' Case studies - IGMPI

IGMPI is conferred with ASSOCHAM Services Excellence Award 2017: Our Directors Mr Syed S. Abbas & Mrs Rafat Abedi, Chief Advisor Dr Mahesh Gupta, Advisor Mr Amitabh Srivastava are being honoured by the Chief Guest & Honorable Member of Parliament Dr. Udit Raj

(L-R) Seetaraju Gembali, Managing Director, GSR Pharma Research; Vinod Arora, Principal Advisor, IGMPI (Moderator); Dr Girish Jain, President, Research & Development, Alkem Laboratories and Pramod Pimplikar, Managing Director, Shalina Laboratories

Maneuver your growth through adequate food safety knowledge

Maneuver your growth through adequate food safety knowledge

Where food safety is a culture, Maneuver your growth through adequate food safety knowledge

Where food safety is a culture, Maneuver your growth through adequate food safety knowledge

 

Case studies

Nestle’s ‘Maggi’ Recall –A Complete Report

Nestle India’s instant noodle brand ‘Maggi’ was found to contain excess levels of lead and monosodium glutamate (MSG) as initially revealed by a report from Uttar Pradesh Food Safety and Drug Administration (FSDA) Agency. As a result of the disclosure, Maggi noodle sales suffered a severe hit with rising consumer concerns while the Food Safety and Standards Authority of India initiated a nationwide testing of the 2-minute noodles based on ten quality parameters. Reportedly, about 35-40 per cent of samples picked up by state agencies failed the test in nine states, containing lead and monosodium glutamate in excess of prescribed limits, though in some, including Goa and Kerala, the noodles passed muster. Test reports from Delhi, Uttar Pradesh, Goa, Gujarat, Kerala, Madhya Pradesh, Telangana, Uttarakhand and Tamil Nadu were sent to the FSSAI. The Food Authority issued a full scale of Maggi noodles in India which caused a severe dent in Nestle’s popularity and brand image. Nestle India’s Maggi exports to US, Canada, UK, Australia, Singapore and Kenya have also been suspended.

The case initiated when the Food Safety and Drug Administration (FDA) in Uttar Pradesh said high lead content was found during routine tests on two dozen packets of instant noodles, manufactured by Nestle in India. They found a lead concentration of 17.2 parts per million (ppm), nearly seven times the permissible limit. The FDA officials said the acceptable limit of lead ranges between 0.01 ppm and 2.5 ppm. The scientists also found high levels of added monosodium glutamate (MSG), a taste enhancer, in the noodles.

Regulations Violated by ‘Maggi’

Three major violations were noted qua the subject cited products, viz.

1st Infringement: Presence of Lead detected in the product in excess of the maximum permissible levels of 2.5ppm;

2nd Infringement: Misleading labelling information on the package reading “No added MSG”, and

3rd Infringement: Release of a non-standardised food product in the market, viz. “Maggi Oats Masala Noodles with Tastemaker” without risk assessment and grant of product approval.

The Company representatives were called for a hearing by the Chairman, FSSAI at the office of the Food Authority with a view to seek their response in the matter and also to know as to what steps the Company had taken in terms of compliance of its obligations under Section 26 of the FSS Act, 2006. Mr. Paul Bulcke, global CEO of the Company, Mr. Etienne Benet, MD & CEO, Nestle (India), Mr. Sanjay Khajuria attended the meeting. The Company representatives stated that they were committed to providing safe food for the consumers and that the whole controversy had been created on account of confusions created and lack of proper understanding of the issue. The Company’s response on each of the above issues was as follows:

  • The Company asserted that the testing protocols had not been followed and interpreted correctly. According to them:
  1. The Product contained two parts i.e. the Noodle and the Tastemaker. The samples had been tested for each of the two components separately whereas it should have been tested as a combined end product, i.e. the form in which it is finally consumed;
  2. The CFL Kolkata had also tested the product as a combined product but the results showed a very high level of Lead because the samples remained open for a considerable period before being tested;
  • The “No added MSG” on the label was on account of lack of clarity in the regulation and that the Company had followed the practice generally followed by the industry in this behalf. However, they added that the Company would rectify the labels if it was interpreted as a case of mislabeling and that the Company had already ordered printing of new labels without mentioning “No added MSG” thereon and that their products would be packed in the re-printed packets after the current stock was exhausted. However, the Company also finally agreed to pack all freshly manufactured food in the new packaging.
  • As regards the issue of release of one of the variants, viz. “Maggi Oats Masala Noodles with Tastemaker” in the market without getting the product assessed for its risk/ safety and grant of product approval, the Company representative stated that this product had been launched at a time when the Advisory dated 11.05.2013 was under stay granted by the Court. The attention of the Company representatives was drawn to the provisions contained in Section 22 under which the food product as a ‘Proprietary Food’ was not at all allowed to be manufactured and placed in the market, the Company representatives stated they would comply with the directions of the Food Authority in this behalf.

