Dehydrated Negative Negative Negative Negative Negative

6.1.7.5 Be exposed to a heat treatment or any other treatment that ensures its innocuousness, regardless of the subsequent use of the product.

6.1.7.6 The heat treatments to which the milk, milk formula, or combined product is exposed for marketing or before use as a raw material may be: boiling, pasteurisation, ultrapasteurisation, sterilisation, or dehydration, in accordance with the specifications of the following table.

Table 2. Temperatures and Times for the Heat Treatment of Milk, Milk Formula, or Combined Product

Treatment Temperature and time*

Pasteurisation Slow 63ºC / 30 min

Flash 72ºC / 15 s

Ultrapasteurisation or sterilisation 135ºC to 149ºC / 2 to 8 s

* Another equivalent time-temperature relationship for killing pathogenic microorganisms can be used.

6.1.7.7 Equipment for slow pasteurisation shall have, at least, a system to record and control the process temperature and time, a vat with a lid and product stirring system and a mercury or equivalent thermometer that is running and calibrated.

6.1.7.8 Equipment used for flash pasteurisation shall be equipped with, at least, an automatic control and logging system for process temperature and time that does not allow the product to pass unless it has reached the minimum temperature established and a mercury or equivalent thermometer that is running and calibrated, placed at the end of the "support area" of the equipment. The temperature recorded by the process control and logging system must be equal to or less than 1.0ºC different from the temperature indicated by such thermometer.

Monday, 23 June, 2008 OFFICIAL GAZETTE (First Section) 6.1.7.9 Equipment used for ultrapasteurisation or sterilisation shall have operating temperature control and

logging devices during the production time, making it possible to verify that the products have been exposed to the heat treatment established.

6.1.7.10 Once the temperature has been reached, the milk, milk formula, or combined product shall be flash-cooled to 6ºC, except for ultrapasteurised or sterilised products.

6.1.7.11 Products exposed to time and temperature relationships above those established in Point 6.1.7.6 and with non-aseptic packaging shall comply, at least, with the health requirements and specifications established for products that undergo pasteurisation.

6.1.7.12 Products exposed to dehydration shall comply with the following:

a) Those used as raw material shall be pasteurised before dehydration.

b) Bulk sale to the consumer is not allowed.

6.1.7.13 Products exposed to rehydration shall be pasteurised, ultrapasteurised, or sterilised, in accordance with this code.

6.1.8 Physical and chemical specifications

6.1.8.1 The residual phosphatase test shall be no more than 12 PU/g for fresh cheeses at the plant, ripened cheeses and processed cheeses and 4 PU/g for all other products covered by this regulation. This is not applicable for ultrapasteurised, sterilised, or dehydrated products.

6.1.8.2 They should not contain foreign matter.

6.1.9 Contaminant specifications

6.1.9.1 The presence of contaminants in the products covered by this standard may be no higher than the maximum limit listed in the following table.

Table 3. Maximum Limits of Contaminants

Contaminant Upper limit Arsenic (As) 0.2 mg/kg

Lead (Pb) 0.1 mg/kg

0.5 mg/kg*

Mercury (Hg) 0.05 mg/kg

Tin (Sn)** 250 mg/kg

Aflatoxin M1*** 0.5 µg/L

* For cheese

** For products packaged in an unvarnished tinplate.

*** For milk, milk formula and combined milk product.

6.1.9.2 The producer or manufacturer of the products covered by this standard shall establish control mechanisms that make it possible to determine the presence and quantity of heavy metals and metalloids in the raw materials or in the product during the preparation process or in the finished product. The information generated should be made available to the Ministry of Health, when requested.

6.1.10 Microbiological specifications

6.1.10.1 The products covered by this standard may not exceed the microorganism limits listed below:


Table 4. Maximum Microbial Content Limits for Milk and Milk Derivatives Microorganism Upper limit Products

< 100 CFU/g Ice creams and sorbets.

< 50 CFU/g Ice cream bases or mixtures.

< 20 CFU/g or ml At point of sale: Milk, milk formula, combined milk product; pasteurised.

Total Coliform Organisms

< 10 CFU/g or ml In plant: Milk, milk formula, combined milk product; pasteurised or dehydrated.

Butter, creams, sweetened condensed milk products, fermented and acidified milk products, milk-based sweets.

Staphylococcus aureus < 100 CFU/g or ml

Butter, creams, sweetened condensed milk products, fermented and acidified milk products, milk-based sweets.

Salmonella spp Absent in 25 g or ml

Milk, milk formula, combined milk product; pasteurised and dehydrated.

Fresh, ripened and processed cheeses.

Creams, fermented or acidified milk products, milk-based sweets*, ice creams, sorbets and ice cream bases

100 CFU/g or ml Milk used as raw material for the preparation of cheese.

Fresh cheeses.

Escherichia coli

< 3 MPN/g Milk, milk formula, combined milk product; dehydrated.

Ripened cheeses.

Listeria monocytogenes ** Absent in 25 g or ml

Milk, milk formula, combined milk product; pasteurised.


