Food safety regulations & standards

The food trade has enormous impact on both the health of populations and the economies of nations.

Organisations from the UN to world trade bodies, national governments and processors accept that people have the right to expect a high standard from food. At the same time they need to ensure trade does not have so many restrictions that it becomes too burdensome.

World food trade

The volume of world food trade is valued between US$300–400 billion, according to FAO.

With the increasing urbanisation of populations, even developing countries are becoming more reliant on global trade and food processing for their supply of food.

It is important that in the long supply chains from farm to consumer food is kept safe, of good quality and suitable for consumption.

Impact on businesses

These requirements impact business sectors like food processors and producers in every country as consumers are demanding better safety and quality. Producers and processors exporting food to other countries are subject to their own national regulations and also the strict enforcements of standards and regulations of the major importing countries.

The implementation of food safety involves a complex mix of laws, standards and accepted good practices, involving governments, international organisations (e.g. WTO), industry organisations (e.g. GFSI, BRC), research agencies, independent standards bodies (e.g. BRC, IFS) and independent certification bodies.

Codex Alimentarius

The global reference point for food producers, processors, consumers, national food safety agencies and the international food trade is the Codex Alimentarius, first drawn up by the FAO and WHO in 1961 and managed by the Codex Alimentarius Commission.

The importance of Codex Alimentarius was recognised in the 1985 United Nations Resolution 39/248:

"Governments should take into account the need of all consumers for food security and should support and, as far as possible, adopt standards from the Food and Agriculture Organization of the United Nations and the World Health Organization Codex Alimentarius..."

Global reference point for food safety and quality

It has become the global driver for harmonisation of practices and standards among national bodies, for food safety and quality and also international trade. Its standards are recognised by the World Trade Organisation (WTO) for the settlement of trade disputes.

The Codex has stimulated countries to introduce new food legislation and Codex-based standards, and to establish or strengthen agencies responsible for monitoring compliance with regulations.

Food Safety Acts in Europe and the UK

The EU set up the European Food Safety Authority in 2002 as an independent source of scientific advice.

The UK government established the independent Food Standards Agency (FSA) in 2001, bringing together several existing agencies into one body, to promote standards through the food chain and advise the government.

India’s Food Safety Act

India introduced the Food Safety and Standards Act in 2006, which consolidated various organisations to create the Food Safety and Standards Authority of India (FSSAI).

EU Food Safety Regulations

In the European Union, the food and drink industry is the biggest manufacturing sector in terms of jobs and value added. It is also both one of the world’s largest importers of food products and the world’s largest exporter of processed food and drink products, with an export value of €43 billion in 2013, according to the European Commission.

The EU negotiates trade agreements for member countries and represents all member countries in the WTO for multilateral trade agreements. It has negotiated bilateral agreements with members of all the major trading blocks, such as OECD countries, Gulf Co-operation Council, Mercosur and Andean countries, etc.

The General Food Law Regulation (EC) 178/2002

All EU and individual national measures are guided by the general principles of food and feed law described in the The General Food Law Regulation (EC) 178/2002. These cover all stages of the production, processing and distribution of food and animal feed.

The general objectives of EU food law are:

• guarantee a high level of protection of human life and health and the protection of consumers’ interests;
• guarantee fair practices in food trade, taking into account animal health and welfare, plant health and the environment;
• ensure free movement of food and feed manufactured and marketed in the EU;
• facilitate global trade of safe feed and safe, wholesome food by taking into account international standards and agreements.

Further regulations on food hygiene were introduced in 2004:

• Regulation (EC) 852/2004 on the hygiene of foodstuffs;
• Regulation (EC) 853/2004 on specific hygiene rules for food of animal origin;
• Regulation (EC) 854/2004 on specific rules for the organisation of official controls on products of animal origin intended for human consumption.

These gave the food business operator primary responsibility for food safety and specified that the general implementation of procedures must be based on HACCP (hazard analysis and critical control point) principles. The regulations also specified the development of guides to good hygiene practices for specific processes to help businesses comply with the rules.

US Food Safety Regulations

The US is the largest exporter and the second largest importer of agricultural products. US federal legislation regarding food processing, however, has lagged behind other developed countries.

Food borne diseases in the US

Around 48 million people suffer from food borne diseases annually and 128,000 are hospitalised, according to estimates by the US Centers for Disease Control and Prevention [CDC] in 2010. Contaminated food has cost the food production and processing industry billions of dollars from recalls, lost sales and legal expenses.

