EFSA Issues Guidance for Demonstrating Food Additive Safety
The European Food Safety Authority (EFSA) has issued new guidance for the submission of food additive applications that reflects recent scientific advances as well as “the latest risk assessment principles.” Developed by EFSA’s Panel on Food Additives and Nutrient Sources Added to Food, the new data submission guidelines aim to streamline the testing process while still generating “the data necessary to demonstrate the high level of consumer safety required.” Food companies seeking market authorization from the European Commission must provide EFSA with “the necessary information and data supporting the safety of the food additive.”
In particular, the guidance introduces “a new tiered approach for the risk assessment of food additives” that will assist applicants with their toxicological testing strategy. Under the new guidance, Tier 1 tests must meet “a minimal dataset applicable to all compounds,” while Tier 2 testing “will be required for compounds which are absorbed, demonstrate toxicity or genotoxicity in Tier 1 tests, in order to generate more extensive data.” According to EFSA, Tier 3 testing “should be performed on a case-by-case basis taking into consideration all the available data, to elucidate specific endpoints needing further investigation of findings in Tier 2 tests.” To these ends, the new approach focuses on the following core areas: “toxicokinetics, genotoxicity, toxicity (encompassing subchronic toxicity, chronic toxicity and carcinogenicity), and reproductive and developmental toxicity.”
“The intention is that in developing their dossier, applicants will be able to
more readily identify relevant data needs, which will allow adequate assessment
of risks to humans from the intended use, whilst strengthening the
scientific basis for the assessment,” states the new guidance. To assist with
these efforts, EFSA has also announced a forthcoming exposure assessment
tool that will support “the calculation by the applicant of estimates of exposure
to the food additive and its by-products and harmonize the submission
of the related data.” After a public consultation, the agency plans to finalize
the new guidance and post the exposure assessment tool on its website by
the end of September 2012. See EFSA News Story, July 18, 2012.
