Your one-stop CRO for assessment of food additives
Safety assessment of food additives, novel foods and food ingredients is an obligation in all marketing authorization applications. It requires particular understanding of potential toxicological properties, attention to palatability issues and detailed knowledge of regulatory compliance.
CiToxLAB can evaluate the physiological impact after administration of your food additives, novel foods and food ingredients for all aspects of toxicity.
The European Food Safety Authority (EFSA) has published their recommendations on the genotoxicity testing strategy best suited to food. They haved indicated in a first tier that Ames and in vitro micronucleus tests should be performed. Then, if the results are not clear, further in vitro tests should be performed, such as a mouse lymphoma or an in vitro chromosome aberrations test. If positive results are obtained for a food additive, novel food or food ingredient, one or more in vivo tests are required, starting with the rat or mouse micronucleus test.
Our scientists offer you the best testing strategy for your food additive, novel food or food ingredient.
Ames test (OECD 471)
- Detection of mutagens
- Salmonella and E. coli
In vitro micronucleus test (OECD 487)
- Detection of chromosome and genome damage
- L5178Y cell and human lymphocytes
In vitro chromosome aberrations test (OECD 473)
- Detection of chromosome damage
- Human lymphocytes
In vitro mouse lymphoma assay (OECD 476)
- Detection of mutagens and chromosome damage
- L5178Y TK
In vivo micronucleus test (OECD 474)
- Rat or mouse
Repeat dose toxicology
We offer sub-chronic and chronic toxicity studies for your food additives, novel foods and food ingredients, in order to meet international guidelines for safety evaluation within the scope of marketing authorization applications.
Known or anticipated human exposure to the food additive, novel food or food ingredient, along with the intended target population, is taken into account. Palatability is also an important factor for food additives intended for human consumption, and full palatability testing is also available.
Sub-chronic and chronic toxicity studies for food additives, novel foods and food ingredients include :
- OECD 408: Repeat dose 90-day oral toxicity study in rodents
- OECD 409: Repeat dose 90-day oral toxicity study in non-rodents
- OECD 452: Chronic toxicity studies
High level scientific expertise and dedicated resources are key factors in the evaluation of potential food related effects on fertility, reproduction and pre/post-natal development.
Your products are unique, so the objective of our teams is to provide you with an ideal package for exploring the potential toxicity of your food additives, novel foods and food ingredients, according to the highest standards and the latest methods.
Studies for additives, ingredients and novel foods include :
- OECD 415: One generation reproduction toxicity
- OECD416: Two generation reproduction toxicity
- OECD 421: Reproductive/Developmental toxicity screening
Investigative combinations can include :
- Hormone determination
- Sperm analysis
- Developmental immunotoxicology
For food additives, novel foods and food ingredients, safety evaluation often relies on existing toxicology data, but when the concern level is high (Level III: cumulative exposure exceeding 1 ppm), carcinogenicity studies (diet/drinking water/gavage) using two rodent species, usually rats and mice, are mandatory and generally combined with chronic toxicity studies and an in utero exposure bioassay.
CiToxLAB proposes safety evaluation of your food additives, novel foods and food ingredients in agreement with the European Food Safety Authority (EFSA) approach and OECD guidelines. For your food additives to be marketed in the USA, FDA recommendations for direct/indirect food additive toxicology safety studies are followed.
The main currently followed carcinogenicity study guidelines for food are :
- OECD n°453 – Combined chronic toxicity/carcinogenicity studies (combined OECD 452 and 451)
- OECD n° 451 – Carcinogenicity studies
- Red Book, 2000, chapter IV.C.6
According to the intended area where the food additive, novel food or food ingredient is to be marketed, our experts can advise you on current world wide guidelines and requirements for safety evaluation.
Toxicokinetic and ADME studies provide data on absorption, distribution, metabolism and elimination of test substances.
The quantitative data obtained in toxicokinetic and ADME studies are taken into consideration for the safety assessment of food additives, novel foods and food ingredients to identify target organs for potential accumulation and toxicity.
The design of toxicokinetic and ADME studies is adapted according to the particular food additive, novel food or food ingredient being tested.
- Determination of toxicokinetic parameters
- ADME study (guideline OECD 417)
- Bioavailability study