International Food Regulations and Regulatory Affairs
International Food Regulatory Affairs can differ drastically from the UK.
Division 5 (Qual) has a binder with all up-to-date regulatory statutes for food law internationally. Due to the constraints of sheer volume, not all regulatory guidance may be on hard file, however, Nathan is familiar with much of these laws, particularly the FDA (US), GCC (Gulf Co-Operation Council), the EU, as well as the UK. Matthias and Nathan may be able to provide help should you require support on a specific set of legislative guidance.
Where multiple countries share a unified system for food safety, the main legislation will be listed as the type (EU, GCC) while any outlier regulations specific to a nation within the group will be listed under the nation’s own entry.
Please note that this list is for a generalised overview of a country's legislation, NOT an up-to-date guide.
Places to look for data;
Codex Alimentarius The Codex Alimentarius Commission was created in 1963 by FAO and WHO to develop food standards, guidelines, codes of practice, etc. to protect the health of consumers, ensure fair trade practices in the food trade, and promote coordination of all food standards work undertaken by international governmental and non-governmental organizations. Also accessible through Knovel
Sanitary and Phytosanitary Measures (SPS) An agreement on how governments can apply food safety and animal and plant health measures (sanitary and phytosanitary or SPS measures) sets out the basic rules in the WTO.
FAOLEX FAOLEX is a comprehensive and up-to-date legislative database, one of the world's largest electronic collection of national laws and regulations on food, agriculture and renewable natural resources.
UK FSA The UK Food Standards Agency publishes and provides guidance on UK Food Law. The FSA is updating all EU references, to accurately reflect the law now in force, in all new or amended guidance published since the Transition Period ended at the end of 2020. In some circumstances it may not always be practicable for us to have all EU references updated at the point we publish new or amended guidance. This is the most up-to-date source for all relevant UK food law.
US FDA
RASFF
EU Law
HFMA
GMP (MHRA)
ISO
GFSI
International Areas
The EU The European Union (EU) has been active for many years in developing harmonized food laws within it's collective nations. The many other countries, including African, Caribbean and Asian countries, have longstanding trade agreements with the EU. As a result, it is now more important than ever that the EU is responsible for establishing effective control systems for food and feed sector operators under the food hygiene legislation.
The application of ISO 9000 series standards on quality assurance, generated food safety management systems, which resulted in the updated ISO 22000 series. EU member countries developed the responsibility for enforcement of food safety standards and the basic principles of food law were set down in Regulation 178/2002. This evolved into the present “good hygienic practices” under new controls, for food and feed production, which were adopted in 2004 and went into effect on Jan. 1, 2006. Food safety has also been coordinated for the transportation of food within the new hygiene code.
The harmonized food hygiene package now affects every point of the EU food chain. Food hygiene legislation applies compulsory, self-run, verification programs to industry and combines them with HACCP principles. The legislation is designed to result in good practice guides for the EU food industry, which, together with self-run verification programs, encourages food operators to be registered. Important features of the new regulation include microbiological standards, to reduce foodborne illness for food products, with set criteria for Salmonella and Listeria levels.
The European Food Safety Authority (EFSA) is expected to list criteria for additional pathogens in the future. This harmonized EU control system applies to all EU member countries and others that wish to export to the EU. It is worth noting that import controls for products destined for the EU require the presentation of EU standard conformance guarantees.
Australia, New Zealand: The Australia-New Zealand food standards development system is a cooperative arrangement between Australia, New Zealand and the Australian States and mainland territories. Its mandate is to develop and implement uniform food standards for a combined population of some 24 million. In Australia, Food Standards Australia-New Zealand (formerly Australia New Zealand Food Authority) is charged with the development of food standards that cover the entire food supply chain, from paddock to plate. This includes primary producers through to the manufacturing industry. This organization works in partnership with Australia’s Commonwealth, state and territory governments and the New Zealand government. Responsibility for enforcing and policing domestic food standards rests with the states and territories in Australia and the New Zealand governments.
When it comes to imported foods, the Commonwealth enforces the Code using the “Imported Food Control Act 1992” as its legal authority. Within each jurisdiction, there are one or more agencies responsible for food surveillance. Each is charged with the task of ensuring the requirements of the Code are met. The Commonwealth uses Standard 3.2.2 (Food Safety Practices and General Requirements) as the basis of enforcement and policy. Its divisions and subdivisions specify process control requirements to be satisfied at each step of the food handling process. The Australian and New Zealand authorities also refer to “The Temperature Control of Potentially Hazardous Foods” guide as it explains the temperature control requirements and provides some advice on how to comply with these requirements.
