Supply Chain Compliance
According to the FDA FSMA regulations importers are responsible for actions that include:
- Determining known or reasonably foreseeable hazards with each food they import;
- Evaluating the risk posed by a food, based on the hazard analysis, and the foreign supplier’s performance (for every food and every supplier);
- Using that evaluation of the risk posed by an imported food and the supplier’s performance to approve suppliers and determine appropriate supplier verification activities;
- Conducting supplier verification activities;
- Conducting corrective actions.
Importers must establish and follow written procedures to ensure that they import foods only from foreign suppliers approved based on an evaluation of the risk posed by the imported food and the supplier’s performance or, when necessary on a temporary basis, from unapproved suppliers whose foods are subjected to adequate verification activities before being imported.
Importers are required to develop, maintain and follow an FSVP (a Foreign Supplier Verification Programme) for each food brought into the United States and the foreign supplier of that food. If the importer obtains a certain food from a few different suppliers, a separate FSVP would be required for each of those suppliers.
The evaluation of the risk posed by the imported food and the supplier’s performance must be reevaluated at least every three years, or when new information comes to light about a potential hazard or the foreign supplier’s performance.
Importers are not required to evaluate the food and supplier or conduct supplier verification activities if they receive adequate assurances that a subsequent entity in the distribution chain, such as the importer’s customer, is processing the food for food safety in accordance with applicable requirements. Importers must also disclose in documents accompanying the food that the food is not processed to control the identified hazard.
Exporters to the US
If your company exports food to the US, you should very likely meet the FDA FSMA Requirements. FSMA is the new US regulation for preventive control of human and animal food. It is intended to ensure the safe manufacturing, processing, packaging and holding of food products for human and animal consumption in the United States. FSMA gives FDA (the US Food and Drug Administration) a full range of new powers to prevent food safety problems, detect and respond to food safety issues, and improve the safety of imported foods.
As an exporter of food to the US you are supposed to meet the same requirements as US domestic companies.
Lucrima’s team is providing a variety of compliance services that you can integrate to suit your needs in reaching compliance with the new FDA regulations and continue your exports to the US uninterruptedly.
- Learn about the FSMA regulations and what they practically mean to the exporters to the US by reading our FAQs
- Get certified as a Preventive Controls Qualified Individual (PCQI)
- Be provided with the knowledge you need to develop/adapt your food safety management system to meet the new and enhanced FDA requirements.
- Improve your ability to speak the same food safety language as FDA does.
- Will be given insights on what your importers in the US are supposed to do to verify that the products you supply to them meet FDA requirements.
- Take advantage of the knowledge and hands-on experience of our team /link/ who can take you by the hand in solving all your FSMA compliance challenges, be them system implementation, product verification or legal compliance. Contact one of our experts now
- Get ahead of your competitors by taking a proactive approach to meeting the regulation requirements and keeping your customers and importers in the US relaxed and assured about your FSMA compliance.