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Assessment of the Antibiotic Resistance Effects of Biocides

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Scientific Committee on Emerging and Newly Identified Health Risks SCENIHR Assessment of the Antibiotic Resistance Effects of Biocides The SCENIHR adopted this opinion at the 28th plenary on 19 January 2009 after public consultation. 1 Antibiotic Resistance Effects of Biocides About the Scientific Committees Three independent non-food Scientific Committees provide the Commission with the scientific advice it needs when preparing policy and proposals relating to consumer safety, public health and the environment. The Committees also draw the Commission's attention to the new or emerging problems which may pose an actual or potential threat. They are: the Scientific Committee on Consumer Products (SCCP), the Scientific Committee on Health and Environmental Risks (SCHER) and the Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR), and are made up of external experts. In addition, the Commission relies upon the work of the European Food Safety Authority (EFSA), the European Medicines Evaluation Agency (EMEA), the European Centre for Disease prevention and Control (ECDC) and the European Chemicals Agency (ECHA). SCENIHR Questions concerning emerging or newly-identified risks and on broad, complex or multi- disciplinary issues requiring a comprehensive assessment of risks to consumer safety or public health and related issues not covered by other Community risk-assessment bodies. In particular, the Committee addresses questions related to potential risks associated with interaction of risk factors, synergic effects, cumulative effects, antimicrobial resistance, new technologies such as nanotechnologies, medical devices, tissue engineering, blood products, fertility reduction, cancer of endocrine organs, physical hazards such as noise and electromagnetic fields and methodologies for assessing new risks. Scientific Committee members Anders Ahlbom, James Bridges, Wim De Jong, Philippe Hartemann, Thomas Jung, Mats- Olof Mattsson, Jean-Marie Pagès, Konrad Rydzynski, Dorothea Stahl, Mogens Thomsen Contact: European Commission Health & Consumer Protection DG Directorate C: Public Health and Risk Assessment Unit C7 - Risk Assessment Office: B232 B-1049 Brussels [email protected] © European Commission 2009 The opinions of the Scientific Committees present the views of the independent scientists who are members of the committees. They do not necessarily reflect the views of the European Commission. The opinions are published by the European Commission in their original language only. http://ec.europa.eu/health/ph_risk/risk_en.htm 2 Antibiotic Resistance Effects of Biocides ACKNOWLEDGMENTS Members of the working group are acknowledged for their valuable contribution to this opinion. The members of the working group are: SCENIHR members: Dr. Jean-Marie Pagès (Chair), Université de Marseille Prof. Jim Bridges, University of Surrey Prof. Philippe Hartemann, Université de Nancy External experts: Prof. P. Cocconcelli1, Università Cattolica del Sacro Cuore, Piacenza Prof. D. Dietrich2, Universität Konstanz Prof. J. Fink-Gremmels, Universiteit Utrecht Dr. J-Y. Maillard2, Cardiff University Prof. C. Pasquarella, Università degli Studi di Parma Prof. S. Rastogi, National Environmental Research Institute, Roskilde 1 Declared Interest (see minutes of the 22nd SCENIHR plenary meeting of 6 February 2008): http://ec.europa.eu/health/ph_risk/committees/04_scenihr/docs/scenihr_mi_022.pdf 2 Declared Interest (see minutes of the 21st SCENIHR plenary meeting of 29 November 2007): http://ec.europa.eu/health/ph_risk/committees/04_scenihr/docs/scenihr_mi_021.pdf 3 Antibiotic Resistance Effects of Biocides ABSTRACT Serious concerns about the resistance of nosocomial, community-acquired and food- borne pathogens to antibiotics have been growing for a number of years at both national and international levels. Resistance of bacterial pathogens to antibiotics has increased worldwide, leading to treatment failures in human and animal infectious diseases. Bacteria have the capacity to adapt rapidly to new environmental conditions and can survive exposure to antimicrobials by using a battery of resistance mechanisms. The frequency of antimicrobial resistance in bacteria has increased in concert with increasing usage of antimicrobial compounds. Bacterial resistance against different types of biocides has been reported and characterised only relatively recently when compared to our understanding of antibiotic resistance. Some resistance mechanisms are common to both biocides and antibiotics. Scientific evidence from bacteriological, biochemical and genetic data does indicate that the use of active molecules in biocidal products may contribute to the increased occurrence of antibiotic resistant