Code of Hygienic Practice for Milk and Milk Products

7/31/2019 Code of Hygienic Practice for Milk and Milk Products

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CODE OF HYGIENIC PRACTICE FOR MILK

AND MILK PRODUCTSCAC/RCP 57-2004

INTRODUCTION

Milk and milk products are a rich and convenient source o nutrients or people inmany countries and international trade o milk-based commodities is signi cant. Thepurpose o this Code is to provide guidance to ensure the sa ety and suitability omilk and milk products to protect consumers health and to acilitate trade. The Codesatis es the ood hygiene provisions in the Codex Alimentarius Procedural Manual under Relations Between Commodity Committees and General Committees oruse in the various dairy standards.

All oods have the potential to cause ood borne illness, and milk and milkproducts are no exception. Dairy animals may carry human pathogens. Suchpathogens present in milk may increase the risk o causing ood borne illness.Moreover, the milking procedure, subsequent pooling and the storage o milkcarry the risks o urther contamination rom man or the environment or growth oinherent pathogens. Further, the composition o many milk products makes themgood media or the outgrowth o pathogenic micro-organisms. Potential also exists

or the contamination o milk with residues o veterinary drugs, pesticides and otherchemical contaminants. There ore, implementing the proper hygienic control omilk and milk products throughout the ood chain is essential to ensure the sa etyand suitability o these oods or their intended use. It is the purpose o this Codeto provide guidance to countries so that their appropriate level o public healthprotection or milk and milk products may be achieved. It is also the purpose o thiscode to prevent unhygienic practices and conditions in the production, processing,and handling o milk and milk products, as in many countries milk and milkproducts orm a large portion o the diet o consumers especially in ants, children,and pregnant and lactating women. This document is ormatted in accordancewith the General Principles o Food Hygiene (CAC/RCP 1-1969). This Code presentsprinciples or the hygienic production and manu acture o milk and milk productsand guidance on their application. This Code takes into consideration, to the extentpossible, the various production and processing procedures as well as the di eringcharacteristics o milk rom various milking animals used by member countries.It ocuses on acceptable ood sa ety outcomes achieved through the use o oneor more validated ood sa ety control measures, rather than mandating speci cprocesses or individual products.

Adopted in 2004. Amendment 2009.


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mIlk AND mIlk PRODUCTs (2nd Edi t ion)

1. OBJECTIVEs

The objective o this Code is to apply the recommendations o the Recommended Code o Practice: General Principles o Food Hygiene to the particular case omilk and milk products. It also provides guidance on how to achieve the generalrequirements contained in the hygiene sections o the Codex commodity standards

or milk products.

2. sCOPE AND UsE OF THE DOCUmENT

2.1 scopeThis Code applies to the production, processing and handling o milk and milkproducts as de ned in the General Standard or the Use o Dairy Terms 1(CODEXSTAN 206-1999). Where milk products are re erred to in the code it is understoodthat this term also includes composite milk products. The scope o this Code doesnot extend to the production o raw drinking milk.

This Code applies to products in international trade. It may also serve as a basis ornational legislation.

2.2 U e o the docu entThe provisions o this document are supplemental to and must be used in conjunctionwith, the General Principles o Food Hygiene (CAC/RCP 1-1969).

This document consists o a series o principles, explanatory narratives and guidelines.Over-arching principles that are applicable to all phases o production, processingand handling o milk and milk products are given in Section 2.3.

Speci c principles and their associated explanatory narratives and guidelines aregiven in the appropriate section.

Princip e , shown in bo d text , are a statement o the goal or objective that is tobe achieved. Explanatory narratives , shown in italicized text, serve to explain thepurpose o the stated principle. Guidelines or the application o the stated principleare shown in normal text.

The annexes are an integral part o this Code. They provide guidelines or di erentapproaches to the application o the principles. The purpose o the guidelinescontained in the annexes is to explain and illustrate how principles in the mainbody o this code may be met in practice. Thus, the General Principles o Food Hygiene (CAC/RCP 1-1969), the main body o this Code and its annexes must beused together to obtain complete guidance on the hygienic production o milk andmilk products.

1 This code applies to the milk and milk products obtained rom all milking animals.


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CODE OF HYGIENIC PRACTICE FOR mIlk AND mIlk PRODUCTs (CAC/RCP 57-2004)

2.3 Overarching princip e app ying to the production, proce ing and hand ingo a i and i productThe ollowing overarching principles apply to the production, processing andhandling o all milk and milk products.

Fro raw ateria production to the point o con u ption, dairy productproduced under thi Code hou d be ubject to a co bination o contro ea ure ,and the e contro ea ure hou d be hown to achieve the appropriate eve opub ic hea th protection.

Good hygienic practice hou d be app ied throughout the ood chain othat i and i product are a e and uitab e or their intended u e. No part o this Code should be used without consideration o what takes placein the chain o events prior to the particular measure being applied or what will take place subsequent to a particular step. The Code should only be used withinthe context o an understanding that there is a continuum o controls that areapplied rom production to consumption.

Wherever appropriate, hygienic practice or i and i producthou d be i p e ented within the context o HACCP a de cribed in

the Annex to the General Principles of Food Hygiene (CAC/RCP 1-1969) .This principle is presented with the recognition that there are limitations to the

ull application o HACCP principles at the primary production level. In the casewhere HACCP cannot be implemented at the arm level, good hygienic practices,good agricultural practices and good veterinary practices should be ollowed.

Contro ea ure hou d be va idated a e ective. The overall e ectiveness othe system o control measures should be subject to validation. Control measuresor combinations thereo should be validated according to the prevalence ohazards in the milk used, taking into consideration the characteristics o theindividual hazards(s) o concern and established Food Sa ety Objectives and/orrelated objectives and criteria. Guidance on validating control measures shouldbe obtained rom the Guidelines or the Validation o Food Hygiene Control Measures (CAC/GL 69-2008).

2.4 Re ative ro e o i producer , anu acturer , di tributor , retai er ,tran porter , con u er , and co petent authoritieAlthough the responsibility lies with the manu acturer or ensuring that the oodsmanu actured are sa e and suitable, there is a continuum o e ective e ort orcontrols needed by other parties, including milk producers, to assure the sa ety andsuitability o milk products. It is important to recognize that distributors, competentauthorities and consumers also have a role in ensuring the sa ety and suitability omilk and milk products.


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The interrelationship and impact o one segment o the ood chain on anothersegment is important to ensure that potential gaps in the continuum are dealtwith through communication and interaction between the milk producer,the manu acturer, the distributor and the retailer. While it is principally theresponsibility o the manu acturer to conduct the hazard analysis within the contexto developing a control system based on HACCP and thus to identi y and controlhazards associated with the incoming raw materials, the milk producer shouldalso have an understanding o the hazards associated with milk, so as to assist inminimizing their presence in the raw material.

To achieve an e ective continuum, the various parties should pay attention, inparticular, to the ollowing responsibilities.

Producers should ensure that good agricultural, hygienic and animal husbandrypractices are employed at the arm level. These practices should be adapted, asappropriate, to any speci c sa ety-related needs speci ed and communicated bythe manu acturer.

Manu acturers should utilize good manu acturing and good hygienic practices,especially those presented in this Code. Any needs or additional measures withregard to controlling hazards during primary production should be e ectivelycommunicated to suppliers to enable the milk producer to adapt their operationsto meet them. Likewise, the manu acturer may have to implement controls oradapt their manu acturing processes based on the ability o the milk producerto minimize or prevent hazards associated with the milk. Such additionalneeds should be supported by an adequate hazard analysis and should, whereappropriate, take into consideration technological limitations during processing,and/or market demands.

Distributors, transporters and retailers should assure that milk and milk productsunder their control are handled and stored properly and according to themanu acturers instructions.

Consumers should accept the responsibility o ensuring that milk and milkproducts in their possession are handled and stored properly and according tothe manu acturers instructions.

In order to e ectively implement this Code, competent authorities should have inplace legislative ramework (e.g., acts, regulations, guidelines and requirements),an adequate in rastructure and properly trained inspectors and personnel.For ood import and export control systems, re erence should be made to theGuidelines or the Design, Operation, Assessment and Accreditation o Food Import and Export Inspection and Certi cation Systems (CAC/GL 26-1997). Controlprogrammes should ocus on auditing relevant documentation that showsthat each participant along the chain has met their individual responsibilitiesto ensure that the end products meet established ood sa ety objectives and/orrelated objectives and criteria.

