Food Packaging Safety Requirements and Audits

Today's reality is that food and related materials typically pass through many "hands" during the "ingredients to consumption" food distribution chain.

Protection of the food materials supply chain--including non-comestible items used in the manufacture, containment, consumption, storage and transportation of foodstuffs -is an integral part of a food safety program. Challenges abound within what were previously considered "secondary" suppliers: manufacturers of primary and secondary packaging, containers, utensils, napkins, as well as service suppliers such as storage, warehousing and transportation.

In most cases, the Industry was comfortable being held to a basic GMP expectations and audit process; that is, as long as the provider of the non-food finished product or service passed a GMP audit (typically comprising sections for general cleanliness, pest control, traceability and recall, training, hygiene and safety, end manufacturing and repacking), users of these materials were satisfied to use them.

Lately, though, there have been several major events which have influenced the process of food safety, expectations and requirements for manufacturers of non-comestibles.

Recent, serious major global safety incidents

  • Salmonella, Listeria & E. coli outbreaks
  • Lead paint in toy coatings
  • Melamine in pet food
  • Non-food approved corn in taco shells
  • Unexpected allergen risks to unsuspecting high-risk children

As the use of "smart" devices explodes, so also does consumer awareness. As a result, consumer advocacy groups, the media and other responsible high profile groups have demanded that regulatory agencies and industry itself do a better job of protecting against microbiological, chemical and physical hazards in food.


Prior to 2008, audit processes, schemes and expectations were fragmented. Too many auditors marketed themselves and their services as being "industry-leaders, cutting edge or revolutionary." Affected suppliers and manufacturers were bombarded with solicitations. The end result was too many auditors, non-uniformity in the process, too much lost time, expense and redundancy.

In a global industry response to this dilemma, the GFSI (Global Food Safety Initiative)* was asked to create a multi-national, multi-company task force charged with the challenge of establishing audit benchmarks and principles that every authority should meet.


GFSI recognized those industry audit leaders whose standards and requirements meet the principles of GFSI. GFSI would then certify those audit Corporations as "Certified 3rd Party Auditors" (see more detail and the entire family of mission statements and the Guidance Document Version 6.1 at

GFSI updated their principles in 2010. They recognize international food (and related industries) safety standards which meet the minimum requirements set forth by their stakeholders through a benchmarking process. Per the GFSI vision and principles, continuous improvement in food safety is mandated, controlled and updated through this process.

Adding Packaging and Package Materials to the Program

As part of the larger initiative, GFSI created a Packaging Technical Group in Q1 of 2011, whose mandate is to:

  1. Review current best practices in the manufacturing of food packaging.
  2. Define/develop the scope(s) of recognition in relation to the food packaging sector and key food safety requirements with packaging manufacturing &schemes" (collection of expectations separated by category and presented in manual form) embraced and recognized by GFSI in their Guidance document.
  3. Review and define the competence of auditors for schemes applying to the GFSI recognition relating to packaging.
  4. Review and define the duration of packaging audits.
  5. Provide technical recommendations to the GFSI board for food supply chain packaging materials.

The Big Picture

GFSI's general objective is to implement a series of global standards for food and food packaging audits, wherein uniform standards would be put in place to oversee acceptance and certification of schemes, audit protocols and standards, training, auditor certifications, evaluation and compliance, with a series of checks and balances developed to control the entire process.

In essence, any supplier should be able to pick a GFSI-certified vendor or organization to perform their audits. Since that vendor met GFSI standards, certifications issued by them would be accepted by and interchangeable with all member entities.

Recognized Member Organizations

Well known organizations whose schemes/programs are expected to meet GFSI standards for packaging materials audits include SQF 2000, level 2, BRC Global standard Version 5 and FSSC 22000 (including ISO 22000 and PAS230)

The Latest

The GFSI advisory group on packaging audit protocol unification is charged with the responsibility of submitting their recommendations to the Board of Directors by the close of 2011. Those recommendations are expected to be accepted.

A process will be put in place for organizations and agencies to submit their GFSI-compliant schemes. Final acceptance and certification would conclude after each organization's scheme was deemed to have met GFSI packaging audit standards.

The Food Safety Modernization Act

The Food Safety Modernization Act is a response by the Federal Government to the need to safeguard consumers from the risk of foodborne illnesses. As stated in the guidance on the FDA website, "The FDA Food Safety Modernization Act (FSMA), signed into law by President Obama on Jan. 4, enables FDA to better protect public health by strengthening the food safety system. It enables FDA to focus more on preventing food safety problems rather than relying primarily on reacting to problems after they occur."

The Act includes the implementation of mandatory supplier verification programs. FDA is expected to begin inspecting against the Act's requirements as early as mid-2012 (access the FDA website to view guidance documents targeted at specific segments of the food industry, as well as related detail on FSMA implementation,

How Will All of This Likely Affect Packaging and Packaging Materials Manufacturers & Converters?

What does this mean to you? Food processors are going to be required to certify to FDA that their suppliers are providing them with safe materials/ingredients and that includes packaging and other non-comestible food-related items. Are those suppliers conforming to a food safety plan consistent with the processor they are supplying? Are they meeting the specifications and assurances agreed to for the packaging materials that they sell?

