Comparison of Microbiological Criteria in Food Products in the EU and China In partnership with: ©2017 The World Bank Group 1818 H Street NW Washington, DC 20433 Telephone: 202-473-1000 Internet: www.worldbank.org All rights reserved. This volume is a product of the staff of the World Bank Group. The World Bank Group refers to the member institutions of the World Bank Group: The World Bank (International Bank for Reconstruction and Development); International Finance Corporation (IFC); and Multilateral Investment Guarantee Agency (MIGA), which are separate and distinct legal entities each organized under its respective Articles of Agreement. We encourage use for educational and non-commercial purposes. The findings, interpretations, and conclusions expressed in this volume do not necessarily reflect the views of the Directors or Executive Directors of the respective institutions of the World Bank Group or the governments they represent. 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Contents 4 Foreword 7 Acknowledgements 8 Explanatory note to the publication 11 Comparison of microbiological criteria in food products (Table 1) 27 Comparison of the maximum permissible levels of certain microorganisms during food processing (Table 2) 41 Annex 1. PRC standards referred to in Tables 1 and 2 44 Annex 2. National Standard of the People’s Republic of China GB29921-2013 3 Foreword Dear Readers, I am pleased to introduce the publication Comparison of microbiological criteria in food products in the EU and the PRC, prepared in cooperation with the World Bank Group project Ukraine Investment Climate Reform. The idea behind this publication arose during discussions related to Ukraine’s preparation for inspection missions from the European Union and the People’s Republic of China. The publication became part of the work that contributed, and hopefully will further contribute to, the opening of new markets for Ukrainian food products. This publication is the result of the hard work of experts dealing with issues of food safety and international trade. Its purpose is to create a directory to help businesses, and our state, bring national food products to new markets. I am very pleased that experts from the State Service of Ukraine for Food Safety and Consumer Protection participated in the preparation of the publication, which resulted in this excellent practical guide. The publication is part of a series of publications that aim to inform food manufacturers about the requirements of the European Union, the People’s Republic of China, and other countries with potential markets. The first publication highlights the common and distinctive features of the food safety systems in the European Union and the Eurasian Economic Union, and includes a comparative analysis of them. It is available on the World Bank’s official website.1 1 http://documents.worldbank.org/curated/ en/973611467993504462/pdf/98140-RUSSIAN- REPLACEMENT-WP-PUBLIC-Box385193B.pdf 4 Comparison of Microbiological Criteria in Food Products in the EU and China It is no coincidence that for the next publication, a comparison of microbiological criteria in the European Union and the People’s Republic of China was selected. There is demand in EU countries and in the People’s Republic of China for Ukrainian food products. Consequently, Ukrainian food producers will find new, loyal consumers and will be able to increase their exports. This will be a win-win situation. Growth in such trade relations will meet the interests of all stakeholders — the state, business and, most importantly, consumers. Mandatory safety requirements for foodstuffs for the European and Chinese markets are very high to ensure maximum protection of consumer health. As more national food producers follow best global practices, for example, by introducing HACCP and the traceability system — which provides rapid notification of unsafe food and their recall from the market — the more secure consumers will be in our country. Yours sincerely, Head of the State Service of Ukraine for Food Safety and Consumer Protection Volodymyr Lapa Foreword 5 Foreword Dear Readers, I am delighted to present you this Guidebook. Its main purpose is to help food business op- erators to access the EU and Chinese markets by providing invaluable information about specific requirements for microbiological criteria for foodstuff in the aforementioned countries. Knowledge of the specific requirements of trading partners is of paramount importance for companies that aspire to open new ex- port markets and to reach new consumers. The comparison of microbiological criteria of food products offered by the Guidebook reflects cases of similarities and differences in the EU and Chinese requirements. The Guidebook is developed in a reader-friendly manner. It provides details of the parameters that producers must test when planning to export their products to the EU and China. I believe potential exporters and relevant state authorities will find this document useful and it will serve them as a basis for further analysis of food related requirements in the EU and China. Lisa Kaestner, Practice Manager, Europe and Central Asia World Bank Group 6 Comparison of Microbiological Criteria in Food Products in the EU and China Acknowledgments The World Bank Group project Ukraine Investment Climate Reform thanks the Swiss Development Agency (SECO) for its support in preparing the publication Comparison of microbiological criteria in food products in the EU and China. A number of experts with significant experi- ence in food safety and international trade relations were involved in the preparation of this publication. This publication grew out of working discus- sions between the World Bank Group project Ukraine Investment Climate Reform, the State Service of Ukraine for Food Safety and Consumers Protection, and private sector representatives. We are pleased to note that the Ministry of Agrarian Policy and Food of Ukraine was strongly supportive of this effort. Kateryna Onul, Adviser on Food Legislation (WBG), was responsible for the overall development of the document. Creation of this publication would have been impos- sible without the professional expertise of Vasyl Gamianin, consultant to the World Bank Group project Ukraine Investment Climate Reform. We also thank Eugene Osmochescu, Heinz Strubenhoff, Zhanna Pastovenska, Vitalii Bashynsky and Yurii Zvazhenko for their sup- port in preparing this publication. We express our special thanks to Olga Shevchenko from the State Service of Ukraine for Food Safety and Consumer Protection for her advice. The authors of the publication are particularly grateful to Lisa Kaestner, Practice Manager in Europe and Central Asia, for her support of this initiative. Foreword 7 Explanatory note to the publication The purpose of this guideline is to compare a range of food safety indicators and hygiene criteria for food production in the European Union (the EU) and the People’s Republic of China (the PRC).1 This will be useful to food business operators who plan to export food to the PRC or the EU, as it will allow them to: 1) identify differences in requirements to the content of pathogenic microorganisms in different categories of food products; 2) familiarize themselves with the rules of sampling; 3) identify differences in the lists of target categories of food products in the PRC and the EU; 4) see differences in approaches to norms setting for specific items; 5) learn about other differences between European and Chinese approaches and techniques related to food safety at different stages of production. We hope that the information provided in this directory will facilitate entry of national producers and exporters of food products into the markets of the PRC and the EU. Methodologically, the directory is based on official documents of the EU and the PRC. Specifically, the EU Commission Regulation No. 2073/2005 dated 15 November 2005 (hereinafter referred to as Regulation No. 2073/2005), which sets the microbiological criteria for food products in the EU, and national standards of the People’s Republic of China (documents of GB series), were subject to consideration and comparison. Unlike the EU, the PRC does not have a single normative document setting microbiological criteria for all categories of food products, as done in EU legislation under Regulation No. 2073/2005. Instead, the PRC has a number of documents for various categories of food products. These documents were adopted at different times beginning in 2010. They are updated and supplemented on a regular basis due to the continuous improvement of the Chinese food safety control system and its compliance with international standards, as well as the requirements of the EU, the United States, Canada, Australia, New Zealand, Japan, SAR Siangan (Hong Kong) and Taiwan. The basic document of the PRC setting the maximum permissible levels of pathogenic microorganisms in food products is the national standard of the PRC GB 29921-2013, which entered into force on July 1, 2014 (hereinafter referred to as GB 29921). GB 29921 is a general standard and applies to pre-packaged foods. In cases where there are differences in criteria between those in GB 29921 and other PRC standards, the requirements of GB 29921 must be applied. It should be noted that when exporting food products to the PRC, the Chinese side usually follows European and American norms and standards in addition to its own, especially when there are no national requirements. One difficulty in comparing the indicators approved by the EU and the PRC is that there is no open access to Chinese regulatory documents in this area. An additional problem was the translation of Chinese standards into English. All available translations are unofficial and only accessible from non-verified commercial sources. 1 As of July 2017 8 Comparison of Microbiological Criteria in Food Products in the EU and China Food business operators planning to export their products to the PRC may benefit from the following websites, with references to PRC food safety regulations:  Certification and Accreditation Administration of the PRC—http://www.cnca.gov.cn/  General Administration of Quality Supervision, Inspection and Quarantine of the PRC— http://www.aqsiq.gov.cn/  China Food Safety Regulations—http://www.cirs-group.com/food/provisions/  A single (unofficial) resource from which food safety control regulations, primarily relevant government standards, can be downloaded (in the original language)— http://down.foodmate.net/ Required documents in current EU legislation are available on the website: http://eur-lex. europa/”http://eur-lex.europa.eu/ homepage.html. Documents presented on this website are in the original languages of the EU Member States. In addition, useful information on EU requirements for food products is available on the European Commission website: https:// ec.europa.eu/food/overview. In comparing food product and safety criteria of the EU and those of the PRC, the following differences were identified: 1) A single consolidated document that regulates microbiological criteria for all categories of food products that may cause potential risks, does not exist in the People’s Republic of China; the list of GB-series documents (PRC national standard), cited in order of the documents’ publication, is provided in Annex 1 to the publication. 