The Food Safety community was taken by surprise. After a long wait, the new FSSC 22000 6.0 version has been published and, unlike the last update, it is full of new features. It has come to further reinforce the importance of food safety as well as Food Safety Management Systems. In this post, I will show you the main changes that certified companies must prepare for and the timeline for implementation. Let’s go?
It is important to remember that the standard has not yet been translated into other languages. The standard is now available for free download in English and you can download it via this link.
What are the reasons for the revision?
According to the FSSC, the main reasons for this new revision of the standard were:
– Integrate the requirements of ISO 22003-1:2022;
– Strengthen requirements to support organizations in their contributions for compliance with the UN Sustainable Development Goals (SDGs);
– Incorporate feedback as a result of the Version 6 development survey, which received almost 2,000 responses.
What is the deadline for compliance?
FSSC 22000 Version 6 was published on April 1, 2023, with a one-year deadline for compliance and fulfillment of the requirements. Until March 31, 2024, all certification audits will follow in scope the guidelines of version 5.1.
The period from April 1, 2024 to March 31, 2025 is the transition period, in which all organizations already certified will be audited in the new version 6, ending version 5.1 on March 31, 2025.
In other words, the standard provided 12 months for companies to adapt to the new requirements. However, the sooner you start implementing changes the better, since some of them require proper critical analysis and risk assessment to determine their new structuring effectively.
Changes in the new version
Summarizing the changes in the new FSSC version 6.0, we have:
- Inclusion of five new requirements, namely: Food Safety and Quality Culture, Equipment Management, Quality Control, Communication Requirements, and Food Loss and Waste.
- 11 new topics were included in existing requirements: Supplier Management, Product Labeling, Food Defense, Food Fraud, Logo Use, Management of Allergens, Environmental Monitoring, Transportation and Delivery, Product Design and Development, Requirements for multi-site organization, and Hazard Control and measures to prevent cross-contamination.
- Two requirements are unchanged: Verification of PPRs and Health Status.
The following is an explanation of the most significant changes in the requirements.
Scope
The standard brought some updates in the scope structure considering several aspects such as the number of certificates, detailing, and in its readjustment, regrouping some niches and segments. Some scopes have been added and others deleted, check out the changes below:
- Primary production (category A) of animal and plant products has been removed and replaced by category BIII “Pre-process handling of plant products (BIII), such as packaging of harvested fruits and vegetables”.
- Category C0 “Conversion of animal carcasses intended for further processing” has been included.
- The pet food categories DIIa and DIIb were removed, and pet food was included in the food categories CI to CIV.
- The transport and storage services category has been merged into a G category.
- The category FII brokering activities has been added.
- Description of the categories are more specific and became more precise in general. Foods for special dietary needs and foods for special medical purposes, when legally classified as foods in the country of manufacture, can be included in category C of the food chain. Products legally classified as pharmaceutical or medical products do not fall within the scope of FSSC 22000 certification.
- Category I, Packaging, includes napkins and packaging materials (such as aluminum foil, waxed paper, plastic wrap) used in the food industry. Packaging materials and napkins used in private households are excluded from the scope.
- The combined FSSC 22000 and ISO 9001 process, which has not been referenced by GFSI in the past, is no longer included in the FSSC 22000 Scheme.
Therefore, the new scope of FSSC 22000 version 6.0 can be defined as:
Source: Foundation FSSC
Additional Requirements – Chapter 2.5
Additional requirements are still listed in chapter 2.5 of the standard. Some of them are now more precise and several new topics and aspects have been added.
2.5.1 – Supplier management
In this item there are two new features, the first is a broadening of the specifications. Organizations must now establish and maintain a process to review specifications not only of finished goods, as it was in version 5.1, but also of raw materials.
The second refers only to category I (packaging). It now includes establishing and ensuring criteria for meeting legal and customer requirements for the use of recycled packaging as a raw material input in the production of finished packaging.
2.5.2 – Labeling
Now, there is a new topic in this requirement bringing attention to the fact that any information/claim placed on the packaging must be validated by creating verification routines and controls that demonstrate that this condition is ensured in the process. This requirement is a tie-in to ensure that there is no risk of fraud being applied to a condition of a claim that is stated on a label but cannot be demonstrated in practice.
