Apropos to the edit dated 2nd January 2014, entitled 'Safety of PET Bottles' published in Pharmabiz.
At the outset, I wish to inform that the undersigned has been associated with PET Industry in particular and plastics in general for last 2 decades both as a professional and entrepreneur. It is highly regrettable that the aforesaid edit seems to convey that the Union Health Ministry has taken a decision to ban PET and plastic bottles for pharma packing.
We wish to state that this message is totally wrong. The article tends to hit at the multibillion plastic and pharma industry of India and millions employed. It is true that DTAB has suggested a phase out of plastic and PET bottles but no order has been issued by the Ministry. Regrettably, the advice has been given despite accepting that there is no evidence to confirm accusations of Him Jagriti against plastic and PET bottles.
It would be in order to add that leading industry associations - IDMA, OPPI, PCMA, FOPE, ICPE, APM-Haridwar have expressed their strong reservation to the DTAB advise and have represented to DTAB and the Ministry against the same.
Polyethylene terephthalate (PET) is a food grade thermoplastic resin and is widely used globally in packing of water, liquor, medicines, food items and carbonated soft drinks. Over 20 mn tonnes of PET is used for packaging globally and the use is growing @ 10 % p.a. PET is approved by US FDA, BIS, US Pharmacopoeia, Indian Pharmacopoeia, EU and others. Stability tests to establish suitably of PET for packing food Items have been conducted by govt recognised labs, and pharma companies conduct its own test for each formulation with PET packaging.
There has been much reporting in media wrt phthalates in PET. The term 'phthalates' refers to the diesters of 1, 2-benzenedicarboxylic acid, better known as phthalic acid. It is important to appreciate the difference between PET and phthalates. Both are chemically dissimilar. Phthalates or phthalate esters, are esters of phthalic acid and are mainly used as plasticizers (substances added to plastics to increase their flexibility, transparency, durability, and longevity). They are used primarily to soften polyvinyl chloride (PVC).
It seems that industry experts and media are assuming that Polyethylene Terephthalate and Phthalates are same. Regrettably, it is like comparing apples to oranges.
Endocrine disruptors - United States Environment Protection Agency is running an Endocrine Disruptors Screening and Testing Programme for a universe of 10,000 chemicals. These chemicals are shortlisted from 85,000 chemicals sold commercially. Polyethylene terephthalate does not appear in this list and therefore clearly it is not endocrine disruptor. However, glass does appear in this list of 10,000 chemicals as potential endocrine disruptor.
Migration/leaching - Heavy metal migration studies have been conducted by Industrial Toxicology Research Centre, Lucknow for several PET bottle customers for evaluation of packaging of ethyl alcohol. The comparisons of PET bottles are done with glass bottles. The migration in glass as well as PET is comparable and is much below the permissible limits.
International Life Science Institute in its report mentions substances which readily migrate are of low molecular weight and volatile. PET has high molecular weight and hence low migration propensity.
We wish to add that already 5 PILs against use of PET bottles in various states have been rejected by High Court in the year 2013. In addition the Supreme Court has not even admitted a PIL seeking ban on PET bottles, says Sarabjit Singh from Polyuno Ventures India, Janakpuri, New Delhi.