QUALITY CONTROL MANAGEMENT SYSTEM IN DAIRY PRODUCE IN INDIA

November 27, 2023

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QUALITY CONTROL MANAGEMENT SYSTEM IN DAIRY PRODUCE IN INDIA

In India food safety generally has always been an important issue. Incidents of food safety hazards have been recurring. It, therefore, became an issue of high concern in the country in the last decade. Indeed, producing safe food is now not a matter of choice, it is a necessity. This is mainly due to greater awareness of safety concerns, emerging risks and challenges in the area of food safety and the globalisation of the food trade, as a result of liberalised trade policies advocated in WTO agreements.

With the recognition of the importance of producing safe food, the 16th World Health Assembly established in May 1963 the Joint Food and Agriculture Organization (FAO)/WHO Food Standards Programme, and requested the Codex Alimentarius Commission to implement it, which included Food Codes. In view of the serious food safety concerns, the 53^rd World Health Assembly (May 2000) advised WHO to develop a global strategy for reducing the burden of food-borne diseases.

The global trade of most commodities, including agricultural products, follows the rules of various World Trade Organization (WTO) agreements. For agricultural products, including dairy products, the three most pertinent agreements are: Agreement on Agriculture (AoA), Sanitary and Phyto-sanitary (SPS).

Agreement, and Agreement on Technical Barrier to Trade (TBT). Some salient features of these agreements are: the SPS and TBT Agreements state that Codex standards, guidelines and code of practices for producing safe food would be used in international trade as reference points; national standards should be harmonised with international ones; and, quantitative restriction on imports should be eliminated. It, therefore, becomes imperative that, in the free market regime, Indian dairy products compete not only with major trading countries in the global market, but with the imported, largely subsidised, products in the domestic market as well. While the first is tough, the other is not easy either. The domestic dairy industry needs to be competitive in, besides price, product safety and quality. It is, therefore, essential that India continues strengthening its national food safety control systems and programmes, since food safety and quality is not one time task, it is a continuing process. . The government set up the Food Safety and Standards Authority of India (FSSAI) in 2007 under the Food Safety and Standards Act 2006 to address these requirements.

Importance of Chemical Quality Control In Dairy Industry

Milk is a highly perishable commodity. This perishable character of milk makes the life tough for the milk handlers, especially in the absence of proper infrastructure of cooling and erratic power supply. Since, dairy animals are fed on agricultural byproducts and crop residues, therefore the contaminant present in the animal get secreted along with milk in the form of pesticide and veterinary drug residues. These contaminants not only affect the health of the consumers, but also the quality of the products especially fermented products. Moreover, some of the unscrupulous persons involved in this trade are further tarnishing the image of Indian dairy industry by adulterating milk with various chemicals, which are injurious to health. In the wake of all these facts, quality control of milk assumes very high importance and priority. The chemical quality control in dairy industry will enable the industry in the following ways:

The strict quality control both chemical and microbiological will deter the adulteration of milk and will improve the quality of raw milk.
The improvement of the raw milk quality through regular checks can improve the quality of the milk products prepared from such milk.
It will install the confidence in national consumers, who are drifting away from the indigenous milk products.
It will also increase the export potential of Indian milk products, and finally the National image with reference to Indian milk quality.
The strict quality control will also increase the revenue of a dairy producer.

Indian dairy products have to compete not only globally but with the imported products in the domestic market as well. The domestic dairy industry needs to be competitive in, besides price, product safety and quality. Producing safe food is now not a matter of choice, it is a necessity. It is therefore imperative that India continues strengthening its national food safety control systems and programmes, since it is not one time job, it’s a continuing process. The dairy industry, too, needs to make more concerted efforts to achieve the international food safety and quality standards. In fact safe and quality product is plain and simply ‘Good Management’. It is amazing how close to perfection you can get, if you are willing to try.

INTER-GOVERNMENTAL ORGANISATIONS

World Health Organization (WHO)

WHO’s role in food safety is to reduce the burden of food-borne disease by advising and assisting member countries to reduce exposure to unacceptable levels of microorganisms or chemicals in food. Its work includes international standard setting. WHO also provides technical assistance to governments to ensure supply of safe food to their people. Many WHO activities in food safety and quality are carried out in close collaboration with FAO. These agencies have developed several technical papers on aspects related to food safety and quality assurance.

Further, FAO and WHO jointly undertake to conduct risk assessment activities through their permanent Committees/Groups, namely the Joint FAO/WHO Expert Committee on Food Additives and Contamination (JECFA), the Joint FAO/WHO Meeting on Pesticide Residues (JMPR) and the Joint FAO/WHO Meeting on Microbiological Risk Assessment (JEMRA), and other expert consultations. The results and recommendations of these consultations are communicated to their member governments, as well as other interested parties, through published reports and websites.