2) Compared to Regulation № 2073/2005, Chinese standards do not include some posi- tions on food products subject to mandatory control (e.g. p.1.7, 1.18, 1.19, 1.29). 3) Compared to Regulation № 2073/2005, absences in Chinese standards are sometimes detailed in categories and subcategories of food products (e.g. p.1.1-1.3, 1.4-1.9). 4) A range of food products categories, present in Chinese documents, are absent in Regulation №2073/2005, for example: casein, cereal crop products, legume products, chocolate and cocoa products, and nuts and seed products. 5) A list of pathogenic microorganisms subject to mandatory controls is at variance for the prevailing number of categories of food products (e.g. p.1.1, 1.4-1.10, 1.16, 1.17, 1.24, 1.5). 6) In some cases, the difference in the maximum permissible level of pathogenic micro- organism content in foodstuffs is identified (e.g. p. 1.21, 1.26, 1.27). 7) Sometimes Chinese standards do not comply with those of the EU in terms of the number of samples to be undertaken (e.g. p.1.22-1.24). 8) For a number of positions existing in the EU (for example, raw meat and poultry, which require thermal or special processing, and are not intended for direct consumption), the requirements of microbiological criteria are absent in China. 9) According to PRC hygiene standards, the system of controls of pathogenic and other microorganisms in food products during processing is absent; such controls are only regulated for sale (pre-packaged) food products/semi-finished food products. Given the substantial differences in category names and food products themselves, exporters are kindly advised to hold meaningful consultations with Chinese partners/importers for each specific issue. Explanatory Note to the Publication 9 10 Comparison of Microbiological Criteria in Food Products in the EU and China Сomparison of 1 microbiological criteria in food products EU: Anneх I to Regulation № 2073/20051 PRC: national standards GB 2707-2016, GB 5420-2010, GB 6783-2013, GB 10765-2010, GB 10767-2010, GB 10769-2010, GB 11674-2010, GB 13102-2010, GB 14967-2015, GB 16869-2005, GB 19301-2010, GB 19302-2010, GB 19644-2010, GB 19645-2010, GB 19646-2010, GB 22556-2008, GB 25191-2010, GB 25192-2010, GB 25596-2010, GB 29921-2013, GB 31619-2014, GB 31638-2016 1 Commission Regulation (EC) No. 2073/2005 of 15 November 2005 on microbiological criteria for foodstuffs. The latest version of the Regulation in English can be found at: http://eur-lex.europa.eu/homepage.html. 2 Full names of PRC standards are specified in the table given in Annex І. Micro-organisms, Sampling plan Limits3 their toxins, me- tabolites (meta- PRC Country Food category Vm (EU) / bolic products)/ n 4 c 5 M standard pathogenic mi- m (PRC)6 croorganisms 1 2 3 4 5 6 7 8 1.18 Ready-to-eat foods Listeria 10 0 Absence in 25 g intended for infants9, monocytogenes 7 EU and ready-to-eat foods for special medical Criteria applied for products placed on the market during their shelf-life purposes10 Staphylococcus aureus 5 2 10 CFU/g 100 CFU/g 金黄色葡萄球菌 Dried infant formulae Enterobacter GB 10765- (for infants below 6 sakazakii 3 0 0/100 g –11 2010 months of age) 阪崎肠杆菌 Salmonella 5 0 0/25 g – 沙门氏菌 Staphylococcus aureus 5 2 10 CFU/g 100 CFU/g PRC Foods for special 金黄色葡萄球菌 medical purposes Enterobacter GB 25596- intended for infants sakazakii 3 0 0/100 g – 2010 below six months of 阪崎肠杆菌 age Salmonella 5 0 0/25 g – 沙门氏菌 Salmonella Foods (dried formulae) 5 0 0/25 g – 沙门氏菌 for special medical GB 29922- purposes (for children Staphylococcus 2013 older than one year) aureus 5 2 10 CFU/g 100 CFU/g 金黄色葡萄球菌 3 In the PRC, unless otherwise specified, the limit values are 25 g or 25 ml. 4 Number of samples taken from the batch of products. 5 ”C” in the EU is the number of samples with parametric values between “m” and “M”; “c” in the PRC is the maximum number of samples, the parametric value of which may exceed “M”. 6 The maximum permissible values for the EU “Vm”, are identical to “m” in the PRC. 7 There is no exact match for this EU category in Chinese standards. The most closely content-related categories do not provide for the control of L. monocytogenes. 8 The numbering corresponds to the numbering used in Annex I to Regulation No. 2073/2005. 9 Children under 12 months. 10 Regular testing against the criterion is not required in normal circumstances for the following ready-to-eat foods: those which have re- ceived heat treatment or other processing effective to eliminate L. monocytogenes, when recontamination is not possible after this treat- ment (for example, products heat treated in their final package); fresh, uncut and unprocessed vegetables and fruits, excluding sprouted seeds; bread, biscuits and similar products; bottled or packed waters, soft drinks, beer, cider, wine, spirits and similar products; sugar, honey and confectionery, including cocoa and chocolate products; live bivalve molluscs; food grade salt. 11 Hereinafter in the text the symbol “–“ refers to the absence of the indicator in one or another Chinese standard. In this case, the absence of the “M” indicator (the maximum permissible levels of pathogenic microorganisms) converts the “m” indicator (limiting the level of permis- sible content of pathogenic microorganisms) into the final criterion, which should be observed. 12 Comparison of Microbiological Criteria in Food Products in the EU and China 1 2 3 4 5 6 7 8 5 0 100 CFU/g12 1.2 Ready-to-eat foods able to support Criteria applied for products placed on the market during the growth of L. their shelf-life monocytogenes, other Listeria than those intended monocytogenes 5 0 Absence in 25 g13 for infants and for Criteria applied for products before the food has left the special medical immediate control of the food business operator, who has purposes EU produced it 1.3 Ready-to-eat foods Listeria unable to support 5 0 100 CFU/g monocytogenes the growth of L. monocytogenes, other than those intended for infants and for Criteria applied for products placed on the market during their shelf-life special medical purposes14, 15 Meat products16  cooked (heat- Listeria treated) meat monocytogenes GB 29921- 5 0 0 – products 单核细胞增生 2013  intended to be eaten 李斯特氏菌 raw Hard cheeses (ripened Listeria PRC cheeses, ripened blue monocytogenes GB 5420- 5 0 0/25 g – cheeses, unripened 单核细胞增生 2010 cheeses) 李斯特氏菌 Processed cheeses Listeria (content of hard monocytogenes GB 25192- 5 0 0/25 g – cheese not less than 单核细胞增生 2010 15%) 李斯特氏菌 12 This criterion shall apply if the manufacturer is able to demonstrate, to the satisfaction of the competent authority, that the product will not exceed the limit 100 cfu/g throughout the shelf-life. The operator may fix intermediate limits during the process that must be low enough to guarantee that the limit of 100 cfu/g is not exceeded at the end of shelf-life. 13 This criterion shall apply to products before they have left the immediate control of the producing food business operator, when he is not able to demonstrate, to the satisfaction of the competent authority, that the product will not exceed the limit of 100 cfu/g throughout the shelf-life. 14 Regular testing against the criterion is not required in normal circumstances for the following ready-to-eat foods: those which have re- ceived heat treatment or other processing effective to eliminate L. monocytogenes, when recontamination is not possible after this treat- ment (for example, products heat treated in their final package); fresh, uncut and unprocessed vegetables and fruits, excluding sprouted seeds; bread, biscuits and similar products; bottled or packed waters, soft drinks, beer, cider, wine, spirits and similar products; sugar, honey and confectionery, including cocoa and chocolate products; live bivalve molluscs; food grade salt. 15 Products with pH ≤ 4,4 or a w ≤ 0,92, products with pH ≤ 5,0 and a w ≤ 0,94, products with a shelf-life of less than five days shall be automatically considered to belong to this category. Other categories of products can also belong to this category, subject to scientific justification. 16 Products from cooked (marinated, stewed, smoked, roasted, steamed, boiled, etc.) and raw (fermented or processed by special technolo- gies) meat (pork, beef, lamb, chicken, rabbit, dog, etc.), suitable for direct consumption. Сomparison of Microbiological Criteria in Food Products 13 1 2 3 4 5 6 7 8 1.4 Minced meat and Salmonella 5 0 Absence in 25 g meat preparations EU intended to be eaten Criteria applied for products placed on the market during their shelf-life raw Salmonella 5 0 0 – 沙门氏菌 Listeria monocyto- Meat products17 genes 5 0 0 –  cooked (heat- 单核细胞增生 treated) meat 李斯特氏菌 GB 29921- products 2013 Staphylococcus  intended to be eaten aureus 5 1 100 CFU/g 1000 CFU/g raw 金黄色葡萄球菌 Escherіchіa colі О 157:Н718 5 0 0 – 大肠埃希氏菌 PRC Fresh (frozen) prod- ucts from animals and poultry: raw, not suitable for direct con- sumption (without heat-treatment) meat of animals (pigs, bovine GB 2707- Requirements for indicators of microbiological criteria are absent cattle, sheep and goats, 2016 rabbits, etc.) and poultry (chickens, ducks, geese, etc.), as well as edible parts (offals, heads, necks, tails, wings, ap- pendages, etc.) 1.5 Minced meat and Salmonella 5 0 Absence in 25 g meat preparations EU made from poultry meat intended to be Criteria applied for products placed on the market during their shelf-life eaten cooked Salmonella 5 0 0 – 沙门氏菌 Meat products19 Listeria  cooked (heat- monocytogenes treated) meat 5 0 0 – GB 29921- 单核细胞增生 products 2013 李斯特氏菌  intended to be eaten raw Staphylococcus PRC aureus 5 1 100 CFU/g 1000 CFU/g 金黄色葡萄球菌 Salmonella Indicator 0/25 g Poultry meat (fresh 沙门氏菌 is absent GB 16869- and frozen) and Escherіchіa colі 2005 products thereof О 157:Н7 0/25 g 大肠埃希氏菌 17 Products from cooked (marinated, stewed, smoked, roasted, steamed, boiled, etc.) and raw (fermented or processed by special technolo- gies) meat (pork, beef, lamb, chicken, rabbit, dog, etc.), suitable for direct consumption. 18 Only for beef products. 19 Products from cooked (marinated, stewed, smoked, roasted, steamed, boiled, etc.) and raw (fermented or processed by special technolo- gies) meat (pork, beef, lamb, chicken, rabbit, dog, etc.), suitable for direct consumption. 