Aug 21, 2015

How legitimate is FSSAI’s product approval mechanism?

Companies have expressed unhappiness with FSSAI’s product approval procedures in the past
SC questioned the product approval process followed by the FSSAI.
New Delhi: The Supreme Court on Wednesday questioned the product approval process followed by the Food Safety and Standards Authority of India (FSSAI), delivering the second judicial rebuke to the food safety regulator within a week.
Sure, companies have expressed unhappiness with FSSAI’s product approval procedures in the past. But this was probably the first time the apex court has questioned the authority, which suffered a setback on 13 August when the Bombay high court set aside the regulator’s ban on the sale of Nestle India Ltd’s Maggi noodles.
Here’s how the country’s food regulator goes about approving food products and declareing them safe for consumption.
The producer or marketer of a product needs to submit an application – electronically or manually – with supporting documents and analysis reports from accredited laboratoties, along with an image of the pack.
FSSAI’s product committee scrutinizes the documents and approves or rejects them or seeks further documentation. The scrutiny process is complicated and entails about a dozen steps, according to the FSSAI’s website.
“A company seeking approval for a particular product or a variant of a product does not require submitting the sample of the product. So, FSSAI does not conduct tests before giving approval to a particular product,” aid an executive at a multinational packaged foods company requesting anonymity.
“The approval comes based on the documents and reports from accredited laboratories that the company submits along with the application,” the same executive said.
FSSAI chief executive officer Y.S. Malik did not respond to emails seeking comment. Malik also did not respond to official requests for a meeting.
According to executives at multi-national food and beverages companies, typically product approval takes about 18 months. The fee for product approval is Rs25,000 for every variant of any product. And, if rejected, a company can reapply for approval any number of times. The company needs to pay an additional Rs25,000 in case the new product approval application requires intervention by FSSAI’s scientific panel.
FSSAI has only set 377 standards for food items. If it wants to change increase the number of notified standards, the regulator would have had to go to Parliament for approval to introduce the new standards, said a lawyer who has recently represented a company in a food safety related case.
According to the lawyer, FSSAI has taken the short-cut called ‘product approval’ route by way of issuing advisories so that it does not require to seek approval from Parliament.
Between January 2010 and May 2013, the regulator issued nine different advisories changing earlier prescribed rules, according to the FSSAI website.
According to the Food Safety and Standards Act, every proprietary product, especially packaged food items – existing or new, ingredients and additives for which FSSAI does not have any notified standards-- need to be approved by FSSAI to ensure food safety.
Even for already approved products, minor compositional changes in ingredients require product approval. Similarly, approved products with changed claims on the label require approval. However, traditional ethnic foods (like chiwda, halwa, jalebi, rasaogolla, idli and dosa batter) are not required to get product approval provided they contain only the permitted quantity of food additives.
According to information available on the FSSAI website, the regulator has evaluated 14,000-15,000 product approval applications since January 2012.
According to a presentation by the FSSAI, the regulator’s job is to ensure safety of more than 2 billion meals per day in the country, bring about 35 million food and beverages outlets under licence and surveillance, enforce the new safety regulations uniformly across the wide spectrum of registered food vendors across the country. Apart from this, FSSAI looks into imported food items, their standards and labeling.
And to perform these tasks, the FSSAI has just about 30 people working at its headquarter in New Delhi.
Besides manpower, there are other issues. FSSAI conducts inspections and surveillances help of the state-level food authorities to ensure food safety. Here, the inspectors pick up random samples, and test those at laboratories which is limited to a network of four referral and about 86 local ones that have the regulator’s approval. It also needs laboratories for testing of imported packaged food and ingredients that FSSAI seizes at ports and airports.
Importers are not happy. “There’s no set standard, and FSSAI seem to be either too lethargic, or horribly short of manpower. It takes months to get clearance for a consignment if it gets stuck at FSSAI door,” said the owner of a Kolkata-based packaged tea company.
The firm was importing jasmine flowers that were to be used in producing jasmine tea packs. “Since it was imported from a different country and not from the usual one, FSSAI seized the consignment of $50,000 for inspection. We followed it up for about eight months (while the flowers would have just a few weeks of shelf life) and then let it go,” said the official.
The experience was more painful for the owner of a Delhi-based cheese company who was importing cheese worth $2.5 lakh last year. “FSSAI simply does not have the capacity to handle these. Surveillance is fine, but they should do it quickly so that the business does not suffer. As the cheese consignment was not kept in a cold store, and FSSAI kept it at the port for months, it was a complete waste. And our business suffered,” said the cheese company owner.
Both the importers said FSSAI do not have the cold store facilities, and most of the consumable products go waste because of the time that FSSAI takes.
FSSAI was set up under the Food Safety and Standard Act, 2006 that was passed by the Government in August 2011. The Act was brought in to create a single independent statutory body for food laws, standards and enforcement (that regulates standards for manufacturing, distribution, sale and import of all kinds of food in India),.
FSSAI asked the government for about Rs5,000 crore to scale up. But in the 12th five year plan (2012-17), the government allocated only Rs2,350 crore to it.

