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International Standard for Addition Limits of Butanone in Cosmetics?

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Analysis of International Standard of Addition Limit of Butanone in Cosmetics

in the cosmetics industry, butanone, as a commonly used chemical ingredient, is widely used in a variety of products due to its unique properties. Due to the toxicity and potential risks of butanone, countries and international organizations have strict restrictions on the amount of butanone added in cosmetics. This article will analyze the application of butanone in cosmetics and its international standards in detail from the aspects of the function of butanone, the addition of limit standards, the formulation of considerations and compliance recommendations.

1. Butanone in cosmetics function and role

Methyl Ethyl Ketone (MEK) is a colorless, flammable organic compound with strong volatility and solubility. In cosmetics, butanone is mainly used as a solvent, dispersant and preservative. It can help dissolve fragrance oil (perfume oil), color and other insoluble ingredients, thereby improving the stability and use effect of the product. Butanone also has a certain bactericidal effect, can extend the shelf life of cosmetics.

The high volatility and flammability of butanone also pose a safety hazard. High concentrations of butanone may irritate the skin and mucous membranes and even have effects on the central nervous system. Therefore, national regulations strictly limit the amount of butanone added in cosmetics.

2. Butanone in cosmetics in the addition of limited international standards

At present, the world's major markets have a clear limit standard for the amount of butanone added in cosmetics. The following are the relevant regulations for several major regions:

  • European Union (EU): According to the "Cosmetics Regulations" (Cosmetics Regulation (EC) No 1223/2009), the maximum amount of butanone added in cosmetics is 2% (by weight). This standard applies to all types of cosmetics, including perfumes, lotions, creams and shampoos.

  • United States (FDA): The U.S. Food and Drug Administration (FDA) has not set strict limits on the amount of butanone added in cosmetics. Butanone still needs to meet the requirements of the Cosmetic Ingredient Dictionary (Cosmetic Ingredient Dictionary, CIC) for safety assessment and to indicate its ingredients on the product label.

  • China: According to the "Cosmetic Safety Technical Specification", China stipulates that the maximum amount of butanone in cosmetics is 1% (by weight). This standard applies to all domestic and imported cosmetics.

  • Japan: Japan's Ministry of Health, Labor and Welfare (MHLW) stipulates that the amount of butanone added in cosmetics should not exceed 2% (by weight).

It is important to note that these standards may be updated with scientific research and technological advances. Therefore, cosmetics manufacturers should pay close attention to changes in relevant regulations to ensure that their products meet the latest requirements.

3. Butanone addition limit standard development considerations

Countries in the development of methyl ethyl ketone to add limit standards, mainly based on the following factors:

  • Toxicological data: Evaluate the effects of butanone on human health through acute and chronic toxicity studies. Scientific studies have shown that butanone may cause damage to human health at high concentrations, especially in the case of long-term exposure.

  • Product Type: Different types of cosmetics may contain different concentrations of ingredients. For example, perfumes and nail polish, because of their high volatility, usually allow higher additions of butanone, while emulsions and creams require strict control of the butanone content.

  • Residues and usage: Taking into account the residues and actual exposure of butanone during use, countries have scientifically evaluated the limits of butanone to ensure that its risks to human health are minimized.

4. Butanone added limited compliance recommendations

To ensure the safety and compliance of cosmetic products, manufacturers should take the following measures:

  • Raw material testing: When purchasing raw materials such as butanone, ensure that their purity and content meet relevant standards. Safety data should be requested for raw materials to assess their potential risks.

  • Formulation design optimization: In cosmetic formulation design, the amount of butanone used should be reduced as much as possible. Through technological innovation and process improvement, we are looking for safer and environmentally friendly alternatives.

  • Product label compliance: in strict accordance with regulatory requirements, in the product label to indicate the composition of butanone information. It is recommended to include precautions in the product description to remind consumers of potential safety risks.

5. Future Outlook and Summary

As consumers pay more and more attention to the safety of cosmetics, the supervision of chemical ingredients such as butanone is also being strengthened in various countries. In the future, cosmetics manufacturers need to pay more attention to product safety and environmental protection, and meet the changing market needs through technological innovation and compliance management.

The international standard of addition limit of butanone in cosmetics is a complex and important issue. Manufacturers need to be fully aware of relevant regulations to properly control the use of butanone to ensure the safety and compliance of their products. Only in this way can we remain invincible in the fierce market competition and provide consumers with safer and higher quality products.


Through the analysis of this paper, it can be seen that the use of butanone in cosmetics must strictly follow international standards and regulatory requirements. For cosmetic manufacturers, understanding and complying with these standards is not only a legal obligation, but also a key to safeguarding consumer health and corporate reputation.

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