Welcome to part 4 of the FSSC 22 000 additional requirements series. We will be covering Product Labelling and Printed Materials, as outlined in Requirement 2.5.2 of the FSSC 22 000 Version 6 additional requirements. We hope you find this article informative and valuable.
We highly recommend also watching the video
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!
Before we get started, we would like to introduce our most popular FSSC 22000 V6 DIY services:
- Complete document templates toolkit for Food Manufacturing / Processing / Packing
- Complete document templates toolkit for Packaging Manufacturing
- Introduction to FSSC 22000 V6 online self-paced course
- Transition to FSSC 22000 V6 online self-paced course (from V5.1 to V6)
Table of Contents
Requirement 2.5.2 in a Nutshell – Product Labelling and Printed Materials Explained
We will dissect the requirements into “bite-size ” chunks to make them easier to discuss. Requirement 2.5.2 (Product Labelling and Printed Materials) has four Clauses numbered from a to d.
Refer to page 18 of the FSSC 22000 V6 scheme document. Do you have a copy? CLICK HERE
(a) Labelling Requirements
(All Food Chain Categories)
In addition to ISO 22000:2018 Clause 8.5.1.3, organisations must label finished products to meet all relevant legal and regulatory standards in the target market, including allergen and customer-specific requirements. Key points to consider are:
- Product Labeling Requirement: Organisations must ensure that finished products are labelled according to all applicable laws and regulations in the country of intended sale.
- Scope of Requirements: This includes statutory (government-set) and regulatory (body-set) requirements, allergen information, and customer-specific requests.
- Allergen Information: Clear identification of allergens present in the product is crucial.
- Customer-specific Requirements: Any additional labelling requests from customers must be included.
- Label Accuracy and Verification: Organisations must have a system in place to ensure labels are accurate, legible, and contain all required information. A verification process should also be implemented to check label compliance before product release.
- Record Keeping: Records of label approvals and changes should be maintained.
(b) Unlabelled Products
(All Food Chain Categories)
If a food product is not labelled, the necessary information for safe consumption must be provided to the customer or consumer. This information is crucial for the safe use of the food by the consumer, and may include details on:
- Ingredients
- Allergens
- Storage and handling instructions
- Best-before date
(c) Label Claims and Verification
(All Food Chain Categories)
Whenever a claim is made on a product label or packaging (e.g., allergen-free, nutritional content, organic certification), the organisation must:
- Maintain Evidence of Validation: This evidence could include supplier documentation, laboratory testing results, or production records.
- Implement Verification Systems: This shall also include traceability procedures to track ingredients throughout the supply chain and mass balance calculations to verify the claimed presence or absence of specific components.
Clarification
Let’s delve deeper into Clause (c). When a claim is made on a product label or packaging, the organisation must maintain validation evidence. This could include comprehensive studies, certifications, or other documentation that supports the claim. For example, if a product is labelled as ‘organic,’ the organisation should have certifications or documentation proving that no chemicals were used in its production. Similarly, a ‘gluten-free‘ claim would require evidence of production methods, certifications, or testing to ensure the product is free of gluten.
The organisation should also implement a verification system to regularly check that the validation methods remain effective. This could involve testing for allergens, using protein analysis, or other appropriate methods. The goal is to ensure that the product continues to meet the claims made on the label.
Internal audits can also be a valuable form of verification. By reviewing production methods and systems, organisations can ensure they are following validated procedures. An auditor would expect to see comprehensive documentation of validation studies, testing, and verification processes.
(d) Artwork Management and Print Control
(Food Chain Category I Only)
To ensure compliance with customer and legal standards, food chain category I products must have artwork management and print control procedures in place. These procedures should cover at least the following:
1. Artwork Approval and Management
- Establishment of a process for approving standard artwork or master samples.
- Creation and management of digital master files.
- Review and approval by relevant departments (marketing, compliance, production).
- Use of master samples as reference for production runs.
- Quality control checks against master samples.
2. Change Management
- Implementation of a system to manage changes to artwork, printing specifications, and materials.
- Documentation and approval of changes by a cross-functional team.
- Archiving of obsolete artwork and materials.
- Access control to prevent accidental use of obsolete materials.
- Retention of obsolete materials for potential future use.
3. Print Run Approval
- Verification of print runs against approved master samples.
- Sign-off by quality assurance and production managers.
- Involvement of customers in the approval process for custom orders.
4. Error Detection
- Use of inline inspection systems to identify printing errors.
- Immediate corrective action for detected errors.
- Colour and alignment checks.
5. Variant Segregation
- Clear labelling and storage of different print variants.
- Warehouse management system tracking for correct distribution.
- Prevention of mixing of different variants.
6. Unused Printed Materials
- Inventory of unused materials after each print run.
- Recycling, rework, or secure storage of excess materials.
- Compliance with regulatory requirements for recycling and disposal.
- Consideration of company sustainability policies.
Examples of Documents to Use
Here is a list of documents to consider:
- Product Information and Consumer Awareness Procedure
- Graphic Design and Artwork Control Procedure
- Production Line Check Form
View an index of all documents HERE
Video Explaining Product Labelling and Printed Materials
Watch the video for a deeper dive: We highly recommend watching the accompanying video for a more detailed explanation of the requirements. The video includes examples, scenarios, and showcases the recommended documentation to use.
Frequently Asked Questions
Here are some of the most frequently asked questions relating to Product Labelling and Printed Materials.
1. How should claims on product labels be validated and verified?
Using allergens as an example. This could include laboratory testing, for example, for allergens. You could have a validation study that you’ve done in collaboration with an accredited laboratory.
And once you’ve done that study, you’ll maintain it as relevant information to support your validation. This includes the methodology you followed, the allergens you were looking at, and, of course, ensuring that the claim you’re making is based on similar products, processes, or methodologies.
This would be considered the validation. And of course, verification could include traceability studies you’ve done, testing conducted internally by your laboratory personnel, and maintaining records of these activities.
2. What evidence is needed to support claims like “Organic” on product labels?
The evidence could include product test results for synthetic fertilizers and pesticides. It could also include organic certification, participation in relevant schemes, and records of the chain of custody throughout the value chain.
As for verification plans, they could include tests to support the claim, such as testing your product for Maximum Residue Limits (MRLs). This would demonstrate that there are no chemical residues present on your product.
3. What procedures must be in place for artwork management and control?
These procedures should ensure that printed materials meet customer and legal requirements. They should also include the following:
- approval of artwork,
- who is responsible for it,
- how it’s done,
- how changes are managed,
- how errors are detected, and
- how print variants are segregated.
Audit Tips
Regarding audit tips for this requirement, ensure that you maintain as much documentation as possible. This documentation should be detailed and include all requirements prescribed by the specific clause to avoid omissions. Additionally, stay updated on any changes.
Another potential weakness we’ve identified is in the artwork approval processes. Clarify who is responsible for approval, especially for customer-branded materials. Ensure that these procedures are detailed, specify the management of artwork and print specifications, and outline the responsibilities of both the customer and your company.
Regularly review and update these procedures to ensure compliance with customer and the latest regulatory requirements.
Conclusion
This concludes part 4 of our FSSC 22000 V6 additional requirements series, covering Product Labelling and Printed Materials. By understanding these requirements and implementing them effectively, you can ensure the safety and quality of your products throughout the supply chain.
Get the tools you need: ASC Consultants offers a variety of FSSC 22000 V6 resources to help you achieve and maintain certification. Explore our document template toolkits and online self-paced courses to streamline the implementation process:
- Complete document templates toolkit for Food Manufacturing / Processing / Packing
- Complete document templates toolkit for Packaging Manufacturing
- Introduction to FSSC 22000 V6 online self-paced course
- Transition to FSSC 22000 V6 online self-paced course (from V5.1 to V6)
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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FSSC 22000 V6 Series-related Articles
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Comments
If you have any questions about FSSC 22000 or these additional requirements, please don’t hesitate to leave a comment below. We’re here to help!
Food safety documents are being used and it is very helpful for our work. I wish you success in your work.
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Have a wonderful day!