Jan 1, 2012
Launch of online Licensing and food Import Clearance System
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Inspection, auditing of food establishments and food testing as per FSSA 2006
India has recently put into practice its FSS Act 2006 / FSS Regulation 2011 and the entire food industry is expected to adhere to it. Apart from several other firsts, one of the primary changes that FSSA has brought about is imposing the responsibility of food safety on the manufacturer for the first time (under the PFA regime, it was the food inspector responsible for examination and prosecution).
Audits and inspections
A periodic internal audit of the whole system is to be done to find out any fault / gap in the adopted SOP to follow GMP/GHP system. Hence the knowledge and skills are needed to evaluate the effectiveness of a Food Safety Management System a requirement of any organisation in the food chain in accordance with Part 2, Schedule 4 of the Food Safety Act 2006 / Rules and Regulations 2011. Therefore FBOs (food business operators) should have a person with the skills and knowledge necessary to implement and conduct internal audit of Food Safety Management Systems (FSMS).
The commissioner of food safety has the authority to appoint a designated officer in charge of a district whose duties shall include issuing or cancelling licenses of FBOs, and shall be responsible for inspection of food business, drawing samples and sending them to food analyst for analysis serving �improvement notices,� prohibiting sale of food articles violating prescribed standards, receiving reports and samples of food articles from FSOs (food safety officers) and getting them analysed, sanctioned or launch prosecutions and get investigated any complaint against any contravention of the Act or against the FSOs.
Powers and duties of FSO
(i) Where the food safety officer is of the opinion or has reason(s) to be recorded in writing that in the given situation it is not possible to comply with the provision of Section 38 (1) (c) or the provision to Section 38 (1) for reasons like non-availability of the food business operator, the food safety officer may seize the adulterant or food which is unsafe or sub-standard or mis-branded or containing extraneous matter, may seal the premises for investigation after taking a sample of such adulterant or food for analysis.
(ii) Where the food safety officer is of the opinion or he has reason(s) to believe that any person engaged in selling, handling or manufacturing any article of food is suffering from or harbouring the germs of any infectious disease, he may cause such a person to be examined by a qualified medical professional duly authorised by the designated officer.
Provided that where such a person is a female, she shall be examined by a qualified lady medical professional duly authorised by the designated officer.
If on such examination the qualified medical professional certifies that such a person is suffering from any such disease, the designated officer, on the recommendation of the food safety officer may by order in writing direct such person not to take part in selling or manufacturing any article of food.
In emergency, in the interest of public health, the food safety officer may direct such a person to suspend food related operations, while informing the designated officer simultaneously.
(iii) Furthermore, it shall be the duty of the food safety officer
(a) To inspect, as frequently as may be prescribed by the designated officer, all food establishments licensed for manufacturing, handling, packing or selling of an article of food within the area assigned to him.
(b) To satisfy himself that the conditions of licenses are being complied with, by each of the food business operators carrying on business within the area assigned to him and report to the designated officer.
(c) To procure and send for analysis if necessary, samples of any article of food which he has reason to suspect are being manufactured, stocked or sold or exhibited for sale in contravention of the provisions of the Act, or rules and regulations framed there-under.
(d) To draw samples for purposes of surveillance, survey and research, which shall not be used for prosecution.
(e) To investigate any complaint which may be made to him in writing in respect of any contravention of the provisions of the Act, or rules framed there-under.
(f) To maintain a database of all food business within the area assigned to him.
(g) To recommend issue of improvement notices to the food business operator whenever necessary.
(h) To maintain a record of all inspections made and actions taken by him in the performance of his duties, including the taking of samples and seizure of stocks, and to submit copies of such records to the designated officer as directed in this regard.
(i) To make such inquiries and inspections as may be necessary to detect the manufacture, storage or sale of articles of food in contravention of the Act or rules framed there-under.
(j) To stop and inspect any vehicle suspected to contain any unsafe food or food which does not comply with the provisions of this Act and rules, intended for sale or delivery for human consumption.
(k) To recommend to the designated officer giving specific grounds, suitable action in regard to licenses issued to any food business operator, if on inspection the food safety officer finds that the food business operator had violated the conditions for grant of license.
(l) To carry out food safety surveillance to identify and address the safety hazards.
(m) To respond to incidents of food poisoning in his area and to send report to and assist the designated officer to enable him to initiate corrective action.
(n) To facilitate preparation of food safety plans for panchayat and municipalities in accordance with the parameters and guidelines given in Schedule IV of Chapter 3 of Regulations.
(o) To detain imported packages which are suspected to contain articles of food, the import or sale of which is prohibited.
(p) To coordinate with the food business operators within his area of operation and facilitate the introduction of food safety systems by the food business operators.
