Any Standard for Hand Sanitizer?

It was another question that puzzled me. What is the standard for hand sanitizer? How much microorganisms it should eliminate? How safe it should be? Is there any law governing its manufacture, sale and use?

Several relevant sites were showing up during my search but all of them were pointing to the same source, the US FDA. I jumped straight to FDA home page and it still took me some time before seeing what I was looking for. Here are the summary of…

To avoid confusion, the term hand sanitizer was replaced with hand antiseptic in 2005.

Sanitizer means:
– agent control bacterial contamination of inert objects such as equipment, utensils and other food-contact surfaces.
– must have a microbial reduction of 99.999%.

Antiseptic means:
– against putrefaction
– substance for destroying microorganisms
– agent used to prevent skin infection

Hand Antiseptic means:
– a drug, a germicide
– wet dressing, ointment, dusting powder intended for prolonged body contact
– it reduces the number of transient microorganisms on intact skin to an initial baseline level after adequate washing, rinsing, and drying

Hand antiseptic should be:
– safe and effective when applied to human skin
– safe food additive when applied to bare hands that will come into direct contact with food.

It is not clear if all existing hand sanitizer should be ditched  and replaced with the name Hand Antiseptic or whether the latter should be as effective as the first, the 99.999% microbial reduction.

FDA Food Code 2009: Annex 3 – Public Health Reasons / Administrative Guidelines – Chapter 2, Management and Personnel


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