Dairy Science & Technology · Quality, Regulation & Dairy Business · also Dairy Legislation, Food Laws and Standards
The standards and laws that define dairy products and govern their production and trade in major jurisdictions.
In the exams: ICAR AICE subject 34 Unit 9 and subject 35b Unit 3; ICAR AIEEA-PG group 16 (PFA, BIS, Codex standards) and group 17; Indian state PSC Food Safety Officer and FSSAI posts
Milk is the most heavily regulated of farm products. Before a litre of milk or a kilogram of cheese can be sold, the law of the country where it is made, and of every country it is shipped to, has something to say about how the animals were milked, how the milk was cooled and heat-treated, what the product must contain to carry its name, which residues and microbes it may carry, what the label must say and who must certify it. A dairy technologist who knows the science but not the law cannot release a batch, approve a label or sign an export certificate.
This manual describes the structure of dairy law in the jurisdictions that matter most for production and trade: the Codex Alimentarius at the international level; India under the Food Safety and Standards Act 2006; the United States under the Grade A Pasteurized Milk Ordinance and federal standards of identity; the European Union under its General Food Law and hygiene package; Australia and New Zealand; and China and other large importing markets. It then takes the cross-cutting topics in turn: microbiological criteria, residue limits, export certification under the WTO SPS and TBT agreements, labelling and the protection of dairy names, and geographical indications.
The manual names instruments and explains how they work. It deliberately does not reproduce numerical limits that change from one amendment to the next, such as maximum residue limits, compositional minima for each class of milk or the numbers in microbiological criteria. Those must always be read from the current consolidated text, and the manual says where to find it. General food law, HACCP and certified food safety systems are covered in the Food Technology subjects food-law-regulatory-affairs and food-safety-management-systems, and in this track's dairy-food-safety-systems. Quality management systems, statistical quality control and laboratory accreditation are covered in this track's dairy-quality-assurance-sqc and in the agribusiness subject quality-management-standards. This manual gives short reminders and keeps to the dairy-specific rules.
In examinations, this subject appears in the ICAR AIEEA-PG Dairy Science paper (PFA, BIS, Codex and ISO standards), in the legal and quality units of the ICAR AICE-JRF/SRF Dairy Chemistry and Dairy Technology papers, in Food Safety Officer and FSSAI analyst recruitment, and in the US Grade A milk certifications built on the Pasteurized Milk Ordinance. Questions test whether a candidate can name the right instrument, explain who sets and enforces it, and apply a stated rule to a case.
The Codex Alimentarius Commission was set up in 1963 by the Food and Agriculture Organization (FAO) and the World Health Organization (WHO) to develop international food standards that protect consumers' health and promote fair practices in the food trade. Its members are national governments. The texts it adopts are of four kinds: standards (for a commodity or a general topic), codes of practice, guidelines, and maximum limits for residues and contaminants. Codex texts are voluntary: no country is obliged to adopt them into its own law. Their force comes from trade law. The World Trade Organization's Agreement on the Application of Sanitary and Phytosanitary Measures (SPS) names Codex as the reference body for food safety, so a national measure that conforms to a Codex standard is presumed to meet the SPS Agreement, while a stricter measure must be justified by a risk assessment. This is why exporting countries such as New Zealand, and importing ones such as India, follow Codex work closely.
Dairy standards were first developed under an FAO/WHO code of principles concerning milk and milk products, adopted in the late 1950s, which is older than Codex itself. The work later passed to the Codex Committee on Milk and Milk Products, hosted by New Zealand. That committee completed most of its programme and has been adjourned sine die, so new dairy questions now go through general subject committees or written procedures; check the Codex website for the current position.
Codex dairy texts fall into three groups. The first is the General Standard for the Use of Dairy Terms (CXS 206-1999). The second is a set of commodity standards: for example the General Standard for Cheese (CXS 283-1978), the Standard for Fermented Milks (CXS 243-2003), the Standard for Butter (CXS 279-1971) and the Standard for Milk Powders and Cream Powder (CXS 207-1999), together with standards for evaporated and condensed milks, creams, whey powders, caseins and more than a dozen individual cheese varieties. The third is the Code of Hygienic Practice for Milk and Milk Products (CXC 57-2004), which applies the General Principles of Food Hygiene (CXC 1-1969) to the whole chain from the farm to the consumer.
The General Standard for the Use of Dairy Terms, usually shortened to GSUDT, sets out who may use words such as milk, cream, butter, cheese and yoghurt. It defines milk as the normal mammary secretion of milking animals obtained from one or more milkings without either addition to it or extraction from it, intended for consumption as liquid milk or for further processing. A milk product is a product obtained by any processing of milk, which may contain food additives and other ingredients functionally necessary for the processing. A composite milk product is one in which milk, milk products or milk constituents are an essential part in terms of quantity in the final product, as consumed, provided the non-milk constituents are not intended to take the place of any milk constituent in part or in whole. Recombined and reconstituted milk products are also defined: recombined products are made by combining milkfat and milk-solids-non-fat, with or without water, and reconstituted products by adding water to the dried or concentrated form.
