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DECISION

www.epa.govt.nz

2 August 2016

Summary

Substance Triclosan

Application code APP202598

Application type To decide whether there are grounds for reassessment under the

Hazardous Substances and New Organisms Act 1996 (“the Act”)

Applicant Green Party of Aotearoa New Zealand

Purpose of the application To establish whether there are grounds for the reassessment of

triclosan

Approvals proposed to be amended HSR003518, HSR002072, HSR001690

Date application received 28 January 2016

Consideration Date 11 July 2016

Considered by A decision-making committee of the Environmental Protection

Authority (“the Committee”)1:

Dr Kerry Laing (Chair)

Dr Deborah Read

Dr Nick Roskruge

Decision Grounds for reassessment of triclosan and the identified approvals

exist

1 The committee referred to in this decision is the subcommittee that has made the decision on this application under delegated authority in accordance with section 18A of the Act

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Application to determine if there are grounds to reassess triclosan-containing substances (APP202598)

July 2016

1. Background

The Green Party of Aotearoa New Zealand has sought a determination on whether there are grounds

to reassess triclosan and substances containing triclosan.

Triclosan is an antibacterial and antifungal chemical used in a wide variety of antimicrobial

applications. It is used in clinical settings and in various consumer products, including in cosmetics,

cleaning products, toys and household plastic products.

Triclosan has an approval under the Act permitting it to be imported into, or manufactured in, New

Zealand. The majority of substances containing triclosan in New Zealand are likely to be those

approved under a range of Group Standards including primarily the Cosmetic Products Group

Standard 2006 and the suite of Cleaning Products Group Standards. There are also two individual

substance approvals under the Hazardous Substances and New Organisms (HSNO) Act for

substances that contain triclosan. The individual substance approvals for triclosan and substances

containing it are identified in Appendix A, while the Group Standard approvals which are expected to

cover other substances that contain triclosan are listed in Appendix B.

The application from the Green Party of Aotearoa New Zealand argues that research both in New

Zealand and internationally supports their view that the chemical is implicated in antibiotic resistance,

human health issues, and environmental effects. The effects discussed in the application include

toxicity to aquatic life resulting from discharges of wastewater containing triclosan into waterways,

and the effects of triclosan when combined with organic material in wastewater treatment systems

resulting in the formation of dioxin-related compounds2. The applicant also provides information on

safer alternatives.

The Green Party of Aotearoa New Zealand wishes to present evidence of these risks during a

reassessment process calling scientific witnesses whose research supports the concerns.

The Green Party of Aotearoa New Zealand is not calling for a total ban on triclosan as the only

option, but for its removal from widely used household products and either licensing its use or

permitting its use in extremely limited specialist circumstances.

2. Application process

The application was formally received by the Environmental Protection Authority (EPA) on 28 January

2016.

The application was considered on 11 July 2016 by a decision-making Committee of the EPA.

The information available to the Committee comprised:

The application form for APP202598

2 Dioxins and dioxin-like compounds (DLCs) are compounds that are highly toxic environmentally persistent organic pollutants (POPs).

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The triclosan literature review by Gordon Jackman BSc, MA1st for the Green Party of Aotearoa New

Zealand 23/07/2015

A review of the literature references by EPA staff (Appendix C)

The Committee considered that the information supplied was sufficient and provided an adequate

basis to consider whether grounds exist to reassess the approvals.

The Committee noted that should grounds for reassessment be established, any person may apply

under s63 for reassessment of the substances. The Committee also noted that risks, costs, and

benefits of all proposed modifications to or revocations of the approvals would be assessed in any

such reassessment application.

3. Matters to be taken into account

The matters to be taken into account when determining whether there are grounds to reassess a

hazardous substance are outlined in Section 62(2) of the Act, as follows:

Section 62(2)(a): significant new information relating to the effects of the substance has become

available, OR

Section 62(2)(b): another substance with similar or improved beneficial effects and reduced

adverse effects has become available, OR

Section 62(2)(c): information showing a significant change of use, or a significant change in the

quantity manufactured, imported, or developed has become available.

The Committee note the EPA review of the literature references provided by the applicant and the

conclusions are summarised below. Full details of the EPA staff review are listed in Appendix C.

Human health

Several of the references relating to human health provide new data on triclosan, however not all of

the data are considered to be significant. Some literature references are not significant on their own,

but are likely to be useful in a weight of evidence approach and could be taken into account if a

reassessment of triclosan were undertaken.

The applicant provided information regarding potential endocrine disrupting effects of triclosan.

However, the level of information available at present is unlikely to be sufficient to conclude whether

triclosan should be considered an endocrine disruptor, or to inform a risk assessment for endocrine

effects. The Committee noted that the European Chemicals Agency (ECHA) has requested further

information be generated for triclosan in order to enable a determination of whether it is an endocrine

disruptor or not.

Ecotoxicology and environmental fate

The Committee agreed with the EPA staff assessment that some of the material relating to the fate of

triclosan in the environment and its ecotoxicity does constitute significant new information. In

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July 2016

particular, the information relating to the formation of metabolites, some of which are also

bioaccumulative and persistent, is considered to be significant new information.

The Committee also noted that some of the information showed that runoff from fields treated with

sewage sludge contained triclosan at concentrations in exceedance of the Predicted No Effect

Concentration (PNEC) used by the Canadian regulator. The environmental significance would need

to be assessed if a reassessment application is received.

The Committee noted that although the Committee consider that there is significant new information

regarding the ecotoxicology and environmental fate of triclosan, it is not known what the impact of this

new information is on the level of risk. This would need to be determined in a risk assessment.

