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,

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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



Date sent for comment

Date returned comments

Date comment addressed

Felicity Clifton-Hadley





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 In particular, products may be withdrawn from sale and/or re-processed or destroyed if Salmonella is present and/or procedures investigated if the amount of Enterobacteriaceae exceeds the maximum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.
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