The FDA (Food and Drug Agency) published the final rule on antibacterial soaps containing certain active substances. The concerned products will have to be removed from the market within a year or have their composition changed.

La FDA statue sur la sécurité et l’efficacité des savons antibactériens

Ban of 19 ingredients in antibacterial soaps

In a press release from 2 September 2016, the FDA, the U.S. Food and Drug Administration, banned some ingredients in antiseptic wash products. 19 active substances will not be allowed to be in some products placed on the market.

Which active substances are concerned by this ban?

Name of the substance CAS
Cloflucarban 369-77-7
Fluorosalan 4776-06-1
Hexachlorophene 70-30-4
Hexylresorcinol 136-77-6
Iodine complex (ammonium ether sulfate and polyoxyethylene sorbitan monolaurate) 9005-64-5 ?
Iodine complex (phosphate ester of alkylaryloxy polyethylene glycol) -
(Nonylphenoxy)poly(ethyleneoxy)ethanoliodine 11096-42-7
Poloxamer-iodine complex 26617-87-8
Povidone-iodine (5 -10 %) 25655-41-8
Undecoylium chloride iodine complex 1338-54-1 ?
Methylbenzethonium chloride 25155-18-4
Phenol (greater than 1.5 percent) 108-95-2
Phenol (less than 1.5 percent) 16 -
Secondary amyltricresols 8063-33-0 ?
Sodium oxychlorosene 52906-84-0
Tribromsalan 87-10-5
Triclocarban 101-20-2
Triclosan 3380-34-5
Triple dye 39389-84-9

This measure applies to products containing one or more of these 19 specific active substances where the most commonly used ingredients are triclosan and triclocarban. These products must be used with water and rinsed after used. This rule does not affect alcohol-based wipes or antibacterial products used in the health sector.

What are the consequences of this ban?

There is not enough data to prove the safety and effectiveness of antibacterial products for hands and/or the body to be considered as Generally Recognised As Safe and Effective (GRAS/ GRAE) by the FDA.

Following the industry comments, the FDA deferred the implementation of this measure to one year concerning 3 other ingredients to allow companies to collect and submit the required data for these ingredients.

Name of the substance CAS
Benzalkonium Chloride 8001-54-5
Benzethonium Chloride 121-54-0
Chloroxylenol (PCMX) 88-04-0

Manufacturers can continue placing products with these substances on the market with the corresponding claims while the data is collected.

Other producers will have a year to comply with the FDA’s measure by removing their products from the market or by changing the formula of their products (removing the active substance(s) from the composition).

Antibacterial ingredients: more harmful than beneficial?

Consumers do not need antibacterial soaps, some can even be dangerous

Janet WoodCock, Director of the Center for Drug Evaluation and Research of the FDA says “Consumers may think antibacterial washes are more effective at preventing the spread of germs, but we have no scientific evidence that they are any better than plain soap and water. In fact, some data suggests that antibacterial ingredients may do more harm than good over the long-term”.

Washing with plain soap and running water remains one of the most important steps consumers can take to avoid getting sick and to prevent spreading germs to others. If soap and water are not available and a consumer uses hand sanitizer instead, the U.S. Centers for Disease Control and Prevention (CDC)recommends that it be an alcohol-based hand sanitizer that contains at least 60 percent alcohol.

A measure that had already been proposed in 2013

In 2013, the FDA had already proposed a measure against certain active substances following studies suggesting that long term exposure to substances like tricosan in liquid soaps and triclocarban in hard soaps could increase bacterial resistance, disrupt hormonal cycles or cause muscle weakness.

Companies could not provide proof on the antibacterial efficiency of their product had to reformulate or change the claim of their products.

Since this proposal, some producers have already decided to remove certain substances from their products, including triclosan and triclocarban. There is only a year left for other producers to comply.

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