The central rule is that the term milk, and the names of milk products, may be used only for products that meet these definitions. A product in which any milk constituent has been replaced by a non-milk constituent may not be called milk or by any milk product name. There is an exception for a product whose exact nature is clear from traditional usage, or when the name is used to describe a characteristic quality of a non-dairy product. Dairy terms may not be used in a way that misleads the consumer, and the standard also governs the use of words, pictures and other devices suggesting a dairy product.
The GSUDT is the reason national laws on plant-based alternatives look the way they do. The EU, India and several other jurisdictions have built on it to reserve dairy designations; others leave room for qualified names. Commodity standards add composition (for example, minimum milkfat and maximum moisture for named varieties), permitted additives by reference to the General Standard for Food Additives (CXS 192-1995), contaminants by reference to the General Standard for Contaminants and Toxins in Food and Feed (CXS 193-1995), hygiene by reference to CXC 57-2004, and labelling by reference to the General Standard for the Labelling of Prepackaged Foods (CXS 1-1985).
South Asia's largest dairy producer, India, is described first because its law is the most detailed in the region; its neighbours follow. Before 2006, Indian food law was spread over several instruments. The Prevention of Food Adulteration Act 1954 (PFA) and its rules set compositional standards and penalties for adulteration, and dairy also came under the Milk and Milk Product Order 1992 (MMPO), made under the Essential Commodities Act, which required registration of larger dairy plants and set hygiene conditions. Separate orders governed fruit products, meat products, vegetable oils and edible oil packaging. The Food Safety and Standards Act 2006 (FSS Act) consolidated these laws and repealed them, including the PFA Act and the MMPO, once the new regulations came into force in 2011.
The FSS Act created the Food Safety and Standards Authority of India (FSSAI) to lay down science-based standards and regulate manufacture, storage, distribution, sale and import of food. It places primary responsibility for safe food on the food business operator, sets out offences for unsafe, substandard and misbranded food, and creates an enforcement structure: a Commissioner of Food Safety in each state, Designated Officers at district level who issue and cancel licences and process cases for prosecution, and Food Safety Officers who inspect premises and draw samples. Samples go to Food Analysts in notified laboratories, with an appeal route to referral laboratories. Adjudicating Officers impose penalties, and special courts try serious offences.
Several regulations made under the Act matter for dairy. The Food Safety and Standards (Licensing and Registration of Food Businesses) Regulations 2011 decide whether a dairy business needs basic registration, a state licence or a central licence, depending on its type and capacity; check the current schedule for the thresholds, which have been revised. The Food Safety and Standards (Food Products Standards and Food Additives) Regulations 2011 contain compositional standards; dairy products and analogues form the first part of the food standards chapter. The Food Safety and Standards (Contaminants, Toxins and Residues) Regulations 2011 set limits for metals, mycotoxins, antibiotics and pesticide residues. Labelling, packaging, laboratory sampling and import each have their own regulations.
The FSSAI compositional standards define milk by species and by treatment. Buffalo, cow, goat, sheep and camel milk, mixed milk, and processed classes such as full cream, standardised, toned, double toned and skimmed milk each carry minimum fat and milk-solids-not-fat (SNF) values. Under the PFA rules some of these minima differed from state to state for buffalo and cow milk; the FSSAI schedule has since been revised more than once, so the current figures must be read from the latest consolidated regulation rather than memorised from an old text. Standards also cover cream, butter, ghee, khoa, paneer, chhana, cheese varieties, dahi, yoghurt, ice cream and frozen desserts, milk powders, condensed milks and whey products. Ghee standards include tests that detect adulteration with foreign fats, such as the Butyro-Refractometer reading, Reichert-Meissl value and Polenske value, with limits that vary by region and season.
Two older quality systems sit alongside FSSAI. The Bureau of Indian Standards (BIS), now governed by the Bureau of Indian Standards Act 2016, publishes Indian Standards (IS) for dairy products, dairy equipment and test methods. A well-known example is IS 1479, the methods of test for the dairy industry. BIS certification marks are mostly voluntary for dairy products, but FSSAI regulations often cite BIS methods and standards, and some packaging and infant food items fall under mandatory certification. Agmark is the grading mark issued under the Agricultural Produce (Grading and Marking) Act 1937 by the Directorate of Marketing and Inspection. Ghee and butter are among the products commonly graded under Agmark, and many consumers recognise the Agmark ghee label.
The practical position for a dairy plant is that FSSAI law is mandatory and enforced, while BIS and Agmark are mostly voluntary quality marks that may be required by buyers or by specific regulations. When the same parameter appears in more than one instrument, the FSSAI standard is the legal minimum for sale.