Having heard the Company representatives on each of the issues, the observations of the Authority with regard to these issues are as under:

A. Presence of Lead in excess of the permissible safety limits:

The sample taken by the establishment of the Commissioner of Food Safety, UP and tested by the CFL, Kolkata found presence of lead at 17.2 ppm. The test results received from the GNCT, Delhi in respect of 13 samples drawn from different batches indicate the presence of Lead in excess of the maximum permissible level of 2.5 ppm in case of 10 out of the 13 samples tested (one of them being the product for which approval had not been taken). Similarly, a total of 40 samples were reported to have been drawn including the noodles of other brands. Having received the Test Reports in respect of 29 samples by last evening and found the presence of Lead in excess of the prescribed limits in 15 samples, the State of Gujarat had already issued a recall order. Further, the results of Test samples drawn and tested in the state of Tamil Nadu also confirmed the presence of Lead in excess of the permissible limits, including in the Noodles of some other manufacturing companies. It was clear from the reports received from various states that there was overwhelming evidence of the said food products being unsafe and hazardous for human consumption. The maximum permissible level of Lead is 2.5 ppm as stated by the Company in its application dated 04.12.2012 submitted for the Product Approval for ‘Instant Noodles with Tastemaker’, of which Masala was one of the variants applied for. As per the Certificate of Analysis furnished by the Company with its application, the Lead was 0.0153 ppm vide report dated 17.10.2012.

Detection of Lead in a food product as a Heavy Metal contaminant beyond permissible levels renders the food product unsafe and hazardous. Reference is made to a document published by the Food Safety Authority of Ireland on “Mercury, Lead, Cadmium, Tin and Arsenic in Food” (Issue No.1, May 2009 in its Toxicology Factsheet Series) which succinctly brings out the adverse toxic effects of lead as under:

“Short-term exposure to high levels of lead can cause brain damage, paralysis, (lead palsy), anaemia and gastrointestinal symptoms. Long term exposure can cause damage to the kidneys, reproductive and immune systems in addition to effects on the nervous system. The most critical effect of low-level lead exposure is on intellectual development in young children and like mercury, lead crosses the placental barrier and accumulates in the foetus. Infants and young children are more vulnerable than adults to the toxic effects of Lead, and they also absorb lead more easily. Even short-term low-level exposure of young children to lead is considered to have an effect on neurobehavioural development. Consumption of food containing lead is the major source of exposure for the general population.”

It was established from numerous scientific studies that presence of heavy metal (Lead in this case) as a contaminant beyond the permissible limits is a serious health hazard and cannot be allowed in any product in the market.

B. Violation of labelling related Regulations:

It was noted with concern that the label of the said product specifically mentions thereon “No Added MSG” whereas the product was found to be containing Mono Sodium Glutamate (MSG). The Company had stated vide its letter dated 2nd June, 2015 that its claim is regarding “Added MSG” which was a correct position since the Company had not added any MSG (E621). It further stated that “it is a known fact that it is not possible to distinguish between naturally occurring glutamate and added glutamate in foods”. The Company’s aforesaid letter further reads “We have been declaring “No Added MSG” on Maggie Noodle Packs as we do not add MSG (flavour enhancer- E621) as an additive in the product. This is a common practice across the industry in many food products viz. instant noodles, ready to eat foods, soups etc.” Drawing support from the legal opinion taken from Mr. Justice V.N. Khare, former Chief Justice of India, it was further stated that “the declaration of “No Added MSG” on the labels of Maggie Noodles does not violate the Food Safety Standards Act, its rules and its regulations thereunder”.