Industry stakeholders include the Australian Food and Grocery Council, the Australian Supermarket Institute and the Refrigerated Warehouse and Transport Association. In order to exhibit their involvement and interest in delivering safe, top quality chilled and frozen foods to the consumer, they have combined efforts to contribute to this common industry/government goal. Their contribution is evidenced by two documents: “Australian Cold Chain Guidelines” and its companion volume “The Australian Cold Chain Food Safety Programs” for the safe handling of frozen and chilled foods. These food safety guidelines seek to strengthen the cold chain by recommending maximum product temperatures and appropriate practices for each link from manufacturer to consumer.
Guidelines per Nation:
A
Afghanistan
Albania
Algeria
Andorra
Angola
Antigua and Barbuda
Argentina
Armenia
Australia
Austria
Azerbaijan
B
Bahamas
Bahrain
Bangladesh
Barbados
Belarus
Belgium
Belize
Benin
Bhutan
Bolivia
Bosnia and Herzegovina
Botswana
Brazil
Brunei
Bulgaria
Burkina Faso
Burundi
C
Cabo Verde
Cambodia
Cameroon
Canada Industry within Canada’s borders has embraced voluntary national food safety standards in partnership with Agriculture and Agri-Food Canada (AAFC) and other government organizations. These standards manifest themselves within the Food Safety Enhancement Program (FSEP) developed by the Canadian Food Inspection Agency (CFIA), which was designed to encourage the establishment and maintenance of HACCP-based food safety systems in federally registered agricultural food processing establishments.[16] The controls exercised by the cold chain within FSEP, such as GMPs and temperature management, are part and parcel of the prerequisite programs, and/or critical control points (CCPs) developed and maintained by each producing member in the food chain. The generic models, including dairy products, egg and processed eggs, meat and poultry meat, and processed products, were developed to cover as many processes and products as possible to facilitate the development of plant-specific HACCP plans.
HACCP is now mandatory in federally inspected meat and poultry processing plants. Prior to the development of HACCP plans under FSEP, establishments are required to have developed, documented and implemented programs to control factors that may not be directly related to manufacturing controls but that support the HACCP plans. The CFIA and the food sector have developed generic models for many commodities including one specific to cold storage/freezer facilities and a mandatory Quality Management Program (QMP) for fish and seafood.
Today, the Canadian approach to food safety is complemented by the Canadian Food Safety and Quality Program (CFSQP) headed up by AAFC under the Agricultural Policy Framework (APF). It is a partnership between the federal government, provinces and territories, the Federation of Agriculture, a multitude of food industry trade organizations and the CFIA. This approach requires the programs to be industry-led, national and accessible; commodity-specific; HACCP-based and auditable; consistent, affordable and recognized in Canada; and internationally acceptable.
The Canadian On-Farm Food Safety Recognition Program (COFFSRP) was developed by the agricultural community, with CFIA and AAFC, to address the requirements of primary producers. In most cases this has been built on existing practices.[20] This is resulting in technically sound programs that are founded on a rigorous “HACCP-based” approach, consistent with the Codex Alimentarius. It uses CFIA’s FSEP/HACCP toolkit to develop a generic model and program requirements. Extending food safety in the other direction, programs are also required for the off-farm sector. Many cold chain stakeholders, including the Canadian Trucking Alliance (CTA), Canadian Federation of Independent Grocers (CFIG) and Canadian Council of Grocery Distributors (CCGD) have, after developing their own specific models, collaborated in order to assist each with their operations’ models. This assures that there is no weak link in product integrity from farm to plate, while avoiding duplication of food safety related issues.
The Canadian Food Inspection System (CFIS) is a collaborative initiative of all levels of government.[21] The CFIS Implementation Group has, as one of its key responsibilities, the creation of harmonized national standards. These standards not only include regulations but point towards codes for guidance. For example, the Food Retail and Food Services Regulations and Code, National Dairy Regulations and Code, National Meat and Poultry Regulations and Code, Good Transportation Practices Code and the General Principles of Food Hygiene Code of Practice are specifically relevant to the cold chain. All these documents fit nicely with the HACCP-based systems that are presently under development.
In Canada, there are many smaller food plants that fall under provincial jurisdictions and rely on the cold chain sector. Provinces are working with the federal government to develop food codes that will apply to these smaller companies that trade within a given province. Ontario and Alberta, for example, have already developed their own “HACCP Advantage” programs. In the province of Nova Scotia, legislation covers food manufacturing, retail and food service operation.[22] They must however, comply with all relevant federal legislation.
Central African Republic (CAR)
Chad
Chile
China China, with a growing population, now at 1.3 billion, also has an expanding food industry. Food safety is receiving its share of public concern and government scrutiny. The food industry in China has grown at a rate of 13% per year since the 1980s. This growth, together with foodborne illness frequency, has made food safety a major challenge. Increasing numbers of supermarkets, growing at a rate of 30-40% a year, have created a dramatic growth of infrastructure. Food distribution and transportation sectors have started to depend increasingly on a more reliable cold chain during this growth process.
