FSSC 22000 (Food Safety System Certification 22000) is a globally recognized food safety and quality management scheme for food companies integrating the requirements of ISO 22000. The Scheme provides a certification model that can be used in the food manufacturing industry and the related supply chain to ensure the production of safe food. The latest version of the FSSC 22000 – Version 6, has introduced new requirements for equipment management.
The good news is that food businesses that purchase equipment that carry the HACCP International logo will more easily comply with the latest version of FSSC 22000. But how?
Firstly, what are the new requirements?
The new requirements mandate that food businesses consider hygienic design features when purchasing new equipment, as well as implementing systems and procedures to assess the associated risks of installing new equipment or changes to existing equipment.
Requirements to be audited as part of FSSC 22000 – Version 6[1]
the organisation shall:
- a) Have a documented purchase specification in place, which addresses the hygienic design applicable legal and customer requirements, and the intended use of the equipment, including the product handled. The supplier shall provide evidence of meeting the purchase specification prior to installation.
- b) Establish and implement a risk-based change management process for new equipment and/or any changes to existing equipment, which shall be adequately documented, including evidence of successful commissioning. Possible effects on existing systems shall be assessed, and adequate control measures determined and implemented.
Secondly, why have the requirements been updated?
Fundamentally, to minimize the risk of microbiological, chemical, and physical contamination of food by ensuring that the equipment being used to manufacture food complies with the principles of hygienic design.
The principles of hygienic design play a crucial role in ensuring the safety of food. Principles of hygienic design as defined by EHEDG, The European Hygienic Engineering and Design Group[2] include:
- Accessibility – All parts of equipment should be easily accessible for cleaning, maintenance, and inspection. The design should contain no dead areas, hollows, poor quality welds cracks or crevices that cannot easily be accessed for cleaning and sanitation. Areas that cannot be accessed for cleaning could potentially harbour, dirt, grime, food debris, microbial growth or even provide an area for the development of biofilms.
- Cleanability – The equipment should be easy to clean. The equipment’s materials of composition must be durable and able to withstand cleaning and sanitising procedures.
- Drainability – The equipment should be designed to drain effectively so no water pooling occurs that could harbour microbiological growth.
- Material Compatibility – The materials of composition must withstand or be compatible with the purpose the equipment is intended.
- Segregation – The equipment is designed so that no cross contamination can occur when the equipment is used as intended.
- Surface and Geometry – The surface of the equipment should be smooth, cleanable, impervious and corrosion resistant. If the surface has a coating it must be durable enough that it won’t chip and become a potential physical contamination risk to food safety. Internal corners should not be sharp and should have a minimum smoothly curving radius of 5mm. The design should have no dead areas, niches or crevices, or ingress opportunities.
Finally, how can HACCP International help food businesses comply with the latest version of FSSC 22000 -version 6?
- A supplier of equipment can confirm compliance to hygienic design principles by obtaining HACCP International Product Certification.
HACCP International operates a certification scheme for equipment, materials and services used by the food industry. Certification is offered to suppliers of equipment or materials that make a contribution to food safety and can be used by the food industry without risking the safety of food or the integrity of a food facility’s HACCP-based food safety management system. HACCP International evaluation of equipment to be used in a food facility assesses that the design of the equipment follows hygienic design principles.
- Food businesses can use the HACCP International Certification as part of the Purchase Specification that is now required for each piece of equipment purchased.
The purchase specification must include:
- Details of the hygienic design principles specific to the equipment being purchased
The hygienic design principles required to achieve HACCP International Certification align with leading recognised standards and guidelines including: ISO 14159:2008, EN1672-2: 2020, GFSI 2020 hygienic design benchmarking requirements and EHEDG hygienic design guidelines.
- Food businesses can use HACCP International Certification as part of the hygienic design risk assessment for food safety hazards on new equipment.
Every product submitted for evaluation for the purposes of HACCP International certification is assessed using a risk-based hazard analysis based on the principles of HACCP as described in the Codex Alimentarius of the World Health Organisation.
The hazard analysis includes:
- Intended use of the equipment including what food product the equipment is in contact with.
- The identification of any food safety hazards (biological, physical and chemical) if the equipment is used as intended.
- A final risk assessment evaluating the severity and likelihood of each identified hazard and the impact on food safety.
The HACCP International evaluation (risk-based hazard analysis) report can be used as part of the hygienic design risk assessment that businesses now require to comply with FSSC 22000.
Summary
HACCP International’s certification mark confirms the ability that certified equipment supports the integrity and safety of food as demanded by industry expectations, legislation, GSFI (Global Food Safety Initiative) endorsed standards and hygienic design principles recognised by FSSC 22000 and EHEDG. Choosing equipment that has HACCP International certification will make complying to the new requirements of FSSC 22000 much easier.
[1] FSSC 22000 Guidance Document: Equipment Management Version 1 September 2023 – 2.5.15 EQUIPMENT MANAGEMENT (ALLFOOD CHAIN CATEGORIES, EXCLUDING Fll) https://www.fssc.com/wp-content/uploads/2023/03/FSSC-22000-V6-Guidance-Document-Equipment-Management.pdf
[2] EHEDG Guidelines – Doc 8- Hygienic Design Principles, Third Edition, March 2018. https://www.ehedg.org/guidelines-working-groups/guidelines/guidelines/detail/guidelines/guidelines/detail/hygienic-design-principles

Juliana Elliott
Technical Manager, HACCP International