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ToggleDuring the process of registering cosmetics in Vietnam, a common misconception is that natural-origin cosmetic ingredients are exempt from declaration in the dossier submitted to the Drug Administration of Vietnam. This understanding easily puts businesses at risk when preparing dossiers, especially in the context of current regulations requiring complete transparency of all ingredients, regardless of origin.
This article clarifies the classification of ingredients according to TCVN 12972-1:2020 (ISO 16128-1:2016) and the mandatory requirements when registering cosmetics in Vietnam, helping businesses avoid errors from the dossier preparation stage.
In reality, when preparing applications, many companies assume that “natural” is synonymous with safe and therefore don’t need to declare details. This understanding stems more from a marketing perspective than from legal regulations.
In cosmetic management, the crucial factor is not the origin of the ingredients, but whether those ingredients are actually used in the product. Therefore, whether extracted from plants, minerals, or animals, all must appear in the ingredient list when submitting the application.
Omitting information can lead to requests for revisions, delays in processing, or rejection, directly impacting plans to bring the product to market.
According to TCVN 12972-1:2020, an ingredient is considered naturally derived when it originates from plants, animals, microorganisms, or minerals and is produced by physical or biological methods such as pressing, extraction, distillation, or fermentation.
The key point of this definition is the degree of intervention in the chemical structure. If the raw material is chemically modified or is derived from petroleum, it is no longer considered natural, even if it initially originated from natural resources.
This regulation helps to standardize the understanding between businesses and regulatory agencies when evaluating ingredients in products.
In cosmetic production, many familiar ingredients are still classified as natural if they meet the correct technical requirements.
Plant extracts such as aloe vera, algae, and mushrooms are often accepted if they undergo only mechanical or physical processing. Minerals such as clay, mica, and zinc oxide also belong to this group. Some ingredients of animal origin, such as beeswax or lanolin, along with products from microbial fermentation, are also considered natural when appropriate.
Factors such as color, scent, or sensory characteristics do not determine classification. In some special cases, ingredients from genetically modified organisms may still be accepted if they meet the prescribed production conditions.
Besides the natural group, the standard also addresses the “naturally derived” group. These are ingredients that originate from nature but have undergone a controlled transformation process.
These ingredients can be created through chemical reactions, enzymes, or fermentation. However, to be classified in this group, the proportion of naturally derived ingredients must be above 50% by molecular weight or renewable carbon.
Some common examples include cocamidopropyl betaine from coconut oil, sodium lauroyl glutamate from plant-based fatty acids, or ester derivatives from glycerin. Although no longer in their original state, these ingredients are still widely used in cosmetics due to their stability and biodegradability.
According to current regulations, there are no exceptions to declaring ingredients in cosmetic product registration dossiers, even if they are natural ingredients.
All ingredients used in the product must be listed according to INCI nomenclature in the dossier submitted to the Drug Administration of Vietnam. This serves as the basis for the regulatory agency to assess safety levels and compare them with common standards in the ASEAN region.
In some specific cases, such as fragrances or secret formulas, businesses may use general names like “Fragrance” or “Parfum.” However, when requested by the regulatory agency, the company must still provide detailed information for inspection purposes.
Incomplete or incorrect declarations may result in the dossier being returned or not approved for circulation.
In the process of registering cosmetics in Vietnam, all ingredients of natural origin must be fully declared, without exception. Understanding the regulations correctly not only ensures a valid application from the outset but also avoids legal risks during product distribution.
Green NRJ supports businesses from ingredient classification and TCVN/ISO standard consulting to completing cosmetic registration dossiers in accordance with the regulations of the Vietnam Drug Administration. If you are preparing to launch a product in the Vietnamese market, Green NRJ can partner with you to ensure the registration process is accurate, efficient, and minimizes errors.