What is food regulation?
Food is regulated in order to ensure that it is safe for human consumption. Food regulation guidelines help set reliable standards of disclosure, so people know what goes into an item of food, and can make informed choices about what they eat. The institutionalisation of food regulation also serves the purpose of providing the public with assurance that food is certified as safe for consumption.
This is however a complex task as there are a very large number of persons and enterprises are in the business of food, and by the diversity of enterprise-scale, food cultures and knowledge systems. Food regulation is a public good: everyone benefits from having a credible framework. Food regulation also has economic effects on the production side. It interacts most directly with food processing and production industries, but has effects for every type of food-related economic activity from farm to fork. Moreover, its effects are both domestic and international, as food regulators determine what foods are permitted for importation into their country. There are also legal requirements of inter-legibility between domestic and international standards by virtue of WTO treaty obligations, in which food regulation plays a part.
Regulations must necessarily contend with vast amounts of scientific uncertainty on many issues relating to food. Food regulators therefore formulate their regulations based on an assessment of risk to human health. These regulations are expected to be reasonable in relation to the anticipated risk, and to balance the concerns of health and safety with the economic interests of food businesses.
Scope and Design of Food Regulation
Food is regulated through activities that include setting food safety standards, developing guidelines, mandating disclosure, devising certification standards, testing of products, monitoring and supervision, and the imposition of sanctions and penalties. It also includes public education about food safety amongst the general public and to people and enterprises in the business of producing and selling food.
Food regulation requires scientific expertise and infrastructure. It also has economic and administrative dimensions. It needs to have feet on the ground in every single place where food is made and sold. It needs to be agile, to keep pace with changing marketplace conditions.
In terms of regulatory design, it might be useful to think of food regulation as a domain of specialisation. Food regulation does not need an arms’ length relationship with government, except to establish a domain of specialisation. In fact, India’s food regulation system is quite closely integrated with the executive state for monitoring and enforcement activities, although it has some financial and administrative independence. The parent ministry for food regulation, i.e., the Ministry of Health and Family Welfare, is responsible for providing approvals and support to FSSAI. Food regulation also has a quasi-judicial side, to support its penal and sanctions-making powers.
The Food Safety and Standards Act, 2006 provides the legal framework for food regulation in India. This law was enacted with the objective of consolidating numerous laws and regulations relating to food regulation. It also established an agency to make and implement science-based rules and guidelines applicable to the manufacture, storage, distribution, sale and import of food. Following this law, the Food Safety and Standards Authority of India (‘FSSAI’ or ‘the food authority’) was established in 2008. The law also provides for monitoring and enforcement, and for a system of integration and coordination between regulation, policy and compliance aspects of food regulation. It also provides for coordination between various agencies and officials of the central and state governments in their regulatory work.
FSSAI’s principal function is to make regulations and policy. It lays down standards and guidelines in relation to articles of food, and provides for licensing, registration and accreditation for food business operators. It is mandated to specify systems for enforcing its standards, for accreditation of certification systems and for certification of food safety management systems for food businesses.
FSSAI lays down procedure and guidelines for regulatory activities, including for quality control of food imports, for accreditation of testing labs, for labelling of food articles, and for sampling and analysis of food items. The manner and procedures for risk analysis and risk management in relation to food are also to be laid down by it.
FSSAI also has broad market shaping roles. It may be called upon to provide scientific advice and technical support to central and state governments for framing policy in areas that have a bearing on food safety and nutrition. It can take up initiatives to educate both food business operators and the general public on food safety, hygiene and nutrition. It can also take up self-regulatory interventions – such as through labelling and information campaigns – to encourage manufacturers and consumers to make and eat healthy food.
FSSAI is expected to collect and collate data regarding food consumption, incidence and prevalence of biological risk, contaminants in food, residues of various, contaminants in foods products, identification of emerging risks and introduction of the rapid alert system. It is also expected to contribute to the development of international technical standards for food, sanitary and phytosanitary standards.
Both the content and the rule-making process of food standards are also required to follow India’s commitments to the WTO, under the Agreement for Sanitary and Phytosanitary Measures and the Agreement on Technical Barriers to Trade, which require for standards to be non-discriminatory to international trade. In this, our food standards often guided by the Codex Alimentarius, an international compilation of food standards, although this is non-binding and its local application is sometimes controversial.
Representation, transparency and consultation are important features of food regulation. The law provides for the representation of consumers, farmers, retailers, and food industry, including small scale industry in the composition of the food authority, and in its various panels and committees. Several other ministries of the central government and the state governments, and experts and food scientists are also represented in it. The law also provides – perhaps uniquely for a statutory regulatory authority – that one-third of its 22 members should be women. The law provides for consultation in the regulation-making process, for formal representations by stakeholder groups, and for the disclosure of scientific opinions that it has received and adopted.
The administrative structure of food regulation is made up at the central level of FSSAI, which is advised by several Scientific Panels, a Scientific Committee and a Central Advisory Committee. The administration of food regulation is headed by the Chief Executive Officer (‘CEO’), who is both member secretary of FSSAI and Chairperson of the Central Advisory Committee. At the state-level, food regulation is administered by Commissioners of Food Safety appointed by state governments. Designated officers and food safety officers function at district and local level in coordination with state and local authorities. They have a frontline role in monitoring, inspecting and ensuring compliance with regulations at the local level. In addition, there are Adjudicating Officers and Food Safety Appellate Tribunals, to carry out the adjudication of offences and penalties under the Act.
The Central Advisory Committee and the CEO are responsible for providing administrative coherence to the overall framework for food regulation.
Issues and Challenges
Food regulation has a critical role to play in allaying public concerns about food adulteration, junk foods and the indiscriminate use of chemicals in farming and food processing. This has some Indian dimensions: poor hygiene practices and lack of enforcement capacity. There are also growing concerns about unhealthy fats, salt and sugar in processed foods, that are to be addressed through food regulation.
There is also the challenge of having differing requirements for small and big enterprises. Regulations that are appropriate for large and organised manufacturers might be quite difficult for small operators to comply with. Perhaps for this reason, our food regulations tend to treat small scale and micro enterprise food businesses as a distinct category from larger businesses, and the rules differently applicable to these categories. This approach might help rationalise the cost of regulation for small enterprises, while ensuring that they are not left out of the regulatory system or made illegal for their inability to comply with regulatory mandates.
Uncertainties about the regulatory process might also be an area of concern for the food authority. The food authority’s actions have been struck down by courts for procedural shortcomings in some instances, whereas in others the courts have directed the authority and food commissioners to ensure improved implementation of the law and regulations.
Some of the other challenges of food regulation include staffing shortages and inadequate laboratory infrastructure, which means that food businesses might see regulation as paperwork rather than as a credible threat of being inspected.
The integration with international markets is another area of challenge. There are several instances in which Indian exporters have been prevented from selling their goods in other countries for failure to comply with local regulations. This could be because of the difference between Indian regulations and international standards, or because it was difficult to monitor and enforce standards for small scale and unorganised suppliers. The Indian government and the food authority have opposed the use of international standards as a backdoor trade barrier, while also promoting increased participation of developing countries in the formulation of international standards.