1 2 3 4 5 6 7 8 9 10 Joint AFC/BIOHAZ draft guidance document on the submission of data for the evaluation of the safety and the efficacy of substances other than potable water intended to be used to decontaminate the surface of foods 1 of animal origin (EFSA-Q-2006-008) 11 1 For the purpose of this document foods of animal origin are limited to fresh unprocessed products of animal origin. www.efsa.eu.int Page 1 of 8
12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 TABLE OF CONTENTS BACKGROUND...3 TERMS OF REFERENCE...3 1. INTRODUCTION...4 2. TECHNICAL DATA...5 2.1. IDENTITY OF THE SUBSTANCE(S) AND SPECIFICATIONS...5 2.2. MANUFACTURING PROCESS...5 2.3. METHODS OF ANALYSIS OF THE TREATED FOODS OF ANIMAL ORIGIN...5 2.4. REACTIONS AND FATE IN THE TREATED FOODS OF ANIMAL ORIGIN...5 2.5. THE PROCESS AND ITS PURPOSE...5 2.6. EXPOSURE ASSESSMENT...6 3. TOXICOLOGICAL DATA...6 4. INFORMATION NEEDED TO JUDGE THE EFFICACY OF DECONTAMINATING PROCESS...6 4.1 PROOF OF THE EFFICACY OF THE PROCESS...6 4.2 OTHER ISSUES...8 REFERENCES...8 29 30 31 32 33 34 www.efsa.eu.int Page 2 of 8
35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 61 BACKGROUND Substances or processes used for the decontamination treatment - other than antibiotics - of foods of animal origin are intended as processing aids to reduce levels of pathogenic microorganisms. For many years, European legislation limited the use of antimicrobial treatment, highlighting the significance and application of good manufacturing practices and/or other safety management systems (e.g. HACCP) in the whole production line. Article 3(2) of Regulation 853/2004 of the European Parliament and Council lays down specific hygiene rules for food of animal origin, effective from 1 January 2006 and provides a legal basis for the use of substances other than potable water to remove surface contamination from foods of animal origin. Moreover, with the adoption of the new Regulations on hygiene 2 and the introduction of the HACCP principles in the entire food chain, establishments will be obliged to improve their hygiene and processing procedures including verification and validation of the used systems. Previous opinions of the Scientific Committee on Veterinary Measures relating to Public Health (SCVPH, 2003 and 1998) concluded that the antimicrobial treatments should be considered as supplementary means of reducing the microbial load of foods of animal origin and should be a part of an integrated control programme throughout the whole food chain. Both opinions stressed that the authorization of antimicrobial substances for antimicrobial treatments should be based on risk assessment, e.g. assessing both the efficacy and the safety. TERMS OF REFERENCE Provide guidance to assist in the evaluation of the safety and efficacy of substances to be used to decontaminate the surface of foods 3 of animal origin intended for human consumption. 62 63 64 65 66 67 2 Regulation 852/2004: OJ L226/25.06.04, p3; Regulation 853/2004: OJ L226/25.06.04, p22 3 For the purpose of this document foods of animal origin are limited to fresh unprocessed products of animal origin www.efsa.eu.int Page 3 of 8
68 69 70 71 72 73 74 75 76 77 78 79 80 81 82 83 84 85 86 87 88 89 90 91 92 93 94 95 96 97 98 1. INTRODUCTION This document is intended as guidance to assist the evaluation of the safety and the efficacy of substances intended to be used to decontaminate the surface of foods of animal origin. Article 3(2) of Regulation 853/2004 of the European Parliament and Council, which lays down specific hygiene rules for food of animal origin, constitutes the legal basis for the use of substances other than potable water to remove surface contamination from foods of animal origin intended for human consumption. The Regulation became effective on 1 January 2006. The use of the substances to decontaminate the surface of foods of animal origin is authorised according to the legislative procedures of the European Commission (EC). However, the Commission shall consult EFSA on any matter within the scope of Regulation 853/2004 that could have a significant impact on public health. The EC informed EFSA that decontamination of foods of animal origin intended for human consumption should principally be used to reduce the numbers and/or prevalence of pathogenic microorganisms and be regarded as a processing aid which will be rinsed off after the application. Furthermore, it is a risk management policy that decontamination should be used only as an additional measure to further reduce the load of pathogenic microorganisms after following good hygienic/manufacturing practices and not as a substitute for those good hygienic practices. From a risk management point of view, the use of substances