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 s tates: United States of Mexico. - Ministry of Health  
DRAFT MEXICAN OFFICIAL STANDARD  PROY -NOM -243-SSA1 -2005. GOODS AND SERVICES. MILK, MILK 
FORMULA , COMBIN ED MILK PRODUCT , AND MILK DERIVATIVES. HEALTH RE QUIREMENTS 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 Sta ndardi sation  and Development, under 
Article 39 of the Organic Law of Federal Public Administration; 4th of the Federal Law o n Administrative 
Procedure; 3rd paragraph XXIV, 13 section A, paragraphs I and II, 17 a 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 
Standardi sation ; 28 and 33 of the Regulation of the Feder al Law on Metrology and Standardi sation ; 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 RE QUIREMENTS 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 Standardi sation  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 rfs@salud.gob.mx  
During the period mentioned, the documents used as a basis to prepar e 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 RE QUIREMENTS  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 Stan dard 
13. Effective  Date   (First Section)  OFFICIAL GAZETTE  Monday, 23 June , 2008  
Regul atory Appendix A. Maximum Limits for Food Additives  
Regulatory Appendix B. Test Methods  
Information Appendix A. List of Recommended Disinfectant Substances  
Information Ap pendix 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 fo rmula , 
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 Hygi ene 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 Potabili sation  
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 
relate d 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 preparatio n, 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 Co mbo pack,  container or wr apping 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 th e 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 sterili sation , 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 manufacture r 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 marketab le 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 pasteuris ed 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 exclud ed 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, prepa red in a single cycle, composed of homogeneous units.  
3.26 Butter,  product obtained from milk fat or cream fat, which has been pasteuris ed, 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 origin ating from a batch and that represent the characteristics and 
conditions thereof.  
3.31 Pasteuri sation , 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 pasteuris ed milk with acidifying 
agents.  
3.34 Combined  milk product,  product prepared from milk solids or other ingr edients 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 whi ch 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 opti onal ingredients 
are added  or not . 
3.37 Commercial sterility test,  temporary retention of representative samples of the product s under 
established time and temperature conditions to verify the commercial sterility of the product.  
3.38 Fresh cheeses,  cheese s prepared by the action of coagulating agent s such as rennet, lactic cultures , 
or acid ifiers and characteri sed by their high moisture content, without rind or with a very fine rind.  
3.39 Ripened cheese s, cheeses prepared by the action of coagulating agent s such as rennet, lactic 
cultures or acidifiers, exposed to a ripening process by addition of microorganisms, under controlled time, 
temperature and humidity conditions; characteri sed as hard, semi -hard or soft ; may or may not have rind.  
3.40 Processed che eses, cheeses characteri sed by being prepared by grinding, blend ing of cheese s, 
melting, or emulsif ying 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 inhi bit 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, plan t, 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 Ultrapasteuri sation , process where by the product is exposed to an adequate temperature and time 
relationship  and aseptically packag ed 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  Pasteuris ed Monday, 23 June , 2008  OFFICIAL GAZETTE  (First Section)  
 
4.1.2  Ultrapasteuris ed 
4.1.3 Sterilis ed 
4.1.4 Dehydrated  
4.2 Milk formula  
4.2.1 Pasteuris ed 
4.2.2  Ultra pasteuris ed 
4.2.3 Sterilis ed 
4.2.4 Dehydrated  
4.3 Combined  milk product  
4.3.1 Pasteuris ed 
4.3.2 Ultrapasteuris ed 
4.3.3 Sterilis ed 
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, N eufchatel  
4.4.1.4 Whey cheeses: B roccio, Broccotle, Cerrase, Geitmysost, Gyetost, Mejetle, Mysost, Recuit, 
Requesón, Ricotta, P icotón, Schottenezinger, Zinder  
4.4.2 Ripened  
4.4.2.1  Hard, pressed, ripened: Matur e, Parmesan, Cotija, Reggianito  
4.4.2.2 Pressed, ripened: Cheddar, Chester, Chi huahua, 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, Samso e, Svecia, Tilsiter, Bola, Jack  
4.4.2.3 Mould -ripened: Blue, Cabrales, Camembert, Roq uefort, 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 Pasteuris ed 
4.6.2 Ultrapasteuris ed 
4.6.3  Sterilis ed 
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   (First Section)  OFFICIAL GAZETTE  Monday, 23 June , 2008  
 
