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epa.govt.nz
Application for the modified reassessment of a hazardous substance
Under Section 63A of the Hazardous Substances and New Organisms Act 1996
Chemical Review 2015: A modified reassessment of a range of substances for which new information was obtained in 2015
Application number: APP202961
Applicant: Chief Executive, Environmental Protection Authority
Chemical Review 2015 (APP202961) 2
Applicant’s details
Name: Allan Freeth, Chief Executive
Address: EPA, Level 10, 215 Lambton Quay, Private Bag 63002, Wellington 6140
Phone: 04 474 5403
Fax: 04 914 0433
Email: [email protected]
Applicant’s contact person
Name: Gayle Holmes
Address: EPA, Level 10, 215 Lambton Quay, Private Bag 63002, Wellington 6140
Phone: 04 474 5463
Fax: 04 914 0433
Email: [email protected]
Signature of Applicant
31 July 2019
Allan Freeth Date
Chief Executive
Environmental Protection Authority
Chemical Review 2015 (APP202961) 3
Background
The Environmental Protection Authority regularly receives new information from stakeholders regarding the
classifications and controls of substances. EPA staff also note where changes to approvals are needed.
Where those changes are not minor or technical, these changes require a reassessment or a modified
reassessment of the approval of the substance under the HSNO Act 1996 (“the Act”)
The Chemical Review is intended as a means of making changes to a number of approvals at once, taking
into account the new information available to the EPA. This is undertaken as a modified reassessment under
section 63A of the Act. This application makes recommendations to change some or all of the following
aspects of the approvals in this application:
The approval name of the substance
The hazard classification(s) applied to the substance
The controls applied to the substance
The controls changes proposed are largely as a result of changes to the hazard classifications of the
substances in this application. These consist of changes to the default controls, as well as changes in
variations of controls, to fit current practise based on recent approvals.
It is important to note that the proposals of EPA staff may or may not be supported by the
decision-making committee for this application. The decision-making committee can choose to
accept, reject or modify the recommendations. For this reason the EPA encourages submissions on
the proposed changes. Additionally, note that a modified reassessment under section 63A of the Act
may not revoke an approval given to a hazardous substance under this Act to import or manufacture
the substance (section 63A (2)(b) of the Act).
Grounds for reassessment
Grounds for reassessment have been obtained as part of the Grounds application, APP202227. A
decision-making committee determined that there were grounds for the reassessment of the substances
listed in the application for grounds for reassessment.
Substances in application
The substances covered by this application are identified in Appendices 1 and 2. These are grouped as
follows:
Appendix 1: Substances for which there is new information.
Chemical Review 2015 (APP202961) 4
Appendix 2: Confidential substances, where a component of a substance appears in Appendix 1, but the
presence of the component in the substance is confidential.
These appendices note the name of the substance, the approval number, the current and proposed
classifications, and the proposed changes to the controls. In Appendix 1, an explanation of the reasoning for
the classification and/or controls changes is given. For Appendix 2, the corresponding explanation is only
provided in the confidential appendix to this application.
Substances for which there is new information
This section discusses the changes to substances likely to be of particular importance to submitters or where
the EPA seeks further information. Included in this section are a range of single chemical approvals and
approvals for mixtures. Where changes recommended for a substance affect mixtures containing that
substance, changes proposed to affected mixtures are also detailed. Changes that may be of particular note
to submitters are:
Benzaldehyde (approval number HSR001395)
The classification of this chemical is proposed to be downgraded from a 3.1C flammable liquid classification
to a 3.1D combustible liquid classification. A number of other changes to the classification are proposed in
line with information in the EU REACH registration dossier. These changes will affect many
benzaldehyde-containing products using group standard approvals. Companies with products that contain
benzaldehyde are encouraged to determine how the proposed changes will affect their products.
Butylated hydroxytoluene (approval number HSR002784)
Based on new information, the staff propose that:
the 6.1D acute oral toxicity classification is removed;
the 9.3C vertebrate ecotoxicity classification is removed;
the sensitisation (6.5B), reproductive/developmental toxicity (6.8C) and specific target organ
toxicity (6.9B) classifications are removed;
the aquatic ecotoxicity hazard classification increases from 9.1D to 9.1A.
Several default controls will be removed as they are no longer applicable, as well as the corresponding
changes associated with the increased ecotoxicity classification. These changes will result in changes to the
hazard classifications of a number of substances with individual approvals, and will also affect many
products using group standard approvals. Companies with products that contain butylated hydroxytoluene
are encouraged to determine how the proposed changes will affect their products.
Furfuryl alcohol (approval number HSR002998)
Based on new information from a number of sources, the staff propose that:
the acute toxicity classifications are increased from 6.1D (oral, dermal, inhalation) to 6.1B
(inhalation) and 6.1C (oral, dermal); and
Chemical Review 2015 (APP202961) 5
the following classifications are added:
o 3.1D (combustible liquid);
o 6.1E (respiratory irritation);
o 6.3A (skin irritation);
o 8.3A (eye damage);
o 6.7B (carcinogenicity);
o 6.9A (specific target organ toxicity - inhalation);
o 6.9B (specific target organ toxicity - oral);
o 9.3B (vertebrate ecotoxicity).
These changes will affect a number of substances with individual approvals, and will also affect many
products using group standard approvals. Companies with products that contain furfuryl alcohol are
encouraged to determine how the proposed changes will affect their products.
Iodocarb (approval number HSR002733)
Based on new information, the classification of this approval is proposed to:
upgrade the eye irritant classification (6.4A) to eye damage (8.3A);
remove the skin irritant classification (6.3B);
remove the specific target organ toxicity classifications for oral (6.9B) and dermal (6.9B)
exposure;
add specific target organ toxicity classification for inhalation exposure (6.9A (inhalation)).
These changes will affect a number of substances with individual approvals, and will also affect many
products using group standard approvals given the widespread use of iodocarb as a water-soluble
preservative in the paints and coatings, wood preservatives, personal care and cosmetics industries.
Companies with products that contain iodocarb are encouraged to determine how the proposed changes will
affect their products.
N-Methylpyrrolidinone (approval number HSR001384)
This approval currently has a 6.8A reproductive toxicity classification. However, this classification has not
consistently been applied to mixtures containing N-methylpyrrolidinone. A number individual approvals for
substances that contain >0.1% N-methylpyrrolidinone are proposed to be revised to include a 6.8A
classification. Companies with products using group standard approvals that contain N-methylpyrrolidinone
are encouraged to check that their products are classified correctly.
Propazine (approval number HSR003357)
The classification of this approval is proposed to be revised by removing the 6.7B carcinogenicity
classification in line with information in the US EPA assessment. These changes will affect several
propazine-containing substances with individual approvals.
Sulfur (approval number HSR001284)
The classification of this approval is proposed to be revised in line with information in the EU REACH
registration dossier by adding acute toxicity classifications 6.1E (oral, dermal, inhalation) and a skin irritant
Chemical Review 2015 (APP202961) 6
classification and removing the eye irritant classification. These changes will affect a number of
sulfur-containing substances with individual approvals, and will also affect many products using group
standard approvals. Companies with products that contain sulfur are encouraged to determine how the
proposed changes will affect their products.
