REGULATORY

Overview of current regulatory status of milk exosomes in Cosmetics

The regulatory status of milk exosomes varies depending on the region (e.g., the United States, the European Union, etc.) and the intended use (e.g., cosmetic products, food products, or pharmaceuticals). There is no unified or specific regulatory framework solely for milk exosomes; however, regulations regarding cosmetics, food ingredients, and biological materials can be applied.

Milk Exosomes in Cosmetics

Milk exosomes are increasingly used in cosmetic formulations, primarily for their potential to enhance skin health, regeneration, and delivery of active ingredients. The regulatory status for cosmetics is governed mainly by:

United States (FDA)

In the U.S., cosmetics are regulated by the Food and Drug Administration (FDA) under the Federal Food, Drug, and Cosmetic Act (FDCA).

Ingredients used in cosmetics must be safe, but they do not require pre-market approval unless they are color additives or intended for a specific medical use (e.g., claims to treat or prevent disease). As a cosmetic ingredient, milk exosomes would fall under the FDA’s general requirement for safety, but they would not need pre-market approval unless they make drug-like claims (e.g., skin treatment or healing). Milk Exosomes are considered to have Generally Recognized as Safe (GRAS) Status.

If milk exosomes are included in cosmetic products (such as moisturisers, serums, or creams), they would be regulated as cosmetics. The FDA does not explicitly regulate exosomes but evaluates the safety of ingredients and products. Manufacturers are responsible for ensuring their products' safety, including using novel ingredients like milk exosomes.

European Union (EU)

The European Commission regulates cosmetics in the EU under Regulation (EC) No 1223/2009.

Similar to the U.S., cosmetics do not require pre-market approval, but they must be proven safe for use. If they are novel, ingredients like milk exosomes must undergo a safety assessment. If classified as novel cosmetic ingredients, they may require a notification or assessment to ensure they comply with safety standards. If milk exosomes are derived from human or animal sources, they must also meet the safety and hygiene standards of the EU’s cosmetic regulations.

Novel Ingredients: If milk exosomes are considered a novel cosmetic ingredient (for example, if they are not commonly used in cosmetics), they might need to be evaluated for their safety and undergo a toxicological assessment before use. The regulatory authorities may require data on the source of exosomes, their manufacturing process, and their potential effects on human skin.

Key Regulatory Considerations for Milk Exosomes

Safety

Regulatory bodies will assess the safety of milk exosomes based on their source, manufacturing process, and intended use. Safety data might include toxicology studies, allergenicity, and biological activity.

Novelty

If milk exosomes are considered novel (not widely used in the market), additional regulatory assessments may be required.

Source and Purity

If exosomes are derived from animals (e.g., cow) or human milk, their source and purity will be considered during safety assessments, especially regarding potential contaminants (e.g., pathogens, residues).

Intended Use

The specific application—whether in cosmetics, food, or pharmaceuticals—determines the applicable regulatory framework, safety standards, and approval processes.

Summary

Milk exosomes are subject to existing regulatory frameworks for cosmetics, but their specific status may depend on the region, intended use, and whether they are considered novel ingredients. Milk Exosomes are currently regulated in the U.S. with GRAS Status, which allows for general use as long as GMP manufacturing is used. While no dedicated regulatory framework for exosomes exists, they would generally be evaluated based on safety, efficacy, and source before being used in consumer products, primarily if they are intended for therapeutic or novel uses. Manufacturers must ensure compliance with relevant safety, efficacy, and labelling standards set by regulatory agencies such as the FDA, EMA, or other national authorities.