FSSC 22000 for Flexible Packaging Manufacturers (Pouches, Films, Laminates)

FSSC 22000 certification for flexible packaging is a way for converters that manufacture pouches, films, and laminates to show that their packaging is safe for use with food products.More buyers are now expecting flexible packaging suppliers to have this certification, either instead of or along with regular food safety audits.certification, either instead of or along with regular food safety audits. This guide explains what FSSC 22000 requires for flexible packaging lines, the differences in this certification compared to that for rigid packaging, and the whole process involved in certification for pouch and film converters.

What Is FSSC 22000 for Flexible Packaging

The FSSC 22000 for flexible packaging is a GFSI-certified program applying the FSSC 22000 Packaging Manufacturing scope to flexible packaging converters, who manufacture pouches, roll stock film, laminates, and other flexible structures. The scheme includes ISO 22000 management system requirement along with packaging specific prerequisite programme standard, which is much more comprehensive than considering packaging manufacturers an add-on to food manufacturing.

In other words, a flexible packaging facility is evaluated according to the same stringency as the food manufacturing facilities – hygienic design of the extrusion and lamination lines, control over inks and adhesives, and migration risk.

Flexible structures have gained popularity in snack foods, spices, sauces and liquid sachets packaging, being more economical in transportation and storage compared to their rigid counterparts. And exactly the rise in the popularity of flexible formats is the reason why more attention is paid to flexible packaging certification – it is easier to find weaknesses in a multilayered structure than in a solid one. 

FSSC 22000 Flexible Packaging Requirements

The FSSC 22000 flexible packaging requirements are based upon the ISO 22000 food safety management system and incorporate its packaging-specific content through the ISO/TS 22002-4 prerequisite program standard for packaging production. The combination addresses:

• Extrusion, lamination, printing, and slitting machinery hygiene
• Control of inks, adhesives, coatings, and solvents used during printing and lamination
• Information on migration of material layers and their suitability for food contact
• Foreign material and contamination control particular to film and pouch conversion
• Tracking of material from resin/substrate batch to final roll/pouch
• Storage and handling procedures to avoid odor transfer and exposure of barrier layers to moisture
• Control of material going into rework, trim, or reground form

Besides ISO/TS 22002-4, FSSC 22000 includes other requirements specific to FSSC 22000 including food defense, food fraud prevention, allergen control wherever applicable, and environmental monitoring requirements which apply uniformly across all scopes covered under FSSC certification, including packaging.

Can Flexible Packaging Manufacturers Get FSSC 22000

Absolutely. Flexible packaging manufacturers may be certified according to the FSSC 22000 scheme in the Category PM (packaging manufacturing) scope, where converters of films, pouches, laminates, and other flexible materials, meant for food contact, are included. This is not a trick or any kind of adaptation of the food-manufacturing certificate; it is the scope designed specifically for packaging.

The certification authority evaluates the particular process (blown or cast film extrusion, lamination, gravure/flexographic printing, pouch making and sealing), taking into account only the criteria that apply to it.

FSSC 22000 Requirements for Flexible Packaging: What Auditors Actually Check

An audit of the FSSC 22000 criteria regarding flexible packaging is going to concentrate on the areas where the flexible structure deviates from the rigid packaging or food item. Areas of concentration should be:

• Documentations layer by layer for multi-layer laminations that consist of barrier film, tie layer, and seal layer
• Migration tests for each substrate and ink system contacting the foodstuff
• Residue levels of solvents from printing and laminating process and curing process validations
• Sealing integrity tests for the pouches such as retort pouches and high-barrier pouches
• Static and dust control during slitting and pouch formation operations
• Validation for changeover between different ink colors, adhesive and substrates

When Does a Flexible Packaging Manufacturer Need FSSC 22000

The FSSC 22000 standard is essential for a flexible packaging manufacturer when its customers are food or beverage products with GFSI recognition, when export countries demand proof of food contact safety, or when the facility manufactures several types of foods and seeks one certification to meet all customer requirements.

• Providing private-label food and/or beverage products requiring GFSI-certified packaging
• Shipping film and/or pouches to destinations with tight regulation of food-contact material
• Decreasing the number of customer audits needed through having one recognized certification
• Bidding on contracts which list FSSC 22000 as a requirement for suppliers

It is not as important for producers that produce only packaging material which does not come into contact with food, such as outer wrapping or transport film.

