Guidelines for the Application of the HACCP System in Food Safety

Where possible, validation activities should include actions to confirm the effectiveness of all elements of the HACCP system. Documentation and record keeping should be appropriate to the nature and size of the operation and sufficient to assist.

PRINCIPLES FOR THE ESTABLISHMENT AND APPLICATION OF MICROBIOLOGICAL CRITERIA FOR FOODS

1. DEFINITION OF MICROBIOLOGICAL CRITERION 36

GENERAL CONSIDERATIONS CONCERNING PRINCIPLES FOR

PRINCIPLES FOR THE ESTABLISHMENT AND APPLICATION OF MICROBIOLOGICAL CRITERIA FOR FOOD OF MICROBIOLOGICAL CRITERIA FOR FOOD.

INTRODUCTION

DEFINITION OF MICROBIOLOGICAL CRITERION
COMPONENTS OF MICROBIOLOGICAL CRITERIA FOR FOODS
PURPOSES AND APPLICATION OF MICROBIOLOGICAL CRITERIA FOR FOODS
GENERAL CONSIDERATIONS CONCERNING PRINCIPLES FOR ESTABLISHING AND APPLYING MICROBIOLOGICAL CRITERIA
MICROBIOLOGICAL ASPECTS OF CRITERIA

Micro-organisms, parasites and their toxins/metabolites of importance in a particular food
Microbiological methods
Microbiological limits

SAMPLING PLANS, METHODS AND HANDLING
REPORTING

When establishing microbiological limits, any changes in the microflora that may occur during storage and distribution (e.g. decrease or increase in numbers) must be taken into account. The time between field sampling and analysis should be as short as reasonably possible, and during transport to the laboratory conditions (e.g. temperature) should not allow an increase or decrease in the numbers of the target organism so that the results reflect – within the limitations given by the sampling plan – the microbiological conditions of the lot.

PRINCIPLES AND GUIDELINES FOR THE CONDUCT OF MICROBIOLOGICAL RISK ASSESSMENT

GENERAL PRINCIPLES OF MICROBIOLOGICAL RISK ASSESSMENT 46
SCOPE
DEFINITIONS
GENERAL PRINCIPLES OF MICROBIOLOGICAL RISK ASSESSMENT
GUIDELINES FOR APPLICATION

General considerations
Statement of purpose of risk assessment
Hazard identiﬁcation
Exposure assessment
Hazard characterization
Risk characterization
Documentation
Reassessment

Risk assessment A science-based process consisting of the following steps: (i) hazard identification, (ii) hazard characterization, (iii) exposure assessment, and (iv) risk characterization. A microbiological risk assessment should clearly state the purpose of the exercise, including the type of risk estimate that will result.

PRINCIPLES AND GUIDELINES FOR THE CONDUCT OF MICROBIOLOGICAL RISK MANAGEMENT (MRM)

GENERAL PRINCIPLES FOR MRM
GENERAL CONSIDERATIONS
PRELIMINARY MICROBIOLOGICAL RISK MANAGEMENT ACTIVITIES

Identiﬁcation of a microbiological food safety issue
Microbiological risk proﬁle
Risk assessment policy
Microbiological risk assessment

IDENTIFICATION AND SELECTION OF MRM OPTIONS

Identiﬁcation of the available MRM options for Codex and countries
Selection of MRM options

IMPLEMENTATION OF MRM OPTIONS

International intergovernmental organizations
Countries
Industry
Consumer

MONITORING AND REVIEW

Monitoring
Review of MRM activities

The definition of the adequate level of protection (ALOP) is that of the World Trade Organization (WTO) Agreement on the Application of Sanitary and Phytosanitary Measures (SPS Agreement). Working principles for risk analysis for application in the context of the Codex Alimentarius”, Codex Alimentarius Commission, procedural manual.

SUGGESTED ELEMENTS TO INCLUDE IN A MICROBIOLOGICAL RISK PROFILE

MRA, and the feasibility of such an assessment being completed within the required timeframe.

GUIDANCE ON MICROBIOLOGICAL RISK MANAGEMENT METRICS

As described in the main body of this document, the ability to articulate the expected performance of food safety control measures and control systems in terms of the necessary public health risk management is a critical component of the evolving Codex Alimentarius risk analysis paradigm. While MRA is increasingly being used to assess the ability of food safety control measures and control systems to achieve a desired level of public health protection, its use is being used to develop metrics that can be used to communicate this stringency in the context of international or national risk to food safety. the governance framework is still in its infancy.

SCOPE

In particular, risk assessment tools for linking the establishment of traditional benchmarks and other guidelines for the hygienic production, distribution and consumption of food to expected public health impacts can be complex and not always intuitive. Furthermore, effective risk assessments should generally take into account the variability and uncertainty associated with risk factors, while most risk management decisions that are consistent with the legal frameworks underpinning the authority of most competent authorities should ultimately be simplified into a binary criterion (e.g.

