Metals in cosmetics: an a posteriori safety evaluation

Area of Science:

• Cosmetic Science
• Toxicology
• Regulatory Affairs

Background:

• EU Regulation No. 1223/2009/CE permits technically unavoidable traces of metals in cosmetics.
• The definition of 'technically unavoidable traces' is vague, necessitating risk assessment for metal contamination in personal care products (PCPs).

Purpose of the Study:

• To characterize the risk of specific metals (antimony, arsenic, cadmium, cobalt, chromium, mercury, nickel, lead) found as unavoidable traces in PCPs.
• To evaluate the safety margins of these metals based on a worst-case scenario analysis.

Main Methods:

• Assessed metals: antimony, arsenic, cadmium, cobalt, chromium, mercury, nickel, lead.
• Adopted a worst-case scenario assuming maximum allowed trace amounts per ingredient and single-ingredient product formulation.
• Calculated Systemic Exposure Dosage (SED) and Margin of Safety (MoS) using available oral absorption data when dermal absorption was unknown.

Main Results:

• Margins of Safety (MoS) generally exceeded the safety threshold of 100, indicating a low risk from unavoidable metal traces in PCPs.
• One exception was noted, suggesting potential for improved safety assessment with dermal absorption data.

Conclusions:

• The presence of technically unavoidable metal traces in PCPs appears reassuring from a safety perspective.
• Recommends minimizing metal contamination according to best manufacturing practices to further enhance consumer safety.