1) GRAS
In the United States (U.S.), food ingredients are considered either as a food additive or are Generally Recognized as Safe (GRAS) for specific uses.
For the determination of the GRAS status of uses of a food ingredient, both technical evidence of safety ("technical element") and a basis to conclude that such evidence is generally known and accepted ("common knowledge element") are required. This evidence must be evaluated by independent scientists, qualified by their relevant experience and scientific training to assess the safety of food ingredients (an expert panel).
GRAS services include:
Conducting feasibility assessments and assisting with the development of a successful regulatory strategy
Conducting literature searches and data gathering
Identifying technical and scientific data gaps and recommending solutions
GRAS dossier preparation for expert panel review
Coordinating and facilitating expert panel review
Preparing GRAS notification submissions to FDA
2) Food Scientific and Regulatory Consulting
Whether it is a food ingredient, a nutritional supplement, or a natural health product, our scientists can help navigate the scientific and regulatory requirements that meet targeted markets. We prepare high quality submissions that ensure successful review within international jurisdictions. These include:
a) Supplement Services
The regulation of supplement products varies from one country to another. Some jurisdictions consider the products as foods and others consider them as drugs. As a result, the application of the supplements should change in many areas like, permitted types of health claims, permitted dosage format, pre-market approval, licenses for the finished product, and good manufacturing practices (GMP).
ACC will help you to prepare supplement petitions and notifications for submission to regulatory authorities in:
United States
China
Australia/New Zealand
Supplement services include:
Conducting feasibility assessments;
Providing safety, efficacy, and quality recommendations to meet regulatory requirements;
Providing product development support;
Submitting technical reports to regulatory authorities;
Acting as a liaison with regulatory authorities.
New Dietary Ingredient (NDI) notifications (U.S.)
Novel Ingredient Foods (China)
b) Novel Food Ingredient Services
Foods or food ingredients that do not have a history of use within the community are considered as novel foods. China has its own novel food ingredient regulation. ACC offers the regulatory and scientific expertise necessary to provide reliable advice on China and US novel food ingredient regulation. These include:
Assessing classification and scope
Conducting feasibility assessments to determine whether sufficient data are available to support a novel food application
Identify information gaps and providing recommendations for more data
Preparing and submitting novel food applications
3) Food Labeling Consulting Services
Food label provides basic product information, as well as nutrition and safety information of the products. Regulatory authorities define the policies and standards to protect consumers against false or misleading representation on food labels. All food products that are offered on a market have to comply with the respective regulation. ACC can undertake food label consulting services:
· Checking labeling for China and US markets; reviewing regulatory requirements of existing label;
· Providing knowledge of the food law and labeling requirements for US and China, including specific regulations on organic products, baby-food, dietary products, etc.;
· Defining product specifications: elaboration and revision;
· Support new label claim using local language.