14 Comparison of Microbiological Criteria in Food Products in the EU and China 1 2 3 4 5 6 7 8 1.6 Minced meat and Salmonella 5 0 Absence in 10 g meat preparations made from other EU species than poultry Criteria applied for products placed on the market during their shelf-life intended to be eaten cooked Salmonella 5 0 0 – 沙门氏菌 Listeria Meat products20 monocytogenes 5 0 0 –  cooked (heat- 单核细胞增生 treated) meat 李斯特氏菌 GB 29921- PRC products Staphylococcus 2013  intended to be eaten aureus 5 1 100 CFU/g 1000 CFU/g raw 金黄色葡萄球菌 Escherіchіa colі О 157:Н721 5 0 0 – 大肠埃希氏菌 1.7 Mechanically Salmonella 5 0 Absence in 10 g separated meat EU22 Criteria applied for products placed on the market during their shelf-life (MSM)23 Fresh (frozen) prod- ucts from animals and poultry: raw, not suitable for direct consumption (with- out heat-treatment) meat of animals (pigs, GB 2707- PRC bovine cattle, sheep Requirements for indicators of microbiological criteria are absent 2016 and goats, rabbits, etc.) and poultry (chickens, ducks, geese, etc.), as well as edible parts (offals, heads, necks, tails, wings, append- ages, etc.) 20 Products from cooked (marinated, stewed, smoked, roasted, steamed, boiled, etc.) and raw (fermented or processed by special technolo- gies) meat (pork, beef, lamb, chicken, rabbit, dog, etc.), suitable for direct consumption. 21 Only for beef products. 22 There is no exact match for this category in the PRC system of standards. 23 This criterion shall apply to mechanically separated meat (MSM) produced with the techniques referred to in paragraph 3 of Chapter III of Section V of Annex III to Regulation (EC) No 853/2004 of the European Parliament and of the Council. Сomparison of Microbiological Criteria in Food Products 15 1 2 3 4 5 6 7 8 1.8 Meat products Salmonella 5 0 Absence in 25 g intended to be eaten raw, excluding products where EU the manufacturing process or the Criteria applied for products placed on the market during their shelf-life composition of the product will eliminate the salmonella risk Salmonella 5 0 0 – 沙门氏菌 Listeria Meat products 24 monocytogenes 5 0 0 –  cooked (heat- 单核细胞增生 treated) meat 李斯特氏菌 GB 29921- PRC products Staphylococcus 2013  intended to be eaten aureus 5 1 100 CFU/g 1000 CFU/g raw 金黄色葡萄球菌 Escherіchіa colі О 157:Н725 5 0 0 – 大肠埃希氏菌 1.9 Meat products Salmonella 5 0 Absence in 25 g made from poultry EU meat intended to be Criteria applied for products placed on the market during their shelf-life eaten cooked Salmonella 5 0 0 – 沙门氏菌 Listeria Meat products26 monocytogenes 5 0 0 –  cooked (heat- 单核细胞增生 treated) meat 李斯特氏菌 GB 29921- PRC products Staphylococcus 2013  intended to be eaten aureus 5 1 100 CFU/g 1000 CFU/g raw 金黄色葡萄球菌 Escherіchіa colі О 157:Н727 5 0 0 – 大肠埃希氏菌 24 Products from cooked (marinated, stewed, smoked, roasted, steamed, boiled, etc.) and raw (fermented or processed by special technolo- gies) meat (pork, beef, lamb, chicken, rabbit, dog, etc.), suitable for direct consumption. 25 Only for beef products. 26 Products from cooked (marinated, stewed, smoked, roasted, steamed, boiled, etc.) and raw (fermented or processed by special technolo- gies) meat (pork, beef, lamb, chicken, rabbit, dog, etc.), suitable for direct consumption. 27 Only for beef products. 16 Comparison of Microbiological Criteria in Food Products in the EU and China 1 2 3 4 5 6 7 8 1.10 Gelatine and Salmonella 5 0 Absence in 25 g EU collagen Criteria applied for products placed on the market during their shelf-life GB 6783- Salmonella 2013, Gelatine Doesn’t have to be detected 沙门氏菌 GB 31619- 2014 Salmonella 5 0 0/25 g – 沙门氏菌 Collagen sausage GB 14967- casings Staphylococcus 2015 PRC aureus 5 1 100 1000 金黄色葡萄球菌 Staphylococcus aureus 5 2 10 1027 金黄色葡萄球菌 GB 31638- Casein 2010 Salmonella 5 0 0/25 g – 沙门氏菌 Сomparison of Microbiological Criteria in Food Products 17 1 2 3 4 5 6 7 8 1.11 Cheeses, butter Salmonella 5 0 Absence in 25 g and cream made from raw milk or milk EU that has undergone a Criteria applied for products placed on the market during their shelf-life lower heat treatment than pasteurisation28 Condensed Staphylococcus milk, sweetened aureus 5 0 0/25 g (ml) – 金黄色葡萄球菌 GB 13102- condensed, 2010 condensed milk with Salmonella additives 5 0 0/25 g (ml) – 沙门氏菌 Staphylococcus aureus 5 0 0/25 g (ml) – 金黄色葡萄球菌 GB 25191- Modified milk 2010 Salmonella 5 0 0/25 g (ml) – 沙门氏菌 Staphylococcus aureus 5 0 0/25 g (ml) – 金黄色葡萄球菌 GB 19645- Pasteurized milk 2010 Salmonella 5 0 0/25 g (ml) – 沙门氏菌 Staphylococcus aureus 5 0 0/25 g (ml) – 金黄色葡萄球菌 GB 19302- PRC Fermented milk 2010 Salmonella 5 0 0/25 g (ml) – 沙门氏菌 Staphylococcus Hard cheeses (ripened aureus 5 2 100 1000 cheeses, ripened blue 金黄色葡萄球菌 GB 5420- cheeses, unripened 2010 cheeses) Salmonella 5 0 0/25 g – 沙门氏菌 Staphylococcus Processed cheeses aureus 5 2 100 1000 (content of hard 金黄色葡萄球菌 GB 25192- cheese not less than 2010 15%) Salmonella 5 0 0/25 g – 沙门氏菌 Cream (10-80% fat), Staphylococcus butter (not less than aureus 5 1 10 100 金黄色葡萄球菌 GB 19646- 80% fat), dehydrated 2010 butter (not less than Salmonella 99,8% fat) 5 0 0/25 g (ml) – 沙门氏菌 28 Excluding products when the manufacturer can demonstrate to the satisfaction of the competent authorities that, due to the ripening time and a w of the product where appropriate, there is no salmonella risk. 18 Comparison of Microbiological Criteria in Food Products in the EU and China 1 2 3 4 5 6 7 8 1.12 Milk powder and Salmonella 5 0 Absence in 25 g EU whey powder Criteria applied for products placed on the market during their shelf-life Staphylococcus aureus 5 2 10 100 Milk powder (dried 金黄色葡萄球菌 GB 19644- milk) 2010 Salmonella 5 0 0/25 g – 沙门氏菌 PRC Staphylococcus Whey powder and aureus 5 2 10 100 serum albumin 金黄色葡萄球菌 GB 11674- powder (whey 2010 albumin) Salmonella 5 0 0/25 g – 沙门氏菌 1.13 Ice cream, exclud- Salmonella 5 0 Absence in 25 g ing products where the manufacturing EU process or the com- position of the product Criteria applied for products placed on the market during their shelf-life will eliminate the sal- monella risk Salmonella 5 0 0 – Frozen drinks29 沙门氏菌 GB 29921- PRC  ice cream Staphylococcus 2013  edible ice aureus 5 1 100 CFU/g 1000 CFU/g (ml) (ml) 金黄色葡萄球菌 1.14 Egg products, Salmonella 5 0 Absence in 25 g excluding products where the manufac- EU turing process or the composition of the Criteria applied for products placed on the market during their shelf-life product will eliminate the salmonella risk Egg products Salmonella GB 29921- intended for human 5 0 0 – PRC 沙门氏菌 2013 consumption30 29 All types of ice cream and food ice, made on the basis of drinking water, sugar, milk, fruit, bean products, edible fats and oils, with the addition of food additives. 30 Products suitable for direct consumption, made from poultry eggs, including cooked eggs. Сomparison of Microbiological Criteria in Food Products 19 1 2 3 4 5 6 7 8 1.15 Ready-to-eat Salmonella 5 0 Absence in 25 g or ml foods containing raw egg, excluding prod- ucts where the manu- EU facturing process or Criteria applied for products placed on the market during their shelf-life the composition of the product will eliminate the salmonella risk Cereal products31 Salmonella 5 0 0 –  cooked (heat- 沙门氏菌 treated) cereal products (including pastries) GB 29921-  cooked (heat- Staphylococcus 2013 treated) flour-rice aureus 5 1 100 CFU/g 1000 CFU/g products with filling 金黄色葡萄球菌  instant (quick – cooking) flour-rice PRC products Condiments Salmonella 5 0 0 – intended for human 沙门氏菌 consumption  soy sauce  soy paste GB 29921-  aquatic products Staphylococcus 100 CFU/g 1000 CFU/g 2013 condiments aureus 5 2 (ml) (ml)  combined 金黄色葡萄球菌 condiments (mayonnaise, etc) 1.16 Cooked Salmonella 5 0 Absence in 25 g EU crustaceans and molluscan shellfish Criteria applied for products placed on the market during their shelf-life Aquatic products32 Salmonella 5 0 0 –  cooked (heat- 沙门氏菌 treated) aquatic products Vibrio 1000  intended to be eaten parahaemolyticus 5 1 100 MPN/g MPN/g GB 29921- PRC raw aquatic animal 副溶血性弧菌 2013 products  intended for human Staphylococcus consumption aureus 5 1 100 CFU/g 1000 CFU/g aquatic plant 金黄色葡萄球菌 products (algae) 31 Products made from rice, wheat, other cereals, roots, corn, etc., whether or not filled, suitable for direct consumption (cereal flakes, cereals / cooked porridge / instant noodles, etc.), as well as bakery products made from cereals, fats, eggs, sugar and food additives, suitable for direct consumption (pastries, cakes, cookies, bread, etc.). 32 Products made from fish, crustaceans, molluscs, invertebrates, echinoderms and other aquatic organisms that have undergone heat treatment (steamed, cooked, baked, deep fried, etc.), suitable for direct consumption. Products that have been cleaned but not thermally processed, suitable for direct consumption, including live, fresh, frozen fish (fish slices), shrimp, cephalopods, live crab, live molluscs, as well as products made from live snails, crabs, molluscs, caviar by non-thermal treatment (salting, marinating, alcoholization), suitable for direct consumption. Products made from algae, suitable for direct consumption, which have undergone a certain treatment, including thermal (boiled, deep fried). 20 Comparison of Microbiological Criteria in Food Products in the EU and China 1 2 3 4 5 6 7 8 1.17 Live bivalve Salmonella 5 0 Absence in 25 g molluscs and live EU echinoderms, tunicates and Criteria applied for products placed on the market during their shelf-life gastropods Aquatic products33 Salmonella 5 0 0 –  cooked (heat-treated) 沙门氏菌 aquatic products Vibrio  intended to be eaten 1000 parahaemolyticus 5 1 100 MPN/g GB 29921- PRC raw aquatic animal MPN/g 副溶血性弧菌 2013 products  intended for human Staphylococcus consumption aquatic aureus 5 1 100 CFU/g 1000 CFU/g plant products (algae) 金黄色葡萄球菌 1.18 Sprouted seeds Salmonella 5 0 Absence in 25 g EU34 (ready-to-eat)35 Criteria applied for products placed on the market during their shelf-life 1.19 Precut fruit and Salmonella 5 0 Absence in 25 g EU vegetables (ready-to- eat)36 Criteria applied for products placed on the market during their shelf-life Salmonella 5 0 0 – 沙门氏菌 Fruit and vegetable Staphylococcus products (including 100 CFU/g 1000 CFU/g aureus 5 1 GB 29921- PRC marinated products) (ml) (ml) 金黄色葡萄球菌 2013 intended for human consumption37 Escherіchіa colі О 157:Н738 5 0 0 – 大肠埃希氏菌 1.20 Unpasteurised fruit Salmonella 5 0 Absence in 25 g EU and vegetable juices (ready-to-eat) Criteria applied for products placed on the market during their shelf-life Salmonella 5 0 0 – Drinks (except packed 沙门氏菌 GB 29921- PRC waters and carbonated Staphylococcus 100 CFU/g 1000 CFU/g 2013 drinks)39 aureus 5 1 (ml) (ml) 金黄色葡萄球菌 33 Products made from fish, crustaceans, molluscs, invertebrates, echinoderms and other aquatic organisms that have undergone heat treatment (steamed, cooked, baked, deep fried, etc.), suitable for direct consumption. Products that have been cleaned but not thermally processed, suitable for direct consumption, including live, fresh, frozen fish (fish slices), shrimp, cephalopods, live crab, live molluscs, as well as products made from live snails, crabs, molluscs, caviar by non-thermal treatment (salting, marinating, alcoholization), suitable for direct consumption. Products made from algae, suitable for direct consumption, which have undergone a certain treatment, including thermal (boiled, deep fried). 34 There is no exact match for this category in the PRC system of standards. 35 Excluding sprouts that have received a treatment effective to eliminate Salmonella spp. and STEC. 36 There is no exact match for this category in the PRC system of standards. 