4.9 Milk-based sweets  
4.9.1 Low-moisture (le ss than 12%) or hardened sweet s: candies , gumm ies, 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%) sweet s, 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  
AFM 1 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 th e Intersecretariate Commission for Process and 
Usage Control of Pesticides, Fertili sers and Toxic Substances.  
• COFEPRIS, it should be understood to mean the Federal Commission for Protection Against Health 
Risks.  
6. Health Specifications  
6.1 General informa tion 
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 modifi ed shall comply with the provisions of NOM -086-
SSA1 -1994 , listed in the reference section.   (First Section)  OFFICIAL GAZETTE  Monday, 23 June , 2008  
 
6.1.5  Products exposed to heat treatment and packaged i n airtight containers, in addition to comply ing 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 
accorda nce 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 for eign mat ter, preservatives, or neutrali sing 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  
Pasteuris ed Negative  Negative  Negative  Negative  Negative  
Ultra pasteuris ed Negative  Negative  Negative  Negative  Negative  
Sterilis ed 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, pasteuri sation , ultrapasteuri sation , sterili sation , or 
dehydration , in a ccord ance with the specifications of the following table.  
Table 2. Temperatures and Times for the Heat Treatment of M ilk, Milk Formula , or Combined  Product  
Treatment  Temperature and time*  
Pasteuri sation  Slow 63ºC / 30 min  
Flash 72ºC / 15 s  
Ultrapasteuri sation  or 
sterili sation  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 pasteuri sation  shall have, at least, a system to record and control the process 
tempe rature 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 pasteuri sation  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 equipm ent. 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 ul trapasteuri sation  or sterili sation  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 ha s been reached, the milk, milk formula , or combined product shall be 
flash -cooled to 6ºC, except for ultra pasteuris ed or sterilis ed 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 re quirements and specifications 
established for products that undergo pasteuri sation . 
6.1.7.12 Products exposed to dehydration shall comply with the following:  
a) Those used as raw material shall be pasteuris ed before dehydration.  
b) Bulk sale to the consumer is not allowed.  
6.1.7.13 Products exposed to rehydration shall be pasteuris ed, ultra pasteuris ed, or sterilis ed, 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 ultra pasteuris ed, sterilis ed, 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 tin plate . 
*** 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 cov ered by this standard may not exceed the microorganism limits listed below:   (First Section)  OFFICIAL GAZETTE  Monday, 23 June , 2008  
 
Table 4. Maximum M icrobial 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; pasteuris ed. Total Coliform  Organisms  
< 10 CFU /g or ml  In plant: Milk, milk formula , combined  milk product; 
pasteuris ed 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 p roducts, milk -based 
sweets.  
Salmonella spp  Absent in 25 g or 
ml Milk, milk formula , combined  milk product; pasteuris ed 
and dehydrated.  
Fresh, ripened  and processed cheeses.  
Creams, fermented or acidified milk products, milk -
based sweets*, ice creams, so rbets  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 2 5 g or 
ml Milk, milk formula , combined  milk product; pasteuris ed. 
Fresh, ripened  and processed cheeses . 
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.  
Fresh, ripened  and processed cheeses . 
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 on e 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 reco rd-keeping frequency are the manufacturer's responsibility , except for heat 
treatment records, which must be continuous.  
Table 5.  Minimal I nformation 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 an alyses 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 -treatme nt temperatures and times 
(pasteuri sation , ultrapasteuri sation  or sterili sation , 
dehydrati on) according to equipment unit  
l Cooling temperature and time.  
l Product quantity and identification  
- Record of un usual events  
Cleaning operating procedure  - Produ cts used   (First Section)  OFFICIAL GAZETTE  Monday, 23 June , 2008  
 