FDA again finds lead in Maggi packs

MUMBAI: Your bowl of noodles could be a cause for concern, after all. The Maharashtra Food and Drug Administration (FDA) has found lead contamination in fresh batches of Nestle India's Maggi noodles tested over the last two months. Out of 46 samples randomly collected from across the state, four showed excess lead content. This lead content, expressed in 'parts per million' (or ppm) was in the range of 2.92 to 3.33. The permissible limit is 2.5 PPM.
The 46 samples had been collected in June at the instructions of the Food Safety Standard Association of India (FSSAI) that wanted FDAs of all states to conduct elaborate tests to ascertain the presence of lead.
Previously, a batch of 20 samples had been tested by the FDA in June before it embarked on scrutinizing of these additional 46 samples. In the previous batch, lead contamination was found in five of the 20 samples. It ranged between 2.59 ppm, running as high as 4.66 ppm in some samples. It was on the basis of this initial finding that the state government had banned the product in Maharashtra on June 3.
The new findings come a week after the Bombay high court struck down the nationwide ban on Nestle India's product. A senior FDA official said that they will share the findings with the FSSAI before deciding on the next step of action. FDA commissioner Harshadeep K amble refused to comment on the issue.
However, another FDA official told TOI on that the four contaiminated samples had been taken from Kolhapur whereas samples from Mumbai, Pune, Sangli, Kolhapur, Aurangabad and Thane conformed to quality norms.
"The first round of tests was done on limited 20 samples as there was spotlight and speculation on the issue. To make the findings authentic, more tests were ordered by FSSAI," said the official. "In the wake of the high court order, we will seek legal opinion on what to do with the new results," the official added.
The fresh tests were carried out at Referral Laboratory in Pune, one of the foremost national testing centres where the earlier tests on 20 samples had also been partly conducted. The high court had, however, raised doubts about the accreditation of the lab and thereby the findings. Accreditation of the lab was also one of the grounds for overruling the ban imposed by FSSAI.
Besides Nestle's Maggi, FDA is testing noodles manufactured by other companies. At least 27 samples are currently under scrutiny. "We are checking several parameters besides lead and MSG, a test enhancer. The tests will take long," the FDA official said.
Abnormal lead exposure is associated with health problems including impaired neurological development. However, lead poisoning takes place only when one is exposed to too much of lead in a short time.

Safe Kerala drive to check hygiene in eateries

Notices served to 93 institutions
: The Health Department served notices to 93 institutions on Wednesday after the inspections it took out across the district as part of the Safe Kerala drive.
The raids were conducted as part of the programme to contain the spread of infectious diseases as well as a precaution for the festive season. “We have had many instances of food poisoning around Onam in the previous years and hence decided to take a precautionary measure this year,” District Medical Officer K. Narayanana Naik said.
The Health Department Officials in association with their counterparts from the food and safety department raided various restaurants, bakeries and other institutions that handled food. The officials divided themselves into 95 teams and inspected 400 restaurants, 281 cool bars, 263 bakeries, 9 catering units, 18 soda manufacturing units, 4 ice factories and 323 other institutions.
The 93 institutions were served notice for either functioning without a license, for cooking in unhygienic conditions, for not processing their waste in the right way, for facilitating spread of infectious diseases, for not destroying places where mosquitoes could breed and for not maintaining drains properly. They have been given a notice period to correct the situation or to be dealt with severe punishment.
A second stage of the drive will be held on Saturday.

