Regulatory

The use of Triclosan is governed by different regulations in many countries. A strict product stewardship program is also in place, which enables us to understand the impact of Triclosan not only on a product or application but also on the environment in which we live.

The scientific data supporting the safety of Triclosan is clear and consistent, and directly contradicts the misconceptions that are sometimes presented in activist campaigns and the media. On the basis of this wealth of data, Triclosan is approved for use in personal care and healthcare applications, on the global market.

Resources

World map

Canada

Canada

Products containing Triclosan are regulated by Health Canada under the Food and Drugs Act and Regulations or the Pest Control Products Act. The Government of Canada has recently reviewed Triclosan in its program called the Chemicals Management Plan (CMP). The draft findings of this review stated that Triclosan is safe for consumers; however, there may be possible environmental concerns. Further data has been requested to help conclude the scientific assessment and a final report is now not expected to be concluded before quarter 2 2016.

USA

USA

The US Food and Drug Administration (FDA) and Environmental Protection Agency (EPA) regulate the use of Triclosan in North America, and also support the Reregistration Eligibility Decision (RED) for this antimicrobial active in pesticide applications. A new assessment of Triclosan according to EPA guidelines has been brought forward to review newly available data. This assessment is ongoing and is expected to be coordinated together with the FDA.

In December 2013, the FDA published its much anticipated final draft rule on the OTC antimicrobial handsoaps monograph.  The proposal described key aspects that handsoaps have to fulfill to show that they are both effective and safe for the consumer.

Along with this further data with respect to human health was requested for Triclosan and other active substances listed in the monograph. The FDA have since made a commitment to publish a final monograph for consumer antiseptic washes for Triclosan by September 15th 2016.

Brazil

Brazil

The Ministry of Health, National Health Surveillance Agency (Anvisa) and National Private Health Insurance Agency (ANS) are responsible for regulating the use of Triclosan in Brazil. The Ministry of Health is a body of the Federal Executive Power, and is in charge of promoting the health of the Brazilian population. Anvisa is a governmental regulatory agency characterized by administrative independence, financial autonomy and stable directorship.

Europe

Europe

The European Commission is responsible for regulating the use of Triclosan in Europe. This is achieved through various regulations such as the Cosmetic Products Regulation, Biocidal Products Regulation and REACH legislation. The Scientific Committee on Consumer Safety (SCCS) and Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR) support the EU in providing scientific evaluations of cosmetic ingredients including Triclosan.

In 2012, Triclosan was included in the REACH CoRAP (Community Rolling Action Plan) for substance evaluation. The assessment is to evaluate Triclosan for potential concerns as an endocrine disrupting chemical and as a PBT substance. The review is currently under appeal and not expected to be completed before 2017.

In January 2016 the European Commission published the legally binding non-inclusion decision for the use of Triclosan in biocidal products (PT 1). This use is regulated by the European Biocidal Products Regulation (EU/528/2012).  Cosmetic uses (toothpastes, handsoaps, body soaps/shower gels, deodorant (non-spray), face powder and blemish concealers, nail products for cleaning nails, mouthwashes) are not affected by this ruling.

China

China

The State Food and Drug Administration (SFDA) Agency is responsible for regulating the use of Triclosan in China under the "Hygiene Standard for Cosmetics 2007". In this "Hygiene Standard for Cosmetics", Triclosan is classified into the category of "Limited Preservatives for Cosmetics" and the maximum dosage allowed is 0.3%.

Japan

Japan

The regulatory agency Ministry of Health, Labour and Welfare is responsible for regulating some of the uses of Triclosan in Japan, for cosmetic as a preservative under the "Cosmetic Standard" and for quasi-drug application. In the Cosmetics Standard, Triclosan is on the positive list for preservatives for cosmetics and the maximum dosage allowed is 0.10% in cosmetics. The Japanese pharmaceutical affairs Law provide guidelines on the use of Triclosan in quasi-drug applications, where Triclosan is allowed to be used in Medicated shampoo (0.2-0.3%) and in the medicated soap including face wash (0.1-0.3%) as an active substance.

Australia

Australia

Triclosan is listed in the Safe Work Australia List of Designated Hazardous Substances, contained in the Hazardous Substances Information System (HSIS). In 2003 a full chemical review of Triclosan took place under the Priority Existing Chemical (PEC) program in accordance with the Industrial Chemicals (Notification and Assessment) Act 1989 (ICNA Act) due to environmental concerns. The decision on regulation of Triclosan was made in 2010. For cosmetic products using up to 0.3% Triclosan no extra requirements were enforced, for all products containing more than 0.3% a schedule 6 requirement must be fulfilled according to NICNAS (National Industrial Chemicals Notification and Assessment Scheme). This scheduling requirement is effective 1 May 2012 and will include a change to the Poisons Standard 2011, Amendment No. 4.

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