and heat -treatment equipment disinfection.  - Dosing  
- Concentrations  
- Contact times  
- Rinses  
- Staff in charge of the operation  
- Frequency  
- Effective date  
Log or record of equipment cl eaning and 
disinfection operations for heat treatment.  - Identification of equipment  
- Shift/time  
- Record of unusual  events  
Maintenance or calibration l og 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 D 3 (200 -300 IU/L).  
6.2.1.2 Products with added vitamin A or D 3 may not contain quantities above those established in this 
code.  
6.2.1.3 Dehydrated products may have a water content no t higher than 4%.  
6.2.1.4 Products exposed to ultrapasteuri sation  or sterili sation  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 sterili sation  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 th e 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 wh ich 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 no t higher than 4%.  Monday, 23 June , 2008  OFFICIAL GAZETTE  (First Section)  
 
6.2.3 Ferme nted or acidified milk products  
6.2.3.1 Fermented milk products and acidified milk products shall have a titratable acidity no t less than 
0.5% expressed as lactic acid and t he 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 mix ture to prepare ice creams, ice cream bases  and sorbets shall be pasteuris ed 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 fo r a minimum time of 25 seconds, or  
6.2.4.3.3 Such products shall be e xpose d 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 a t 4ºC.  
6.2.4.3.5 Once the mixtures are pasteuris ed, 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 Hea lth Law  and  the sample shall be kept under conditions that prevent its contamination or 
decomposition.  
8. Test Methods  
For official verification of the specifications establish ed in this standard , the test methods listed in 
Regulatory Appendix B of this co de 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 co mbo 
pack  using clear, visible, indelible characters in contrasting colours that are easy for the co nsumer 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 a ny 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.   (First Section)  OFFICIAL GAZETTE  Monday, 23 June , 2008  
 
9.1.6  In the case of multipacks or co mbo packs for consumer sale, the information referred to in this 
Official Mexican Standard shall be listed o n 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 co mbo pack s. In 
addition, the products shall include the legend "Not labelled for individual sale" whe n 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 co mbo 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 na ture of the product  is not mis leading or 
dece ptive 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 r espective 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 te rm "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 covere d by this standard contain iodi sed 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 accompan ied by a list in parentheses of its ingredients by de scending 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 associa ted with allergic reactions shall be stated, in compliance 
with the respective legal codes.  Monday, 23 June , 2008  OFFICIAL GAZETTE  (First Section)  
 
9.3.8  In the case of dehydrated or condense d foods to be used to be reconstituted, the ingredients may be 
listed by de scending 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 includ e any additives used in the ingredients that ha ve 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 produc ts 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 compan y 
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 lab el, 
followed by the name or address (street, number, urbani sation , 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 lege nd 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 "B est Before  _________" , specifying  the date in the blank  
space , stating : 
9.7.1.1 For pasteuris ed products, at least: day and month.  
9.7.1.2 Frozen, ultra pasteuris ed or sterilis ed 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 "Bes t Before" date or its abbreviations.  
9.7.4 Labels for pasteuris ed products and products requiring  refrigerat ed storage shall include the 
following legend: "Keep refrigerat ed" or "Store refrigerat ed" or any other equivalent phrase.   (First Section)  OFFICIA L GAZETTE  Monday, 23 June , 2008  
 
