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Lead in Cosmetics

Lead in Cosmetics. Summary of RRL. Allowable Levels of Lead in Cosmetics. Currently no lead content limit set by FDA Campaign for Safe Cosmetics, 2007 FDA limit of lead in candy: 0.01 PPM 1/3 of lipsticks in the market: 0.03-0.65 PPM FDA study in 2009 Lipsticks in the market: 0.09-3.06 PPM

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Lead in Cosmetics

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  1. Lead in Cosmetics Summary of RRL

  2. Allowable Levels of Lead in Cosmetics • Currently no lead content limit set by FDA • Campaign for Safe Cosmetics, 2007 • FDA limit of lead in candy: 0.01 PPM • 1/3 of lipsticks in the market: 0.03-0.65 PPM • FDA study in 2009 • Lipsticks in the market: 0.09-3.06 PPM • Lipsticks should not be compared to candies because they are not ingested.

  3. Allowable Levels of Lead in Cosmetics • FDA has set a lead content limit as an impurity in the color additives used in cosmetics • 10-20 PPM: safe and acceptable • BFAD statement • Maximal allowable lead limit in cosmetics: 20 PPM • Based on consolidation of data from other ASEAN countries

  4. Comparison of Commercial Brands of Lipsticks with Significant Lead Content • FDA study in 2009 • 20 lipsticks of varying brands • Highest: Cover Girl brand, 3.06 PPM • Lowest: Avon brand, 0.09 PPM • Average level: 1.07 PPM

  5. Comparison of Commercial Brands of Lipsticks with Significant Lead Content • Study by Al-Saleh et al, 2009 • 48 lipsticks from 26 brands • Lead content range: 0.27-3760 PPM • There were 3 outliers in the data • Without outliers: 0.27-36.90 PPM • Only 2 brands above the 20 PPM limit • All 5 lipsticks that exceeded the limit: from China • Lipsticks with shimmers: 0.33-3760 PPM • All exceeded the 0.1 PPM limit in candy

  6. Effect of Cosmetics with Lead to Human Health • Inter-organization Programme for the Sound Management of Chemicals, 1998 • Allowable blood levels of lead: <20 µg/dl • Allowable levels for children: <10 µg/dl • This amount can already lead to a 2.5-point decrease in intelligence quotient of IQ

  7. Effect of Cosmetics with Lead to Human Health • Inter-organization Programme for the Sound Management of Chemicals, 1998 • There is no exposure level below which lead appears to be safe • Children are more susceptible to the toxic effects of lead due to their behavior and stage of development • American Academy of Child and Adolescent Psychiatry, 2006 • Lead exposure to children: paint, water, soil

  8. Effect of Cosmetics with Lead to Human Health • Center for Disease Control • About 6 percent of children aged 1-2 years old have toxic blood lead levels • Blood lead levels as low as 10 µg/dl can hamper blood cell formation and affect one’s IQ or cause some form of learning disruption • Higher levels may cause colic, encephalopathy, renal atrophy, and interstitial nephritis

  9. Effect of Cosmetics with Lead to Human Health • Lead exposure during pregnancy • Lead in the body are mainly stored in the bone • These stores may be mobilized due to hormonal effects in pregnancy • Lead readily crosses the placental barrier and may affect the fetus • Pregnant women may not manifest symptoms but their future children could be affected via prenatal exposure

  10. Effect of Cosmetics with Lead to Human Health • Currently FDA assessment of lipsticks tested • Lead content levels are safe, not a concern • Based on the premise that lipstick is for topical use only • Majority are below the recommended limit given by public health officials, 10 PPM

  11. Effect of Cosmetics with Lead to Human Health • Study by Al-Ashban et al, 2002 • Blood analyses of regular kohl users revealed a high lead concentration and relatively low hemoglobin levels • Kohl was also estimated to have lead levels as high as 52.3%

  12. Effect of Cosmetics with Lead to Human Health • Study by Al-Ashban et al, 2002 • Blood lead levels • Control group mean value: 0.9µg/dl ± 0.43 • Kohl users group mean value: 17.65µg/dl ±2.29 • Hemoglobin levels • Control group mean value: 14.02g/dl ± 0.21 • Kohl users group mean value: 12.22g/dl ± 0.37 • The study by Al-Saleh et al (1999) supports the findings made by Al-Ashban et al (2002).

  13. References • CSC, the Campaign for Safe Cosmetics (2007). A Poison Kiss: The Problem of Lead in Lipsticks. Available from: <http://www.safecosmetics.org/about/reports.cfm> • Hepp, N.M., Mindak, W.R., and Cheng, J. (2009). Determination of total lead in lipstick: Development and validation of a microwave-assisted digestion, inductively coupled plasma–mass spectrometric method. Journal of Cosmetic Science, 60, 405-414. • Al-Saleh, I, Al-Enazi, S. and Shinwari, N. (2009). Assessment of lead in cosmetic products. Regulatory Toxicology and Pharmacology, 54, 105-133. • Bureau of Food and Drugs (2006). Bureau circular 2006-012, Maximum allowable limits of heavy metals for cosmetic products. Retrieved from www.bfad.gov.ph/oldsite/BC/bc%202006-012.pdf • Health Canada (2009), Draft Guidance on Heavy Metal Impurities in Cosmetics.  • Al-Saleh I, Nester M, DeVol E, et al (1999). Determinants of blood lead levels in Saudi Arabian schoolgirls. International Journal of Occupational Environmental Health 5,107-14. • Inter-organization Programme for the Sound Management of Chemicals (1999). Global opportunities for reducing the use of leaded gasoline. Available from: http://www.chem.unep.ch/pops/pdf/lead/toc.htm • American Academy of Child and Adolescent Psychiatry (2006). Lead exposure in children affects brain and behavior. Retrieved from http://www.aacap.org/cs/root/facts_for_families/lead_exposure_in_children_affects_brain_and_behavior.

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