这是FDA官方发布的一则关于三氯生的消费者资讯,这两天三氯生的问题引起大家广泛关注,所以转过来给大家参考。因为我时间着急,请@JUSTAP_agepoyo 作了翻译,我本人作了审校。向她的辛苦劳动表示感谢:)
原标题:Triclosan: What
Consumers Should Know
发布于2010年4月,更新于2013年11月25日。
What is triclosan?
什么是三氯生?
Triclosan is an ingredient added to many consumer products
to reduce or prevent bacterial contamination. It may be found in
products such as clothing, kitchenware, furniture, and toys. It
also may be added to antibacterial soaps and body washes,
toothpastes, and some cosmetics—products
regulated by the U.S. Food and Drug Administration
(FDA).
很多消费品里都会添加三氯生这种成分,以减少和防止细菌污染。常见于服饰类、厨房用具、家具和儿童玩具。除菌皂、沐浴露、牙膏以及一些化妆品中也含有该成分——这样的产品是由美国食品药品监督管理局(FDA)监管。
What is known about the safety of
triclosan?
对于三氯生的安全性我们知多少?
Triclosan is not currently known
to be hazardous to humans. But several scientific studies have come
out since the last time FDA reviewed this ingredient that merit
further review.
Animal studies have shown
that triclosan alters hormone regulation. However, data showing
effects in animals don’t always predict effects in
humans. Other studies in bacteria have raised the possibility that
triclosan contributes to making bacteria resistant to
antibiotics.
In light of these studies, FDA is
engaged in an ongoing scientific and regulatory review of this
ingredient. FDA does not have sufficient safety evidence to
recommend changing consumer use of products that contain triclosan
at this time.
目前尚不知三氯生对人体有什么害处,但自从FDA上次评估以来,有数项有关三氯生的研究完成了,因此FDA认为有必要进一步评估。
动物研究显示,三氯生会改变动物体内激素调节。但是对动物有影响并不表示一定会对人类有影响;细菌研究显示,三氯生有可能使细菌对抗生素产生耐药性。
根据这些研究成果,FDA正针对该成分开展科学和规范层面的评估。就当前而言,FDA还没有充足的证据建议消费者改变使用含三氯生产品的习惯。
Does triclosan provide a benefit in consumer
products?
含三氯生的消费品更有效吗?
For some consumer products, there
is clear evidence that triclosan provides a benefit. In 1997, FDA
reviewed extensive effectiveness data on triclosan in Colgate Total
toothpaste. The evidence showed that triclosan in this product was
effective in preventing gingivitis.
For other consumer products, FDA
has not received evidence that the triclosan provides an extra
benefit to health. At this time, the agency does not have evidence
that triclosan in antibacterial soaps and body washes provides any
benefit over washing with regular soap and water.
部分含有三氯生的消费品,有确凿的证据表明更有效——1997年,FDA全面评估了高露洁牙膏中的关于三氯生的有效性数据,证明此牙膏中的该成分对预防齿龈炎有效。
对于其他产品,FDA并没有收到该成分对人体健康更加有益的证据。目前,FDA没有证据证明含三氯生的除菌皂和沐浴露比普通肥皂和水更好。
What consumers should
know:
消费者该知道什么:
Triclosan is not known to be
hazardous to humans.
FDA does not have sufficient
safety evidence to recommend changing consumer use of products that
contain triclosan at this time.
In light of questions
raised by recent animal studies of triclosan, FDA is reviewing all
of the available evidence on this ingredient’s safety in consumer products. FDA
will communicate the findings of its review to the public in winter
2012.
At this time, FDA does not have
evidence that triclosan added to antibacterial soaps and body
washes provides extra health benefits over soap and water.
Consumers concerned about using hand and body soaps with triclosan
should wash with regular soap and water.
Consumers can check product
labels to find out whether products contain triclosan.
- 尚不知三氯生对人体有何害处。
- FDA没有足够的可靠证据来建议消费者改变使用含三氯生产品的做法。
- 根据近期针对三氯生进行的动物研究中发现的问题,FDA正在评估所有能得到的、与消费品中该成分安全性相关的证据,调查结果将会在2012年的冬季发布。
- 目前,FDA没有证据显示含三氯生的除菌皂和沐浴露比普通肥皂和水更好,如果消费者担心使用含三氯生洗手皂、沐浴露的安全性,可以改用普通的肥皂和水。
- 消费者可以根据产品标签来确认产品是否含有三氯生。
How can I tell if there is triclosan in a product that
I am using?
怎样判断我正在使用的产品中是否含有三氯生呢?
Antibacterial soaps and body
washes, and toothpastes are considered over-the-counter drugs. If
an over-the-counter drug contains triclosan, it will be listed as
an ingredient on the label, in the Drug Facts box. If a cosmetic
contains triclosan, it will be included in the ingredient list on
the product label.
除菌皂、沐浴露以及牙膏属于非处方药,若含有三氯生,则会在标签上的“药物成分”栏列出;如果化妆品中含有三氯生,则会在产品的成分表上列出。
What is FDA doing to evaluate the safety of
triclosan?
针对三氯生的安全问题FDA正在采取哪些措施?
We are engaged in a comprehensive
scientific and regulatory review of all the available safety and
effectiveness data. This includes data relevant to the emerging
safety issues of bacterial resistance and endocrine disruption due
to triclosan in FDA-regulated products.
We also have partnered with other
Federal Agencies to study the effects of this substance on animal
and environmental health (see
http://www.epa.gov/oppsrrd1/REDs/factsheets/triclosan_fs.htm;
http://www.epa.gov/endo/).
FDA is working to incorporate the
most up-to-date data and information into the regulations that
govern the use of triclosan in consumer products. FDA anticipates
communicating the findings of our review to the public in winter
2012 through our rule-making process.
FDA has updated its "Guidance
Agenda: New and Revised Draft Guidances CDER is Planning to Publish
During Calendar Year 2012," to include "Guidance for Industry:
Endocrine Disruption Potential of Drugs: Nonclinical
Evaluation."
This article appears on FDA's
Consumer Updates page, which features the latest on all
FDA-regulated products.
Posted April, 2010; Updated Nov.
25, 2013
FDA正在对所有可获得的安全性、有效性数据进行全面的评估,包括科学层面和管理层面。相关数据包括由FDA监管的、含三氯生产品引起的细菌耐药性和内分泌干扰等安全问题的数据。
我们也与其他联邦机构进行合作,研究该成分对动物和环境卫生产生的影响。
(见http://www.epa.gov/oppsrrd1/REDs/factsheets/triclosan_fs.htm
; http://www.epa.gov/endo/)
FDA正致力于将最新的数据和信息整合进指导三氯生使用的管理条例里,期望在2012年冬能够根据我们的立法程序向公众沟通评估的结果。
同时,FDA更新了自己的《指导议程》,药物评估与研究中心计划于2012年发布新修订的指导草案,加入《行业指南:引起内分泌紊乱的潜在药物——非临床评估报告》部分。
本文刊登于FDA的“消费者资讯”栏目,该栏目的内容涵盖了由FDA监管的所有产品的最新资讯。
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