Food sampling and testing procedures
Procedure for taking sample and manner of sending it for analysis -
The food safety officer while taking sample of food for analysis under Clause A of Sub Section (1) of Section 38 and Section 47 (except 47 (5)) of the Act, shall also ensure that
1. The presence of at least two witnesses at the time of drawing of the samples.
2. Obtain the signatures from the witnesses in all the forms and documents prepared.
3. Serve the notice in Form V A to the business operator then and there.
4. In case the food business operator discloses that the product has been obtained from the manufacturer, the distributor or supplier, a notice shall be given to such manufacturer, distributor or supplier.
5. In case where the sample is drawn from an open container, the person drawing the sample shall also draw a sample from a container in original condition of the same article bearing the same declaration, if such container is available, and intimate the same to the food analyst.
6. Where a food safety officer takes a sample of an article of food for analysis, he shall pay, the cost of such sample, to the person from whom the sample is taken, calculated at the rate at which the article is sold to the public.
The FSO shall draw four samples. The product sample drawn shall be divided into four parts, sealed and signature of the person from whom sample is drawn shall be obtained. If FBO refuses to sign one of the witnesses called at the sight of sampling shall be asked to put his / her signatures on the sample drawn and sealed. One part of the drawn sample shall be sealed and sent to the food analyst and the two parts of the sample sealed shall be sent to the designated officer by suitable means. The food safety officer must serve a notice in form VA to the FBO right there and then only. However, as per the provision if FBO requests for analysis of the sample by NABL-accredited laboratory in that case fourth sample has to be sent to NABL-accredited lab. In case if the reports of food analyst and accredited laboratory are at variance, FBO can go in appeal to appropriate authority (designated officer). Then out of the 2nd and 3rd retained sample DO shall send one sample to a Referral Laboratory for analysis the results of which shall be considered final. The action will be initiated against the FBO based on this result either failed or complied with.
Food analyst duties
The food analyst after receiving the sample from the food safety officer shall analyse the sample and send the analysis report mentioning method of sampling and analysis within 14 days to designated officer with a copy to commissioner of food safety.
The designated officer after scrutiny of the report of food analyst shall decide as to whether the contravention is punishable with imprisonment or fine only and in the case of Contravention punishable with imprisonment, he shall send his recommendations within 14 days to the commissioner of food safety for sanctioning prosecution.
The commissioner of food safety shall, if he so deems fit decide, within the period Prescribed by the Central government, as per the gravity of offence, whether the matter be Referred to�
(a) A court of ordinary jurisdiction in case of offences punishable with imprisonment for a term up to three years; or
(b) A special court in case of offences punishable with imprisonment for a term exceeding three years where such special court is established and in case no special court is established, such cases shall be tried by a court of ordinary jurisdiction.
(5) The commissioner of food safety shall communicate his decision to the designated officer and the concerned food safety officer who shall launch prosecution before courts of ordinary jurisdiction or special court, as the case may be; and such communication shall also be sent to the purchaser if the sample was taken under Section 40.
The FSSAI has the provision of Notified Laboratories and Referral Laboratories as mentioned above
�Notified laboratory� means any of the laboratories notified by the food authority under sub-sections (1) and (2) of Section 43 of the Act.
�Referral laboratory� means any of the laboratories established and / or recognised by the food authority by notification under sub-section (2) of Section 43 of the Act.
Functions - of Referral Laboratory
In addition to the functions entrusted to it under the Act, the Referral Laboratory shall carry out the following functions, namely:
1) Analysis of samples of food sent by any officer or authority authorised by the food authority for the purpose and submission of the certificate of analysis to the authorities concerned;
2) Investigation for the purpose of fixation of standard of any article of food;
3) Investigation in collaboration with the laboratories of food analysts in the various states and such other laboratories and institutions which the food authority may approve on its behalf, for the purpose of standardising methods of analysis;
4) Ensuring that the laboratory follows the scientific protocols laid down for handling / testing the articles of food;
5) Maintaining high standards of accuracy, reliability and credibility in the operation of the laboratory and achieving and maintaining the required levels of accreditation and reliability;
6) Laying down mechanism for ensuring that personnel of the laboratory adhere to high professional standards and discipline.
Impact of FSSA on the F&B industry
The F&B industry has a mixed reaction to FSSA. On one hand, the industry appreciates the timely deliverables from the Act, in terms of registration & licensing. But on the other hand, it is apprehensive about the high penalty structure. I personally think a good deterrent system is a must for any law to be enforced well. But misuse of this penalty structure should be prevented.