Ice creams, ice cream bases and sorbets.

Vibrio cholerae *** Absent in 25 g Fresh cheeses.

Ice creams, sorbets and ice cream bases.

Staphylococcal enterotoxin Negative Milk, milk formula and combined milk product; dehydrated and milk used as a raw material to manufacture cheese.


Botulinum toxin*** Negative Fresh, ripened and processed cheeses, ultravacuum-packed.

* For products containing chocolate, cocoa, coconut, eggs and seeds.

** The presence of this bacterium shall be determined if the health authority detects outbreaks of such bacterium.

*** This shall be determined only under emergency health situation[;] the Ministry of Health, without prejudice of the authorities of other executive institutions, will determine the cases to identify the presence of this harmful biological agent.

Monday, 23 June, 2008 OFFICIAL GAZETTE (First Section) 6.1.11 Additives

6.1.11.1 Additives are only allowed with the limits and products listed in Regulatory Appendix A of this code.

6.1.12 Documentary control of the process

6.1.12.1 The process of the products covered by this standard shall be documented in logs or records, such that they ensure traceability throughout the process. These records shall comply with the following:

a) Have evidence that ensures the accuracy of the information and a procedure to prevent uncontrolled access and corrections.

b) Be stored for at least one month beyond the established shelf life period for the product and be available to the health authority when required.

c) Specify the date, batch number, name and signature of the person or supervisor in charge of monitoring

d) The format design and record-keeping frequency are the manufacturer's responsibility, except for heat treatment records, which must be continuous.

Table 5. Minimal Information on the Procedures, Logs, or Records of the Various Process Stages

DOCUMENT INFORMATION Log or record of raw materials - Name of raw material

- Supplier

- Results of analysis, including at least the following:

l Name of raw material

l Batch

l Health parameter analysed

l Laboratory

- Or health quality certificate supporting its innocuousness

- Or results of analyses performed by the raw material supplier

- Storage temperature, when applicable, according to the raw material involved

Finished product log or record - Analysis of the finished product, including at least the following:

l Product name

l Batch

l Health parameter analysed

l Laboratory

Storage chamber temperature records - Identification of cold store, refrigerator, or freezer

- Temperature

- Date of monitoring

- Person responsible

Process log or record - Heat-treatment control

l Plots of heat-treatment temperatures and times (pasteurisation, ultrapasteurisation or sterilisation, dehydration) according to equipment unit

l Cooling temperature and time.

l Product quantity and identification

- Record of unusual events

Cleaning operating procedure - Products used


and heat-treatment equipment disinfection. - Dosing

- Concentrations

- Contact times

- Rinses

- Staff in charge of the operation

- Frequency

- Effective date

Log or record of equipment cleaning and disinfection operations for heat treatment.

- Identification of equipment

- Shift/time

- Record of unusual events

Maintenance or calibration log or record for operating control instruments and temperature monitoring systems.

- Identification of instrument or equipment

- Type of maintenance (preventive or corrective)

- Operation performed

Process flowchart - Process stages with times and temperatures for each operation.

6.2 Specific

In addition to the general health specifications laid down in number 6 of this code, the following must be met:

6.2.1 Milk, milk formula and combined milk product

6.2.1.1 Such products shall contain between 310 and 670 •g of retinol equivalents/L (1033 to 2333 IU/L), naturally or through restoration and between 5 to 7.5 •g/l of vitamin D3 (200-300 IU/L).

6.2.1.2 Products with added vitamin A or D3 may not contain quantities above those established in this code.

6.2.1.3 Dehydrated products may have a water content not higher than 4%.

6.2.1.4 Products exposed to ultrapasteurisation or sterilisation shall comply with the following:

6.2.1.4.1 Be aseptically packaged in containers with have barriers to protect the product from oxygen and light and be filled in the absence of air.

6.2.1.4.2 The container closure shall be airtight and control tests and the respective records shall be carried out.

6.2.1.4.3 The package used shall undergo a sterilisation treatment.

6.2.1.4.4 Sterilising agents shall have sporicidal activity, may not degrade the packaging material, shall readily evaporate from the package surface and may not react with the product.

6.2.1.4.5 The use of hydrogen peroxide is only allowed for purposes of disinfecting the containers; hydrogen peroxide shall be used at a concentration of 30% to 50%.

6.2.1.4.6 Establishments shall set aside an incubation area for the commercial sterility test for purposes of internal control of a representative sample from production, of which a subsample shall be taken to undergo microbiological analyses.

6.2.2 Creams

6.2.2.1 Acidified and fermented creams shall have a titratable acidity of not less than 0.5% expressed as lactic acid.

6.2.2.2 Dehydrated creams may have a water content not higher than 4%.

Monday, 23 June, 2008 OFFICIAL GAZETTE (First Section) 6.2.3 Fermented or acidified milk products

6.2.3.1 Fermented milk products and acidified milk products shall have a titratable acidity not less than 0.5% expressed as lactic acid and the maximum pH shall be 4.4.