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", "On ce prepared, keep or store the product 
refrigerat ed" 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 ultra pasteuris ed or sterilised milk products in airtight containers shall include "No 
refrigeration needed until opened" or "Once opened, keep r efrigerate d", or any other equivalent legend.  
9.8 Nutritional information  
9.8.1  General i nformation  
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 characteri sing it. 
9.8.1.2 The nutritional information on prepack aged product  label s is voluntary. Th e infor mation 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 car bohydrates  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. Addition ally, 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 
kiloca lories; 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 po rtion. 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 pe rcentage 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 nutri tion statement of the product shall be 
weighted mean values derived from analys es, databases, or natio nally and internationally recogni sed tables.  Monday, 23 June , 2008  OFFICIAL GAZETTE  (First Section)  
 
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 thei r 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 D 3 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 D 3. 
1 IU of vitamin D 3 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 
stora ge 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 wher e 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).   (First Section)  OFFICIAL GAZETTE  Monday, 23 June , 2008  
 
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 nut ritional 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  polyunsaturate s ___ g; of which monounsaturate s ___ g; of which saturate s ___ g; of which 
cholesterol ___ mg  
b) The statement of one of the following does not require the statement of the others:  
of which s ugars ___ g; of which starches ___ g; dietary fib re ___ 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, relie ve, treat, or cure a disease, disor der, 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 c alculations  
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 Monday, 23 June , 2008  OFFICIAL GAZETTE  (First Section)  
 
b) Protein calculations  
The quantity of proteins to be indicated sh all 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 produc ts, their use, 
application, ingredients, or any other characteristic are recommended, backed, or accepted by research 
centres, associations, organi sation s, 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 provide d and available to the Ministry when requested. Such statements shall 
comply with the following: the legend shall clearly describe the character istic 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 standard s: 
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. Co dex General 
Standard for Cheese  
10.4 Codex Alimentarius. CODEX STAN 221 -2001. Codex Group Standard for Unripene d Cheese 
Including Fresh Cheese  
10.5 Mexican Standard NMX -F-10-1982. Human  Foods -Butter From Milk or Pasteuris ed Cream , Ministry 
of Trade and Industrial Development , Director General for Regulations  
11. References  
11.1 Ministry of Economy , 1992 , Federal Law on Metrology and Standardi sation , Reforms of 20 May 1997 , 
Official Gazet te of Mexico , Mexico, D.F.  
11.2 Ministry of Economy , Regulations of the Federal Law on Metrology and Standardi sation , 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   (First Section)  OFFICIAL GAZETTE  Monday, 23 June , 2008  
 
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" Pasteuris ed 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 Agricu lture Organi zation  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 Nutrit ion. Foodborne 
pathogenic microorganisms and natural toxins handbook. "Bad bug book".  
11.11  Ministry of Health,  Director ate General of Health Control of Goods and Services , Use of Risk 
Analysis, Identification and Critical Point Control in the Pasteuris ed Milk Industry , Mexico, 1994.  
11.12  Ministry of Health,  Director ate General of Health Control of Goods and Services , Milk Pasteuri sation , 
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 Stand ard voids the following official Mexican 
standards:  
• NOM -035-SSA1 -1993, Goods and Services , Whey Cheeses , Health Specifications, published in the 
Official Gazet te 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 Ma rch 1995  
• NOM -121-SSA1 -1994, Goods and Services,  Cheeses: Fresh, Ripened and Processed , Health 
Specifications, published i n the Official Gazett e 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 Gazet te of Mexico on 23 October 2002  
• NOM -185-SSA1 -2002, Goods and Ser vices , 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 Chai rman of the National Advisory Committee of Health Regulation and 
Development Standardi sation , Miguel Angel Toscano Velasco .- Signature.  Monday, 23 June , 2008  OFFICIAL GAZETTE  (First Section)  
 
