Version 1.1 Created November, 2012
A summary of the microbiological criteria specified within European Union (EU) Regulation (EC) No. 142/2011 and proposed changes
Project Report: SE4403
Milestone 4
Report Prepared by Rowena Kosmider
SE4403 Project team: Rowena Kosmider1, Rob Davies2, Alastair Smith3, Anne Seaton4 and Petrina Carmody5
1Epidemiology, Surveillance and Risk Group, AHVLA Weybridge
2Food and Environmental Safety, AHVLA Weybridge
3Laboratory Services, AHVLA Preston
4Ayr Divisional Office, AHVLA Ayr
5Consultant, Agile Information
Final Project Report
December 17th, 2012
Review Log
Felicity Clifton-Hadley / 1.0 / 12/12/12 / 16/12/12 / 17/12/12
Executive Summary
Animal by-products (ABPs) are the parts of animals or products of animal origin that are not intended for human consumption. Given the risk that these products may pose to human and animal health if not disposed of properly, the European Union (EU) has instigated Regulations (Regulation (EC) No. 1069/2009 and its implementing Regulation (EC) No. 142/2011) to provide rules on the appropriate use, collection, transport, storage, handling and disposal of such products. Within the implementing regulation, microbiological criteria have been specified for enhancing the safety of final products derived from ABP materials. These criteria focus on the sampling of products at, or on removal from, storage and testing for Salmonella and Enterobacteriaceae. In particular, products may be withdrawn from sale and/or re-processed or destroyed if Salmonella is present and/or procedures investigated if the amount of Enterobacteriaceae exceeds the maximum limit specified by the sampling plan. At the present time, complying with these maximum limits, particularly for Enterobacteriaceae, is challenging and whether it is appropriate to apply maximum values of Enterobacteriaceae for ABPs has been questioned by the United Kingdom (UK) in EU ABP Working Group meetings.
Based on the literature review undertaken, it is concluded that there is limited evidence to underpin the rationale for using the current microbiological limits, particularly for Enterobacteriaceae, in EU Regulation (EC) No. 142/2011 particularly as EFSA Scientific Opinions would suggest that this is currently not feasible. The use of Enterobacteriaceae as indicators of hygiene processes can only be effectual if the limits for highlighting such a significant change are realistic and account for the underlying variation of Enterobacteriaceae within the product after agreed controls are in place. The use of microbiological criteria for Salmonella is well established and is used internationally for foods for human consumption whereby absence in a sample is required. These criteria form part of the extensive drive to reduce Salmonella along the entire farm-to-consumption chain. The sampling plans used within the EU legislation for Salmonella in ABPs are akin to the generic sampling plans developed by the ICSMF (1986) which stipulate the absence of the bacteria in n samples.
Once established, it is important that microbiological criteria are regularly reviewed to ensure that they remain appropriate and protect human (and/or animal) health. Any modifications should, ideally, be based on risk assessment and current scientific evidence and understanding. It is proposed that rather than using microbiological criteria, testing for Enterobacteriaceae (or other micro-organism) is done within process hygiene criteria at specific control points along the production chain. This would be in addition to the microbiological criteria for Salmonella at the end of the process. Both aspects would be embedded within a Hazard Analysis Critical Control Points (HACCP) based approach. An additional proposed change would be to have the hygiene process criteria monitored by the operator and the operator is responsible for implementing corrective action. The authorities would be required to ensure that such corrective actions are enforced. Further research would be required to explore the validity of using Enterobacteriaceae as a process hygiene indicator (results from recently commissioned EFSA Study on process hygiene indicators in poultry may usefully feed into this) and a valid level which indicates what is acceptable or not acceptable from a hygiene perspective.