37 Products intended for direct consumption, made from vegetables and fruits: frozen vegetables / fruits, dried vegetables / fruits, fruit in vinegar, oils or salt, comfiture, jam, marmalade, candied fruits, syrup fruits, pickled vegetables, vegetable pasta and sauces (except tomato), products from fermented vegetables and fruits. 38 Only for vegetables and fruits intended to be eaten raw. 39 Vegetable and fruit juices, protein drinks, water-based mixed drinks, tea, coffee, vegetable drinks, dry drinks, and other beverages. Сomparison of Microbiological Criteria in Food Products 21 1 2 3 4 5 6 7 8 1.21 Cheeses, Staphylococcal Doesn’t have to be 5 0 milk powder and enterotoxins40 detected in 25 g whey powder, as referred to in the coagulase-positive EU staphylococci criteria in Chapter 2.2 Annex Criteria applied for products placed on the market during their shelf-life I of Commission Regulation № 2073/2005 Hard cheeses (ripened Staphylococcus cheeses, ripened blue GB 5420- aureus 5 2 100 CFU/g 1000 CFU/g cheeses, unripened 2010 金黄色葡萄球菌 cheeses) Processed cheeses Staphylococcus (content of hard GB 25192- aureus 5 2 100 CFU/g 1000 CFU/g cheese not less than 2010 金黄色葡萄球菌 PRC 15%) Staphylococcus Milk powder (dried GB 19644- aureus 5 2 10 CFU/g 100 CFU/g milk) 2010 金黄色葡萄球菌 Whey powder and Staphylococcus serum albumin GB 11674- aureus 5 2 10 CFU/g 100 CFU/g powder (whey 2010 金黄色葡萄球菌 albumin ) 1.22 Dried infant Salmonella 3041 0 Absence in 25 g formulae and dried dietary foods for EU special medical purposes intended Criteria applied for products placed on the market during their shelf-life for infants below six months of age Staphylococcus aureus 5 2 10 100 金黄色葡萄球菌 Dried infant formulae Enterobacter GB 10765- (for infants below 6 sakazakii 3 0 0/100 g – 2010 months of age) 阪崎肠杆菌 Salmonella 5 0 0/25 g – 沙门氏菌 PRC Staphylococcus aureus 5 2 10 100 Foods for special 金黄色葡萄球菌 medical purposes Enterobacter GB 25596- intended for infants sakazakii 3 0 0/100 g – 2010 below six months of 阪崎肠杆菌 age Salmonella 5 0 0/25 g – 沙门氏菌 40 In the EU standards, the presence of staphylococcal enterotoxins is controlled, while the PRC standards control the presence of Staphylococcus. Perhaps this results in a significant difference in the permissible limits for the presence of the specified pathogenic organ- isms in this category of food products. 41 In terms of the required number of samples, the Chinese standard (5 samples) does not match the European standard (30 samples). 22 Comparison of Microbiological Criteria in Food Products in the EU and China 1 2 3 4 5 6 7 8 1.23 Dried follow-on Salmonella 3042 0 Absence in 25 g EU formulae Criteria applied for products placed on the market during their shelf-life Dried follow-on Salmonella GB 10767- formulae for children 5 0 0/25 g – 沙门氏菌 2010 (6 -36 months of age) PRC Cereal-based foods for Salmonella GB 10769- children (6 -36 months 5 0 0/25 g – 沙门氏菌 2010 of age) 1.24 Dried infant Cronobacter spp. formulae and dried (Enterobacter 3044 0 Absence in 10 g dietary foods for sakazakii) EU special medical purposes intended for infants below 6 Criteria applied for products placed on the market during their shelf-life months of age43 Staphylococcus aureus 5 2 10 100 金黄色葡萄球菌 Dried infant formulae Enterobacter GB 10765- (for infants below 6 sakazakii45 3 0 0/100 g – 2010 months of age) 阪崎肠杆菌 Salmonella 5 0 0/25 g – 沙门氏菌 PRC Staphylococcus aureus 5 2 10 100 Foods for special 金黄色葡萄球菌 medical purposes Enterobacter GB 25596- intended for infants sakazakii 3 0 0/100 g46 – 2010 below six months of 阪崎肠杆菌 age Salmonella 5 0 0/25 g – 沙门氏菌 42 In terms of the required number of samples, the Chinese standard (5 samples) does not match the European standard (30 samples). 43 Parallel testing for Enterobacteriaceae and E. sakazakii shall be conducted, unless a correlation between these micro-organisms has been established at an individual plant level. If Enterobacteriaceae are detected in any of the product samples tested in such a plant, the batch must be tested for E. sakazakii. It shall be the responsibility of the manufacturer to demonstrate to the satisfaction of the competent author- ity whether such a correlation exists between Enterobacteriaceae and E. sakazakii. 44 In terms of the required number of samples, the Chinese standard (3 samples) does not match the European standard (30 samples). 45 The PRC standard requirement to the presence of the pathogenic microorganism in a certain product concentration is higher than the EU standard. 46 The PRC standard requirement to the presence of the pathogenic microorganism in a certain product concentration is higher than the EU standard. Сomparison of Microbiological Criteria in Food Products 23 1 2 3 4 5 6 7 8 230 700 1.25 Live bivalve MPN/100 g MPN/100 g molluscs and live E. coli48 549 1 of flesh and of flesh and EU47 echinoderms, intravalvular intravalvular tunicates and marine liquid liquid gastropods Criteria applied for products placed on the market during their shelf-life Aquatic products Salmonella 5 0 0 –  cooked (heat- 沙门氏菌 treated) aquatic products Vibrio 1000  intended to be eaten parahaemolyticus 5 1 100 MPN/g MPN/g 副溶血性弧菌 GB 29921- PRC raw aquatic animal 2013 products  intended for human Staphylococcus consumption aureus 5 1 100 CFU/g 1000 CFU/g aquatic plant 金黄色葡萄球菌 products (algae) 1.26 Fishery products Histamine 951 2 100 mg/kg 200 mg/kg from fish species EU associated with a high Criteria applied for products placed on the market during their shelf-life amount of histidine50 Fish species with a high amount of histamine52 (standard Histamine53 Indicator Not more than GB 2733- applies to fresh, 组胺 is absent 40 mg / 100 g54 2015 frozen aquatic animal products grown in PRC marine or fresh waters) Fishery products manufactured Histamine56 Indicator Not more than GB 10136- from fish species 组胺 is absent 40 mg / 100 g57 2015 with a high level of histamine55 47 In the PCR there is no standard to detect this pathogenic microorganism (E. сoli) in the specified product category. 48 E. coli is used here as an indicator of faecal contamination. 49 Each sample consists of a minimum number of individual animals in accordance with EN/ISO 6887–3. 50 Particularly fish species of the families: Scombridae, Clupeidae, Engraulidae, Coryfenidae, Pomatomidae, Scombresosidae. 51 Single samples may be taken at retail level. In such a case the presumption laid down in Article 14(6) of Regulation (EC) No 178/2002, ac- cording to which the whole batch should be deemed unsafe, shall not apply, unless the result is above M. 52 Specifically, the species of fish families Scombridae, including mackerel, bonito, tuna, Carangidae, Scombresosidae, sardines and various species of fatty sea fish with red meat. Not applicable to live aquatic products 53 The Chinese system of food standards does not include histamines to the category of pathogenic microorganisms, which explains the lack of standards for sampling. 54 The Chinese standard determines only the maximum permissible safe value. 55 Specifically, the species of fish families Scombridae, including mackerel, bonito, tuna, Carangidae, Scombresosidae, sardines and various species of fatty sea fish with red meat. 56 The Chinese system of food standards does not include histamines to the category of pathogenic microorganisms, which explains the lack of standards for sampling. 57 The Chinese standard determines only the maximum permissible safe value. 24 Comparison of Microbiological Criteria in Food Products in the EU and China 1 2 3 4 5 6 7 8 58 1.27 Fishery products, Histamine 9 2 200 mg/kg 400 mg/kg except those in food category 1.27a, which have undergone enzyme maturation EU treatment in brine, Criteria applied for products placed on the market during their shelf-life manufactured from fish species associated with a high amount of histidine Fishery products (including salted fish) manufactured Indicator Not more than GB 10136- PRC from fish species is absent 40 mg / 100 g60 2015 with a high level of histamine59 1.27а Fish sauce Histamine 1 0 400 mg/kg produced by EU fermentation of fishery Criteria applied for products placed on the market during their shelf-life products Fishery products (including salted fish) Histamine61 Indicator Not more than GB 10136- PRC manufactured from 组胺 is absent 40 mg / 100 g62 2015 fish species with a low level of histamine Salmonella typhimurium64, 1.28 Fresh poultry 5 0 Absence in 25 g EU Salmonella meat63 enteritidis Criteria applied for products placed on the market during their shelf-life Salmonella65 Indicator 0/25 g Poultry meat (fresh 沙门氏菌 is absent GB 16869- PRC and frozen) and Escherіchіa colі Indicator 2005 products thereof О 157:Н7 0/25 g is absent 大肠埃希氏菌 58 Single samples may be taken at retail level. In such a case the presumption laid down in Article 14(6) of Regulation (EC) No 178/2002, ac- cording to which the whole batch should be deemed unsafe, shall not apply, unless the result is above M. 59 The Chinese standard determines only the maximum permissible safe value. 60 The Chinese standard determines only the maximum permissible safe value. 61 The Chinese system of food standards does not include histamines to the category of pathogenic microorganisms, which explains the lack of standards for sampling. 62 The Chinese standard determines only the maximum permissible safe value. 63 This criterion shall apply to fresh meat from breeding flocks of Gallus gallus, laying hens, broilers and breeding and fattening flocks of turkeys. 64 As regards monophasic Salmonella typhimurium, only 1,4,[5],12: i is included. 65 The Chinese standard determines only the general category of a pathogenic microorganism — salmonella, without presenting a detailed categorization by subclasses, in contrast to the EU standard. Сomparison of Microbiological Criteria in Food Products 25 1 2 3 4 5 6 7 8 Shiga toxin producing E. coli (STEC) O157, O26, 5 0 Absence in 25 g EU 1.29 Sprouts66 0111, O103, O145 and O104:H4 Criteria applied for products placed on the market during their shelf-life Salmonella, Shigella (causes dysentery), Staphylococcus Indicator Doesn’t have to be GB 22556- PRC Soybean sprouts67 aureus is absent detected 2008 沙门氏菌、志贺氏 菌、金黄色葡萄 球菌 Legume products Salmonella 5 0 0 – intended for human 沙门氏菌 consumption68 GB 29921- PRC  fermented legume Staphylococcus 2013 products aureus 5 1 100 CFU/g 1000 CFU/g  non fermented 金黄色葡萄球菌 legume products Chocolates and cocoa Salmonella GB 29921- 5 0 0 – PRC products69 沙门氏菌 2013 Products from nuts and seeds Salmonella GB 29921- PRC  paste from nuts and 5 0 0 – 沙门氏菌 2013 seeds  marinated nuts, etc. Total number of Indicator GB 19301- Raw milk bacterial colonies 2 × 106 PRC is absent 2010 菌落总数 66 Excluding sprouts that have received a treatment effective to eliminate Salmonella spp. and STEC. 67 In Chinese standards the “sprouts” category is represented by soy-bean sprouts only. 68 Including furu (soy-marinated bean cheese), fermented black bean sauce, natto and other products prepared by wet fermentation, as well as soy milk, tofu (soy cheese), hard soy cheese, soy protein and other products prepared by wet methods without fermentation. 69 Chocolate, including made from cocoa butter substitutes, chocolate fillings and creams; liquid, solid cocoa products and cocoa powder. 