The assertions made by the Company in its aforesaid letter were not found acceptable. The following Regulation 2.2.1:1 may be referred for this, which reads as under:

     “  1.   Every pre-packaged food shall carry a label containing information as required hereunder unless otherwise provided,  namely,

  1. Pre-packaged food shall not be described or presented on any label or in any labelling manner that is false, misleading or deceptive or is likely to create an erroneous impression regarding its character in any respect;”

It is amply clear that this sub-regulation prohibits any other information on the label other than what is otherwise provided for in the FSSR. It defies the common understanding as to why the Company has to make this assertion when it is not required to do so. The apparent reason for using such information on the label is driven by an undue commercial advantage/ benefit to create an erroneous impression in the minds of consumers regarding the character of the product.

C. “Maggi Oats Masala Noodles with Tastemaker”:

M/s Nestle India was aware that the said products, being proprietary food in nature, being non-standardised, are covered under Section 22 of the FSS Act, 2006 and require risk/ safety assessment and approval before these are manufactured and placed in the market. The Company had applied for ‘Product Approval’ in respect of product titled “Maggie Oats Masala Noodles with Tastemaker” vide its application dated 27.08.2014. Certain clarifications were sought from the Company for Safety/ Risk assessment in respect of the said product vide FSSAI communication dated 25.02.2015. The Company did not respond to the clarifications within the prescribed time, and as such the application already stands ordered to be closed being non-responsive.

The disturbing fact was that the Company had already released the said product in the market without completing the process of risk assessment and has been promoting its sales. The argument that this product was launched when the Advisory dated 11.05.2013 was under stay holds no ground in the face of legal provisions. This is illegal and a serious violation of the FSS Act, Rules and Regulations thereunder. In the absence of safety/risk assessment and grant of Product Approval of a food product covered under Section 22 of the FSS Act, the Company has acted in violation of law. As such, the product cannot be allowed to be intended for human consumption and has to be withdrawn from the market forthwith.

From the aforesaid, it is evident that the Company has also failed to comply with its obligations laid down under Section 26 of the Act. Further, the Company has violated the FSS Act, Rules and Regulations thereunder and rendered itself liable to prosecution under Sections 20, 22, 23, Section 24 read with Section 53, Section 26, 27, 48, 50, 52, 58 and Section 59 of the FSS Act, 2006, read with the applicable Rules and Regulations thereunder.

In the meantime, the Commissioners of Food Safety of various states, viz. the U.P., GNCT of Delhi, Gujarat, Tamil Nadu, J&K, Assam and a few other are reported to have passed orders prohibiting the said products for varying periods within their respective jurisdictions.

Keeping the aforesaid in view, without prejudice to the rights of the respective Commissioners of Food Safety and the Food Safety establishments of various States and Union Territories and the consumers to file prosecutions against the Company for various violations, and in exercise of powers vested in the Food Authority under Section 16(1) of the FSS Act, read with the general principles enshrined under clauses (a), (b), (c), (f) and (g) of Sub-section (1) of Section 18, further read with the provisions contained in Sections 26 and 28 and the powers vested under Section 10(5) read with Section 29 of the FSS Act, 2006, the Company was hereby directed to:

  • Withdraw and recall all the 09 approved variants of its Maggi Instant Noodles from the market having been found unsafe and hazardous for human consumption, and stop further production, processing, import, distribution and sale of the said product with immediate effect;
  • As already agreed by the Company during the hearing in respect of the rectification of label and removal of “No added MSG”, the Company is directed to comply with the related labelling regulations in this behalf forthwith;
  • Withdraw and recall the food product, “Maggie Oats Masala Noodles with Tastemaker” for which risk/ safety assessment has not been undertaken and Product Approval has not been granted.
  • In case any other food product falling under Section 22 of the Act is being manufactured and marketed by the Company, for which risk assessment has not been undertaken by way of grant of Product Approval/ NoC by the FSSAI, the same be withdrawn from the market with immediate effect and the FSSAI be informed about such products within 24 hours of the receipt of this communication, and
  • Take appropriate action to re-ascertain the safety of its products in compliance of the obligations cast upon the Company in terms of provisions contained in Section 26 of the Act under intimation to the FSSAI.

M/s Nestle India Private Limited was further called upon to show cause within a period of 15 days from the date of issue of this communication as to why the Product approval granted by FSSAI in respect of “Instant Noodles with Tastemaker – (9 variants)” vide its letter dated 04.07.2013 be not withdrawn.

The Company was further directed to submit a compliance report in this behalf within a period of three days and furnish progress reports on the recall process on a daily basis thereafter till the process is completed.

Letter issued by the FDA to Intershell International Corporation.