Efficacy and benefits

As triclosan was approved under HSNO as part of the transfer of approvals from previous chemical

management systems in New Zealand, an evaluation of the benefits of triclosan has not been

performed. Therefore new information on the benefits of triclosan may be useful in a reassessment of

triclosan.

Status of triclosan in the EU

The European Chemicals Agency's Biocidal Products Committee has evaluated triclosan within the

framework of active substance approval for use in liquid soap formulations for hand disinfection and

concluded on non-approval under the Biocidal Product Regulation as no safe use could be

demonstrated. A risk was identified for both surface water and for the non compartment specific

effects relevant to the food chain (secondary poisoning).

On the basis of an opinion of the ECHA Member State Committee that there are initial grounds for

concern relating to its persistence, bioaccumulation and toxicity (PBT) properties and potential

endocrine disrupting (ED) properties, triclosan was included in the Community Rolling Action Plan

(CoRAP)3 for substance evaluation under the REACH Regulation.. Industry has been requested by

the ECHA to provide studies to inform an assessment of the PBT and ED properties. This decision is

currently under appeal.

4. Issues and concerns to Māori

In accordance with Sections 5(b), 6(d) and 8 of the Act, the Committee considered whether this

application would have any significant impacts (positive or negative) on the capacity of Māori to

provide for their cultural well-being, the relationship of Māori and their culture and traditions with their

ancestral lands, water, sites, waahi tapu, valued flora and fauna, and other taonga, or would be

inconsistent with the principles of the Treaty of Waitangi (Te Tiriti o Waitangi).

3 The REACH Regulation Article 44(1) provides the general criteria for substances to be selected for substance evaluation. Both hazard and exposure information (or a lack of it) is taken into consideration upon prioritising the substances.

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Application APP202598 Triclosan meet grounds for reassessment under Section 66(2)(a) of the

HSNO Act, as significant new information on potential risks and adverse effects in relation to Māori

interests has become available. Triclosan or its metabolites have been shown to bioaccummulate in

culturally significant species of algae, shrimp and earthworms. This raises concern in relation to

taonga food species e.g. kākahi (freshwater mussel), kōura / kēwai (freshwater crayfish) and kanae

(grey mullet) and prey species for a range of culturally significant aquatic organisms. Furthermore,

the new information also raises the possibility of endocrine disruption, which, if confirmed would raise

concerns in relation to taha hauora (human health and wellbeing), whanaungatanga (relationships)

and whakapapa (genealogy).

Reassessing Triclosan would be consistent with the practice of kaitiakitanga and manaakitanga and

the principles of the Treaty of Waitangi, in particular the principle of active protection.

5. Consideration

The Committee considered that the information provided by the applicant was significant new

information relating to the effects of the substance. This significant new information related to:

the formation of metabolites

ecotoxicology and environmental fate data.

In the event that a subsequent application for reassessment is received, EPA Staff would consider all

of the above significant new information. EPA staff would also consider any information provided by

the applicant including any potential endocrine disrupting effects of triclosan, and such other

information that EPA staff are able to locate relevant to the reassessment application. The

Committee would also consider any information provided by any other party.

The Committee therefore concluded that there are valid grounds under section 62 of the Act for the

reassessment of the substance approvals identified in Appendix A. The Committee noted that the

reassessment of the substance approvals are amended under section 63 of the Act.

In regards to the request of the Green Party of Aotearoa New Zealand to reassess all uses of

triclosan, such a reassessment would largely depend on amendments to Group Standards as the

majority of substances containing triclosan are approved under Group Standards.

The Committee noted that reassessment of approvals under section 63 of the Act would not cover

Group Standards; they are instead amended under section 96C of the Act.

The outcome of any reassessment may indicate that the Group Standards need to be amended. This

would need to be achieved subsequently by a different process.

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Dr Kerry Laing Date: 2 August 2016

Chair, Decision Making Committee

Environmental Protection Authority

Appendix A: Substance approvals for which grounds for reassessment are being sought

HSNO Approval name HSNO Approval

number

Hazard

classifications

Triclosan HSR003518 6.1E (oral), 6.3A, 6.4A,

9.1A, 9.3C

Liquid containing 50 - 60%

ammonium lauryl ether

sulphate and 0.5 - 1%

triclosan

HSR002072 6.1D (oral), 6.3A, 8.3A,

9.1A, 9.3C

Calmic Type S HSR001690 3.1C, 6.1E (oral), 6.3A,

6.8B, 8.3A, 9.1A

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Appendix B: Examples of Group Standards which may include triclosan containing substances

The Environmental Protection Authority (EPA) does not have details of all substances containing triclosan

that are present in New Zealand. This is because the majority of substances that contain triclosan are

deemed to be approved under Group Standards, and companies are able to self-assign substances to

Group Standards without notifying the EPA.

Examples of suites of Group Standards that are considered likely to cover substances containing triclosan

are listed below. These, and possibly other suites of Group Standards would not be included in a

reassessment of triclosan, but could require subsequent amendment under section 96C of the Act as a

consequence of any reassessment of triclosan.

Group Standard

Additives, process chemicals and raw materials

Animal nutritional and animal care products

Cleaning products

Cosmetic Products

Dental products

'Not otherwise specified'

Pharmaceutical active ingredients

Surface coatings and colourants

Veterinary medicines

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Appendix C: EPA staff review of the literature references provided

Executive summary

Introduction

The applicant submitted a number of literature references on triclosan relating to potential human health

effects, environmental fate, ecotoxicity and efficacy. The EPA staff reviewed the information provided and

considered whether it represents significant new information on the effects of triclosan. A summary of each

key piece of information provided and the evaluation is in Table 1.

In reviewing this information the EPA staff have also taken into account information provided in recent

evaluations of triclosan by regulators in Australia4, Canada5 and the EU6.

Human health

Several of the references relating to human health provide new data on triclosan, however not all of the data

are considered to be significant. Some literature references are not significant on their own, but are likely to

be useful in a weight of evidence approach and could be taken into account if a reassessment of triclosan

were undertaken.

The applicant provided information regarding potential endocrine disrupting effects of triclosan. However, the

level of information available at present is unlikely to be sufficient to conclude on whether triclosan should be

considered an endocrine disruptor, or to inform a risk assessment for endocrine effects. The European

Chemicals Agency (ECHA) has requested further information be generated for triclosan in order to enable a

determination of whether it is an endocrine disruptor or not.

Ecotoxicology and environmental fate

In the opinion of the EPA staff, some of the material relating to the fate of triclosan in the environment and its

ecotoxicity does constitute significant new information. In particular the information relating to the formation

of metabolites, some of which are also bioaccumulative and persistent, is significant new information. The

EPA staff also note that some studies provided to the EPA showed that runoff from fields treated with

sewage sludge contained triclosan at concentrations in exceedance of the Predicted No Effect Concentration

(PNEC) used by the Canadian regulator. The environmental significance would need to be assessed if a

reassessment application is received.

4 Priority Existing Chemical Assessment Report No. 30, National Industrial Chemicals Notification and Assessment Scheme (NICNAS), 2009 5 Preliminary Assessment Triclosan, Health Canada and Environment Canada, 2012 6 Decision on substance evaluation pursuant to article 46(1) of regulation (EC) NO 1907/2006, European Chemicals Agency (ECHA), 2014

Opinion on Triclosan COLIPA n° P32 ADDENDUM to the SCCP Opinion on Triclosan (SCCP/1192/08) from January 2009, Scientific Committee on Consumer Safety (SCCS), 2011

Opinion on triclosan, Antimicrobial Resistance, Scientific Committee on Consumer Safety (SCCS), 2010

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It should be pointed out that although EPA staff believe there is significant new information regarding the

ecotoxicology and environmental fate of triclosan, it is not known what the impact of this new information is

on the level of risk the environment. This would need to be determined in a risk assessment. The suggestion

that triclosan is more toxic than alternatives is also important information which would be considered if a

reassessment application is received.

Efficacy and benefits

As triclosan was approved under HSNO as part of the transfer of approvals from previous chemical

management systems in New Zealand, an evaluation of the benefits of triclosan has not been performed.

Therefore new information on the benefits of triclosan that may be useful in a reassessment of triclosan.

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Review of the references

Table 1 Review of submitted references

Key piece of information provided in the

review

EPA staff response Significant new

information?

Characteristics

[Triclosan] is relatively hydrophobic (log

KOW7 = 4.76).

Value is approximately equivalent to that in

the EPA substance database (4.8).

No

Methyl triclosan, a biotransformation

product, is considered more persistent and

bioaccumulative (log KOW = 5.2) [than

triclosan].

This is correct. It should be noted that this

information alone does not necessarily

mean that there would be a risk, but when

it is viewed in the context of other

information (such as the toxicity of methyl

triclosan) it does appear to be significant.

More information is described below.

Yes

Laboratory experiments have demonstrated

triclosan is rapidly decomposed by

photolysis in lake water whereas methyl

triclosan is relatively stable and resistant to

photodegradation.

This paper (Lindstrom et al., 2002) appears

to confirm what is stated in the literature

review. It is, however, not clear what

implications this could have on the level of

risk posed by this metabolite. This paper

was published before the substance was

approved and so is not new information.

EPA staff note that the Australian and

Canadian reviews considered the impact of

the metabolite on the environment. If the

EPA were doing a reassessment this would

be something EPA staff need to consider.

No

Origin and use

It is widely used in personal care products

including deodorants, hand soaps,

toothpaste, textiles, laundry detergents,

antiseptics, shower gels and cleaning

agents, but is also increasingly used in

consumer products such as kitchen

utensils, toys, bedding, socks, and rubbish

bags. In the EU alone over 1000 tonnes a

year are produced with 450 tonnes used

domestically, 85% in personal care

products, 5% in textiles, 10% in plastics and

food contact materials. In 1999/2000,

triclosan (or the very similar triclocarban)

were present in 75% of liquid soaps and

29% of bar soaps in the U.S. market. The

most significant use of triclosan is in the

healthcare sector where it is commonly

used in surgical scrubs and hand washes

and has proven to be an effective agent

If the EPA were to do a reassessment,

more information on New Zealand use

patterns would be required.

No

7 The octanol-water partition coefficient

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information?

and treatment for patients carrying MRSA

(Methicillin-resistant Staphylococcus

aureus) in their skin.

Fate

The mixing of triclosan with chlorinated

drinking water can result in the formation of

carcinogenic chloroform and, upon release

into surface water and irradiation with

sunlight, of additional toxic polychlorinated

dioxins and less toxic dechlorinated dioxins,

for example, 2,8-dichlorodibenzo-p-dioxin.

The level of concern is dictated by the

exposure which is unknown. EPA staff note

the conclusion of the Canadian regulators

who stated that these particular

metabolites were not likely to be of concern

for human health or the environment based

on the likely exposure being below levels of

concern.

No

Triclosan binds readily to soils and is not

expected to evaporate from soil or water

surfaces. In aquatic environments, triclosan

attaches mainly to the surface of

suspended solids and sediments and it also

bioaccumulates in organisms.

This appears to be consistent with what

EPA staff know about the substance based

on its physical and chemical properties.

This information was known at the time of

approval.

No

Effluents from sewage treatment works

(STW) contribute to the widespread

occurrence of triclosan in surface waters.

Chlorination of STW effluents leads to

formation of chlorinated triclosan products

that are photochemically transformed to tri-

and tetra-chlorinated dioxins when

discharged into natural waters.

EPA staff are aware that triclosan can be

removed from treated effluent but the

efficacy does depend on the type of

sewage treatment works. The information

about the chlorinated triclosan derivatives

would be new information. At this stage it is

not clear, however, how significant this

would be in the New Zealand context.

No

Aerobic biodegradation is one of the major

and most efficient biotransformation

pathways for triclosan. Microbial

methylation of triclosan has been reported,

leading to the more lipophilic methyl

triclosan with a higher bioaccumulation

potential.

From the paper (Lindstrom et al, 2002)

provided EPA staff cannot determine if

aerobic biodegradation is one of the major

degradation pathways for triclosan.

However, it suggests that methyl triclosan

does have a higher bioaccumulation

potential than triclosan, while the impact of

this on risk is unknown we note that it has

been considered by both the Canadian and

Australian regulators. If the EPA were

doing a reassessment this would be

something EPA staff need to consider.

Yes

Environmental fate in wastewater

Products that contain triclosan wash down

our drains and into water systems and

waterways, where triclosan has become a

common contaminant. Sewer overflows and

wastewater effluent deposits both contribute

to triclosan contamination of waterways. A

This would be expected given the use

profile and physical and chemical

properties of this substance, it is therefore

not significant new information.

No

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information?

major source of triclosan in waterways is

sewage sludge.

A study of triclosan in the influent and

effluent of 13 waste water treatment plants

in New Zealand found triclosan

concentrations ranging from 25 to 100 ng/L

(parts per trillion) in the influent and 4.43 to

158 ng/L in treated effluents.

This is correct. This does appear to

suggest that emissions leaving wastewater

treatment plants are higher than other

regulators’ Predicted No Effects

Concentration (PNEC) values e.g. that

suggested by the Canadian regulator (115

ng/L).

Yes

Concentrations of triclosan in biosolids

have been found to be orders of magnitude

higher than in effluents ranging from 0.43 to

133 mg/ kg (parts per million) in the USA,

from 0.09 to 16.79 mg/ kg in Australia and

1.05 to 17.23 mg/ kg in New Zealand

biosolids.

This information is correct. It is not,

however, clear if on its own this constitutes

significant new information. The exact

impact would depend on the toxicity; this

would have to be considered in any

assessment.

No

When the treated sewage sludge (biosolids)

is spread on land, and triclosan leaches

down through the soil and runs off into

surface water from the fields.

Concentrations of triclosan in runoff have

been found to be at levels above what was

shown to alter thyroid-mediated gene

expression and development in frogs.

The study (Northcott, 2013) estimating the

concentration of triclosan in runoff from

fields treated with sewage sludge detected

triclosan at concentrations of 258 ± 39

ng/L. The report states that there are

adverse effects upon frog gene expression

and development at 150 ng/L. EPA staff

note that the concentration of triclosan

detected from runoff is greater than the

Canadian PNEC value (115 ng/L). This

does, therefore, constitute significant new

information.

Yes

Triclosan was detected in runoff from

treated fields as long as 266 days after the

biosolids application meaning triclosan can

accumulate in the soil, similar to other

persistent organic pollutants

The exact impact of this will depend on the

toxicity. On its own this does not constitute

significant new information, as the EPA

substance database notes that triclosan is

not rapidly biodegradable.

No

Triclosan has also been shown to persist in

sediment for long periods of time. One

study of sediment cores near wastewater

treatment plants led the authors to state,

“Triclosan concentrations in sediments

show no significant evidence of degradation

within the first few years after deposition.”

This is correct and is a concern for the

EPA, however, the exact impact of this will

depend on the toxicity (EPA staff note that

the Australian and Canadian regulators

pointed out that there was a lack of data on

sediment toxicity). It was also known at the

time of approval that triclosan was not

rapidly biodegradable hence this could not

be described as new information.

It is also not clear if this is the case for all

sediment, or just those in the study which

were tested.

No

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information?

The test must be done according to

Organisation for Economic Cooperation

and Development (OECD) standards. On

its own this does not constitute significant

new information, however, this is

something that EPA staff would need to

take into account in the risk assessment.

Biosolids contain elevated heavy metals

such as copper and zinc. New Zealand

studies have found that the elevated levels

of copper and zinc have inhibited the

degradation of triclosan in solids, raising

concerns that the presence of co-

contaminants in complex waste materials

such as biosolids may combine to produce

synergistic or additive ecotoxicological

impact upon soil function and health

indicators.

This study shows that the degradation and

toxicity of triclosan in soils are affected by

the presence of metals.

This study is preliminary and was not

carried out according to OECD or other

recognised standards. If the EPA were to

reassess this substance EPA staff would

need to take all of these factors into

account, but on its own this report does not

constitute significant new information.

No

New Zealand research into the fate of

triclosan in wastewater and greywater when

applied to soil indicates that triclosan has

the potential to causes significant

environmental contamination in soils and

groundwater.

This research is a master’s thesis. While

the research is well done, none of it is

carried out to any recognised Good

Laboratory Practice (GLP) or to any OECD

standards.

No

Environmental concerns

Triclosan is toxic to algae, phytoplankton,

and other aquatic life.

This information is consistent with the

HSNO classification of the substance (9.1A

i.e. very ecotoxic for fish, crustaceans and

algae). There is a study which investigates

the potential of triclosan to be a non-

steroidal estrogenic compound. The paper

concluded that:

“These results do not support the

hypothesis that triclosan is potently

estrogenic. However, changes in fin length

and non-significant trends in sex ratio

suggest triclosan is potentially weakly

androgenic.”

This is new information but on its own it

would not be significant as the results are

only a suggestion that there may be an

issue.

No

As triclosan’s mode of action is to inhibit

fatty acid synthesis in bacteria, and

because bacteria and plants have similar

The substance is already classified as a

9.1A (very ecotoxic) for algae, so this could

No

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information?

fatty acid biosynthesis pathways, triclosan

may also have inhibitory effects on plants

(the reference is for aquatic plants)

not be considered to be significant new

information.

Triclosan has also been shown to have

genotoxic and cytotoxic effects in algae.

This paper does suggest that the

substance could potentially cause

genotoxic effects. However, the test was

not carried out according to any recognised

test guideline and was not performed in the

recommended species used for

genotoxicity testing. The study is therefore

not significant new information.

No

Triclosan is lipophilic, and has been found

to bioaccumulate in earthworms, and in

algae.

A study provided (Kinney et al, 2008) does

suggest that triclosan can bioaccumulate in

earthworms. EPA staff note that the

information available to the EPA has a data

gap with respect to the toxicity of triclosan

to earthworms. This was known at the time

of the original approval.

The algal study confirmed that triclosan

bioaccumulates in algae. This was known

at the time of approval.

The study also shows that a metabolite

(methyl triclosan) is bioaccumulative. The

exact impact of this would depend on the

toxicity, but this is significant new

information.

Yes

Triclosan has also been demonstrated to

transfer and bioaccumulate in marine food

webs as demonstrated by its presence in

the plasma of Atlantic Bluenose dolphins

It was known that the substance was

bioaccumulative when it was approved, so

this is not new information. However, it

would be considered if the substance is to

be reassessed.

No

Researchers are concerned that it will

accumulate and spread through aquatic

and terrestrial food webs

The reference was not provided but given

the properties of the substance this might

be expected to happen. This was known at

the time of approval.

No

Triclosan has also been found to have

additive and even synergistic effects when

combined with other common contaminants

of waterways, potentially making triclosan

more toxic to aquatic organisms when

multiple pollutants are in waterways, as is

often the case.

The study provided evidence of triclosan

and methyl triclosan being toxic to marine

bacteria. While the result may not be new

information for triclosan it is new

information for methyl triclosan which is a

concern given its tendency to

bioaccumulate.

Yes

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information?

The study found that there may be additive

effects from the triclosan and methyl

triclosan and that there may be synergistic

impacts between triclosan and other

substances likely to be found in waste

water plants such as linear alkyl benzene

sulfonates.

While none of these studies were carried

out using recognised test guidelines used

by the EPA and overseas regulators such

as OECD guidelines (there are no OECD

guideline tests for toxicity tests on marine

bacteria), they still should be considered as

significant new information, especially the

evidence that methyl triclosan is toxic to

marine bacteria.

One study found that a mixture of low

environmentally relevant concentrations of

12 commonly used antibacterial agents

significantly inhibits algal growth, including a

level of triclosan that is well below the

concentration that produced no observed

effect.

This study is significant new information. It

suggests that triclosan is more toxic than

other alternative antibacterials.

The study also indicates that triclosan has

additive effects with other antibacterials,

which is a concern if it is released in

combination with these other substances

(which is a possibility in waste water).

Yes

Triclosan in the home

Triclosan also persists in the home. A 2007

study looking at indoor dust samples found

triclosan present in all samples of dust from

private homes, and in surprisingly large

amounts. “The average value (702 ng/g)

was not far from the micro gram per gram

range, which is the typical level reported for

this compound in sludge.”

No reference was provided. No

Numerous studies have shown that

triclosan, when exposed to sunlight, and

when interacting with chemicals such as

chlorine in tap water, degrades into toxic

breakdown and intermediate products. The

most commonly detected chemical

breakdown products and metabolites of

triclosan include (see bold bullet points

below):

This does appear to be produced as a

breakdown product. The exact impact of

this, however, is unclear. The Canadian

review concluded “DCDDs are not likely to

be of environmental concern”. The

Canadian review also concluded that the

potential for general population exposure to

these DCDDs is expected to be low.

This information does not therefore

constitute significant new information.

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2,8-Dichlorodibenzo-p-dioxin (2,8-

DCDD): a dioxin. Researchers in the UK

and Japan found that close to 1 percent of

triclosan is converted to 2,8-DCDD when

photodegraded, and that the 2,8-DCDD

persists longer than triclosan. 2,8-DCDD

was also found to be a toxic intermediate

product when triclosan degrades in surface

waters, on fiber coatings, and in real

contaminated wastewater samples.

2,4-Dichlorophenol (2,4-DCP): an endo-

crine disruptor and a U.S. EPA priority

pollutant. Detected by researchers in Spain

and Cuba and the USA studying the

degradation of triclosan in the presence of

low levels of chlorine within wastewater

samples, and in a New Zealand soil.

This does appear to be produced by the

degradation of triclosan. It is not however,

clear from the studies referenced if this

substance is an endocrine disruptor.

From the information provided it is also not

clear if 2,4-DCP has been detected in New

Zealand soils separately from an

experiment using lysimeters where

triclosan was deliberately added to the soil.

The Canadian review notes that human

exposure to this chemical from the use of

products containing 2,4-DCP and from the

environment is expected to be low.

No

2,4,6-trichlorophenol (2,4,6-TCP): an en-

docrine disruptor. Detected by researchers

in Spain and Cuba studying the degradation

of triclosan in the presence of low levels of

chlorine. Confirmed in studies by

researchers at Virginia Polytechnic.

This degradation product was found in the

study by Canosa et al (2005). The

significance of this metabolite would

depend on its toxicity. This would need to

be reviewed in any reassessment.

The fact, however, that a metabolite can be

produced in certain conditions does not

necessarily constitute significant new

information.

No

Chloroform: a carcinogen. Researchers at

Virginia Polytechnic found that chloroform is

created when triclosan reacts with free

chlorine in tap water, and that, in some

circumstances, it occurs in levels above the

U.S. EPA Maximum Contaminant Levels for

chloroform in drinking water. The

researchers stated, "...The potential exists

for substantial chloroform production to

occur via daily household use of triclosan-

containing products."

It is true that chloroform is produced,

however, the exact impacts on human

health depends on the exposure. EPA staff

note the conclusions of the Canadian

regulator in 2012 who stated that:

“Triclosan was also shown to react with

chlorine ion in tap water to form chloroform

(Rule et al 2005). The 2001 Government of

Canada Priority Substances List

Assessment Report for Chloroform

(Canada 2001) indicated that human

exposure to chloroform from all potential

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routes and sources of exposure is

expected to be considerably less than the

level to which a person may be exposed

daily over a lifetime without harmful effect.”

This indicates that the information provided

is not significant.

Methyl triclosan: a metabolite of triclosan.

Bioaccumulates in algae and grass shrimp,

has been found to be more bioaccumulative

than triclosan. One study concluded,

"...Triclosan and methyl triclosan have been

identified as two of the major pollutants that

currently contribute to the acute toxicity of

domestic wastewater."

It does appear that methyl triclosan is both

bioaccumulative and persistent. EPA staff

note the review by the Canadian regulator

which stated that although methyl triclosan

is of lesser toxicity than triclosan it is still

highly toxic to the environment.

EPA staff note the conclusion of the

Canadian regulator who concluded that

based on Canadian predicted

environmental concentration (PEC) that

“methyl-triclosan would be unlikely to

represent a risk to aquatic organisms”. It is

not known if this would be the same with

New Zealand use patterns.

While EPA staff note the Canadian

regulators could not carry out a risk

assessment in 2012 of the risks of methyl-

triclosan to sediment dwelling organisms

and terrestrial organisms, EPA staff still

consider that these risks should be

assessed.

Yes

Body burden

Triclosan exposure has become so

common that it has shown up in the blood,

urine and breast milk of people across the

globe. While people who use triclosan

products daily have higher levels of the

chemical in their bodies, even consumers

who do not use triclosan on their skin are

exposed to it through food, water, and even

household dust.

Researchers have found that people in their

3rd decade of life have the highest levels of

triclosan in their bodies.

Although the studies were performed in

USA and Sweden, it can be assumed the

socio-economic status is similar to New

Zealand.



based on the results of the aggregate risk

assessment, it can be concluded that

exposure of adults (including pregnant

females) and children over the age of 6

years to triclosan residues is below the

level of concern.

Furthermore, the results of the Canadian

risk assessment indicate that the

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aggregate risk for children less than 6

years of age, including breastfed infants, is

below the level of concern.

This information can be useful for future

risk assessment, this information does not

constitute “significant new information” this

would, however, need to be considered in

any review of triclosan.

A study of triclosan levels in the blood of

Australians confirms that the 31-45 year old

age group had the highest levels of

triclosan. Overall, though, the researchers

noted that triclosan levels were startlingly

[sic] homogenous. “The most remarkable

feature of the dataset was its homogeneity.

No highly exposed or low-exposure

subgroups were identified.”

One of the two references cited, ‘Allmyr et

al. (2006) The influence of age and gender

on triclosan concentrations in Australian

human blood serum’, was not provided.

The reference that was provided notes that

the study includes a relatively small study

population, exposed for a relatively short

period of time. However the conclusion of

the study authors was that based on the

available information everyday triclosan

use is not likely to cause immediate

adverse effects on thyroid hormone

homeostasis in adult human beings.

No

Women in Australia have levels of triclosan

twice as high as women in Sweden. A

Swedish warning statement in 2000

encouraging consumers to avoid the use of

antibacterial products with triclosan may be

a contributing factor.


Effectiveness of triclosan as an antimicrobial

Triclosan is commonly used in surgical

scrubs and hand washes and has proven to

be an effective agent and treatment for

patients carrying MRSA in their skin.


Although triclosan is effective in killing

microorganisms when applied judiciously by

professionals in health care settings, the

proliferating use by the general population,

which accounts for the vast majority of the

chemicals’ production volume, lacks

convincing data on health benefits,

according to epidemiological studies.

This information may be useful for benefit

analyses in any reassessment of triclosan.

However, in itself it is not considered to be

significant new information that would

trigger the need to reassess triclosan.

No

These seemingly contradictory findings

between antimicrobials’ efficacy in clinical

settings and their failure to perform in

household settings can be understood

easily when considering the contact time

between the chemicals and their microbial

Although efficacy studies of the substances

can be used for a benefits analysis, social

studies on behaviour of the general

population will not be used in the hazard

and risk assessment.

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targets. Thoroughly designed clinical

studies reproducibly yield favourable results

from hand washing times of 30 seconds to

several minutes. However, hand-washing

routines of the general population differ

significantly from this optimal standard. In

real-world settings, the application of soaps

on the hands of consumers is followed

immediately by rinsing away of the active

antimicrobial ingredients. Thus, for the

majority of household consumers, effective

contact times amount to an average of six

seconds, too short to provide a measurable

impact on antimicrobial efficacy.

In 2005, an expert panel convened by the

FDA had concluded by a vote of 11-to-1

that use of antiseptics does not provide a

measurable benefit to consumers.

The reference provided is not significant for

the benefit analyses. The background

materials provided to the expert panel

might be significant. These data have not

been provided to the EPA.

No

This assessment apparently has not

changed in years since, as the FDA has

issued in late 2013 a notice to industry of its

intent to institute tighter regulations in the

near future.

The link provided indicates that the FDA

has proposed to require manufacturers

provide more data to demonstrate safety

and effectiveness of antibiotic soaps.

A change in data requirements from the

FDA doesn’t change the data requirements

under the HSNO Act. Although the data

requirements from regulators

internationally are similar, there are country

specific requirements and guidelines.

No

Health concerns

A number of recent studies lead to

concerns that triclosan is an endocrine

disruptor. Two laboratory studies, on rats

and frogs, demonstrate that triclosan can

disrupt thyroid hormone.

The effects on the thyroid hormone system

in rat have been reported by Crofton et al.

(2007)

EPA staff note the review of the Canadian

regulator which concluded that the current

level of information does not support a

conclusion that triclosan may cause

adverse effects on thyroid function in

humans.

EPA staff also note that the European

Chemicals Agency (ECHA) has requested

that further studies be conducted in order

to determine whether triclosan is an

endocrine disruptor or not.

Until this information is available, it is

unlikely to be possible to determine

New information

but not significant

by itself.

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whether triclosan should be considered an

endocrine disruptor and to perform a risk

assessment.

In the frog study, researchers found that

tadpoles exposed to low levels of triclosan

have altered thyroid hormone-mediated

development. Exposure to triclosan also

disrupts thyroid hormone-associated gene

expression

Veldhoen et al. (2006) studied the effects

of triclosan on precocious metamorphosis

in bullfrog (Rana catesbeiana) tadpoles.



these studies do not demonstrate a

consistent effect of triclosan on thyroid-

mediated amphibian metamorphosis.

EPA staff also note the conclusion of

NICNAS that this study in isolation is

considered insufficient to determine the

regulatory endpoint, these data contribute

to the weight of evidence that adverse

effects are likely to occur at concentrations

below those measured in the field.

While EPA staff note the conclusions of

other regulators, EPA staff believe that

these risks should be assessed.

New information,

but not significant

by itself.

…and alters female postnatal reproductive

development and uterine response to

exogenous estrogen in the developing

female rat.

Stoker et al. (2010) performed an

uterotrophic and a puberatal assay in

female Wistar rats.

EPA staff note that ECHA has requested

new studies be conducted to consider


endocrine disruptor. These studies are

expected to include consideration of

possible estrogenic effects.

Until this information is available, it is

unlikely to be possible to determine


endocrine disruptor.

New information,

but not significant

by itself.

A study by British researchers found that

triclosan has estrogenic and androgenic

hormone properties, and exposure could

potentially contribute to the development of

breast cancer.

Gee et al. (2008) concluded that triclosan

possesses intrinsic oestrogenic and

androgenic activity in a range of assays in

vitro.

EPA staff note the conclusion of the ECHA

(European Chemicals Agency) that the

results of these assays demonstrate

binding of Triclosan to the hER and the

hAR rather than estrogenic or androgenic

effects.

New information,

but not significant

by itself.

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While EPA staff note the conclusion of

ECHA, EPA staff believe that these risks

should be assessed. However, until more

information is available it may not be

possible to determine whether triclosan

contribute to the development of breast

cancer and to perform a risk assessment.

A more recent study has found that

triclosan promoted the growth of human

breast cancer cells in lab dishes and breast

cancer tumours in mice.

Lee et al. (2014) concluded that exposure

to triclosan may significantly increase the

risk of breast cancer development and

adversely affect human health. However,

the relevance of an in vitro study to an

assessment of whether triclosan may have

the potential to cause cancer in humans is

very limited.

No

Triclosan was investigated for links to

allergies, asthma and hay fever in the

United States. Triclosan levels in children

under 18 years of age were tightly

correlated with development of these

diseases in data taken from the 2003-2006

USA NHANES database.

These studies have multiple limitations, but

the ability of triclosan to affect the immune

system should be further studied.

This information could be useful for a future

risk assessment, however this information

does not constitute “significant new

information”. The information would need

to be considered in any reassessment of

triclosan.

No

Similar results have been found in Norway. Bertelsen et al. (2012) concluded that

rhinitis was associated with the highest

levels of triclosan, whereas no association

was seen for current asthma.






triclosan.

No

Levels of triclosan in urine have also been

found to be significantly associated with

allergic sensitisation, especially in males.

These studies have multiple limitations, but

the ability of triclosan to affect the immune

system should be further studied.






triclosan.

No

Researchers at UC Davis found that

triclosan elevates calcium levels in cells,

which can potentially affect

Ahn et al. (2008) concluded that triclosan

has shown weak agonistic activity in the

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neurodevelopment and neurological

function.

aryl hydrocarbon receptor (AhR)-

responsive bioassay.

Although these observations have potential

implications for human and animal health,

further investigations are needed.

Resistance concerns and efficacy

Two review articles summarising the

literature on resistance and efficacy of

triclosan came to the same conclusion:

there is a public health risk of bacteria

becoming cross-resistant to triclosan and

antibiotics and that the two are linked.


analysis in any reassessment of triclosan.