USE OF THE DOCUMENT

This Annex should be used in conjunction with the Codex "Working Principles for Risk Analysis for Use within the Codex Alimentarius,"15 Principles and Guidelines for the Implementation of Microbiological Risk Assessment (CAC/GL 30-1999), Principles and Guidelines for the Implementation of Microbiological Risk Management ( CAC/.GL 63-2007), Working Principles for Food Safety Risk Analysis for Use by Governments (CAC/GL's Hazard Analysis and Critical Control Point (HACCP) System and Guidelines for Its Use" ( Annex to the Recommended International Code of Practice – General Principles of Food Hygiene [CAC/RCP 1-1969]), Principles for the Establishment and Application of Microbiological Criteria for Foods (CAC/GL 21-1997) and Guidelines for the Certification of Food Safety Control Measures (CAC/GL 69-2008). use also depends on risk assessment and risk management teams that are familiar with the concepts, tools and limitations of risk management and assessment.

PRINCIPLES FOR THE ESTABLISHMENT AND IMPLEMENTATION OF MICROBIOLOGICAL RISK MANAGEMENT METRICS

It is up to the competent authorities to prioritize foods relevant to the countries for consideration of the application of MRM metrics. Accordingly, it is recommended that the members of such teams use this appendix in conjunction with standard references such as the technical information developed by FAO/WHO and Codex Alimentarius.

RELATIONSHIP BETWEEN VARIOUS RISK MANAGEMENT METRICS

Traditional metrics

An MC also requires formulating the actions to be taken if the MC is exceeded. An MC must be based on a transparent articulation of the predetermined limit and the rationale for the chosen sampling plan.

Emerging metrics

If it can be demonstrated and validated that the level of danger will decrease. If the frequency and/or concentration of the hazard is not likely to increase or.

INTEGRATION OF MICROBIOLOGICAL RISK MANAGEMENT METRICS WITHIN A FOOD SAFETY CONTROL SYSTEM

As indicated earlier, the establishment of MRM metrics at different points along the food chain must take into account the changes in the frequency and/or concentration of a hazard occurring during a specific segment of the food safety control system, if the desired level of overall control must be achieved. Recent advances in MRA increasingly relate MRM metrics at different points to each other and to the overall level of protection achieved by the food safety control system.

KEY RISK ASSESSMENT CONCEPTS RELATED TO THE DEVELOPMENT AND USE OF MICROBIOLOGICAL RISK MANAGEMENT METRICS

In general, the microbiological limit associated with an MC will need to be more stringent than its corresponding PO to account for the degree of confidence required that the food does not exceed a PO. The ability to link POs and other metrics applied at intermediate steps in the food chain to a PO or FSO established by a competent authority would be a useful tool for industry to design and verify that their control measures are achieve the desired level of control.

AN EXAMPLE OF A PROCESS FOR ESTABLISHING AND IMPLEMENTING MICROBIOLOGICAL RISK MANAGEMENT METRICS

The risk managers instruct the risk assessors to develop a risk assessment or other suitable scientific analysis that can inform the possible development of MRM metrics. The risk manager selects the MRM measures to be implemented, their level of stringency and the strategy for their implementation. h).

GENERAL STANDARD FOR IRRADIATED FOODS

GENERAL REQUIREMENTS FOR THE PROCESS

Radiation sources
Absorbed dose
Facilities and control of the process

HYGIENE OF IRRADIATED FOODS
TECHNOLOGICAL REQUIREMENTS

General requirement
Food quality and packaging requirements

RE-IRRADIATION
LABELLING

Inventory control
Prepackaged foods intended for direct consumption
Foods in bulk containers
Post-irradiation veriﬁcation

The labeling of prepackaged irradiated foods should indicate the treatment and should comply in all aspects with the relevant provisions of the General Standard for the Labeling of Prepackaged Foods (CODEX STAN 1-1985). The declaration of exposure should appear clearly on the relevant shipping documents.

RECOMMENDED INTERNATIONAL CODE OF PRACTICE FOR RADIATION PROCESSING OF FOOD

OBJECTIVES
SCOPE, USE AND DEFINITIONS

Scope
Deﬁnitions

PRE-IRRADIATION TREATMENT

Primary production and/or harvesting
Handling, storage and transport

PACKAGING
ESTABLISHMENT: DESIGN, FACILITIES AND CONTROL

Design and layout
Radiation sources
Control of operation .1 Legislation

IRRADIATION

General
Process determination
Dosimetry
Dosimetry systems
Dosimetry and process control
Control of hazards

POST-IRRADIATION STORAGE AND HANDLING
LABELLING

Food intended for irradiation processing must comply with the handling, storage and transport requirements of the Recommended International Code of Practice – General Principles of Food Hygiene (CAC/RCP 1-1969) as well as relevant Codex Standards and Codes of Practice for specific food products. The effectiveness of the radiation process depends on the correct administration of the dose and its measurement.

