Food Laws And Regulations



Food laws and regulations

• Until recently, effectiveness of food control in the Indian domestic market was found to be severely undermined by the existence of multiple jurisdictions, and weaknesses in surveillance, monitoring and enforcement.
• Several of these food laws were enacted under different ministries in India that had their own rules and orders, which created a perplex and sometime contradictory environment for the food business sector.
• Thus, despite a notable list of food legislations, not much could be achieved in terms of food safety and consumers’ protection in the country.
• In the second quarter of 2006, the country witnessed a new initiative of enactment of the latest Act, ‘the Food Safety and Standards Act, 2006, under the Ministry of Health and Family Welfare that integrates the existing eight food laws.
•  It brings about one statute under a single apex regulatory authority known as Food Safety and Standards Authority of India (FSSAI) with minor revisions, while adding the key provisions to further strengthen food safety regulation.
• The Central Government notifies Food Safety and Standards Rules,2011 on May 5, 2011. This new initiative lays down science-based standards for better food quality control.
• The Act is based on international legislations, instrumentalities and Codex Alimentarius Commission.
• It is divided in 12 chapters containing 101 sections and two schedules that provide key provisions to improve food safety in primary food from production to consumption

FOOD SAFETY AND STANDARDS ACT, 2006

• An Act to consolidate the laws relating to food and to establish the Food Safety and Standards Authority of India for laying down science based standards for articles of food and to regulate their manufacture, storage, distribution, sale and import, to ensure availability of safe and wholesome food for human consumption and for matters connected therewith or incidental thereto.

Establishment of Food Safety and Standards Authority of India

1. The Central Government shall, by notification, establish a body to be known as the Food Safety and Standards Authority of India to exercise the powers conferred on, and to perform the functions assigned to, it under this Act.
2. The Food Authority shall be a body corporate by the name aforesaid, having perpetual succession and a seal with power to acquire, hold and dispose of property, both movable and immovable, and to contract and shall, by the said name, sue or be sued.
3. The head office of the Food Authority shall be at Delhi.
4. The Food Authority may establish its offices at any other place in India.

Duties and functions of Food Authority

• It shall be the duty of the Food Authority to regulate and monitor the manufacture, processing, distribution, sale and import of food so as to ensure safe and wholesome food.
• Without prejudice to the provisions of sub-section (1),the Food Authority may by regulations specify

1. The standards and guidelines in relation to articles of food and specifying an appropriate system for enforcing various standards notified under this Act;
2. The limits for use of food additives, crop contaminants, pesticide residues, residues of veterinary drugs, heavy metals, processing aids, myco-toxins, antibiotics and pharmacological active substances and irradiation of food;
3. The mechanisms and guidelines for accreditation of certification bodies engaged in certification of food safety management systems for food businesses;
4. The procedure and the enforcement of quality control in relation to any article of food imported into India;
5. The procedure and guidelines for accreditation of laboratories and notification of the accredited laboratories;
6.  The method of sampling, analysis and exchange of information among enforcement authorities;
7. Conduct survey of enforcement and administration of this Act in the country;
8. Food labelling standards including claims on health, nutrition, special dietary uses and food category systems for foods;
9. The manner in which and the procedure subject to which risk analysis, risk assessment, risk communication and risk management shall be undertaken.

GENERAL PRINCIPLES OF FOOD SAFETY

• The Central Government, the State Governments, the Food Authority and other agencies, as the case may be, while implementing the provisions of this Act shall be guided by the following principles namely:-

1. Endeavour to achieve an appropriate level of protection of human life and health and the protection of consumer’s interests, including fair practices in all kinds of food trade with reference to food safety standards and practices;
2. Carry out risk management which shall include taking into account the results of risk assessment and other factors which in the opinion of the Food Authority are relevant to the matter under consideration and where the conditions are relevant, in order to achieve the general objectives of regulations;
3. Where in any specific circumstances, on the basis of assessment of available information, the possibility of harmful effects on health is identified but scientific uncertainty persists, provisional risk management measures necessary to ensure appropriate level of health protection may be adopted, 21 pending further scientific information for a more comprehensive risk assessment;
4. The measures adopted on the basis of clause
5. Shall be proportionate and no more restrictive of trade than is required to achieve appropriate level of health protection, regard being had to technical and economic feasibility and other factors regarded as reasonable and proper in the matter under consideration;
6. The measures adopted shall be reviewed within a reasonable period of time, depending on the nature of the risk to life or health being identified and the type of scientific information needed to clarify the scientific uncertainty and to conduct a more comprehensive risk assessment;
7. In cases where there are reasonable grounds to suspect that a food may present a risk for human health, then, depending on the nature, seriousness and extent of that risk, the Food Authority and the Commissioner of Food Safety shall take appropriate steps to inform the general public of the nature of the risk to health, identifying to the fullest extent possible the food or type of food, the risk that it may present, and the measures which are taken or about to be taken to prevent, reduce or eliminate that risk; and
8. Where any food which fails to comply with food safety requirements is part of a batch, lot or consignment of food of the same class or description, it shall be presumed until the contrary is proved, that all of the food in that batch, lot or consignment fails to comply with those requirements.

