Product Safety & Regulatory Support

Foods & Food Ingredients

ENVIRON provides strategic, regulatory, and scientific support necessary to gain regulatory approvals and successfully market a wide variety of food-related products. In addition to the traditional petition process, we work with clients to utilize new regulatory strategies, all with an eye toward achieving international approvals and effective market penetration.

ENVIRON's scientific credentials and experience serve clients well in successfully establishing regulatory strategies in all jurisdictions where legislation is in place regarding products like novel foods, food additives, food ingredients, flavorings, food supplements, food contact materials, and foods for particular nutritional use. Our nutritionists and food scientists also support clients on issues including intake estimates of proposed new ingredients, nutritional evaluation of bioengineered food crops, and intake determinations of botanical ingredients.

We work with clients to develop a step-by-step global regulatory strategy and provide technical and strategic support along the way, including:

• preparation and submission of GRAS Exemption Notifications (GRN) to the US Food and Drug Administration on behalf of clients.
• preparation of expert reports on safety and toxicological issues.
• toxicological safety evaluations and risk assessment (environmental or occupational exposure, impact on ecosystems, consumer safety).
• selection of scientific experts and testing facilities, formation of scientific expert panels, formation and management of multidisciplinary teams.
• placing and monitoring of laboratory studies.
• conducting critical literature reviews.
• help in identifying health and label claims.
• designing and realizing GCP field studies to support functional and health claims of functional foods and nutraceuticals.
• feasibility analysis prior to dossier preparation.
• preparation of dossiers for registration or notification (e.g. novel foods, food additives, flavorings, diet foods).
• representation before regulatory authorities.