Parabens is the general term used to describe a class of ingredients that are derived from para-aminobenzoic acid. The ingredients most often used in the formulation of cosmetic and personal care products includes Methylparaben, Ethylparaben, Propylparaben, Isopropylparaben, Butylparaben and Isobutylparaben. The potassium (Potassium Methylparaben, Potassium Ethylparaben, Potassium Propylparaben, Potassium Butylparaben) and sodium (Sodium Methylparaben, Sodium Ethylparaben, Sodium Propylparaben, Sodium Isopropylparaben, Sodium Butylparaben, Sodium Isobutylparaben) salts of these parabens can also be used in the formulation of cosmetics and personal care products. These paraben ingredients are widely used in cosmetics and personal care products, and can be found in almost all product categories.
The safety of Parabens has been assessed by the Cosmetic Ingredient Review (CIR) Expert Panel. The CIR Expert Panel evaluated scientific data and concluded that Methylparaben, Ethylparaben, Propylparaben, Isopropylparaben, Butylparaben and Isobutylparaben were safe as for use as ingredients in cosmetics and personal care products.CIR Safety Review: Data reveiwed by the CIR Expert Panel included negative genotoxicity data, negative carcinogenicity data, and negative developmental toxicity data. Parabens were practically nonrritating and nonsensitizing in populations with normal skin. The CIR Expert Panel discussed “paraben paradox” in which paraben-sensitive patients can tolerate paraben-containing cosmetics applied to normal, unbroken skin but not when applied to eczematous or ulcerated skin.
The CIR Expert Panel recognized that Parabens penetrate the stratum corneum and noted that the metabolism of Parabens in the skin was likely to result in as little as 1% of unmetabolized parabens available for absorption into the body.
The CIR Expert Panel considered new data on the potential endocrine effects of Parabens and concluded that parabens were, at most, weakly estrogenic. Based on the available data demonstrating the metabolism of Parabens in the human body and the absence of any tissue accumulation over time, the CIR Expert Panel considered that infant exposure to parabens via breast feeding was unlikely. Because of potential endocrine effects, the CIR Expert Panel was concerned that infants may be a sensitive subpopulation. They determined that potential exposure of infants to Parabens from baby products containing Parabens would result in exposure much lower than those reported to cause endocrine effects in studies of animals.
More information aboutParabens.
More information aboutendocrine disruptors.
FDA: Link to the Code of Federal Regulations for Butyl p-hydroxybenzoate (Butylparaben), Methylparaben and Propylparaben.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRS... http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRS...
Parabens (4-hydroxybenzoic acid and its salts and esters) may be used as preservatives in the European Union at concentrations up to 0.4% for one ester and up to 0.8% for mixtures of esters (see Annex VI).
Link to the EU Cosmetics Directive:
http://ec.europa.eu/enterprise/cosmetics/html/consolidated_d...
The European Commission's Scientific Committee on Consumer Products (SCCP) has reviewed information about the safety of Parabens. They agreed with current regulations for Methylparaben and Ethylparaben (use up to 0.4% for one ester and up to 0.8% for mixtures of esters). They are waiting for additional information before reaching a conclusion regarding Propylparaben, Isopropylparaben, Butylparaben and Isobutylparaben.
Links to SCCP Opinions on Parabens:
http://ec.europa.eu/health/ph_risk/committees/04_sccp/docs/s...
http://ec.europa.eu/health/ph_risk/committees/04_sccp/docs/s...
The Joint FAO/WHO Expert Committee on Food Additives has established an acceptable daily intake of 0-10 mg/kg body weight for the sum of Ethyl-, Methyl- and Propyl-parabens. http://www.inchem.org/documents/jecfa/jecmono/v05je13.htm