Other countries of the region regulate dairy through comparable structures, with power divided differently. In Pakistan, food regulation was largely devolved to the provinces after the 18th constitutional amendment of 2010; provincial food authorities, beginning with the Punjab Food Authority set up under a 2011 Act, license food businesses, set provincial standards and inspect dairies and milk shops, while the Pakistan Standards and Quality Control Authority publishes national standards. Bangladesh's Food Safety Act 2013 created the Bangladesh Food Safety Authority to coordinate regulation, while the Bangladesh Standards and Testing Institution sets and certifies product standards, including for milk powder and other dairy products. Sri Lanka regulates food under its Food Act of 1980, administered by the health ministry with a food advisory committee.
Across the region the recurring enforcement problems are similar: a large informal sector of loose milk sold by vendors, adulteration with water, starch, detergent or vegetable fat, and limited laboratory capacity outside cities. The compositional and adulteration tests described above, including those for ghee, are therefore used throughout the region, and Codex standards serve as the common reference for traded products.
Fluid milk safety in the United States rests on a cooperative federal-state programme. The Food and Drug Administration (FDA) publishes the Grade A Pasteurized Milk Ordinance (PMO), a model regulation that states adopt into their own law or by reference. The PMO sets requirements for dairy farms, milk haulers, bulk milk tank trucks, receiving and transfer stations, milk plants and single-service container manufacturers. It covers construction, cleaning, cooling, bacterial and somatic cell standards, drug residue testing, pasteurisation and the equipment that controls it, and the standards for finished Grade A products. Its appendices give detailed methods; Appendix N deals with drug residue testing and farm surveillance, requiring every bulk tanker of raw milk to be screened for beta-lactam drugs before it is processed.
The PMO is maintained through the National Conference on Interstate Milk Shipments (NCIMS), founded in 1950. The NCIMS brings together state regulators, FDA, USDA, industry and academia. Proposals to change the PMO are debated and voted on at its conference, which normally meets every two years, and FDA then issues the revised ordinance. Students should always state which revision they are citing.
Trust between states is built through ratings. State rating officers, certified by FDA, rate each milk supply for compliance with the PMO, and FDA checks the raters. Shippers whose ratings meet the required level are listed on the Interstate Milk Shippers (IMS) List. A receiving state may then accept Grade A milk from any listed shipper without inspecting it again. This system is what allows milk to move across state lines. The PMO's pasteurisation standards include the familiar combinations of 63 °C for 30 minutes for batch (vat) pasteurisation and 72 °C for 15 seconds for high-temperature short-time pasteurisation, together with higher-heat, shorter-time combinations, and it specifies recording thermometers, flow-diversion devices and holding-tube tests.
Composition is set separately, in federal standards of identity issued by FDA under the Federal Food, Drug, and Cosmetic Act. They are published in Title 21 of the Code of Federal Regulations (CFR): Part 131 covers milk and cream products (milk, cream, yoghurt, sour cream, evaporated and condensed milks and others), Part 133 covers cheeses and related cheese products, and Part 135 covers frozen desserts such as ice cream. A standard of identity names the product, defines its required ingredients and optional ingredients, sets compositional limits (for cheese, typically minimum milkfat in the solids and maximum moisture), and prescribes how it must be labelled. A food that resembles a standardised food but does not meet its standard cannot use the standardised name. The current numbers must be read from the electronic CFR, which is updated as rules change.
Not all milk is Grade A. Milk for manufacturing purposes, used for cheese, butter and powders, has historically been regulated through USDA recommended requirements adopted by states, and USDA's Agricultural Marketing Service offers voluntary grading services, such as the U.S. grades for butter and Cheddar cheese. FDA's preventive controls rules under the Food Safety Modernization Act (FSMA) also apply to dairy plants, with adjustments for plants already operating under the PMO; this track's dairy-food-safety-systems subject covers those rules.
For an exporter or an inspector, the essential distinction is between safety and hygiene rules (the PMO and FSMA), identity and composition rules (21 CFR), and voluntary quality grades (USDA). Each has a different author, a different enforcement route and a different consequence for a non-compliant product.
EU food law starts from Regulation (EC) No 178/2002, the General Food Law. It sets out the principles that every later act follows: decisions based on risk analysis, the precautionary principle where evidence is incomplete, primary responsibility of food business operators for the safety of their food, traceability one step back and one step forward, and duties to withdraw and recall unsafe food and inform the authorities. It also created the European Food Safety Authority (EFSA) to give independent scientific advice and the rapid alert system for food and feed.
The hygiene package applies these principles to production. Regulation (EC) No 852/2004 on the hygiene of foodstuffs applies to all food businesses: it requires general hygiene, registration, and permanent procedures based on HACCP principles for everyone after primary production. Regulation (EC) No 853/2004 adds specific hygiene rules for food of animal origin. Establishments handling products of animal origin, including dairy plants, must be approved by the competent authority, and their products carry an oval identification mark showing the country and the establishment's approval number. Annex III, Section IX of 853/2004 deals with raw milk, colostrum, dairy products and colostrum-based products. It sets health requirements for the animals, hygiene on the holding, cooling of milk after milking, and criteria for raw cow's milk based on plate count and somatic cell count as rolling geometric averages, with corrective action when the criteria are exceeded. It also sets temperature and time requirements for collection and processing and requires that heat-treated products be verified, for example by alkaline phosphatase testing. Read the numbers from the current consolidated text.