One of the major changes that the F&B industry is going to face is to document all their Good Manufacturing Practices (GMP) and Good Hygiene Practices (GHP) in the form of a FSMS. This FSMS document should be able to prove that by following these steps, their food output is safe & hygienic. The industry will also have to get Water Sampling done regularly and submit the reports while applying.
Audits and inspections
A periodic internal audit of the whole system is to be done to find out any fault / gap in the adopted SOP to follow GMP/GHP system. Hence the knowledge and skills are needed to evaluate the effectiveness of a Food Safety Management System a requirement of any organisation in the food chain in accordance with Part 2, Schedule 4 of the Food Safety Act 2006 / Rules and Regulations 2011. Therefore FBOs (food business operators) should have a person with the skills and knowledge necessary to implement and conduct internal audit of Food Safety Management Systems (FSMS).
The commissioner of food safety has the authority to appoint a designated officer in charge of a district whose duties shall include issuing or cancelling licenses of FBOs, and shall be responsible for inspection of food business, drawing samples and sending them to food analyst for analysis serving �improvement notices,� prohibiting sale of food articles violating prescribed standards, receiving reports and samples of food articles from FSOs (food safety officers) and getting them analysed, sanctioned or launch prosecutions and get investigated any complaint against any contravention of the Act or against the FSOs.
Powers and duties of FSO
(i) Where the food safety officer is of the opinion or has reason(s) to be recorded in writing that in the given situation it is not possible to comply with the provision of Section 38 (1) (c) or the provision to Section 38 (1) for reasons like non-availability of the food business operator, the food safety officer may seize the adulterant or food which is unsafe or sub-standard or mis-branded or containing extraneous matter, may seal the premises for investigation after taking a sample of such adulterant or food for analysis.
(ii) Where the food safety officer is of the opinion or he has reason(s) to believe that any person engaged in selling, handling or manufacturing any article of food is suffering from or harbouring the germs of any infectious disease, he may cause such a person to be examined by a qualified medical professional duly authorised by the designated officer.
Provided that where such a person is a female, she shall be examined by a qualified lady medical professional duly authorised by the designated officer.
If on such examination the qualified medical professional certifies that such a person is suffering from any such disease, the designated officer, on the recommendation of the food safety officer may by order in writing direct such person not to take part in selling or manufacturing any article of food.
In emergency, in the interest of public health, the food safety officer may direct such a person to suspend food related operations, while informing the designated officer simultaneously.
(iii) Furthermore, it shall be the duty of the food safety officer
(a) To inspect, as frequently as may be prescribed by the designated officer, all food establishments licensed for manufacturing, handling, packing or selling of an article of food within the area assigned to him.
(b) To satisfy himself that the conditions of licenses are being complied with, by each of the food business operators carrying on business within the area assigned to him and report to the designated officer.
(c) To procure and send for analysis if necessary, samples of any article of food which he has reason to suspect are being manufactured, stocked or sold or exhibited for sale in contravention of the provisions of the Act, or rules and regulations framed there-under.
(d) To draw samples for purposes of surveillance, survey and research, which shall not be used for prosecution.
(e) To investigate any complaint which may be made to him in writing in respect of any contravention of the provisions of the Act, or rules framed there-under.
(f) To maintain a database of all food business within the area assigned to him.
(g) To recommend issue of improvement notices to the food business operator whenever necessary.
(h) To maintain a record of all inspections made and actions taken by him in the performance of his duties, including the taking of samples and seizure of stocks, and to submit copies of such records to the designated officer as directed in this regard.
(i) To make such inquiries and inspections as may be necessary to detect the manufacture, storage or sale of articles of food in contravention of the Act or rules framed there-under.
(j) To stop and inspect any vehicle suspected to contain any unsafe food or food which does not comply with the provisions of this Act and rules, intended for sale or delivery for human consumption.
(k) To recommend to the designated officer giving specific grounds, suitable action in regard to licenses issued to any food business operator, if on inspection the food safety officer finds that the food business operator had violated the conditions for grant of license.
(l) To carry out food safety surveillance to identify and address the safety hazards.
(m) To respond to incidents of food poisoning in his area and to send report to and assist the designated officer to enable him to initiate corrective action.
(n) To facilitate preparation of food safety plans for panchayat and municipalities in accordance with the parameters and guidelines given in Schedule IV of Chapter 3 of Regulations.
(o) To detain imported packages which are suspected to contain articles of food, the import or sale of which is prohibited.
(p) To coordinate with the food business operators within his area of operation and facilitate the introduction of food safety systems by the food business operators.