Confidential Substances
Confidential Appendix 2 contains approvals where a component changing in classification is not, to the
EPA’s knowledge, publicly disclosed as being in the approved substance.
Controls Codes
Appendix 3 lists the text of the controls referred to by their control codes in appendices 1 and 2.
Submissions
Electronic submissions are encouraged. Please send your submissions to:
Environmental Protection Authority
Private Bag 63002
Wellington 6140
Email: [email protected]
Phone: +64 4 916 2426
Fax: +64 4 914 0433
All submissions must be received by 5pm, 25 September 2019
Any submissions received will be used to inform a decision-making committee to assist their evaluation of
the proposed changes. Confidential information may be provided in a separate document attached to the
main submission.
In accordance with section 54 of the Act, submitters must state the reasons for making the submission, and
whether the person making the submission wishes to be heard at a public hearing. The submission may also
state any particular decision sought.
Chemical Review 2015 (APP202961) 7
Appendix 1. Substances for which there is new information
Table 1: Approved substances with proposed changes
Substances affected Approval
numbers
Current
classification
Proposed
classification Effect on controls Justification for change
Benzaldehyde
CAS# 100-52-7
HSR001395 3.1C, 6.1D (oral),
6.1D (dermal),
6.3B, 6.5B, 9.1D,
9.2D, 9.3C
3.1D, 6.1D (oral),
6.3B, 6.4A, 9.1D,
9.2D, 9.3C
Remove:
HSW8-1, HSW10-1,
HSW10-4, HSW10-10,
HSW10-13, HSW10-15,
HSW13-7.
The flashpoint of benzaldehyde is 63-64 ºC, above the
threshold of 60 ºC for classification as 3.1C. Therefore we
propose to downgrade this to 3.1D
The current acute dermal toxicity classification of 6.1D is
based on a rabbit study indicating an LD50 of 1250 mg/kg.
However, this is more correctly expressed as being > 1250
mg/kg, given the study summary and supporting
information in the EU registration dossier. We consider that
there is no sufficient information to warrant classification as
6.1D (dermal) at this time, and so propose to change this
classification to ND.
Based on animal studies the addition of 6.4A and removal
of the 6.5B classification is proposed.
Benzenesulphonic acid,
4-[[1-[[(2-methylphenyl)-
amino]carbonyl]-2-
oxopropyl]azo]-3-nitro-,
calcium salt (2:1)
CAS# 12286-66-7
Pigment Yellow 62
HSR007202 6.7A Non-hazardous,
carcinogenicity is
ND (no data)
Remove:
all controls.
The original classification was based on the substances
being identified as an azo dye, some of which have been
associated with carcinogenicity. This substance is more
correctly referred to as an azo pigment and it does not
have structural similarity to the azo dyes associated with
carcinogenicity.
The REACH registration for this substance states that this
substance has no GHS classifications.
No data is available on carcinogenicity. We propose
removing this classification as there is no evidence to
justify classification.
Chemical Review 2015 (APP202961) 8
Substances affected Approval
numbers
Current
classification
Proposed
classification Effect on controls Justification for change
Butylated
hydroxytoluene
CAS# 128-37-0
Synonyms:
BHT
Phenol, 2,6-bis(1,1-
dimethylethyl)-4-methyl-
HSR002784 6.1D (oral), 6.5B,
6.8C, 6.9B (oral),
9.1D, 9.3C
9.1A Remove:
HSW2-4, HSW3-1,
HSW3-2, HSW4-2,
HSW13-3, HSW13-7,
HSW13-8, HSW13-9,
HSW16-1.
New information has become available that supports
revising the hazard classifications of this substance. This
new data does not support the acute toxicity, sensitiser,
reproductive/developmental toxicity and specific target
organ toxicity classifications.
New data provided supported the increase of the
ecotoxicity classification of this substance from 9.1D to
9.1A. This was based on the aquatic toxicity value found in
the Daphnia magna acute test and the fact that this
substance is bioaccumulative and not readily degradable.
There are no studies available for birds, thus the 9.3C
classification is based on the acute toxicity data with
mammals. The LD50 value (> 2930 mg/kg) indicates that
there is no reason to classify this substance for vertebrate
ecotoxicity.
Dioctyltin dilaurate or
(Stannane, dioctylbis[(1-
oxododecyl)oxy]-)
CAS# 3648-18-8
HSR007500 3.1C 6.9A (oral) Remove:
HSW2-2, HSW5-1,
HSW8-1, HSW8-2,
HSW10-1, HSW10-3,
HSW10-4, HSW10-5,
HSW10-10, HSW10-12,
HSW10-13, HSW10-15,
HSW11-1.
Add:
HSW13-2, HSW13-3,
HSW13-8, HSW13-9,
HSW13-14.
New information was provided to the EPA relating to dioctyl
tin oxide (CAS No 870-18-6) that indicates that the
substance warrants classification as a target organ toxicant
by the oral route. The staff consider that it is appropriate to
use a ‘read-across’ argument to apply this classification to
dioctyltin dilaurate.
The EU REACH dossier for this substance includes an
experimental value of 198 ºC as justification for not
classifying the substance as a flammable liquid. We
therefore propose to remove the 3.1C classification.
Chemical Review 2015 (APP202961) 9
Substances affected Approval
numbers
Current
classification
Proposed
classification Effect on controls Justification for change
Furfuryl Alcohol
CAS# 98-00-0
Synonyms include:
2-furanmethanol
Furfuranol
2-hydroxymethylfuran
HSR002998 6.1D (oral, dermal,
inhalation)
3.1D, 6.1B
(inhalation), 6.1C
(oral, dermal),
6.1E (respiratory
irritation), 6.3A,
6.7B, 6.9A
(inhalation), 6.9B
(oral), 8.3A, 9.3B
Add:
HPC-2, HPC-4A,
HPC-4B;
HSW4-1, HSW5-1,
HSW8-2, HSW10-3,
HSW10-5, HSW10-12,
HSW11-1, HSW13-1,
HSW13-4, HSW13-5,
HSW13-7, HSW13-13,
HSW13-15, HSW13-16,
HSW13-17, HSW19-1.
We undertook a full review of the classification of furfuryl
alcohol. This included a range of publications, studies and
the EU CLP GHS classifications.
A 3.1D classification should be added as this substance
has a flashpoint of 65°C.
The acute toxicity classifications are proposed to be
changed on the basis of study data. There was a lack of
complete data and so the lowest LD50 value was used for
classification in each case. Rat and mice studies also
indicated this substance may cause respiratory irritation so
a 6.1E (respiratory irritation) classification is proposed.
The results of a series of animal studies indicate that 6.3A,
8.3A, 6.7B and 6.9 classifications are also warranted.
A 9.3B classification is proposed based on the acute oral
toxicity study in rats.
Furfuryl alcohol, >25% in
a non-hazardous diluent
HSR007402 6.1D (oral, dermal,
inhalation)
3.1D, 6.1B
(inhalation), 6.1C
(oral, dermal),
6.1E (respiratory
irritation), 6.3A,
6.7B, 6.9A
(inhalation), 6.9B
(oral), 8.3A, 9.3B
GTL gasoil
CAS# 848301-67-7
HSR100066 6.1E (oral), 6.7B,
9.1B
6.1E (oral), 9.1B Remove:
HSW13-3.
