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.
· Annex IV - approved colours list.
· Annex V - approved list of preservatives.
· Annex VI - approved UV filter.
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:
· Bithionol - prohibited
· Chlorofluorocarbon propellants - prohibited in cosmetic aerosol products intended for domestic consumption
· Chloroform - prohibited
· Halogenated salicylanilides (di-, tri-, metabromsalan and tetrachlorosalicylanilide) - prohibited
· Hexachlorophene - May be used only when no other preservative has been shown to be as effective. The HCP concentration in a cosmetic may not exceed 0.1 percent, and it may not be used in cosmetics that are applied to mucous membranes, such as the lips (21 CFR 250.250).
· Mercury compounds -The use of mercury compounds in cosmetics is limited to eye area products at no more than 65 parts per million (0.0065 percent) of mercury calculated as the metal and is permitted only if no other effective and safe preservative is available.
· Methylene chloride - prohibited
· Prohibited cattle materials - To protect against bovine spongiform encephalopathy (BSE), also known as "mad cow disease," cosmetics may not be manufactured from, processed with, or otherwise contain, prohibited cattle materials
· Sunscreens in cosmetics - Use of the term "sunscreen" or similar sun protection wording in a product's labeling generally causes the product to be subject to regulation as a drug or a drug/cosmetic, depending on the claims.
· Vinyl chloride - prohibited as an ingredient of aerosol products
· Zirconium-containing complexes - prohibited in aerosol cosmetic products.
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.
· Colors subject to certification. These color additives are derived primarily from petroleum and are sometimes known as "coal-tar dyes" or "synthetic-organic" colors. Except in the case of coal-tar hair dyes, these colors must not be used unless FDA has certified that the batch in question has passed analysis of its composition and purity in FDA's own labs.
· Colors exempt from certification. These color additives are obtained primarily from mineral, plant, or animal sources. They are not subject to batch certification requirements. However, they still are considered artificial colors, and when used in cosmetics or other FDA-regulated products, they must comply with the identity, specifications, uses, restrictions, and labeling requirements stated in the regulations [21 CFR 73].
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).
· Introduction to Safety and Technical Standards for Cosmetics
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.