The Food and Drug Administration, USA had carried out an inspection in the seafood processing facility of the Intershell International Corporation in the month of August 2014. There were a series of observations found during this inspection that were considered to be as violations of the seafood HACCP regulation given by the FDA.

The hazard analysis was absent and the HACCP plan did not feature the critical control point for the control of the food safety hazard of the clostridium botulinum toxin formation for the pasteurized canned crab meat. Thus it was not adequate to control the hazard from clostridium botulinum toxin formation. It was observed that no continuous monitoring of the refrigerated trucks was being done to ensure adequate temperatures and the product was also not covered in ice during transport. Further, it was highlighted that random selection of the product containers for recording the internal temperature of the product was not being carried out. The transport records were not reviewed to determine the date and time of the product, when it was removed from a controlled temperature environment before shipment. No records for date and time of delivery were present. It was noted that the response to these violations by the firm did not include an amended copy of the HACCP plan for review and no evidence for the implementation of the corrective actions and also no timetable to implement the proposed corrective actions.

During the inspection it was observed that a continuous temperature monitoring device was not used to monitor the cooler temperature and continuous temperature monitoring documentation could not be provided for review. Further, there was no indication what refrigerated storage monitoring measures that will be employed in the interim while waiting for the installation of a continuous monitoring device. It was also observed that the corrective action plan does not include procedures to bring affected products back under temperature control or procedures to investigate the root cause of the deviation to ensure control of the process.

This company was required to have a strong HACCP plan that should have covered all the aspects. HAACP (CFR 21 part 123) is a mandatory requirement by the FDA for the seafood. Seafood is a high risk product and should be dealt with extra care. The FDA after inspection highlighted the key aspects of a food safety system that can never be compromised while dealing with food safety.

When a processor of fish or fishery products fails to have and implement a HACCP plan that complies with 21 CFR 123.6(g) or otherwise operate in accordance with the requirements of part 123, it will render the fish or fishery products adulterated within the meaning of Section 402(a) (4) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 342(a) (4).

The pasteurized canned crabmeat was declared adulterated, as it had been prepared, packed, or held under insanitary conditions whereby it may have been rendered injurious to health.

The HACCP plan is the foremost thing that drives the whole system in terms of food safety.  If it is relevant the critical limits and their controls could be easily identified but if the important factors i.e. the holistic approach is neglected then there would be a sheer source of contamination in the food.

Clostridium Botulinum is a serious microorganism that can cause death through the neurotoxin botulinum, whose lethal dose is just 1 µg.

To prevent the occurrence of botulism one has to be very careful.

A hazard analysis has to be done and critical limits should comply with 21 CFR 123.6(a) and (c) (2).The product should be covered in ice as it ensures the maintenance of the right temperatures in the product and also prevents the contamination of food from external source.

Transport records should always be reviewed to ensure the suitability of the product carrier. There could be a possibility of contamination or spoilage if the refrigerator is not functioning properly during the transportation. The transport records should have all the information related to the food product they are carrying to be known at the time of delivery and these results in a greater traceability system.

The transport records are an important source of information for transparent traceability system.

A continuous temperature control device should be installed to ensure the presence of required temperature in the refrigerator. The continuous monitoring of the temperature (i.e., at or below 40°F (4.4°C) should be done to verify if the temperature is maintained or not. This should be done at regular intervals. The periodic check will ensure the correct temperature in the food product and prevent it from spoilage.

In the case of refrigerated pasteurized canned crabmeat, strict refrigeration control (i.e., at or below 40°F (4.4°C)) should be maintained during storage and distribution to prevent growth and toxin formation byClostridium botulinum type A and proteolytic types B and F.

The critical control point’s records should be maintained and produced by a responsible person for both continuous monitoring and for future reference. They should be verified and validated.

All the changes in the plan or any document should be mentioned on the document and the previous documents should either be destroyed or kept in a place where it is not considered for present compliance.

The corrective actions should be initiated with a holistic approach. All the members of the HACCP team should be involved to ensure the best output and it should be such that there be obtained an evidence to prove its efficiency. The HACCP team should always be composed of multidisciplinary people.

There should be defined procedures to handle the non- conforming or the affected product so that it may not contaminate the normal product.

 Internal Audits should be carried out to ensure the efficiency of the system to prevent any unwanted audit non compliance during inspection.

As food safety is a continuous discipline thus it can never be neglected and if it is involved in every step that a firm makes; there would be seldom an instant of breach in food safety.

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