Provisions of the “Food Hygiene Law of the Peoples Republic of China” contain food safety regulations and risk management measures. Its fifth provision stipulates that “the government encourages and protects the supervision of food safety by social bodies and individuals.”
Ministries of Agriculture and Health are responsible for food safety. Some 69 standards are under development to guide the safe production, storage and transport of food. These standards are expected to be active in 2006, meet the requirements of Codex Alimentarius and include HACCP standards.
Colombia
Comoros
Congo, Democratic Republic of the
Congo, Republic of the
Costa Rica
Cote d'Ivoire
Croatia
Cuba
Cyprus
Czechia
D
Denmark
Djibouti
Dominica
Dominican Republic
E
Ecuador
Egypt
El Salvador
Equatorial Guinea
Eritrea
Estonia
Eswatini
Ethiopia
F
Fiji
Finland
France
G
Gabon
Gambia
Georgia
Germany
Ghana
Greece
Grenada
Guatemala
Guinea
Guinea-Bissau
Guyana
H
Haiti
Honduras
Hungary
I
Iceland
India The need to meet food safety challenges, and provide a population of almost 1.1 billion with safe food, has raised the awareness of international food safety systems in India. While many small food enterprises and street vendors supply local food needs in accordance with local standards, the assurance of safe food production for international markets has created an opportunity to harmonize domestic and Codex Alimentarius standards with a HACCP approach. The Food Safety and Standards Bill, 2005, aims to consolidate eight laws governing the food sector and seeks to establish the Food Safety and Standards Authority.
The Directorate General of Health Services in the Ministry of Health and Family Welfare is presently integrating Codex standards into domestic food laws. The national standards body, the Bureau of Indian Standards, has adopted Codex, HACCP and food hygiene standards. Food processors are being encouraged to adopt these standards voluntarily. The cold chain is expanding in accordance with international market demand and regional food distribution needs.
Export certification is mandatory, for a variety of foods, under India’s Export Inspection Act. Inspections are carried out under ISO standards.
Indonesia
Iran
Iraq
Ireland
Israel
Italy
J
Jamaica
Japan
Jordan
K
Kazakhstan
Kenya
Kiribati
Kosovo
Kuwait
Kyrgyzstan
L
Laos
Latvia
Lebanon
Lesotho
Liberia
Libya
Liechtenstein
Lithuania
Luxembourg
M
Madagascar
Malawi
Malaysia
Maldives
Mali
Malta
Marshall Islands
Mauritania
Mauritius
Mexico
Micronesia
Moldova
Monaco
Mongolia
Montenegro
Morocco
Mozambique
Myanmar
N
Namibia
Nauru
Nepal
Netherlands
New Zealand
Nicaragua
Niger
Nigeria
North Korea
North Macedonia
Norway
O
Oman
P
Pakistan
Palau
Palestine
Panama
Papua New Guinea
Paraguay
Peru
Philippines
Poland
Portugal
Q
Qatar
R
Romania For product approval in Romania, the Romanian Authorities require several sets of data which giver a broader understanding of the product and it’s intended use. This required data is;
• A product presentation sheet- a document which provides a more general overview of the product. It should have information pertaining to the nature of the product, such as what it is made from (ie synthetic chemicals, plant extracts); active substances and their action on the body including accepted effects on the body; data on product toxicity including warnings on consumption; and ideally a bibliography of the data presented.
• CERTIFICATE OF CONFORMITY AND COUNTRY OF ORIGIN OF THE PRODUCT - showing that the product is suitable for human consumption, does not affect health and the environment
• DOCUMENTS CERTIFYING THE QUALITY OF THE INGREDIENTS - bulletins / certificates of physico-chemical and microbiological analyzes for each active ingredient and excipient • CERTIFICATE OF PHYSICAL-CHEMICAL AND MICROBIOLOGICAL ANALYSIS OF THE FINISHED PRODUCT
• CoA / QUALITY CERTIFICATE FOR PACKAGING - issued in accordance with current legislation.
• A DOCUMENT SIMILAR TO THE TECHNICAL SPECIFICATION (such as "Technical Data Sheet") - which may have various names, from country to country, and may include other information, eg: List of ingredients, Stability study, etc.
