Medical associations and expert committees urge that ethanol be approved as a virucidal active substance for use in hand antiseptics under the European Biocidal Products Regulation, without a CMR classification.

IF 1.7 Q3 PUBLIC, ENVIRONMENTAL & OCCUPATIONAL HEALTH
GMS Hygiene and Infection Control Pub Date : 2024-08-21 eCollection Date: 2024-01-01 DOI:10.3205/dgkh000495
Axel Kramer, Didier Pittet, Martin Exner, Constanze Wendt
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引用次数: 0

Abstract

Introduction: Since 2007, the classification of ethanol under the Biocidal Products Regulation has paradoxically remained unresolved due to conflicting views among experts and authorities. Initially, there was a discussion about classifying ethanol as carcinogenic. The current proposal to extend its harmonized classification includes, among other things, categorizing it as reproductive toxicity category 2 ("suspected to have CMR potential for humans"; carcinogenic, mutagenic, reprotoxic). If ethanol were classified under reproductive toxicity category 2, it would mean that the only active ingredient in hand antiseptics effective against non-enveloped viruses would no longer be available.

Scientific assessment of the safety of ethanol-based hand rubs ebhr: Available epidemiological studies do not confirm an increased risk for cancer from EBHR in exposed individuals, except under uncommon or unlikely routes or levels of exposure.The evidence for ethanol's reprotoxic effect originates from the consumption of alcoholic beverages by pregnant women, where ethanol uptake is incomparably higher. The amount of transdermal ethanol absorption during hand antisepsis is up to ten times lower than the oral intake of beverages containing hidden ethanol, such as apple juice, kefir, or non-alcoholic beer. Blood alcohol levels after using EBHR remain within the physiological range associated with food intake.

Conclusion: There is no epidemiological evidence of toxicity for workers handling ethanol-containing products in industry or using EBHR in healthcare settings. Given that the classification of EBHR as reproductive toxicity category 2 is not supported by current scientific research and that no alternative biocidal active substance in hand rubs is effective against non-enveloped viruses, medical associations and expert committees from Europe, the USA, Canada, the Asia-Pacific region, and the World Society for Virology unequivocally recommend, with the highest priority, that EBHR be approved as an active substance for PT1 biocides and not be classified as a reproductive toxicant in category 2.

医学协会和专家委员会敦促根据《欧洲杀菌剂产品条例》批准乙醇作为杀病毒活性物质用于手部消毒剂,而无需进行 CMR 分类。
导言:自 2007 年以来,《杀菌剂产品条例》对乙醇的分类问题一直悬而未决,原因是专家和权威机构之间存在意见分歧。最初,人们曾讨论过将乙醇归类为致癌物质。目前扩大其统一分类的建议包括将其归入生殖毒性类别 2("怀疑对人类具有 CMR 潜力";致癌、诱变、生殖毒性)。如果乙醇被归入生殖毒性第 2 类,这将意味着手部消毒剂中唯一能有效抵抗无包膜病毒的活性成分将不再可用:现有的流行病学研究并未证实接触乙醇擦手液的人患癌症的风险会增加,除非接触的途径或程度不常见或不可能。乙醇具有生殖毒性的证据来自孕妇饮用含酒精的饮料,因为孕妇对乙醇的摄入量要高得多。在手部防腐过程中,乙醇的透皮吸收量要比口服含有隐性乙醇的饮料(如苹果汁、酸乳酒或无醇啤酒)低 10 倍。使用 EBHR 后,血液中的酒精含量仍在与食物摄入相关的生理范围内:没有流行病学证据表明在工业中处理含乙醇产品或在医疗保健环境中使用 EBHR 的工人会中毒。鉴于目前的科学研究并不支持将 EBHR 划分为生殖毒性第 2 类,而且擦手布中没有其他杀菌活性物质可有效杀灭非显性病毒,欧洲、美国、加拿大、亚太地区的医学协会和专家委员会以及世界病毒学协会明确建议,最优先批准将 EBHR 作为 PT1 杀菌剂的活性物质,而不将其划入生殖毒性第 2 类。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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GMS Hygiene and Infection Control
GMS Hygiene and Infection Control PUBLIC, ENVIRONMENTAL & OCCUPATIONAL HEALTH-
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