REGULATORY APPENDIX A  
A.1 Maximum L imits for Food Additives  
Additive Maximum L imit 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  Fresh and processed cheeses.  
Ice creams, sorbets  and ice cream bases .  
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 pho sphorus)  Fresh and processed cheeses  
3,000  
(mixed with other additives 
that have the same function 
and are listed in this section, 
expressed as anhydrous 
substances)  UHT and/or sterilis ed cream, fermented cream, whipped 
cream  and whipping cream.  Phosphoric acid  
2,000  
(only, ex pressed as 
anhydrous substance)  UHT and/or sterilis ed cream, fermented cream, whipped 
cream  and whipping cream.  
Fumaric acid  GMP  Fermented and acidified  milk products.  
L (±)-tartaric acid  GMP  Fermented and acidified  milk products.  
Lactic acid  
GMP  Fresh and processed cheeses.  
Ice creams, sorbets  and ice cream bases .  
Milk-based sweets.  
Fermented and acidified  milk products.  
For all kinds of creams (this heading includes acidified  
creams).   (First Section)  OFFICIAL GAZETTE  Monday, 23 June , 2008 
 
D,L-malic acid  
GMP  Ice creams, sorbets  and ice cream bases . 
Fermented and acidified  milk products.  
Propionic acid  GMP  Fresh and processed cheeses.  
3,000  
(alone or mix ed, 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  
(alone or mixed with other 
additives that have the same 
function and are listed in this 
section)  For all kinds of creams.  
Fermented and acidified  milk products.  
Milk-based sweets.  Agar  
GMP  Milk, milk formula  and combined milk product  (flavoured).  
Fresh and processed cheeses.  
10,000  Ice creams, sorbets  and ice cream bases . 
5,000  
(alone or mixed with other 
additives that have the same 
function and are listed in this 
section)  Fermented and acidified  milk products.  
Milk-based sweets.  Ammonium alginate  
GMP  For all kinds of creams   
10,000  Ice creams, sorbets  and ice cream bases .  
5,000  
(alone or mixed with other 
additives that have the same 
function and are listed in this 
section)  For all kinds of creams  
2,000  Fermented and acidified milk products  Calcium alginate  
GMP  Milk formula  and combined  milk product (flavoured).  
Fresh and processed cheeses.  
10,000  Ice creams, sorbets  and ice cream bases .  Potassium alginate  
5,000  
(alone or mixed with other 
additives that have the sam e 
function and are listed in this 
section)  UHT and/or sterilis ed cream, fermented cream, whipped 
cream, whipping cream, fat -reduced cream.  
Fermented and acidified  milk products.  
Milk-based sweets.  Monday, 23 June , 2008  OFFICIAL GAZETTE  (First Section)  
 
2,000  Fermented and acidified  milk products.   
GMP  Milk formula  and combined  milk product (flavoured).  
Fresh and processed cheeses.  
10,000  Ice creams, sorbets  and ice cream bases .  
8,000  
(alone or mixed with other 
additives  that have the same 
function and are listed in this 
section)  Fresh and processed cheeses.  
5,000  
(alone or mixed with other 
additives that have the same 
function and are listed in this 
section)  Milk-based sweets.  
Whipping cream and vegetable cream.  Propylene glycol alginate  
1,400 Milk formula  and combined  milk product (flavoured).  
10,000  Ice creams, sorbets  and ice cream bases . 
5,000  
(alone or mixed with other 
additives that have the same 
function and are listed in this 
section)  For all kinds of creams.  
Fermen ted and acidified  milk products.  
2,000  Fermented and acidified  milk products.  Sodium alginate  
GMP  Milk formula  and combined  milk product (flavoured).  
Fresh and processed cheeses.  
10,000  
(alone or mixed with other 
additives that have the same 
functio n and are listed in this 
section)  Fermented and acidified  milk products.  Acetylated starch  
GMP  Milk-based sweets.  
10,000  
(alone or mixed with other 
additives that have the same 
function and are listed in this 
section)  Fermented and acidified  milk products . Oxidi sed starch  
GMP  Milk-based sweets.  
10,000  
(alone or mixed with other 
additives that have the same 
function and are listed in this 
section)  Fermented and acidified  milk products.  
Ice creams, sorbets  and ice cream bases .  Modified starches  
GMP  Milk-based sweets.   (First Section)  OFFICIAL GAZETTE  Monday, 23 June , 2008  
 
