Opinion from the Scientific Panel on Biological Hazards on the evaluation of the efficacy of L (+) Lactic acid for carcass decontamination 1 (EFSA-Q-2005-107A) Adopted on 15-16 March 2006 SUMMARY The European Commission requested EFSA to evaluate the efficacy of L (+) Lactic Acid and Buffered Lactic acid as antimicrobial substances applied to poultry carcasses. The evaluation was based on the documentation submitted from the applicant to European Commission and further provided to EFSA. The BIOHAZ panel concludes that it was not possible to evaluate the efficacy of the treatment with lactic acid on pathogenic microorganisms on poultry carcasses because i) the purpose of the treatment was not clearly specified in the documentation provided, ii) the method(s) of application, the point(s) in the processing chain where applied, the concentration(s) of lactic acid, and the temperature(s) of application were not clearly indicated, iii) the documentation provided did not represent a coherent body of arguments and experimental results supporting the efficacy of the substance and iv) it was recommended not to rinse after the decontaminating treatment, which is not in accordance with the EC requirements where decontaminating agents are to be regarded as processing aids used in slaughterhouses to reduce numbers of pathogenic microorganisms on surfaces of raw foods of animal origin and should then be rinsed off. KEY WORDS: Decontamination, poultry carcasses, lactic acid Campylobacter spp. Salmonella. 1 For citation purposes: The EFSA Journal (2006) 342, 1-6, Evaluation of the efficacy of the lactic acid on www.efsa.eu.int Page 1 of 6
TABLE OF CONTENTS SUMMARY...1 BACKGROUND...3 TERMS OF REFERENCE...4 DOCUMENTATION PROVIDED TO EFSA AND USED FOR THE ASSESSEMENT OF THE EFFICACY...4 ASSESSMENT...4 1. INTRODUCTION...4 2. CONCLUSIONS ON THE EVALUATION OF THE EFFICACY OF L (+) LACTIC ACID AND BUFFERED LACTIC ACID FOR POULTRY CARCASS DECONTAMINATION...5 REFERENCES...6 SCIENTIFIC PANEL MEMBERS...6 ACKNOWLEDGEMENTS...6 www.efsa.eu.int Page 2 of 6
BACKGROUND Article 3(2) of Regulation (EC) No 853/2004 2 of the European Parliament and of the Council laying down specific hygiene rules for food of animal origin, provides a legal basis to permit the use of a substance other than potable water to remove surface contamination from products of animal origin. For many decades the use of substances other than potable water, i.e. antimicrobial substances, has been resisted, because they could mask unhygienic slaughter or processing practices and would certainly not be an incentive for businesses to implement hygienic practices. If permitted for use, it was also feared that their widespread use coupled with high bacterial counts due to unhygienic practices, would consequently induce microbial resistance of the flora present on the surface of the treated products. An opinion prepared by the Scientific Committee on Veterinary Measures relating to Public Health (SCVPH) issued on 30 October 1998, stated that antimicrobial substances should only be permitted for use if a fully integrated control programme is applied throughout the entire food chain. The SCVPH opinion issued on 14-15 April 2003 on the evaluation of antimicrobial treatments for poultry carcasses concluded that decontamination can constitute a useful element in further reducing the number of pathogens. Both opinions stressed that antimicrobial substances shall be assessed thoroughly before their use is authorised. With the adoption of the hygiene package and the introduction of the HACCP principles in the entire food chain, establishments will be obliged to improve their hygiene and processing procedures. In addition, Regulation (EC) No 2160/2003 3 will force Member States to initiate implementing control programmes for poultry and pigs at the farm level. Under such circumstances the use of antimicrobial substances on food of animal origin can be reconsidered. The Commission envisages the approval of certain antimicrobial substances as part of an implementing measure of the Hygiene Regulations, which became applicable with since 1 January 2006. In the light of the above regulation, (L+) lactic acid and the buffered version of lactic acid for poultry carcass decontamination have been submitted to EFSA for evaluation of the efficacy 4 as an antimicrobial substance on poultry carcasses. 2 OJ L226/25.06.04, p22 3 OJ L325/12.12.2003, p1 4 The Scientific Panel on Biological Hazards is requested to evaluate the efficacy of the substance. The Scientific panel on Food Additives is requested to evaluate the safety of the substance. www.efsa.eu.int Page 3 of 6
