Occupational Health, Safety and Regulatory Issues: Guidelines and Regulations
USA
FDA recommends that the safety assessment for cosmetic products using nanomaterials should address several important factors, including:
- the physicochemical characteristics,
- agglomeration and size distribution of nanomaterials under the conditions of toxicity testing and as expected in the final product,
- impurities,
- potential routes of exposure to the nanomaterials,
- potential for aggregation and agglomeration of nanoparticles in the final product,
- dosimetry for in vitro and in vivo toxicology studies, and
- in vitro and in vivo toxicological data on nanomaterial ingredients and their impurities, dermal penetration, potential inhalation, irritation (skin and eye) and sensitization studies, mutagenicity/genotoxicity studies.
The safety of a cosmetic product should be evaluated by analyzing the physicochemical properties and the relevant toxicological endpoints of each ingredient in relation to the expected exposure resulting from the intended use of the finished product. If industries wish to use a nanomaterial in a cosmetic product, either a new material or an altered version of an already marketed ingredient, FDA encourages companies to engage in communication with FDA to discuss the test methods and data needed to substantiate the product’s safety, including short-term toxicity and other long-term toxicity data, as appropriate.
When companies develop a submission for a Food Additive Petition (FAP) for a nanomaterial animal food additive, FDA recommends that you consider the following:
Identy - for a nanomaterial animal food additive must include information which identifies and characterizes the nanomaterial animal food additive.
Manufacturing Methods and Controls -For any animal food additive, it may be important to provide information regarding the presence of byproducts and impurit ies associated with its manufacturing. Toxicity may be associated with byproducts and impurities resulting from the manufacture of a nanomaterial food ingredient.
Intended Use, Use Level, and Labeling
Analytical Methods -Scientifically valid analytical methods that are capable of determining the chemical composition and the amount of the nanomaterial animal food additive contained in various animal food matrices should be used. The analytical methods should correctly identify the nanomaterial animal food ingredient by its relevant physical properties (e.g., 3-dimensional properties such as size and/or shape).
Safety Evaluat ion and Proposed Tolerances for the Food Additive
As with all other food additives, these two sections of an Food Additive Petition (FAP) for nanomaterial animal food additives should contain the scientific data necessary to demonstrate the safety of the nanomaterial animal food additive for humans and target animals under the conditions of intended use.
Environmental Assessment-
The potential adverse environmental impact of a nanomaterial may differ from that of a larger -scaled material with the same chemical composition.