HYGIENE
serves as the basis on which the European Commission decides whether to approve the active substance and for how long that approval will last. For existing active substances a review
programme has been set up by the European Commission.6
The substances that were
accepted on to the review programme were those that were on the market as active substances in biocidal products on 14 May 2000 and for which a company has notified European Chemicals Agency of its participation in the review process. The Review program is expected to be completed by 2024.
Ethanol and isopropanol The two most common active substances used in hand sanitisers are ethanol and propan- 2-ol (isopropanol). Ethanol has not yet been approved as an active substance for product type 1 (human hygiene) and is still under review. Article 89 of the Biocidal Products Regulation (EU) 528/2012 permits biocidal products containing an active which is still under review to be made available on the market and used subject to national rules for up to 3 years after the active is approved. Hand sanitisers containing ethanol can be made available on the market even though ethanol is not an approved active substance. They can remain on the market for up to 3 years after the approval of ethanol as an active before they must be authorised.
Authorisation Isopropanol was approved7
as an active
substance for product type 1 (human hygiene) in 2014. Hand sanitisers containing isopropanol must be authorised before they are made available on the European Union market. If the product is only going to be made available in a single country then authorisation from that country is sufficient. If a company wishes to place the product on the market in several countries it can apply for mutual recognition. If a company wishes to place the product on all the markets within the European Union then it can apply for Union authorisation. A search of the European Chemicals Agency database for authorised products containing propan-2-ol (isopropanol) revealed that very few products have been authorised for product type 1 (human hygiene) and that the national authorisation route was used.8
Authorisation
requires companies to put together a dossier of information and to pay fees to European Chemicals Agency and the competent authority for their product to be approved. Ethanol-based hand sanitisers do not need to go through this process as ethanol is still under review.
US
The Food and Drugs Administration in United States of America regulates hand sanitisers as over the counter drugs and requires that companies register with the Food and Drugs Administration (FDA). In March 2020 the Food and Drugs Administration published guidance for the temporary preparation of alcohol-based hand sanitisers by companies which register with the Food and Drugs Administration as over
www.personalcaremagazine.com January 2021 PERSONAL CARE
the counter drug manufacturers, re-packagers or re-labelers. The guidance will last for the duration of the public health emergency.1
The
guidance recommends that if soap and water are not readily available to wash your hands with then an alcohol-based hand sanitiser containing at least 60 percent ethanol should be used. In response to increased demand for alcohol based hand sanitisers the Food and Drugs Administration has stated that it will not take action against companies that prepare alcohol based hand sanitisers for consumer use or for use as hand rubs in health care settings for the duration of the public health emergency provided that the following requirements are met.1
The first requirement is that hand sanitisers must be manufactured using alcohol (ethanol) that is not less than 94.9% ethanol by volume or United States Pharmacopoeia (USP) grade isopropyl alcohol. The glycerine used in the hand sanitiser formulation must be United States Pharmacopoeia (USP) grade. The hand sanitiser should also contain hydrogen peroxide and the water used in its manufacture must be sterile. The formulation that should be used to manufacture the hand sanitiser is stated in the temporary policy.1 Quality standards and specifications for
alcohol used in hand sanitisers is set by the United States Pharmacopoeia and enforced by the Food and Drugs Administration according to section 501(b) of the FD & C Act. Alcohol (ethanol) that does not meet the United States Pharmacopoeia monograph is considered to be adulterated. The Food and Drugs Administration has raised concerns that methanol is being used to denature ethanol in hand sanitisers. Although hand sanitisers are intended to be used on the hands it is possible that young children may accidentally ingest the product. It may also be drunk by adolescents or adults as an alcohol substitute. If ingested in a sufficiently large quantity methanol poisoning can result
29
in nausea, vomiting, headache, blurred vision, permanent blindness, seizures, coma or damage to the nervous system and even death.1 Any alcohol (ethanol) or isopropanol
that contains more than 630 ppm methanol will be deemed to be non-compliant with the temporary policy and the hand sanitiser containing the methanol will be considered to be an adulterated product under the Federal Food, Drug and Cosmetic Act (FD & C Act).1
The
Food and Drugs Administration recommends that alcohol (ethanol) and isopropanol used in hand sanitisers is tested according to the test method in the United States Pharmacopoeia monograph for alcohol (ethanol). The monograph and test method have been made available on the internet.9 In April 2020 the Food and Drugs
Administration became aware that consumers and health care personnel were experiencing difficulties in getting hold of alcohol-based hand sanitisers due to a large increase in demand due to COVID-19. The Food and Drugs Administration has taken the decision to allow alcohol (ethanol) that does not meet the requirements of United States Pharmacopoeia or Food Chemical Codex (FCC) to be used in hand sanitisers on a temporary basis for the duration of the public health emergency. Ethanol that is used for fuel can contain harmful chemicals such as gasoline, benzene and excessive levels of acetaldehyde. The Food and Drugs Administration is permitting alcohol that does not meet the requirements of United States Pharmacopoeia or Food Chemical Codex to be used on a temporary basis providing it does not contain gasoline or any of its components e.g. n-heptane, it does not contain more than 630 ppm methanol; not more than 2 ppm benzene; not more than 50 ppm acetaldehyde; not more than 50 ppm acetal (1,1-diethoxyethane); and the sum of all other impurities is not more than 300 ppm. Where fuel and technical grade ethanol do not meet the limits previously stated because
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