Statement by John Bailey, Chief Scientist, Personal Care Products Council, Fragrances Used in Cosmetics and Personal Care Products in the U.S. Are Safe and Regulated By the FDA
On December 2, 2009, the Environmental Working Group (EWG) released the results of a biomonitoring study it commissioned that examined the umbilical cord blood of 10 American infants. EWG alleges that the test found a number of chemicals in the cord blood of the newborns, including fragrances used in personal care products, and that this sample produces sufficient evidence that American children are being prenatally exposed to dangerous substances that may have lifelong consequences.
The Centers for Disease Control and Prevention (CDC), however, has already determined that “the measurement of an environmental chemical in a person’s blood or urine does not by itself mean that the chemical causes disease.” Like all other ingredients used in cosmetic and personal care products, fragrances are evaluated for safety prior to use in marketed products, and regulated under the Federal Food, Drug, and Cosmetic Act, which gives the Food and Drug Administration (FDA) broad legal authority to protect the public if any personal care product is determined to be unsafe.
“Biomonitoring is a method for measuring human exposures to materials that might originate from both naturally occurring materials and those that are man-made. Biomonitoring relies on the testing of human tissues and fluids, such as blood or urine, to determine if people have been exposed to particular substances.
“While biomonitoring can identify certain materials in human fluids, the detection of a chemical does not mean that a person has been exposed to a toxic level of that substance. As the Centers for Disease Control and Prevention (CDC), the U.S. public health research organization that conducts the national biomonitoring program, has said, ‘The measurement of an environmental chemical in a person’s blood or urine does not by itself mean that the chemical causes disease.’
“Biomontioring shows that both naturally occurring and manmade substances can be found in human blood and urine at measurable quantities, but it does not provide information about the amount of exposure, how that exposure is linked to the quantity found in the blood or urine, or how these levels may change over time.
“A recent biomonitoring study commissioned by the Environmental Working Group (EWG) specifically examined blood in the umbilical cord of ten babies. While synthetic fragrances were among the 232 materials reported in the ten samples, the Center for Disease Control and Prevention has previously stated that the detection of a chemical through the biomonitoring process is not sufficient to establish a health risk. Moreover, cord blood measurements provide no information about sources or duration of exposure. The mere presence of a substance does not mean that there is a health risk. It is necessary to conduct a risk assessment to make this determination and the EWG does not include such an assessment.
“Like other ingredients used in cosmetic and personal care products, Fragrances are evaluated for safety prior to use in marketed products. In the U.S., fragrances (as with other ingredients) in cosmetics and personal care products are regulated under the Federal Food, Drug, and Cosmetic Act, which gives the Food and Drug Administration (FDA) broad legal authority to protect the public if any personal care product or ingredient is determined to be unsafe. Several expert scientific groups have been established to study the safety of individual fragrance ingredients and to make recommendations for their use. For example, the Research Institute for Fragrance Materials assesses the safety of individual ingredients and the International Fragrance Association enforces a Code of Practice to ensure that products comply with established conditions of use. (see http://www.rifm.org and http://www.ifraorg.org ).
“The technologies for detecting small amounts of substances in human fluids has advanced so far beyond previous methods that almost any substance, whether natural or manmade, can be detected in the environment and in human blood. Biomonitoring can detect levels of materials present below one part per billion, which is analogous to one second in 32 years. Failing to put the results of biomonitoring testing into perspective can cause parents confusion and unwarranted anxiety about the safety of their children.”