Food sampling and testing procedures
Procedure for taking sample and manner of sending it for analysis -
The food safety officer while taking sample of food for analysis under Clause A of Sub Section (1) of Section 38 and Section 47 (except 47 (5)) of the Act, shall also ensure that
1. The presence of at least two witnesses at the time of drawing of the samples.
2. Obtain the signatures from the witnesses in all the forms and documents prepared.
3. Serve the notice in Form V A to the business operator then and there.
4. In case the food business operator discloses that the product has been obtained from the manufacturer, the distributor or supplier, a notice shall be given to such manufacturer, distributor or supplier.
5. In case where the sample is drawn from an open container, the person drawing the sample shall also draw a sample from a container in original condition of the same article bearing the same declaration, if such container is available, and intimate the same to the food analyst.
6. Where a food safety officer takes a sample of an article of food for analysis, he shall pay, the cost of such sample, to the person from whom the sample is taken, calculated at the rate at which the article is sold to the public.
The FSO shall draw four samples. The product sample drawn shall be divided into four parts, sealed and signature of the person from whom sample is drawn shall be obtained. If FBO refuses to sign one of the witnesses called at the sight of sampling shall be asked to put his / her signatures on the sample drawn and sealed. One part of the drawn sample shall be sealed and sent to the food analyst and the two parts of the sample sealed shall be sent to the designated officer by suitable means. The food safety officer must serve a notice in form VA to the FBO right there and then only. However, as per the provision if FBO requests for analysis of the sample by NABL-accredited laboratory in that case fourth sample has to be sent to NABL-accredited lab. In case if the reports of food analyst and accredited laboratory are at variance, FBO can go in appeal to appropriate authority (designated officer). Then out of the 2nd and 3rd retained sample DO shall send one sample to a Referral Laboratory for analysis the results of which shall be considered final. The action will be initiated against the FBO based on this result either failed or complied with.
Food analyst duties
The food analyst after receiving the sample from the food safety officer shall analyse the sample and send the analysis report mentioning method of sampling and analysis within 14 days to designated officer with a copy to commissioner of food safety.
The designated officer after scrutiny of the report of food analyst shall decide as to whether the contravention is punishable with imprisonment or fine only and in the case of Contravention punishable with imprisonment, he shall send his recommendations within 14 days to the commissioner of food safety for sanctioning prosecution.
The commissioner of food safety shall, if he so deems fit decide, within the period Prescribed by the Central government, as per the gravity of offence, whether the matter be Referred to�
(a) A court of ordinary jurisdiction in case of offences punishable with imprisonment for a term up to three years; or
(b) A special court in case of offences punishable with imprisonment for a term exceeding three years where such special court is established and in case no special court is established, such cases shall be tried by a court of ordinary jurisdiction.
(5) The commissioner of food safety shall communicate his decision to the designated officer and the concerned food safety officer who shall launch prosecution before courts of ordinary jurisdiction or special court, as the case may be; and such communication shall also be sent to the purchaser if the sample was taken under Section 40.
The FSSAI has the provision of Notified Laboratories and Referral Laboratories as mentioned above
�Notified laboratory� means any of the laboratories notified by the food authority under sub-sections (1) and (2) of Section 43 of the Act.
�Referral laboratory� means any of the laboratories established and / or recognised by the food authority by notification under sub-section (2) of Section 43 of the Act.
Functions - of Referral Laboratory
In addition to the functions entrusted to it under the Act, the Referral Laboratory shall carry out the following functions, namely:
1) Analysis of samples of food sent by any officer or authority authorised by the food authority for the purpose and submission of the certificate of analysis to the authorities concerned;
2) Investigation for the purpose of fixation of standard of any article of food;
3) Investigation in collaboration with the laboratories of food analysts in the various states and such other laboratories and institutions which the food authority may approve on its behalf, for the purpose of standardising methods of analysis;
4) Ensuring that the laboratory follows the scientific protocols laid down for handling / testing the articles of food;
5) Maintaining high standards of accuracy, reliability and credibility in the operation of the laboratory and achieving and maintaining the required levels of accreditation and reliability;
6) Laying down mechanism for ensuring that personnel of the laboratory adhere to high professional standards and discipline.
Impact of FSSA on the F&B industry
The F&B industry has a mixed reaction to FSSA. On one hand, the industry appreciates the timely deliverables from the Act, in terms of registration & licensing. But on the other hand, it is apprehensive about the high penalty structure. I personally think a good deterrent system is a must for any law to be enforced well. But misuse of this penalty structure should be prevented.
One of the major changes that the F&B industry is going to face is to document all their Good Manufacturing Practices (GMP) and Good Hygiene Practices (GHP) in the form of a FSMS. This FSMS document should be able to prove that by following these steps, their food output is safe & hygienic. The industry will also have to get Water Sampling done regularly and submit the reports while applying.
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