why Fumigation with formaldehyde is banned by different regulatory bodies?
Corresive and due to the produce carcinogens with product and didn’t have any process to remove from area where ever fogging done
Also it leaves harmfull residue on surface which is hard to remove
formaldehyde is carcinogenic ( Cancer causing) in nature and there is risk of cancer associate with this to the personnel who is handling formaldehyde. It is not safe for the personnel. There are also other drawbacks like fumigation with formaldehyde causes irritation to the eyes and nose. After fumigation with formaldehyde there is requirement for de-fumigation of area in which AHU (Air Handling Unit) has to be continuously run for few hours without any activity to remove the residues from the air and cleaning and moping of equipments and area is also required.
Quoted from PDA TR 70:
While effective, Paraformaldehyde is an older methodology that has been replaced by most GMP firms with current more modern chemistries and systems. Characteristically, Paraformaldehyde decontamination leaves concerning residuals on all surfaces (as defined by FDA) and requires the utmost safety concerns for its implementation realting to human health. For these reason this methodology is declining in use in the marketplace.
Formaldehyde is available as a 37 to 40 percent aqueous solution known as formalin. Paraformaldehyde is a solid polymerized form of formaldehyde. Formaldehyde is a potential carcinogen, causes burns and the vapour irritates the eyes and respiratory tract. It must be handled with caution and only used as a disinfectant when there are no suitable alternatives.
Fumigation of the Future (authored by Andrew Ramage (a Microbiology Product Specialist at Cherwell Laboratories, UK | 17/3/2016(
Well, apart from the smell and the stinging eyes when you get a whiff, and the fact that formaldehyde is a sensitizer that can cause allergic reactions, do remember that it is also identified as a class 1 carcinogen (3) by the World Health Organization’s International Agency for Research on Cancer and is highly toxic. And then there is the paraformaldehyde residue that remains post fumigation – frequently stuck hard to the surface. I hated cleaning up after formaldehyde fumigations; it takes a long time to clean and can also remain in your room’s HEPA filters for a considerable time afterwards, which can mean a long down time for your facility – definitely not the way to go in today’s competitive industry (the less downtime the better) . In short, formaldeyhde is toxic, carncinogenic and corrosive.
In the medium to long term, however, there is a reasonable possibility that you won’t be able to use formaldehyde for fumigations at all in Europe, even if you wanted to.
Another reason as to why formaldehyde’s use for fumigation may be limited are due to the EU’s REACH (Regulation, Evaluation, Authorization and restriction of Chemicals) regulation – which was discussed in a recent issue of The Medicine Maker (http://tmm.txp.to/0116/reach). There may come a point in the future under REACH when the disposal of formaldehyde will be even more strictly regulated; most likely the release of formaldehyde into the air or into sewerage will be banned. At this point the use of formaldehyde in fumigations will become extremely problematic, to put it mildly.
I’m not going to commit to a timeframe as to when any of this may happen. However, if you’re using formaldehyde (wherever you are) then I recommend you read up on your respective regulations and to be prepared for change. It would also be prudent to have a plan in place to validate an alternative system sooner rather than later. Obviously, the EU regulations I’ve mentioned only apply to Europe.
The best established of the alternatives is hydrogen peroxide.