Environmental Effects
47
14 PUBLICATION SUMMARY REPORT
Z-34
Summary Report
Reference No: PLC/244
Lubrizol International Inc of 28 River Street Silverwater NSW 2128 (ACN 002 747 944) has
submitted a synthetic polymer of low concern (PLC) notification statement in support of their
application for an assessment certificate for Z-34. The notified polymer is intended to be used
as a metalworking additive. Up to 50 tonnes of the notified polymer will be imported per
annum for the first five years.
ASSESSMENT OF PUBLIC, OCCUPATIONAL HEALTH AND SAFETY AND
ENVIRONMENTAL EFFECTS
Hazard Assessment
An Ames test using the notified polymer showed that it was not mutagenic in bacterial
strains. Irritation studies on a product, OS135262 containing 10% the notified polymer
indicated the product was a slight skin and eye irritant in rabbits. The notified polymer cannot
be classified as a hazardous substance according to the NOHSC Approved Criteria for
Classifying Hazardous Substances for the endpoints tested.
Occupational Health and Safety
Transport and Storage
Under normal working conditions, waterside, transport and storage workers are unlikely to be
exposed to the notified polymer and the occupational health risk posed to these workers is
considered low.
End use
The notified polymer is imported at 10% in Lubrizol 0805.2. At metalworking plants,
Lubrizol 0805.2 will be directly added to the metalworking fluid reservoir at a final
concentration of 500 ppm and sprayed onto the cutting edge during the machining operation.
Occupational exposure to the 10% notified polymer product may occur during filling,
spraying and cleaning up containers. Inhalation exposure is expected to be low as the
generation of mist is suppressed during metalworking. Skin and eye contact will be the main
routes of exposure. Significant dermal absorption of the notified polymer through intact skin
is not expected because of the high molecular weight and low concentration of the notified
polymer in metalworking fluid. The potential for mild skin/eye irritation exists for workers
exposed to the product. Workers will need to wear overalls, nitrile or neoprene gloves, and
safety glasses or goggles.
Conclusion
Risk of adverse health effects due to the notified polymer is low due its expected low toxicity
and low exposure potential. However, due to the presence of other components in the
formulated products control measures are required to minimize skin and eye contact.
Public Health
The notified polymer and the product containing the notified polymer are not available for
sale to the general public. The product containing the notified polymer will be used in
metalworking fluids for industrial use. The notified polymer is not likely to be a risk to public
Chemical Gazette Commonwealth of Australia Gazette
No. C 11, 6 November 2001
48
health since the potential for public exposure to the notified polymer is negligible.
Environmental Effects
The environmental hazard from the notified polymer is considered to be low provided that the
material is used as indicated, and that disposal of waste metalworking fluid follows approved
practices. Apart from transport accidents or accidental spills or leaks, minimal release of the
notified polymer is expected as a result of transfer to metalworking fluid reservoirs. The
notifier has indicated that spent fluid will be treated similarly to waste engine oils and will be
recycled or incinerated. However, inappropriate disposal by smaller operators could mean
that up to 30 tonnes of the polymer may be disposed to landfill and other land, and up to 31
tonnes of the polymer may be disposed of to sewer. The Predicted Environmental
Concentration based on an Australia-wide use pattern is estimated to be 30 礸/L.
Exposure levels of this magnitude are of little ecotoxicological concern for poly(aliphatic
acid) polymers, such as the notified polymer, which typically have LC50 values >100 mg/L.
If deposited on soil or into landfill, the notified polymer will be mobile with the potential to
leach, while if released into waterways it would become associated with the aqueous phase.
However, release is expected to be diffuse, thus limiting the potential for adverse
environmental effects. Incineration of waste oil containing the notified chemical would
destroy the substance with evolution of water vapour and oxides of carbon, nitrogen and
sulphur, and sodium compounds that would be assimilated with the ash. Sludges from oil
recycling facilities could also be incinerated.
The high water solubility and high molecular weight of the notified polymer indicate little
potential for bioaccumulation.
Overall, the environmental risk presented by the introduction of the notified chemical is
predicted to be low.
RECOMMENDATIONS
Control Measures
Occupational Health and Safety
? Employers should implement the following safe work practices to minimise
occupational exposure during handling of the notified polymer:
- Spillage of the notified polymer should be avoided. Spillages should be cleaned
up promptly with absorbents which should then be put into containers for
disposal.
? Employers should ensure that the following personal protective equipment is used by
workers to minimise occupational exposure to the notified polymer:
- Protective eyewear, chemical resistant industrial clothing and footwear and nitrile
or neoprene impermeable gloves should be used during occupational use of the
products containing the notified polymer; where engineering controls and work
practices do not reduce vapour and particulate exposure to safe levels, an air fed
respirator should also be used.
Chemical Gazette Commonwealth of Australia Gazette
No. C 11, 6 November 2001
49
Guidance in selection of personal protective equipment can be obtained from
Australian, Australian/New Zealand or other approved standards.
? A copy of the MSDS should be easily accessible to employees.
? If products and mixtures containing the notified polymer are classified as hazardous to
health in accordance with the NOHSC Approved Criteria for Classifying Hazardous
Substances, workplace practices and control procedures consistent with provisions of
State and Territory hazardous substances legislation must be in operation.
Chemical Gazette Commonwealth of Australia Gazette
No. C 11, 6 November 2001
50
15 PUBLICATION SUMMARY REPORT
Polymer in Uralac SE901 S2G3-55
Summary Report
Reference No: PLC/248
PPG Industries Australia Pty Ltd of McNaughton Road, Clayton Victoria 3168 (ABN 82 055
500 939) has submitted a notification statement in support of their application for an
assessment certificate for the synthetic polymer of low concern (PLC) `Polymer in Uralac
SE901 S2G3-55'. The notified polymer is intended to be used as a component of packaging
coatings (aerosol can). Up to 10 tonnes of the notified chemical will be imported per annum
for each of the first five years.