other than potable water can only be accepted if the toxicological safety and efficacy of that treatment can be demonstrated. The evaluation of the safety and the efficacy of such treatments fall within the remit of EFSA. Other relevant considerations, as mentioned in the SCVPH report (1998), which include the impact of the treatment on product quality, on worker safety, on the environment and consumer acceptance must be dealt with by other fora. All the items below must be addressed for the dossier to be considered valid for the evaluation process. If the petitioner submits data other than that required or considers a topic irrelevant in the case(s) of the substance(s) in question, this must be clearly justified for each of those topics. This guidance document will be revised in the light of any new legislation and the experience that EFSA develops handling applications. www.efsa.eu.int Page 4 of 8
99 100 101 102 103 104 105 106 107 108 109 110 111 112 113 114 115 116 117 118 2. TECHNICAL DATA 2.1. Identity of the substance(s) and specifications Substances, either single or in a simple or complex mixture, must be clearly identified giving respective chemical names (IUPAC), CAS registry numbers, synonyms and trade names, molecular weight, molecular and structural formula, purity, impurities present and their level and description of physical state of the product as marketed. 2.2. Manufacturing process Method of manufacture with description of the source (raw materials), the process used to produce the antimicrobial substance(s), production controls and quality assurance. 2.3. Methods of analysis of the treated foods of animal origin A detailed description of methods of analysis for an adequate detection and quantification of antimicrobial substances, its degradation products and any major reaction products in the foods of animal origin should be provided. 2.4. Reactions and fate in the treated foods of animal origin i. Residual levels in the treated food. 119 120 121 122 123 ii. iii. Description and quantification of any reaction or degradation by-product that may remain in the treated food. Determination of products resulting from potential reactions with natural compounds in the food during and after treatment, especially proteins, peptides, free amino acids and lipid compounds. 124 125 126 127 128 2.5. The process and its purpose i. A statement of the purpose of the treatment including a list of the type of foods of animal origin to be treated and the microorganisms the decontaminating treatment is intended to target. 129 130 131 132 133 134 ii. iii. A list of the pathogenic microorganisms occurring on the surface of foods of animal origin to be treated, and the possible human risks. A description of how the substance(s) will be applied to the surfaces of foods of animal origin, the mode of application, any recycling of the decontaminating substance and description of where in the processing lines the treatment will be applied. This includes the intended doses to be used, ways of www.efsa.eu.int Page 5 of 8
135 136 137 138 iv. application (i.e. - rinsing, spraying, etc.), conditions of use (i.e. - temperature, ph, etc.) and duration of treatment. A quantification of the expected residues, by-products and any relevant reaction products to be found in the treated food. 139 140 141 142 143 144 145 146 147 148 149 150 151 152 153 154 155 156 157 158 159 160 161 162 163 164 165 166 167 168 169 170 2.6. Exposure assessment An estimate of potential daily exposure to residues, by-products and any relevant reaction products must be provided in the dossier. 3. TOXICOLOGICAL DATA Available toxicological data on each antimicrobial substance, including its potential degradation products and any identified reaction products and degradation and reaction products should be submitted. Depending on these data and on the chemical structure of the substances and the levels remaining in the foods of animal origin, further toxicological data might be requested by EFSA. See e.g. the guidance document on submissions for food additives evaluations (http://europa.eu.int/comm/food/fs/sc/scf/out98_en.pdf). In cases where a substance is already approved for direct addition to food in the EU, a reference to the exact legislation may suffice in first instance. 4. INFORMATION NEEDED TO JUDGE THE EFFICACY OF DECONTAMINATING PROCESS The proposal should be a coherent presentation of the arguments for use of the decontaminating substance(s) supported by studies of the efficacy of pathogen reduction performed according to the guidelines below and presented in a structured way. It is suggested that each of the items below is addressed briefly in a summary cross-referenced to appropriate enclosures or annexes. 