Cell-cultivated products: classification and HACCP principles

This guidance outlines how producers of cell-cultivated products can create and adhere to a HACCP plan. HACCP plans, as well as being a legal requirement, are the cornerstone of the food safety management system in all food production premises. HACCP plans ensure all hazards and risks are identified and mitigated throughout the entire production process and the final product is safe for human consumption. 

Food must not be placed on the market if it is unsafe (Article 14 of Regulation (EC) No 178/2002). This means that it is neither injurious to health nor unfit for human consumption. To ensure this happens, Article 5 of Regulation (EC) 852/2004 requires food business operators to put in place, implement and maintain permanent procedures based on HACCP principles. As cell-cultivated products are food, the above legal requirement applies to the producers of these products.

To produce safe food for consumers, all safety hazards associated with the production of a food must be prevented, eliminated or reduced to acceptable levels.

Please refer to our HACCP guide published on the FSA website for general information, as well as access to the MyHACCP tool.

Please note – both “cell-cultivated products” and “critical control points” can be shortened to “CCPs”. For the avoidance of doubt, throughout this document this acronym will not be used. 

The HACCP principles provide a systematic way of identifying food safety hazards, making sure that they are being managed responsibly and showing that this is being done continuously.

The seven HACCP principles are:

1. Identify any hazards that must be prevented, eliminated, or reduced to acceptable levels.
2. Identify the critical control points at the step or steps at which control is essential to prevent or eliminate a hazard or to reduce it to acceptable levels.
3. Establish critical limits at critical control points which separate acceptability from unacceptability for the prevention, elimination or reduction of identified hazards.
4. Establish and implement effective monitoring procedures at critical control points.
5. Establish corrective actions when monitoring indicates that a critical control point is not under control.
6. Establish procedures, which shall be carried out regularly, to verify that the above measures are working effectively.
7. Establish documents and records commensurate with the nature and size of the food business to demonstrate the effective application of the above measures.

It is vital that food business operators, including those producing cell-cultivated products, have reliable hygiene procedures in place before starting to apply HACCP principles. Management of food safety is achieved by a combination of good hygiene practices (also called prerequisites) and operational procedures based on HACCP principles. HACCP-based procedures for controlling hazards throughout food production will not be effective unless good hygiene practices are also being followed. Good hygiene practices are set out in Regulation (EC) 852/2004.

As mentioned above, another important piece that needs to be implemented, that also sets the basis for the HACCP-based procedures, are the prerequisites. These are systems that are in place to control more common hazards. They may include areas of control such as cleaning, maintenance, personal hygiene, pest control and waste management. Some other key areas of control such as microbiological markers and temperature control might also fall under the prerequisites, even if they are also involved in control points or critical control points. These must be appropriately documented and follow the same rules as the rest of the HACCP-based procedures and records.