The FSMA sets new requirements for exporters


june 2017, Jeroen Sleenhoff

Do you export to the United States? Then you will need to comply with the regulations established by the FDA; FSMA

The FSMA represents the biggest reform of the American food law in the past 70 years. I’ve recently taken a closer look into this and concluded that many companies in the Netherlands and Belgium do not know what these regulations mean to them. According to the FSMA, companies must have a qualified person within their organisation. This qualified person must already be currently properly educated. I’ve noticed that only a limited number of qualified people are actually available in the Netherlands and Belgium. In the meantime, the date of implementation is getting closer. Are you already getting nervous? Then read further.

The Food Safety Modernization Act (FSMA)

Some focus on the background of FSMA. The FSMA was signed under President Obama on 4 January 2011 with the aim of better protecting public health in the United States. All companies that manufacture for and / or export to the United States are obliged to work under this legislation. I have not yet heard that President Trump will reverse this legislation, so I assume it will be passed.

By setting demands on the food safety system, the FDA wants to reduce the number of food incidents. These requirements include Good Manufacturing Practices, Hazard Analysis, and Risk Based Preventive Controls. In addition, the regulation describes that the food safety system (under supervision) must be drawn up and verified by a qualified person: a Preventive Controls Qualified Individual (PCQI).

What does a Preventive Controls Qualified Individual (PCQI) have to do with FSMA?

According to the definitions in the FDA Preventive Controls for Human Food Rule, a PCQI is
a qualified individual who has successfully completed the PCQI certification program.

  • The development or supervision of the preparation for the food safety plan.
  • Validation of preventive controls.
  • Registration controls.
  • Hazard identification and risk analysis of the food safety plan.

Therefore, it’s important to have a qualified person when you export to the United States. In the Netherlands and Belgium, there are only a couple of trainers available, such as KTBA. I recommend having a look at their website. After the training, the PCQI is registered with the FSPCA and receives an approved certificate issued by the Association of Food and Drug Officials of the United States.

Do I need to hurry?

Yes, because the first important date for importers to the U.S., under the Foreign Supplier Verification Programs (FSVP) rule, was May 30, 2017. FSP is one of seven fundamental rule of the FDA’s Food Safety Modernization Act (FSMA). A key principle of this law is that the same preventive food safety standards apply to food in the United States, regardless of where the food is produced. FSVP achieves this by requiring importers to verify that their foreign food and food service providers comply with the FDA’s safety standards.

Other important data:

  • Small businesses (on average less than $ 1 million per year (adjusted for inflation)
    annual sales of human food plus market value of human food
    produced, processed, packed, or held without sales: September 2018
  • Companies covered by the pasteurized milk regulation: September 2018
  • Small and medium-sized enterprises (a company with less than 500 full-time equivalent employees): September 2017
  • All other companies: September 2016

I advise all companies which export to the United States to take action now. This will prevent any unfortunate situations in the future.


Uw naam


Naam ontvanger

E-mail adres ontvanger

Uw bericht