GENERAL POVISIONS AS TO ARTICLES OF FOOD

Use of food additive or processing aid

• No article of food shall contain any food additive or processing aid unless it is in accordance with the provisions of this Act and regulations made thereunder.
• Explanation– For the purposes of this section, “processing aid” means any substance or material, not including apparatus or utensils, and not consumed as a food ingredient by itself, used in the processing of raw materials, foods or its ingredients to fulfil a 23 certain technological purpose during treatment or processing and which may result in the non-intentional but unavoidable presence of residues or derivatives in the final product.

Contaminants, naturally occurring toxic substances, heavy metals, etc

• No article of food shall contain any contaminant, naturally occurring toxic substances or toxins or hormone or heavy metals in excess of such quantities as may be specified by regulations.

Pesticides, veterinary drugs residues, antibiotic residues and microbiological counts

1. No article of food shall contain insecticides or pesticides residues, veterinary drugs residues, antibiotic residues, solvent residues, pharmacological active substances and micro-biological counts in excess of such tolerance limit as may be specified by regulations.
2. No insecticide shall be used directly on article of food except fumigants registered and approved under the Insecticides Act, 1968 (46 of 1968)

Genetically modified foods, organic foods, functional foods, proprietary foods, etc

• Save as otherwise provided under this Act and regulations made thereunder, no person shall manufacture, distribute, sell or import any novel food, genetically modified articles of food, irradiated food, organic foods, foods for special dietary uses, functional foods, neutraceuticals, health supplements, proprietary foods and such other articles of food which the Central Government may notify in this behalf.

Packaging and labelling of foods

1. No person shall manufacture, distribute, sell or expose for sale or despatch or deliver to any agent or broker for the purpose of sale, any packaged food products which are not marked and labelled in the manner as may be specified by regulations: Provided that the labels shall not contain any statement, claim, design or device which is false or misleading in any particular concerning the food products contained in the package or concerning the quantity or the nutritive value implying medicinal or therapeutic claims or in relation to the place of origin of the said food products.
2. Every food business operator shall ensure that the labelling and presentation of food, including their shape, appearance or packaging, the packaging materials used, the manner in which they are arranged and the setting in which they are displayed, and the information which is made available about them through whatever medium, does not mislead consumers.

Restrictions of advertisement and prohibition as to unfair trade practices

1. No advertisement shall be made of any food which is misleading or deceiving or contravenes the provisions of this Act, the rules and regulations made thereunder.
2. No person shall engage himself in any unfair trade practice for purpose of promoting the sale, supply, use and consumption of articles of food or adopt any unfair or deceptive practice including the practice of making any statement, whether orally or in writing or by visible representation which –

1. falsely represents that the foods are of a particular standard, quality, quantity or grade-composition;
2. makes a false or misleading representation concerning the need for, or the usefulness;
3. gives to the public any guarantee of the efficacy that is not based on an adequate or scientific justification thereof:

• Provided that where a defence is raised to the effect that such guarantee is based on adequate or scientific justification, the burden of proof of such defence shall lie on the person raising such defence.

PROVISIONS RELATING TO IMPORT

All imports of articles of food to be subject to this Act.

1. No person shall import into India –

1. any unsafe or misbranded or sub-standard food or food containing extraneous matter;
2. any article of food for the import of which a licence is required under any Act or rules or regulations, except in accordance with the conditions of the licence; and
3. Any article of food in contravention of any other provision of this Act or of any rule or regulation made thereunder or any other Act.

2. The Central Government shall, while prohibiting, restricting or otherwise regulating import of article of food under the Foreign Trade (Development and Regulation) Act, 1992 (22 of 1992), follow the standards laid down by the Food Authority under the provisions of this Act and the Rules and regulations made there under.

SPECIAL RESPONSIBILITIES AS TO FOOD SAFETY

Responsibilities of the Food business operator

1. Every food business operator shall ensure that the articles of food satisfy the requirements of this Act and the rules and regulations made there under at all stages of production, processing, import, distribution and sale within the businesses under his control.
2. No food business operator shall himself or by any person on his behalf manufacture, store, sell or distribute any article of food
1. which is unsafe; or
2. which is misbranded or sub-standard or contains extraneous matter; or
3. for which a licence is required, except in accordance with the conditions of the licence; or
4. which is for the time being prohibited by the Food Authority or the Central Government or the State Government in the interest of public health; or
5. In contravention of any other provision of this Act or of any rule or regulation made there under.

1. No food business operator shall sell or offer for sale any article of food to any vendor unless he also gives a guarantee in writing in the form specified by regulations about the nature and quality of such article to the vendor: Provided that a bill, cash memo, or invoice in respect of the sale of any article of food given by a food business operator to the vendor shall be deemed to be a guarantee under this section, even if a guarantee in the specified form is not included in the bill, cash memo or invoice.
2. Where any food which is unsafe is part of a batch, lot or consignment of food of the same class or description, it shall be presumed that all the food in that batch, lot or consignment is also unsafe, unless following a detailed assessment within a specified time, it is found that there is no evidence that the rest of the batch, lot or consignment is unsafe.