Codex Alimentarius Commission (CAC)

It was established by the FAO Conference in 1961 (the Latin words Codex Alimentarius mean ‘food code’ or ‘food law’). In 1963, the World Health Assembly delegated it the responsibility of implementing the Joint FAO/WHO Food Standards Programme (Understanding the Codex Alimentarius, FAO and WHO, 1999). The primary objectives of the programme are to protect the health of consumers and ensure fair practice in food trade. CAC, with 186 members — 185 member countries and one member organisation (EU) — has elaborated a number of food standards, guidelines and recommendations with the assistance of its subsidiary committees. The work of these committees is supported by JECFA, JMPR, JEMRA and other Joint FAO/WHO expert consultations.

World Trade Organization (WTO)

The Uruguay Round Agreement (the Marrakesh Agreement), concluded in April 1994, resulted in the establishment of WTO in January 1995, from which date the Agreement also became effective. It includes a number of multilateral agreements to which all members of the WTO are committed to apply in international trade. The WTO has 160 member countries. With respect to food safety and quality matters, the SPS and TBT Agreements are important. The SPS Agreement covers health-related aspects of food, such as food additives, levels of contaminants, codes of hygienic practices and packaging materials in contact with food. These should be based on risk assessment. The TBT Agreement covers technical standards of food, such as product description, labelling, nutrition, method of analysis and package specifications.

GLOBAL APPROACH

The guidelines for quality and safety requirements are set by the SPS and TBT Agreements, and Codex for global food trade. Their approach for food safety and quality is based on the following basic principles:

Science-based standards

Codex standards are based on risk assessment carried out at the international level by JECFA, JMPR, JEMRA and other Joint FAO/WHO expert consultations, taking into account global data. Codex recommends that national standards, too, should be based on risk assessments.

Precautionary measures

There could be instances when there is evidence of a risk to human health but scientific data are insufficient. In such cases, Codex would not elaborate a standard, but would consider to elaborate a related text, such as a code of practice, supported by the available scientific evidence. Codex has not so far suggested what governments should do in such cases.

Consensus

All Codex decisions are taken by consensus of the participating member countries in the meetings of CAC and its subsidiary bodies. This makes Codex standards acceptable to most governments, ensuring wider application.

Farm-to-table approach

The concept of merely sampling and analysing the final product is considered inadequate to ensure producing safe food for the consumer. Codex advocates introduction of preventive measures at all stages of the food production and distribution chain.

Food safety and quality assurance system elements

International inter-governmental organisations have been evolving approaches with shared responsibilities for governments, industry and consumer to ensure safe and quality food (Figure 1). The approach aims that the end food product should be entirely safe and of high quality.

Specific safety and quality standards: In its FSQA system, Codex specifies maximum permissible residue limits of important chemical contaminants in food; high microbiological quality; important quality attributes; maximum limits of use of additives, and labelling and packaging requirements.

Minimising contaminants: An important aspect of Codex standards is specification of maximum permissible limits for residues of several toxic chemical contaminants (Tables 2 to 6).

Another important aspect of Codex standards is the emphasis on high microbiological quality of milk and milk products. Although Codex has not specified any microbiological standards for raw milk or products so far, it has provided guidelines through its document Principles for the establishment and application of microbiological criteria for foods to establish microbiological criteria in raw materials, ingredients and end-products. Several countries have specified microbiological quality of raw milk.

Figure 1: Shared responsibility—safe food for all.

There is a strong global opinion for a more exact approach for microbiological safety management to achieve the Appropriate Level of Protection suggested in the SPS Agreement. Thus, the concepts of Food Safety Objective (FSO), Performance Objective (PO) and Performance Criteria in the food safety management have been accepted by Codex. This means setting microbiological standards for identified pathogens in the end product at consumer level (FSO) and at the intermediate stages of the food chain (POs).

Limits for use of food additives: Codex has evaluated more than a thousand food additives and specified maximum level for use of these additives considered health risk if they exceed the permissible levels.

Product quality attributes: Codex has elaborated standards for major milk products. Quality factors specified mostly include specifications of raw materials and permitted ingredients, brief process description and product composition.

Labelling requirements: General labelling requirements for all foods have been elaborated in the Codex General Standard for the Labelling of Prepackaged Foods. Any specific requirements are provided in the individual product standard itself.

Methods of analysis: Codex has recommended methods of sampling and analysis for important contaminants and product constituents.

Practices and guidelines to achieve standards

It is always prudent to prepare and prevent rather than repair and repent. Thus, Codex has several codes of practices/guidelines for reduction and control of contaminants. These codes recommend maintaining records at all stages, including at primary production level (example for animal diseases, drugs used, pesticides used). Not only that, the global approach includes in the food ‘chain’ all the ‘links’ that provide inputs to the production of food (Figure 2). In this direction, Codex has elaborated several codes of practices/guidelines.