GTL Gasoil was previously classified 6.7B based on the
classifications of diesel fuel in the absence of other
available information. Shell provided new information on
the genotoxicity of GTL Gasoil which indicated that this
substance was not carcinogenic. Thus the 6.7B
classification should be removed.
Hydrogen peroxide,
8-20% aqueous solution
HSR001450 5.1.1C, 6.1E (oral),
6.9B (oral,
inhalation), 8.3A,
9.1D
5.1.1C, 6.1E (oral),
6.9B (oral,
inhalation), 8.3A
Remove:
HPC-4A, HPC-4B.
Hydrogen peroxide is classified as 9.1D. Based on our
mixture rules the cut-off for applying a 9.1D classification to
mixtures of hydrogen peroxide is a concentration of >25%.
As the concentration of hydrogen peroxide in this
substance is under 25%, this substance should not have
the 9.1D classification.
Chemical Review 2015 (APP202961) 10
Substances affected Approval
numbers
Current
classification
Proposed
classification Effect on controls Justification for change
Hydroperoxide,
1,1-dimethylethyl,
70% aqueous solution
CAS# 75-91-2
Synonyms:
Tert-butyl hydroperoxide
TBHP
HSR001365
5.2F, 6.1C
(dermal), 6.1D
(inhalation), 6.1D
(oral), 6.6B, 6.9B
(oral), 8.2C, 8.3A,
9.1B, 9.3B
3.1C, 5.2F, 6.1C
(dermal), 6.1B
(inhalation), 6.1D
(oral), 6.5B, 6.6B,
6.9B (oral), 8.2C,
8.3A, 9.1B, 9.3B
Add:
HSW4-1, HSW10-1,
HSW10-3, HSW10-4,
HSW10-5, HSW10-10,
HSW10-12, HSW10-13,
HSW10-15, HSW11-1,
HSW13-4, HSW19-1.
New information is available from EU registration of this
substance.
This substance has a boiling point of 89 °C and a flashpoint
of 43 °C which corresponds to a 3.1C classification.
Under the conditions of a rat study the 4h rat LC50 for
TBHP was 500 ppm, corresponding to 1843 mg/m3
(vapour), so 6.1B (inhalation) classification is warranted.
TBHP was also found to cause delayed contact
sensitisation in Guinea pigs and we therefore propose to
add a 6.5B classification to this substance.
Iodocarb
CAS# 55406-53-6
Synonyms:
3-iodo-2-propynylbutyl
carbamate
IPBC
HSR002733
6.1D (oral),
6.1C (inhalation),
6.3B, 6.4A, 6.5B,
6.9B (dermal),
6.9B (oral), 9.1A,
9.3C
6.1D (oral),
6.1C (inhalation),
8.3A, 6.5B,
6.9A (inhalation),
9.1A, 9.3C
No change. New information is available relating to the classification of
iodocarb, in particular publications from the EU including a
RAC review and a CLH harmonised classification proposal.
Based on the new information, several changes should be
made to the classifications of iodocarb.
The 6.3B classification should be removed based on the
result of a skin irritation/corrosion study presented in the
EU RAC review.
New data has been provided to the EPA that demonstrates
that the effect on the eye should be upgraded from irritant
(6.4A) to corrosive (8.3A). This was based on testing
results where there was no sign of recovery in the
incidence or severity of effects prior to termination of the
study, so the reversibility requirements to classify as an eye
irritant are not met. This is corroborated by the EU CLP
GHS classification of iodocarb.
We propose that the 6.9B dermal and oral classifications
be removed. This is based on the results of studies that
found that no changes or no functional changes were
observed in repeated dose dermal or oral studies
respectively.
Chemical Review 2015 (APP202961) 11
Substances affected Approval
numbers
Current
classification
Proposed
classification Effect on controls Justification for change
Iodocarb should be classified as 6.9A (inhalation) based on
studies demonstrating increased incidence of
histopathological changes in the larynx, with a lowest
observed effect concentration of 0.0067 mg/L.
Protim Antimould HSR000017 6.1D (oral), 6.4A,
6.5B, 6.9B (oral),
9.1A, 9.3C
6.1D (oral), 8.3A,
6.5B, 6.9A
(inhalation), 9.1A,
9.3C
No change. Changes based on changes to iodocarb.
Ready to use liquid
containing 2.5 g/litre
cyproconazole and
1 g/litre iodocarb
(Substance A)
HSR000632 6.4A, 6.7B, 6.8C,
6.9B, 9.1A
6.4A, 6.7B, 6.8C,
9.1A
No change. Changes based on mixture rules.
Ready to use liquid
containing 2.5 g/litre
cyproconazole and
1 g/litre iodocarb
(Substance B)
HSR000635 9.1B 6.8B, 9.1B Add:
HSW2-4, HSW3-1,
HSW3-2, HSW4-2,
HSW13-3, HSW13-8,
HSW13-9, HSW16-1.
Changes based on mixture rules.
Emulsifiable
concentrate
containing 603
g/litre didecyl
dimethyl ammonium
chloride and 71
g/litre iodocarb
(Substance A)
HSR000832 3.1C, 6.1C
(inhalation), 6.1C
(oral), 6.1E
(dermal), 6.5B,
6.7B, 6.9B
(dermal), 6.9B
(oral), 8.2B, 8.3A,
9.1A, 9.3B
3.1C, 6.1C
(inhalation), 6.1C
(oral), 6.1E
(dermal), 6.5B,
6.7B, 6.9B
(inhalation), 8.2B,
8.3A, 9.1A, 9.3B
No change. Changes based on iodocarb.
Chemical Review 2015 (APP202961) 12
Substances affected Approval
numbers
Current
classification
Proposed
classification Effect on controls Justification for change
Emulsifiable
concentrate
containing 330
g/litre of iodocarb
HSR000859 6.1C (inhalation),
6.1E (oral), 6.3B,
6.4A, 6.5B, 6.9B,
9.1A
6.1C (inhalation),
6.1E (oral), 8.3A,
6.5B,
6.9A (inhalation),
9.1A, 9.3C
No change. Changes based on iodocarb.
Emulsifiable
concentrate
containing 36 g/litre
carbendazim, 20-21
g/litre iodocarb and
460 g/litre sodium
orthophenylphenate
HSR000874 6.1D (oral), 6.3A,
6.5B, 6.6A, 6.8A,
6.9A, 8.1A, 8.3A,
9.1A, 9.2B, 9.3C
6.1D (oral), 6.3A,
6.5B, 6.6A, 6.8A,
6.9A (oral), 6.9B
(inhalation), 8.1A,
8.3A, 9.1A, 9.2B,
9.3C
No change. Changes based on iodocarb and including all routes of
exposure.
Soluble concentrate
containing 500
g/litre benzalkonium
chloride, 50 g/litre
iodocarb and
50 g/litre
propiconazole
HSR000876 6.1D (oral), 6.1D
(dermal), 6.5A,
6.5B, 6.9B, 8.2C,
8.3A, 9.1A, 9.3B
6.1D (oral), 6.1D
(dermal), 6.5B,
6.9B (oral,
inhalation), 8.2B,
8.3A, 9.1A, 9.3B
Add:
HSW13-1, HSW13-13,
HSW13-15, HSW13-16,
HSW13-17.