Therefore, claims such as allergen, nutritional, method of production, chain of custody, and raw material status must be validated in a verifiable manner. Labels or printed materials must be traceable, including mass balance. This is undoubtedly a significant challenge for most certified companies.
For category I (packaging) there is also a new requirement to now have a system for artwork approval and print control, covering changes and management of obsolete artwork and printed materials. The organization needs to have an approval of each print run against the agreed standard or the standard sample. A procedure should also be established to detect and identify printing errors. Unused printed products must be accounted.
2.5.3 Food Defense
Food defense was already a requirement in the previous version. Now, however, it presents the need to document in a traceable way the threat assessment by means of a defined methodology. The food defense plan should be based on the threat assessment and the risk mitigation measures and verification procedures should be specified in the plan.
For the new FII category (Brokering, Trading and E-commerce), there is an additional requirement that companies must ensure that their suppliers have a food defense plan.
2.5.4 – Food Fraud
This item has undergone very similar changes to the food defense item. A defined methodology and documentation of mitigation measures with reference to the vulnerability assessment is now required.
Also, the FII category has included an additional requirement to ensure that their suppliers have a food fraud mitigation plan in place.
Food Fraud and Food Defense: Do you know the difference?
2.5.5 Logo use
The guidelines are similar to the previous version of the standard, only adding that if the company uses the logo, it needs to request the current artwork from the certifying body to ensure correct use. Included within the usage restrictions is the non-use of the FSSC logo in products’ certificates of analysis (COAs) or certificates of conformance.
2.5.6 Management of Allergens
The most extensive changes in this new version of the FSSC have been made in the section on management of allergens. The following requirements have been added:
- The organization must have a list of all allergens handled on site, including raw materials and finished products.
- Information on validation and verification (e.g., surface testing, air sampling, and/or product testing) of control measures to reduce cross-contamination must be documented.
- Precautionary or warning labels on packaging shall only be used when the outcome of the risk assessment actually identifies a risk of cross-contamination with allergens, even if all necessary control measures have been effectively implemented, that is, the new version specifies that the application of warning labels does not exempt an organization from implementing all possible and necessary allergen control measures or performing periodic verification tests.
- All personnel should receive allergen awareness training and specific training on allergen control measures associated with their work areas.
- An annual review of the allergen management plan should be conducted, as well as revisions after significant allergen-related changes, recalls, or withdrawals, and when allergen problems occur in the industry.
- For food chain category D (animal feed and animal food), the section related to allergens may be indicated as “not applicable” under defined conditions.
2.5.7 Environmental Monitoring
Now there is a need for a risk-based environmental monitoring taking into consideration relevant microorganisms, whether they are pathogens, spoilage agents, or indicator organisms, expanding the range within sampling (item applicable only for categories BIII, C, I and K).
For the same categories, a periodic review of the environmental monitoring program is now required for effectiveness and continuous adequacy. It is also mandatory to have documented the program defining the criteria and controls according to legal and/or customer requirements.
2.5.8 – Food safety and quality culture
This requirement is entirely new and of paramount importance. Until now, the FSSC’s position was that the topic of food safety culture was sufficiently included in ISO 22000.
However, to give more attention to the topic in the new version, a completely new chapter has been included in the additional requirements.
For all categories, the standard now requires a quality culture in addition to the already known aspects of Codex Alimentarius and Regulation (EU) 2021/382. As part of the organization’s commitment to cultivating a positive culture, top management should establish, implement, and maintain food safety and quality culture objectives. The aspects to consider in this requirement are communication, training, employee feedback and engagement, and performance measurement.
It explicitly requires organizations to have a documented plan for food safety and quality culture with targets and timelines that show continuous improvement and evaluation in management review.
2.5.9 Quality Control
This is also a new chapter and is one of the big surprises in version 6.0 of FSSC 22000. It requires a systematic quality control procedure, including establishing, implementing, and maintaining quality parameters according to finished product specifications and product release. In addition, analysis and review of the results of the quality control parameters should be conducted and used as input for management review. The quality control procedure should be included in the internal audits.