6.2.4 Ice creams, ice cream bases and sorbets

6.2.4.1 The inclusion of clean air as an aid to preparation is allowed for the preparation of ice cream and sorbets.

6.2.4.2 Products may not be refrozen once thawed.

6.2.4.3 The mixture to prepare ice creams, ice cream bases and sorbets shall be pasteurised as follows:

6.2.4.3.1 Such products shall be exposed to a temperature of 68.5ºC for a time of 30 minutes, or

6.2.4.3.2 Such products shall be exposed to a temperature of 79.4ºC for a minimum time of 25 seconds, or

6.2.4.3.3 Such products shall be exposed to another time-temperature relationship with the same effect.

6.2.4.3.4 In any case, once the temperatures and times are reached, respectively, the product shall be flash-frozen at 4ºC.

6.2.4.3.5 Once the mixtures are pasteurised, they must be kept at a maximum temperature of 6ºC before they are frozen.

7. Sampling

7.1 The sampling procedure for products covered by this standard shall be subject to the provisions of the General Health Law and the sample shall be kept under conditions that prevent its contamination or decomposition.

8. Test Methods

For official verification of the specifications established in this standard, the test methods listed in Regulatory Appendix B of this code shall be applied.

9. Labelling

The label of products covered by this standard, in addition to meeting the provisions of the Regulation, shall be subject to the following, without interfering with the authority of other official institutions:

9.1 General Information

9.1.1 Products to be sold on the Mexican market shall display a label with the information referred to in this standard in the Spanish language, notwithstanding the possibility that it may also be shown in other languages, taking care that the characters are at least equal in type size and proportionality and equally prominent manner.

9.1.2 Information contained in the labels shall be displayed and described clearly, accurately and verifiably.

9.1.3 Labels displayed by prepackaged products shall be affixed such that they remain available until the time of use and consumption under normal conditions and shall be applied to each unit, multipack or combo pack using clear, visible, indelible characters in contrasting colours that are easy for the consumer to read under normal circumstances of purchase and use.

9.1.4 The main display surface of the product shall list at least the name of the prepackaged product. The remaining information referred to in this Official Mexican Standard may be listed on any other part of the package.

9.1.5 The main display surface of containers of milk, milk formula and combined milk product shall state the heat treatment to which the product was exposed, as well as other treatments applied to ensure product innocuousness, as established in other legal codes that may apply.


9.1.6 In the case of multipacks or combo packs for consumer sale, the information referred to in this Official Mexican Standard shall be listed on this package. However, the batch and expiry or best before date shall be displayed on prepackaged products and do not need to be listed on multipack or combo packs. In addition, the products shall include the legend "Not labelled for individual sale" when the products do not state the information referred to in this standard. This legend will not be necessary when the individual containers in a multipack or combo pack display the information referred to in this Official Mexican Standard.

9.2 Designation

9.2.1 The name or designation of the prepackaged product shall comply with the provisions of the specific legal codes; if such codes are absent, it is possible to state the customary name or else a description in accordance with the basic characteristics of the composition and nature of the product is not misleading or deceptive to the consumer. If the product has undergone any kind of treatment, the name of such treatment may be stated, except in the case of treatments that are mandatory, according to the respective codes.

9.3 Ingredients

9.3.1 The label of prepackaged products sold in individual form shall contain a list of ingredients; products consisting of a single ingredient are exempt.

9.3.2 The list of ingredients shall be headed or preceded by the term "ingredients:"

9.3.3 The ingredients shall be stated in descending order of quantity (m/m) and with the specific name of such ingredients, except in the classes of ingredients shown in the following table, including added nutrients.

Table 6

INGREDIENTS GENERIC NAME Dehydrated powdered milk

Fluid milk regardless of fat content

Milk

Butter whey

Cheese whey

Milk whey

Milk or whey protein concentrate

Whey protein

Lactose

Milk solids

Edible fats or oils

Hydrogenated or partially hydrogenated

Vegetable fats

Caseinate blend Caseinates

9.3.4 Notwithstanding the specifications of the above point, lard and tallow shall always be stated by their specific name.

9.3.5 When the products covered by this standard contain iodised salt, this must be stated as such in the list of ingredients.

9.3.6 When non-cow's milk is used to prepare the products covered by this standard, its origin shall be stated.

9.3.7 A compound ingredient shall be stated when it comprises more than 25 per cent and the statement shall be accompanied by a list in parentheses of its ingredients by descending quantitative order (m/m). When such ingredient comprises less than such percentage, the additives that play a technological role in product preparation and those ingredients or additives associated with allergic reactions shall be stated, in compliance with the respective legal codes.


9.3.8 In the case of dehydrated or condensed foods to be used to be reconstituted, the ingredients may be listed by descending quantitative order (m/m) in the reconstituted product, provided that statement such as the following is included: "ingredients of the product when prepared according to the label instructions".