26 Comparison of Microbiological Criteria in Food Products in the EU and China Comparison of the maximum permissible 2 levels of certain microorganisms during food processing EU: Annex I to Regulation № 2073/20051 PRC: national standards GB 2707-2016, GB 2749-2015, GB 2759-2015, GB 5420-2010, GB 9959.1-2001, GB/T 9959.2-2008, GB/T 9960-2008, GB/T 9961-2008, GB 10136-2015, GB 10765-2010, GB 10767-2010, GB 10769-2010, GB 11674-2010, GB 16869-2005, GB/T 17238-2008, GB/T 17239-2008, GB 19644-2010, GB 19645-2010, GB 19646-2010, GB 21710-2016, GB 25192-2010, GB 25596-2010, GB 29921-2013, GB 29922-20132 1 Commission Regulation (EC) No. 2073/2005 of 15 November 2005 on microbiological criteria for foodstuffs. The latest version of the Regulation in English can be found at: http://eur-lex.europa.eu/homepage.html 2 Full names of PRC standards are specified in the table given in Annex І. Sampling Limits PRC Food category Micro-organisms plan standard n c m M 1 2 3 4 5 6 7 8 2.1 Meat and products thereof 2.1.1 Carcasses Aerobic colony 3,5 log CFU/cm2 5,0 log CFU/cm2 of cattle, sheep, count5 daily mean log daily mean log goats and EU 1,5 log CFU/cm2 2,5 log CFU/cm2 horses3, 4 Enterobacteriaceae6 daily mean log daily mean log Criteria apply to carcasses after dressing but before chilling Fresh, chilled, Total number of frozen car- bacterial colonies 5 × 105 CFU/g casses of sheep 菌落总数 and goats (af- Coliforms ter slaughter, 1 × 103 MPN / 100 g 大肠菌群 dressing and post mortem Shigella (causes inspection) bacterial dysentery) Doesn’t have to be detected GB/T 9961- 志贺氏菌 2008 Staphylococcus aureus Doesn’t have to be detected 金黄色葡萄球菌 Enterotoxigenic E. coli Doesn’t have to be detected 致泻大肠埃希氏菌 PRC Fresh, chilled, Total number of 1 × 106 CFU/g (fresh carcass) frozen carcass- bacterial colonies 5 × 105 CFU/g (frozen carcass) es of rabbits7 菌落总数 GB/T 17239- (after slaughter, 1 × 104 MPN / 100 g (fresh carcass) 2008 dressing and Coliforms post mortem 5 × 103 MPN / 100 g (frozen 大肠菌群 inspection) carcass) Fresh and fro- Total number of 1 × 105 CFU/g (fresh) zen beef (quar- bacterial colonies 5 × 105 КУО/ g (frozen) ters)8 菌落总数 Coliforms 1 × 104 MPN / 100 g (fresh) GB/T 9960- 大肠菌群 1 × 103 MPN / 100 g (frozen) 20089 Enterotoxigenic E. coli Doesn’t have to be detected 致泻大肠埃希氏菌 3 The limits (m and M) shall apply only to samples taken by the destructive method. The daily mean log shall be calculated by first taking a log value of each individual test result and then calculating the mean of these log values. 4 There is no exact match for this category in the PRC system of standards. 5 Chinese standards do not include this control item. 6 Chinese standards do not include this control item. 7 This position is missing in the European requirements. 8 There is no exact match for the EU standard category “Cattle carcasses” in the PRC system of standards. 9 According to microbiological data, this document gives reference to the standard GB18406.3-2001, which expired in 2005. Currently the Chinese system of standards has no document regulating microbiological indicators for raw cattle meat. 28 Comparison of Microbiological Criteria in Food Products in the EU and China 1 2 3 4 5 6 7 8 2 2 2.1.2 Carcasses Aerobic colony 4,0 log CFU/cm 5,0 log CFU/cm of pigs11 count daily mean log daily mean log 2,0 log CFU/ EU10 3,0 log CFU/cm2 Enterobacteriaceae cm2 daily mean log daily mean log Criteria apply to carcasses after dressing but before chilling 2.1.3 Carcasses Absence in the area tested per Salmonella 5013 214 of cattle, sheep, carcass EU goats and horses12 Criteria apply to carcasses after dressing but before chilling Fresh, chilled, frozen car- casses of sheep and goats (af- Salmonella GB/T 9961- Doesn’t have to be detected ter slaughter, 沙门氏菌 2008 dressing and post mortem inspection) Fresh, chilled, PRC frozen car- casses of rabbits15(after Salmonella GB/T Doesn’t have to be detected slaughter, 沙门氏菌 17239-2008 dressing and post mortem inspection) Fresh and fro- Salmonella GB/T 9960- zen beef (quar- Doesn’t have to be detected 沙门氏菌 200816 ters) 10 The limits (m and M) shall apply only to samples taken by the destructive method. The daily mean log shall be calculated by first taking a log value of each individual test result and then calculating the mean of these log values. 11 There is no exact match for this category in the PRC system of standards. 12 There is no exact match for this category in the PRC system of standards, there are no norms for cattle carcasses, horses, no distinction is made between goats and sheep. 13 The 50 samples shall be derived from 10 consecutive sampling sessions in accordance with the sampling rules and frequencies laid down in the Regulation 2073/2005. 14 The number of samples where the presence of salmonella is detected. The c value is subject to review in order to take into account the progress made in reducing the salmonella prevalence. Member States or regions having low salmonella prevalence may use lower c values even before the review. 15 This position is missing in the European standards. 16 According to microbiological data, this document gives reference to the standard GB18406.3-2001, which expired in 2005. Currently the Chinese system of standards has no document regulating microbiological indicators for raw cattle meat. Сomparison of the Maximum Permissible Levels of Certain Microorganisms During Food Processing 29 1 2 3 4 5 6 7 8 2.1.4 Carcasses Absence in the area tested per Salmonella 5018 319 EU of pigs17 carcass Criteria apply to carcasses after dressing but before chilling Fresh and frozen half carcasses GB 9959.1 – PRC of pigs(after Requirements for microbiological criteria are absent in this PRC standard 200120 slaughter, dressing, before or after chilling) 2.1.5 Poultry Absence in 25 g об’єднаної Salmonella spp.22 5023 524 carcasses of вибірки зразків зі шкіри на шиї EU broilers and turkeys 21 Criteria apply to carcasses after chilling 2.1.6 Minced Aerobic colony 5 2 5 × 105 CFU/g 5 × 106 CFU/g meat25 count26 EU E. coli27 5 2 50 CFU/g 500 CFU/g Criteria apply at the end of the manufacturing process 17 There is no exact match for this category in the PRC system of standards. 18 The 50 samples shall be derived from 10 consecutive sampling sessions in accordance with the sampling rules and frequencies laid down in the Regulation 2073/2005. 19 The number of samples where the presence of Salmonella is detected. The c value is subject to review in order to take into account the progress made in reducing the Salmonella prevalence. Member States or regions having low Salmonella prevalence may use lower c values even before the review. 20 The respective normative document of the PRC does not include standards (or references to another normative document) in relation to microbiological indicators. 21 There is no exact match for this category in the PRC system of standards. 22 Where Salmonella spp. is found, the isolates shall be further serotyped for Salmonella typhimurium and Salmonella enteritidis in order to verify compliance with the microbiological criterion set out in Row 1.28 of Chapter 1 of the EU Regulation No. 2073/2005. 23 The 50 samples shall be derived from 10 consecutive sampling sessions in accordance with the sampling rules and frequencies laid down in the Regulation 2073/2005. 24 The number of samples where the presence of salmonella is detected. The c value is subject to review in order to take into account the progress made in reducing the salmonella prevalence. Member States or regions having low salmonella prevalence may use lower c values even before the review. 25 There is no exact match for this category in the PRC system of standards. 26 This criterion shall not apply to minced meat produced at retail level when the shelf-life of the product is less than 24 hours. 27 E. coli is used here as an indicator of faecal contamination. 30 Comparison of Microbiological Criteria in Food Products in the EU and China 1 2 3 4 5 6 7 8 2.1.7 Mechani- Aerobic colony 5 2 5 × 105 CFU/g 5 × 106 CFU/g cally separated count30 EU meat (MSM)28, 29 E. coli31, 32 5 2 50 CFU/g 500 CFU/g Criteria apply at the end of the manufacturing process Fresh and Total number of frozen lean bacterial colonies 1 × 106 CFU/g pork 菌落总数 GB/T 9959.2- Coliforms 1 × 104 MPN / 100 g 2008 大肠菌群 Salmonella Doesn’t have to be detected 沙门氏菌 Fresh and Total number of frozen beef bacterial colonies (meat with 菌落总数 bones cut into pieces) Coliforms 大肠菌群 Requirements for microbiological criteria are GB/T 17238- Enterotoxigenic absent in this PRC standard 200833 E. coli 致泻大肠埃希氏菌 Salmonella 沙门氏菌 PRC Fresh (frozen) products from animals and poultry: raw, not suitable for di- rect consump- tion (without heat-treatment) meat of animals (pigs, bovine GB 2707- cattle, sheep Requirements for microbiological criteria are absent in this PRC standard 2016 and goats, rab- bits, etc.) and poultry (chick- ens, ducks, geese, etc.), as well as edible parts (offals, heads, necks, tails, wings, ap- pendages, etc.) 28 These criteria apply to mechanically separated meat (MSM) produced with the techniques referred to in paragraph 3 of Chapter III of Section V of Annex III to Regulation (EC) No 853/2004 of the European Parliament and of the Council. 29 There is no exact match for this category in the PRC system of standards. 30 Chinese standards do not include this control item. 31 Chinese standards do not include this control item. 32 E. coli is used here as an indicator of faecal contamination. 33 According to microbiological data, this document gives reference to the standard GB18406.3-2001, which expired in 2005. Currently the Chinese system of standards has no document regulating microbiological indicators for raw cattle meat. Сomparison of the Maximum Permissible Levels of Certain Microorganisms During Food Processing 31 1 2 3 4 5 6 7 8 2.1.8 Meat prepa- 500 CFU/g 5000 CFU/g EU E. coli34, 35 5 2 rations or см2 or см2 Criteria apply at the end of the manufacturing process Fresh (fro- zen) products from animals and poultry: raw, not suit- able for direct consumption (without heat- treatment) meat of animals (pigs, GB 2707- bovine cattle, Requirements for microbiological criteria are absent in this PRC standard 2016 sheep and goats, rabbits, etc.) and poul- try (chickens, ducks, geese, etc.), as well as edible parts PRC (offals, heads, necks, tails, wings, append- ages, etc.) Poultry meat 1 × 106 CFU/g (fresh and fro- Total number of (fresh) zen) and prod- bacterial colonies 5 × 105 CFU/g ucts thereof 菌落总数 (frozen) 1 × 104 MPN / 100 g Coliforms (fresh) GB 16869- 大肠菌群 5 × 103 MPN / 100 g 2005 (frozen) Salmonella 0/25 g 沙门氏菌 Escherіchіa colі О 157:Н7 0/25 g 出血性大肠埃希氏菌 34 Chinese standards do not include this control item. 35 E. coli is used here as an indicator of faecal contamination. 