Exposure of babies to C15-C45 mineral paraffins from human milk and breast salves

Regul Toxicol Pharmacol. 2003 Dec;38(3):317-25. doi: 10.1016/s0273-2300(03)00098-9.


Mineral paraffins widely occur in foods, but are also ingredients of body lotions, lip sticks, and breast salves. In this study it is shown that mineral paraffins are detectable in human milk. Thirty three human milk samples were found to contain mineral C(15)-C(45) paraffins at a mean concentration of 95+/-215mg/kg fat and a maximum of 1300mg/kg. The mineral paraffins found in human milk had average molecular weights between C(23) and C(33), and often more than half of the paraffins were below C(25). Beside exposure of babies via human milk, the intake by direct licking off salves (in the worst case consisting of vaseline) from the breast of their nursing mothers may be much higher. In a worst case situation, daily intake from breast care products by babies is estimated to reach 40mg/kg bw. Many compositions do not comply with the specifications and a temporary group ADI of 0-4mg/kg bw established by the SCF. This possible exposure of babies either calls for a toxicological re-evaluation of the mineral paraffins or for measures ensuring that exposure of babies is reduced.

Publication types

  • Comparative Study
  • Evaluation Study

MeSH terms

  • Administration, Oral
  • Animals
  • Breast / drug effects*
  • Breast / metabolism
  • Breast Feeding
  • Cosmetics / administration & dosage
  • European Union
  • Female
  • Food Additives / chemistry
  • Humans
  • Infant
  • Infant, Newborn
  • Maximum Allowable Concentration
  • Milk, Human / chemistry*
  • Milk, Human / metabolism
  • Mineral Oil / chemistry
  • Mineral Oil / metabolism
  • Mineral Oil / pharmacology*
  • Molecular Weight
  • Ointments / administration & dosage*
  • Paraffin / chemistry
  • Paraffin / metabolism
  • Paraffin / pharmacology*
  • Rats
  • Rats, Inbred F344
  • Switzerland


  • Cosmetics
  • Food Additives
  • Ointments
  • Paraffin
  • Mineral Oil