The new Version 5 of FSSC 22000 was published 28 May 2019. It is freely available electronically at https://www.fssc22000.com/scheme/scheme-documents/. Part II of the FSSC 22000 Scheme Version 5 documentation describes certification requirements for organisations.
Summary of Changes
The main reasons for the new version are to ensure its compatibility with ISO 22000:2018, compliance with the Global Food Safety Initiative (GFSI) benchmarking requirements and to resolve some issues raised with the previous version (Version 4.1).
Most of the changes are in the certification body’s management of the certification process but there are some important changes for clients as described below.
What are the Changes?
- Management of Services – organizations are to ensure that external laboratories used for food safety analysis use validated test methods (ie accreditation to international Standards such as ISO 17025).
- Product Labelling – organizations are to ensure that finished products are labelled according to all applicable food safety (including allergens) statutory and regulatory requirements in the country of intended sale.
- Food Defence – a Food Defence Plan is required based on a threat assessment to identify and assess potential threats, and implement mitigation measures for significant threats.
- Food Fraud Mitigation – a Food Fraud Mitigation Plan (also known as a Food Fraud Vulnerability Plan) is required based on a vulnerability assessment to identify and assess potential vulnerabilities, and implement mitigation measures for significant vulnerabilities.
- FSSC Logo – the FSSC logo may only be used for marketing activities such as printed matter, website and promotional material. It must be coloured Green (PMS 348U) or Grey (60% black) but use of the logo in black and white is permitted when all other text and images are in black and white. Certified organisations are not allowed to use the logo, any statement or make reference to its certified status on a product, its labelling or packaging or any other manner that implies FSSC 22000 approves a product, process or service.
- Allergens – an Allergen Management Plan is required based on a risk assessment of potential allergen cross contamination.
- Environmental Monitoring – an Environmental Monitoring Program is required based on a risk assessment of potential contamination from the manufacturing environment, including as a minimum the evaluation of microbiological and allergen controls.
- Formulation of Products – feed and pet food manufacturers are to have procedures managing the use of ingredients that contain nutrients that can have adverse animal health impact.
- Transport & Delivery – retailers and wholesalers must ensure product is transported and delivered under conditions which minimise the potential for contamination.
- Scope of Certification – claims are not allowed in scope statements (eg allergen free, organic, etc).
- Minor Nonconformities – evidence of the immediate correction and a corrective action plan is to be provided within 30 days for TQCSI clients.
- Major Nonconformance – a Follow-Up Audit is required within 28 calendar days of the Exit Meeting.
- Critical Nonconformities – immediate suspension and a Follow-Up Audit is required between 6 weeks and 6 months of the Exit Meeting.
Transition of Certification to New Version
TQCSI’s rules for transitioning certification to the new Version are as follows:
• Clients may apply for certification to Version 4.1 as long as the respective audit is completed in 2019.
• Clients must be audited to the new Version from 1 January 2020.
• All audits to the new Version in 2020 will be announced.
• There is no additional audit duration required for upgrading from Version 4.1 to Version 5.
• A new certificate will be issued for successfully upgrading to Version 5.
• All clients must be audited and certified to Version 5 by 31 December 2020.
• The client’s original expiry of certification date will not change (eg upgrading to Version 5 may be achieved at a Surveillance Audit but the next Triennial Audit will remain as scheduled).
All FSSC 22000 auditors will need to undergo an approved ‘ISO 22000:2018 Transition Course’ and ‘FSSC 22000 Version 5’ training. They will then need to successfully complete respective competency examinations before they are approved to audit against Version 5. Auditors also need to requalify for their approved food chain sub-categories before 1 June 2020 and complete a GFSI examination before 1 July 2022.
Version 5 makes what was a prescriptive Scheme even more prescriptive and difficult. Organisations will need to think smart in order to implement processes ensuring compliance while not burdening already stretched resources.