CIR Safety Review: The CIR Expert Panel noted that Lanolin and related ingredients, as a group, are used extensively in cosmetics and personal care products, as well as in many other consumer products, and there has been ample opportunity for a large proportion of the population to be exposed to some of these materials. Tests with Acetylated Lanolin, its related cosmetic ingredients, and with numerous cosmetics and personal care products containing these materials attest to the safety of these ingredients used in cosmetics and personal care products. The acute toxicity of these materials is low and tests for skin sensitization are negative. Extensive clinical experience indicates that there is a low incidence of sensitivity to these materials among exposed persons. This appears to be mainly due to the Lanolin Alcohols.

There was no evidence of photosensitization. However, comedogenic effects, or the formation of pimples, from cosmetics and personal care products containing Lanolin and related materials have been reported.

FDA: Link to Code of Federal Regulations for the OTC uses of Lanolin
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRS...
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRS...
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRS...

FDA: Link to Code of Federal Regulations for the food additive uses of Lanolin
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRS...
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRS...
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRS...
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRS...

When conforming to European Union animal by-products legislation, Lanolin and Lanolin-derived ingredients may be used in cosmetics and personal care products marketed in Europe according to the general provisions of the Cosmetics Directive of the European Union.
Link to the EU Cosmetics Directive:
http://ec.europa.eu/consumers/sectors/cosmetics/documents/di...

Lanolin is a complex esterified mixture of high molecular weight esters of fatty acids with aliphatic and alicyclic alcohols and sterols. Hydrolysis yields a mixture of compounds; purification yields individual components which may then be further modified by alkoxylation, esterification, or amidation to form materials not found in natural lanolin. Lanolin can also be separated into components by temperature-dependent physical or mechanical methods. This yields a variety of materials, possessing different properties, which can then be subjected to further chemical processes.

Lanolin and its derivatives include hard solids, pastes, and mobile liquids. They may be water-soluble or water insoluble. They may be mixtures (e.g., Lanolin Wax) or fairly pure compounds (e.g., Lanosterol). Lanolin is also an important commercial source of certain sterols, especially cholesterol. As the characteristics of Lanolin derivatives are variable, these materials find uses in all types of cosmetics and personal care products designed for skin, nail and hair care.