Table of Contents
1 Introduction 7
1.1 Aims and objectives 7
1.2 Methodology 8
2 Current microbiological criteria in EU Regulation (EC) No. 142/2011 9
2.1 Overview of the microbiological criteria 9
2.1.1 Salmonella 9
2.1.2 Enterobacteriaceae 10
2.1.3 Enterococcaceae and Escherichia coli 11
2.2 Summary of the issues with the current criteria 11
2.3 Conclusions 13
3 Setting, establishing and modifying microbiological criteria 14
3.1 Background and main principles 14
3.2 Setting of microbiological criteria within EU Regulation EC No. 142/2011 15
3.2.1 Micro-organism of concern 15
3.2.2 Analytical reference methods 18
3.2.3 Sampling plan 19
3.2.4 Microbiological limits 19
3.2.5 Point in the production where the criterion is applied 21
3.2.6 Actions to be taken when the criterion is not met 22
3.3 Modifying and amending microbiological criteria 22
3.4 Summary 23
4 Proposed changes to the EU Regulation (EC) No. 142/2011 24
4.1 HACCP, Microbiological criteria and Process Hygiene criteria 24
4.1.1 Microbiological criteria 25
4.1.2 Process hygiene criteria 25
4.1.3 HACCP 27
4.2 Microbiological guidelines 28
4.3 Summary 28
5 References 30
Glossary
Food safety criteria: criteria defining the acceptability of a product or batch of products ready to be placed on the market or are already on the market
Good Manufacturing Practice (GMP): production and testing practice that assists in ensuring a quality product
Hazard Analysis & Critical Control Points (HACCP): a systematic preventative approach to food safety that identifies biological (and other) hazards in the production process and aims to reduce these risks to a safe level through the identification of critical control points and verification procedures.
Microbiological criteria: criteria defining the acceptability of a product, a batch or process, based on the absence, presence, or number of micro-organisms, per unit(s) mass, volume area or batch.
Process hygiene criteria: criteria indicating the acceptable functioning of the production process. Such criteria are not applicable to products placed on the market. It sets an indicative contamination value which corrective actions are required in order to maintain the hygiene of the process.
Risk analysis: a process consisting of three interconnected components: risk assessment, risk management and risk communication.
1 Introduction
Animal by-products (ABPs) are the parts of animals or products of animal origin that are not intended for human consumption. Given the risk that these products may pose to human and animal health if not disposed of properly, the European Union (EU) has instigated Regulations to provide rules on appropriate use, collection, transport, storage, handling and disposal of such products. The first unified EU Regulation outlining these rules was Regulation (EC) No 1774/2002 which came into force in November 2002. It was in these Regulations that the concept of three categories of ABPs (i.e. Category 1, Category 2, and Category 3) based on risk, was introduced. In 2005, after a comprehensive review of the ABP Regulations by the European Commission, a revised EU Regulation (EC) No 1069/2009 was instated with its implementing Regulation (EC) 142/2011 which revoked all preceding legislation. These new Regulations simplify some of the requirements and reduce burdens on operators and, importantly, take into account current scientific information in the revision of the categorisation of some ABPs according to the risk they pose.
Within the current and preceding legislation, microbiological criteria have been specified for enhancing the safety of the final products derived from ABP products. Specifically, the criteria define the acceptability of the ABP product depending upon the presence/absence or quantity of micro-organism present in a sample(s). These criteria focus on the sampling of products at, or on removal from, storage and testing for Salmonella and Enterobacteriaceae (or E. coli/Enterococcaceae). In particular, products may be withdrawn from sale and/or be re-processed or destroyed if Salmonella is present and/or procedures investigated if the amount of Enterobacteriaceae exceeds the maximum limit specified by the sampling plan for a specific ABP. Prior to the implementation of Regulation (EC) No. 142/2011, the United Kingdom (UK) raised the issue of the use of microbiological criteria for Enterobacteriaceae in 2 EU ABP Working Group Meetings (18th June 2010 and 13th September 2010). In these meetings, the UK questioned whether it was appropriate to apply maximum values of Enterobacteriaceae for ABPs and cited some conclusions from a European Food Safety Authority (EFSA) Scientific Opinion on “Microbiological Risk Assessment in feedingstuffs for food-producing animals” as part of their evidence for the Commission’s consideration. The Commission stated in the latter Working Group meeting that this evidence could not be considered for the current version of the implementing rules but any changes to microbiological criteria would be applied in future amendments of the ABP Implementing Regulation. This report aims to provide additional evidence to support the UK position regarding this issue and propose an alternative set of criteria.
1.1 Aims and objectives
The overall objective of this report is to provide a critical review of the derivation of the microbiological standards specified within EU Regulation (EC) No 142/2011. To meet this objective, the research was divided into three key areas:
1) An overview of the current criteria within the Regulation
2) Critical review of each component of the criteria and whether it adheres to the principles of establishing microbiological criteria
3) Alternative criteria for producing ABPs whilst still maintaining an equivalence level of safety for animal and human health
This report addresses each of these key research areas. Specifically, Section 2 outlines the current microbiological criteria, Section 3 provides an overview of how microbiological criteria are established and critically reviews each component of the criteria within the current Regulation and, Section 4 includes an overview of alternative criteria.
