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FSMA: does your Company already meet requirements?

The Food Safety Modernisation Act (FSMA), a law signed in January 2011, authorises the US Food and Drug Administration (FDA) to adopt a preventative approach to food safety. This new approach includes the authority to determine the food safety requirements for agriculture companies, and to set new requirements for companies that process food.

In September 2015, the FDA finalised the definite version of the preventive controls rule 1, which regulates food processing activities, also called “facilities”. In November 2015, the FDA finalised the Produce Safety Rule in which standards for food safety were set up for agriculture companies.

These two rules are part of the seven big rules which cover the entire supply chain. In short, “farm to fork”. However, not all companies are subject to the new regulations; some will be exempted from the requirements, and some may qualify for adapted requirements. Contact the Mérieux Nutrisciences to see if this applies to your company.

Who does the new legislation apply to?

It’s important for companies to know what changes the new laws and regulations entail. The new law applies to the entire chain, including manufacturers, packers, storage locations and distributors. All links in the chain are required to establish a so-called Food Safety Plan that specifies which steps or controls have been carried out to prevent or limit risks. The FSMA sets new requirements here, including a written food safety plan, risk analysis, preventive control measures, monitoring and corrective measures.


The new legislation presents a challenge to all parties in the chain. We have highlighted the most important obstacles for you here.

Challenge # 1: Lack of knowledge

We believe the biggest obstacle for compliance to the FSMA is a lack of knowledge regarding what these new laws in practice actually mean. Many companies are not informed about the details of the new regulations. Even when these details are known, it is often not clear what it means in practice.

Challenge # 2: Lack of management commitment

Challenge # 2: Lack of management commitment
The changed FSMA demands commitment from the entire organisation, including management. During the implementation phase, management support and participation is particularly important to ensure a successful execution of the new regulations.

Mérieux Nutrisciences believe that this is the most important part of the puzzle: “A company must begin with a commitment from top management to make food safety part of its mission statement. Without this support, the implementation of the FSMA and the adaptation of the HACCP plan will never succeed”.

Challenge # 3: The lack of an adequate HACCP plan

FSMA calls for a shift from a reactive HACCP plan (Hazard Analysis Critical Control Points) to a proactive HARPC (Hazard Analysis and Risk Based Preventive Controls). An HACCP plan on its own is not enough. Companies that already have this are on the right track. However, many small and medium-sized companies do not have an adequate HACCP plan. For them, there’s still work to be done.

Challenge # 4: A lack of resources

Depending on the current state of your HACCP plan, GFSI and other food safety standards, FSMA implementation can be a large, time-consuming process. In addition, FSMA implementation requires financial, technical and practical resources that many small and medium-sized companies do not often have.

Challenge # 5: Lack of training

Training is closely linked to all the other challenges in this list. The preventive control rule also requires that companies must have at least one Preventive Controls Qualified Individual (PCQI). A PCQI is someone who has completed the necessary training required in your sector to design or adapt the food safety plan and is also able to implement it.

All employees responsible for the implementation of the FSMA must at least receive training from a recognised qualified PCQI. Mérieux Nutrisciences employs trainers and consultants who can ensure your organisation is brought up to the right level of knowledge. For example, you can opt for group training, which can also be held at your company location. When you work together with KTBA, you can be sure that the new FSMA legislation will be implemented in the correct way.


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Mérieux Nutrisciences wijst u graag de weg door dit doolhof. Experts Esther Baan (Consultant en PCQI-trainer) en Britt van Mensvoort (Labelling specialist) nemen mee in het Amerikaanse exportproces.