Hand Sanitizer Regulations Europe
If you swallow these products call a poison control center immediately.
Hand sanitizer regulations europe. Do not swallow them. Fda issues final rule on safety and effectiveness of consumer hand sanitizers action completes a series of actions on the fda s review of otc antiseptic active ingredients. The product was popularized in the early 1990s. Hand sanitizer fda final rule approval after reviewing the safety and effectiveness of hand sanitizers the us food and drug administration has ruled that dozens of active ingredients can t be used in the antiseptic rubs but the agency still wants answers about the most common active ingredient.
Hand sanitizer regulations vary with each country. Use hand sanitizers and antiseptic wipes only as directed on the label. Hand sanitizers were first introduced in 1966 in medical settings such as hospitals and healthcare facilities. This list is updated daily monday to friday so please check back often.
How to find out which antiseptic skin cleansers or hand sanitizers meet. European hand sanitizer standards are updated two european hand disinfectant standards have recently been updated. They are bs en 1499 2013 edition chemical disinfectants and antiseptics. And the new fda guidance for manufacturers of alcohol based hand sanitizer can be found here.
In most other countries hand sanitizer comes under cosmetic regulations which require labeling compliance and complying with iso 22716 2007 good manufacturing practice for cosmetics. The agency s new guidance for compounders covers sanitizer products by pharmacists in state licensed pharmacies or federal facilities and registered outsourcing facilities according to the fda that document can be found online here. In the us fda regulate antiseptic hand sanitizer as an otc monograph drug. Alcohol based hand sanitizer is more convenient compared to hand washing with soap and water in most situations in the healthcare setting.
A north american company is looking to sell hand sanitizers in europe. What is the process for achieving approval to legally sell into europe. The hand sanitizers are anti microbial. Do not swallow them.
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