Changes based on iodocarb, mixture rules and including all
routes of exposure.
Emulsifiable
concentrate
containing 40 g/litre
iodocarb and 120
g/litre orthophenyl
phenol
HSR000878 3.1D, 6.1D (oral),
6.3A, 6.5B, 6.9B
(oral), 8.3A, 9.1A,
9.2B, 9.3C
3.1D, 6.1D (oral),
6.3A, 6.5B, 6.9B
(oral, inhalation),
8.3A, 9.1A, 9.2B,
9.3C
No change. Changes based on iodocarb.
Chemical Review 2015 (APP202961) 13
Substances affected Approval
numbers
Current
classification
Proposed
classification Effect on controls Justification for change
Soluble concentrate
containing 500
g/litre benzalkonium
chloride, 50 g/litre
guazatine and
50 g/litre iodocarb
HSR000886 6.1C (oral), 6.5A,
6.5B, 6.7B, 6.9B,
8.2C, 8.3A, 9.1A,
9.3B
6.1D (oral),
6.1D (dermal),
6.1D (inhalation),
6.5B, 6.9B (oral
and inhalation),
8.2B, 8.3A, 9.1A,
9.3B
Remove:
HPC-2;
HSW13-5.
Changes based on iodocarb, mixture rules and including all
routes of exposure.
Emulsifiable
concentrate
containing
0.65 g/litre 5-chloro-
2-methyl-
4-isothiazolin-3-one,
600 g/litre didecyl
dimethyl ammonium
chloride 70 g/litre
iodocarb and 0.18
g/litre 2-methyl-
4-isothiazolin-3-one
HSR000892 3.1C, 6.1C (oral),
6.5B, 6.8B, 8.2B,
8.3A, 9.1A, 9.3B
3.1C, 6.1C (oral),
6.5B, 6.8B, 6.9B
(inhalation), 8.2B,
8.3A, 9.1A, 9.3B
No change. Changes based on iodocarb.
Soluble concentrate
containing 245
g/litre benzalkonium
chloride, 87 g/litre
boric acid and
23 g/litre iodocarb
HSR000900 6.1D (oral), 6.1E
(dermal), 6.5A,
6.5B, 6.8B, 6.9A,
8.2C, 8.3A, 9.1A,
9.3C
6.1D (oral), 6.1E
(dermal), 6.5B,
6.8B, 6.9A (oral),
6.9B (dermal),
6.9B (inhalation),
8.2B, 8.3A, 9.1A,
9.3C
Add:
HSW13-1, HSW13-13,
HSW13-15, HSW13-16,
HSW13-17.
Changes based on iodocarb, mixture rules and including all
routes of exposure.
Chemical Review 2015 (APP202961) 14
Substances affected Approval
numbers
Current
classification
Proposed
classification Effect on controls Justification for change
Emulsifiable
concentrate
containing 0.6 g/litre
5-chloro-2-methyl-
4-isothiazolin-3-one,
311.1 g/litre didecyl
dimethyl ammonium
chloride, 36.5 g/litre
iodocarb and 0.2
g/litre 2-methyl-4-
isothiazolin-3-one
HSR000903 3.1C, 6.1C (oral),
6.5B, 6.8B, 6.9A,
8.2B, 8.3A, 9.1A
(F), 9.3B
3.1C, 6.1C (oral),
6.5B, 6.8B,
6.9A (oral), 6.9B
(inhalation), 8.2B,
8.3A, 9.1A, 9.3B
No change. Changes based on iodocarb.
TF3 Substance A HSR002459 3.1D, 6.1C (oral),
6.1E (dermal),
6.5A, 6.5B, 6.8A,
6.9B (oral), 8.2C,
8.3A, 9.1A, 9.3B
3.1D, 6.1C (oral),
6.1E (dermal),
6.5A, 6.5B, 6.8A,
6.9B (oral, dermal
and inhalation),
8.2C, 8.3A, 9.1A,
9.3B
No change. Changes based on iodocarb and including all routes of
exposure.
TF3 Substance B HSR002460 3.1D, 6.1D (oral),
6.1E (dermal),
6.5A, 6.5B, 6.8A,
6.9B (oral), 8.2C,
8.3A, 9.1A, 9.3B
3.1D, 6.1D (oral),
6.1E (dermal),
6.5A, 6.5B, 6.8A,
6.9B (oral, dermal
and inhalation),
8.2C, 8.3A, 9.1A,
9.3B
No change. Changes based on iodocarb and including all routes of
exposure.
Blue Control IC HSR002472 6.1B (inhalation),
6.3B, 6.5B, 6.7B,
6.9A (oral), 6.9B
(dermal), 8.3A,
9.1A, 9.2C, 9.3B
6.1B (inhalation),
6.5B, 6.7B, 6.9A
(oral), 6.9A
(inhalation), 8.3A,
9.1A, 9.2B, 9.3B
No change. Changes based on iodocarb and mixture rules.
Chemical Review 2015 (APP202961) 15
Substances affected Approval
numbers
Current
classification
Proposed
classification Effect on controls Justification for change
Ready to use liquid
containing 2.5 g/litre
cyproconazole and
1 g/litre iodocarb
(Substance C)
HSR007703 6.5B, 6.8B, 9.1B 6.5B, 6.8B,
6.9B (oral), 9.1B
No change. Changes based on iodocarb and mixture rules.
Linflo 450 HSR000938 6.1E (oral), 6.4A,
6.8B, 6.9A (oral),
9.1A, 9.2A
6.1E (oral), 6.4A,
6.8B, 6.9A (oral),
9.1A, 9.2A, 9.3B
No change. Substance should have a 9.3B classification based on
mixture rules and the 9.3B classification of the component
linuron.
N-Methylpyrrolidinone
CAS# 872-50-4
Synonyms:
NMP
1-methyl-2-pyrrolidinone
HSR001384 6.1E (oral), 6.3A,
6.4A, 6.8A
No changes to
classifications.
No change. N-Methylpyrrolidinone has a 6.8A classification. However,
this has not been applied to all of the mixtures containing
this substance.
A 6.8A classification is proposed to be added to affected
mixtures containing ≥ 0.1% N-methylpyrrolidinone that do
not currently have a 6.8A classification.
Oils, Fish
CAS# 8016-13-5
Synonyms:
Fish oil
Fats and glyceridic oils,
fish
HSR005575 5.1.1C Remove 5.1.1C Remove:
all controls.
As no data can be found to support the 5.1.1C
classification, it should not apply to this substance and
should be removed. The substance will then be considered
non-hazardous.
Chemical Review 2015 (APP202961) 16
Substances affected Approval
numbers
Current
classification
Proposed
classification Effect on controls Justification for change
Oxalic acid
CAS# 144-62-7
HSR002710 6.1D (oral, dermal,
inhalation), 6.8C,
6.9B (dermal),
8.1A, 8.2C, 8.3A,
9.3B
6.1D (oral), 6.1E
(respiratory
irritation), 6.9B
(oral, dermal),
8.1A, 8.2C, 8.3A,
9.3B
No change. Data from the US EPA re-registration eligibility decision
(RED) and the EU registration dossier has been used to
review the classifications of this substance. This new data
indicates that the acute toxicity of this substance can be
downgraded. This is based on studies outlined in the RED
which showed no deaths occurred from inhalation or
dermal exposure but reported that this substance was
irritating to the respiratory tract.