Official controls, once covered by Regulation (EC) No 854/2004, are now set by Regulation (EU) 2017/625, the Official Controls Regulation, which applies to all food and feed and to imports. Microbiological criteria are in Regulation (EC) No 2073/2005, discussed in a later chapter.
Alongside hygiene law, the EU regulates the market for dairy products through the common market organisation, now Regulation (EU) No 1308/2013. Its Annex VII, Part III defines milk as exclusively the normal mammary secretion obtained from one or more milkings without either addition thereto or extraction therefrom, closely following Codex. The term milk may be used for a mixture with added constituents only where the nature of the product is clear. The annex then reserves a list of designations exclusively for milk products: whey, cream, butter, buttermilk, butteroil, caseins, anhydrous milk fat, cheese, yogurt, kephir, kumis, viili or filli, smetana and fil. Plant-based products may not use these designations, except for products whose exact nature is clear from traditional usage, which are listed in a Commission decision; examples include coconut milk and peanut butter in English. The same regulation also covers marketing standards for spreadable fats, which set when a spread may be called butter.
The EU also sets rules for drinking milk, which divide it by fat content into categories such as whole milk, semi-skimmed milk and skimmed milk, and for food information to consumers (Regulation (EU) No 1169/2011), discussed in the labelling chapter. National rules may add requirements in some areas, such as raw milk sales direct to consumers, which some member states allow under national conditions and others restrict.
For an exporter to the EU, the practical steps are to be in a country listed for the relevant commodity, to be in an establishment listed as approved by the competent authority of that country, to meet EU-equivalent residue monitoring and hygiene standards, and to ship with the correct official certificate. The chapter on export certification describes how this works.
Australia and New Zealand share a joint food standards system. Food Standards Australia New Zealand (FSANZ) develops the Australia New Zealand Food Standards Code, which ministers of both countries adopt. The Code is in chapters. Chapter 1 covers general standards such as labelling, additives, contaminants and microbiological limits; Chapter 2 covers food product standards, with the dairy standards in Part 2.5 (milk, cream, fermented milk products, cheese, butter, ice cream, and dried, evaporated and condensed milks); Chapter 3 covers food safety standards; and Chapter 4 covers primary production and processing standards. Chapter 4 applies in Australia only. Standard 4.2.4, the Primary Production and Processing Standard for Dairy Products, requires dairy primary producers, transporters and processors in Australia to have food safety programmes, controls on animal health and inputs, traceability, and heat treatment or an approved alternative for most dairy products.
Australia enforces through its states and territories. Each has a dairy regulator or food authority that licenses dairy farms, carriers and factories, audits them and responds to incidents. Export dairy is handled federally, by the Department of Agriculture, under export legislation, so an Australian exporter answers to both levels.
New Zealand applies the composition and labelling parts of the joint Code to its domestic market but keeps its own primary production and processing law. Its dairy sector is overwhelmingly export-oriented, and the main instrument is the Animal Products Act 1999, administered by the Ministry for Primary Industries (MPI). Under that Act, dairy farms, collectors and processors operate under a Risk Management Programme (RMP), a written, operator-designed programme based on HACCP principles, which is registered with MPI and verified by recognised agencies. The Food Act 2014 covers food that is not covered by the Animal Products Act, mostly domestic food service and retail.
Because almost all of New Zealand's milk is exported, the system is built around official assurances. MPI negotiates requirements with each importing country, records them as Overseas Market Access Requirements, and issues official certificates when an exporter shows that the product meets them. Dairy products for export must come from operators and premises listed with MPI and must pass through a system that traces milk from farm to product. If a defect is found after export, MPI can revoke certificates and require recall.
A well-known feature of the New Zealand system is that it treats the regulator's role as setting outcomes and verifying them, rather than prescribing every step. The operator designs the RMP; MPI and its recognised agencies check that it is followed and that it works. Students comparing systems should note that the EU and India also make the operator responsible but rely more on prescriptive annexes, while the US PMO prescribes equipment and procedures in detail.
The Australian and New Zealand systems also show how a joint code can sit beside separate enforcement. A product may meet the Code's compositional standard for cheese in both countries, yet be produced under different primary production rules: Standard 4.2.4 in Australia and an RMP under the Animal Products Act in New Zealand. Export certification adds a third layer, set by the importing country. When studying any of these instruments, read the current version on the FSANZ, MPI or Australian government websites, because standards and RMP requirements are revised frequently.