• DOCUMENTS CERTIFYING THE QUALITY OF THE INGREDIENTS - bulletins / certificates of physico-chemical and microbiological analyzes for each active ingredient and excipient
• A Full LIST OF INGREDIENTS AND THEIR QUANTATY
Russia Food safety regulation in Russia involves a number of federal government bodies, each with their own area of specialization. These include the National Body of Sanitary Control, Ministry of Agriculture, Agency of Technical Regulation, State Trading Inspection, Ministry of Economic Development and State Grain Inspection. Each is involved in traceability, safety and hygiene for the food market in Russia. As a major food producer, it was necessary to set standards for food safety and quality for domestic and international requirements. Standard GOST R 51074-1997 provided the classification of some food products and also prohibited the use of ambiguous product descriptions. The new Russian food standard, GOST P 51074-2003, became law on Jan. 1, 2005. It is more fully developed and designed to integrate with international food safety standards.
HACCP based food safety programs are being used more frequently by Russian industry to satisfy international and local market demands. Russia’s 2002 census revealed a population of 145 million, with most of the food consumers located in major urban centers. The cold chain is becoming more visible in the new regional refrigerated warehouses that are being built to maintain a safe food supply.
Proof of compliance with the new EU Hygiene Code for food products imported from Russia has made it necessary to modify food production techniques. Russian food exports to Commonwealth of Independent States countries must still present proof that Russian safety regulations are met.
Rwanda
S
Saint Kitts and Nevis
Saint Lucia
Saint Vincent and the Grenadines
Samoa
San Marino
Sao Tome and Principe
Saudi Arabia
Senegal
Serbia
Seychelles
Sierra Leone
Singapore
Slovakia
Slovenia
Solomon Islands
Somalia
South Africa
South Korea
South Sudan
Spain
Sri Lanka
Sudan
Suriname
Sweden
Switzerland
Syria
T
Taiwan
Tajikistan
Tanzania
Thailand
Timor-Leste
Togo
Tonga
Trinidad and Tobago
Tunisia
Turkey
Turkmenistan
Tuvalu
U
Uganda
Ukraine
United Arab Emirates (UAE)
United Kingdom (UK) The principal aim of retained EU law Regulation (EC) 178/2002, 'General Food Law' is to protect human health and consumer’s interest in relation to food. It applies to all stages of production, processing and distribution of food and feed with some exceptions. Food businesses must comply with food and feed safety law.
To place safe food on the market food businesses must ensure:
- traceability of food - appropriate presentation of food - suitable food information is provided - prompt withdrawal or recall of unsafe food placed on the market - food and feed imported into, and exported from, Great Britain (GB) shall comply with food law.
United States of America (USA) The population of this modern, food-producing nation is estimated at 298 million in 2006. U.S. federal and state governmental bodies regulate the manufacture, distribution and retailing of chilled (refrigerated) foods. The U.S. Food and Drug Administration (FDA) monitors the manufacture, import, storage and sale of foods that are required to be in compliance with the relevant U.S. Food Code. The 2005 Code provides guidelines on sanitation and the safe handling of refrigerated and frozen foods. The Code requires that the stored frozen foods be maintained frozen and that potentially hazardous foods shall be maintained at 5°C (41°F) or less; or 7°C (45°F) in existing refrigeration equipment that is not capable of maintaining the food at 5°C (51°F) or less.[23]
To complement this Code, the new 2005 Sanitary Food Transportation Act has transferred authority for regulating the safe transportation of food from the Department of Transportation to the Department of Health and Human Services. It requires shippers, motor vehicles, or rail vehicle carriers and other persons engaged in the transportation of food to use sanitary transportation practices.[24] Other documents speaking to the storage, handling and transportation of cold chain products include the U.S. “Transportation and Storage Requirements for Potentially Hazardous Foods” guidelines.[25-27]
In addition to government legislation, industry has developed voluntary recommended practices for the handling and merchandising of frozen foods.[28] This was necessary in order to ensure frozen food quality for the benefit of the consumer. Some important factors considered are maintaining a temperature of 0°F (-18°C) and rotation of inventory throughout the cold chain.
Of course, the U.S. is involved in food law harmonization efforts through its work with Codex Alimentarius, and several government representatives from FDA and USDA sit on the various food safety-related committees, including Food Hygiene. This committee has issued several proposed draft principles and guidelines related to improving cold chain management, including those for the conduct of microbiological risk management and the application of general principles of food hygiene to the control of Listeria monocytogenes in ready-to-eat foods. Similarly, the U.S. provides leadership in the Codex Committee on Food Import and Export Certification and Inspection Systems, which is charged with developing principles and guidelines for food import and export certification and inspection systems. In November 2006, this committee will consider draft appendices to the Codex “Guidelines for the Judgment of Equivalence of Sanitary Measures Associated with Food Import and Export Inspection and Certification Systems.”[29] Uruguay
Uzbekistan
V
Vanuatu
Vatican City (Holy See)
Venezuela
Vietnam
Y
Yemen
Z
Zambia
Zimbabwe