30 HYGIENE
the sum of all the impurities exceeds 300 ppm, it can only be used if all the impurities have been identified and it does not contain more than 4400 ppm acetone; 1000 ppm n-propanol (1-propanol); 2200 ppm ethyl acetate; 6200 ppm sec-butanol (2-butanol); 21700 ppm iso-butanol (2-methyl-1-propanol); 1000 ppm n-butanol (1-butanol); 4100 ppm iso-amyl alcohol (3-methyl-1-butanol); and 4100 ppm amyl alcohol. For any impurities identified that are not listed above, companies are required to submit data to the Food and Drugs Administration on the identity of the impurity, the concentration level and safety. The Food and Drugs Administration will assess whether the ethanol is suitable for use. The second requirement is that the alcohol is
denatured either by the producer of the alcohol or during the production of the hand sanitiser. The denaturants permitted for denaturing the alcohol include Formula No. 40A or No. 40B with or without tert-butyl alcohol, Formula No. 3C (isopropanol). The alcohol may also be denatured with a formula containing 3% triethyl citrate. Full details of the denaturant formulas can be found in attachment 2 of the temporary policy.1
The third requirement is that the hand
sanitser is manufactured according to the following formulation which is consistent with World Health Organization (WHO) recommendations: Alcohol (ethanol) (formulated to 80%, volume/volume (v/v) in an aqueous solution or Isopropyl Alcohol (formulated to 75%, v/v) in an aqueous solution; Glycerin (glycerol) (1.45 % v/v); Hydrogen Peroxide (0.125% v/v); and sterile distilled water or boiled cold water.10 The fourth requirement is that the
manufacturer does not add other active or in active ingredients to the formulation. The fifth requirement is that companies ensure that the Alcohol (ethanol) or Isopropyl Alcohol used is correct and the correct amount is used. Companies should test the Alcohol (ethanol) or Isopropanol Alcohol to ensure
PERSONAL CARE January 2021
that the methanol content does not exceed 630 ppm. The sixth requirement is that the hand sanitiser is prepared under sanitary conditions. The seventh requirement is that the company uses the most accurate method of analysis at their site for the verification of alcohol content for each batch of hand sanitiser before releasing the product on to the market. The eighth requirement is that the hand sanitiser is an aqueous solution and not in the form of a gel, foam or aerosol spray. The ninth requirement is that the product is labelled according to the requirements of the temporary policy. The tenth requirement is that companies register their facility and products in the Food and Drug Administration Drug Registration and Listing System.11 The eleventh and final requirement is that companies have a process for accepting adverse event reports for any product they manufacture under the Food and Drug Administration temporary policy and submit these adverse event reports to the Food and Drug Administration.12
Conclusion This article has considered antibacterial hand products as cosmetic products and as biocidal products. It has looked at the stages that have to be gone through for bringing a biocidal product to market in the European Union. It has looked at ethanol and isopropanol as active substances in biocidal products. As ethanol is an active substance that is still under review biocidal products can be placed on the European Union market without going through the authorisation process and paying fees to European Chemicals Agency and competent authorities. At some point in the future ethanol will be approved as an active substance and alcohol-based hand sanitisers will need to be authorised before they are placed on the market. For more information on how biocidal products are regulated please refer to the European Chemicals Agency website.13 The second part of the article considers the
requirements for placing hand sanitisers on to the market in the Unites States of America. It takes a look at the temporary policy that the Food and Drug Administration has put in place to make hand sanitisers more readily available. It is important to note that the temporary policy will only last as long as the public health emergency.1
PC
References 1 Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (COVID-19) Guidance for Industry, March 2020, Updated August 7, 2020 (
https://www.fda.gov/ media/136289/download )
2 Guidance on the applicable legislation for leave-on hand cleaners and hand disinfectants (gel, solution, etc.)
https://ec.europa.eu/ docsroom/documents/40523
3 Medicines & Healthcare products Regulatory Agency, A Guide to what is a medicinal product, MHRA Guidance Note 8, March 2020 https://
tinyurl.com/y8j7tu6t
4 Article 3 of Regulation (EU) No 528/2012 5
https://echa.europa.eu/regulations/biocidal- products-regulation/approval-of-active- substances/new-active-substances
6
https://echa.europa.eu/regulations/biocidal- products-regulation/approval-of-active- substances/existing-active-substance
7
https://echa.europa.eu/documents/10162/ fa45ff3d-7f6f-4633-b426-18fd96612b62
8
https://tinyurl.com/y3q7unzd 9
https://www.usp.org/sites/default/files/usp/ document/health-quality-safety/usp-hand- sanitizer-ingredients.pdf.
10 “Guide to Local Production: WHO- recommended Handrub Formulations,” are available at
https://www.who.int/gpsc/5may/ Guide_to_Local_Production.pdf.
11
https://www.fda.gov/drugs/guidance- compliance-regulatory-information/drug- registration-and-listing-system-drls-and-edrls).
12
https://www.fda.gov/media/77193/download 13
https://echa.europa.eu/legislation
www.personalcaremagazine.com
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