9.3.9 The list of ingredients shall include any additives used in the ingredients that have been transferred to another product in appreciable or sufficient quantity to play a technological role.

9.3.10 The additives used to prepare the products covered by this standard shall be listed by the customary name or the preferred synonyms in Regulatory Appendix A, except for flavourings and enzymes, which may be listed by the generic name.

9.3.11 The statement of the list of ingredients does not need to include additives transferred to prepackaged products that no longer play a technological role in the finished product, nor preparation aids, except those additives that could cause allergic and intolerance reactions.

9.4 Legal name and address

9.4.1 The label shall list the name or business name and legal address of the manufacturer or company responsible for manufacturing.

9.4.2 The label for prepackaged imported products shall specify the name, business designation or name and legal address of the importer. This information may be included in the product prepackaged in Mexico, before product marketing.

When an establishment other than the natural or legal person, the licensee or assignee, brand owner, is involved in the product process, the legend "MADE FOR..." or any equivalent shall be listed on the label, followed by the name or address (street, number, urbanisation, postal code, city and state) of the party responsible for the product and the batch shall allow the establishment(s) involved in the process to be identified.

9.5 Country of origin

The legend that identifies the product's country of origin, for example: "Made in....", "Product of...", "Manufactured in....", or equivalent legend shall be included, followed by the country of origin.

9.6 Batch

9.6.1 The batch number or code to which the product pertains shall be stated, such that it allows traceability; this number or code shall be listed on the individual container.

9.6.2 The batch identification listed by the manufacturer on the prepackaged product may not be altered or hidden in any way.

9.6.3 When labelled using a date format, the word "Batch" or its abbreviation "B" shall be indicated.

9.7 Expiry date

9.7.1 The use by or best before date shall be stated, preceded by the following legend: "Use by _________", "Best Before End _________", or "Best Before _________", specifying the date in the blank space, stating:

9.7.1.1 For pasteurised products, at least: day and month.

9.7.1.2 Frozen, ultrapasteurised or sterilised and dehydrated products: at least month and year.

9.7.2 The use by date listed by the manufacturer on the prepackaged product may not be altered in any case and under any circumstances.

9.7.3 If the batch identification corresponds to the use by or best before date, the following legends must be stated: "Batch" and "Use By " or "Best Before" date or its abbreviations.

9.7.4 Labels for pasteurised products and products requiring refrigerated storage shall include the following legend: "Keep refrigerated" or "Store refrigerated" or any other equivalent phrase.


9.7.5 Ice creams, sorbets and other products that require freezing shall display the legend "Keep frozen" or "Store frozen" or any other equivalent statement.

9.7.6 For dehydrated products: "Store in a cool, dry place", "Once prepared, keep or store the product refrigerated" or any other equivalent phrase.

9.7.7 Low- and medium-moisture milk-based sweets shall state "Keep in a cool, dry place" or any other equivalent statement.

9.7.8 The legend for ultrapasteurised or sterilised milk products in airtight containers shall include "No refrigeration needed until opened" or "Once opened, keep refrigerated", or any other equivalent legend.

9.8 Nutritional information

9.8.1 General information

9.8.1.1 Any products covered in this standard that have experienced changes in nutritional composition shall display, along with the name and in the same font type and size, the change characterising it.

9.8.1.2 The nutritional information on prepackaged product labels is voluntary. The information is only mandatory when a nutritional property statement is expressed in quantitative or qualitative form.

9.8.1.3 When the nutritional information is included, the following shall be stated:

a) Energy content

b) Quantities of proteins, available carbohydrates and fats or lipids

c) Quantity of sodium

d) Quantity of any other nutrient for which properties are stated.

9.8.1.4 Nutritional information shall be provided per 100 grams or per portion or per package, if the package contains only one portion.

9.8.1.5 Nutritional information shall be provided in the respective numerical units. Additionally, other forms of presentation thereof may be used.

9.8.1.6 Information on energy content shall be expressed in kilojoules. Likewise, it may be stated in kilocalories; in both cases, the abbreviations kJ or kcal, respectively, may be used.

9.8.1.7 Information on the quantity of proteins, available carbohydrates and fats or lipids in the foods must be expressed in grams.

9.8.1.8 Information on sodium content shall be expressed in milligrams.

9.8.1.9 Numerical information on vitamins and minerals shall be expressed in metric units or as a percentage of the recommended daily allowance (RDA), per 100 g, or per portion or per package if the package contains only one portion. If the information is provided as a percentage of the RDA, the following legend may be cited: recommended daily allowance for the Mexican population or similar legend.

9.8.1.10 When the numerical information on vitamins and minerals is shown as a percentage of the RDA, only the table of weighted recommendations established in NOM-086-SSA1-1994 Regulatory Appendix B, indicated in the reference section, may be used.

9.8.1.11 The products covered in this standard may only display a nutritional property statement when the nutrient content is equal to or greater than 5% of the RDA per portion.

9.8.1.12 The nutritional composition values listed on the nutrition statement of the product shall be weighted mean values derived from analyses, databases, or nationally and internationally recognised tables.