32 Comparison of Microbiological Criteria in Food Products in the EU and China 1 2 3 4 5 6 7 8 2.2 Milk and dairy products 2.2.1 Pasteurised Enterobacteriaceae37 5 0 10 КУО/мл milk and other EU pasteurised liq- uid dairy prod- Criteria apply at the end of the manufacturing process ucts36 Pasteurised Total number of 50 000 CFU/g 100 000 CFU/g milk bacterial colonies 5 2 (ml) (ml) 菌落总数 Coliforms 5 2 1 CFU/g (ml) 5 CFU/g (ml) 大肠菌群 GB 19645- PRC Staphylococcus 38 2010 – aureus 5 0 0/25 g (ml) 金黄色葡萄球菌 Salmonella 5 0 0/25 g (ml) – 沙门氏菌 2.2.2 Cheeses 40, 41 made from milk E. coli 5 2 100 CFU/g 1000 CFU/g or whey that has EU undergone heat Criteria apply at the time during the manufacturing process when the E. coli count is treatment39 expected to be highest42 Hard cheeses Coliforms 5 2 100 CFU/g 1000 CFU/g (ripened chees- 大肠菌群 es, ripened Listeria blue cheeses, monocytogenes – GB 5420- unripened 5 0 0/25 g 单核细胞增生 2010 cheeses) 李斯特氏菌 Salmonella 5 0 0/25 g – 沙门氏菌 Processed Total number of PRC cheeses (con- bacterial colonies 5 2 100 CFU/g 1000 CFU/g tent of hard 菌落总数 cheese not less than 15%) Coliforms 5 2 1 CFU/g (ml) 5 CFU/g (ml) 大肠菌群 GB 25192- 2010 Listeria monocytogenes 单核细胞增生 5 0 0/25 g – 李斯特氏菌 Salmonella – 5 0 0/25 g 沙门氏菌 36 The criterion shall not apply to products intended for further processing in the food industry. 37 Chinese standards do not include this control item. 38 Hereinafter in the text the symbol “–“ means the absence of the indicator in one or another Chinese standard. In this case, the absence of “M” indicator (the maximum permissible safe limit of the content of pathogenic microorganisms) converts “m” indicator (limiting the level of permissible content of pathogenic microorganisms) into the final criterion, which should be observed. 39 There is no exact match for this category in the PRC system of standards. 40 Chinese standards do not include this control item. 41 E. coli is used here as an indicator for the level of hygiene. 42 For cheese types that are unable to support E. coli growth, E. coli usually has the highest value at the beginning of the ripening period, and for cheese types that are capable of supporting E. coli growth, this indicator is considered normal at the end of the ripening period. Сomparison of the Maximum Permissible Levels of Certain Microorganisms During Food Processing 33 1 2 3 4 5 6 7 8 2.2.3 Cheeses Coagulase-positive 5 2 104 CFU/g 105 CFU/g made from raw staphylococci EU milk43 Criteria apply at the time during the manufacturing process when the E. coli count is expected to be highest Hard cheeses (ripened chees- Staphylococcus es, ripened GB 5420- aureus 5 2 100 CFU/g 1000 CFU/g blue cheeses, 2010 金黄色葡萄球菌 unripened PRC cheeses Processed cheeses (con- Staphylococcus GB 25192- tent of hard aureus 5 2 100 CFU/g 1000 CFU/g 2010 cheese not less 金黄色葡萄球菌 than 15%) 2.2.4 Cheeses Coagulase-positive 5 2 100 CFU/g 1000 CFU/g made from staphylococci milk that has undergone a lower heat treatment than pasteurization44 and ripened EU cheeses made Criteria apply at the time during the manufacturing process when the E. coli count is from milk or expected to be highest whey that has undergone pasteurization or a stronger heat treat- ment45,46 Hard cheeses (ripened chees- Staphylococcus es, ripened GB 5420- aureus 5 2 100 CFU/g 1000 CFU/g blue cheeses, 2010 金黄色葡萄球菌 unripened PRC cheeses ) Processed cheeses (con- Staphylococcus GB 25192- tent of hard aureus 5 2 100 CFU/g 1000 CFU/g 2010 cheese not less 金黄色葡萄球菌 than 15%) 43 There is no exact match for this category in the PRC system of standards. 44 Excluding cheeses where the manufacturer can demonstrate, to the satisfaction of the competent authorities, that the product does not pose a risk of staphylococcal enterotoxins. 45 There is no exact match for this category in the PRC system of standards. 46 Excluding cheeses where the manufacturer can demonstrate, to the satisfaction of the competent authorities, that the product does not pose a risk of staphylococcal enterotoxins. 34 Comparison of Microbiological Criteria in Food Products in the EU and China 1 2 3 4 5 6 7 8 2.2.5 Unripened Coagulase-positive 5 2 10 CFU/g 100 CFU/g soft cheeses staphylococci (fresh cheeses) made from milk or whey EU that has un- dergone pas- Criteria apply at the end of the manufacturing process teurization or a stronger heat treatment47, 48 Hard cheeses (ripened chees- Staphylococcus es, ripened GB 5420- aureus 5 2 100 CFU/g 1000 CFU/g blue cheeses, 2010 金黄色葡萄球菌 unripened PRC cheeses) Processed cheeses (con- Staphylococcus GB 25192- tent of hard aureus 5 2 100 CFU/g 1000 CFU/g 2010 cheese not less 金黄色葡萄球菌 than 15%) 2.2.6 Butter and E. coli49, 50 5 2 10 CFU/g 100 CFU/g cream made from raw milk or milk that EU has undergone Criteria apply at the end of the manufacturing process a lower heat treatment than pasteurisation Cream (10-80% Total number of 10 000 CFU/g 100 000 CFU/g fat), butter (not bacterial colonies 5 2 (ml) (ml) less than 80% 菌落总数 fat), dehydrated butter (not less Coliforms 5 2 10 CFU/g (ml) 100 CFU/g (ml) than 99,8% fat) 大肠菌群 GB 19646- PRC Staphylococcus 2010 aureus 5 1 10 CFU/g (ml) 100 CFU/g (ml) 金黄色葡萄球菌 Salmonella 5 0 0/25 g (ml) – 沙门氏菌 47 There is no exact match for this category in the PRC system of standards. 48 Excluding cheeses where the manufacturer can demonstrate, to the satisfaction of the competent authorities, that the product does not pose a risk of staphylococcal enterotoxins. 49 Chinese standards do not include this control item. 50 E. coli is used here as an indicator for the level of hygiene. Сomparison of the Maximum Permissible Levels of Certain Microorganisms During Food Processing 35 1 2 3 4 5 6 7 8 2.2.7 Milk pow- Enterobacteriaceae52 5 0 10 CFU/g der and whey powder51 Coagulase-positive EU 5 2 10 CFU/g 100 CFU/g staphylococci Criteria apply at the end of the manufacturing process Milk powder Total number of (dried milk) bacterial colonies 5 2 50 000 CFU/g 200 000 CFU/g 菌落总数 Coliforms 5 1 10 куо / g 100 куо / g 大肠菌群 GB 19644- Staphylococcus 2010 aureus 5 2 10 CFU/g 100 CFU/g PRC 金黄色葡萄球菌 Salmonella 5 0 0/25 g – 沙门氏菌 Whey powder Staphylococcus and serum al- aureus 5 2 10 CFU/g 100 CFU/g bumin powder 金黄色葡萄球菌 GB 11674- (whey albumin) 2010 Salmonella 5 0 0/25 g – 沙门氏菌 2.2.8 Ice- cream53 and Enterobacteriaceae54 5 2 10 CFU/g 100 CFU/g EU frozen dairy desserts Criteria apply at the end of the manufacturing process Frozen drinks Total number of 2 2,5 × 104 (102) 105 ( - ) and their main bacterial colonies 5 (0) CFU/g (ml) CFU/g (ml) GB 2759- components/ 菌落总数 ingredients 2015 Coliforms 2 10 (10) 102 ( - ) 5 大肠菌群 (0) CFU/g (ml) CFU/g (ml) PRC Frozen drinks55 Salmonella 5 0 0 沙门氏菌 – GB 29921- Staphylococcus 2013 aureus 5 1 100 CFU/g (ml) 1000 CFU/g (ml) 金黄色葡萄球菌 51 The criterion shall not apply to products intended for further processing in the food industry. 52 Chinese standards do not include this control item. 53 Only ice creams containing milk ingredients. 54 Chinese standards do not include this control item. 55 All types of ice cream and food ice, made on the basis of potable water, sugar, milk, fruit, bean products, edible fats and oils, with the addition of food additives. 36 Comparison of Microbiological Criteria in Food Products in the EU and China 1 2 3 4 5 6 7 8 2.2.9 Dried infant Enterobacteriaceae 10 0 Absence in 10 g formulae and dried dietary foods for special EU medical purpos- es intended for Criteria apply at the end of the manufacturing process infants below six months of age Foods for special medi- cal purposes Enterobacter GB 25596- PRC intended for in- sakazakii 3 0 0/100 g – 2010 fants below six 阪崎肠杆菌 months of age 2.2.10 Dried Enterobacteriaceae 5 0 Absence in 10 g EU follow-on for- mulae Criteria apply at the end of the manufacturing process Dried infant Total number of formulae (for bacterial colonies 5 2 1 000 CFU/g 10 000 CFU/g infants below 6 菌落总数 months of age) Coliforms 5 2 10 CFU/g 100 CFU/g 大肠菌群 Staphylococcus GB 10765- aureus 5 2 10 100 2010 金黄色葡萄球菌 Enterobacter sakazakii 3 0 0/100 g – 阪崎肠杆菌 Salmonella 5 0 0/25 g – 沙门氏菌 Dried follow- Total number of on formulae for bacterial colonies 5 2 1 000 CFU/g 10 000 CFU/g children (6 -36 菌落总数 months of age) GB 10767- Coliforms 5 2 10 CFU/g 100 CFU/g 2010 大肠菌群 PRC Salmonella – 5 0 0/25 g 沙门氏菌 Cereal-based Total number of foods for chil- bacterial colonies 5 2 1 000 CFU/g 10 000 CFU/g dren (6 -36 菌落总数 months of age) GB 10769- Coliforms 5 2 10 CFU/g 100 CFU/g 2010 大肠菌群 Salmonella 5 0 0/25 g 沙门氏菌 – Foods (dried Total number of formulae) for bacterial colonies 5 2 1 000 CFU/g 10 000 CFU/g special medical 菌落总数 purposes (for Coliforms children older 5 2 10 CFU/g 100 CFU/g 大肠菌群 GB 29922- than one year) Salmonella 2013 5 0 0/25 g – 沙门氏菌 Staphylococcus aureus 5 2 10 100 金黄色葡萄球菌 Сomparison of the Maximum Permissible Levels of Certain Microorganisms During Food Processing 37 1 2 3 4 5 6 7 8 2.2.11 Dried Presumptive 5 1 50 CFU/g 500 CFU/g infant formulae Bacillus cereus56 and dried di- etary foods for special medi- EU cal purposes intended for Criteria apply at the end of the manufacturing process infants below six months of age Foods for Total number of special medi- bacterial colonies 5 2 1 000 CFU/g 10 000 CFU/g cal purposes 菌落总数 intended for infants below Coliforms 5 2 10 CFU/g 100 CFU/g six months of 大肠菌群 GB 25596- PRC age Staphylococcus 2010 aureus 5 2 10 100 金黄色葡萄球菌 Salmonella 5 0 0/25 g – 沙门氏菌 2.3 Egg products 2.3.1 Egg prod- 10 CFU/g Enterobacteriaceae57 5 2 100 CFU/g or ml EU ucts or ml Criteria apply at the end of the manufacturing process. Eggs and egg GB 21710- Salmonella Doesn’t have to be detected products 2016 Total number of bacterial colonies 菌落总数 5 2 5 × 104 CFU/g 106 CFU/g (for products made from liquid, dry and PRC frozen eggs) GB 2749- Total number of 2015 bacterial colonies 菌落总数 5 2 104 CFU/g 105 CFU/g (whole eggs, except wine pickled eggs) Coliforms 5 2 10 CFU/g 102 CFU/g 大肠菌群 56 Chinese standards do not include this control item. 57 Chinese standards do not include this control item. 38 Comparison of Microbiological Criteria in Food Products in the EU and China 1 2 3 4 5 6 7 8 2.4 Fishery products 2.4.1 Shelled E. coli58 5 2 1 MNP/g 10 MNP/g and shucked Coagulase-positive products of 5 2 100 CFU/g 1000 CFU/g EU staphylococci cooked crusta- ceans and mol- Criteria apply at the end of the manufacturing process. luscan shellfish Aquatic prod- Vibrio ucts59 parahaemolyticus 5 1 100 MPN/g 1000 MPN/g  cooked 副溶血性弧菌 (heat-treated) aquatic GB 29921- products Staphylococcus 2013  intended to aureus 5 1 100 CFU/g 1000 CFU/g PRC be eaten raw 金黄色葡萄球菌 aquatic ani- mal products Aquatic animal Total number of products bacterial colonies 5 2 5 × 104 CFU/g 105 CFU/g 菌落总数 GB 10136- 2015 Coliforms 5 2 10 CFU/g 102 CFU/g 大肠菌群 2.5. Vegetables, fruits and products thereof 2.5.1 Precut fruit and vegetables E. coli61 5 2 100 CFU/g 1000 CFU/g EU (ready-to-eat)60 Criteria apply during the manufacturing process Fruit and veg- Staphylococcus etable products aureus 5 1 100 CFU/g (ml) 1000 CFU/g (ml) (including mar- 金黄色葡萄球菌 GB 29921- PRC inated prod- Escherіchіa colі – 2013 ucts) intended О 157:Н763 5 0 0 for human 大肠埃希氏菌 consumption 2.5.2 Unpasteur- E. coli65 5 2 100 CFU/g 1000 CFU/g ised fruit and EU vegetable juices (ready-to-eat)64 Criteria apply during the manufacturing process Drinks (except Staphylococcus packed waters GB 29921- PRC aureus 5 1 100 CFU/g (ml) 1000 CFU/g (ml) and carbonated 2013 金黄色葡萄球菌 drinks)66 58 Chinese standards do not include this control item. 59 Products made from fish, crustaceans, molluscs, invertebrates, echinoderms and other aquatic organisms that have undergone heat treatment (steamed, cooked, baked, deep fried, etc.), suitable for direct consumption. Products that have been cleaned but not thermally processed, suitable for direct consumption, including live, fresh, frozen fish (fish slices), shrimp, cephalopods, live crab, live molluscs, as well as products made from live snails, crabs, molluscs, caviar by non-thermal treatment (salting, marinating, alcoholization), suitable for direct consumption. 