28 HYGIENE
Regulation of hand sanitisers in the EU and US
Dr Martin Perry – Advanced Development and Safety Laboratories Limited, UK
Hand hygiene has never been as important as now in the midst of the coronavirus disease 2019 (COVID-19). Washing hands with soap and water for at least 20 seconds is essential to help stop the spread of this virus. If soap and water are not available then using an alcohol based hand sanitiser is recommended.1
This
article looks at the regulatory requirements for placing on to the market hand sanitisers in the European Union. It considers whether products are biocides or cosmetics. It then looks at the requirements of the European Biocides Regulation (EU) 528/2012. The second part of this article looks at how hand sanitisers are regulated in the United States of America and the temporary policy that the Food and Drug Administration (FDA) has adopted for hand sanitisers.
European Union Antibacterial products can be classed as cosmetics, biocides or medicines based on their function, the way they are presented and the claims made. For an antibacterial product to be a cosmetic it must have a cosmetic primary function (e.g. moisturising, protecting, perfuming skin). The antibacterial claim has to be a secondary claim and it must be made clear that this is a secondary claim. This can be done by making the antibacterial claim less prominent than the cosmetic claim or by stating the cosmetic claim first followed by the antibacterial claim. An antibacterial hand wash would be regarded as a cosmetic product as its primary function is cleansing. A moisturising hand gel with antibacterial properties would be a cosmetic product providing that moisturising is the primary claim and antibacterial the secondary claim. An antibacterial hand gel would be a biocidal product as the primary claim is for a biocide. When determining whether a product is
a cosmetic product or a biocidal product it is important to consider the claims that are made for the product, its composition, its purpose and its mode of action on the organism. According to the guidelines2
published by the
European Commission the following claims would suggest that a product was a biocidal product: “Antibacterial”; “Unique antibacterial formulation”; “Kills bacteria”; “Kill bacteria /
PERSONAL CARE January 2021
a wide range of germs and words having the same meaning”; “Antiviral”
and words having the same meaning; “Kills viruses,
Virokill” and words having the same meaning; “Effective against flu
virus H1N1” and “Effective against coronavirus”. In these claims the biocidal function is likely to be considered to be the primary function. Most European Union countries do not
accept numerical claims such as kills 99.9% of bacteria for cosmetic products. However these claims are permitted for cosmetic products within the United Kingdom. The United Kingdom regards products that claim to kill a named pathogen (e.g. MRSA, bird flu etc.) to be medicinal products.3
Biocidal products In the European Union, products that are marketed as hand sanitisers are biocidal products as their primary function and claim is to sanitise and disinfect hands. They must comply with the requirements of the Biocidal Products Regulation (EU) 528/2012. Regulation (EU) 528/2012 came into force on 1 September 2013 and covers the placing on the market and use of biocidal products within the European
Union. It replaced the Biocidal Products Directive 98/8/EC. The regulation applies to 22 product types that protect humans, animals, materials or articles against harmful organisms such as pests or bacteria. Biocidal products have to contain an active substance. Hand sanitisers are in product type 1 (human hygiene).
Approval of active substances The Biocidal Products Regulation (EU) 528/2012 considers there to be two types of active substance.4
There are “existing active
substances” which are active substances which were in biocidal products that were on the European Union market on 14 May 2000 and there are new active substances. New active substances are ones which were not on the market as active substances on 14 May 2000. For new active substances, companies have
to apply for approval of the active substance by submitting a dossier to the European Chemicals Agency (ECHA).5
A validation check is carried
out by the European Chemicals Agency and then the competent authority in a member state has one year to carry out a completeness check and an evaluation. The result of the evaluation is then sent to European Chemicals Agency’s Biocidal Products Committee which has 270 days to prepare its opinion. The opinion
www.personalcaremagazine.com
Page 1 |
Page 2 |
Page 3 |
Page 4 |
Page 5 |
Page 6 |
Page 7 |
Page 8 |
Page 9 |
Page 10 |
Page 11 |
Page 12 |
Page 13 |
Page 14 |
Page 15 |
Page 16 |
Page 17 |
Page 18 |
Page 19 |
Page 20 |
Page 21 |
Page 22 |
Page 23 |
Page 24 |
Page 25 |
Page 26 |
Page 27 |
Page 28 |
Page 29 |
Page 30 |
Page 31 |
Page 32 |
Page 33 |
Page 34 |
Page 35 |
Page 36 |
Page 37 |
Page 38 |
Page 39 |
Page 40 |
Page 41 |
Page 42 |
Page 43 |
Page 44 |
Page 45 |
Page 46 |
Page 47 |
Page 48 |
Page 49 |
Page 50 |
Page 51 |
Page 52 |
Page 53 |
Page 54 |
Page 55 |
Page 56 |
Page 57 |
Page 58 |
Page 59 |
Page 60 |
Page 61 |
Page 62 |
Page 63 |
Page 64 |
Page 65 |
Page 66 |
Page 67 |
Page 68 |
Page 69 |
Page 70 |
Page 71 |
Page 72 |
Page 73 |
Page 74 |
Page 75 |
Page 76 |
Page 77 |
Page 78 |
Page 79 |
Page 80 |
Page 81 |
Page 82 |
Page 83 |
Page 84
