Are you struggling to understand the new FSSC 22000 V6 additional requirements? This comprehensive guide will break it down for you, one step at a time.
Confused by the FSSC 22000 V6 scope and applicable food chain categories? We’ll unveil their meaning and how they impact your FSMS.
Wondering about the additional requirements? We’ll explore each one in detail, covering everything from management of services to allergen control and beyond.
Uncertain about proper implementation? We’ll provide clear explanations with practical examples in future instalments.
In Part 1, we’ll provide a quick overview of the FSSC 22000 V6 food chain categories and additional requirements. We won’t go into extensive detail here, but we’ll link you to the relevant parts of the series for more clarity on each topic.
This series is designed to be your one-stop shop for understanding the FSSC 22000 V6 additional requirements. Stay tuned for upcoming parts that delve deeper into each requirement!
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Summary of the Scope of FSSC 22000 V6 – Food Chain Categories
In this article, reference will be made to the relevant food chain categories. Here is a quick reference guide for all the food chain categories:
| Cat. | Sub-cat. | Description |
|---|---|---|
| B | BIII | Pre-process handling of plant products |
| C | C0 | Animal – Primary conversion |
| C | CI | Processing of perishable animal products |
| C | CII | Processing of perishable plant-based products |
| C | CIII | Processing of perishable animal and plant products (mixed products) |
| C | CIV | Processing of ambient stable products |
| D | D | Processing of feed and animal food |
| E | E | Catering / food service |
| F | FI | Retail / Wholesale / E-commerce |
| F | FII | Brokering / Trading / E-commerce |
| G | G | Transport and storage services |
| I | I | Production of packaging material |
| K | K | Production of Bio/chemicals |
You can visit PART 2 HERE, for more details regarding the scope of FSSC 22000 V6.
FSSC 22000 V6 Additional Requirements in a Nutshell
FSSC 22000 Version 6 introduces 18 main additional requirements that build upon the foundation of ISO 22000 and Prerequisite Programs (PRPs). These additional requirements are outlined in detail under Part 2 of the FSSC 22000 v6 scheme document.
They focus on strengthening various aspects of your food safety management system, including conducting a thorough hazard analysis, assessing risks, implementing robust control measures, and ensuring continual improvement throughout your processes.
2.5.1: Management of Services and Purchased Materials
Applicable food chain categories: All
This requirement has different additional requirements for different food chain categories. Here is a quick summary:
All food chain categories have additional requirements to Clause 7.1.6 of the ISO 22000:2018 related to the use of competent laboratories (both internal and external laboratories where applicable) for food safety verification and validation. Competency can be in the form of participating in proficiency testing or ensuring the laboratory has ISO/IEC 17025 certification. The organisation must ensure that these laboratories can produce precise and repeatable test results using validated methods and best practices.
Food chain categories C, D, I, FIl, G and K have additional requirements to Clause 7.1.6 of the ISO 22000:2018 regarding specific requirements for procurement in emergency situations.
Food chain categories CO, CI, CIll and CIV have additional requirements to Clause 9.2 of the ISO/TS 22002-1:2009 regarding policies for the procurement of animals, fish, and seafood subject to controlled substances.
For food chain categories C, D, I, FIl, G and K the organisation must establish and maintain a review process for raw material and finished product specifications to ensure compliance with food safety, quality, legal, and customer requirements.
Food chain category I have additional requirements to Clause 7.1.6 of the ISO 22000:2018 relating to using recycled packaging as a raw material input into the production of finished packaging material.
You can visit PART 3 HERE, for more details regarding the management of services and purchased materials.
2.5.2: Product Labeling and Printed Materials
Applicable food chain categories: All
In addition to Clause 8.5.1.3 of ISO 22000:2018.
This section highlights the importance of labelling finished products according to statutory and regulatory requirements in the country of intended sale, including allergen and customer-specific requirements. It also addresses providing relevant product information for unlabelled products to ensure consumer safety.
Moreover, the organisation must maintain evidence of validation for any claims made on product labels or packaging and implement verification systems to ensure product integrity.
Additionally, for food chain category I guidelines for artwork management, print control procedures, and approval processes are detailed to meet customer and legal requirements.
You can visit PART 4 HERE, for more details regarding product labelling and printed materials.
2.5.3: Food Defence
Applicable food chain categories: All
This requirement consists of two parts:
2.5.3.1: Threat Assessment – The section discusses the necessity for conducting a food defence threat assessment based on a defined methodology to identify and evaluate potential threats to processes and products. It emphasises the development and implementation of mitigation measures for significant threats.
2.5.3.2: Plan – The organisation must have a documented food defence plan supported by the FSMS, complying with legislation and covering processes and products within its scope. Specific requirements for the food chain category FIl include ensuring suppliers also have a food defence plan in place.
We will discuss the details and provide more clarity using examples in Part 5 of the series.
2.5.4: Food Fraud Mitigation
Applicable food chain categories: All
This requirement consists of two parts:
2.5.4.1: Vulnerability Assessment – Here, the focus is on conducting a vulnerability assessment to identify and assess potential vulnerabilities related to processes and products. The organization must develop and implement appropriate mitigation measures for significant vulnerabilities.
2.5.4.2: Plan – A documented food fraud mitigation plan based on the vulnerability assessment output is required, along with compliance with legislation and coverage of processes and products within the organisation’s scope. Similar to food defence, suppliers in the food chain category FIl must also have a food fraud mitigation plan.
We will discuss the details and provide more clarity using examples in Part 6 of the series.
2.5.5: Logo Use
Applicable food chain categories: All
This requirement focuses on the use of the FSSC 22000 logo.
Certified organisations, Certification Bodies, and Training Organisations are permitted to use the FSSC 22000 logo for marketing activities, subject to specific guidelines. The use of the logo is restricted to certain materials, and organisations are prohibited from using it in ways that imply endorsement by FSSC 22000. Additionally, restrictions on using the logo on products, labelling, packaging, certificates, or in a manner suggesting certification approval are outlined.
We will discuss the details and provide more clarity using examples in Part 7 of the series.
2.5.6: Management of Allergens
Applicable food chain categories: All
This section focuses on the importance of having a documented allergen management plan that includes a list of handled allergens, risk assessments for cross-contamination, implementation of control measures, validation and verification of these measures, and personnel training.
It also emphasizes the regular review of the allergen management plan and the need for additional measures when significant changes occur.
Specific considerations for Food Chain Category D regarding allergen-related legislation are also discussed.
We will discuss the details and provide more clarity using examples in Part 8 of the series.
2.5.7: Environmental Monitoring
Applicable food chain categories: BIII, C, I & K
The organisation must implement a risk-based environmental monitoring program for relevant pathogens, spoilage, and indicator organisms. It also entails evaluating the effectiveness of controls to prevent contamination, regular trend analysis, and annual reviews for continued effectiveness and suitability.
Triggers for more frequent reviews are outlined, such as significant changes, prolonged absence of positive testing results, or repeat detection of pathogens.
We will discuss the details and provide more clarity using examples in Part 9 of the series.
2.5.8: Food Safety and Quality Culture
Applicable food chain categories: All
In addition to Clause 5.1 of ISO 22000:2018.
In this section, the organisation is encouraged to establish, implement, and maintain a food safety and quality culture objective as part of the management system. Key elements to address include communication, training, employee feedback and engagement, and performance measurement.
These objectives should be supported by a documented plan with targets and timelines, integrated into the management review and continuous improvement processes.
We will discuss the details and provide more clarity using examples in Part 10 of the series.
2.5.9: Quality Control
Applicable food chain categories: All
In addition to Clause 5.2, 6.2, 9.1, 9.2, 9.3 of ISO 22000:2018.
The organisation is required to establish, implement, and maintain a quality policy, quality objectives, and quality parameters aligned with finished product specifications. Additionally, analysis and evaluation of quality control parameters, quantity control procedures, and line start-up and change-over procedures are emphasised to ensure compliance with customer and legal requirements.
We will discuss the details and provide more clarity using examples in Part 11 of the series.
2.5.10: Transport, Storage, and Warehousing
Applicable food chain categories: All
This section outlines establishing procedures and stock rotation systems incorporating FEFO principles for effective product storage.
Food chain category C0 has additional requirements to Clause 16.2 of the ISO/TS 22002-1:2009 related to specific requirements for post-slaughter time and temperature control.
Food chain category FI has additional requirements to Clause 9.3 of the BSI/PAS 221:2013 regarding the transportation conditions to minimise contamination.
There are also additional requirements to Clause 8.2.4 of the ISO 22000:2018 where transport tankers are used. There must be risk-based plans for tanker cleaning. Supplier agreements for product safety and prevention of cross-contamination are also highlighted where tankers are used.
We will discuss the details and provide more clarity using examples in Part 12 of the series.
2.5.11: Hazard Control and Measures for Preventing Cross-Contamination
Applicable food chain categories: All, excluding FII
This requirement has different additional requirements for different food chain categories. Here is a quick summary:
Food chain categories BIII, C, and I have additional requirements to Clause 8.5.1.3 of the ISO 22000:2018 related to packaging functional effects on food.
Food chain category C0 has additional requirements to Clause 10.1 of the ISO/TS 22002-1:2009 regarding the inspection processes for animal fitness for human consumption.
Food chain category D has additional requirements to Clause 4.7 of the ISO/TS 22002-6:2016 related to the procedures for managing ingredients/additives with adverse impacts on animal health.
All food chain categories, excluding FII, have additional requirements to Clause 8.4.2 (h) of the ISO 22000:2018 regarding additionally, guidelines for foreign matter management, including risk assessment for foreign body detection equipment and controls for physical contamination.
We will discuss the details and provide more clarity using examples in Part 13 of the series.
2.5.12: PRP Verification
Applicable food chain categories: BIII, C, D, G, I & K
In addition to Clause 8.8.1 of ISO 22000:2018.
This section emphasises the establishment, implementation, and maintenance of routine site inspections/PRP checks to ensure the maintenance of a suitable condition for food safety. The frequency and content of these checks are based on risk assessment criteria linked to the relevant technical specifications.
We will discuss the details and provide more clarity using examples in Part 14 of the series.
2.5.13: Product Design and Development
Applicable food chain categories: BIII, C, D, E, F, I & K
The organisation must have a product design and development procedure for new products and changes to ensure the production of safe and legal products. This includes evaluating the impact of changes on the FSMS, considering process flow implications, resource and training needs, equipment requirements, and conducting trials for product validation and shelf-life verification.
We will discuss the details and provide more clarity using examples in Part 15 of the series.
2.5.14: Health Status
Applicable food chain categories: D only
In addition to ISO/TS 22002-6 Clause 4.10.1.
This requirement focuses on ensuring that personnel health does not adversely affect feed production operations. The organisation must conduct medical screenings for employees, with additional examinations as required, to maintain health clearance and prevent adverse impacts on operations.
We will discuss the details and provide more clarity using examples in Part 16 of the series.
2.5.15: Equipment Management
Applicable food chain categories: All, excluding FII
In addition to Clause 8.2.4 of ISO 22000:2018.
The organisation must have a documented purchase specification addressing various aspects like the hygienic design, legal requirements, intended use of equipment, etc. Also, a risk-based change management process for new and existing equipment changes is essential to maintain control measures and successful commissioning. it also outlines the requirements for suppliers.
We will discuss the details and provide more clarity using examples in Part 17 of the series.
2.5.16: Food Loss and Waste
Applicable food chain categories: All, excluding I
In addition to Clause 8 of ISO 22000:2018.
This section focuses on establishing policies and objectives to reduce food loss and waste within the organisation and supply chain. It includes the controls for managing donated products, surplus products, or by-products to prevent contamination, ensuring compliance with legislation and maintaining food safety.
We will discuss the details and provide more clarity using examples in Part 18 of the series.
2.5.17: Communication Requirements
Applicable food chain categories: All
In addition to Clause 8.4.2 of ISO 22000:2018.
The organisation must inform the certification body promptly of events impacting the FSMS, legality, or certification integrity. This includes serious events like natural disasters, legal proceedings, or fraudulent activities that threaten food safety or certification integrity.
We will discuss the details and provide more clarity using examples in Part 19 of the series.
2.5.18: Requirements for Organisations with Multi-Site Certification
Applicable food chain categories: E, F and G
This requirement consists of two parts and applies to organisations with multi-site certification:
2.5.18.1: Central Function – The management of the central function must ensure sufficient resources are available and the roles, responsibilities, and requirements for all key personnel involved in the FSMS are clearly defined.
2.5.18.2: Internal Audit Requirements (in addition to Clause 9.2 of ISO 22000: 2018) – This section covers various topics like the requirements for internal audits and audit programs; requirements for internal auditors (including the training requirements, monitoring, calibration etc); the frequency of the internal audits and the technical review of internal audit reports.
We will discuss the details and provide more clarity using examples in Part 20 of the series.
Conclusion
In conclusion, this article has provided a brief overview of the 18 additional requirements introduced in FSSC 22000 Version 6. By understanding these requirements and how they apply to your specific food chain category, you can ensure your Food Safety Management System (FSMS) is robust and effective.
We encourage you to stay tuned for the upcoming parts of this series, where we’ll delve deeper into each requirement with practical examples and explanations. You’ll also find links to relevant resources throughout the series to support your learning.
If you have any questions about FSSC 22000 or these additional requirements, please don’t hesitate to leave a comment in the comment section at the end of the article. We’re here to help!
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