Available reproductive and developmental studies showed
that oxalic acid does not warrant a 6.8C classification for
reproductive/developmental effects on or via lactation.
Data from the US EPA and EU also indicated that this
substance has chronic renal toxicity from excessive or
prolonged exposure. This occurs via the oral route and is
the basis of adding the 6.9B (oral) classification.
Oxirane, methyl-
CAS# 75-56-9
Synonyms include:
Propylene oxide
Epoxypropane
Methyloxirane
Oxirane
HSR001220 3.1A, 6.1C
(inhalation), 6.1D
(oral, dermal),
6.3A, 6.4A, 6.6A,
6.7B, 6.8B, 6.9B
(inhalation), 9.1C,
9.3B
3.1A, 6.1C (dermal,
inhalation), 6.1D
(oral), 6.1E
(respiratory
irritant), 6.4A,
6.6A, 6.7A, 6.8B,
9.1C, 9.3B
No change. New information has been provided which justifies a review
of the classifications of this substance, including
information in the EU CLH dossier. This includes a study
that reports a LC50 value of 950 mg/kg for dermal exposure
which supports upgrading the dermal acute toxicity from
6.1D to 6.1C.
The new studies available do not support the classification
of this substance as a skin irritant. This classification
should be removed.
There is also study data that supports classification of this
substance as a known or presumed human carcinogen, so
the 6.7B classification should be changed to 6.7A.
This substance is a respiratory tract irritant. This
classification should come under 6.1E but was previously
classified under 6.9 (inhalation). We propose to replace the
6.9 (inhalation) classification with 6.1E (respiratory irritant).
Chemical Review 2015 (APP202961) 17
Substances affected Approval
numbers
Current
classification
Proposed
classification Effect on controls Justification for change
2-Phenoxyethanol
CAS# 122-99-6
HSR003045 6.1D (oral, dermal,
inhalation), 6.4A,
6.8B, 9.3C
6.1D (oral), 6.4A,
9.3C
No change. Data is available in the EU including REACH registration,
CLP GHS classifications, and a SIDS Initial Assessment
Report which indicate that no classification for reproduction
or developmental toxicity is warranted.
Based on the EU registrations, no classifications are
warranted for acute inhalation and acute dermal toxicity
and we propose that these classifications also be removed.
1,3-Propanediol,
2,2-dimethyl-
CAS# 126-30-7
Synonyms:
Neopentyl glycol
HSR003955 6.1D (oral), 6.4A 6.4A Remove:
HSW2-2, HSW5-2,
HSW13-3.
The original classification was based on SDS data. New
data has become available due to REACH registration
which shows the 6.1D classification is not warranted (LD50
> 6400 mg/kg reported).
Propazine
CAS# 139-40-2
HSR003357 6.1D (oral,
inhalation), 6.1E
(dermal), 6.3B,
6.4A, 6.7B, 9.1A,
9.2A, 9.3C
6.1D (oral,
inhalation), 6.1E
(dermal), 6.3B,
6.4A, 9.1A, 9.2A,
9.3C
No change. This substance was originally classified as a carcinogen
(6.7B) based on EU and US EPA classifications. However,
the US EPA removed this classification after a rat study
determined carcinogenicity to be species specific
(Sprague-Dawley rat) and not operative in humans. Based
on the US EPA assessment, the 6.7B classification should
be removed.
Suspension
concentrate
containing
494 g/litre propazine
HSR000387 6.1D (inhalation),
6.1E (oral), 6.3B,
6.4A, 6.7B, 9.1A,
9.2A
6.1D (inhalation),
6.1E (oral), 6.3B,
6.4A, 9.1A, 9.2A,
9.3C
No change. See above for reasoning for removing 6.7B.
Substance should have a 9.3C classification based on
mixture rules and the 9.3C classification of the component
propazine.
Wettable powder
containing 500 g/kg
propazine
HSR000399
6.1D (inhalation),
6.1E (oral), 6.3B,
6.4A, 6.7B, 9.1A,
9.2A
6.1D (inhalation),
6.1E (oral), 6.3B,
6.4A, 9.1A, 9.2A,
9.3C
No change. See above for reasoning for removing 6.7B.
Substance should have a 9.3C classification based on
mixture rules and the 9.3C classification of the component
propazine.
Chemical Review 2015 (APP202961) 18
Substances affected Approval
numbers
Current
classification
Proposed
classification Effect on controls Justification for change
Sulfur
Sulfur, excluding formed
sulfur
CAS# 7704-34-9
HSR001284 4.1.1B, 6.4A 4.1.1B,
6.1E (oral, dermal,
inhalation), 6.3A
Add:
HSW13-3.
The current classification of this substance differs from the
EU Reach registration. New information indicates that this
substance has acute toxicity properties through dermal,
inhalation and oral routes.
The new information also supports the classification of this
substance as a skin irritant and supports removal of the
eye irritant classification.
Wettable powder
containing 350 g/kg
copper as copper
oxychloride and 240
g/kg sulphur
HSR000510 6.1D (oral), 6.4A,
6.5B, 6.9B (oral),
9.1A, 9.3C
6.1D (oral), 6.3A,
6.5B, 6.9B (oral),
9.1A, 9.3C
No change. See above for reasoning for removing 6.4A and adding
6.3A.
Granular material
containing 7.5 g/kg
pendimethalin
HSR000548 6.3B, 6.4A, 9.1A,
9.2A, 9.3C
6.3B, 6.4A, 6.5B,
9.1A, 9.2A, 9.3C
Add:
HSW13-3, HSW13-7.
Substance should have a 6.5B classification based on
mixture rules and the 6.5B classification of the component
pendimethalin.
Wettable powder
containing 115 g/kg
carbaryl, 250 g/kg
copper as copper
oxychloride and 284
g/kg sulphur
HSR000594 6.1D (oral), 6.4A,
6.5B, 6.7B, 6.9B
(oral), 9.1A, 9.2B,
9.3C, 9.4B
6.1D (oral), 6.3A,
6.5B, 6.7B, 6.9B
(oral), 9.1A, 9.2B,
9.3C, 9.4A
No change. See above for reasoning for removing 6.4A and adding
6.3A.
Substance should have a 9.4A classification based on
mixture rules and the 9.4A classification of carbaryl.
Suspension
concentrate
containing 720 - 800
g/litre sulphur
(Substance A)
HSR000666 6.4A, 9.1D 6.1E (oral),
6.1E (dermal),
6.3A, 9.1D
Add:
HSW13-3.
See sulfur for reasoning for all changes.
Chemical Review 2015 (APP202961) 19
Substances affected Approval
numbers
Current
classification
Proposed
classification Effect on controls Justification for change
Water dispersible
granule or wettable
powder containing
800 g/kg sulphur
HSR000741 6.4A, 9.1D 6.1E (oral),
6.1E (dermal),
6.1E (inhalation),
6.3A, 9.1D
Add:
HSW13-3.
See sulfur for reasoning for all changes.