China is one of the largest importers of dairy products, especially milk powder, infant formula base powders, whey and butter. Its food law rests on the Food Safety Law of the People's Republic of China, first passed in 2009 and substantially revised in 2015. The revision followed the 2008 melamine scandal, in which melamine was added to raw milk to make its protein content appear higher, causing illness and deaths among infants fed contaminated formula. The scandal led to a complete review of Chinese dairy standards and to a new set of national food safety standards issued from 2010 onward.
These national food safety standards carry the prefix GB and are mandatory. Separate GB standards cover raw milk, pasteurised milk, sterilised milk, fermented milk, milk powder, cheese, cream and butter, whey powder and infant formula, while general GB standards cover contaminants, mycotoxins, pesticide residues, veterinary drug residues, food additives, labelling and microbiological limits. Infant formula is regulated most strictly: formulas sold in China must have their recipes registered with the State Administration for Market Regulation, and manufacturers must meet production licensing conditions.
Imports are controlled by the General Administration of Customs of China (GACC). Overseas manufacturers of imported food must be registered with GACC, either on the recommendation of their own national authority (for higher-risk categories such as dairy) or by applying directly for lower-risk foods, under rules that took effect in 2022. Each consignment must carry the official certificate agreed between China and the exporting country, and products are inspected on arrival. Exporters must also label in Chinese and meet Chinese GB standards, which may differ from Codex in composition, additives and limits.
Other importing markets build their systems differently, and an exporter must know each one. The Gulf states set common standards through the GCC Standardization Organization (GSO), and halal certification by an approved body is a condition of entry for dairy products, along with labelling in Arabic and shelf-life rules. Several Southeast Asian markets, including Indonesia and Malaysia, also require halal certification and register importers and products. Japan regulates food under the Food Sanitation Act, and since 2006 has applied a positive list system for agricultural chemical residues, in which any residue without a specific limit is held to a uniform low default limit. The Eurasian Economic Union (Russia, Kazakhstan, Belarus, Armenia and Kyrgyzstan) applies common technical regulations, including one specifically for milk and dairy products, and lists approved foreign establishments.
Large dairy importers in Africa and South Asia often apply Codex standards directly or adapt them, while relying on certificates from the exporting authority. Some countries also require pre-shipment inspection or conformity assessment certificates for consumer goods, including dairy.
The common thread is that importing countries regulate through three levers: who may export (country and establishment listing), what the product must meet (national standards, which may differ from Codex), and how compliance is shown (official certificates, registration and border checks). An exporter's regulatory team keeps a market-by-market file of requirements, checks it before each contract, and tracks changes through the exporting country's competent authority, which usually publishes importing country requirements.
A microbiological criterion is a legal or contractual rule that decides whether a food, a batch or a process is acceptable, based on the presence, absence or number of micro-organisms or their toxins per unit of mass, volume or area. The Codex Principles and Guidelines for the Establishment and Application of Microbiological Criteria Related to Foods (CXG 21-1997) set out what a complete criterion must specify: the purpose; the food to which it applies; the point in the food chain where it applies; the micro-organism or toxin; the analytical method; the sampling plan, defining the number of sample units and their size; the microbiological limits; and the action to take when the criterion is not met. A number without these elements is not a usable criterion.
Sampling plans follow the logic set out by the International Commission on Microbiological Specifications for Foods (ICMSF). In a two-class plan, n sample units are tested against a single limit m; the lot is accepted if no more than c units exceed m, and for pathogens such as Salmonella c is usually zero and the limit is absence in a stated quantity. In a three-class plan there are two limits, m and M. Results at or below m are acceptable; results between m and M are marginal and up to c of them are allowed; any result above M rejects the lot. Increasing n or reducing c makes a plan more stringent: a defective lot is less likely to be accepted. No sampling plan can prove a lot is free of a pathogen, because sampling only gives a probability of detecting contamination at a given level. This is why microbiological testing verifies a food safety system but cannot replace it.
The EU's Regulation (EC) No 2073/2005 is the most cited example of microbiological criteria in law. It distinguishes two types. A food safety criterion defines the acceptability of a product or batch placed on the market; failure means the batch is unsafe and must be withdrawn or recalled. For dairy, food safety criteria include Listeria monocytogenes in ready-to-eat foods, Salmonella in cheeses, butter and cream made from raw or low-heat-treated milk and in milk and whey powder, staphylococcal enterotoxins in cheeses, milk powder and whey powder, and Cronobacter species in dried infant formula intended for infants below a stated age. A process hygiene criterion indicates whether the production process is working acceptably; it applies during or at the end of manufacture and failure requires corrective action on the process, not necessarily withdrawal. Dairy process hygiene criteria include Enterobacteriaceae in pasteurised milk and other pasteurised liquid dairy products, Escherichia coli in certain cheeses, according to the heat treatment of the milk, coagulase-positive staphylococci in cheeses and powders, and Enterobacteriaceae in dried infant formula. The regulation also requires food businesses to do shelf-life studies for ready-to-eat foods that can support growth of Listeria.