60 There is no exact match for this category in the PRC system of standards. 61 Chinese standards do not include this control item. 62 Products intended for direct consumption, made from vegetables and fruits: frozen vegetables / fruits, dried vegetables / fruits, fruit in vinegar, oils or salt, comfiture, jam, marmalade, candied fruits, syrup fruits, pickled vegetables, vegetable pasta and sauces (except tomato), products from fermented vegetables and fruits. 63 Only for vegetables and fruits intended to be eaten raw. 64 There is no exact match for this category in the PRC system of standards. 65 Chinese standards do not include this control item. 66 Vegetable and fruit juices, protein drinks, water-based mixed drinks, tea, coffee, vegetable drinks, dry drinks, and other beverages. Сomparison of the Maximum Permissible Levels of Certain Microorganisms During Food Processing 39 Annexes Annex 1. PRC standards referred to in tables 1 and 2 Annex 2. National Standard of the People’s Republic of China 40 Comparison of Microbiological Criteria in Food Products in the EU and China Annex 1 PRC standards referred to in tables 1 and 2 Full name PRC National Publication Effective Full name (Chinese to English Standard date date translation) National food safety standard 食品安全国家标准 GB 2707-2016 23.12.2016 23.06.2017 Products from fresh (frozen) 鲜（冻）畜、禽产品 animals, poultry 食品安全国家标准 GB 2733-2015 13.11.2015 13.11.2016 National food safety standard 鲜、冻动物性水产品 食品安全国家标准 干酪 National food safety standard GB 5420-2010 26.03.2010 01.12.2010 National food safety standard Dry cheese Cheese 食品安全国家标准 National food safety standard GB 6783-2013 29.11.2013 01.06.2014 食品添加剂 明胶 Food supplement gelatin National food safety standard 食品安全国家标准 GB 10136-2015 13.11.2015 13.11.2016 Water products of animal 动物性水产制品 origin 食品安全国家标准 婴儿配方食品 National food safety standard GB 10765-2010 26.03.2010 01.04.2011 National food safety standard Infant formulae Infant formula 食品安全国家标准 较大婴儿和幼儿配方食品 National food safety standard GB 10767-2010 26.03.2010 01.04.2011 National food safety standard Older infants and young Older infants and young children children formula formula 食品安全国家标准 婴幼儿谷类辅助食品 National food safety standard National food safety standard Cereal-based complimentary GB 10769-2010 26.03.2010 01.04.2011 Cereal-based complimentary foods for infants and young foods for infants and young children children 食品安全国家标准 National food safety standard 乳清粉和乳清蛋白粉 Whey powder and whey GB 11674-2010 26.03.2010 01.12.2010 National food safety standard protein powder (serum Whey powder and whey protein albumin) powder 食品安全国家标准 炼乳 National food safety standard National food safety standard GB 13102-2010 26.03.2010 01.12.2010 Evaporated milk, sweetened Sweetened condensed milk condensed milk and formulated condensed milk Annexes 41 Full name PRC National Publication Effective Full name (Chinese to English Standard date date translation) 食品安全国家标准 National food safety standard GB 14967-2015 22.09.2015 22.09.2016 胶原蛋白肠衣 Collagen sausage casing National food safety standard GB 16869-2005 23.03.2005 01.01.2006 鲜、冻禽产品 Products from fresh, frozen poultry 食品安全国家标准 生乳 National food safety standard GB 19301-2010 26.03.2010 01.06.2010 National food safety standard Raw milk Raw milk 食品安全国家标准 发酵乳 National food safety standard GB 19302-2010 26.03.2010 01.12.2010 National food safety standard Fermented milk Fermented milk 食品安全国家标准 乳粉 National food safety standard GB 19644-2010 26.03.2010 01.12.2010 National food safety standard Milk powder Milk powder 食品安全国家标准 巴士杀菌乳 National food safety standard GB 19645-2010 26.03.2010 01.12.2010 National food safety standard Pasteurized milk Pasteurized milk 食品安全国家标准 稀奶油、奶油和无水奶油 National food safety standard GB 19646-2010 26.03.2010 01.12.2010 National food safety standard Cream, butter and anhydrous Cream, butter and anhydrous milkfat milkfat 豆芽卫生标准 Hygienic standard for bean GB 22556-2008 03.12.2008 01.06.2009 Hygienic standard for bean sprouts sprouts 食品安全国家标准 调制乳 National food safety standard GB 25191-2010 26.03.2010 01.12.2010 National food safety standard Modified milk Modified milk 食品安全国家标准 再制干酪 National food safety standard GB 25192-2010 26.03.2010 01.12.2010 National food safety standard Process(ed) cheese Process(ed) cheese National food safety standard 食品安全国家标准 Provisions on infant food GB 25596-2010 21.12.2010 01.01.2012 products for special medical 特殊医学用途婴儿配方食品通则 purposes intended for infants under 6 months National food safety standard 食品安全国家标准 Restrictions on the content of GB 29921-2013 26.12.2013 01.07.2014 食品中致病菌限量 pathogenic microorganisms in food products 42 Comparison of Microbiological Criteria in Food Products in the EU and China Full name PRC National Publication Effective Full name (Chinese to English Standard date date translation) National food safety standard 食品安全国家标准 GB 29922-2013 26.12.2013 01.07.2014 Provisions on food products 特殊医学用途配方食品通则 for special medical purposes 食品安全国家标准 National food safety standard GB 31619-2014 24.12.2014 24.05.2015 食品添加剂 决明胶 Food supplement gelatin 食品安全国家标准 National food safety standard GB 31638-2016 23.12.2016 23.06.2017 酪蛋白 Casein 食品安全国家标准 National food safety standard GB 2749-2015 13.11.2015 13.11.2016 蛋与蛋制品 Eggs and egg products National food safety standard 食品安全国家标准 GB 2759-2015 13.11.2015 13.11.2016 Frozen beverages and ready- 冷冻饮品和制作料 to-cook foods 鲜、冻片猪肉 National food safety standard GB 9959.1-2001 20.07.2001 01.12.2001 Fresh and frozen demi carcass Fresh and frozen half carcass pork pork 分割鲜、冻猪瘦肉 Cut-up fresh and frozen lean GB/T 9959.2-2008 12.08.2008 01.12.2008 Fresh and frozen pork lean, cuts pork 鲜、冻四分体牛肉 GB/T 9960-2008 27.06.2008 01.10.2008 Fresh and frozen beef, quarters Fresh and frozen beef, quarters 鲜、冻胴体羊肉 Fresh and frozen mutton GB/T 9961-2008 12.08.2008 01.12.2008 Fresh and frozen mutton carcass carcass 鲜、冻分割牛肉 GB/T 17238-2008 27.06.2008 01.10.2008 Cut-up fresh and frozen beef Fresh and frozen beef, cuts 鲜、冻兔肉 GB/T 17239-2008 12.08.2008 01.10.2008 Fresh and frozen rabbit meat Fresh and frozen rabbit meat National food safety standard 食品安全国家标准 Hygienic standards for the GB 21710-2016 23.12.2016 23.12.2017 蛋与蛋制品生产卫生规范 production of eggs and egg products National food safety standard 食品安全国家标准 Provisions on infant food GB 25596-2010 21.12.2010 01.01.2012 products for special medical 特殊医学用途婴儿配方食品通则 purposes intended for infants under 6 months Annexes 43 Annex 2 National Standard of the People’s Republic of China Translation from Chinese (unofficial) GB GB29921–2013 National Food Safety Standard Maximum permissible levels of the content of pathogenic microorganisms in food products Published on 26.12.2013 Entered into force on 01.07.2014 Published by the State Committee of the People’s Republic of China on health protection and birth control 1. Scope This standard sets requirements for indicators and limits of pathogenic microorganisms in food products, as well as control methods. This standard is applicable to pre-packaged food products. This standard is not applicable to canned food products. 2. Applicable principles 2.1. Irrespective of the established limits for the presence of pathogenic microorganisms, food manufacturers and processors, as well as traders, must implement control measures to ensure maximum possible reduction of the level of pathogenic microorganisms in foods and, accordingly, the possibility of risks occurrence. 2.2. The control inspections are carried out based on the methods specified in Table to this standard after sampling in accordance with the rules of GB4789.1. 3. Requirements for the criteria The limits of the amount of pathogenic microorganisms in food products are given in Table to this standard. Note 1: Food products were categorized for the sole purpose of fixing the scope of application of the limits of pathogenic microorganisms. The categories are used only in this table. Note 2: n — number of selected samples for one batch of products; c — the maximum number of samples with a deviation from index m; m — restriction on the permissible content level of pathogenic microorganisms. M — maximum permissible safe limit of the content of pathogenic microorganisms. 44 Comparison of Microbiological Criteria in Food Products in the EU and China Explanation to the National Standard of the People’s Republic of China GB29921–2013 1. The purpose of this standard Pathogenic microorganisms often cause various diseases of both humans and animals. Among the disease- causing microorganisms found in food products, Salmonella, Vibrio parahaemolyticus, E.coli, Staphylococcus aureus, etc., should be the first to mention. According to statistics, every year the number of diseases caused by pathogens present in food products is about 40–50% of all reported cases of diseases in the People’s Republic of China. The Food Safety Act stipulates that the food safety standards establish permissible levels of the content of patho- genic microorganisms, residues of plant protection products, residues of veterinary drugs, heavy metals, contaminants and other substances harmful to the human body in food products and related products. At present, there are more than 500 current standards in the PRC dealing with restrictions on the level of pathogenic microbes in foods, while the indicators in these documents are sometimes duplicated, overlapping, contradictory to each other or simply lacking. In order to control the contamination of food products by pathogenic microorganisms and to prevent the emer- gence of diseases caused by microbes present in foodstuffs, as well as to consolidate all scattered norms regarding the permissible levels of pathogenic microbes, the State Committee of the People’s Republic of China on Health and Birth Control commissioned the State Center for Food Safety Risks Assessment to prepare a draft standard GB29921– 2013 “Maximum Permissible Levels of Pathogenic Microorganisms in Food Products.” The document was reviewed and approved by the Committee for Assessing National Standards in Food Safety and published on December 26, 2013. It came into force on July 1, 2014. GB 29921 is a general standard and applies to pre-packaged foods. In cases where there are differences in criteria between those in GB 29921 and other PRC standards, the requirements of GB 29921 must be applied. All require- ments for the permissible levels of pathogenic microorganisms in food products as set out in other standards must be repealed or brought in line with this standard. 