Quantity control procedures according to legal and customer requirements are also included in this chapter.
An additional item is the need to establish and implement startup and line change procedures. This shall include implementing controls to ensure that labeling and packaging from previous production is removed from the line.
2.5.10 Transportation and Storage
Additional conditions associated with transportation by truck or tanker have been included. Now, the need for effective control, with a risk assessment and detailed controls, must be considered whenever this type of transportation is used.
2.5.11 Control and measures to prevent cross-contamination
For all categories except FII, it is now mandatory to use risk analysis to identify the need for foreign body detection equipment (such as magnets, metal detectors, X-rays, filters, and sieves). A documented procedure must be in place for the management and use of foreign body equipment.
Likewise, it should be documented when the use of this type of equipment is not necessary.
There is also a new mandatory requirement for managing foreign materials and all breakage related to potential contamination (e.g., metal, ceramic, and hard plastic).
2.5.13 Product Design and Development
There were two additional amendments to this requirement, both applicable in categories BIII, C, D, F, I and K. The first amendment establishes an obligation to check the expiration date of products based on risk assessment.
In the second complement, for ready-to-cook products, the cooking instruction provided on the product label or packaging must be validated to ensure food safety.
2.5.15 Equipment Management
Here we have another new chapter applicable to all categories except FII. From now on, to purchase new equipment or parts of it, it is necessary to have documented specification providing details of that equipment including the hygienic finish design conditions and surface characteristics that meet the application or end use.
The supplier must provide evidence that the delivered equipment meets this condition. It is also necessary to do a risk assessment on changes in equipment or structures in the composition of that equipment to ensure that that commissioning has been done properly and that it will not impact the operations.
2.5.16 Food Loss and Waste
Some of the items in this chapter, which is also new, are associated with social and environmental responsibility. Here is the major connection between FSSC 22000 and the UN’s 17 Sustainable Development Goals. One example is the requirement for food loss and waste, which is directly related to goal number 2 of the SDGs – Zero Hunger. Here are the new features that apply to all categories except I:
- The organization’s strategy for reducing food loss and waste in the related supply chain shall be described by means of a policy and documented objectives.
- Food provided to non-profit organizations, employees, and other organizations must be safe. This donation must be controlled, and the products handled according to food safety.
- Organizations must have a management of surplus products or by-products intended for animal feed to prevent contamination of these products.
2.5.17 Communication Requirements
This new section requires that within three days the certification body is informed of events or situations (force majeure, natural or man-made disasters) that affect food safety, legality and/or integrity of certification (e.g., war, strike, terrorism, crime, flood, earthquake, hacker attacks etc.).
Similarly, certification bodies must also be notified within three days in serious situations where the integrity of certification is at risk and/or the FSSC may be undermined (e.g., recalls, withdrawals, disasters, food safety outbreaks), and the certification body must be informed within three days.
This situation also applies to actions imposed by regulatory authorities as a result of food safety issues, where additional monitoring or forced production stoppages are required, such as in case of food safety related lawsuits, legal proceedings, malpractice and negligence, or fraudulent activities and corruption.
Software to help with FSSC 22000 implementation
With so many changes in this new version, it is important that you have technological solutions in your company that help maintain a culture of quality and food safety in the daily routine of your organization and give you confidence in the risk analysis, verification, and documentation during your audits, whether internal or for certifications.
SoftExpert offers the most comprehensive and advanced software solution for food safety management, meeting the needs of the most stringent global regulations. SoftExpert Excellence Suite helps companies adhere to FSSC 22000 by reducing compliance costs, maximizing success, increasing productivity, and reducing risk.
SoftExpert’s solution enables organizations to easily meet the requirements of FSSC 22000. The system assists in the management of food safety hazards, controls, action plans, product description, production process, food safety procedures, non-conformities, performance indicators, among other items. This boosts organizational efficiency, reduces rework and waste. Do you want to learn more about our solution? Request a demo right now!