Other jurisdictions set microbiological limits in different places. In India they are in the FSSAI standards for each product; in the US the PMO sets bacterial and coliform limits for raw and pasteurised Grade A milk, while FDA handles pathogen findings under its general adulteration powers; in Australia and New Zealand, Standard 1.6.1 of the Food Standards Code sets microbiological limits. Because the numbers, sampling plans and methods change, students should learn the structure and the type of criterion, and read the current limits from the current text when they need them.
Milk can carry residues of veterinary drugs used to treat cows, pesticides from feed or the environment, and contaminants such as mycotoxins and heavy metals. Limits for these are set through a chain of risk assessment and risk management. For a veterinary drug, scientists first find the no-observed-adverse-effect level in animal studies and divide it by safety factors to set an acceptable daily intake (ADI), the amount a person can take every day over a lifetime without appreciable risk. A maximum residue limit (MRL) is then set for each food, such as milk, so that the total intake from all foods with the drug stays within the ADI under a model diet. For pesticides, the MRL is also tied to good agricultural practice. Withdrawal periods on veterinary product labels are the time after the last treatment during which milk must be discarded so that residues fall below the MRL.
At the international level, the Joint FAO/WHO Expert Committee on Food Additives (JECFA) evaluates veterinary drugs, additives and contaminants, and the Joint FAO/WHO Meeting on Pesticide Residues (JMPR) evaluates pesticides. Codex committees then set MRLs and maximum levels, which the Codex Alimentarius Commission adopts. National authorities use these or set their own. In the EU, Regulation (EU) No 37/2010 lists pharmacologically active substances and their MRLs in foods of animal origin, and contains a separate table of prohibited substances for which no MRL can be set, such as chloramphenicol. Regulation (EC) No 396/2005 sets pesticide MRLs, and contaminant maximum levels are set by Regulation (EU) 2023/915, which replaced Regulation (EC) No 1881/2006. In India, the Contaminants, Toxins and Residues Regulations 2011 set the limits; in the US, FDA sets tolerances for animal drugs and EPA sets tolerances for pesticides.
Aflatoxin M1 is the classic dairy contaminant. It is the hydroxylated metabolite of aflatoxin B1, which cows ingest in mouldy feed such as groundnut cake or maize, and it passes into milk. Different jurisdictions set very different maximum levels: the EU limit for aflatoxin M1 in raw and heat-treated milk is far stricter than the Codex level, which is why a consignment can be legal in one market and illegal in another. Control is mainly at the feed stage, by testing and rejecting contaminated feed.
Residue control has three parts. Farmers must use veterinary drugs only as authorised and respect withdrawal periods; this is enforced through records and farm audits. Processors screen incoming milk, usually with rapid tests for beta-lactams and other antibiotic groups at reception, and reject or divert positive loads. Authorities run national residue monitoring plans, sampling milk at farms and plants for a wide list of substances using confirmatory laboratory methods such as liquid chromatography with mass spectrometry. Exporting countries' residue plans are reviewed by importing authorities; the EU, for example, requires third countries to have approved residue monitoring plans before their dairy products may be imported.
Two distinctions are commonly examined. First, a screening test is designed to catch residues near the limit with few false negatives; a positive screening result must be confirmed before legal action, because screening tests can give false positives. Second, a substance with no permitted use, such as chloramphenicol in the EU, is controlled by testing to the lowest level that can be reliably detected and enforced, not against an MRL.
When the World Trade Organization was founded in 1995, two agreements were concluded to stop technical rules being used as hidden trade barriers. The Agreement on the Application of Sanitary and Phytosanitary Measures (SPS) covers measures to protect human, animal and plant life or health from risks such as additives, contaminants, toxins, disease-causing organisms, pests and diseases. For dairy, this includes microbiological criteria, residue limits, hygiene requirements, animal health conditions and the certificates that attest to them. The SPS Agreement recognises each member's right to set its own level of protection but requires measures to be based on science, applied only to the extent necessary, and not to discriminate arbitrarily. It encourages harmonisation with international standards, naming Codex for food safety, the World Organisation for Animal Health (WOAH) for animal health and the International Plant Protection Convention for plant health. A member may adopt a stricter measure if it has a scientific justification based on risk assessment. Other key articles cover equivalence (an importing member must accept another member's measures as equivalent if they achieve its level of protection), regionalisation (recognising disease-free areas), and transparency (notifying draft measures to the WTO).
The Agreement on Technical Barriers to Trade (TBT) covers technical regulations, voluntary standards and conformity assessment procedures that are not SPS measures. For dairy, compositional standards, standards of identity, product names and most labelling rules are TBT measures, unless they are directly aimed at food safety. TBT requires that technical regulations treat imports no less favourably than domestic or other foreign products, are not more trade-restrictive than necessary to fulfil a legitimate objective, and use relevant international standards as a basis where they exist. Disputes under either agreement go to the WTO dispute settlement system.