Water dispersible
granule containing
800 g/kg sulphur
HSR000816 9.1D 6.1E (oral),
6.1E (dermal),
6.1E (inhalation),
6.3A, 9.1D
Add:
HSW2-4, HSW3-1,
HSW3-2, HSW4-2,
HSW13-3, HSW13-8,
HSW13-9, HSW16-1
See sulfur for reasoning for all changes.
Cream containing
7 – 13 g/kg copper
sulphate, 275 - 360
g/kg sulphur and
15 - 25 g/kg tar
acids
HSR002023 6.1E (oral), 6.3A,
6.4A, 6.5B, 6.6B,
6.8B, 6.9B (oral),
6.9B (dermal), 9.1A
6.1E (oral), 6.1D
(inhalation), 6.3A,
6.4A, 6.5B, 6.6B,
6.8B, 6.9B (oral),
6.9B (dermal),
9.1A, 9.3C
No change. See sulfur for reasoning for changes except for 9.3C which
was added based on mixture rules.
Flammable liquid
containing 20 - 40
g/litre linseed oil,
120 - 160 g/litre
sulphur and
700 - 800 g/litre
turpentine
HSR002162 3.1C, 6.1D
(dermal), 6.1D
(oral), 6.3A, 6.4A,
6.5B, 9.1C
3.1C, 6.1D
(dermal), 6.1D
(oral), 6.1D
(inhalation), 6.3A,
6.4A, 6.5B, 9.1C
No change. See sulfur for reasoning for change.
Liquid containing 3 -
7 g/litre neomycin
sulphate, 0.4 - 1.4
g/litre prednisolone,
3 - 7 g/litre sulphur
and 26 - 50 g/litre
zinc oxide
HSR002281 6.5B, 9.1A No changes
proposed
No change.
Chemical Review 2015 (APP202961) 20
Substances affected Approval
numbers
Current
classification
Proposed
classification Effect on controls Justification for change
Suspension
concentrate
containing 720 - 800
g/litre sulphur
(Substance B)
HSR007707 6.4A, 6.5B, 9.1D 6.1E (oral), 6.1E
(dermal), 6.3A,
6.4A, 6.5B, 6.9B
(oral), 9.1C, 9.2C
No change. See sulfur for reasoning for all changes except for 6.9B,
9.1C and 9.2C classifications which were added based on
mixture rules and the classifications of confidential
components.
Sulgran 80% WG HSR100627 6.3B, 6.4A, 9.1D 6.1E (oral),
6.1E (dermal),
6.1E (inhalation),
6.3A, 9.1D
Add:
HSW13-3.
See sulfur for reasoning for all changes.
Sodium
dioctylsulphosuccinate
CAS# 577-11-7
HSR003166 6.1D (oral), 6.3A,
8.3A, 9.1D, 9.3C
6.3A, 8.3A, 9.1D No change. Name to be updated to sodium dioctylsulfosuccinate
A REACH dossier is available that shows that the most
relevant acute toxicity LD50 is > 2100 mg/kg in rat (clinical
signs were observed but no mortality). As a result we
propose that this substance not be classified for 6.1 or 9.3.
Soluble concentrate
containing
190 – 250 g/litre fatty
acids (potassium salts)
HSR000690 9.1D No change. No change. Name change to “Soluble concentrate containing
180 – 250 g/litre fatty acids (potassium salts)”. This
name change is required as the amount of fatty acids in
one of the original products of this transfer approval was
miscalculated. The name change ensures that the original
products fit the approval name of the substance.
Chemical Review 2015 (APP202961) 21
Appendix 2. Affected mixtures containing confidential components
The approvals listed in this appendix are affected mixtures that contain one or more of the substances listed in appendix 1 of this application form, and
which accordingly require changes to classification and/or controls. For these mixtures, the presence of the specific substance(s) that drive
classification changes may be confidential. As such this table intentionally does not identify the component(s) driving the classification changes in the
affected mixtures and supporting comments are similarly withheld from public view. The full details are disclosed within the confidential appendix to this
application.
Table 2: Affected mixtures containing confidential components
Approval number Approval name Component
changing in
classification
Current
classification
Proposed
classification
Controls changes
HSR000026 RB-2-100 Refer to confidential
appendix
3.1D, 6.9B (oral), 9.1A 3.1D, 6.1E
(aspiration hazard),
6.9B (oral), 9.1A
No change.
HSR000154 Soluble concentrate
containing 195 g/litre
acephate. Also contains
ethylene glycol
Refer to confidential
appendix
6.1D (oral), 6.3A,
6.4A, 6.8A, 6.8C,
6.9A, 9.1D, 9.3C, 9.4B
6.1D (oral), 6.3A,
6.4A, 6.8A, 6.9A (oral
and inhalation),
6.9B (dermal), 9.1C,
9.3C, 9.4B
No change.
HSR000157 Emulsifiable concentrate
containing 45 g/litre
acephate and 39 g/litre
triforine
Refer to confidential
appendix
3.1D, 6.1E (oral),
8.2B, 8.3A, 6.8A,
6.8C, 6.9B, 9.1D,
9.3C, 9.4B
3.1D, 6.1E (oral),
8.2B, 8.3A, 6.8A,
6.9B (oral, dermal,
inhalation), 9.1C,
9.3C, 9.4B
No change.
HSR000158 Emulsifiable concentrate
containing 22.5 g/litre
acephate and 19.5 g/litre
triforine
Refer to confidential
appendix
6.1E (oral), 6.3A,
8.3A, 6.8A, 6.8C,
6.9B, 9.3C, 9.4C
6.3A, 8.3A, 6.8A,
6.9B (oral, dermal,
inhalation), 9.1C,
9.3C, 9.4C
No change.
Chemical Review 2015 (APP202961) 22
Approval number Approval name Component
changing in
classification
Current
classification
Proposed
classification
Controls changes
HSR000022 Hy-D BEADLET Refer to confidential
appendix
6.1E (inhalation),
6.1E (oral), 6.5B,
6.8B, 6.9A (oral),
9.1C
6.1E (inhalation), 9.1C Remove:
HSW13-3, HSW13-7.
HSR007880 Pyradym Refer to confidential
appendix
6.1E (oral), 6.3B,
6.5A, 6.5B, 6.8C, 6.9B
(inhalation), 6.9B
(oral), 9.1A, 9.4A
6.1E (aspiration
hazard), 6.3B, 6.5A,
6.5B, 6.9B
(inhalation), 6.9B
(oral), 9.1A, 9.4A
Add:
Label variation 1 -
potential for pyrethrin
to cause paresthesia.
HSR101120 Pygar Refer to confidential
appendix
3.1D, 6.1E (aspiration
hazard), 6.3B, 6.5A,
6.5B, 6.9B
(inhalation), 8.3A,
9.1A, 9.3C, 9.4B
3.1D, 6.1E (aspiration
hazard), 6.3B, 6.5A,
6.5B, 6.9B (oral),
6.9B (inhalation),
8.3A, 9.1A, 9.4B
Add:
Label variation 1 -
potential for pyrethrin
to cause paresthesia.