2. Requirements for the implementation of this standard Before the standard entered into force (07.01.2014), manufacturers and distributors of food products could optionally comply with this standard and the authorities encouraged them to do so. Since its entry into force, manufacturers, food safety control authorities and inspection authorities have become obliged to comply with this standard. Control of the levels of pathogenic microorganisms is carried out in accordance with the verification methods provided in GB29921. Manufacturers and distributors must strictly adhere to the standards and rules for the production and distribution of food products or take measures to strictly control pathogenic microorganisms in the production and distribution process in order to ensure that products meet the requirements of GB29921 standard. The PRC’s State Committee on Health and Birth Control will monitor and assess the implementation of this stan- dard and, based on the results, will propose amendments to improve it. 3. Principles and procedure for developing this standard 1) The main objective is health protection. The purpose of GB29921 is to control the contamination of food by pathogenic microorganisms and to prevent diseases caused by them. Having analyzed the causes of diseases associ- ated with microorganisms present in food products within 2005–2011, the editorial expert group carried out a com- prehensive risk assessment of the line “pathogenic microorganisms — food products” taking into account international experience on food safety management. Based on the results of monitoring and risk assessment, the maximum levels of the content of pathogenic microorganisms in high-risk food products have been identified with the aim of reduc- ing the risk of foodborne diseases. 2) Determination of criteria based on scientific approach. On the basis of monitoring and assessment of the risks associated with the presence of pathogenic microorganisms in food products the editorial expert group carried out a comprehensive analysis of: • possible harmful effects of the influence of pathogenic microorganisms or microbial products on human health; • the content of pathogenic microorganisms in raw materials; • changes that occur to pathogenic microorganisms at each stage of processing, storage, sale and consumption of food products. Annexes 45 The research has fully taken into account the correlation factors of the consumer groups of each category of prod- ucts and the cost price (economic effect) of compliance with the standard in terms of permissible levels of pathogenic microorganisms. In general, this led to the application of a scientific approach to the determination of the permissible levels of pathogenic microorganisms in food products. 3) Consideration of foreign assessments and standards. Standard GB29921 took into account the results of risk assessment associated with the presence of pathogenic microorganisms in food products conducted by relevant international organizations such as CAC, ICMSF, etc., and the principles they used to develop the standards. Regulations and standards of the United States, the EU, Australia, New Zealand, Japan, Canada and some other countries and regions regarding restrictions on the content of pathogenic microorganisms in food products were also taken into account. 4) Consideration of the proposals of all interested parties, ensuring openness and transparency. Preparation of the standards was supported by regular meetings and seminars, where the proposals of the relevant agencies, re- search organizations, industry professional associations and enterprises were heard, and open internet surveys were conducted. On the basis of this, the text of the standard was finalized and its approval was conducted in an open and transparent manner. 4. Scope of application and the main content of the standard Standard GB 29921 applies to pre-packaged foods. GB 29921 establishes the permissible levels of five pathogenic microorganisms (Salmonella, Listeria monocytogenes, E.coli O 157: H7, Staphylococcus aureus and Vibrio parahae- molyticus) in 11 categories of food products (see paragraph 5). Manufacturers and distributors of non-pre-packaged foods must strictly adhere to hygiene rules in the process of producing and distributing food products to minimize the risk of their contamination by pathogenic microorganisms. Canned foods must meet the requirements of commercial sterility; therefore this standard is not applicable to them. 5. Main food categories to which the standard applies 1) Cooked meat products (thermally processed) or intended to be eaten raw: products from cooked (marinated, stewed, smoked, roasted, steamed, boiled, etc.) and raw (fermented or processed by special technologies) meat (pork, beef, lamb, chicken, rabbit, dog, etc.), suitable for direct consumption. 2) Aquatic products: cooked (thermally processed) aquatic products (products made from fish, crustaceans, mol- luscs, invertebrates, echinoderms and other aquatic organisms that have undergone heat treatment — steamed, cooked, baked, deep fried, etc.— suitable for direct consumption); raw aquatic products intended for the con- sumption (products that have been cleaned but not thermally processed, suitable for direct consumption, including live, fresh, frozen fish (fish slices), shrimp, cephalopods, live crab, live molluscs, as well as products made from live snails, crabs, molluscs, caviar by non-thermal treatment — salting, marinating, alcoholiza- tion, — suitable for direct consumption); vegetable aquatic products intended for consumption — algae (prod- ucts made from algae, suitable for direct consumption, which have undergone a certain treatment, including thermal — boiled, deep fried). 3) Egg products intended for consumption: products suitable for direct consumption, made from poultry eggs, including cooked eggs. 4) Cereal products: cooked (thermally processed) grain products (including pastries); cooked (thermally processed) flour-rice products with filling; flour and rice instant (quick-cooking) products: products made from rice, wheat, other cereals, roots, corn, etc., whether or not filled, suitable for direct consumption (cereal flakes, cereals / cooked porridge / instant noodles, etc.), as well as bakery products made from cereals, fats, eggs, sugar and food additives, suitable for direct consumption (pastries, cakes, cookies, bread, etc.). 5) Bean products intended for consumption (fermented and not fermented): furu (soy-marinated bean cheese), fermented black bean sauce, natto and other products prepared by wet fermentation, as well as soy milk, tofu (soy cheese), hard soy cheese, soy protein and other products prepared by wet methods without fermentation. 6) Chocolate and cocoa products: chocolate, including made from cocoa butter substitutes, chocolate fillings and creams; cocoa products (liquid, solid, cocoa powder). 46 Comparison of Microbiological Criteria in Food Products in the EU and China 7) Fruit and vegetable products (including marinated) intended for consumption: products intended for direct consumption, made from fruits and vegetables: frozen vegetables / fruits, dried vegetables / fruits, fruit in vin- egar, oils or salt, confiture, jam, marmalade, candied fruits, syrup fruits, pickled vegetables, vegetable pasta and sauces (except tomato), products from fermented vegetables and fruits. 8) Beverages (except packed potable water and carbonated drinks): fruit and vegetable juices, protein drinks, water-based mixed drinks, tea, coffee, vegetable drinks, dry drinks, and other beverages. 9) Frozen beverages (ice cream, food ice): all types of ice cream and food ice, made on the basis of drinking water, sugar, milk, fruit, bean products, edible fats and oils, with the addition of food additives. 10) Condiments intended for consumption: soy sauce (fermented and mixed), soy paste (fermented and mixed), condiments from aquatic products (fish, oysters, shrimp sauce), combined condiments (mayonnaise, broths, juices and other condiments with animal and plant bases). This standard does not apply to spices and condi- ments made therefrom. 11) Nuts and seeds: paste from nuts and seeds, pickled nuts etc. 6. Determination of criteria for pathogenic microorganisms within the framework of the standard 1) Salmonella (2nd risk group). The standard indicators were approved on the basis of similar standards in force at CAC, ICMSF, the EU, Australia, New Zealand, the USA, Canada, SAR Siangan (Hong Kong), Hong Kong, Taiwan. General requirements: n = 5, c = 0, m = 0. 2) Listeria monocytogenes (2nd risk group). Given the lack of sufficient data from clinical trials in the PRC, the standard criteria were approved based on the reporting data of FAO, WHO, and on the basis of the current standards of CAC, ICMSF, the EU etc. General requirements: n = 5, c = 0, m = 0. 3) E.coli О 157: Н7 (2nd risk category). Although the PRC did not record cases of mass infection by this microor- ganism of consumers of cooked meat and meat products, in order to reduce the risk of disease this criteria was adopted at a high level. General requirements: n = 5, c = 0, m = 0. 4) Staphylococcus aureus (3rd risk group). For China, it is one of the major causes of food poisoning associated with the enterotoxins it produces. The standard indicators were approved on the basis of similar standards in force at CAC, ICMSF, Australia, New Zealand, SAR Siangan (Hong Kong), Taiwan. General requirements (for 8 product categories): n = 5, c = 1, m = 100 CFU / g (ml), M = 1000 CFU / g (ml); for condiments: n = 5, c = 2, m = 100 CFU / g (ml), M = 10 000 CFU / g (ml). 5) Vibrio parahaemolyticus (3rd risk group). For the seaside and a number of inland regions of the People’s Republic of China it is one of the main causes of food poisoning. It is largely contained in products of the aquatic industry and in meat products in case of cross-contamination. The standard criteria were approved based on similar criteria in force at the ICMSF, the EU, Canada, Japan, Australia, New Zealand, SAR Siangan (Hong Kong). General requirements: n = 5, c = 1, m = 100 MPN / g (ml), M = 1000 MPN / g (ml). 7. Other Permissible levels of pathogenic microorganisms for milk, dairy products, special products of supplementary feed- ing are determined by separate national food safety standards. Since the risk of contamination with pathogenic microorganisms of such products (or raw materials) such as honey, fats and oils, emulsified fats, marmalades, sweets, edible fungi, etc., is extremely low, taking into account the norms and regulations of CAC, ICMSF, it was decided not to establish the corresponding сriteria for these products for a while. However, criteria of the standards may be specified and amended based on the results of monitoring and risk assessment. Infection of food products with the Shigella microorganism can occur due to contact with dirty hands or carrying flies, improper treatment of potable water, sewage leakage, etc. Considering the situation in the PRC and long-term monitoring data, this microorganism is extremely rare in processed foods. Subject to the norms and regulations in force at CAC, ICMSF, the EU, the USA, Canada, Australia, New Zealand, this position was not included in the list of food content restrictions under this standard. Annexes 47 In partnership with: