What is ISO/TS 22002-4? The Packaging PRP Standard Explained

If your business is involved in packaging food products and you have heard about ISO/TS 22002-4, you may have wondered how it is different from the usual food safety standards.This is not a separate certification; rather, it is a set of prerequisite programme (PRP) requirements used by food packaging manufacturers along with ISO 22000 to meet the requirements for FSSC 22000 certification. 

In this guide, we explain the ISO/TS 22002-4 in simple words, give its particular requirements, and discuss its place for those companies who wish to get FSSC 22000 certification. 

What Is ISO/TS 22002-4

The ISO/TS 22002-4 is an ISO technical specification defining the requirements for the prerequisite programme applicable for food packaging manufacturing. The standard is complementary to the ISO 22000 standard on food safety management system requirements and focuses on the requirements on the physical, hygienic and operational aspects of the production of food packaging.

Unlike the ISO 22000 which describes how to develop the food safety management system, ISO/TS 22002-4 deals with specific packaging issues such as cleanroom design, print and ink migration control, foreign body prevention and traceability of materials. It is part of the ISO 22002 series together with the PRPs for food manufacturing (22002-1), catering (22002-2) and transport and storage (22002-5).

Why ISO/TS 22002-4 Exists

Though packaging is not considered food in itself, once it touches the food product, it becomes a part of the food safety system from then on. Printing ink migration, contamination during the lamination process, or a foreign body such as a staple in the carton could be equally responsible for compromising food safety as the contamination of ingredients.

General food safety guidelines applicable to food manufacturers do not cover issues related to the printing process or barrier property of the material used. The ISO/TS 22002-4 standard bridges this gap.

Who Needs ISO/TS 22002-4

This standard applies to a specific, fairly broad slice of the packaging industry. You likely need it if you manufacture:

• Packaging materials for flexible food contact (bags, laminates, films)
• Packaging materials for rigid plastic containers, trays, or bottles
• Paperboard or corrugated cartons used for primary or secondary food packaging
• Metal or glass containers and closures
• Printed labels or films that go directly on food-contact packaging

In case your packaging does not come into direct contact with any food (for example, outer shipping boxes without any product contact), the scope might not be applicable in the same way and you should verify this with a certification body.

ISO/TS 22002-4 Requirements: What the Standard Actually Covers

The ISO/TS 22002-4 requirements are organized into distinct operational areas. Here’s what each one requires in practice.

1. Facility and Building Layout

• Zoning that keeps hygienic areas separate from general production and storage
• A product flow that avoids cross-contamination between raw material handling and final packaging
• Pest management strategies suitable for a food-related manufacturing plant that is not a food manufacturer

2. Utilities and Air Quality

• Production compressed air systems filtered to eliminate oil or other particles
• Water purification where water comes into contact with packaging materials
• Ventilation systems to minimize airborne contamination in printing and laminating areas

3. Cleaning and Sanitation

• Cleaning schedule for equipment including between print runs and during material changeovers
• Cleaning process validation that allows transfer of contamination between batches
• Separation of cleaning products from packing materials in storage

4. Foreign Body and Contamination Prevention

• Policies for glass and hard plastic, as packaging plants frequently have high-speed machinery with fragile components
• Metal detection or X-ray inspection compatible with the packaging material and its intended use
• Controlling any loose items like staples, clips, and fasteners that can end up in the final packaging product

5. Print, Ink, and Migration Control

This is the requirement area most specific to packaging and least familiar to food manufacturers moving into this space.

• Documents demonstrating that ink and coatings are suitable for the intended food application
• Set-off controls that prevent the transfer of ink from one sheet to another in a stack
• Migration testing or supplier documents for substances in direct contact with food products

6. Storage and Traceability

• Separate storage of raw materials, works-in-progress, and package-ready goods
• Traceability of batches/ lots from receipt of raw materials to dispatch of finished goods
• FIFO (First In First Out) inventory management especially for items having shelf life

7. Personnel Hygiene and Training

• Hygiene requirements for packaging manufacture that include protective clothing where there is contamination risk
• Training related specifically to packaging, not general food handling training, that includes ink safety, foreign bodies, and materials handling

Benefits of Building ISO/TS 22002-4 Into Your Operations Early

In contrast to facilities that only work on ISO/TS 22002-4 when an audit looms near, facilities that incorporate ISO/TS 22002-4 in their day-to-day operations end up spending less money on corrective actions. Here are just a few of the benefits to getting started early:

Less non-conformities during stage-one audit:  Certification bodies report documentation non-conformities the most, and a vast majority of such documentation is associated with processes that were performed informally without prior documentation.

Efficient buyer qualification process: Large food companies are now requiring certified FSSC 22000 packaging suppliers, and having ISO/TS 22002-4 control measures in place before a buyer requests it will prevent losing a contract due to delay.

Lower cost of rework: Resolving ink migration or contamination problems detected during the post-packing process is significantly more costly than resolving the issue detected by in-process inspection.

Scope expansion: Facilities that have already met ISO/TS 22002-4 requirements will have no difficulties expanding their scope by adding a new packaging format, like moving from rigid to flexible pouches.

What an ISO/TS 22002-4 Gap Assessment Typically Finds

Prior to any formal process of certification, it is generally advised by most of the consultants and certification organizations that there should be an internal or external gap assessment. It is not like any formal audit but a structured tour through all the areas that are lacking.

A typical gap assessment for a mid-sized packaging facility looks at:

1. Review of documentation – verification of whether any written procedures have been prepared regarding cleaning, changeover and materials handling, apart from informal verbal knowledge
2. Walk-through of physical facility – comparison of zoned areas, air handling systems and pest controls with that required by the standard for that particular package
3. Supplier documentation verification – confirmation whether ink, adhesive and substrate suppliers will be able to supply food contact suitability certificates, apart from quality certificates
4. Traceability verification – selection of finished product lot and going back through documents to verify that there is no break at conversion step
5. Training record verification – confirmation whether hazard identification training specific to packaging has taken place and been recorded, apart from induction training

ISO/TS 22002-4 vs Other PRP Standards

Packaging producers have been wrongly directed to a particular PRP since it appears to be very broad. Below is the comparison between the packaging-specific standard and those which are commonly mistaken for it.

How ISO/TS 22002-4 Fits Into FSSC 22000 Certification

ISO/TS 22002-4 cannot be used for certification purposes individually; it becomes applicable as soon as your site applies for FSSC 22000 certification for packaging manufacturing.

In the FSSC 22000 standard, there are three components to consider: the ISO 22000 management system standard, the sector-related PRP (ISO/TS 22002-4 for packaging), and additional FSSC’s criteria which include food defense and food fraud prevention. All of them are audited together as part of the FSSC 22000 packaging certification process.

What it means for you as a company is that your certification body will audit both your food safety management system documentation and your production facility according to ISO/TS 22002-4 criteria from the list above (including cleanroom control, ink migration control, foreign body prevention, etc.).

Common Gaps Packaging Manufacturers Run Into

A few issues show up repeatedly during ISO/TS 22002-4-aligned audits, especially for facilities converting from a general manufacturing background rather than dedicated food-contact packaging production:

• Documentation regarding ink and coating suppliers is available; however, it does not explicitly state that the materials are suitable for contact with food.
• Validation of the cleaning process is performed on equipment but there is no documented evidence which could be traced by an auditor.
• A traceability system is available to track raw material lots until such material is made into rolls or sheets.
• Training for employees is performed about factory safety but not about contamination risks associated with packaging.

Getting Started with FSSC 22000 Certification Registration

In case your packaging plant is ready to get certified, the practical way to begin is by doing the gap analysis according to ISO/TS 22002-4 standards before proceeding further towards the process of FSSC 22000 Certification Registration. It would be better to make sure that all documentation and physical gaps are sorted before the certification body comes to perform the stage one audit.

Legal4sure is an expert in providing assistance to packaging converters and manufacturers in India regarding conducting the gap analysis, sorting out PRPs related documentation, and performing registration and audit scheduling in the smoothest way possible.

Key Takeaways

• ISO/TS 22002-4 is the packaging specific prerequisite program standard which is to be implemented along with ISO 22000 and not certified separately like ISO 22000
• It focuses on packaging specific hazards such as ink migration, print hygiene, foreign body control and traceability which are not covered by general food production PRP
• This applies to all packaging types – flexible, rigid, paperboard, metal and glass packaging which comes into direct contact with food products
• ISO/TS 22002-4 requirements are audited along with ISO 22000 and FSSC additional requirements in FSSC 22000 certification audit process and not separately
• The two most common areas where deficiencies have been identified in packaging facilities are ink traceability and conversion process documentation

Conclusion

ISO/TS 22002-4 came about due to the fact that packaging does have risks associated with food safety despite it not being considered as food. The importance of knowing what ISO/TS 22002-4 is and where it fits in the bigger picture of the FSSC 22000 helps make the process of obtaining the certificate much simpler, particularly for those manufacturing packaging who are new to this process.