HSR000333 Ready to use liquid
containing 20.9 g/litre
esbiothrin. Also contains
hydrocarbons
Refer to confidential
appendix
3.1D, 6.1E (oral),
6.3B, 6.8C, 6.9B,
9.1A, 9.4C
3.1D, 6.1E
(aspiration hazard),
6.3B, 6.9B (oral),
9.1A, 9.3C, 9.4C
No change.
HSR001629 Repair Mortar Resin Refer to confidential
appendix
3.1B, 6.1D
(inhalation), 6.1E
(oral), 6.3B, 6.4A,
6.5B, 6.8C, 6.9B
(inhalation), 6.9B
(oral), 9.1C
3.1B, 6.1D
(inhalation), 6.1E
(oral), 6.3B, 6.4A,
6.5B, 6.9B
(inhalation), 6.9B
(oral), 9.1D
No change.
HSR001680 IGB4130NC Refer to confidential
appendix
6.1D (oral), 6.8C,
6.9B, 9.1A, 9.2C,
9.3C, 9.4A
No change No change.
Chemical Review 2015 (APP202961) 23
Approval number Approval name Component
changing in
classification
Current
classification
Proposed
classification
Controls changes
HSR007786 DWC0111 Refer to confidential
appendix
6.3B, 6.5B, 6.6B,
6.8B, 6.8C, 9.1A,
9.2C, 9.4C
6.1D (oral), 6.3B,
6.5B, 6.6B, 6.8B,
6.8C, 6.9B (oral),
9.1A, 9.2C, 9.3C,
9.4C
No change.
HSR100103 NTNCS2 Refer to confidential
appendix
3.1D, 6.3A, 6.4A,
6.8A, 6.8C, 6.9B
(oral), 9.1A, 9.2B,
9.3B, 9.4A
3.1D, 6.3A, 6.4A,
6.8A, 6.9B (oral),
9.1A, 9.2B, 9.3B, 9.4A
No change.
HSR100069 BEPO1621RH Refer to confidential
appendix
6.3A, 6.4A, 6.8A,
6.8C, 9.1A, 9.2C,
9.3C, 9.4A
6.3A, 6.4A, 6.8A,
9.1A, 9.2C, 9.3C, 9.4A
No change.
HSR100394 KSI777 Refer to confidential
appendix
6.1D (oral), 6.5B,
6.6B, 6.8A, 6.8C,
6.9A (oral), 9.1A,
9.2C, 9.3B, 9.4A
6.1D (oral), 6.5B,
6.6B, 6.8A,
6.9A (oral), 9.1A,
9.2C, 9.3B, 9.4A
No change.
HSR100414 Movento OD Refer to confidential
appendix
6.4A, 6.5B, 6.8B,
6.8C, 6.9B
(inhalation), 9.1B
6.4A, 6.5B, 6.8B,
6.9B (inhalation), 9.1B
No change.
HSR100639 Polynate Bee attractant
controlled release
dispensers
Refer to confidential
appendix
6.3A, 6.4A, 6.5B,
6.8C, 6.9B (oral)
6.3A, 6.4A, 9.1C Add:
HPC-4A, HPC-4B.
Remove:
HSW13-7.
Chemical Review 2015 (APP202961) 24
Approval number Approval name Component
changing in
classification
Current
classification
Proposed
classification
Controls changes
HSR100703 Nexan Abamectin
Pour On
Refer to confidential
appendix
6.1D (oral), 6.1E
(dermal), 6.3B, 6.4A,
6.5B, 6.8B, 6.8C, 6.9B
(inhalation),
6.9B (oral), 9.1A,
9.2C, 9.3C, 9.4A
6.1D (oral), 6.1E
(dermal), 6.3B, 6.4A,
6.8B, 6.8C, 6.9B
(inhalation),
6.9B (oral), 9.1A,
9.2C, 9.3C, 9.4A
Remove:
HSW13-7.
HSR100790 SCJ-12-120164 Refer to confidential
appendix
6.1E (oral), 6.3B,
6.5B, 6.8C, 6.9B
(oral), 9.1A, 9.4A
6.1E (aspiration
hazard), 6.3B, 6.9B
(oral), 9.1A, 9.4A
Remove:
HSW13-7.
HSR100932 Warlock Insecticide Refer to confidential
appendix
3.1D, 6.1E
(inhalation), 6.1E
(aspiration hazard),
6.3B, 6.4A, 6.8A,
6.8C, 6.9B (oral),
9.1A, 9.3B, 9.4A
3.1D, 6.1E
(inhalation), 6.1E
(aspiration hazard),
6.3B, 6.4A, 6.8A,
6.9B (oral), 6.9B
(narcotic effects),
9.1A, 9.3C, 9.4A
No change.
HSR100392 RF-011 Refer to confidential
appendix
6.3B, 6.5A, 6.5B,
6.8C, 6.9B
(inhalation), 9.1A,
9.3C, 9.4A
6.3B, 6.5A, 6.5B,
6.9B (oral and
inhalation), 9.1A, 9.4A
No change.
HSR007640
J57.23A Refer to confidential
appendix
3.1C, 6.1C (dermal),
6.1D (oral), 6.3B,
6.4A, 6.9B (oral),
9.1A, 9.3C
3.1C, 6.1D (oral),
6.3B, 6.4A, 6.8B, 6.9B
(oral), 9.1A, 9.3C
Remove:
HPC-2;
HSW13-1, HSW13-5,
HSW13-7, HSW13-13,
HSW13-15,
HSW13-16,
HSW13-17.
Chemical Review 2015 (APP202961) 25
Approval number Approval name Component
changing in
classification
Current
classification
Proposed
classification
Controls changes
HSR007641
J57.23B Refer to confidential
appendix
3.1C, 6.1C (dermal),
6.1D (oral), 6.3B,
6.4A, 6.5B, 6.9B
(oral), 9.1A, 9.3C
3.1C, 6.1D (oral),
6.3B, 6.4A, 6.5B,
6.8B, 6.9B (oral and
inhalation), 9.1A,
9.3C
Remove:
HPC-2;
HSW13-1, HSW13-5,
HSW13-13,
HSW13-15,
HSW13-16,
HSW13-17.
HSR007642 J57.23C Refer to confidential
appendix
3.1C, 6.1C (dermal),
6.1D (oral), 6.1D
(inhalation), 6.3B,
6.4A, 6.5B, 6.9B
(oral), 9.1A, 9.3C
3.1C, 6.1D (oral),
6.1D (inhalation),
6.3B, 6.4A, 6.5B,
6.8B, 6.9B (oral and
inhalation), 9.1A,
9.3C
Remove:
HPC-2;
HSW13-1, HSW13-5,
HSW13-13,
HSW13-15,
HSW13-16,
HSW13-17.
HSR100818 KShield Concentrate Refer to confidential
appendix
6.3A, 6.4A, 6.5B, 9.1A No change No change.
HSR000545 Emulsifiable concentrate
containing 240 g/litre
oxyfluorfen
(Substance A)
Refer to confidential
appendix
3.1D, 6.1E (oral),
6.3A, 6.4A, 6.8B,
6.9B, 9.1A, 9.2A
3.1D, 6.1E (oral), 6.1E
(aspiration hazard),
6.3A, 6.4A, 6.8A,
6.9B (oral), 9.1A, 9.2A
Add:
HSW13-14.