9.8.2 Specific

9.8.2.1 Milk, milk formula and combined milk product to which vitamin D or vitamins A and D have been added, as applicable, shall list their content using the following legends:

i) "Contains _________ µg of vitamin D per L", or

ii) "Contains _________ µg of Vitamin D and _________ µg retinol equivalents (vitamin A)/L".

iii) The content of such nutrients shall be listed in the blank space, in accordance with the provisions of Points 6.2.1.1 or their equivalent per 100 g, per portion, or per package, if the package contains only one portion. The term in parentheses is optional.

iv) The text "Vitamin D Added" for products to which Vitamin D3 has been added, in accordance with the provisions of Point 6.2.1.1 of this code

m) When voluntarily listed on the nutritional statement, such nutrients shall be listed as shown below:

Table 7

Nutrient Quantity per 100 g or per portion or per package Vitamin A µg retinol equivalents

Vitamin D µg

9.8.2.2 Products with a modification in their composition shall comply with the provisions of NOM-086-SSA1-1994, cited in the reference section, except for those indicated in Point 9.8.2.1, which shall comply with the provisions of this code.

9.8.2.3 Vitamin calculations

i) Vitamin A

1 IU of vitamin A is equivalent to 0.3 µg retinol equivalents (all "trans" retinols).

ii) Vitamin D3.

1 IU of vitamin D3 is equivalent to 0.025 µg of cholecalciferol.

9.9 Best Before Date

9.9.1 The best before date for marketing of the prepackaged product is optional. If included, the following shall be observed:

i) Such date shall be preceded by a legend that specifies "Best Before End _____ " or "Use by ______ "; specify the date in the blank, indicating:

a) The day and month for products lasting up to three months;

b) The month and year for products lasting more than three months.

9.9.2 When the best before date is stated, the package or label shall list any conditions required for storage of the prepackaged product.

9.9.3 The best before date listed by the manufacturer on the prepackaged product may not be altered in any case and under any circumstances.

9.10 Instructions for use

9.10.1 The label shall contain the directions for use where instructions are needed, including reconstitution, if applicable, to ensure proper use of the prepackaged product.

9.11 Precautionary statements

9.11.1 Products containing ethyl alcohol or alcoholic beverages in quantities above 0.5% shall include the following statement on the main display surface of the label: "This product contains ______% alcohol. Not recommended for children". (Specify the alcohol content in % in the blank space).


9.11.2 Precautionary statements that promote an advisable diet may be included.

9.12 Additional information

9.12.1 The label may present any information or graphic representation as well as written, printed, or graphic material, provided that this does not contradict the mandatory requirements of the present standard.

9.12.2 The label may present any information or graphic representation indicating that the pack containing the prepackaged product does not affect the environment when this is true.

9.12.3 Additional nutritional information (optional)

Complementary nutritional information may optionally be included, but in no case may replace the nutrient statement of Section 9.8.1.3 and if stated, shall comply with the following:

a) All or none of the following:

of which polyunsaturates ___ g; of which monounsaturates ___ g; of which saturates ___ g; of which cholesterol ___ mg

b) The statement of one of the following does not require the statement of the others:

of which sugars ___ g; of which starches ___ g; dietary fibre ___ g

c) When expressing the types of constituents of available carbohydrates and of fats or lipids listed in b) and c), such constituents shall be preceded by the text "of which..." or similar legend such that the information is clear to the consumer. This legend may be omitted if the layout of the information on the label is sufficiently clear.

d) Number of portions per package

9.13 Prohibited claims

9.13.1 The use of the following statements is prohibited:

a) Claims:

that lead to the assumption that a proper diet based on ordinary foods cannot supply sufficient quantities of all nutritional elements;

that cannot be proven;

regarding the usefulness of a food to prevent, relieve, treat, or cure a disease, disorder, or physiological condition;

that may raise questions about the innocuousness of analogous foods or may lead to or cause fear in the consumer.

b) Misleading claims

Meaningless claims, including comparatives and superlatives

Claims regarding proper hygiene or business practices, such as "genuine", "healthy", "healing", except as laid down in other applicable legal codes.

Claims affirming the "organic" or "biological" nature or origin of a food, except in those cases in which it is proven that the product actually has such characteristic.

9.14 Calculations

9.14.1 Nutrient calculations

a) Energy calculations

The quantity of energy to be stated shall be calculated using the following conversion factors:

Available carbohydrates 17 kJ or 4 kcal/g

Proteins 17 kJ or 4 kcal/g

Fats (lipids) 38 kJ or 9 kcal/g


b) Protein calculations

The quantity of proteins to be indicated shall be calculated using the following formula:

Protein = total nitrogen content by Kjeldahl X 6.25

9.15 Presentation of mandatory requirements

General information

9.15.1 When the package is covered by a wrapping, such wrapping shall contain all information necessary, except in cases in which the label applied to the package can be easily read through the outer wrapping.

