PENRECO

 

May 27, 2008

To Whom It May Concern:,

The European Dangerous Substance Directive, 67/548/EEC and its various amendments, including the 7th amendment of the EC cosmetic directive76/768/EEC, includes a "Consolidated List of C/M/R Substances, classified as category 1 or 2 carcinogens, mutagens, or toxic to reproduction". Category 2 (Carcinogens) lists 550 products. Most are petroleum or coal derives materials. One of the materials on the list is petrolatum with CAS number 8009-03-8. It is also the name and CAS number that is used with the INCI (International Cosmetic Ingredient) inventory for cosmetic products. The CAS definition for 8009-03-8 does not describe a purity specification. Therefore this number is used for both refined and unrefined petrolatums.

 

Penreco USP grade Petrolatums are not carcinogenic, mutagenic, or toxic to reproduction. They meet the purity requirements in FDA regulation 21CFR 172.880 that includes an analytical procedure that is specifically intended to indicate the level of total polycyclic aromatic hydrocarbons. Our experience tells us that petrolatum meeting this test will also pass the European Pharmacopoeia (EP) test for polycyclic aromatic hydrocarbons. Petrolatums meeting the FDA test can be used in certain food applications. The technical literature for petrolatum was reviewed with mineral oils in IARC (International Agency for Research on Cancer) Volume 33, 1984. That report, and a supplement in 1987, concluded that there was inadequate evidence of carcinogenicity in humans and animals for highly refined oils (and petrolatums included in class 5 petroleum products). Penreco Petrolatums are severely hydrotreated during manufacture. They do not fall in to the "mildly" hydrotreated definition that OSHA (Occupational Safety and Health Administration) used in 1985 (FR 50, No.245) to describe petroleum oils that had the potential to cause cancer.

 

The C/M/R List of Dangerous Substances Directive has a notation "N" next to petrolatum entry that says "The classification as a carcinogen need not apply if the full refining history is known and it can be shown that the substance from which it is is produced is not a carcinogen." Colipa (The European Cosmetic, Toiletry, and Perfumery Association) and EWF (The European WAX Federation) recently recommended that refined petrolatum include the following statement on their certificates of analysis:

It is hereby guaranteed that the product is produced from substances that are not carcinogens according to the EU's)* Dangerous Substances Directive and of which the full refining history is known.

As we stated above Penreco USP grade Petrolatums are not carcinogenic, mutagenic or toxic to reproduction. We include the statement above on all of our certificates of analysis for our USP grade petrolatums. This letter applied to the following Penreco products:

Penreco Ultima
Penreco Super
Penreco Snow
Penreco Snow®
Penreco Regent
Penreco Lily
Penreco Cream
Penreco Royal
Penreco Blond
Penreco Amber
Ointment Base No.4
Ointment Base No.6
Ointment Base No.8

 

I hope this Information is helpful. Please let me know if we can help with anything else.

 

Sincerely

Thomas E. Rozic
Technical Service Manager

*(EU's) added by Penreco

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