It is important that clear communications and interactions exist between all partiesto help assure good practices are employed, that problems are identi ed andresolved in an expeditious manner, and that the integrity o the entire ood chainis maintained.


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2.5 De nitionDe nitions contained in the General Standard or the Use o Dairy Terms (CODEXSTAN 206-1999) are incorporated into this document by re erence. De nitionsrelevant to a particular annex (e.g., heat treatment de nitions) will be contained inthe relevant annex.

Avoid To keep away rom, to the extent reasonably practicable. This term will beused when it is possible, in theory, to have no contamination or to constrain aparticular practice.

Control measure Any action and activity that can be used to prevent or eliminatea ood sa ety hazard or reduce it to an acceptable level. 2

Food safety objective 3 Minimize To reduce the likelihood o occurrence or the consequence o an

unavoidable situation such as microbiological growth.Process criteria 4 The process control parameters (e.g. time, temperature) applied

at a processing step.Raw milk Milk (as de ned in the General Standard or the Use o Dairy Terms

(CODEX STAN 206-1999)) which has not been heated beyond 40C or undergoneany treatment that has an equivalent e ect.

Shelf life The period during which the product maintains its microbiological sa etyand suitability at a speci ed storage temperature and, where appropriate,speci ed storage and handling conditions.

Validation 5

2.6 suitabi ityFood Suitability as de ned in the General Principles o Food Hygiene (CAC/RCP1-1969) is: Assurance that ood is acceptable or human consumption according toits intended use.

For the purposes o this Code, Suitability includes: The concept o wholesomeness and soundness. Only matters relating to hygiene. Matters relating to grade, commercial quality

or compliance to standards o identity are not included.

Additionally: Suitability o milk and milk products may be achieved by observing good hygienic

practice as outlined in the General Principles o Food Hygiene (CAC/RCP 1-1969) and speci ed in detail in this Code. The use o a management system based onHACCP principles is an e ective way o ensuring suitability and demonstratingthat suitability is achieved.

2 For purposes o this Code, a control measure encompasses any action or activity used to eliminate a hazard or reduce it to anacceptable level. In addition the term re ers to any action or activity taken to reduce the likelihood o the occurrence o a hazardin milk or milk products. Thus, control measures include both process controls such as heating, cooling, acidifcation, etc., aswell as other activities such as general hygiene and pest control programmes, etc.

3

Procedural Manual, Codex Alimentarius Commission.4 This term is defned in Guidelines for the Validation of Food Hygiene Control Measures (CAC/GL 69-2008).5 This term is defned in Guidelines for the Validation of Food Hygiene Control Measures (CAC/GL 69-2008).


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Milk and milk products may not be suitable i the milk or milk product, orexample:

Is damaged, deteriorated or perished to an extent that makes the milk or milkproduct un t or its reasonable intended use; or

Contains any damaged, deteriorated or spoiled substance that makes the milkor milk product un t or its reasonable intended use; or

Contains a biological or chemical agent, or other matter or substance, that isoreign to the nature o the ood and that makes the milk or milk product un tor its reasonable intended use.

The intended use is the purpose or which the product is speci cally statedor could reasonably be presumed to be intended having regard to its nature,packaging, presentation and identi cation.

3. PRImARY PRODUCTION

These principles and guidelines supplement those contained in Section 3 o theGeneral Principles o Food Hygiene (CAC/RCP 1-1969) and the general principlespresented in Section 2.3 above. Details on speci c approaches to the production omilk are given in Annex I o this Code.

PRINCIPlEs APPlYING TO THE PRImARY PRODUCTION OF mIlkmi hou d not contain any conta inant at a eve that jeopardize the appropriate

eve o pub ic hea th protection, when pre ented to the con u er.Because o the important infuence o primary production activities on the sa ety o milk products, potential microbiological contamination rom all sources should be minimized to the greatest extent practicable at this phase o production. It isrecognized that microbiological hazards can be introduced both rom the armenvironment and rom the milking animals themselves. Appropriate animal husbandry practices should be respected and care should be taken to assurethat proper health o the milking animals is maintained. Further, lack o good agricultural, animal eeding and veterinary practices and inadequate general hygiene o milking personnel and equipment and inappropriate milking methodsmay lead to unacceptable levels o contamination with chemical residues and other contaminants during primary production.

Conta ination o i ro ani a and environ enta ource during pri aryproduction hou d be ini ized.Note: A contaminant is any biological or chemical agent, oreign matter, or other

substances not intentionally added to ood which may compromise ood sa ety or suitability ( General Principles o Food Hygiene (CAC/RCP 1-1969)).


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The icrobia oad o i hou d be a ow a achievab e, u ing good iproduction practice , ta ing into account the techno ogica require ent or

ub equent proce ing .Measures should be implemented at the primary production level to reduce theinitial load o pathogenic micro-organisms and micro-organisms a ecting sa ety and suitability to the extent possible to provide or a greater margin o sa ety and/ or to prepare the milk in a way that permits the application o microbiological control measures o lesser stringency than might otherwise be needed to assure

product sa ety and suitability.

UsE OF THIs sECTIONGuidelines or applying the principles in this section are contained in Annex I. Theguidelines are intended to result in raw material that is acceptable or urtherprocessing and that will ultimately result in the level o protection required or theparticular nished milk product.

Annex I provides details o the general approach that should be used or theprimary production o milk intended or urther processing o an unspeci ednature. Additional provisions to be used in the production o milk intended orthe manu acture raw milk products are identi ed in relevant sections o the annex.Flexibility in the application o certain aspects o the primary production o milk

or small holder dairy arms is also provided or. Milk produced according to theprovisions o this section should be subjected to the application o control measuresdescribed in Annex II.

3.1 Environ enta hygieneWater and other environ enta actor hou d be anaged in a way that ini izethe potentia or the tran i ion, direct y or indirect y, o hazard into the i .Contaminated water, and or example pests (such as insects and rodents), chemicalsand the internal and external environments where the animals are housed and milked, may contaminate eed, equipment or milking animals leading to theintroduction o hazards into milk.

Water u ed in pri ary production operation hou d be uitab e or it intendedpurpo e and hou d not contribute to the introduction o hazard in i .

3.2 Hygienic production o i

3.2.1 Area and pre i e or i productionArea inc uding pre i e u ed or the production o i hou d be de igned,

ituated, aintained and, to the extent practicab e, u ed in a anner that ini izethe introduction o hazard into i .Improperly protected and maintained premises or the holding and milking o dairy animals have been shown to contribute to the contamination o milk.


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3.2.2 Ani a hea thThe hea th tatu o i ing ani a and herd hou d be anaged in a annerthat addre e the hazard o concern or hu an hea th.mi hou d co e ro ani a in good hea th o that, con idering the end u e, itdoe not adver e y a ect the a ety and uitabi ity o the end product.It is important to prevent the spread o zoonotic diseases among animals and romanimals (including milking animals) to milk. Milk and milk products produced rommilk obtained rom certain diseased animals has been known to be neither sa e nor

suitable or human consumption.Maintenance o healthy milking animals has been shown to reduce the likelihood that human pathogens will be introduced into the milk via the mammary gland or

rom the aeces.

3.2.3 Genera hygienic practice

3.2.3.1 FeedingWith con ideration given to the end u e o the i , orage and eed or actatingani a hou d not introduce, direct y or indirect y, conta inant into i ina ount that pre ent an unacceptab e hea th ri to the con u er or adver e ya ect the uitabi ity o i or i product .It has been shown that improper procurement, manu acturing and handling o animal eed can result in the introduction o pathogens and spoilage organisms tomilking animals and the introduction o chemical hazards such as pesticide residues,mycotoxins and o other contaminants which can a ect the sa ety and suitability o milk or milk products.

3.2.3.2 Pe t controPe t hou d be contro ed, and in a way that doe not re u t in unacceptab e eveo re idue , uch a pe ticide , in the i .Pests such as insects and rodents are known vectors or the introduction o humanand animal diseases into the production environment. Improper application o pest control chemicals used to control these pests may introduce chemical hazards intothe production environment.

3.2.3.3 Veterinary drugAni a hou d on y be treated with veterinary drug authorized by the co petentauthority or the peci c u e and in a anner that wi not adver e y i pact on the

a ety and uitabi ity o the i , inc uding adherence to the withdrawa periodpeci ed.

Milk rom animals that have been treated with veterinary drugs that can betrans erred to milk should be discarded appropriately until the withdrawal period

speci ed or the particular veterinary drug has been achieved.