4.1 Proof of the efficacy of the process i. All in-plant studies intended to demonstrate efficacy should be made with the decontaminating product formulation for which authorisation is sought. ii. A comparison of surfaces of food of animal origin treated with the decontaminating agent and a corresponding untreated control food, where the only difference is the decontaminating agent and not the method of application or other factors e.g. if the decontaminating agent is used as a spray or dip, the control food must be sprayed or dipped under identical conditions. 171 172 iii. Tests on sufficient number of samples depending on the actual numbers and/or prevalence of the target organisms. www.efsa.eu.int Page 6 of 8
173 174 175 176 iv. The study design must be justified in relation to the specific claim(s) made for the substance and must include a consideration of statistical sound methodology and the capacity to measure expected changes with a probability of P 0.05. 177 178 179 180 181 v. The prevalence and/or the number of the target microorganisms must be measured before treatment, after treatment and at the end of the shelf life of the raw food to ensure that there is no repair of sublethally injured organisms. The same testing should also be followed for the control foods. In addition, indicator microorganisms and total viable counts could be measured. 182 183 184 185 186 187 188 189 190 191 192 193 194 vi. vii. viii. ix. Despite the antimicrobial treatment being intended to reduce the prevalence and/or numbers of pathogenic microorganisms, experimental data on the behaviour of non-pathogenic microorganisms such as indicator microorganisms and total viable counts, may assist judging the overall efficacy of the proposed treatment. The processing conditions in the study must be comparable with those where the decontaminating agent is intended to be used, e.g. in processing plant or a pilot plant. As far as possible the efficacy of the decontaminating agent should be tested on naturally contaminated foods. Particular attention should be paid to the sensitivity and specificity of the microbiological methods employed and to the adequacy and appropriateness of controls. 195 196 197 x. Experimental confirmation of the procedure to neutralise or eliminate the residual activity of the substance(s) to prevent interference with enumeration or detection of the target microorganism(s). 198 199 200 201 202 203 204 205 206 207 208 209 210 211 212 xi. xii. xiii. xiv. Tests may be used with pathogenic bacteria to evaluate the efficacy, and should take account of strain diversity by testing at least 5-10 different strains, for example strains isolated from human cases and from the particular food. It is recommended to be able to differentiate between strains. Experimental demonstration that the concentration of the decontaminating agent proposed is justified, for instance laboratory data showing the effect of different concentrations of the antimicrobials on the target microorganism(s). A description of the methods to control and monitor the concentration of the active substance(s) in the processing plant along operational time, including identifying factors that may influence the efficacy of the active substances (e.g. ph, temperature etc). If the decontamination treatment effectively reduces numbers / prevalence of a pathogen and also extends the shelf-life, the impact of that extended shelf-life on survival and possible growth of other pathogens should be considered, e.g. Listeria monocytogenes and Yersinia enterocolytica on decontaminated pork. www.efsa.eu.int Page 7 of 8
213 214 215 216 4.2 Other issues i. Only studies that directly support the purpose of the application will be considered. 217 218 219 220 221 222 ii. iii. iv. The dossier should include reports of all experiments done including the raw data from those experimental studies. The data and supporting documentation should be of the quality expected of data submitted to a peer-review journal. Any statistical analysis of data should explain the method applied and the statistical power. 223 224 225 226 227 228 229 230 231 232 v. Because of the fact that microorganisms naturally resistant to the decontamination treatment may occur, and others might develop resistance to the decontamination treatment, it is recommended, as a control measure, to perform tests of the efficacy of the treatment at intervals. REFERENCES SCVPH (2003) Opinion on the evaluation of antimicrobial treatments for poultry carcasses. http://europa.eu.int/comm/food/fs/sc/scv/out63_en.pdf SCVPH (1998) Report on the benefits and limitations of antimicrobial treatments for poultry carcasses. http://europa.eu.int/comm/food/fs/sc/scv/out14_en.pdf www.efsa.eu.int Page 8 of 8