9.15.2 In the event that the products covered in this standard contain or include prepackaged products as part of promotions or complimentary gifts, such as breadmaking products, cereals, chocolate or other foods, at least the following information shall be included in the package of the promotional product or complimentary gift: list of ingredients, identification of party responsible for the product, use by date and batch.

9.15.3 When the labels state or display in written, graphic, or descriptive form that the products, their use, application, ingredients, or any other characteristic are recommended, backed, or accepted by research centres, associations, organisations, among others, such institutions shall have national or international recognition of their expertise and be qualified to give an opinion on the information stated. The respective technical support shall be provided and available to the Ministry when requested. Such statements shall comply with the following: the legend shall clearly describe the characteristic reported, be preceded by the symbol or name of the organism and be shown in clear, readily legible characters.

9.14.4 The use of educational legends that promote the use of a recommendable diet are allowed.

9.15.5 The products to be reconstituted or those contained in containers that require special instructions of use or consumption shall include a written or graphic description of the instructions of use, employment, or preparation.

10. Consistency with International Standards

This standard is partially equivalent to the following standards:

10.1 Codex Alimentarius. CODEX STAN 232-2001. Codex Standard for Aflatoxin M1 in Milk: Maximum Level

10.2 Codex Alimentarius. CODEX STAN A-9-1976, Rev. 1-2003. Codex Standard for Cream and Prepared Creams

10.3 Codex Alimentarius. CODEX STAN A-6-1978, Rev. 1-1999, amended in 2003. Codex General Standard for Cheese

10.4 Codex Alimentarius. CODEX STAN 221-2001. Codex Group Standard for Unripened Cheese Including Fresh Cheese

10.5 Mexican Standard NMX-F-10-1982. Human Foods-Butter From Milk or Pasteurised Cream, Ministry of Trade and Industrial Development, Director General for Regulations

11. References

11.1 Ministry of Economy, 1992, Federal Law on Metrology and Standardisation, Reforms of 20 May 1997, Official Gazette of Mexico, Mexico, D.F.

11.2 Ministry of Economy, Regulations of the Federal Law on Metrology and Standardisation, Official Gazette of Mexico, Mexico, D.F.

11.3 Ministry of Health, General Health Law, Official Gazette of Mexico (Latest Reform Published on 19 September 2006), Mexico, D.F.

11.4 Ministry of Health, Health Control Regulations for Goods and Services, Official Gazette of Mexico 090899, Mexico, D.F.

11.5 Ministry of Economy, NOM-008-SCFI-1994, General System for Units of Measure, Mexico, D.F. Official Gazette of Mexico 241002


11.6 Ministry of Economy, 1994, NORMA-Z-13; Guidelines for Writing, Structuring and Presentation of the Official Mexican Regulations, Mexico, D.F.

11.7 Food and Drug Administration. Grade "A" Pasteurised Milk Ordinance (2003 Revision), Department of Health and Human and Services, U.S.A.

11.8 Fernández Escartin, E. 2000. "Microbiology and Innocuousness of Foods". Autonomous University of Querétaro.

11.9 Food and Agriculture Organization of the United Nations. 1994. "Summary of evaluations performed by the Joint FAOM/HO Expert Committee on Food Additives (JECFA)". ILSI Press, Washington.

11.10 U.S. Food & Drug Administration. 2001. Center for Food Safety & Applied Nutrition. Foodborne pathogenic microorganisms and natural toxins handbook. "Bad bug book".

11.11 Ministry of Health, Directorate General of Health Control of Goods and Services, Use of Risk Analysis, Identification and Critical Point Control in the Pasteurised Milk Industry, Mexico, 1994.

11.12 Ministry of Health, Directorate General of Health Control of Goods and Services, Milk Pasteurisation, Testing and Examinations Course 302, Translation of FDA documents, Mexico, 1994.

11.13 NMX-F-703-COFOCALEC-2004, System of Milk Product-Foods-Dairy-Milk and Milk Product (or Dairy Food)-Fermented or Acidified-Names, Specifications and Test Methods

11.14 NMX-F-709-COFOCALEC-2004, System of Milk Product-Food-Regional Dairy Food-Chongos, Zamoranos and Chongo- and Zamorano-Type Milk Product-Names, Specifications and Test Methods

12. Compliance with the Standard

12.1 Enforcement of the present standard shall be the responsibility of the Ministry of Health, the governments of the federal entities, in the scope of their respective competencies.

13. Effective Date

13.1 All sections of the present Official Mexican Standard shall take effect at 60 days following the date of its publication in the Official Gazette of Mexico.