Re idue o veterinary drug in i hou d not exceed eve that wou d pre entan unacceptab e ri to the con u er.The improper use o veterinary drugs has been shown to result in potentially harm ul residues in milk and milk products, and may a ect the suitability o milk intended

or the manu acture o cultured products.


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3.2.4 Hygienic i ingmi ing hou d be carried out in uch a anner that ini ize conta ination othe i being produced.E ective hygienic practice during milking is an important element o the system o controls necessary to produce sa e and suitable milk and milk products. Failure tomaintain adequate sanitation and employee practices has been shown to contributeto the contamination o milk with undesirable or pathogenic micro-organisms or chemical or physical hazards.

3.3 Hand ing, torage and tran port o iWith con ideration given to the end u e o the i , hand ing, torage andtran port o i hou d be conducted in a anner that wi avoid conta inationand ini ize any increa e in the icrobio ogica oad o i .Proper handling, storage and transport o milk are important elements o the

system o controls necessary to produce sa e and suitable milk and milk products.Contact with unsanitary equipment and oreign materials are known causes o milkcontamination. Temperature abuse is known to increase the microbiological load o milk.

3.3.1 mi ing equip entmi ing equip ent hou d be de igned, con tructed, in ta ed, aintained andu ed in a anner that wi avoid the introduction o conta inant into i .Milking equipment is normally designed and constructed according to recognized

standards that avoid the introduction o contaminants into milk. Equipment selected or installation on dairy arms should meet recognized design and construction

standards. Recognized guidelines also exist or the proper use, cleaning and maintenance o milking equipment; such guidelines should be ollowed to avoid trans er o disease between animals through milking equipment and to help ensureobtaining milk that is sa e and suitable.

mi ing equip ent hou d be operated in a anner that wi avoid da age to udderand teat and that wi avoid the tran er o di ea e between ani a through the

i ing equip ent.It is important to prevent any damage to udder and teats by milking equipment

since such damage can lead to in ections and consequently adversely a ect the sa ety and suitability o milk and milk products.

3.3.2 storage equip entmi torage tan and can hou d be de igned, con tructed, aintained andu ed in a anner that wi avoid the introduction o conta inant into i and

ini ize the growth o icro-organi in i .

3.3.3 Pre i e or, and torage o , i and i ing-re ated equip entPre i e or the torage o i and i ing-re ated equip ent hou d be

ituated, de igned, con tructed, aintained and u ed in a anner that avoid theintroduction o conta inant into i .


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Whenever i i tored, it hou d be tored in a anner that avoid the introductiono conta inant into i and in a anner that ini ize the growth o icro-organi .

3.3.4 Co ection, tran port and de ivery procedure and equip entThis section also covers the activities o personnel involved in the transport o milk.

mi hou d be co ected, tran ported and de ivered without undue de ay, and in aanner that avoid the introduction o conta inant into i and ini ize the

growth o icro-organi in the i .Note: See Section 10 or provisions on the training o personnel involved in thecollection, transport and delivery o milk.

mi tran port tan er and can hou d be de igned, con tructed, aintained andu ed in a anner that wi avoid the introduction o conta inant into i and

ini ize the growth o icro-organi in i .

3.4 Docu entation and record eepingRecord hou d be ept, a nece ary, to enhance the abi ity to veri y thee ectivene o the contro y te .

4. EsTABlIsHmENT: DEsIGN AND FACIlITIEs

These principles and guidelines are supplemental to those contained in Section 4o the General Principles o Food Hygiene (CAC/RCP 1-1969) and to the generalprinciples presented in Section 2.3 above.

4.1 Equip entEquip ent hou d be de igned and in ta ed uch that a ar a po ib e dead endor dead pot in i pipe ine do not occur.Where dead ends or dead spots occur, special procedures should ensure they aree ectively cleaned or otherwise do not permit a sa ety hazard to occur.

5. CONTROl OF OPERATION

These principles and guidelines are supplemental to those contained in Section 5o the General Principles o Food Hygiene (CAC/RCP 1-1969) (including the Annexon Hazard Analysis and Critical Control Point (HACCP) System and Guidelines or its

Application) and to the overarching principles presented in Section 2.3 above.

UsE OF THIs sECTIONThis section contains principles or the control o operation that are intended tobe applied in such a manner as to result in meeting acceptable levels o relevanthazards speci ed as Food Sa ety Objectives and/or related objectives and criteria, or


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end product criteria that have been established to express the level o protection orthe speci c situation. Guidelines or applying the principles with respect to physical,chemical and microbiological hazards are provided in this section as well. Detailsgiven in Annex II provide guidance on the establishment and management ocontrol measures used to achieve sa ety and suitability during and a ter processing.

For the e ective implementation o the provisions in this Section, milk should beproduced in accordance with Section 3 and Annex I o this Code.

5.1 Contro o ood hazardThe co bination o contro ea ure hou d e ective y contro the identi edhazard in i and i product .The combination o control measures should be designed in a systematic way,and the chosen combination should be adapted to the hygiene status o the milkand raw materials used with consideration given to the relevant microbiological,chemical and physical hazards o concern and to the establishment o Food Sa ety Objective(s) and/or related objectives and criteria.

Where appropriate control measures and/or control measure combinations arechosen to control hazards that are reasonably likely to occur, the proceduresdescribed in sections 5.1.1 to 5.1.3 and corresponding guidelines contained in AnnexII should be implemented in order to minimize or prevent the likelihood o a healthrisk to the consumer.

The ollowing procedures are intended to enhance and supplement those aspectso the HACCP Annex to the International Recommended Code o Practice General Principles o Food Hygiene, which are critical to the success ul design o a system o

ood sa ety controls.

5.1.1 Hazard identi cation and eva uationA potentia hazard hou d be identi ed.This should be done be ore control measures are selected and is the rst step in thehazard analysis.The identi cation should be based on the initial descriptions developed duringpreliminary steps and on experience, external in ormation, as well as epidemiologicaland other historical data that have been associated with the type o ood underconsideration, the type o raw materials and ingredients used, and that may beintroduced during processing and distribution. To insure a comprehensive approach,the various step(s) in the manu acturing process, rom material selection throughprocessing and distribution, where a hazard may occur or be introduced should beidenti ed.

Each potentia hazard hou d be eva uated to deter ine the everity o it adver ehea th e ect and rea onab e i e ihood o occurrence.Potential hazards that are determined to have severe adverse health e ects and/orare reasonably likely to occur should be subject to control by the system o controlmeasures.


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5.1.2 Contro ea ure e ection Fo owing hazard eva uation, contro ea ure and contro ea ure co bination

hou d be e ected that wi prevent, e i inate, or reduce the hazard to acceptab eeve .

The next step in the hazard analysis process is to select control measures that will be e ective in controlling those hazards. A number o such control measures are

urther described in Annex II, Parts A and B.Guidance on how to provide re erence validations o individual control measures orcontrol measure combinations against individual hazards in various media is given inGuidelines or the Validation o Food Hygiene Control Measures (CAC/GL 69-2008).

5.1.3 E tab i h ent o proce criteria Proce criteria or contro ea ure hou d be e tab i hed in order or the proceto be app ied in a anner that wi eet the per or ance required, i.e., a ure theadequate de ivery o the contro ea ure.Process criteria should be established at such intensities that the control measuresactually deliver the expected per ormance, taking into account normal processdeviations.

5.2 key a pect o hygiene contro y te

5.2.1 Te perature and ti e controFro i production through to ni hed product , product hou d be toredat appropriate te perature and or appropriate ti e uch that the growth ordeve op ent o a ood a ety hazard wi be ini ized and the product uitabi itywi not be adver e y a ected.Because milk and many milk products have a su cient moisture content to

support the growth o pathogens, temperature and time controls represent key microbiological control measures to control growth throughout the manu acturing

process, rom the handling o milk to the distribution and storage o perishable milk products (e.g., pasteurized drinking milk, desserts, and so t cheeses, depending on shel li e). For instance, or liquid milk, increased storage temperature will decreasethe shel li e.

5.2.1.1 manage ent o product within the p ant

Incoming milk When arriving at the dairy plant, and provided that urther processing does notallow otherwise, the milk should be cooled and maintained at such temperatures asnecessary to minimize any increase o the microbial load o the milk.

The princip e o r t arrived, r t proce ed hou d app y.

Intermediate productsInter ediate product that are tored prior to urther proce ing hou d, un e

urther proce ing doe not a ow it, be ept under uch condition that i it/prevent icrobia growth or be urther proce ed within a hort ti e period.


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The ultimate sa ety and suitability o milk and milk products, as well as the intensity o the control measures that need to be applied during processing, depends not only on the initial microbial load upon receipt at the dairy plant but also on preventingthe growth o micro-organisms. Application o proper storage temperatures and management o raw materials is an essential actor in minimizing microbial growth.The ability o a product to meet intended Food Sa ety Objectives and/or related objectives and criteria is dependent upon the proper application o the control measures, including time and temperature controls.

There hou d be adequate toc rotation, ba ed on the princip e o r t in, r tout.

5.2.1.2 Di tribution o ni hed productIt i e entia that i and i product be ept at an appropriate te perature inorder to aintain their a ety and uitabi ity ro the ti e it i pac aged unti it icon u ed or prepared or con u ption.While the storage temperature should be su cient to maintain the products

sa ety and suitability throughout the intended shel li e, the appropriate storagetemperature will vary depending upon whether the product is perishable or non-

perishable. For perishable products, the distribution system should be designed tomaintain adequate low-temperature storage to ensure both sa ety and suitability.For non-perishable products designed to be shel -stable at ambient temperature,extremes o temperature should be avoided, primarily to assure maintaining

suitability. Reasonably anticipated temperature abuse should be taken into account in designing the normal patterns o distribution and handling.

5.2.1.3 E tab i h ent o he i eIt i the re pon ibi ity o the anu acturer to deter ine the he i e o the productand the condition or torage.Limitation o shel li e is a control measure that, in many cases, is decisive or the

sa ety and suitability o the product. The corresponding storage conditions are anintegral aspect o product shel li e.

5.2.2 speci c proce tepAnnex II, Appendices A and B contain examples o processes used during themanu acture o milk products that can control hazards that are reasonably likely tooccur. These processes include both extrinsic and intrinsic actors that infuence thegrowth o micro-organisms.

Extrinsic factors re er to actors impacting the product rom the environment inwhich the ood is placed. Examples include temperature, time, and relative humidity o the air.

Intrinsic factors re er to internal actors in the product itsel ( ood matrix),infuenced by or as consequence o extrinsic actors, that have an impact on thegrowth and/or survival o micro-organisms. Examples include water activity, pH,nutrient availability, competition o micro-organisms, and bacteriocins or other growth inhibitors.


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5.2.3 microbio ogica and other peci cationWhere they are employed, microbiological criteria, including those used to veri y thee ective application o control measures within the ramework o HACCP principles,should be developed in accordance with the Principles or the Establishment and

Application o Microbiological Criteria or Foods , CAC/GL 21-1997, including the useo a risk assessment approach as speci ed in the Principles and Guidelines or theConduct o Microbiological Risk Assessment, CAC/GL 030-1999.

5.2.3.1 Inco ing imanu acturer hou d e tab i h inco ing i criteria that ta e into account theend u e o the i and the condition under which the i wa produced.Depending upon the end use o the milk, particularly or milk used in the productiono raw milk products, certain speci c microbiological criteria may be appropriate toveri y the microbiological quality o the milk used as raw material.

Corrective action ta en or non-co p iance with inco ing i criteria hou d beco en urate with the potentia ri pre ented by the non-co p iance.Incoming milk that is out o compliance with established criteria indicates that thecontrol measure system is not working properly and corrective action should betaken to identi y and resolve causative problems.

5.2.3.2 microbio ogica criteria microbio ogica criteria ay be nece ary to be e tab i hed at di erent point inthe proce or carrying out the de ign o contro ea ure co bination and orthe veri cation that the contro y te ha been i p e ented correct y.In some cases, or example where more comprehensive control measures are put into place to ensure the sa ety and suitability o milk (such as may be the case

or raw milk intended to be used in the production o raw milk products), it may be necessary to establish criteria or in-process product, intermediate product or

nished product in order to veri y that the more comprehensive set o control measures have been properly carried out.

5.2.4 microbio ogica cro conta inationThe fow o the product and o the ingredient within equip ent and throughthe proce ing aci ity hou d aintain a orward progre ion ro raw ateriareceipt to ni hed product pac aging o a to avoid cro conta ination.The fow o the water, air, e fuents, and milk should be care ully evaluated toensure that the potential or cross-contamination does not occur. Similarly, the fowo personnel should be evaluated to ensure that their actions couldnt contaminatemilk.

There hou d be adequate eparation o area with di erent eve o conta inationri .Milk products that have been returned rom other locations should be identi ed,segregated and stored in a clearly designated area.

Where there is the potential or cross-contamination between end products andraw materials or intermediate products, and rom contaminated areas such as


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construction and rebuilding areas, consideration should be given to a physicalseparation, such as by the application o barrier hygiene (the application o physicalor mechanical barriers to prevent or minimize the trans er o contaminants orpotential sources o contaminants) and wet/dry area segregation.

5.2.5 Phy ica and che ica conta inationPreventive ea ure hou d be i p e ented to ini ize ri o conta inating

i and i product with phy ica and che ica hazard and oreign ub tance . Avoiding physical and chemical contamination o milk and milk products during processing requires the e ective control o equipment maintenance, sanitation programmes, personnel, monitoring o ingredients and processing operations.Preventive measures should include those that will minimize the potential or crosscontamination o allergenic components and/or ingredients that may present inother products to a milk product in which these components and/or ingredients arenot supposed to be present.

5.3 Inco ing ateria (other than i ) require entIngredient u ed or the proce ing o i product hou d be purcha ed accordingto peci cation , and their co p iance with the e peci cation hou d be veri ed.Contaminated ingredients have been known to lead to unsa e/unsuitable milk

products, since these ingredients are o ten added during processing where nourther control measures are applied.

Pre erably, speci cations or raw materials should be established such that their usewill result in a sa e and suitable product. No raw material should be accepted i itis known to contain chemical, physical or microbiological contaminants that wouldnot be reduced to an acceptable level by normal sorting and/or processing. Rawmaterials should, where appropriate, be inspected and sorted be ore processing.Any claims that raw materials meet sa ety and suitability speci cations should beveri ed periodically.

5.4 WaterDairy proce ing e tab i h ent hou d have potab e water avai ab e, which priorto it r t u e, hou d eet the criteria peci ed by the co petent authoritiehaving juri diction and hou d be regu ar y onitored.

Water recircu ated or reu e hou d be treated and aintained in uch a conditionthat no ri to the a ety and uitabi ity o ood re u t ro it u e.Proper maintenance o water conditioning systems is critical to avoid the systemsbecoming sources o contamination. For example, lter systems can become sourceso bacteria and their metabolites i bacteria are allowed to grow on the organicmaterials that have accumulated on the lter.

Appropriate a ety and uitabi ity criteria that eet the intended outco e hou dbe e tab i hed or any water u ed in dairy proce ing.These criteria depend upon the origin and the intended use o the water. For example, reuse water intended or incorporation into a ood product should at least meet the microbiological speci cations or potable water.


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Reconditioning o water or reu e and u e o rec ai ed, recircu ated and recyc edwater hou d be anaged in accordance with HACCP princip e .Any reuse o water should be subject to a hazard analysis including assessmento whether it is appropriate or reconditioning. Critical control point(s) should beidenti ed, as appropriate, and critical limit(s) established and monitored to veri ycompliance.

6. EsTABlIsHmENT: mAINTENANCE AND sANITATION

These principles and guidelines are supplemental to those contained in Section 6 othe General Principles o Food Hygiene (CAC/RCP 1-1969).

6.1 maintenance and c eaningProce ing area hou d be ept a dry a po ib e.Use o dry cleaning methods, and limiting the use o water in processing areas,helps to avoid the spread o contamination by water. Wet cleaning (other thanCleaning-in-Place) has been known to lead to milk product contamination due tothe production o aerosols.

A ood product contact ur ace in piping and equip ent, inc uding area that aredi cu t to c ean uch a by-pa va ve , a p ing va ve , and overfow iphon in

er hou d be adequate y c eaned.

6.2 C eaning progra eA routine progra e to veri y the adequacy o c eaning hou d be in p ace.All equipment and utensils used in processing should, as necessary, be cleaned anddisin ected, rinsed with water which is sa e and suitable or its intended purpose(unless the manu acturers instructions indicate rinsing is not necessary), thendrained and air dried where appropriate.

7. EsTABlIsHmENT: PERsONAl HYGIENE

No speci c requirements beyond those contained in the General Principles o Food Hygiene (CAC/RCP 1-1969) are needed.

8. TRANsPORTATION

These principles and guidelines are supplemental to those set orth in Section 8 othe General Principles o Food Hygiene (CAC/RCP 1-1969) and, as appropriate, thoseset orth in Code o Hygienic Practice or the Transport o Foodstu s in Bulk and Semi-Packed Foodstu s (CAC/RCP 47 2001).


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8.1 Require entProduct covered under thi Code hou d be tran ported at ti e/te peratureco bination that wi not adver e y a ect the a ety and uitabi ity o the product.

8.2 U e and aintenanceIn the ca e o re rigerated product , the vehic e product co part ent hou dbe coo ed prior to oading and the product co part ent hou d be ept at anappropriate te perature at a ti e , inc uding during un oading.

9. PRODUCT INFORmATION AND CONsUmER AWARENEss

These principles and guidelines are supplemental to those contained in Section 9 othe General Principles o Food Hygiene (CAC/RCP 1-1969).

9.1 labe ingMilk products should be labelled in accordance with the General Standard or theLabelling o Prepackaged Foods (CODEX STAN 1-1985), the General Standard or the Use o Dairy Terms (CODEX STAN 206-1999) and the relevant labelling section oCodex commodity standards or individual milk products.Unless the product is shel stable at ambient temperatures, a statement regardingthe need or re rigeration or reezing should be included on the label o the product.

Additiona provi ion or raw i productRaw i product hou d be abe ed to indicate they are ade ro raw iaccording to nationa require ent in the country o retai a e.

10. TRAINING

These principles and guidelines are supplemental to those contained in Section 10o the General Principles o Food Hygiene (CAC/RCP 1-1969).

10.1 Training progra eMilk producers and personnel involved in the collection and transport and retail omilk should be trained as necessary and have appropriate skills in the areas listedbelow:

health o animals and use o veterinary drugs; manu acturing and use o eeds (more speci cally ermented eeds); herd management; hygienic milking; storage, handling, collection and transport o milk (cleaning o storage tanks,

temperature requirements, sampling procedures, etc.); microbiological, chemical and physical hazards and their control measures.


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ANNEX I

GUIDELINES FOR THE PRIMARY PRODUCTION OF MILK

INTRODUCTION AND OBJECTIVEs

The detailed in ormation contained in this annex should be implemented in order toreduce the likelihood o milk contamination through inadequate primary productionpractices. This in ormation will enable the implementation o the principles laiddown in Section 3 o the main body o the Code by providing guidelines or theirapplication.

These measures, in combination with microbiological control measures ound inAnnex II, should be used to e ectively control the microbiological hazards in milkproducts. There is a close relationship between the hygienic conditions ound inprimary production and the sa ety and suitability o processed milk products basedon the control measures presented in Annex II.

sCOPE

This Annex provides details o the approaches that should be used or the primaryproduction o milk intended or urther processing o an unspeci ed nature. Themilk should be subjected to the application o microbiological control measuresdescribed in Annex II.

The degree to which on- arm practices control the likelihood o occurrence o oodsa ety hazard in milk will have an impact on the nature o controls needed duringthe subsequent processing o the milk. Under normal circumstances, milk will besubjected to control measures su cient to address any hazards that may be present.Where the subsequent processing o milk does not involve the application o controlmeasures necessary to address any hazards that may be present, the ocus thenbecomes preventative in nature in order to reduce the likelihood that such hazardswill occur during the primary production phase o the continuum. Likewise, in certainprimary production situations, the occurrence o ood sa ety hazards may be lessavoidable, which will mandate the application o more stringent control measuresduring subsequent processing in order to insure the sa ety and suitability o the

nished product.

UsE OF ANNEX I

The in ormation in Annex I is organized to correspond with the relevant sectionsin the main part o the Code and the General Principles o Food Hygiene (CAC/ RCP 1-1969). Where a particular principle has been identi ed in the main body


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o the Code, guidelines or the application o that principle will be located in thecorresponding section o this Annex.

Additiona provi ion or the production o i u ed or raw i productWhen milk is intended to be used or the manu acture o raw milk products, thehygienic conditions used at the primary production are one o the most importantpublic health control measures, as a high level o hygiene o the milk is essential inorder to obtain milk with a su ciently low initial microbial load in order to enablethe manu acturing o raw milk products that are sa e and suitable or humanconsumption. In such situations, additional control measures may be necessary.Where applicable, these additional measures are provided at the end o each sub-section.

Compliance with these additional hygienic provisions is important, and is consideredmandatory in certain circumstances (where the nature o the nished product ornational legislation requires), throughout the milk production process, up to themanu acture o the particular raw milk product. In addition, increased emphasisin certain aspects o the production o milk or raw milk products (animal health,animal eeding, milk hygiene monitoring) are speci ed and are critical to theproduction o milk that is sa e and suitable or the intended purpose. To refectthe greater emphasis on the compliance needed on certain provisions, the wordshould has been substituted with the word shall where applicable.

As is the case with the rest o this code, this section also does not mandate or speci ythe use o any one set o controls to be used, but leaves it up to those responsible

or assuring the sa ety o the nished product to choose the most appropriate seto control measures or the particular situation.

There are a wide variety o raw milk products, most o which are cultured productssuch as cheeses. The range o moisture content, pH and salt content (among otherparameters) in these products will have varying degrees o impact on any potentialmicrobiological hazards that may be present in the milk used or their manu acture.The degree to which the inherent characteristics o the product (or process usedto manu acture the product) will control the hazard should guide the extent towhich these potential hazards need to be prevented or controlled during primaryproduction.

A wide range o ood sa ety approaches exist or the production o raw milkproducts. As is the case with the rest o this code, the approach taken in this sectionis intended to be fexible enough to take into account the di erent approachesused in di erent countries regarding the manu acture and marketing o raw milkproducts.

specia provi ion or the production o i on a ho der dairy arIn the context o this Code, the expression Small Holder Dairy Farm re ers to armswhere the number o animals per armer or per herd usually does not exceed 10,milking machines are not generally used, milk is not chilled at the producers leveland/or the milk is transported in cans.


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Flexibility in the application o certain requirements o the primary productiono milk in small holder dairy arms can be exercised, where necessary, providedthat the milk is received by dairy plants and will be subjected to a combinationo microbiological control measures su cient to obtain a sa e and suitablemilk product. Such fexibility is indicated throughout this annex by the use o aparenthetical statement i used or i applicable placed next to the particularprovision where the fexibility is needed.

Flexibility as above may also apply to arms with larger number o animals but havingsimilar economic constraints or limited water and/or power supplies, preventinginvestment in technological acilities and in rastructure.

3. PRImARY PRODUCTION

3.1 Environ enta hygieneWhen water is used or the cleaning o the udder and or cleaning equipment used

or the milking and storage o milk it should be o such quality that it does notadversely a ect the sa ety and suitability o the milk.

Precautions should be adopted to ensure that milking animals do not consume orhave access to contaminated water or other environmental contaminants likely tocause diseases transmissible to humans or contaminate milk.

3.2 Hygienic production o i

3.2.1 Area and pre i e or i production

3.2.1.1 Ani a ho ding area The design, layout and provision o holding areas should not adversely a ect the

health o animals. In particular, holding areas should be kept clean and maintainedin a manner that minimizes the risk o animal in ection or contamination o themilk.

Access to the animal holding area, including the stable and attached premises, iused, should preclude the presence o other species that would adversely a ectthe sa ety o the milk.

The holding area should, as ar as practicable, be kept clean and ree oaccumulations o manure, mud or any other objectionable materials.

I used, stable and stalls should be designed and constructed to keep them reeo accumulations o manure, eed residues, etc.

Animal holding areas should be designed such that animals with contagiousdiseases can be separated to prevent the transmission o disease to healthyanimals.

Animal holding areas should not adversely a ect the health o animals. Inparticular, the litter and the stabling area should be maintained in a manner thatminimizes the risk o teat injuries and udder diseases.


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3.2.1.2 mi ing area and re ated aci itie Premises where milking is per ormed should be situated, constructed (i applicable)

and maintained in a manner that will minimize or prevent contamination o themilk.

Milking areas should be kept ree o undesirable animals such as pigs, poultryand other animals whose presence may result in the contamination o milk.

Premises where milking is per ormed should be easy to clean, especially in areassubject to soiling or in ection, e.g., they should have: ooring constructed to facilitate draining of liquids and adequate means of

disposing o waste; adequate ventilation and lighting; an appropriate and adequate supply of water of a suitable quality for use

when milking and in cleaning the udder o the animals and equipment usedor milking;

effective separation from all sources of contamination such as lavatories (ifused) and manure heaps; and

effective protection against vermin.

Additiona provi ion or the production o i u ed or raw i productOnly potable water can be used in milking areas, product storage areas and othercritical areas.

3.2.2 Ani a hea thAdequate management measures should be implemented to prevent animal diseasesand to control drug treatment o diseased animals or herds in an appropriate way.In particular, preventive measures should be taken to prevent disease including:

Eradication o animal diseases or control o risk o transmission o the diseases,according to the speci c zoonosis

Management o other animals in the herd and other armed animals present(including the segregation o diseased animals rom healthy animals)

Management o new animals in the herd

The milk should originate rom herds or animals that are o cially ree o brucellosisand tuberculosis, as de ned by the OIE Terrestrial Animal Health Code . I not o cially

ree, then milk should originate rom herds or animals that are under o cialcontrol and eradication programmes or brucellosis and tuberculosis. I controls orbrucellosis and tuberculosis were not su ciently implemented, it would be necessary

or the milk to be subjected to subsequent microbiological control measures (e.g.,heat treatment) that will assure the sa ety and suitability o the nished product.

Milk should be drawn rom animals that:

are identi able to acilitate e ective herd management practices; do not show visible impairment o the general state o health; and do not show any evidence o in ectious diseases trans erable to humans through

milk including but not limited to diseases governed by the OIE Terrestrial Animal Health Code .


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Adequate measures should be implemented in order to prevent udder in ections,especially:

the correct use o milking equipment (e.g. daily cleaning, disin ection anddisassembling o equipment);

the hygiene o milking (e.g. udder cleaning or disin ection procedures); the management o the animal holding areas (e.g. cleaning procedures, design

and size o areas); the management o dry and lactation periods (e.g., treatment or the drying o ).

Additiona provi ion or the production o i u ed or raw i productThe milk cannot carry unacceptable levels o zoonotic agents. There ore, the milkshall originate rom individual animals:

that are identi able such that the health status o each animal can be ollowed.To this e ect: the herd shall be declared to the competent authorities and registered; each animal shall be identi ed with a stead ast device and registered by the

competent authorities. that do not show visible impairment o the general state o health and which are

not su ering rom any in ection o the genital tract with discharge, enteritis withdiarrhoea and ever, or recognizable infammation o the udder;

that do not show any evidence (signs or analytical results) o in ectious diseasescaused by human pathogens (e.g., Listeriosis) that are trans erable to humansthrough milk including but not limited to such diseases governed by the OIE Terrestrial Animal Health Code ;

that, in relation to brucellosis and tuberculosis, shall comply with the ollowingcriteria: cows milk shall be obtained rom animals belonging to herds that are o cially

ree o tuberculosis and brucellosis in accordance with the relevant chapters othe OIE Terrestrial Animal Health Code ;

sheep or goat milk shall be obtained rom animals belonging to sheep or goatherds that are o cially ree or ree o brucellosis as per the OIE Terrestrial

Animal Health Code ; when a arm has a herd comprised o more than one species, each species

shall comply with sanitary conditions that are mandatory or each particularspecies;

i goats are in the same environment with cows, goats shall be monitored ortuberculosis.

In addition, it is necessary that the milk also be checked or other relevant aspects inaccordance with point 5.2.3.1. (microbiological and other speci cations) which canhave an impact on the sa ety and suitability o raw milk products; these results mayprovide in ormation regarding the health status o the animals.


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In particular, preventive measures are needed to prevent disease including:

animals o unknown health status shall be separated, be ore being introduced inthe herd, until such time that their health status has been established. During thatseparation period, milk rom those animals shall not be used or the productiono milk or the manu acture o raw milk products;

the owner shall keep a record o relevant in ormation, e.g., results o tests carriedout to establish the status o an animal just being introduced, and the identity oreach animal either coming or leaving the herd.

3.2.3 Genera hygienic practice

3.2.3.1 FeedingThe relevant aspects o the Code o Practice on Good Animal Feeding (CAC/RCP 54-2004) should be applied to minimize or prevent the introduction o contaminantsthrough eed or eeding practices.

Additiona provi ion or the production o i u ed or raw i productWhen using ermented eed, it is necessary that the eed be prepared, stored andused in a manner that will minimize microbial contamination. Particular attentionshall be given to compliance with good practices concerning the ollowing aspects:

the design o silos; good production practices o silage; regular check of the quality of the fermented feed (organoleptic inspection or pH).

The owner shall keep a record o relevant in ormation concerning eed.

3.2.3.2 Pe t contro Be ore pesticides or rodenticides are used, all e orts should be made to minimize

the presence o insects, rats and mice. Although stables and milking parlours(i used) attract such pests, good preventive measures such as proper buildingconstruction and maintenance (i applicable), cleaning, and removal o aecalwaste can minimize pests.

Accumulations of manure should not be allowed to develop close to milking areas. Mice and rats are also attracted to animal eed stores. Hence, any such eed stores

should be located at a suitable place and eed kept in containers that provideadequate protection against such pests.

I it is necessary to resort to chemical pest control measures, such products shouldbe approved o cially or use in ood premises and used in accordance with themanu acturers instructions.

Any pest control chemicals should be stored in a manner that will not contaminatethe milking environment. Such chemicals should not be stored in wet areas orclose to eed stores. It is pre erable to use solid baits, wherever possible.

No pesticides should be applied during milking.


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3.2.3.3 Veterinary drug 6

The relevant aspects o the Guidelines or the Design and Implementation o National Regulatory Food Sa ety Assurance Programmes Associated with theUse o Veterinary Drugs in Food Producing Animals (CAC/GL 71-2009) shouldbe applied to minimize or prevent the introduction o drug residues in milk ormilk products.

Good husbandry procedures should be used to reduce the likelihood o animaldisease and thus reduce the use o veterinary drugs.

Only those medicinal products and medicinal premixes that have been authorizedby competent authority or inclusion in animal eed should be used.

Milk rom animals that have been treated with veterinary drugs that can betrans erred to milk should be discarded until the withdrawal period speci ed orthe particular veterinary drug has been achieved. Established MRLs or residueso veterinary drugs in milk may serve as a re erence or such veri cation.

The veterinarian and/or the livestock owner or the collection centre should keepa record o the products used, including the quantity, the date o administrationand the identity o animals. Appropriate sampling schemes and testing protocolsshould be used to veri y the e ectiveness o on- arm controls o veterinary druguse and in meeting established MRLs.

3.2.4 Hygienic i ingMinimizing contamination during milking requires that e ective hygienic practicesbe applied in respect o the skin o the animal, the milking equipment (wheneverused), the handler and the general environment e.g. aecal sources o contamination.

Milking should be carried out under hygienic conditions, including:

good personal hygiene o the milking personnel; clean udders, teats, groins, fanks and abdomens o the animal; clean and disin ected milking vessels/equipment; and avoidance o any damage to the tissue o the teat/udder.

In particular, during any milking, consideration should be given to minimizing and/orpreventing contamination rom the milk production environment and maintainingpersonal hygiene.

Animals showing clinical symptoms o disease should be segregated and/or milkedlast, or milked by using separate milking equipment or by hand, and such milkshould not be used or human consumption.

Operations such as eeding the animals or placement/removal o litter should beavoided prior to milking in order to reduce the likelihood o contamination o themilking equipment and the milking environment rom manure or dust.

6 Treatment with veterinary drugs should be consistent with the Code of Practice to Minimize and Contain Antimicrobial Resistance (CAC/RCP 61-2005).


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The milking animals should be maintained in an as clean state as possible. Priorto any milking, teats should be clean. The milker should monitor by appropriatemeans that the milk appears normal, or example by care ul observation o thecondition o milking animals, by checking the milk o each animal or organolepticor physicochemical indicators, and by using records and identi cation o treatedanimals. I the milk does not appear normal, the milk should not be used or humanconsumption. The producer should take appropriate precautions to minimize therisk o in ections to teats and udders, including the avoidance o damage to tissue.Foremilk (initially drawn small quantity o milk) rom each teat should be discardedor collected separately and not used or human consumption unless it can be shownthat it does not a ect the sa ety and suitability o the milk.

3.2.4.1 Environ enta conta inationMilking operations should minimize the introduction o ood-borne pathogens and

oreign matter rom the skin and general milking environment as well as chemicalresidues rom cleaning and disin ection routines .

3.2.4.2 mi ing equip ent de ign Milking equipment, utensils and storage tanks should be designed, constructed

and maintained in such a way that they can be adequately cleaned and do notconstitute a signi cant source o contamination o milk.

Milking equipment should be designed such that it does not damage teats andudders during normal operation.

3.2.4.3 mi ing equip ent c eaning and di in ection Milking equipment and storage tanks (and other vessels) should be thoroughly

cleaned and disin ected ollowing each milking, and dried when appropriate. Rinsing o equipment and storage tanks ollowing cleaning and disin ection

should remove all detergents and disin ectants, except in those circumstanceswhere the manu acturer instructions indicate that rinsing is not required.

Water used or cleaning and rinsing should be appropriate or the purpose, suchthat it will not result in contamination o the milk.

Additiona provi ion or the production o i u ed or raw i product Only potable water can be used in contact with milking equipment and other

milk contact sur aces.

3.2.4.4 Hea th and per ona hygiene o i ing per onne Milking personnel should be in good health. Individuals known, or suspected

to be su ering rom, or to be a carrier o , a disease likely to be transmitted tothe milk, should not enter milk handling areas i there is a likelihood o theircontaminating the milk. Medical examination o a milk handler should be carriedout i clinically or epidemiologically indicated.

Hands and orearms (up to elbow) should be washed requently and alwayswashed be ore initiating milking or handling o milk.


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Milking should not be per ormed by persons having exposed abrasions or cuts ontheir hands or orearms. Any injury on hands or orearms must be covered with awater-resistant bandage.

Suitable clothing should be worn during milking and should be clean at thecommencement o each milking period.

3.3 Hand ing, torage and tran port o iTime and temperature control is important during storage and transport o milkand depends highly on the type and e ectiveness o the control measures appliedduring and a ter processing. There ore, the needs or time/temperature controlat arm level should be clearly communicated by the manu acturer o the milkproducts.

3.3.1 mi ing equip entThe design o milking equipment, where used, and cans, should ensure there are nocrevices or recesses that can inter ere with proper cleaning.

Milking equipment should be installed and tested (i applicable) in accordancewith manu acturers instructions and in accordance with any available technicalstandards that have been established by appropriate technical standards settingorganizations or such equipment (e.g., IDF, ISO, 3A) in order to assist in assuringthat the equipment is unctioning properly.

Milking equipment and cans should be cleaned and disin ected regularly and withsu cient requency to minimize or prevent contamination o milk.

There should be a periodic veri cation process to ensure that milking equipment isin good working condition.

Milking equipment and utensils which are intended to come into contact withmilk (e.g., containers, tanks, etc.) should be easy to clean and disin ect, corrosionresistant and not capable o trans erring substances to milk in such quantities as topresent a health risk to the consumer.

Between inspections, milking equipment should be maintained in proper workingcondition.

3.3.2 mi torage equip entMilk storage tanks and cans should be so designed to ensure complete drainage andconstructed to avoid contamination o the milk when it is stored.

Milk storage equipment should be properly installed, maintained and tested inaccordance with manu acturers instructions and in accordance with any availabletechnical standards that have been established by appropriate technical standardssetting organizations or such equipment (e.g., IDF, ISO, 3A) in order to assist inassuring that the equipment is unctioning properly.


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Sur aces o milk storage tanks, cans and associated equipment intended to comeinto contact with milk should be easy to clean and disin ect, corrosion resistantand not capable o trans erring substances to milk in quantities that will present ahealth risk to the consumer.

Milk tanks and cans should not be used to store any harm ul substance that maysubsequently contaminate milk. I milk storage tanks and cans are used to store

oods other than milk, precautions should be taken to prevent any subsequent milkcontamination.

Storage tanks and cans should be cleaned and disin ected regularly and withsu cient requency to minimize or prevent contamination o milk.

Storage tanks or portions o storage tanks that are outdoors should be adequatelyprotected or designed such that they prevent access o insects, rodents and dust inorder to prevent contamination o milk.

There should be a periodic veri cation process to ensure that milk storage equipmentis properly maintained and in good working condition.

Additiona provi ion or the production o i u ed or raw i productMilk tanks and cans can be used only to store milk and milk products.

It is necessary to veri y, at least once a year, that milk storage equipment is maintainedand in good working order.

3.3.3 Pre i e or, and torage o , i and i ing-re ated equip entPremises or the storage o milk should be situated and constructed to avoid risk ocontamination o milk or equipment.

Premises or the storage o milk should have:

suitable milk re rigeration equipment, when appropriate; a su cient supply o water o a suitable quality o or use in milking and in

cleaning o equipment and instruments; protection against vermin; easily cleanable foors, i applicable; and adequate separation between milking areas and any premises where animals are

housed in order to prevent contamination o milk by animals. Where separationis not possible, adequate measures should be taken to ensure that the milk is notcontaminated.

Immediately a ter milking, the milk should be stored in properly designed andmaintained tanks or cans in a clean place.


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Storage temperatures and times should be such that minimizes any detrimentale ect on the sa ety and suitability o milk. The time and temperature conditions ormilk storage at the arm should be established taking into account the e ectivenesso the control system in place during and a ter processing, the hygienic condition othe milk and the intended duration o storage. In situations where the milk cannotbe chilled on the arm, collection and delivery o this milk to a collection centre orprocessing acility within certain time limits may be required. These conditions maybe speci ed in legislation, in Codes o Practice, or by the manu acturer receiving themilk in collaboration with the milk producer and the competent authority.

Additiona provi ion or the production o i u ed or raw i productWhen milk or urther processing is not collected or used within 2 hours a termilking, it shall be cooled:

to a temperature equal to or below 6 C when collected on a daily basis; or to a temperature equal to or below 4 C when not collected every day.

Deviations rom those temperatures may be acceptable i those deviations will notresult in an increased risk o microbiological hazards, have been approved by themanu acturer receiving the milk, have been approved by the competent authority,and the end product will still meet the microbiological criteria established inaccordance with 5.2.3.2.

3.3.4 Co ection, tran port and de ivery procedure and equip ent

3.3.4.1 Co ection, tran port and de ivery procedure Personnel and vehicular access to the place o collection should be adequate

or the suitable hygienic handling o milk. In particular, access to the place ocollection should be clear o manure, silage, etc.

Prior to collection, the milk hauler or collection/chilling centre operator shouldcheck the individual producers milk to ensure that the milk does not presentobvious indications o spoilage and deterioration. I the milk shows indicationso spoilage and deterioration, it should not be collected.

Collection and chilling centres, i employed, should be designed and operated insuch a manner that minimizes or prevents the contamination o milk.

Milk should be collected under hygienic conditions to avoid contamination omilk. In particular, the milk hauler or collection centre operator should, whereappropriate, take samples in such a way to avoid contamination o the milk andshould ensure that the milk has the adequate storage/in-take temperature priorto collection.

The milk hauler should receive adequate training in the hygienic handling o rawmilk.

Milk haulers should wear clean clothing. Milk hauling operations should not be per ormed by persons at risk o trans erring

pathogens to milk. Appropriate medical ollow-up should be done in the case oan in ected worker.


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Milk haulers should per orm their duties in a hygienic manner so that theiractivities will not result in contamination o milk.

The driver should not enter the stables or other places where animals are kept, orplaces where there is manure.

Should driver clothing and ootwear be contaminated with manure, the soiledclothes and ootwear should be changed or cleaned be ore work is continued.

The tanker driver should not enter the processing areas o the dairy plant.Conditions should be arranged to allow necessary communication with thesta o the dairy, delivery o milk samples, dressing, rest breaks, etc. withoutdirect contact taking place with the dairy processing areas or with sta membersinvolved with processing milk and milk products.

Additiona provi ion or the production o i u ed or raw i product

Milk to be used or the manu acture o raw milk products shall be collectedseparately. Mixing, or cross-contamination with milk which does not comply withthe quality (including microbiological) expected or the processing o raw milkproducts shall not be allowed.For example: organize collection pick-ups in such a way that milk for the manufacture of

raw milk products be collected separately; or use milk transport tankers with compartments that will allow the separation

o the milk or raw milk products rom milk to be heat processed combinedwith the pick-up o milk or raw-milk products be ore milk or other products.

3.3.4.2 Co ection, tran port and de ivery equip ent Guidance on the bulk transport o oods is given in the Code o Hygienic Practice

or the Transport o Food in Bulk and Semi-Packed Food (CAC/RCP 47-2001). Milk transport tankers and cans should be designed and constructed such that

they can be e ectively cleaned and disin ected. Milk transport tankers and cans should be designed and constructed to ensure

complete drainage. Milk transport tankers and cans should not be used to transport any harm ul

substance. I milk transport tanks and cans are used to transport oods other thanmilk, precautions such as the implementation o adequate cleaning protocolsshould be taken to prevent any subsequent milk contamination.

Sur aces o milk transport tankers, cans and associated equipment intended tocome into contact with milk should be easy to clean and disin ect, corrosionresistant and not capable o trans erring substances to the milk in such quantitiesas to present a health risk to the consumer.

Milk cans and transport tankers (including the milk discharge area, valves, etc.)should be cleaned and disin ected with su cient requency in order to minimizeor prevent contamination o milk.

A ter disin ection, tankers and cans should be drained. Lorries, trucks or other vehicles which carry the tank or cans should be cleaned

whenever necessary.


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3.3.4.3 Tran port ti e and te perature Transport temperature and time should be such that milk is transported to

the dairy or to the collection/chilling centre in a manner that minimizes anydetrimental e ect on the sa ety and suitability o milk.

The time and temperature conditions or the collection and transport o milkrom the arm should be established taking into account the e ectiveness o the

control system in place during and a ter processing, the hygienic condition o themilk and the intended duration o storage. In situations where the milk cannotbe chilled on the arm, collection and delivery o this milk to a collection centre orprocessing acility within certain time limits may be required. These conditions maybe speci ed in legislation, in Codes o Practice, or by the manu acturer receivingthe milk in collaboration with the milk producer, collector and transporter andthe competent authority.

Additiona provi ion or the production o i u ed or raw i product The temperature o the milk to be used or the manu acture o raw-milk products

shall not exceed 8C, unless the milk has been collected within 2 hours a termilking.

Deviations rom this temperature may be acceptable i these deviations will notresult in an increased risk o microbiological hazards, have been approved by themanu acturer receiving the milk, have been approved by the competent authorityand the end product will still meet the microbiological criteria established inaccordance with 5.2.3.2.

3.4 Docu entation and record eepingWith respect to ood sa ety, records should be kept where necessary on:

Prevention and control o animal diseases with an impact on public health; Identi cation and movement o animals; Regular control o udder health; Use o veterinary drugs and pest control chemicals; Nature and source o eed; Milk storage temperatures; Use o agricultural chemicals; Equipment cleaning.


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ANNEX II

GUIDELINES FOR THE MANAGEMENT OF CONTROL MEASURESDURING AND AFTER PROCESSING

INTRODUCTION AND OBJECTIVEs

The detailed in ormation contained in this annex should be implemented in orderto prevent, eliminate or reduce hazards associated with incoming materials toacceptable levels and to reduce the likelihood o milk contamination resulting rominadequate control o manu acturing operations. This in ormation will enable theimplementation o the principles laid down in Section 5 o the main body o theCode by providing guidelines or their application.

These measures should be used in combination with guidelines on primaryproduction ound in Annex I in order to e ectively control the microbiologicalhazards in milk products. There is a close relationship between the control omanu acturing operations and the sa ety and suitability o processed milk productsbased on the control measures presented in Annex II.

sCOPE

The provisions in this Annex rein orce and supplement the principles and guidelinesspeci ed in Section 5 o the Code (Control o Operation), in particular Section 5.1,and should apply to the manu acture o any milk product. The principles in Section5, Control o Operation, as well as the hazard identi cation provisions o this annexapply not only to the control o microbial hazards but also to the control o chemicaland physical hazards.

The most common microbiological control measures are addressed in urtherdetail in Part A (microbiostatic control measures) and Part B (microbiocidal controlmeasures), respectively. However, this does not preclude in any way the use oadditional and/or alternative microbiological control measures, provided that thegeneral guidance provided in this Annex is ollowed.

UsE OF ANNEX II

The in ormation in Annex II is organized to correspond with the relevant sectionsin the main part o the Code and the General Principles o Food Hygiene (CAC/ RCP 1-1969). Where a particular principle has been identi ed in the main bodyo the Code, guidelines or the application o that principle will be located in thecorresponding section o this part o the Annex.

These guidelines are supplemental to those contained in Section 5 o the General Principles o Food Hygiene (CAC/RCP 1-1969) (including the Hazard Analysis and


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Critical Control Point (HACCP) System and Guidelines or its Application Annex) andto the overarching principles presented in Section 2.3 o the base document.

The guidelines presented in this annex are intended to enhance and supplementthose aspects o the General Principles o Food Hygiene (CAC/RCP 1-1969) HACCPAnnex which are critical to the success ul design o a system o ood sa ety controls.The users o this document are encouraged to implement the guidelines containedin the HACCP Annex when designing a HACCP system and to re er to those Annex IIguidelines or urther details on the hazard analysis, control measure selection andcritical limit determination.

DEFINITIONs

The de nitions below apply or the purpose o this Annex, and in addition to thosede nitions contained in Section 2.5 o the main body o this Code.

Microbiocidal treatments are control measures that substantially reduce or practicallyeliminate the number o micro-organism present in a ood.

Microbiostatic treatments are control measures that minimize or prevent the growtho micro-organisms present in a ood.

Pasteurization is a microbiocidal heat treatment aimed at reducing the number oany pathogenic micro-organisms in milk and liquid milk products, i present, to alevel at which they do not constitute a signi cant health hazard. Pasteurizationconditions are designed to e ectively destroy the organisms Mycobacteriumtuberculosis and Coxiella burnettii .

UHT (ultra-high temperature) treatment o milk and liquid milk products isthe application o heat to a continuously fowing product using such hightemperatures or such time that renders the product commercially sterile at thetime o processing. When the UHT treatment is combined with aseptic packaging,it results in a commercially sterile product. 7

5. CONTROl OF OPERATIONs

5.1 Contro o ood hazardIt is important that control measures are applied during both primary productionand processing to minimize or prevent the microbiological, chemical or physicalcontamination o milk. In addition, special attention should be given during theprocessing o di erent milk products so that inadvertent cross-contaminationdoes not occur, including with respect to ingredients that may contain allergenicsubstances. Note: A distinction can be drawn between the types o control measuresused or microbiological hazards and those used or chemical and physical hazards.

7 The concepts o aseptic packaging and commercially sterile can be ound in the Codex documents on Low Acid and AcidifedCanned Foods (CAC/RCP 23-1979) and Aseptic Processing (CAC/RCP 40-1993).


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The control measures used or chemical and physical hazards in ood are generally preventive in nature, i.e., they ocus on avoiding the contamination o ood withchemical or physical hazards in the rst place rather than on reducing or eliminating

such hazards once they have been introduced into the product. It should be noted however that there are some exceptions to this type o distinction, e.g., the use o

lters, screens and metal detectors to remove certain physical hazards.

Microbiological ood hazards are controlled by appropriate selection o controlmeasures applied during primary production in combination with control measuresapplied during and a ter processing. The result o applying any microbiocidal controlmeasure depends signi cantly on the microbial load (including the concentration omicrobiological hazards) in the material subjected to it. It is there ore important thatpreventive measures are applied in primary production to reduce the initial load opathogenic micro-organisms as well as during processing to avoid contaminationwithin the processing environment. The initial microbial load signi cantly impactsthe per ormance needed or the microbiological control measures applied duringand a ter processing as well as the per ormance required or suitability. The sa etyand suitability o the end product depends not only on the initial microbiologicalload and the e ciency o the process, but also on any post-process growth osurviving organisms and post-process contamination.

Individual control measures should be selected and applied in such combinationas to achieve a su cient per ormance as to result in end products with acceptablelevels o hazards.

Acceptable levels o contaminants in the end product should be identi ed and bebased upon:

Food sa ety objectives, end product criteria and similar regulatory requirements,as applicable;

Acceptable levels derived rom the purchaser constituting the subsequent link othe ood chain; and/or

The maximum levels ound acceptable by the manu acturer, taking intoaccount acceptable levels agreed with the customer and/or regulatory measuresestablished by public health authorities.

The guidelines contained in sections 5.1.1 to 5.1.3 are intended to be supplementalto the General Principles o Food Hygiene (CAC/RCP 1-1969) HACCP Annex.

5.1.1 Hazard identi ca

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Code of Hygienic Practice for Milk and Milk Products

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