bacteria. The selective stress exerted by biocides may favour bacteria expressing resistance mechanisms and their dissemination. Some biocides have the capacity to maintain the presence of mobile genetic elements that carry genes involved in cross-resistance between biocides and antibiotics. The dissemination of these mobile elements, their genetic organisation and the formation of biofilms, provide conditions that could create a potential risk of development of cross-resistance between antibiotics and biocides. To date, the lack of precise data, in particular on quantities of biocides used, makes it impossible to determine which biocides create the highest risk of generating antibiotic resistance. However, horizontal gene transfer and overlapping genetic cascades of regulation that can be stimulated by external chemical compounds such asbiocides are likely triggers of bacterial resistance. In view of the large and increasing use of biocides and the continuous increase of bacterial resistance to antibiotics, data and methodologies are urgently needed to clearly characterise the risk, especially: a) Quantitative data on exposure to biocides: "in use" and residual concentrations, environmental conditions (e.g. water, soiling, exposure time, temperature, pH, etc.), change in microbial population, dissemination of resistant determinants (horizontal transfer) and potential synergies or interactions with other molecules. b) Standards and methods to evaluate the ability of a biocide to induce/select for resistance against biocides and antibiotics. Surveillance programmes using these standardised methods must be developed to monitor the level of resistance and cross resistance in all areas of biocide usage. c) Environmental studies focussing on the identification and characterisation of resistance and cross-resistance to antibiotics following use and misuse of biocides. Keywords: Biocides, resistance to antibiotics, bacteria, SCENIHR Opinion to be cited as: SCENIHR (Scientific Committee on Emerging and Newly Identified Health Risks), Assessment of the Antibiotic Resistance Effects of Biocides, 19 January 2009 4 Antibiotic Resistance Effects of Biocides TABLE OF CONTENTS ACKNOWLEDGMENTS ........................................................................................... 3 ABSTRACT .......................................................................................................... 4 EXECUTIVE SUMMARY........................................................................................... 8 1.BACKGROUND................................................................................................. 10 2.TERMS OF REFERENCE ..................................................................................... 11 3.SCIENTIFIC RATIONALE ................................................................................... 12 3.1. Introduction............................................................................................. 12 3.2. Scope of opinion, definition of active substances considered............................ 12 3.2.1.Definitions ....................................................................................... 12 3.2.1.1. Official definitions............................................................. 12 3.2.1.2. Other definitions .............................................................. 13 3.2.2.Active substances ............................................................................. 14 3.3. Production, use and fate of biocides............................................................. 19 3.3.1.Biocides in health care ...................................................................... 19 3.3.1.1. Biocides (disinfectants) on medical devices and surfaces ........ 19 3.3.1.2. Biocides (disinfectants and antiseptics) used on skin and mucosa 21 3.3.2.Biocides in consumer products............................................................ 22 3.3.2.1. General aspects ............................................................... 22 3.3.2.2. Cosmetics and personal care products ................................. 22 3.3.2.3. Household products .......................................................... 23 3.3.2.4. Triclosan in consumer products and textiles ......................... 23 3.3.3.Biocides in food production ................................................................ 24 3.3.3.1. Biocides as disinfectants.................................................... 24 3.3.3.2. Biocides as food preservatives............................................ 24 3.3.4.Biocides in animal husbandry ............................................................. 24 3.3.4.1. Biocides as feed preservatives............................................ 26 3.3.4.2. Biocides for specific applications ........................................
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