Friday, January 1, 2016

Safety of PET bottles for packing medicines, foods and beverages under cloud-Will the real truth emerge ever?

What do we understand by the oft used word PET when it comes to food packing? Probably common man may have no clue about the chemical nature and the implications underlying its use by the food industry. But there is a general awareness that all plastics are not good when it comes to their use for food contact applications. It is true that plastic materials, mostly made from fossil fuels, have taken over the lives of people in to day's world because of convenience and cost. Glass and metal containers are unbearably costly though they are much more safer than plastics. There are a number of plastic materials varying in their characteristics and functionality and food industry has a wide choice before them for packing foods. Protection from air, moisture and tainting from the environment are the primary concerns when plastics are used as far as the industry is concerned but environmentalists are more worried about the pollution caused by the used plastics which take more than 800 years to be completely degraded in nature. World over restrictions are being placed on use of plastics and make recycling a priority to save the planet. 

Quality and safety requirements of plastics vis-a-vis food contact applications are more or less standardized though there could be small variations in the methodology used to determine their suitability. Safety authorities in developed countries focus on the foods consumed in their countries and tests using model systems reflecting these foods are used to arrive at the permissibility of various packaging materials. However in India there is a sea change in the chemical, physical, biological and sensory characteristics of foods we eat here and therefore the interaction between food and the packaging materials used needs to be assessed by appropriately tailor made tests. The safety aspects of some of the packing materials used for ethnic foods or traditionally consumed foods in this country have not yet been determined conclusively as the authorities concerned is rather slow in tackling this crucial issue with any sense of urgency. The responsibility of the plastic manufacturer ends once a certificate is generated by testing laboratories using standard testing protocols involving simulated solvent systems for acidic, neutral and alkaline foods. What is appalling is that once such a certificate is produced the manufacturer can produce tons and tons of the materials and sell to the food industry without any further overseeing or vigilance from independent authorities. 

The issue of safety of PET bottles for packing pharmaceutical products became a debating one after some concern was raised recently and the government's knee-jerk reaction in setting up a committee to "look" this controversy. Consumers are genuinely concerned about the impact of packing medicines in PET bottles which is becoming a standard practice of the industry which finds it a better packing material compared to glass due to logistical and economic reasons. This has compelled the authorities to arbitrate on this issue. The demand of consumer organizations and environmentalists to ban PET plastics must be based on an assessment of the balance between risk and advantages and scientific data therefore is necessary. The government approved testing laboratory to which this problem was referred, came out with a shocking conclusion that PET bottles are not safe for packing liquid drug formulations because of high levels of leachates passed on to the contents from the container. The controversy became more "controversial" because both drug industry as well as the plastic industry questioned the veracity of the report alleging that too few samples were tested and no important decision should be taken based on the findings of a single laboratory. Probably they may have a valid argument and further testing can be ordered in multiple laboratories controlled by the government on a proprity.     

If we go back to history of this problem it was due to the diligence of an Uttarakhand-based non-governmental organization (NGO) that works in the health sector which raised this issue requesting the ministry of health to impose a ban on the use of PET for pharmaceutical packaging. The present impasse is due to the testing results showing high levels of some chemicals in the products tested. The Government is sitting on the recommendations of a technical group set up to examine this issue which categorically suggested banning of liquid pharmaceutical formulations to be packed in PET bottles and eventually extend this ban to the entire industry. More concerns were expressed with regard to the potential impact of the contaminants leaching out from the bottle on the health of children and other consumers with normal health as well as with weak state of health. There are documentary evidences to support the adverse impact of leachates like Chromium, Antimony, Lead and Diethylhexyl Phthalate at concentrations much beyond the safety limits. According to experts health risks to people can manifest in the form of diseases like cancer, diabetes, endocrine damage kidney damage, reproductive diseases and obesity when these contaminants are present at levels far exceeding the safety standards and this cannot be ignored that easily. calling for emergency measures to tackle this issue once for all.

An interesting argument put forward by the packaging industry is that instead of banning PET blindly, some way should be found to modify the technology of manufacture of this commercially important material to make it safer. A larger question that begs for an answer is why the industry did not take adequate precaution before and was indulging in making and selling a material of doubtful safety credentials? Similarly why it should have been left to an NGO to raise this issue of grave concern where as a responsible and diligent government with enormous powers at its command was sleeping over it all these years with least concern for the health of the 1.3 billion people it is "ruling"? Is it not criminal and shameful? Probably there will be lot of "passing the buck" game when some thing seriously happens due to possible systematic poisoning of its helpless citizens! God forbid such a contingency.

What is perplexing in this entire saga is whether PET bottles and films are safe for packing water, beverage and foods? In India food safety is a portfolio in the domain of the Health Ministry which incidentally also controls the drug industry. Though there are a few reports indicating that PET bottles are safe for packing water, beverages and most food products, there is no clarity as to the minimum thickness of the bottle, impact of long storage and exposure to temperatures prevalent in tropical countries. The same question that has bedevilled the drug industry vis-a-vis use of pet bottles for packing drug formulations does bother the food sector also and there is practically no report of any real time study using any food product packed in such containers. Here again the safety is assumed or presumed based on model systems using standard solvents and solutions which might not really represent any foods we consume in this country. Also to be borne in mind is that in the absence of overseeing of the PET production facilities, food industry has to depend on the unilateral view of the manufacturers that their bottles are food grade. If toxic materials like Chromium, Lead, Antimony and Diethylhexyl phthalate have been found in drug preparations in quantities beyond the permitted levels, there is all the more reason that chemically complex food can leach out much more of them over the duration of their shelf life. It is a million dollar question as to why the Indian government and the research institutions specialized in food, packaging, health and toxicology controlled by it are sleeping over the issue for so long! 

While the issue of safety of pet bottles for packing food and medicines is sill being debated, there is a tug of war between the PET industry and glass industry, both of them having a vested interest in the business generated by the products they make. According to the PET bottle industry more than 200 manufacturing may have to close shop if the Government enforces an across the board ban for food, beverages and pharma products which together account for about Rs 2000 crores market, almost 50% of the total production of 6 lakh tons per annum. In contrast glass bottle industry which was once the prime materials used by both food and pharma industries is witnessing a decline in its growth because of the increasing preference shown for PET bottles. One of the last bastions for glass bottle is the liquor industry which consumes almost 50% of the production estimated at about 3 million tons per annum probably because of the ability of glass to retain the flavor in its original form. Only cheap liquors have switched over to PET bottles in preference to glass because of cost considerations. If banning of PET bottles does materialize there is no option for the industry but to go back to glass bottles. Thus what is a lose to PET industry will be a gain for the glass industry. We will have to wait and see how the situation is going to develop in the next few months. In the mean time glass industry must invest in new technologies that can give glass bottles with lighter weight and extra strength to with stand rigors of handling and transportation . 


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