1.2 Methodology
The information summarised in this report is a culmination of research from a range of different sources including:
· Email communication with European Commission Directorate General, scientific experts, policy makers and industry representatives
· EFSA scientific opinions and risk assessments
· European Commission Regulations including draft documents and minutes of European Parliament and relevant European Union Working groups
· Scientific literature via searches in the ISI Web of Knowledge, Google search engines and references within other documents.
It also includes social science research specific to the project as summarised in Milestone 2 report (Focus group study) and Milestone 3 report (questionnaire study). In both studies, the participation level was very low and, therefore, caution should be made in extrapolating results from these to the wider ABP stakeholders. Where relevant, this is stipulated within the report.
2 Current microbiological criteria in EU Regulation (EC) No. 142/2011
2.1 Overview of the microbiological criteria
In recent decades, the implementation of Good Hygiene Practices (GHP) and Hazard Analysis Critical Control Points (HACCP) throughout the ‘farm-to-fork’ production chain has enhanced the quality and safety of our food. In conjunction with these principles, the use of microbiological criteria to verify HACCP plans and provide a degree of assurance that a food product is safe and of suitable quality is recommended (Stannard, 1997). This is because the presence and concentration of micro-organisms is thought to bear a direct or indirect relationship to the safety and quality of food (ICMSF, 1986). In applying microbiological criteria, distinctions can be made between food products that are considered to be acceptable and unacceptable and test results can provide an indication of the hygienic quality of food handling practices, thereby providing guidance on the acceptability of foodstuffs and their manufacturing processes (ICMSF, 1986; EC, 2005). Microbiological criteria, however, cannot guarantee foodstuff safety (e.g. absence of a pathogen in a product) (ICMSF, 1986; EC, 2005). Even though microbiological criteria were originally developed for application to food for human consumption, the principles can be applied to criteria for other applications including, for example, feedingstuffs.
The microbiological monitoring requirements specified in EU ABP Regulation (EC) No. 142/2011 provides a framework for the number of samples to be taken and tested for Salmonella and Enterobacteriaceae and the acceptable limit of bacteria within those samples; for some ABP products Enterococcaceae or E. coli may be tested for instead. The overall aim, therefore, is to enhance the safety of final products derived from APB materials including, for example, petfood, ABP derived products intended to be used as feed materials, digestion residues, compost and rendered products. Safety in this context is in regards to protecting public and animal health.
2.1.1 Salmonella
Within Annexes X, XI and XIII of EU Regulation (EC) No. 142/2011, a two-class attribute sampling plan is specified for Salmonella in derived products, other than rendered fats and fish oil, and pet food and certain other derived products, from the processing of ABPs. Two-stage sampling plans are used to decide whether to accept or reject a product by testing for absence or presence of an organism. The specific criteria for final products, dog chews and processed pet food (other than canned) and raw pet food are summarised below in Table 1.
Table 1: Outline of the microbiological criteria for Salmonella stipulated in EU Regulation (EC) No. 142/2011
Product / n1 / c1Final products* / 5 / 0
Dog chews and processed pet food / 5 / 0
Raw pet food / 5 / 0
*Includes organic fertilisers and soil improvers, digestion residues and compost, and ABP derived products intended to be used as feed materials
1n=number of sample units required for testing, c= maximum allowable number of sample units yielding unsatisfactory results
As can be seen in Table 1, for all ABP products, Salmonella must be absent in the five 25 gram samples taken during or upon withdrawal from storage (i.e. before dispatch). If Salmonella is identified within a sample, the product may be withdrawn from sale and/or be re-processed or destroyed. This stipulation is the same in the preceding EU Regulation (EC) No. 1774/2002 and Council Directive 90/667/EEC.
2.1.2 Enterobacteriaceae
The microbiological criterion for Enterobacteriaceae for derived products, other than rendered fats and fish oil is stipulated in Annexes X and XIII of EU Regulation (EC) No. 142/2011. The criterion for Enterobacteriaceae for processed pet food, dog chews and flavoured innards and raw petfood is described in Annex XIII of the legislation.
The criteria encompass a 3-class attribute sampling plan which is applied when the quality of the product is dependent upon the concentration of the organism within the sample units. It is often used to examine hygiene indicators. The 3-class plans for the different products are outlined in Table 2 below.