Further, Codex advocates that the raw milk should be produced in a way that minimizes bacterial count, growth and contamination, and therefore suitable preventive measures should be taken during the entire milk chain. To achieve this, Codex recommends the application of its Recommended International Code of Practice: General Principles of Food Hygiene and its extension Code, specific to dairy sector, Code of Hygienic Practice for Milk and Milk Products. The Hygiene Code includes the guidelines for the application of the Hazard Analysis and Critical Control Point (HACCP) system. There are other related codes.

Figure 2: Principal stages of the milk chain

Another important recommendation is on traceability. There is a strong global view that governments, along with the food industry, should have an effective traceability system in place, so that in case of detection of unsafe food in the market, or any outbreak of food-borne disease, the unsafe food can be recalled from the market and the source of the trouble could be traced. This would help in taking corrective actions to ensure that such incidents do not recur.

Implementation procedure

The inter-governmental organisations have recommended actions to be taken by the member countries to ensure that the food produced and provided to consumer is safe. One such recommendation is on harmonisation of national standards and practices with those of Codex. SPS and TBT Agreements also recommend such harmonisation.

FAO provides technical assistance-assessment of existing national food control programmes; assistance in establishing food legislation; training on good manufacturing practices, HACCP, food inspection and quality assurance, food export and import inspection and certification systems, food analysis, laboratory management and quality assurance systems- to countries, especially the least-developed countries, who lack resources, capacity and technical expertise to face challenges associated with the international requirements.

Table 2. Standards for Contaminants in Milk and Milk Products in Codex and Indian Food Laws—Maximum residue limits (MRLs) for pesticides.

*Pesticide*	*MRL in milk mg/kg, (mg/kg=ppm)*
	*Codex*		*FSS(C,T & R)R*
	*Limit*	*Remark*	*Limit*	*Remark*
2, 4- D	0.01		0.05	MMP
Abamectin	0.005, Cattle & goat milk
Acephate	0.02
Aldicarb	0.01	*
Aldrin and dieldrin	0.006	F	0.15	FAT BASIS, MMP
Aminopyraid	0.02
Amitraz	0.01	V, *
Azoxystrobin	0.01, milk 0.03, milk fats
Benomyl			0.1	FAT BASIS, MMP
Bentazone	0.05	*
Bifenthrin	0.2, milk 3, milk fat	*
Bitertanol	0.05	*
Boccalid	0.1
Buprafezin	0.01
Carbaryl	0.05
Carbendazim	0.05		0.10	FAT BASIS, MMP
Carbofuran			0.05	FAT BASIS, MMP
Chlorantraniliprola	0.05, milk 0.2, milk fats	*
Chlordane	0.002	F	0.05	FAT BASIS, MMP
Chlorfenvinphos			0.2	FAT BASIS, MMP
Chlormeqaut	0.5, Cattle, goat & sheep milk
Chlorothalonil	0.07, milk
Chlorpropham	0.01, milk 0.02, milk fats	* *
Chlorpyrifos	0.02, Cattle, goat & sheep milk		0.01	FAT BASIS, MMP
Chlorpyrifos-methyl	0.01, milk 0.01, milk fats	* *
Clethodim	0.05	*
Clofentezine	0.05	*
Clothianidin	0.02
Cyfluthrin & beta- cyfluthrin	0.04C	F
Cyhalothrin (including lambda-cyhalothrin)	0.2
Cypermethrin	0.05 (including alpha- & zeta- Cypermethrin), milk 0.5 (including alpha- & zeta-Cypermethrin), milk fats		0.01	FAT BASIS, MMP Sum of isomers
Cyproconazole	0.01, milk
Cyprodinil	0.0004	*
Cyromazine	0.01
DDT	0.02	F	1.25	FAT BASIS, MMP
Deltamethrin	0.05	F
Diazinon	0.02	F, V
Dicamba	0.2, milk
Dichlorvos	0.01	*
Difenoconazole	0.005	*
Diflubenzuron	0.02	F, *
Dimethenamid-P	0.01	*
Dimethoate	0.05, Cattle, goat & sheep milk	*
Dimethomorph	0.01	*
Dimethipin	0.01	*
Dinotefuran	0.1
Diphenylamine	0.01, milk 0.01, milk fats	*
Diquat	0.01	*
Disulfoton	0.01, Cattle, goat & sheep milk
Dithiocarbamate	0.05	*
Edifenfos			0.01	FAT BASIS, MMP
Emamectin benzoate	0.002
Endosulfan	0.01, milk 0.1, milk fats	F
Ethephon	0.05, Cattle, goat & sheep milk	*
Ethoprophos	0.01	*
Ethion			0.5	FAT BASIS, MMP
Etofenprox	0.02
Etoxazole	0.01	*
Famoxadone	0.03	F
Fenamiphos	0.005	*
Fenbuconazole	0.01, milk	*
Fenbutatin oxide	0.05	*
Fenhexamid	0.01	F, *
Fenitrothion	0.01	*	0.05	FAT BASIS, MMP
Fenpropathrin	0.10, Cattle milk	F
Fenpropimorph	0.01
Fenpyroximate	0.005, Cattle milk	F, *
Fenthion			0.05	FAT BASIS, MMP
Fenvalerate	0.10	F	0.01	FAT BASIS, MMP
Fipronil	0.02, Cattle milk
Flubendiamide	0.1, milk 5, milk fats
Fludioxinil	0.01
Flumethrin	0.05, Cattle milk	F, V
Flupicolide	0.02
Flupyram	0.3
Fluxapyroxad	0.02, milks 0.5, milk fat
Flusilazole	0.05	F
Flutolanil	0.05	*
Glyphosate	0.05	*
Glufosinate ammonium	0.02	*
Haloxyfop	0.3, milk 7, milk fats
Heptachlor	0.006	F	0.15	FAT BASIS, MMP
Hexachlorocylohexane (HCH) (alpha)			0.05
Hexachlorocylohexane (beta)			0.02
Hexachlorocylohexane (gamma i.e. lindane)	0.01	*	0.01
Hexachlorocylohexane (gamma i.e. lindane)			0.20 0.20	FAT BASIS, MP Milk products with less than 2% fat
Hexachlorocylohexane (delta)			0.02
Hexythiazox	0.05, milk 0.05, milk fat
Imidacloprid	0.1
Indoxacarb	0.1, milks 2, milk fats
Isopyrazam	0.01, milk 0.02, milk fats
Kresoxim-methyl	0.01	*
MCPA	0.04
Metaflumizone	0.01, milk 0.02, milk fats	*
Methamidophos	0.02	*
Methidathion	0.001
Methomyl	0.02	*
Methoprene	0.1	F
Methoxyfenozide	0.05
Monocrotophos			0.02	MMP
Myclobutanil	0.01, Cattle milk	*
Novaluron	0.4, milk 7, milk fats
Oxamyl	0.02	*
Oxydemeton-methyl	0.01	*
Paraquat	0.005	*	0.01
Penconazole	0.01, Cattle milk	*
Permethrin	0.10	F
Phenthoate			0.01	FAT BASIS, MMP
Phorate	0.01	*	0.05	FAT BASIS, MMP
Phosmet	0.02
Piperonyl butoxide	0.20, Cattle milk	F
Piperonyl butoxide	0.05, Milk excl. cattle milk	F
Pirimicarb	0.01	*
Pirimiphos-methyl	0.01		0.05	FAT BASIS, MMP
Prochloraz	0.05	*
Profenofos	0.01	*
Propamocarb	0.01	*
Propargite	0.10	F, *
Propiconazole	0.01	*
Prothioconazole	0.004	*
Pyraclostrobin	0.03
Pyrimethanil	0.01
Quinoxyfen	0.01, milk 0.2, milk fats
Saflufenacil	0.01
Sedaxane	0.01, milks 0.01, milk fats
Spinetoram	0.01, milk 0.1, milk fats	*
Spinosad	1, cattle milk 5, cattle milk fat	V
Spirodiclofen	0.004	*
Spirotetramate	0.005	*
Sulfoxaflor	0.2
Tebuconazole	0.01	*
Tebufenozide	0.01, milks except cattle milk 0.05, cattle milk	*
Terbufos	0.01	*
Thiabendazole	0.2, Cattle milk
Thiacloprid	0.05
Thiamethoxam	0.05
Triadimefon	0.01	*
Triadimenol	0.01	*
Trichlorfon			0.05
Trifloxystrobin	0.02	*

Note: Blank cells indicate that limit does not exist.

* = at or about the limit of determination

F = residue is fat soluble^a

V = MRL accommodates veterinary uses

MMP = for milk and milk products

MP = for milk products

(^aFor a milk product with a fat content less than 2%, the MRLs applied should be half those specified in milk. The MRL for the milk products with a fat content of 2% or more should be 25 times the maximum residue limit specified for milk, expressed on a fat basis.)

NATIONAL FOOD SAFETY AND QUALITY ASSURANCE SYSTEMS

In India, there are systems in place to ensure production, import and export of quality and safe food. In the last few years the systems have been improved. These, however, need to be further strengthened and continuously monitored for effectiveness.

Regulatory systems in place for dairy industry

Food standards: The Food Safety and Standards Authority of India (FSSAI) has been established under Food Safety and Standards Act, 2006 which consolidates various acts and orders on food related issues that were earlier handled by various Ministries and Departments. FSSAI has been created for laying down science-based standards for articles of food and to regulate their manufacture, storage, distribution, sale and import to ensure availability of safe and wholesome food for human consumption.

The Indian Food Laws include various Food Safety & Standards Rules and Regulations, such as FSS Rules 2011, FSS Regulations 2011, FSS (Food Products Standards & Additives) Regulations 2011, FSS (Contaminants, Toxins & Residues) Regulation 2011 and FSS (Licensing & Registration of Food Businesses) Regulations 2011. These standards are mandatory and prescribe minimum compositional standards and various other provisions to make food safe. They also specify maximum levels for several chemical contaminants (Tables 2 to 6). The Scientific Committees and Scientific Panels of the FSSAI, on different technical areas, recommend food standards.

The FSS (Licensing & Regulation of Food Businesses) Regulations 2011 specifies the mandatory hygiene and sanitary practices to be followed by all food business operators. The Regulations (Part III of Schedule 4) also lays down specific requirement of hygiene and sanitary practices to be followed by milk and milk products business operators for their manufacture, processing, storage and selling.

The FSSAI has been quite serious and active in addressing areas of concerns related to food safety and standards, which were paid indifferent attention before the Authority was established. These include microbiological standards for milk products, guidelines for minimising contamination, monitoring of contaminants in foods, sampling methodology and methods of analysis, monitoring and implementing system, and laboratory infrastructure facilities. Action to harmonize contaminants standards with those of Codex, where desirable, has already been initiated. The FSSAI needs to continue working steadfastly on improving the above mentioned areas. It may, however, be conceded that since the problems were aplenty, their solutions will take some time to yield positive results. A very critical need yet is to implement Food Laws effectively.

Another important Food Law related to quality is Agricultural Produce (Grading and Marking) Act 1937 (as amended in 1986). Better known as ‘Agmark’, the Act includes ghee, butter and fat spread among dairy products for grading under the scheme.

For infant foods, the governing Act is Infant Milk Substitute, Feeding Bottles and Infant Foods (Regulation of production, supply and distribution) Act 1992 & Rules, 1993. An important provision of these Rules is that infant foods and feeding bottles cannot be advertised.

The Bureau of Indian Standards (BIS) has formulated and revised standards and guidelines for various dairy products and processes. BIS standards are in general voluntary.

The specific requirements to be complied by food plants for exports are provided in the Export (Quality Control and Inspection) Act, 1963. Registration of food manufacturing plants with the Export Inspection Council of India (EICI) has been made mandatory for undertaking exports. Around 50 dairy plants have been accorded registration under the Act by EICI. There are however cases of rejection of our products by the importers. There is therefore a need to strengthen the monitoring system and implementation of the rules.

Likewise, provisions of the Livestock Importation Act 1898, amended 1953, are to be complied with while importing livestock products. To prevent entry of any diseases through import of livestock and livestock products, four Animal Quarantine and Certification Stations (AQCSs) have been functioning for quarantine, health check and certification of animals for export/import. However, the operation of the system needs improvement, as several exotic diseases enter into the country from time to time. It is also mandatory to obtain an import permit from the Ministry of Agriculture before importing some livestock products that include milk and milk products also. Cases however have been reported of imports of sub-standard products. Therefore, the system needs to be made more effective.

In India, some safety aspects related to genetically modified (GM) foods are covered under the Environmental Protection Act. The Genetic Engineering Approval Committee and the Review Committee on Genetic Manipulation are the agencies to examine and approve matters related to GM foods. Another legislation is Atomic Energy (Control of Irradiation of Food) Rules, 1996, which regulates the production of irradiated foods.

While we have these food legislations, the important issues of risk assessment, risk monitoring and risk management of foods are not being fully and effectively addressed by the regulatory agencies and the industry. Reports of food poisoning and adulteration of milk and milk products are not scarce. Therefore, there is a need to set up or upgrade the mechanism to address these issues effectively in a unified manner.

Testing facilities

There are noticeable analytical facilities in the country, which have improved over the years. FSSAI, Bureau of Indian Standards, Directorate of Marketing and Inspection (Agmark), Council of Scientific and Industrial Research and Export Inspection Council of India have several well-equipped food laboratories. Agricultural and Processed Food Products Export Development Authority (APEDA) has recognised several laboratories in private sector. Additionally, research institutions have their own facilities. Considering the large size of the country and the requirement, the existing facilities need to be augmented. Moreover, there is inadequacy of skilled and trained manpower manning these laboratories. FSSAI has plans to up-grade the existing laboratories and set up new ones.