HSR000459 Emulsifiable concentrate
containing 250 g/litre
triadimenol
Refer to confidential
appendix
3.1D, 6.1D (oral),
6.8B, 6.9A (oral),
9.1C, 9.3C
3.1D, 6.1D (oral),
6.8A, 6.9A (oral),
9.1C, 9.3C
No change.
Chemical Review 2015 (APP202961) 26
Approval number Approval name Component
changing in
classification
Current
classification
Proposed
classification
Controls changes
HSR002251 Cream containing
0.3 – 0.7% cetrimide and
0.3 – 0.7% chlorhexidine
gluconate
Refer to confidential
appendix
6.3B, 6.5B, 6.8B, 9.1B 6.3B, 6.5B, 9.1B No change.
HSR001652 Thermal 980 Negative
Developer for Thermal
News
Refer to confidential
appendix
6.3B, 6.8B, 6.9B
(dermal), 6.9B (oral),
8.3A
6.3B, 6.9B (dermal),
6.9B (oral), 8.3A
No change.
HSR002702 SD-1005 Refer to confidential
appendix
6.4A, 6.5B,
6.9B (oral), 9.1A, 9.4B
6.1E (oral), 6.3A,
6.5B, 6.9B (oral),
9.1A, 9.4B
No change.
Chemical Review 2015 (APP202961) 27
Appendix 3. Controls codes for changes in Appendices 1 and 2
The default EPA control codes are listed below in Table 3.
Some controls are varied using standard variations to match current practice in setting controls. The
variations referred to in this document are listed in Table 4 below.
Table 3: EPA Control codes used in this application
Control
code EPA Notice Control description
LAB EPA Labelling
Notice 2017 Requirements for labelling of hazardous substances
PKG EPA Packaging
Notice 2017 Requirements for packaging of hazardous substances
SDS EPA Safety Data
Sheet Notice 2017 Requirements for safety data sheets for hazardous substances
DIS EPA Disposal
Notice 2017 Requirements for disposal of hazardous substances
HPC-1
EPA Hazardous
Property Controls
Notice 2017 Part 1 Hazardous Property Controls preliminary provisions
HPC-2
EPA Hazardous
Property Controls
Notice 2017 Part 2 Certain substances restricted to workplaces only
HPC-3
EPA Hazardous
Property Controls
Notice 2017 Part 3 Hazardous substances in a place other than a workplace
HPC-4A
EPA Hazardous
Property Controls
Notice 2017 Part 4A Site and storage controls for class 9 substances
HPC-4B
EPA Hazardous
Property Controls
Notice 2017 Part 4B Use of class 9 substances
HPC-4C
EPA Hazardous
Property Controls
Notice 2017 Part 4C Qualifications required for application of class 9 pesticides
Chemical Review 2015 (APP202961) 28
Table 4: HSNO Variations to control codes used in this application
Control
code HSNO Act Control
Label
variation 1
Section 77 variation
to Labelling Notice
The substance label must include a warning of the effects of paraesthesia
and how to avoid it.
The requirements in Table 5 below are not set for a substance under its approval but apply in their own right
under the HSW legislation according to the classification of the substance. They are listed in this document
for information purposes only.
Table 5: HSW Requirements referred to in this application
Code Regulation Description
HSW2-1 Reg 2.1-2.4 Workplace labelling of hazardous substance containers
HSW2-2 Reg 2.5-2.10 Signage
HSW2-3 Reg 2.11 Safety data sheets
HSW2-4 Reg 2.12-2.14 Packaging
HSW3-1 Reg 3.1 Inventory
HSW3-2 Reg 3.2-3.3 Managing risks associated with hazardous substances
HSW4-1 Reg 4.1-4.4 Compliance certificates for certified handlers
HSW4-2 Reg 4.5-4.6 Information, instruction, training and supervision
HSW5-1 Reg 5.2-5.5 Fire extinguishers
HSW5-2 Reg 5.6-5.13 Emergency response plans
HSW7-1 Reg 7.1-7.11 Controlled substance licences
HSW8-1 Reg 8.1-8.2 Compliance certification
HSW8-2 Reg 8.3-8.4 Requirements for public transportation of class 1 to 5 substances
HSW10-1 Reg 10.3 General controls on class 2, 3, and 4 substances
HSW10-2 Reg 10.4 Substances that must be secured
HSW10-3 Reg 10.5 Requirement to segregate class 2, 3, and 4 substances
HSW10-4 Reg 10.6-10.7 Duty of PCBU to establish a hazardous area
HSW10-5 Reg 10.8-10.20 Requirements to prevent unintended ignition of class 2.1.1, 2.1.2 and 3.1
substances
HSW10-10 Reg 10.26 Duty of PCBU to establish hazardous substance location
HSW10-12 Reg 10.30-10.33 Secondary containment for class 3 and 4 pooling substances
Chemical Review 2015 (APP202961) 29
HSW10-13 Reg 10.34-10.35 Requirement to have compliance certificate if class 2.1.1, 2.1.2, or 3.1
substance present at hazardous substance location
HSW10-15 Reg 10.37 Requirement for transit depot
HSW11-1 Part 11 Controls relating to adverse effects of unintended ignition of class 2 and 3.1
substances
HSW13-1 Reg 13.3-13.4 Records of application for class 6 substances
HSW13-2 Reg 13.7 Duty of PCBU who directs work using class 6, 8.1, 8.2, or 8.3 substances
to ensure equipment is appropriate
HSW13-3 Reg 13.8 Duty of PCBU who directs work using class 6 and 8 substances to ensure
personal protective equipment used
HSW13-4 Reg 13.9, 13.11 Certain substances to be under personal control of certified handler or
secured
HSW13-5 Reg 13.10 Substances not requiring a certified handler to be secured
HSW13-6 Reg 13.12-13.13 Controlled substance licences for certain class 6 substances
HSW13-7 Reg 13.14-13.16 Transportation of certain class 6 and 8 substances
HSW13-8 Reg 13.17 Prohibition on use of substance in excess of tolerable exposure limit
HSW13-9 Reg 13.18 Duty of PCBU to ensure prescribed exposure standards for class 6
substances not exceeded
HSW13-10 Reg 13.19-13.21 Vertebrate toxic agent requirements
HSW13-11 Reg 13.22 Duties of PCBU who directs work using antifouling paints
HSW13-12 Reg13.23-25 Restricted entry intervals
HSW13-13 Reg 13.26-13.29,
13.34-13.37 Storage and segregation of certain class 6 or 8 substances
HSW13-14 Reg 13.30-33 Secondary containment requirements for class 6 and 8 pooling substances
HSW13-15 Reg 13.34,
13.38-13.39
Duty of PCBU to establish hazardous substance location and compliance
certificate requirements where certain class 6 or 8 substances present
HSW13-16 Reg 13.40-13.44 Separation of hazardous substance locations holding class 6 and 8
substances
HSW13-17 Reg 13.45 Additional emergency management requirements for certain class 6 or 8
substances
HSW15-1 Part 15 Requirements for gases under pressure
HSW16-1 Part 16 Requirements for tank wagons and transportable containers
HSW17-1 Part 17 Requirements for stationary container systems
HSW19-1 Part 19 Tracking hazardous substances