TERMS OF REFERENCE In accordance with Article 29 (1) (a) of Regulation (EC) No 178/2002, the European Commission requests EFSA to evaluate the efficacy of lactic acid as antimicrobial substances applied on poultry carcasses. DOCUMENTATION PROVIDED TO EFSA AND USED FOR THE ASSESSEMENT OF THE EFFICACY Purac (2005) L (+) Lactic acid for poultry carcass decontamination. Purac (2005) Buffered Lactic acid for poultry carcass decontamination. ASSESSMENT 1. Introduction Foodborne pathogens are an important public health problem throughout the world. Poultry and poultry products are frequently incriminated in foodborne disease caused by Salmonella serovars and by thermophilic Campylobacter spp. Successful control of foodborne human pathogens will require a farm to fork approach involving risk management interventions applied at production of feed, in breeding and production animals, at slaughterhouses, and by processors, distributors, retailers, caterers and consumers. In the case of poultry meat production, the aim must be to establish an integrated control programme throughout the poultry supply chain. Decontamination of poultry carcasses is generally intended to reduce the number and/or prevalence of pathogenic microorganisms. However according to the Commission and the opinion of SCVPH (2003), decontamination should only be used as an additional measure to further reduce the load of pathogenic microorganisms and not as a substitute for normal good hygienic practices. It must be emphasised that while antimicrobial treatments generally reduce the contamination level, they do not completely eliminate pathogens. Their effectiveness depends on the initial microbial load and treatment conditions. Many factors affect the efficacy of these antimicrobials including the concentration of the antimicrobial substance, duration of exposure, temperature, ph and hardness of the water, firmness of bacterial attachment to the carcasses, biofilm formation and the presence of fat or organic material in water. www.efsa.eu.int Page 4 of 6
2. Conclusions on the evaluation of the efficacy of L (+) Lactic Acid and Buffered Lactic acid for poultry carcass decontamination Evaluation of the efficacy of L (+) Lactic Acid and Buffered Lactic acid for poultry carcass decontamination was based on the documentation provided to EFSA (see above). The applicant requested to evaluate and approve L (+) lactic acid as carcass decontamination treatment. In the documentation provided, the purpose of the treatment was not clearly specified. Which pathogenic microorganisms the treatment or process was intended to target was not clearly stated. A single process or protocol was not clearly defined but several different options were offered such as between 1-2.5% lactic acid at a range of temperatures, at any of several steps of the process, using different modes of application. It was therefore not possible to judge the efficacy of decontamination with lactic acid because the method(s) of application, the point(s) in the processing chain where applied, the concentration(s) of lactic acid, and the temperature(s) of application were not clearly indicated. The documentation describing the efficacy of different lactic acid treatments was presented as a summarized literature review where some of the references dealt with concentrations of lactic acid outside the range of the proposed treatment (1-2.5%). Some of the quoted publications claimed reduction of pathogens (e.g. Campylobacter spp., Salmonella spp.) but many dealt with non-pathogenic bacteria. No attempt was made to identify one, or more, single effective treatment(s) or to interpret the scientific literature to support the treatment(s). The documentation provided did not represent a coherent body of arguments and experimental results supporting the efficacy of the substance. Moreover, in the application dossier it was recommended not to rinse after the decontaminating treatment, which is not in accordance with the EC requirements 5 where decontaminating agents are to be regarded as processing aids used in slaughterhouses to reduce numbers of pathogenic microorganisms on surfaces of raw foods of animal origin and should then be rinsed off. As a consequence, it was not possible to evaluate the efficacy of the treatment with lactic acid on pathogenic microorganisms on poultry. 5 After communication with the European Commission www.efsa.eu.int Page 5 of 6
REFERENCES SCVPH (2003) Opinion on the evaluation of antimicrobial treatments for poultry carcasses, adopted on 14-15 April 2003. 6 SCIENTIFIC PANEL MEMBERS Herbert Budka, Sava Buncic, Pierre Colin, John D Collins, Christian Ducrot, James Hope, Mac Johnston, Günter Klein, Hilde Kruse, Ernst Lücker, Simone Magnino, Riitta Liisa Maijala, Antonio Martínez López, Christophe Nguyen- The, Birgit Noerrung, Servé Notermans, George-John E Nychas, Maurice Pensaert, Terence Roberts, Ivar Vågsholm, Emmanuel Vanopdenbosch. ACKNOWLEDGEMENTS The Scientific Panel on Biological Hazards wishes to acknowledge the contribution of the working group that prepared the opinion: Pierre Colin, Christophe Nguyen-The, Birgit Noerrung (rapporteur) and Terence Roberts (chair). 6 http://europa.eu.int/comm/food/fs/sc/scv/out63_en.pdf www.efsa.eu.int Page 6 of 6