உணவுப்பொருட்களில் நச்சு கண்டறிய தற்காலிக ஆய்வுக்கூடம் அமைத்த கேரளா

பாலக்காடு: வெளி மாநிலங்களிலிருந்து வரும் உணவு பொருட்களில், 'நச்சு இருக்கிறதா' என்று கண்டறிய, கேரள உணவு பாதுகாப்புத்துறையினர் அமைத்துள்ள தாற்காலிக ஆய்வுக்கூடம், வாளையார் மற்றும் மீனாட்சிபுரத்தில் செயல்பட தொடங்கியுள்ளது.
கேரளாவில், 28ம் தேதி ஓணம் பண்டிகை கொண்டாடப்படுவதை முன்னிட்டு, வெளி மாநிலங்களில் இருந்து உணவுப்பொருட்கள் கொண்டு வருவது அதிகரித்துள்ளது. அவற்றில், 'நச்சு கலந்திருக்கிறதா' என்று ஆய்வு செய்ய மாநில அரசு உத்தரவிட்டுள்ளது. அதன்படி மாநில உணவுப் பாதுகாப்புத்துறையினர், எல்லையில் அமைந்துள்ள வாளையார், மீனாட்சிபுரம் சோதனைச்சாவடிகளில், தற்காலிக ஆய்வு கூடங்களை அமைத்துள்ளனர்.
இது குறித்து உணவு பாதுகாப்பு அதிகாரி ஒருவர் கூறியதாவது:-
மீனாட்சிபுரம் வணிக வரி சோதனைச்சாவடியிலும், வாளையார் வணிக வரி சோதனைச்சாவடி அருகேயுள்ள வாடகை கட்டடத்திலும், தற்காலிக ஆய்வுக்கூடங்கள் நேற்று முன்தினம் முதல் செயல்பட துவங்கியுள்ளன. பால், பால் பொருட்கள், எண்ணெய் கொண்டு வந்த நான்கு வாகனங்களில் சோதனையிடப்பட்டது. அவற்றில் நச்சுத்தன்மை இல்லை என்பது தெரியவந்தது.
ஓணம் பண்டிகையை முன்னிட்டு அதிகப்படியான உணவு பொருட்கள் வருவதையொட்டி இந்த தற்காலிக ஆய்வுக்கூடம் அமைக்கப்பட்டுள்ளது.
செப்.,1 வரை, இந்த ஆய்வு தொடரும். பால் பொருட்களை சோதனையிடும் பணியில், பால் பண்ணை மேம்பாட்டு துறை ஊழியர்கள் ஈடுபடுத்தப்பட்டுள்ளனர். நச்சுத்தன்மை கண்டுபிடித்தால் உணவு பொருட்களை திருப்பி அனுப்புவது மட்டுமல்லாமல் தொடர்புடைய நிறுவனங்கள் மீது நடவடிக்கை எடுக்கவும் உத்தரவிடப்பட்டுள்ளது. காய்கறி, பழ வகைகளில் இருந்தும் மாதிரிகள் எடுக்கப்பட்டுள்ளன. அவை, சோதனை செய்வதற்காக, கோழிக்கோடு ஆய்வகத்துக்கு அனுப்பி வைக்கப்பட்டுள்ளன.இவ்வாறு அவர் தெரிவித்தார்.
உத்தரவை வாபஸ் பெற வேண்டும்
இது குறித்து கேரள தமிழ் பாதுகாப்பு இயக்க தலைவர் பேச்சிமுத்து கூறுகையில்,
''உணவுப்பாதுகாப்பு சட்டத்தின் பேரில், சோதனை சாவடிகளில் காய்கறி வாகனங்களை தேவையில்லாத சோதனைக்கு உட்படுத்துகின்றனர். விவசாயிகள், நுகர்வோர் பாதிக்கப் படுவதை தவிர்க்கும் வகையில், சோதனை உத்தரவை கேரள அரசு வாபஸ் பெற வேண்டும்,'' என்றார்.

உணவு பாதுகாப்பு ஆணையத்துக்கு சுப்ரீம் கோர்ட் கடும் கண்டனம்

புதுடில்லி: மும்பை ஐகோர்ட் பிறப்பித்த உத்தரவை எதிர்த்து, மத்திய உணவு பாதுகாப்பு மற்றும் தர நிர்ணய ஆணையமான, எப்.எஸ்.எஸ்.ஏ.ஐ., சார்பில் தாக்கல் செய்யப்பட்ட மனுவை, சுப்ரீம் கோர்ட் தள்ளுபடி செய்தது.
'உடல் நலத்தை பராமரிக்கும் வகையிலான உணவுகள், உள்ளிட்ட, சில உணவுப் பொருட்களை தயாரிப்பதற்கு முன், அதற்கான அனுமதியை பெற வேண்டும்' என, 2013ல், எப்.எஸ்.எஸ்.ஏ.ஐ., தரப்பில் ஆலோசனை தெரிவிக்கப்பட்டிருந்தது. இது தொடர்பான வழக்கு, மும்பை ஐகோர்ட்டில் விசாரணைக்கு வந்தபோது, எப்.எஸ்.எஸ்.ஏ.ஐ.,யின் ஆலோசனை தள்ளுபடி செய்யப்பட்டது. 'இந்த ஆலோசனை, சட்டரீதி யான அங்கீகாரம் பெற்றதல்ல' என, மும்பை ஐகோர்ட் தெரிவித்து விட்டது. இதை எதிர்த்து, எப்.எஸ்.எஸ்.ஏ.ஐ., தரப்பில், சுப்ரீம் கோர்ட்டில் மேல் முறையீடு செய்யப்பட்டது. இந்த மனு, ஜெ.எஸ்.கேஹர், நாகப்பன் ஆகியோர் அடங்கிய, 'பெஞ்ச்' முன், நேற்று விசாரணைக்கு வந்தது.
அப்போது, நீதிபதிகள் உத்தரவிட்டதாவது:
'எப்.எஸ்.எஸ்.ஏ.ஐ.,யின் ஆலோசனைக்கு எந்தவிதமான சட்ட அங்கீகாரமும் இல்லை' என்ற, மும்பை ஐகோர்ட்டின் உத்தரவு சரியானதே. இந்த விஷயத்தில், கோர்ட்டின் அதிகார வரம்பிற்குள் தலையிடுவதற்கு, எப்.எஸ்.எஸ்.ஏ.ஐ.,க்கு எந்த அதிகாரமும் இல்லை. இந்த மனு, தள்ளுபடி செய்யப்படுகிறது. இவ்வாறு, நீதிபதிகள் உத்தரவிட்டனர்.