13.2 Entry into effect of the present Official Mexican Standard voids the following official Mexican standards:

• NOM-035-SSA1-1993, Goods and Services, Whey Cheeses, Health Specifications, published in the Official Gazette of Mexico on 30 January 1995

• NOM-036-SSA1-1993, Goods and Services, Ice Cream with Cream, Milk or Vegetable Fat, Sorbets and Ice Cream Bases or Mixtures, Health Specifications, published in the Official Gazette of Mexico on 10 March 1995

• NOM-121-SSA1-1994, Goods and Services, Cheeses: Fresh, Ripened and Processed, Health Specifications, published in the Official Gazette of Mexico on 23 February 1996

• NOM-184-SSA1-2002, Goods and Services, Milk, Milk Formula and Combined Milk Product, Health specifications, published in the Official Gazette of Mexico on 23 October 2002

• NOM-185-SSA1-2002, Goods and Services, Butter, Creams, Sweetened Condensed Milk Product, Fermented and Acidified Milk Products, Milk-Based Sweets, Health Specifications, published in the Official Gazette of Mexico on 16 October 2002.

Yours sincerely,

Mexico, D.F., 25 April 2008. The Chairman of the National Advisory Committee of Health Regulation and Development Standardisation, Miguel Angel Toscano Velasco.- Signature.


REGULATORY APPENDIX A A.1 Maximum Limits for Food Additives

Additive Maximum Limit mg/kg Observations

Glacial acetic acid

GMP

Fresh and processed cheeses.

Ice creams, sorbets, ice cream bases.

Acidified fermented milk products.

10,000 Ice creams, sorbets and ice cream bases. Alginic acid

GMP Milk, milk formula and combined milk product (flavoured).

Fresh and processed cheeses

500

(expressed as ascorbic acid)

Milk, milk formula and combined milk product (dehydrated or with vegetable fat).

Dehydrated cream.

Ascorbic acid *

GMP Flavoured or sweetened products covered by this standard.

1000 Milk-based sweets. Benzoic acid

50 Fermented and acidified milk products **

Citric acid

GMP



Milk-based sweets, fermented and acidified milk products.

Sterilised flavoured milk, milk formula and combined milk product.

For all kinds of creams (acidified creams are included under this heading).

Erythorbic acid GMP Milk-based sweets.

9,000

(total phosphorus compounds added,

calculated as phosphorus)


3,000

(mixed with other additives that have the same function and are listed in this section,

expressed as anhydrous substances)

UHT and/or sterilised cream, fermented cream, whipped cream and whipping cream.

Phosphoric acid

2,000

(only, expressed as anhydrous substance)


Fumaric acid GMP Fermented and acidified milk products.

L (±)-tartaric acid GMP Fermented and acidified milk products.

Lactic acid

GMP



Milk-based sweets.

Fermented and acidified milk products.

For all kinds of creams (this heading includes acidified creams).


D,L-malic acid GMP



Propionic acid GMP Fresh and processed cheeses.

3,000

(alone or mixed, expressed as sorbic acid)

Fresh, processed and ripened cheeses.

600 Milk-based sweets.

Sorbic acid

200 Fermented and acidified milk products. **

10,000

(alone or mixed with other additives that have the same function and are listed in this

section)

Fermented and acidified milk products. Acetylated distarch adipate

GMP Milk-based sweets.

5,000


section)

For all kinds of creams.


Milk-based sweets.

Agar



10,000 Ice creams, sorbets and ice cream bases.

5,000


section)


Milk-based sweets.

Ammonium alginate

GMP For all kinds of creams


5,000


section)

For all kinds of creams

2,000 Fermented and acidified milk products

Calcium alginate

GMP Milk formula and combined milk product (flavoured).


10,000 Ice creams, sorbets and ice cream bases. Potassium alginate

5,000


section)

UHT and/or sterilised cream, fermented cream, whipped cream, whipping cream, fat-reduced cream.


Milk-based sweets.


2,000 Fermented and acidified milk products.




8,000


section)


5,000


section)

Milk-based sweets.

Whipping cream and vegetable cream.

Propylene glycol alginate

1,400 Milk formula and combined milk product (flavoured).


5,000


section)



2,000 Fermented and acidified milk products.

Sodium alginate



10,000


section)

Fermented and acidified milk products. Acetylated starch


10,000


section)

Fermented and acidified milk products. Oxidised starch


10,000


section)



Modified starches


(First Section) OFFICIAL GAZETTE Monday, 23 June, 2008 Sunset Yellow FCF

Food Yellow 3

CI No. 15985

300


section)

Sweetened condensed milk products.

200


section)

Milk-based sweets.

100 Ice creams, sorbets and ice cream bases.

Flavoured cheeses.

35 Milk, milk formula and combined milk product (flavoured or aromatised).

12 Fermented and acidified milk products.

Calcium ascorbate* 500



Potassium ascorbate* 500



Sodium ascorbate* 500



Dehydrated cream

Saffron (stigmas of Crocus sativus L.)

Natural Yellow 6

CI No. 75100

GMP

Milk, milk formula and combined milk product (flavoured or aromatised).

Azorubine and its lakes

Food Red 3 [E122] and its lakes

CI No. 14720

100

Milk, milk formula and combined milk product (flavoured or aromatised), ice creams, sorbets and ice cream bases.


200 Milk-based sweets. Brilliant Blue FCF and its lakes

Food Blue 2 and its lakes

CI No. 42090 150



Whipping cream.