No

One study also concludes that, for

consumer use, triclosan has no added

health benefits over soap and water. The

researchers conclude, “The results of our

review call into question the marketing of

soaps containing triclosan as a product

providing efficacy beyond the use of plain

soap in the community setting... Current

findings warrant actions by the FDA for

evaluating consumer product advertising

claims.”


analysis in any reassessment of triclosan.




No

In a risk assessment by the Norwegian

Scientific Committee for Food Safety,

experts concluded: “Widespread use of

triclosan, including use in cosmetic

products, selects for development of

triclosan resistance. Since this may

contribute to the development and spread

of concomitant resistance to clinically

important antimicrobial agents, such use

represents a public health risk. Therefore,

the use of triclosan should be restricted.”


SCENIRH8 that in order to clearly

characterize potential risk, new data and

methodologies are needed, including

quantitative data on exposure to biocides,

surveillance programs to evaluate the

ability of a biocide to induce/select for

resistance against biocides and antibiotics,

as well as environmental studies to identify

and characterise biocide-related resistance

and cross-resistance to antibiotics

(SCENIRH 2009, 2010).

The EU’s SCCS9 concluded that, based on

the available scientific information, it is not

possible to quantify the risk of development

of antimicrobial resistance induced by

triclosan applications, including its use in

cosmetics (SCCS 2010).

No

Muscle impairment

8 Scientific Committee on Emerging and Newly Identified Health Risks 9 Scientific Committee on Consumer Safety (SCCS)

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According to a study at the University of

California, Davis and the University of

Colorado, exposure to triclosan is linked in

humans and mice with: Depressing

hemodynamics (blood flow), impairing

cardiac and skeletal muscle function. In

mice they showed a 25% reduction in heart

function within 20 minutes of exposure to

triclosan, and a 18% reduction in grip

strength for up to 60 minutes after being

given a single dose of triclosan. They also

demonstrated that exposure to triclosan

caused a slowing of swimming in fish.

The researchers report that triclosan

interferes with Excitation Contraction-

Coupling (ECC) and calcium signaling,

entry and release. Calcium ions (Ca2+)

play a pivotal role in cell physiology where

they act as messengers that regulate

muscle contraction and many other

processes in cells, such as normal cell

function, neural transmission, intracellular

signaling, blood coagulation, bone

structure, secretion and membrane stability.

The report said that triclosan (even in low

concentrations) can:

• Disrupt the signaling between the L-type

(long-lasting) Ca2+ (calcium ions)

channels and Ca2+ release channels

(ryanodine receptors) in skeletal muscle

• Impair L-type Ca2+ entry in cardiac

muscle

• Interfere with ‘excitation-contraction

coupling’.

According to the study cited

(Cherednichenko et al. 2012) a cardiotoxic

effect on humans is suspected based on

the in vitro and in vivo data in mice.

EPA staff note that the relevance of a study

in mice conducted by i.p.10 administration

at high doses may be of limited value in

assessing risks to humans from anticipated

exposure routes and doses.

This information may be useful for a future

risk assessment but it does not constitute

“significant new information” alone.

No

Nasal colonisation of Staphylococcus aureus

Because the biocide triclosan is used in

many personal care products, including

toothpastes, soaps, clothing, and medical

equipment it is present as a contaminant in

the environment and has been detected in

some human fluids, including serum, urine,

and milk. Staphylococcus aureus is an

Syed et al. (2014) concluded that triclosan

is commonly found in the nasal secretions

of healthy adults and the presence of

triclosan trends positively with nasal

colonisation by S. aureus.

No

10 Intraperitoneal injection

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opportunistic pathogen that colonizes the

noses and throats of approximately 30% of

the population. Colonisation with S. aureus

is known to be a risk factor for several types

of infection. Researchers have found that

triclosan is commonly found in the nasal

secretions of healthy adults and the

presence of triclosan trends positively with

nasal colonisation by S. aureus. This shows

that triclosan can promote the binding of S.

aureus to host proteins such as collagen,

fibronectin, and keratin. They also found

that triclosan-exposed rats are more

susceptible to nasal colonisation with S.

aureus.

Although this study is of interest it is not

sufficient in isolation to trigger a

reassessment. Further research is likely to

be needed.

Triclosan was shown in 2005 to impair

mitochondrial function in mammalian cells.

This study could potentially provide

information on the mode of action of

triclosan in animal cells. However it does

not provide information on the toxicological

effects of triclosan in vivo which could be

used in a risk assessment. Further

experiments are being carried out in order

to evaluate possible deleterious effects of

triclosan on oral epithelium.

This information may be useful for any

future risk assessment of triclosan as part

of a weight of evidence evaluation.

However it does not constitute “significant

new information”.

No

A Study this year [Ajoa et al 2014] has

found triclosan exerts adverse effects

towards different somatic and reproductory

cells at extracellular concentrations 100 -

1000 fold lower that those permitted in

consumer goods (<1–5 μg/mL). Repeated

external exposures may result into adverse

effects especially in cells that are non-

renewable (pancreatic β-cells) or where

there is no elimination route, e.g. testis or

neuronal cells. Triclosan as a mitochondrial

toxic chemical, depending on its tissue

distribution and elimination, may lead to

unexpected long-term toxic effects similar

to what has resulted into withdrawal of

numerous mitochondrial toxic

pharmaceuticals.

Ajoa et al (2014) concluded that triclosan is

a mitochondrial toxic chemical which,

depending on its tissue distribution and

elimination, may lead to unexpected long-

term toxic effects.

However this study does not provide

information on the toxicological effects of

triclosan in vivo which could be used in a

risk assessment. This information may be

useful for any future risk assessment of

triclosan as part of a weight of evidence

evaluation. However it does not constitute

“significant new information”.

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