The European Union (EU) recently adopted a regulation requiring food business operators to establish and provide evidence of an appropriate food safety culture and detailing the steps they must take to satisfy this obligation. Food safety culture also is a priority area within the United States, and it is one of the four pillars of the U.S. Food and Drug Administration's (FDA) New Era of Smarter Food Safety. However, there are no FDA regulations or guidance documents defining food safety culture. Although the EU regulation is not enforceable for food sold in the United States, the regulation may be of interest to U.S. food companies because it helps identify what it means to regulators for a food company to have a strong food safety culture and the types of activities that potentially can demonstrate that a company is fostering a strong food safety culture within its business.
On 3 March 2021, the European Commission adopted Commission Regulation (EU) 2021/382, which amends an existing food safety regulation ((EC) No 852/2004). EU 2021/282 adds the following new chapter to EC No 852/2004:
Food Safety Culture
1. Food business operators shall establish, maintain, and provide evidence of an appropriate food safety culture by fulfilling the following requirements:
- commitment of the management, in accordance with point two, and all employees to the safe production and distribution of food;
- leadership towards the production of safe food and to engage all employees in food safety practices;
- awareness of food safety hazards and of the importance of food safety and hygiene by all employees in the business;
- open and clear communication between all employees in the business, within an activity and between consecutive activities, including communication of deviations and expectations;
- availability of sufficient resources to ensure the safe and hygienic handling of food.
2. Management commitment shall include:
- ensuring that roles and responsibilities are clearly communicated within each activity of the food business;
- maintaining the integrity of the food hygiene system when changes are planned and implemented;
- verifying that controls are being performed timely and efficiently and documentation is up to date;
- ensuring that the appropriate training and supervision are in place for personnel;
- ensuring compliance with relevant regulatory requirements;
- encouraging continual improvement of the food safety management system of the business, where appropriate, taking into account developments in science, technology and best practices.
3. The implementation of the food safety culture shall take account of the nature and size of the food business.
Next steps
FDA Deputy Commissioner for Food Policy and Response Frank Yiannas has long identified food safety culture as a priority, and he tweeted about the new regulation, calling it a “[s]ignificant milestone.” We expect the FDA’s attention to food safety culture will continue to increase as the agency works toward the goals set out in the New Era of Smarter Food Safety. Accordingly, the EU’s new regulation may be a useful resource to those companies interested in evaluating or improving their food safety culture because it is the first authoritative source that aims at defining the key elements.
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