Sodium benzoate 1,000 Milk-based sweets, creams, butters and ice cream bases.

600 Processed cheeses.

35 Milk, milk formula and combined milk product (flavoured or aromatised).

Synthetic beta-carotene

Food Orange 5

CI No. 40800

25 Ripened cheeses.

Butter.


35 Ripened and processed cheeses.

Beta-apo-8-carotenal

Food Orange 6

CI No. 40820 35 Milk, milk formula and combined milk product (flavoured

or aromatised).


Tertiary butylhydroquinone 100 Milk-based sweets.

Butylated hydroxyanisole 100

Dehydrated cream and dehydrated vegetable cream.

Milk-based sweets.

100 Milk-based sweets. Butylated hydroxytoluene

200 Butters.

Caffeine 400 Ice creams, sorbets and ice cream bases.

Canthaxanthin

Food Orange 8

CI No. 40850

100


Caramel Class 1

GMP

Milk, milk formula, combined milk product (flavoured or aromatised), sweetened condensed milk product, fermented or acidified milk products, milk-based sweets, ice cream sorbets and ice cream bases, flavoured cheeses.

3,200 Milk, milk formula and combined milk product (flavoured or aromatised).

150

Sweetened condensed milk product.

Fermented milk products and acidified.

Milk-based sweets.

Caramel Class II


Flavoured cheeses.


150



Milk-based sweets.

Caramel Class III


Flavoured cheeses.


150



Milk-based sweets.

Caramel Class IV

100 Ice creams, sorbets and ice cream bases

Flavoured cheeses

Ammonium carbonate GMP Milk, milk formula and combined milk product (flavoured).

10,000


section, expressed as anhydrous substance)

Milk, milk formula and combined milk product (dehydrated).

Dehydrated cream.


3,000




2,000


UHT and/or sterilised cream, fermented cream, whipped cream and whipping cream. Sweetened condensed milk product.

Calcium carbonate

GMP Fresh cheeses.

(First Section) OFFICIAL GAZETTE Monday, 23 June, 2008 Magnesium carbonate GMP Milk, milk formula and combined milk product (flavoured).

5,000



Dehydrated cream.

3,000





2,000




Potassium carbonate


5,000



Dehydrated cream.

3,000





2,000




Butter.

Sodium carbonate



Ammonium hydrogenate carbonate GMP Milk, milk formula and combined milk product (flavoured).

Potassium hydrogen carbonate GMP Milk, milk formula and combined milk product (flavoured).

2,000



Butter. Sodium hydrogen carbonate

GMP

Milk, milk formula and combined milk product (flavoured).

Milk-based sweets.



8,000 Fresh, ripened and processed cheeses. Carboxymethyl cellulose

GMP Milk, milk formula and combined milk product (flavoured or with modified composition).

Fresh cheeses, ice creams, sorbets and ice cream bases.


10,000


section)

UHT and/or sterilised cream, fermented cream, whipped cream, whipping cream and fat-reduced cream.


Milk-based sweets.

8,000 Fresh and processed cheeses.

Sodium carboxymethyl cellulose

GMP Milk, milk formula and combined milk product (flavoured or sterilised).

50 Fermented and acidified milk products. Natural carotenes

Food Orange 5

CI No. 75130 100

Ice creams, sorbets and ice cream bases. Products covered by this standard, except: milk, milk formula and combined milk product.

10,000


section)


Milk-based sweets.

Ammonium carrageenate

1,200


section)

Milk, milk formula and combined milk product (flavoured or with modified composition).

Calcium carrageenate 1,200


section)


10,000


section)


Milk-based sweets.

Potassium carrageenate

1,200


section)

Sterilised milk, milk formula, combined milk product (flavoured or modified in their composition), condensed milk products.


10,000


section)


Milk-based sweets.

Sodium carrageenate

1,200


section)


10,000


section)



8,000


section)

Processed cheeses.

5,000


section)



Milk-based sweets.

1,200


section)

Milk formula and combined milk product.

150


section)

Sweetened condensed milk products, sterilised products.

Carrageenin


Fresh cheeses.

Microcrystalline cellulose

GMP



Flavoured milk, fermented and acidified dairy beverages.

White and yellow beeswax GMP Cheese coating.

Candelilla wax GMP Cheese coating.

Carnauba wax GMP Cheese coating.

Rice bran wax GMP Cheese coating.

Microcrystalline wax GMP Cheese coating.


3,000



Milk, milk formula and combined milk product (sterilised).


2,000




Calcium citrate

GMP Fresh and processed cheeses.

5,000




Dehydrated cream.

3,000







2,000






Tripotassium citrate

GMP Fresh and processed cheeses.

5,000




UHT and/or sterilised cream, fermented cream, whipped cream, whipping cream, fat-reduced cream and dehydrated cream.

3,000






2,000



Formula milk and combined milk product.


Milk-based sweets.


Trisodium citrate

GMP Fresh and processed cheeses. (Continued in Second Section)

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