No longer will a "Letter of Regulatory Compliance" sitting in the file (what packaging suppliers commonly referred to as "an FDA" letter) be enough to constitute compliance. Going forward, converters and manufacturers of food packaging and other non-comestibles should expect and prepare to be held to the same food safety-related standards, expectations and documentation as the (edible) food and ingredient producers.

Will the FDA Enforcement and Inspection Unit target a small sampling of non-comestible manufacturing plants, showing up unannounced at Packaging plants in order to obtain a "snapshot" of the state of the industry? While it is unknown how aggressive FDA will be in applying the new rules to the Packaging industry, experts suggest that the number of FDA inspections of food packaging plants will increase with enforcement of this Act.

While there are no recent, known incidents of packaging or non-comestibles facilitating a food safety incident, it only takes 1 for FDA to get involved and re-focus its energies on the Packaging Industry.

How We Can Help

Maintaining a relationship with EHA bridges the knowledge gap of process safety, instructs your quality and manufacturing organization of the latest expectations and practices, recommends which standards to benchmark and then works with your Organization to understand, train, implement, evaluate and correct--mastering the Quality and Safety Process with confidence.

EHA's team of food industry safety consultants have extensive experience in auditing materials supply facilities including packaging manufacturing, adjunct materials manufacture (utensils, napkins, intermediate storage containers, etc.), storage facilities, warehouses and all modes of transportation (including road, air and sea). EHA is positioned to become your one-stop source for end-to-end knowledge and protection against unexpected quality and safety issues.

How Do I Prepare My Company for An Unexpected or Inevitable Inspection?

A converter must take the same approach as a food manufacturing company. It starts with understanding food safety risks associated with your process and operation, then moves to creation of a comprehensive plan (on paper), developing and implementing that plan, and then challenging and testing that plan to be sure that it is practical and functional. Mock responses during the trial phase must be diligent.

Consider your response in the event of a challenge. Is it reasonable, based on your size and the scope of your business? Does it reflect what a peer food company or competitor would do under similar circumstances?

I use a lot of adjunct materials in the manufacture of my finished packaging; adhesives, inks, coatings, appliqués, processing aides, lubricants. How can I certify that they are all safe, meet the manufacturer's specifications and are free of toxins, adulterants, contaminants or unexpected allergens?

As prices of critical raw materials increase or supply is affected, there is always a risk of adulteration or substitution. Materials with components sourced outside the USA add additional risk, and there is always the possibility of unexpected, accidental contamination from non-food sources during distribution.

As stated earlier, COAs, CSOC and Regulatory letters are a necessary start, but not nearly enough to constitute diligence in the event of an incident. It is incumbent upon packaging manufacturers and converters to challenge their suppliers and the supply process itself to show proof of independent GFSI-certified 3rd party audits and/or evaluations.

In some cases, when overriding concern or suspicion arises, it may be necessary to send materials out for laboratory analysis. Preparation for that step will require the packaging materials manufacturer to maintain a manageable library of standard references to act as controls for analysis.

This is involved and overwhelming. What can EHA do to help me successfully navigate through this maze of new requirements?

EHA's staff of experts will take a comprehensive, collaborative approach to implement and validate a program which will withstand audits and inspections. EHA will apply the following principles and processes:

  1. Work with the appropriate functions in your organization to map your process, then evaluate and identify risk points which need control or mitigation.
  2. Evaluate your existing prerequisite and/or HACCP plans or assist you in the creation of new plans, followed by validation against practicality and performance.
  3. Examine your defense processes and plans in order to ensure accuracy and compliance.
  4. Assess all of your standard SSOPs and GMPs, embargo and hold policy, warehousing, receiving, shipping, documentation and all other required processes which compose an industry standard food audit.
  5. Stand behind and work with you in the event of an inspection, audit, challenge or issue with your customer or vendor.

EHA expertise includes:

  • A thorough knowledge of US and global benchmarks, schemes, expectations and requirements for applying principles of quality and safety to your specific facilities.
  • Assessment, implementation and modifications of existing prerequisite, CCP and HACCP programs OR development of sensible programs for those manufacturers of food-industry adjunct materials who are unsure as to whether their plans are compliant with 2012 standards.
  • Ability to perform comprehensive inspections and audits of manufacturer, supplier, packaging, storage, warehousing and transportation partners. We work with your professionals to develop a quality and safety program focusing on:
    • Prevention of cross contamination.
    • Verification, consistency and application of effective facility SSOP's, perst control, security, hygiene and implementation and maintenance of facility GMP programs.
  • Accurate, on-target identification of process gaps which add risk, coupled with recommendations for reasonable corrective actions, monitoring and enforcement.
  • Crisis management of potential and actual CCP system failures, actual and mock product recalls etc.
  • Laboratory services for accurate and reliable evaluation of biological and chemical risks to food and food-contact materials in order to determine inventory disposition.
  • Assistance with local, state or federal agencies.
  • Monitoring of changes and updates from industry-standard certifying and regulatory agencies.
  • Legal consult services for litigation related to food safety or quality issues.

*[NOTE: GFSI is a European non-profit foundation managed by The Consumer Goods Forum, a multi-national, industry-represented organization providing a global platform for knowledge exchange and initiatives centering around five strategic priorities central to the advancement of today's consumer goods industry – Emerging Trends, Sustainability, Safety & Health, Operational Excellence and Knowledge Sharing & People Development. The Forum is governed by its Board of Directors, which is composed of 50 major manufacturer and retailer CEOs and Chairmen.]