An export health certificate is an official document, issued by the competent authority of the exporting country, in which an official veterinarian or authorised officer attests that a consignment meets the importing country's requirements. The wording is usually agreed between the two governments. Typical attestations for dairy cover the animal health status of the country or region, for example freedom from foot-and-mouth disease or the heat treatment applied to inactivate its virus; the approval of the establishment; compliance with hygiene requirements; residue monitoring; and the identity of the consignment. The certifier must have evidence for every statement: plant audits, laboratory results, traceability records and, where needed, product sampling.
Several layers make certification work. The exporting authority must be recognised by the importer, often after an audit of the national system. The establishment must be listed, either in the importer's list of approved foreign plants or through the exporter's own listing. The certificate must be in the agreed model, and increasingly it is issued and checked electronically. Many governments now use electronic certification and exchange data directly with importing authorities, which reduces fraud.
In India, export inspection and certification of notified dairy products is carried out by the Export Inspection Council and its agencies, and export promotion of dairy products is the role of the Agricultural and Processed Food Products Export Development Authority (APEDA). In the EU, imports must enter through border control posts, where documents, identity and physical checks are made. Equivalence agreements, such as the EU's veterinary agreements with some trading partners, let certificates attest equivalence to the importer's rules rather than full compliance with each detail.
The Codex General Standard for the Labelling of Prepackaged Foods (CXS 1-1985) lists the information that national laws typically require: the name of the food, the list of ingredients in descending order of weight, the declaration of allergens, the net contents, the name and address of the manufacturer, packer or importer, the country of origin where omission would mislead, lot identification, date marking and storage instructions, and instructions for use where needed. Dairy commodity standards add specific rules, for example that a cheese's name may be accompanied by its fat content expressed as fat in dry matter, or that a fermented milk with added flavours be described as flavoured.
Milk is one of the major allergens that must be declared in most jurisdictions. In the EU, Regulation (EU) No 1169/2011 on food information to consumers lists milk and products thereof among the fourteen allergens in Annex II, which must be emphasised in the ingredient list, for example in bold type. The same regulation requires a quantitative ingredient declaration (QUID) when an ingredient is named in the product name or emphasised on the label, a nutrition declaration, and minimum font sizes. India's Food Safety and Standards (Labelling and Display) Regulations 2020 require similar particulars and the vegetarian or non-vegetarian symbol; milk and milk products are labelled with the green vegetarian symbol. In the US, nutrition labelling, allergen declaration under federal allergen labelling law, and the standard-of-identity name together determine what a dairy label says.
Date marking differs between products. Perishable products such as pasteurised milk and yoghurt carry a use-by or expiry date, after which they should not be eaten for safety reasons; longer-life products such as milk powder and UHT milk usually carry a best-before date, which relates to quality. The terms used differ by jurisdiction.
Disputes over the names of plant-based products are the clearest example of how dairy terms are protected. The EU position comes from Regulation (EU) No 1308/2013, Annex VII Part III, which reserves milk and the listed designations for milk products. In the TofuTown case, decided by the Court of Justice of the European Union in 2017 (Case C-422/16), the Court held that purely plant-based products cannot be marketed under designations such as milk, cream, butter, cheese or yoghurt, even if the name is clarified by descriptive words indicating the plant origin, unless the product appears on the list of exceptions. This makes the EU among the strictest jurisdictions.
India follows a similar approach in its FSSAI standards, which treat products that resemble milk products but contain non-dairy ingredients as analogues and restrict the use of dairy terms for them. The United States regulates through standards of identity; FDA has issued draft guidance recognising that names such as soy milk or almond milk are commonly used and understood, and suggesting voluntary nutrient statements comparing them with milk. Other jurisdictions sit between these positions.
Two further rules protect dairy names. First, a product named after a standardised dairy food must meet that food's standard; a cheese labelled Cheddar in a standards-of-identity jurisdiction must meet the Cheddar standard. Second, words and pictures that suggest a dairy product, such as a cow on the pack or words like creamy, can mislead and may be restricted even where the main name is lawful. A label reviewer should therefore check the name, the standard it implies, the allergen and QUID rules, and the overall impression together.
A geographical indication (GI) identifies a good as originating in a territory where a given quality, reputation or other characteristic of the good is essentially attributable to its geographical origin. Cheeses are among the most valuable GIs in the world. Under the WTO Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS), Article 22 requires members to provide legal means to prevent the use of a GI in a way that misleads the public about the true origin of a good or constitutes unfair competition. Article 23 gives additional, stronger protection, but only for wines and spirits: their GIs must be protected even when the true origin is indicated or the name is used in translation or with words such as kind, type or style. Article 24 contains exceptions, notably for names that have become generic in a member's territory and for some prior uses. Whether stronger Article 23-style protection should be extended to other products, including cheeses, is a long-running dispute between the EU and countries such as the US, Australia and New Zealand.
