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Commercial Information Circulars
24-hour hotline : 23 922 922
e-mail address : enquiry@tid.gov.hk
Ref : EIC 111/3/10/1
28 August 2007
Dear Sirs,
Commercial Information Circular No. 315/2007
US : Proposed Rule on Sunscreen Products
The US Food and Drug Administration (FDA) announced in the Federal Register (FR) notice of 27 August 2007 a proposed rule to set standards for formulating, testing and labelling over-the-counter (OTC) sunscreen drug products with ultraviolet A (UVA) and ultraviolet B (UVB) protection. The FDA is seeking comments from interested parties concerning the proposed rule by 26 November 2007.
DETAILS
- UVA and UVB rays are types of ultraviolet light emitted from the sun. UVA is responsible for tanning and UVB for sunburn. Both can damage skin and increase the risk of skin cancer. In May 1999, the FDA published a rule setting standards for formulating, testing and labelling of OTC sunscreen products that protect against UVB rays. The FDA is now proposing a new regulation which would address, among other things, manufacturing, testing and labelling of UVA sunscreens.
- Under the FDA's proposal, the UVA protection rating of a sunscreen would be derived by two tests to determine its ability to reduce the amount of UVA light that passes through it and its ability to prevent tanning. The results would be presented by a consumer-friendly, four-star rating system to evaluate the UVA protection level from "low" (one star) to "highest" (four stars). Sunscreen products found to provide no UVA protection would be required to be so labelled. Regarding UVB, the proposed regulation would amend the existing OTC suncreen rule. It would mandate that OTC UVB sunscreen products be labelled with an SPF (the rating for UVB protection), rename "SPF" from "sun protection factor" to "sunburn protection factor", as well as increase SPF values from SPF 30+ to SPF 50+. Furthermore, the proposed rule would revise the existing SPF (UVB) testing procedures and allow new combinations of active ingredients. All sunscreen products would also be required to carry a warning statement to educate consumers on the added importance of limiting time in the sun and wearing protective clothing as part of a sun protection regimen. The FDA is also asking for comments on the safety and effectiveness of sunscreen ingredients formulated in particle sizes as small as a few nanometers.
- For details of the proposed rule, interested parties may download the FR notice at: http://a257.g.akamaitech.net/7/257/2422/01jan20071800/edocket.access.gpo.gov/2007/pdf/07-4131.pdf. Hardcopies of the above FR notice are also available in the Americas (Commercial Relations) Branch of the Department for reference.
ENQUIRIES
- For enquiries concerning the content of this circular, please contact the undersigned at 2398 5682.
Yours faithfully,
(Scott MAK)
for Director-General of Trade and Industry
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Electronic services for Production Notification and Certificate of Origin enable traders to make the relevant applications directly through their office computer faster and easier. Electronic service has now been extended to the lodgement of Cargo Manifests and Textiles Notifications. For details and enquiries,
please call the following service providers:
Global e-Trading Services Limited (Tel. : 8109 1820)
Tradelink Electronic Commerce Limited (Tel. : 2599 1700) | ¡@
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While every effort is made to ensure the accuracy of the above information, the Department cannot guarantee this to be so and will not be held liable for any reliance placed on the same. | ¡@ |
