| 美 FDA, 자외선 차단제 새 지침 발표 |
라벨 개정 시기 내년 여름까지 완료해야
미국의 식품의약품안전청(FDA)은 “자외선 차단 선크림의 효과 표시에 관한 새로운 지침”을 발표했다
미 FDA는15일(현지시각) 일반 소비자들이 자외선차단제를 구매할 때 제품 선택을 보다 더 쉽게 하기 위해 이 같은 기준에 따라 제품 라벨(labels)을 제작할 것을 제조사들에게 요구했다.
이 새로운 지침에 따르면 자외선 차단지수(SPF=Sun Protection Factor)가 15 미만인 선크림의 경우 효과 표기를 마음대로 할 수 없게 됐다.
FDA는 태양의 자외선A(UVA)와 B(UVB) 모두를 차단하고, 자외선 차단지수가 15 이상인 선크림만 일광화상(sunburn), 피부암, 피부노화 위험을 줄일 수 있다는 내용을 라벨에 기재할 수 있으며, 자외선 A와 B를 모두 차단할 수 있어야 ‘광범위(broad spectrum, 광역차단)’ 선크림이라는 표시를 할 수 있게 했다. 다시 말해 ‘장파장 자외선’은 물론 피부암의 주요 원인인 ‘중파장 자외선’을 차단하는 기능을 가진 선크림에 대해서만 ‘광역차단용’으로 표기하기로 했다.
또, 자외선 차단지수 2~14에 해당하는 선크림은 UVA와 UVB 모두를 차단하는 경우 ‘광범위(broad spectrum)한 선크림이라는 표시를 사용할 수 있으나 피부암이라든가 피부노화 위험을 막을 수 있다는 표시는 과거와 같이 시용할 수 없게 됐다.
UVB보다는 덜 강한 UVA(자외선A)는 UVB보다 30~50배 피부 깊은 곳까지 침투해 심각한 피부손상과 노화를 유발하며, UVB(자외선B)는 피부 일광 화상(Sunburn)을 일으키고 피부암(skin cancer)을 유발시키는 주범으로 알려져 있다.
또한 FDA는 선블록(sunblock, 자외선차단제)이나 방수(waterproof), 또 방한(sweat-proof, 땀 방지용)이라는 문구는 사용해서는 안 되며, 물에 얼마나 오래 저항하는 시간을 표시할 경우에만 ‘내수(耐水, water resistant, 물에 잘 스며들지 않는)’라는 표현을 사용할 수 있는데 ‘40~80분 동안 물에 견딜 수 있다(40 or 80 minutes of protection)’라는 표시만 사용하도록 했다.
이외에 FDA는 자외선차단지수가 50을 넘을 경우에는 추가적인 장점이 없어 자외선차단지수 표기의 최대치는 50 이하로 할 것을 요구했으며, 이 같은 새로운 자외선차단제 제품 라벨 개정은 내년(2012년) 여름까지 해야 한다고 요구했다.
한편, 자외선차단지수(SPF)가 15일 경우, 맨 피부가 태양에 타는 데 10분이 걸린다면 이 선크림을 발랐을 땐 150분이 걸린다는 뜻이다.
이번 FDA의 새로운 방침 결정으로 우리나라를 비롯해 전 세계 화장품 업계에도 큰 영향을 미칠 것으로 보인다.
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FDA PRESS RELEASE
For Immediate Release: June 14, 2011
Media Inquiries: Shelly Burgess, 301-796-4651, shelly.burgess@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA
FDA Announces Changes to Better Inform Consumers About Sunscreen
New Rules Give Consumers More Information to Help Reduce the Risk of Skin Cancer, Early Aging The U.S. Food and Drug Administration announced today that sunscreen products meeting modern standards for effectiveness may be labeled with new information to help consumers find products that, when used with other sun protection measures, reduce the risk of skin cancer and early skin aging, as well as help prevent sunburn.
The final regulation allows sunscreen products that pass the FDA’s test for protection against both ultraviolet A (UVA) and ultraviolet B (UVB) rays to be labeled as “Broad Spectrum.” Both UVB and UVA radiation contribute to sunburn, skin cancer, and premature skin aging. Sunburn is primarily caused by UVB radiation.
Under the new labeling, sunscreens labeled as both Broad Spectrum and SPF 15 (or higher), if used regularly, as directed, and in combination with other sun protection measures will help prevent sunburn, reduce the risk of skin cancer, and reduce the risk of early skin aging.
“FDA has evaluated the data and developed testing and labeling requirements for sunscreen products, so that manufacturers can modernize their product information and consumers can be well-informed on which products offer the greatest benefit,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research. “These changes to sunscreen labels are an important part of helping consumers have the information they need so they can choose the right sun protection for themselves and their families.”
Products that have SPF values between 2 and 14 may be labeled as Broad Spectrum if they pass the required test, but only products that are labeled both as Broad Spectrum with SPF values of 15 or higher may state that they reduce the risk of skin cancer and early skin aging, when used as directed.
Any product that is not Broad Spectrum, or that is Broad Spectrum but has an SPF between 2 to 14, will be required to have a warning stating that the product has not been shown to help prevent skin cancer or early skin aging.
“Most skin cancers are caused by sun exposure. FDA encourages consumers to protect themselves,” Woodcock added. “Not only should consumers regularly apply and reapply sunscreens with Broad Spectrum and SPF of 15 or higher, they should also limit sun exposure.”
In addition to the final rule for sunscreen labeling, today the FDA released three additional regulatory documents -- a Proposed Rule, an Advance Notice of Proposed Rulemaking (ANPR) for Dosage Forms, and a Draft Enforcement Guidance for Industry.
- The proposed rule would limit the maximum SPF value on sunscreen labels to “50 +”, because there is not sufficient data to show that products with SPF values higher than 50 provide greater protection for users than products with SPF values of 50. The proposal creates the opportunity for the submission of data to support including higher SPF values in the final rule. FDA looks forward to receiving public comment on this document.
- The ANPR will allow the public a period of time to submit requested data addressing the effectiveness and the safety of sunscreen sprays and to comment on possible directions and warnings for sprays that the FDA may pursue in the future, among other issues regarding dosage forms for sunscreens.
- The Draft Enforcement Guidance for Industry outlines information to help sunscreen product manufacturers understand how to label and test their products in light of the new final rule and other regulatory initiatives.
To ensure that sunscreen products meet modern safety standards, FDA is also currently reexamining the safety information available for active ingredients included in sunscreens marketed today. The ingredients in sunscreens marketed today have been used for many years and FDA does not have any reason to believe these products are not safe for consumer use.
The new regulations will become effective for most manufacturers in one year. Manufacturers with annual sales less than $25,000 have two years to comply.
출처 - 뉴스타운, 2011-06-16
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http://www.fda.gov/