Liability of the manufacturers, packers, wholesalers, distributors and sellers

1. The manufacturer or packer of an article of food shall be liable for such article of food if it does not meet the requirements of this Act and the rules and regulations made there under.
2. The wholesaler or distributor shall be liable under this Act for any article of food which is
1. Supplied after the date of its expiry; or
2. Stored or supplied in violation of the safety instructions of the manufacturer; or
3. Unsafe or misbranded; or
4. Unidentifiable of manufacturer from whom the article of food have been received; or
5. Stored or handled or kept in violation of the provisions of this Act, the rules and regulations made thereunder; or
6.  received by him with knowledge of being unsafe
3. The seller shall be liable under this Act for any article of food which is
1. sold after the date of its expiry; or
2. handled or kept in unhygienic conditions; or
3. misbranded; or
4. unidentifiable of the manufacturer or the distributors from whom such articles of food were received; or
5. received by him with knowledge of being unsafe

ANALYSIS OF FOOD

Recognition and accreditation of laboratories, research institutions and referral food laboratory

1. The Food Authority may notify food laboratories and research institutions accredited by National Accreditation Board for Testing and Calibration Laboratories or any other accreditation agency for the purposes of carrying out analysis of samples by the Food Analysts under this Act.
2. The Food Authority shall, establish or recognise by notification, one or more referral food laboratory or laboratories to carry out the functions entrusted to the referral food laboratory by this Act or any rules and regulations made thereunder.
3. The Food Authority may frame regulations specifying –
1. The functions of food laboratory and referral food laboratory and the local area or areas within which such functions may be carried out;
2. The procedure for submission to the said laboratory of samples of articles of food for analysis or tests, the forms of the laboratory’s reports thereon and the fees payable in respect of such reports; and
3. Such other matters as may be necessary or expedient to enable the said laboratory to carry out its functions effectively.

Recognition of organisation or agency for food safety audit

The Food Authority may recognise any organisation or agency for the purposes of food safety audit and checking compliance with food safety management systems required under this Act or the rules and regulations made thereunder.

OFFENCES AND PENALTIES

Penalty for selling food not of the nature or substance or quality demanded

• Any person who sells to the purchaser’s prejudice any food which is not in compliance with the provisions of this Act or the regulations made thereunder, or of the nature or substance or quality demanded by the purchaser, shall be liable to a penalty not exceeding five lakh rupees.

Penalty for sub-standard food

• Any person who whether by himself or by any other person on his behalf manufactures for sale or stores or sells or distributes or imports any article of food for human consumption which is sub-standard, shall be liable to a penalty which may extend to five lakh rupees.

Penalty for misbranded food

1. Any person who whether by himself or by any other person on his behalf manufactures for sale or stores or sells or distributes or imports any article of food for human consumption which is misbranded, shall be liable to a penalty which may extend to three lakh rupees.
2. The Adjudicating Officer may issue a direction to the person found guilty of an offence under this section, for taking corrective action to rectify the mistake or such article of food shall be destroyed.

Penalty for food containing extraneous matter

• Any person whether by himself or by any other person on his behalf manufactures for sale or stores or sells or distributes or imports any article of food for human consumption containing extraneous matter, shall be liable to a penalty which may extend to one lakh rupees.

Penalty for misleading advertisement

1. Any person who publishes, or is a party to the publication of an advertisement, which (a) falsely describes any food; or (b) is likely to mislead as to the nature or substance or quality of any food or gives false guarantee, shall be liable to a penalty which may extend to ten lakh rupees.
2. In any proceeding the fact that a label or advertisement relating to any article of food in respect of which the contravention is alleged to have been committed contained an accurate statement of the composition of the food shall not preclude the court from finding that the contravention was committed.

Penalty for failure to comply with the directions of Food Safety Officer

• If a food business operator or importer without reasonable ground, fails to comply with the requirements of this Act or the rules or regulations or orders issued thereunder, as directed by the Food Safety Officer, he shall be liable to a penalty which may extend to two lakh rupees.

Penalty for unhygienic or unsanitary processing or manufacturing of food

• Any person who, whether by himself or by any other person on his behalf, manufactures or processes any article of food for human consumption under unhygienic or unsanitary conditions, shall be liable to a penalty which may extend to one lakh rupees

Punishment for false information

• If a person, in connection with a requirement or direction under this Act, provides any information or produces any document that the person knows is false or misleading, he shall be punishable with imprisonment for a term which may extend to three months and also with fine which may extend to two lakh rupees.

Punishment for carrying out a business without licence

If any person or food business operator (except the persons exempted from licensing under sub-section (2) of section 31 of this Act), himself or by any person on his behalf who is required to obtain licence, manufacturers, sells, stores or distributes or imports any article of food without licence, shall be punishable with imprisonment for a term which may extend to six months and also with a fine which may extend to five lakh rupees.