FSSC 22000 Certification for Pouch Manufacturers

In addition to the usual standards of certification for film or laminate manufacturer, pouch certification according to FSSC 22000 has some additional standards since pouches bring along more risks, such as forming, filling-line compatibility, and seal integrity. Spout pouches, stand up pouches, and retort pouches have their own specific risks.

• Retort pouches require validated seal strength and barrier integrity that can withstand heat sterilization
• Spout & fitment pouches require controlled contamination in fitment insertion and welding process
• Stand-up pouches with gusseted bottom require uniform seal geometry to prevent any weak spots that will fail during transport
• Pouches that come pre-printed and in direct contact with food should have the same ink migration certification as flat films

A pouch manufacturer which is preparing for certification must map these process-specific hazards against ISO/TS 22002-4’s requirement at the outset itself, rather than looking at the pouch forming process as an extension of film manufacturing.

Flexible Packaging Certification vs. Rigid Packaging Certification

Both flexible packaging certification and rigid packaging certification belong to the scope of FSSC 22000 Category PM; however, there is a distinct difference in risk profile and non-conformances that makes it important for audits.

Both flexible and rigid lines that operate under one factory can have an FSSC 22000 certification, provided the individual processes are evaluated based on their respective prerequisite programs.

Step-by-Step FSSC 22000 Certification Process for Flexible Packaging Plants

• Gap Assessment according to ISO 22000, ISO/TS 22002-4, and additional requirements of FSSC 22000
• Prepare the Food Safety Management System documents for hazards specific to packaging
• Install hygiene and contamination prevention measures in the extrusion, lamination, and printing process lines
• Gather all migration tests and food contact compliance information for all layers of materials
• Carry out internal audits and management review cycle before the certification audit
• Carry out the first stage (documents review) and second stage (on-site) audits using an accredited certifying organization
• Resolve all non-conformances within the stipulated time for getting the certificate
• Maintain the system with annual surveillance audits and 3-year recertification cycle

Common Mistakes Flexible Packaging Manufacturers Make

• Considering ink suppliers and adhesive suppliers as approved without seeking current migration data compliance information
• Undervaluing the hygiene design flaws of old extruder and laminator machines
• Not performing integrity test validation on newly developed pouches prior to production
• Failure to document rework/regrind management within the traceability system
• Developing food safety documents in a general manner rather than correlating them with ISO/TS 22002-4’s packaging-specific provisions

Cost and Timeline Factors

The cost and time needed for certification of a flexible packaging facility are influenced by the number of production lines, the number of different materials used in production, and the maturity of the current quality system. A facility that has clean batch records and is already equipped with a hygienic design program will be certified faster compared to a facility having a basic ISO 9001 program.

• Number of different processes involved (extrusion, laminating, printing, pouch manufacturing)
• Amount of existing migration and food contact materials information available
• Number of plants included within the scope of the certification
• Costs of the certification body, which depend on the time required for audit and plant complexity

Getting FSSC 22000 Certification for a Flexible Packaging Line

The majority of flexible packaging manufacturers already have a structured production process in place – the certification process mainly revolves around proving it meets ISO/TS 22002-4 and filling any holes that will be found during the audit process. Our Legal4sure helps film, laminate, and pouch manufacturers undergo gap assessment, document, and prepare for the audit process.

This way, our FSSC 22000 Certification Service provides the entire process from gap assessment to surveillance audits.

Key Takeaways

• Category PM FSSC 22000 for flexible packaging merges ISO 22000 with packaging-related prerequisites in ISO/TS 22002-4
• Flexible packaging companies are able to obtain certification without the adaptation of any standard for the production of food products
• A lot of attention from auditors is paid to migration documentation, adhesion and inks and the quality of the seal of the packages and laminated structures
• For pouch manufacturing there are additional demands for retort processability, welds of the fitments and seal shape
• Both lines of flexible and rigid packaging can have the same FSSC 22000 certificate provided that the scope of both is evaluated based on requirements

Conclusion

FSSC 22000 for Flexible Packaging enables flexible packaging pouches, films, and laminates producers to get certified using a process which is based on the specific process of each manufacturer, not a general food safety check-list. Having the proper migration documents, hygienic design, and seal validation done from the very beginning makes the audit part easy.