Sunset Yellow FCF  
Food Yellow 3  
CI No. 15985  300 
(alone or mixed with other 
additives that have the same 
function and are listed in this 
section)  Sweetened condensed milk products.  
200 
(alone or  mixed with other 
additives that have the same 
function and are listed in this 
section)  Milk-based sweets.  
100 Ice creams, sorbets  and ice cream bases . 
Flavoured cheeses.  
35 Milk, milk formula  and  combined milk product  (flavoured 
or aromatis ed).  
12 Fermented and acidified  milk products.  
Calcium ascorbate*  500 
(expressed as ascorbic acid)  Milk, milk formula  and combined milk product  (dehydrated 
or with vegetable fat).  
Potassium ascorbate*  500 
(expressed as ascorbic acid)  Milk, milk formula  and comb ined milk product  (dehydrated 
or with vegetable fat).  
Sodium ascorbate*  500 
(expressed as ascorbic acid)  Milk, milk formula  and combined milk product  (dehydrated 
or with vegetable fat).  
Dehydrated cream  
Saffron ( stigmas of  Crocus 
sativus L. ) 
Natural Yell ow 6  
CI No. 75100  GMP  Milk, milk formula  and  combined milk product  (flavoured 
or aromatis ed).  
Azorubine and its lakes  
Food Red 3 [E122] and its 
lakes  
CI No. 14720  100 Milk, milk formula  and  combined milk product  (flavoured 
or aromatis ed), ice creams, sor bets and ice cream bases . 
Fermented and acidified  milk products.  
200 Milk-based sweets.  Brilliant Blue FCF and its 
lakes  
Food Blue 2 and its lakes  
CI No. 42090  150 Fermented and acidified  milk products.  
Ice creams, sorbets  and ice cream bases .  
Whippi ng 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 aromatis ed).  Synthetic beta -carotene  
Food Orange 5  
CI No. 40800  
25 Ripened  cheeses.  
Butter.  
100 Ice creams, sorbets  and ice cream bases .  
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 aromatis ed). Monday, 23 June , 2008  OFFICI AL GAZETTE  (First Section)  
 
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 Butter s.  
Caffeine  400 Ice creams, sorbets  and ice cream bases .  
Canthaxanthin  
Food Orange 8  
CI No. 40850  100 Ice creams, sorbets  and ice cream bases .  
Caramel Class 1  
GMP  Milk, milk formula , combined  milk product (flavoured or 
aromatis ed), sweetened condensed milk produc t, 
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 aromatis ed).  
150 Sweetened condensed milk product.  
Fermented milk products and acidified.  
Milk-based sweets.  Caramel Class II  
100 Ice creams, sorbets  and ice cream bases . 
Flavoured cheeses.  
4,000  Milk, milk formula  and  combined milk product  (flavoured 
or aromatis ed).  
150 Sweetened condensed milk product.  
Fermented and acidified  milk products.  
Milk-based sweets.  Caramel Class III  
100 Ice creams, sorbets  and ice cream bases . 
Flavoured cheeses.  
4,000  Milk, milk formula  and  combined milk product  (flavoured 
or aromatis ed).  
150 Sweetened condense d milk product.  
Fermented and acidified  milk products.  
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  
(alone  or mixed with other 
additives that have the same 
function and are listed in this 
section, expressed as 
anhydrous substance)  Milk, milk formula  and  combined milk product  
(dehydrated).  
Dehydrated cream.  
Fermented and acidified  milk products.  
3,000  
(mixed  with other additives 
that have the same function 
and are listed in this section, 
expressed as anhydrous 
substances)  For all kinds of creams.  
2,000  
(only, expressed as 
anhydrous substance)  UHT and/or sterilis ed 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  
(alone or mixe d with other 
additives that have the same 
function and are listed in this 
section, expressed as 
anhydrous substance)  Dehydrated cream.  
3,000  
(mixed with other additives 
that have the same function 
and are listed in this section, 
expressed as anhydrous 
substances)  UHT and/or sterilis ed cream, fermented cream, whipped 
cream  and whipping cream.  
Sweetened condensed milk product.  
2,000  
(only, ex pressed as 
anhydrous substance)  UHT and/or sterilis ed cream, fermented cream, whipped 
cream  and whipping cream.  
Sweetened condensed milk product.  Potassium carbonate  
GMP  Milk, milk formula  and combined milk product  (flavoured).  
5,000  
(alone or mixed with other 
additives that have the same 
function and are listed in this 
section, expressed as 
anhydrous substance)  Dehydrated cream.  
3,000  
(mixed with other additives 
that have the same function 
and are listed in this section, 
expressed as anhydrous 
substances)  UHT and/or sterilis ed cream, fermented cream, whipped 
cream  and whipping cream.  
Sweetened condensed milk pro duct.  
2,000  
(only, ex pressed as 
anhydrous substance)  UHT and/or sterilis ed cream, fermented cream, whipped 
cream  and whipping cream.  
Sweetened condensed milk product.  
Butter.  Sodium carbonate  
GMP  Milk, milk formula  and combined milk product  (flavoured).  
Ice creams, s orbets  and ice cream bases .  
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  
(alone  or mixed with other 
additives that have the same 
function and are listed in this 
section, expressed as 
anhydrous substance)  Butter.  Sodium hydrogen carbonate  
GMP  Milk, milk formula  and combined milk product  (flavoured).  
Milk-based sweets.  
Fresh and processed cheeses  Monday, 23 June , 2008  OFFICIAL GAZETTE  (First Section)  
 
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 cre am bases .  
10,000  Ice creams, sorbets  and ice cream bases .  
10,000  
(alone or mixed with other 
additives that have the same 
function and are listed in this 
section)  UHT and/or sterilis ed cream, fermented cream, whipped 
cream, whipping cream and fat -reduced cream.  
Fermented and acidified  milk products.  
Milk-based sweets.  
8,000  Fresh and processed cheeses.  Sodium carboxymethyl 
cellulose  
GMP  Milk, milk formula  and  combined milk product  (flavoured 
or sterilis ed).  
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  
(alone or mixed with other 
additives t hat have the same 
function and are listed in this 
section)  Fermented and acidified  milk products.  
Milk-based sweets.  Ammonium carrageenate  
1,200  
(alone or mixed with other 
additives that have the same 
function and are listed in this 
section)  Milk, milk formula  and  combined milk product  (flavoured 
or with modified composition).  
Calcium carrageenate  1,200  
(alone or mixed with other 
additives that have the same 
function and are listed in this 
section)  Milk, milk formula  and  combined milk product  (flavoured 
or with modified c omposition).  
10,000  
(alone or mixed with other 
additives that have the same 
function and are listed in this 
section)  Fermented and acidified  milk products.  
Milk-based sweets.  Potassium carrageenate  
1,200  
(alone or mixed with other 
additives that have the same 
function and are listed in this 
section)  Sterilis ed milk, milk formula , combined  milk product 
(flavoured or modified in their composition), condensed 
milk products.   (First Section)  OFFICIAL GAZETTE  Monday, 23 June , 2008  
 
10,000 
(alone or mixed with other 
additives that have the same 
function and are listed in this 
section)  Fermented and acidified  milk products.  
Milk-based sweets.  Sodium carrageenate  
1,200  
(alone or mixed with other 
additives that have the same 
function and are listed in this  
section)  Milk, milk formula  and  combined milk product  (flavoured 
or with modified composition).  
10,000  
(alone or mixed with other 
additives that have the same 
function and are listed in this 
section)  Ice creams, sorbets  and ice cream bases . 
Fermented and acidified  milk products.  
8,000  
(alone or mixed with other 
additives that have the same 
function and are listed in this 
section)  Processed cheeses.  
5,000  
(alone or mixed with other 
additives that have the same 
function and are listed in this 
section)  UHT and/or sterilis ed cream, fermented cream, whipped 
cream, whipping cream and fat -reduced cream.  
Fermented and acidified  milk products.  
Milk-based sweets.  
1,200  
(alone or mixed with other 
additives that have the same 
function and are li sted in this 
section)  Milk formula  and combined  milk product.  
150 
(alone or mixed with other 
additives that have the same 
function and are listed in this 
section)  Sweetened condensed milk products, sterilis ed products.  Carrageen in 
GMP  Milk, milk formula  and comb ined milk product  (flavoured).  
Fresh cheeses.  
Microcrystalline cellulose  
GMP  Ice creams, sorbets  and ice cream bases . 
For all kinds of creams.  
Flavoured milk, fermented and acidified dairy beverages.  
White and yellow beeswax  GMP  Cheese coating.  
Candel illa wax  GMP  Cheese coating.  
Carnauba wax  GMP  Cheese coating.  
Rice bran wax  GMP  Cheese coating.  
Microcrystalline wax  GMP  Cheese coating.  Monday, 23 June , 2008  OFFICIAL GAZETTE  (First Section)  
 
3,000  
(mixed with other additives 
that have the same function 
and are listed in this section, 
expressed as anhydrous 
substances)  Milk, milk formula  and combined milk product  (sterilis ed). 
Milk formula  and combined  milk product.  
2,000  
(only, expressed as 
anhydrous substance)  Milk, milk formu la and combined milk product  (sterilis ed). 
Milk formula  and combined  milk product.  Calcium citrate  
GMP  Fresh and processed cheeses.  
5,000  
(alone or mixed with other 
additives that have the same 
function and are listed in this 
section, expressed a s 
anhydrous substance)  Milk, milk formula  and  combined milk product  
(dehydrated).  
Dehydrated cream.  
3,000  
(mixed with other additives 
that have the same function 
and are listed in this section, 
expressed as anhydrous 
substances)  Milk, milk formula  and combined milk product  (sterilis ed). 
Milk formula  and combined  milk product.  
UHT and/or sterilis ed cream, fermented cream, whipped 
cream, whipping cream and fat -reduced cream.  
Sweetened condensed milk product.  
2,000  
(only, expressed as 
anhydrous substance ) Milk, milk formula  and combined milk product  (sterilis ed). 
Milk formula  and combined  milk product.  
UHT and/or sterilis ed cream, fermented cream, whipped 
cream, whipping cream and fat -reduced cream.  
Sweetened condensed milk product.  Tripotassium citrate  
GMP  Fresh and proce ssed cheeses.  
5,000  
(alone or mixed with other 
additives that have the same 
function and are listed in this 
section, expressed as 
anhydrous substance)  Milk, milk formula  and  combined milk product  
(dehydrated).  
UHT and/or sterilis ed crea m, fermented cream, whipped 
cream, whipping cream, fat -reduced cream and 
dehydrated cream.  
3,000  
(mixed with other additives 
that have the same function 
and are listed in this section, 
expressed as anhydrous 
substances)  Milk, milk formula  and combined m ilk product  (sterilis ed). 
Milk formula  and combined  milk product.  
Sweetened condensed milk product.  
2,000  
(only, expressed as 
anhydrous substance)  Milk, milk formula  and combined milk product  (sterilis ed). 
Formula milk and combined  milk product.  
Sweetened condensed milk product.  
Milk-based sweets.  
Fermented and acidified  milk products.  Trisodium citrate  
GMP  Fresh and processed cheeses.  
(Continued in Second Section)   (First Section)  OFFICIAL GAZETTE  Monday, 23 June , 2008