Outbreaks of the more serious preventable food-borne diseases, a recent rapid expansion in the global scale and complexity of the food system and threats of bioterrorism have all stimulated the US Congress to introduce a new law: the Food Safety Modernisation Act (FSMA). This is the first major piece of federal legislation on food safety since 1938.

Food Safety Modernization Act (FSMA)

The Food Safety Modernization Act (FSMA) was signed into law by President Obama on 4 Jan 2011. It puts a major emphasis on ensuring food safety and public health using preventive action, rather than reacting after incidents of contamination.

This will change the role of the US Food and Drug Administration (FDA) as the Act comes into force over the next few years. It gives the FDA legal authority to require comprehensive, science-based preventive controls across the food supply chain.

FSMA rules

As a requirement of the Act, the FDA is required to provide FSMA rules and guidance for industry specifying detailed requirements of the Act.

Some of the Final Rules include, but are not limited to, the following:

• Final Rule: Amendments to Registration of Food Facilities (effective July 2016)
• Final Rule: Mitigation Strategies to Protect Food Against Intentional Adulteration (effective May 2016)
• Final Rule: Food Supplier Verification Programs (FSVP) for Importers of Food for Humans and Animals (effective November 2015)
• Final Rule: Produce Safety (effective November 2015)

One of the FSMA rules addresses the Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food issued in September 2015.

The rules require food facilities to have a food safety plan that includes:

• hazard analysis, preventive controls
• oversight and management of preventive controls
• monitoring; corrections and corrective actions (documented)
• and verification that preventive controls are implemented and effective

The new Hazard Analysis and Risk-based Preventive Controls (HARPC) apply to all food processing facilities except those covered by USDA regulations (meat, poultry, eggs), farmers and growers, seafood and juice producers, low acid canned food processors, and small businesses (product value under $500,000).

FSMA compliance

The many FSMA Rules continue to roll-out with the compliance dates impacting companies at different times based on organization size and type of operation.

The FDA has the ultimate responsibility for ensuring compliance through guidance and training and now it also has important new tools to aid with inspections and compliance.

Compliance with the FSMA Final Rule on Produce Safety is on-going. Delay in the roll-out has caused much confusion in the industry around meanings, which led to the FDA having to re-evaluate their terminology for transparency.

Compliance dates for the Final Rule on Sanitary Transportation were only delivered in April 2017.

The FDA is still writing the draft industry guidance for complying with the Final Rule on Current Good Manufacturing Practice, Hazard Analysis, and Risk Based Preventive Controls for Human Food.

Good manufacturing practices

FSMA Final Rule for Preventive Controls for Human Food updates the current good manufacturing practices (GMPs) for manufacturing, processing, and packing or holding human food.

Some previously voluntary provisions are now binding, including education and training of employees.

• Now employees must have the “necessary combination of education, training, and/or experience necessary to manufacture, process, pack, or hold clean and safe food”.
• Employees must also “receive training in the principles of food hygiene and food safety, including the importance of employee health and hygiene”.

Large businesses have one year to comply with the rules (ie by September 2016), medium businesses two years and small businesses three years.

The FSMA also provides the FDA with the power to require imported foods to have the same standards as domestic foods, along with powers of inspection, so it has global consequences for food production and processing businesses.

The new scale of responsibilities of the FDA means that it has to rely on inspections by other federal, state and local agencies in the country and build partnerships and agreements with other organisations to carry out inspections of facilities in other countries. The number of inspections in other countries was legislated to start at 600 and double every year for five years.

Food safety in China

Since China joined the World Trade Organisation in 2001, trade with the rest of the world increased dramatically and provided a stimulation to adhere to international standards. It is a major food importer, being the largest market for the US, now taking 20% of all US food exports.

China has also strengthened its food safety laws recently. In 2009, following a series of food scandals and the changes in laws in other countries, it passed legislation similar to that in other countries regarding standards, inspection, imports and exports and responding to food safety incidents.

Learn more about China’s food law.

Food safety standards

Food safety standards help companies establish good manufacturing processes so they can produce safe products that comply with food safety legislation and meet quality levels expected by consumers.

They are generally formulated by independent bodies such as BRC and IFS, adopted by food processing businesses and checked by certified accreditation bodies.

Global Food Safety Initiative

The Global Food Safety Initiative (GFSI) is a body set up by the world’s leading retailers and manufacturers in 2000 to provide thought leadership and guidance on food safety management systems.

GFSI facilitates collaboration between the food safety experts from retail, manufacturing and food service companies, and also international organisations, governments, academia and service providers to the global food industry.

