Annex II of Regulation (EC) 1223/2009 prohibits the use of heavy metals or heavy metals compounds containing lead, cadmium, arsenic, antimony and mercury in cosmetics. However, Article 17-Traces of prohibited substances of the regulation permits prohibited heavy metals substances in cosmetic at trace levels if their presence is technically unavoidable under good manufacturing practice provided that such presence is in conformity with Article 3- Safety. Therefore, manufacturers are responsible for assessing and ensuring product safety, which includes heavy metal testing.
Heavy Metal Testing
Heavy metal tests are generally performed using techniques such as atomic emission spectroscopy (AES), inductively coupled plasma mass spectrometry (ICP-MS), or other appropriate analytical techniques. These tests are conducted to determine the total heavy metal content of products and the concentration of specific heavy metals.
Heavy metal tests generally include the following metals:
| Heavy Metals | Related Cosmetic Products | Possible Health Risk |
|---|---|---|
| Lead (Pb) | Dyes, lipsticks, eye make-up | Serious health problems |
| Mercury (Hg) | Skin lightening products, mascara | Harmful to the nervous system and kidneys |
| Cadmium (Cd) | Pigments and dyes | Kidney damage, bone weakness, and an increased risk of cancer |
| Chromium (Cr) | Pigments and dyes | Can cause allergic reactions and skin irritation |
Acceptable impurity values for heavy metals may vary depending on the target user group, average amount of application, the area of application and the type of the cosmetic product (leave-on / rinse-off) according to the current standards and test methods the limit values can be listed as below:
| Heavy Metal | Method | Limit Value |
|---|---|---|
| Lead (Pb) | Inductively Coupled Plasma Mass Spectrometry (ICP-MS) | 20 mg / kg
Toothpaste: 1 mg /kg |
| Cadmium (Cd) | 5 mg / kg
Toothpaste: 1 mg /kg |
|
| Mercury (Hg) | 1 mg / kg
Toothpaste: 1 mg /kg |
|
| Arsenic (As) | 5 mg / kg
Toothpaste: 1 mg /kg |
|
| Antimony (Sb) | 10 mg / kg
Toothpaste: 1 mg /kg |
|
| Nickel (Ni) | 5 mg / kg
Toothpaste: 1 mg /kg |
|
| Aluminum (Al) | 5 mg / kg
Toothpaste: 1 mg /kg |
To ensure compliance with regulations and protect the health of users, it is important to conduct heavy metal tests, especially on cosmetic products applied to the oral cavity (toothpaste) and coloured cosmetics (foundation, lipstick, nail polish, blush, etc.) with high concentrations of dyes.
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