Food Contact / Food Packaging
Experien Health Sciences has the scientific and regulatory expertise to help clients comply with global regulations pertaining to food contact / food packaging substances and materials. While help from an expensive law firm may be tempting, we can do much of the same work at a fraction of the cost and often more quickly and that translates to a competitive advantage for you. Our team includes industry veterans with degrees in chemical engineering, toxicology, and chemistry and with the practical experience needed to help you navigate this complex and specialized regulatory area. We have the expertise to:
- Evaluate food contact materials/substances for use under and compliance with U.S. FDA, Canadian HPFB, EU EFSA, China NHFPC, Central and South America (e.g. MERCOSUR), and other standards / regulations.
- Determine if substances can be marketed as food contact substances without a notification because of an exemption, coverage under an existing regulation/standard, or a determination as Generally Recognized as Safe (GRAS) and provide written confirmation of a substance’s status under these regulations.
- Prepare FDA Food Contact Notifications (FCNs), either in an advisory or oversight capacity, or as your lead technical resource, for pre-submission conferences with FDA, for acquiring (through third-party laboratories) the required chemistry, toxicology, and environmental data and information, and for preparing all parts of the notification package to submit to FDA. This includes securing the appropriate migration test data and translating the results of that testing into estimated daily intake (EDI) values to include with your food contact notification(s).
- Prepare and/or Obtain FDA Letters of Guarantee that provide the end-user with the necessary assurances that a specific food contact / food packaging material complies with FDA regulations.
- Prepare and/or Obtain EU Declarations of Compliance that provide the end-user with the necessary assurances that a specific food contact / food packaging material complies with EU EFSA regulations.
- Provide Division 23 / Health Canada Compliance Assistance, including obtaining Letters of No Objection (LONOs) and preparing or obtaining certification statements that a specific food contact / food packaging material complies with Canada’s Food and Drug regulations.
- Navigate the requirements for substances/materials which fall under the jurisdiction of multiple agencies (e.g., bacteriostatic additives for use in food contact materials).
- Prepare FDA Drug Master Files to maintain confidentiality of proprietary drug packaging substances / materials.
- Provide Training of staff members on various aspects of food contact / food packaging regulations.
- Assist with Completing Customer Questionnaires pertaining to food contact substances / materials and regulatory compliance.
- Determine if substances can be marketed as food contact substances without a notification because of an exemption, coverage under an existing regulation/standard, or a determination as Generally Recognized as Safe (GRAS) and provide written confirmation of a substance’s status under these regulations.
- Assist with securing appropriate migration testing of your food contact substance / material with qualified laboratories and translate the results of that testing into estimated daily intake (EDI) values to include with your food contact notification(s).
- Assist with securing the necessary toxicological data to support your food contact notification(s), whether through testing using qualified laboratories or by negotiating for permission to use existing data owned by other companies.
United States/Canada (281) 812-6667
Europe (+44) 1845-525637
