THE COUNTRY OF ORIGIN MARKING OF HPA® LANOLIN

N184161 October 7, 2011 MAR-2 RR:NC:2:240 CATEGORY: MARKING Ms. Doreen M. Edelman Baker, Donelson, Bearman, Caldwell & Berkowitz, P.C. 920 Massachusetts Avenue, NW Suite 900 Washington, D.C. 20001 RE: THE COUNTRY OF ORIGIN MARKING OF HPA® LANOLIN Dear Ms. Edelman: This is in response to your letter dated September 9, 2011 requesting a marking ruling on behalf of your client Lansinoh Laboratories, LLC (hereinafter "Lansinoh"). The inquiry pertains to whether the proposed marking "Made in Australia" is an acceptable country of origin marking for imported lanolin of Australian origin that is purified in Japan and packaged for retail sale in China. A sample marked "Product of the United Kingdom," in lieu of the actual sample, was submitted with your letter for review and will not be returned. You state that your client will export bulk crude lanolin of Australian origin to Japan for purification. The bulk purified lanolin will be exported to China to be packaged for retail sale in individual tubes. There is no manufacturing process other than packaging performed in China. You indicate that no additional ingredients will be added to the lanolin. Section 304, Tariff Act of 1930, as amended (19 U.S.C. 1304), provides that, unless excepted, every article of foreign origin (or its container) imported into the U.S. shall be marked in a conspicuous place as legibly, indelibly and permanently as the nature of the article (or its container) will permit, in such a manner as to indicate to the ultimate purchaser in the United States the English name of the country of origin of the article. Congressional intent in enacting 19 U.S.C. 1304 was "that the ultimate purchaser should be able to know by an inspection of the marking on the imported goods the country of which the goods is the product. Part 134 of the Customs Regulations implements the country of origin marking requirements and exceptions of 19 U.S.C. 1304. Section 134.41(b), mandates that the ultimate purchaser in the United States must be able to find the marking easily and read it without strain. "Country of origin" is defined in section 134.1(b), Customs Regulations, as the country of manufacture, production, or growth of any article of foreign origin entering the United States. Further work or material added to an article in another country must effect a substantial transformation in order to render such other country the "country of origin" within the meaning of this part. A substantial transformation is said to have occurred when an article emerges from a manufacturing process with a name, character, or use that differs from the original material subjected to the process. The bulk crude lanolin is simply purified and packaged for retail sale in tubes as a skincare preparation. The purification process, filling the tubes, and packaging the lanolin for retail sale do not effect any significant change in the character or use of the lanolin for purposes of establishing country of origin. It is our determination that the foreign purification, and retail packaging in tubes do not constitute a substantial transformation; therefore, the lanolin remains a product of Australia. Perfumery, cosmetic, and toiletry products are subject to the requirements of the Food, Drug and Cosmetic Act, and the Fair Packaging and Labeling Act (FPLA), which are administered by the U.S. Food and Drug Administration. Questions regarding FDA requirements may be addressed to the U.S. Food and Drug Administration, Office of Cosmetics and Colors, 5100 Paint Branch Parkway, College Park, MD 20740-3835, telephone number (301) 436-1130. The proposed marking "Made in Australia", as described above, meets the marking requirements of 19 U.S.C. 1304 and 19 CFR Part 134, and is an acceptable country of origin marking for the imported HPA® (high purity anhydrous) Lanolin. This ruling is being issued under the provisions of Part 177 of the Customs Regulations (19 CFR Part 177). A copy of the ruling or the control number indicated above should be provided with the entry documents filed at the time this merchandise is imported. If you have any questions regarding the ruling, contact National Import Specialist Stephanie Joseph at 646-733-3268. Sincerely, Robert B. Swierupski Director, National Commodity Specialist Division