The EU protects agricultural and food GIs through a registration system. Protected designation of origin (PDO) requires that all stages of production, processing and preparation take place in the defined area and that the product's quality is essentially due to that environment. Protected geographical indication (PGI) requires that at least one stage takes place in the area and that a quality, reputation or characteristic is attributable to the origin. Traditional speciality guaranteed (TSG) protects a traditional recipe or method, not an origin; mozzarella is a TSG, while Mozzarella di Bufala Campana is a PDO. These schemes were set by Regulation (EU) No 1151/2012 and have since been reformed by a regulation adopted in 2024 that brings the GI schemes together; check the current text. The EU also protects its GIs abroad through bilateral trade agreements.
The hardest question in dairy GIs is when a name has become generic. Cheddar, Camembert and Brie are widely treated as generic cheese types, although Camembert de Normandie and Brie de Meaux are PDOs. Gouda Holland and Edam Holland are registered PGIs in the EU, but gouda and edam alone remain generic. Feta was registered as a PDO for Greece in 2002 after years of dispute; Denmark and Germany challenged the registration, and the Court of Justice upheld it in 2005, finding that the name was not generic. In a 2008 case the Court held that parmesan evoked the PDO Parmigiano Reggiano, so cheese not meeting the specification could not be sold as parmesan in the EU. Outside the EU, the same names may be freely used, which leads to trade disputes and to lists of names negotiated in trade agreements.
India protects GIs under the Geographical Indications of Goods (Registration and Protection) Act 1999, which came into force in 2003, with registration through the Geographical Indications Registry in Chennai. Registered Indian dairy GIs include Dharwad pedha from Karnataka and the rasagola of West Bengal and of Odisha, which were registered separately. Registration lets authorised users prevent others from using the name on products not from the area.
For a dairy business, GIs create both opportunity and risk. A producer group can raise prices by building and protecting a GI with a clear product specification and an inspection body. An exporter must check that its cheese names are not protected GIs in the target market, and its labels may need to drop a name such as feta or parmesan for one market while using it in another. The certification bodies that check GI specifications are usually accredited to ISO/IEC 17065.
A student uses this subject to learn which instrument governs which question: Codex for international reference standards, the FSS Act and FSSAI regulations for India, the PMO and 21 CFR for the US, the EU hygiene package and market regulation, and the joint Australia New Zealand code. The useful skill is to name the instrument and the body behind it, apply a stated sampling plan or limit to a set of results, and say whether a rule is an SPS or a TBT measure. These are exactly the points that PG entrance and Food Safety Officer papers test, and the student who learns structure rather than numbers does not have to relearn the subject when limits change.
A quality or regulatory officer five years into a dairy career uses this subject daily. Typical tasks are checking a new product's composition against the FSSAI or 21 CFR standard before launch, approving a label for allergen emphasis, QUID and the correct product name, preparing for an inspection by a Food Safety Officer or a PMO rating, reviewing residue screening records at milk reception, and assembling evidence for an export certificate. The key decisions are whether a product can carry a dairy name, which licence category a new site needs, and what to do when a batch fails a food safety criterion as opposed to a process hygiene criterion.
A head of quality or regulatory affairs with twenty-five years' experience manages compliance across several markets at once. That means keeping a market-by-market register of requirements, judging when a change in an importing country's rules requires reformulation or relabelling, negotiating with buyers whose specifications go beyond the law, and handling recalls and border rejections. Senior staff also represent the company or cooperative in industry associations and in consultations on new standards, and they decide whether to invest in GI registration, new export market listings or a change of certification scheme. Knowing which rule is law, which is a buyer's demand and which is a voluntary mark keeps cost and risk under control.
A senior scientist or professor works at the point where science becomes law. They serve on expert committees that advise on standards, contribute risk assessments that underpin MRLs or microbiological criteria, represent their country in Codex or IDF work, and set and moderate examination papers on standards and law. Their research questions include the scientific basis of compositional standards for traditional products, the performance of sampling plans, exposure assessment for residues and contaminants in milk, and the economic effect of GI protection. Their teaching task is to give students a durable map of the instruments and the reasoning behind them, and to keep that map current.
This manual describes the structure of dairy law and names its instruments but deliberately does not reproduce numerical limits that change with amendments: compositional minima for each class of milk and product, maximum residue limits, contaminant maximum levels, microbiological criteria values, licensing thresholds and pasteurisation equivalents beyond the two classic combinations. Read these from the current consolidated texts named in the sources. Coverage of China, the Gulf, Japan, the Eurasian Economic Union and Southeast Asia is outline only; the article and annex numbers of most national regulations other than those of the EU are not given, and recent amendments after the review date are not reflected. HACCP, certified food safety schemes and FSMA preventive controls are covered in dairy-food-safety-systems and in the Food Technology subjects.
Original practice questions written to the syllabus and pattern of the exams named in each question's examTags. They are not past papers and do not reproduce any board's questions. Where a question applies a numerical limit, the limit is stated in the stem as the rule to apply; it is not a statement of the current legal value, which must be read from the current text.
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