Little Pro on 2018-07-20 Views: Update:2018-10-17
The safety of a cosmetic product largely depends on the safety of cosmetic ingredients. Many countries have developed their own regulatory lists of banned or restricted cosmetic ingredients and positive lists. In this article, we will give you an overview of global regulatory lists for cosmetic ingredients. EU, USA and China are covered.
Regulation (EC) 1223/2009 on cosmetic products (EU Cosmetics Regulation) is the main regulatory framework for finished cosmetic products placed on the EU market. The legislation includes restrictions on the substances that may, or may not, be included in cosmetic products.
List of banned substances
The list of banned substances is given in the annex II of the EU Cosmetics Regulation. They are not allowed to be used in cosmetic products.
List of restricted substances
The list of restricted substances is given in the annex III of the EU Cosmetics Regulation. They are allowed to be used. However, their use must comply with corresponding use conditions (i.e, content limit, use scope).
Positive lists of cosmetic ingredients
If a substance is not on the list of banned or restricted substances then it is allowed in cosmetic products provided the manufacturer/supplier has the appropriate safety data to ensure the ingredient and the final product is safe.
However, there are some exceptions. Some ingredients with special functions (colorant, preservative or UV filter) are listed on 'positive lists'. This means that if your products contain those special ingredients, you can only use those ingredients on the positive lists and no other.
These lists can be found in Annexes IV, V and VI to the EU Cosmetics Regulation.
Above lists can also be found in CosIng - EU's official cosmetic ingredient database.
The Federal Food, Drug, and Cosmetic Act does not require cosmetic products and ingredients to be approved by FDA before they go on the market, except for color additives that are not intended for use as coal tar hair dyes. Companies and individuals who market cosmetics have a legal responsibility for the safety of their products and ingredients.
List of banned or restricted substances
Although it’s against the law to use any ingredient that makes a cosmetic harmful when used as intended, FDA has regulations that specifically prohibit or restrict the use of the following ingredients in cosmetics:
US FDA has established a positive list system for color additives used in cosmetics. Color additives are permitted in cosmetics only if FDA has approved them for the intended use. In addition, some may be used only if they are from batches that FDA has tested and certified.
In China, cosmetics must be tested and approved by food and drug authority first before they can be marketed in China. You must also comply with regulatory requirements on the use of cosmetic ingredients.
List of banned substances and restricted substances
The list of banned and restricted substances is given in Safety and Technical Standards for Cosmetics (化妆品安全技术规范).
Example: 1,4-dioxane (<30mg/kg), Pb (<10mg/kg), As (<2mg/kg), Cd (<5mg/kg)
Positive lists of cosmetic ingredients
For special functional ingredients such as colorant, preservative and UV filter, you can only use those approved and listed in Safety and Technical Standards for Cosmetics (化妆品安全技术规范). For other ingredients, you can only use those listed in the Inventory of Existing Cosmetic Ingredients in China (China IECIC). Otherwise, you have to apply for new cosmetic ingredient registration.
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