A benchmark for food safety standards

GFSI creates the benchmark for food safety standards and gives approval to those that reach its ‘standard for standards’.

The BRC Global Standard for Food Safety was the first to be approved by GFSI and is the most widely used worldwide. This sets out seven sections for an effective food safety system:

1. Senior management commitment and continual improvement.
2. The Food Safety Plan: HACCP (hazard analysis and critical control point) program based on the requirements of the Codex Alimentarius system.
3. Food safety and quality management system: product specifications, supplier approval, traceability, and the management of incidents and product recalls. This builds on the principles of ISO 9000.
4. Site standards: layout and maintenance of the buildings and equipment, cleaning, pest control, waste management and foreign body control.
5. Product control: product design and development including allergen management, product and ingredient provenance, product packaging and product inspection and testing.
6. Process control: safe process controls, weight/volume control, equipment calibration, ensuring the HACCP plan is implemented.
7. Personnel: standards for staff training, protective clothing and personal hygiene.

Learn more about the BRC Food Safety Standard.

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Hazard Analysis & Critical Control Point

HACCP (Hazard Analysis and Critical Control Point) is a systematic approach to food safety that focuses on preventing contamination from biological, chemical, physical and radiological hazards.

HARPC (Hazard Analysis and Risk-Based Preventive Controls) is a recent adaptation for certain businesses in the USA that come under the Food Safety and Modernization Act.

HACCP was first developed for the design and manufacture of food for the US space programme.

The hazards include bacteria, viruses, natural toxins, pesticides, drug residues, decomposition, parasites, allergens, unapproved food and colour additives, and radioactive compounds.

HACCP is used at all stages of food production, from raw material production, procurement and handling, to manufacturing, distribution and consumption of the finished product. Each food processing or handling business must develop an HACCP system and tailor it to its individual product, processing and distribution conditions.

The 7 principles of HACCP

The seven principles of HACCP are accepted by government agencies, trade associations and the food industry around the world. These principles are:

1. Conduct a hazard analysis.
2. Identify critical control points (CCPs).
3. Establish critical limits for critical control points.
4. Establish monitoring procedures.
5. Establish corrective actions.
6. Establish verification procedures.
7. Establish record-keeping and documentation procedures.

Responding to terrorism threats

The US FSMA and standards used in Europe and the US, such as the BRC version 7 of its Global Standard for Food Safety and the British Standards Institute PAS96: 2014, now add the prevention of deliberate attack on a food or drink supply chain, including from terrorism, to the procedures.

PAS96: 2014 uses a risk management methodology called Threat Assessment Critical Control Points (TAACP) to assess the entire production process and food chain.

CARVER + shock method

In the US, food processors use the CARVER + shock method to assess vulnerabilities within a system or infrastructure to an attack using seven attributes graded on a scale of 1-10 according to FDA guidelines:

• criticality;
• accessibility;
• recuperability;
• vulnerability;
• effect — direct loss in production;
• recognisability — ease of identifying target;
• shock.

Examples of risk-based preventive controls include hygiene procedures for equipment, utensils and surfaces; environmental sampling; food allergen controls; supplier verification.

GMP (Good Manufacturing Practice)

GMPs describe the methods, equipment, facilities, and controls for producing processed food to produce high quality and safe products and are generally specified in regulations. In the US GMPs are written into the food regulations by the FDA. The regulations address personnel, buildings and facilities, equipment and utensils, and production and process controls.

GMPs, along with standard operating procedures (SOPs), form the basis for HACPP and the ISO9000 quality management standard. They are often visualised as a pyramid of dependencie

Figure: The foundation of HACCP and ISO9000
Source: University of Nebraska (link)

Bibliography

Food Standards Agency. Food Hygiene. A Guide for Businesses. London, Food Standards Agency, 2013

Overview of HACCP Principles. University of Nebraska – Lincoln.
www.unl.edu

FDA. Food Safety Modernisation Act.
www.fda.gov/Food/GuidanceRegulation/FSMA

North Dakota State University. Food Law. International Considerations.
www.ag.ndsu.edu/foodlaw/international-considerations

European Commission.Food Hygiene Basic Legislation.
ec.europa.eu/food/food/biosafety/hygienelegislation/comm_rules_en.htm

www.fda.gov/Food/GuidanceRegulation/FSMA/ucm334115.htm

www.fda.gov/Food/GuidanceRegulation/FSMA/ucm253380.htm