GUIDELINES ON THE APPLICATION OF GENERAL PRINCIPLES OF FOOD HYGIENE TO THE CONTROL OF

ESTABLISHMENT: PERSONAL HYGIENE 107

PRODUCT INFORMATION AND CONSUMER AWARENESS 109

RECOMMENDATIONS FOR AN ENVIRONMENTAL MONITORING

RECOMMENDATIONS FOR THE USE OF MICROBIOLOGICAL TESTING FOR ENVIRONMENTAL MONITORING AND PROCESS CONTROL

Quantitative assessment of the relative risk to public health from foodborne Listeria monocytogenes among selected categories of ready-to-eat foods (available at www.cfsan.fda.gov). Many of the ready-to-eat products associated with foodborne listeriosis include a listericidal step in their production.

OBJECTIVES

Another strategy to control foodborne listeriosis is thus to reduce recontamination of the product and/or to introduce an additional preventive treatment after the final packaging. The analyzes carried out within this risk assessment clearly indicate that the greatest risk associated with ready-to-eat products is the small proportion of products with high contamination levels of L.

SCOPE

Deﬁnitions

In many cases, these control measures are articulated in a general way in the International Code of Recommended Practice – General Principles of Food Hygiene (CAC/RCP 1-1969) as part of the overall strategy for the control of foodborne pathogens in all foods. The definitions of the Principles and Guidelines for the Conduct of Microbiological Risk Management (MRM) (CAC/GL 63-2007) apply.

PRIMARY PRODUCTION

Environmental hygiene
Hygienic production of food sources
Handling, storage and transport
Cleaning, maintenance and personnel hygiene at primary production

Refer to the International Code of Recommended Practice – General Principles of Food Hygiene (CAC/RCP 1-1969). Refer to the International Code of Recommended Practice – General Principles of Food Hygiene (CAC/RCP 1-1969).

ESTABLISHMENT: DESIGN AND FACILITIES

Location .1 Establishments
Premises and rooms .1 Design and layout
Equipment .1 General
Facilities .1 Water supply

Where possible, premises and rooms should be designed so that the areas for raw and ready-to-eat products are separated. Insulation should be designed and installed so that it does not become a refuge for L.

CONTROL OF OPERATION

Control of the food hazard
Key aspects of hygiene control systems .1 Time and temperature control
Incoming material requirements
Packaging
Water
Management and supervision
Documentation and records
Recall procedures
Monitoring of effectiveness of control measures for L. monocytogenes An effective environmental monitoring programme is an essential component of a

The shelf life of such foods must be consistent with the need to control the growth of L. Listericidal processes must be validated to ensure that the treatments are effective and can be applied consistently (see Section V of the Recommended International Code of Practice – General Principles of Food Hygiene [CAC/RCP 1-1969]).

ESTABLISHMENT: MAINTENANCE AND SANITATION

Maintenance and cleaning .1 General
Cleaning programmes
Pest control systems
Waste management
Monitoring effectiveness

Food contact surfaces on equipment must be cleaned and disinfected after maintenance work, before production use. Therefore, drains must be cleaned and disinfected in a way that prevents contamination of other surfaces in the room.

ESTABLISHMENT: PERSONAL HYGIENE

Health status
Illness and injuries
Personal cleanliness
Personal behaviour
Visitors

Environmental monitoring (see Section 5.9) can also be used to verify the effectiveness of sanitation programs so that sources of contamination with L. Recommendations for planning an environmental monitoring program in processing areas are given in Appendix 1.

TRANSPORTATION

General
Requirements
Use and maintenance

PRODUCT INFORMATION AND CONSUMER AWARENESS

Lot identiﬁcation
Product information
Labelling
Consumer education

TRAINING

Awareness and responsibilities
Training programmes
Instruction and supervision
Refresher training

RECOMMENDATIONS FOR AN ENVIRONMENTAL MONITORING 8 PROGRAMME FOR LISTERIA MONOCYTOGENES IN PROCESSING

However, positive findings require additional testing to determine the location of the positive sample. Fingerprinting using one or more of the available genetic techniques (e.g. pulsed field gel electrophoresis, ribotyping) can provide very useful information about the source(s) of L.

MICROBIOLOGICAL CRITERIA FOR LISTERIA MONOCYTOGENES IN READY-TO-EAT FOODS

Introduction

Scope

In particular, testing for microbiological criteria for L. monocytogenes may not be useful for: (a) products that undergo listericidal treatment after being sealed in a final packaging that prevents re-contamination until opened by the consumer or otherwise compromised; Different foods pose different risks from L. monocytogenes; Therefore, different microbiological criteria could apply to the following categories of food: (a) ready-to-eat foods in which the growth of L.

RECOMMENDATIONS FOR THE USE OF MICROBIOLOGICAL TESTING FOR ENVIRONMENTAL MONITORING AND PROCESS CONTROL

Introduction

The competent authority should also determine the measures that the food business operator must take if the criteria are exceeded. The discovery of positive environmental samples by the competent authority that exceeds the decision criteria should lead to an investigation by the food business operator and/.