Harmonisation of national standards with Codex standards

The FSSAI is in the process of harmonisation of national food standards with those of Codex to the extent possible and in due course of time we may have many of our safety and quality standards for dairy products at par with Codex standards. Many Indian standards have already been harmonised. While this is likely to have positive effect, it is important that caution is exercised and required facilities are created to achieve the standards.

Table 3: Maximum residue limits (MRLs) for veterinary drugs.

*Veterinary Drug*	*MRL in milk, mg/kg (mg/kg = ppb)*
*Veterinary Drug*	*Codex*	*FSS(C,T & R)R*
Albendazole	100
Amoxicillin	4, cattle & sheep milk
Benzylpenicillin	4, cattle milk
Ceftiofur	100, cattle milk
Chlortetracycline	100, cattle & sheep milk
Clenbuterol	0.05, cattle milk
Colistin	50, cattle & sheep milk
Cyfluthrin	40, cattle milk
Cyhalothrin	30, cattle milk
Cypermethrin & alpha-cypermethrin	100, cattle milk
Deltamethrin	30
Dexamethasone (Glucocorticosteroid)	0.3, cattle milk
Dihydrostreptomycin	200, cattle & sheep milk
Diminazene	150, cattle milk
Doramectin	15, cattle milk
Eprinomectin	20, cattle milk
Febantel	100, cattle & sheep milk
Fenbendazole	Included in Febantel
Gentamicin	200, cattle milk
Imidocarb	50, cattle milk
Isometamidium	100, cattle milk
Ivermectin	10, cattle milk
Lincomycin	150, cattle milk
Monensin	2, cattle milk
Metrifonate	Included in Febantal
Neomycin	1500, cattle milk
Oxfendazole	Included in Febantel
Oxytetracycline	Included in Chlortetracycline
Pirlimycin	200*, cattle milk
Procaine benzylpenicillin	Included in Benzylpenicillin
Spectinomycin	200, cattle milk
Spiramycin	200, cattle milk
Streptomycin	Included in Dihydrostreptomycin
Sulfadimidine	25, cattle milk
Tetracycline	Included in Chlortetracycline
Thiabendazole	100, cattle & goat milk
Trichlorfon	50, cattle milk	FSS C,T & R) R – as pesticide
Tylosin	100, cattle milk

Note: Blank cells indicate that limit does not exist.

*Countries may adapt national/regional MRLs for trade of fresh liquid milk intended for processing using starter culture.

ASSURANCE PROGRAMMES IN PLACE

Animal health

An important factor in producing safe milk and milk products is good animal health. The SPS Agreement includes a provision that the areas from where the export is being effected are pest– and disease-free, or are of low prevalence of pest and disease.

In India, animal health care service is being provided by the government as well as by the industry. One of the major thrusts of the government has been on animal health with special emphasis on creation of disease free zones and control of Foot and Mouth Disease. There is a vast network of state-run 33,846 veterinary polyclinics/hospitals and dispensaries as well as 27,050 veterinary aid centres including stockmen centres and mobile dispensaries (as on April 2014). These are supported by about 250 diagnostic laboratories in the states in addition to one Central and 5 Regional Disease Diagnostic Laboratories to provide good animal health care service. Further, almost all the animal vaccines required are produced in India. There have been several government programmes to control animal disease. The whole country is at present officially free from rinderpest according to the Office Internationale des Epizooties (OIE).

The dairy industry is also providing animal health services. Most dairy cooperatives provide such services, regular and/or on call, to their member producers. Many large private dairy plants too have adopted this system. However, most of the producers supplying milk to the private dairy plants are required to make their own arrangement for animal health care, as is the case with other producers.

The primary emphasis of veterinary service is presently on clinical services (provided at subsidised rate in case of government). As a result, endemic diseases, such as Foot-and-Mouth Disease (FMD) and Brucellosis are still prevalent due to inadequate disease prevention programmes.

Hygiene control

Another important requirement for production of quality and safe milk and milk products is that good hygienic practices (GHP) are followed throughout the milk chain. An important law in this respect is the FSS (Licensing & Regulation of Food Businesses) Regulations 2011, which specifies in its Schedule 4 the hygiene and sanitary practices to be followed by all food business operators. Additionally, the Part III of the Schedule also lays down specific requirement of hygiene and sanitary practices to be followed in the production and processing of milk and milk products manufactured in a dairy establishment.

In primary milk production and handling in India, the principles of GHP are generally employed ‘liberally’ rather than ‘religiously’. In the organised sector, a large proportion of milk collected is still unchilled. The proportion of bulk chilled milk collected is still small at present, but is increasing. Since distances are generally long, chilled milk will have superior bacteriological quality. In the non-organised sector, almost the entire milk is unchilled when it is supplied to the buyer. All these result in most milk being received at plants with a high bacterial content.

With the above objective, the National Dairy Development Board (NDDB) had, until recently, spearheaded its drive of ‘clean milk production’ in cooperatives, mostly in Operation Flood areas. Where feasible, milk collection centres were also equipped with chilling facilities. Similarly, introduced in the Tenth Five Year Plan, the Central Government continued in Eleventh Plan with the ‘Strengthening infrastructure for quality and clean milk production’ scheme with expanded scope. The scheme was implemented through the district level cooperative milk unions/state level cooperative milk federations.

In February 2012, the Central Government approved National Dairy Plan Phase-I (NDP-I) with a total investment of about `22,420 million to be implemented from 2011-12 to 2016-17 (now extended to 2018-19). The NDP-1 was launched in March 2012. A glaring and unfortunate omission in NDP-I is the important component of product safety and quality assurance. It is hoped that this is compensated in the second phase.

While the requirement is not small, it has been there for a long time when ample opportunity was presented to employ measures to produce milk of global quality. The progress made, however, does not warrant applause. Presently there is no legislation on quality for primary production of milk probably because its enforcement in the large number of villages, where most of milk is produced, spread over the vast country would be very difficult. But FSSAI has provided the necessary guidelines to produce quality milk. It is earnestly required for the dairy industry to commit itself seriously for improvement and to help producers and milk collection centres to produce quality milk. Without this progress would remain abominably slow.

A major hurdle in ensuring quality milk production and handling at village level still is poor infra-structural facilities, like road, water and electricity in most villages. Sanitary conditions in villages too are not very satisfactory. Many villages still do not have adequate potable water facility. There has been some improvement in the last decade, but a lot needs to be done to improve these basic facilities. Although the concerned government ministries are implementing programmes to improve the required infrastructure, the progress is slow. The work has to be done zealously and fast: like a mission with committed timelines.

Minimising chemical contamination

There have been scattered reports of levels of specific contaminants being higher than permissible in milk and milk products. The monitoring of contaminant levels is however inadequate. To control the contaminant level in milk preventive measures are more effective, and require fewer resources in the long run. Codex has suggested measures to control several contaminants. These measures are required to be introduced and enforced by the government and the industry.

Some contaminants need long-drawn, multi-department plans. For example, lead comes into milk through air, soil (feed and fodder) and water. Legal standards for the discharge of liquid effluent and gaseous-emission from industry, which could include high levels of lead, have been laid down, but their implementation is rather ineffective. In order to reduce the lead contamination of environment through vehicular exhaust, the petroleum industry in India has been providing only unleaded petrol in the market with effect from February 1, 2000. However, since it takes over 10 years after the leaded petrol ban to effect up to a three-fold reduction in lead in food, the positive effects of petroleum industry’s measures in terms of reduced concentration of contaminants in milk should be manifest now.

Quality assurance in processing plants

The FSS (Licensing & Regulation of Food Businesses) Regulations 2011 specifies the basic, compulsory requirements for food business operators for ensuring safety of the food manufactured in any premise with a provision that they shall continuously try to improve the sanitary and hygienic conditions at the premises with a goal of attaining HACCP (Hazard Analysis and Critical Control Points) standards within a previously determined period.

Five years back, only about 14% of the registered dairy plants had HACCP/ISO certification. Observing this disappointing scenario, the Ministry of Health had then implemented a programme ‘Food safety management through GHP, GMP and HACCP’ to sensitize the food industry. This motivated many dairy establishments to prepare for HACCP certification. The dairy industry needs to make more concerted efforts to achieve the international food safety and quality standards, and should implement Codex/FSSAI recommended approaches and practices. Indeed, if progress is only ever blocked for one reason, it is the belief that what one is doing at the moment cannot be improved upon. In fact safe and quality product is plain and simply ‘Good Management’. It is amazing how close to perfection you can get, if you are willing to try. The primary element needed is industry’s firm resolve and sincere commitment.

Table 4: Maximum level (ML) for aflatoxin.

*Toxin*	*ML in milk, mg/kg (mg/kg = ppb)*
*Toxin*	*Codex*	*FSS(C,T & R)R*
Aflatoxin M₁	0.5	0.5

Table 5: Maximum level (ML) for toxic metals.

*Metal*	*ML in milk, mg/kg (mg/kg=ppm)*
*Metal*	*Codex*	*FSS(C,T & R)R*
Arsenic		0.1, milk 1.1, milk products 0.05, infant milk substitutes & infant foods 0.5, ice-cream, ice lollies & similar frozen confections
Cadmium		1.5* 0.1, infant milk substitutes & infant foods
Copper		30* 15 but not less 2.8, infant milk substitutes & infant foods
Lead	0.02**	2.5* 0.2, infant milk substitutes & infant foods 1.0, ice-cream, ice lollies & similar frozen confections
Mercury		1*
Methyl-mercury		0.25*
Tin	150, canned milk beverages 250, canned milk products other than canned milk beverages	250* 5, infant milk substitutes & infant foods
Zinc		50* 50 but not less than 25, infant milk substitutes & infant foods

* Applies for milk products also.

** Concentration factor applies for partially and wholly dehydrated milk. Applies also to secondary milk products and ready to use infant formulae.

Table 6: Maximum level (ML) for melamine

Contaminant

ML, mg/kg (mg/kg = ppm)

Codex

FSS(C,T&R)R

Melamine

1, Powdered infant formula

2.5*, Milk and milk products other than infant formula

0.15, Liquid infant formula (ready to consume)

* The maximum level does not apply to food for which it can be proven that the level of melamine higher than 2.5 mg/kg is the consequence of

authorised use of cyromazine as insecticide. The melamine level shall not exceed the level of cyromazine
migration from food contact materials taking account of any nationally authorised migration limit.

ACTIONS TO BE TAKEN

It is seen that India now has food safety and quality assurance system in place in great measure. But it is not adequate and as effective as to be comparable with an international system. Several gaps need to be bridged as indicated earlier. The food safety and quality assurance system is required to be suitably upgraded to a comprehensive, robust system that also incorporates in itself the element of food safety based on risk analysis.

An effective food regulatory system is needed to protect the consumers from unsafe, low quality, adulterated, misbranded or contaminated foods. This is necessary to protect the health of the nation and to participate in international trade in food products. Trade is an important stimulus to a country’s economic development, and in the current global economy, it is not possible for any one country to remain isolated from changing demands of international requirements for food safety and quality regulations. An effective food regulatory system would include for FSSAI to take the following set of actions periodically and regularly:

Assess food safety infrastructure and problems

A systematic assessment of all factors that may be relevant to food safety at each stage of food chain should be done. Data would be required in the following areas:

Government organisations related to food safety
Food production and consumption
Food imports and exports
Food legislation
Epidemiological information
Human resources and training requirements
Extension and advisory services
Public education and participation

For type of information to be collected, WHO publication on the Evaluation of Programmes to Ensure Food Safety: Guiding Principles (Geneva, 1989) provides useful details.

Prepare National Food Safety and Quality Programme

This will involve setting objectives and goals for development of the National Food Safety and Quality Programme and will include:

Formulation of a National Food Safety & Quality Policy and National Plan of Action.
Developing and upgrading food legislation as also stimulating the existing one — Food standards with respect to microbiological and chemical contaminants and for foods derived from biotechnological methods are required to be set up or reviewed, as appropriate. Guidelines for producing safe food are required to be prepared or reviewed. Where appropriate harmonisation with Codex standards to be considered.
Strengthening food control systems: Facilities for analysis of agents in food identified as health hazard to be created or augmented suitably. The Food Control System should provide for regular testing of food products produced domestically or imported, and provide measures to deal with safety emergencies, analysing them and taking corrective measures to prevent their recurrence. It should also provide for penalty proportionate to the extent and type of breaches.
Promotion of voluntary management systems for food safety assurance.
Education of food-handlers in food safety matters commensurate with their work activity.
Research and data collection.

Implementation of National Food Safety Programme

This will involve identifying time-bound activities that must be completed to achieve the above objectives, identifying resources that are available to support activities, setting intermediate targets or milestones to monitor progress, identifying factors that may have positive or negative influence on the outcome of planned activities and setting a management review process in motion to evaluate the activities that are being undertaken. In addition, major activities will include:

Formation of a Food Safety Committee;
Consultation process involving all government departments concerned with food safety, food control, and public health functions and responsibilities; all organisations involved in the food chain and consumer groups and trade associations; and,
Collaboration and consultation with research institutes and academic bodies.

Evaluation of food safety activities

This should take into account the effectiveness, impact, efficiency, progress, adequacy and relevance of the food safety programme and must be done from the planning stage through to implementation and monitoring.

The FSSAI needs to regularly and closely coordinate with the various relevant government agencies like Department of Animal Husbandry, Dairying and Fisheries, Ministry of Agriculture; central and states Pollution Control Boards etc., the industry and the consumer to ensure the success of the above system. The dairy industry on its part needs to become efficient and safe and quality product-oriented earnestly by following Codex/FSSAI standards and practices. Production of safe and quality food needs genuine efforts, it is not automatic. Indeed, safe and quality food happens when you care enough to do your best.

QUALITY CONTROL MANAGEMENT SYSTEM IN DAIRY

Quality Aspects of Milk and Milk Products

The Export of Milk and Milk Products (Quality Control, Inspection and Monitoring) Rules, 2020