ASSESSMENT OF PUBLIC, OCCUPATIONAL HEALTH AND SAFETY AND
ENVIRONMENTAL EFFECTS
Hazard Assessment
No toxicological data was provided and the notified polymer cannot be assessed against the
NOHSC Approved Criteria for Classifying Hazardous Substances. Polymers of high
molecular weight do not readily cross the skin or other biological membranes, and the overall
toxicity is expected to be low.
MSDS for the imported end use product 709-Z8726 HOBA 8726 Overprint Varnish indicates
that it is a possible skin, eye and a respiratory irritant. The MSDS lists a number of potential
health effects due to inhalation, or repeated skin contact namely breathing problems, cardiac
arrest and irritant contact dermatitis. These relate mainly to the solvents present in the
product rather than the notified polymer. The imported product 709-Z8726 HOBA 8726
Overprint Varnish is classed as a Class 3 dangerous good (flammable liquid) and a Schedule
Poison (S6) because of the solvent content. Three of the solvents in the end use product have
NOHSC exposure standards.
Occupational Health and Safety
There is little potential for significant occupational exposure to the notified polymer during
transport and storage of the imported end use product.
Coating applicators may be exposed to the notified polymer during application of the varnish.
There is some opportunity for exposure during adhesive stirring and thinning with solvent.
Personal protective equipment will be employed to reduce exposure. The coating process is a
closed system, therefore is not expected to result in worker exposure.
Exposure to the polymer during and following coating may occur due to spillage during
maintenance work. As these operations involve small volumes, exposure is expected to be
limited. The notifier states that personal protective equipment such as protective clothing,
gloves, goggles and respirators is used. Maintenance workers also rely on personal protective
equipment to limit exposure. The use of engineering controls and protective equipment is
necessary to prevent exposure to solvent components via dermal, inhalation and ocular
routes. The coating room should be equipped with adequate air extraction. The employer
must ensure that a respirator is used if any aerosols are likely to be formed during mixing,
thinning or application of the varnish and impervious gloves, goggles and protective clothing
worn.
Chemical Gazette Commonwealth of Australia Gazette
No. C 11, 6 November 2001
51
A number of ingredients in the varnish containing the notified polymer (solvent naphtha
heavy aromatic, 2-butoxyethanol, formaldehyde, 2-butoxyethyl acetate) may present health
hazards to workers. They are listed as appropriate in the relevant MSDS, together with the
NOHSC exposure standards. For the use of varnish, employers are responsible for ensuring
that the relevant NOHSC exposure standards are not exceeded in the workplace.
The solutions containing the notified polymer are flammable due to their solvent content.
Precautions must be taken to avoid sources of ignition, e.g. use of earthing leads. Operators
should wear antistatic overalls and footwear.
Once the applied coating has hardened, the polymer will not be separately available for
exposure or absorption. The wastes containing the notified polymer may be hazardous
substances on the basis of the solvent content and the precautions used for the additional
materials should be adequate for protection from the notified polymer. In addition, much of
the polymer will be crosslinked and hardened, and therefore immobile, by the time of
disposal.
The polymer size, mode of use, use of personal protective gear and in situ engineering
controls indicate that significant risks to human health through occupational exposure to the
notified polymer are unlikely. No specific control measures are required to reduce the risk of
skin, eye and respiratory irritation due to the notified polymer.
Overall, the polymer is of low concern to human health although controls indicated by the
notifier should be adhered to reduce risk of adverse health effects due to other ingredients in
the final varnish products.
Public Health
The public will only come into contact with the coating, after the notified polymer has
become an integral part of a hard durable coating on the surface of packaging articles.
Therefore, the potential risk for public exposure to the notified polymer is considered to be
low.
Environmental Risk Assessment
The majority of the notified polymer will be released into the environment through disposal
of end products containing the polymer in the coating to landfill. The notified polymer in
these products will slowly degrade through abiotic and biotic processes.
The notifier estimates that less then 500 kg per annum will be released to the environment
from the importation, and use of the notified polymer. This will be from spills, equipment
cleaning and residues in import containers where the majority will be disposed of to landfill.
Release to the sewer is expected to be insignificant. In landfill the polymer is expected to be
immobile due to its low water solubility and will become part of the soil matrix.
In the event of the polymer entering waterways, it would be expected to associate with the
sediments. The polymer is not expected to cross biological membranes due to its high
molecular weight and is therefore not expected to bioaccumulate.
Chemical Gazette Commonwealth of Australia Gazette
No. C 11, 6 November 2001
52
RECOMMENDATIONS
Control Measures
Occupational Health and Safety
? Employers should implement the following engineering controls to minimise
occupational exposure to the notified polymer as introduced in the product 709-Z8726
HOBA 8726 Overprint Varnish:
- NOHSC exposure standards for all components of the polymer solution are not
exceeded in the workplace.
- Local exhaust ventilation and enclosed cabinet for coating operations.
? Employers should implement the following safe work practices to minimise
occupational exposure during handling of the notified polymer as introduced in the
product 709-Z8726 HOBA 8726 Overprint Varnish:
- Workers should receive regular instruction on good occupational hygiene
practices in order to minimise personal contact, contamination of the work
environment with products, including those containing the notified polymer.
- Avoid contact with sources of ignition.
? Employers should ensure that the following personal protective equipment is used by
workers to minimise occupational exposure to the notified polymer as introduced in
the product 709-Z8726 HOBA 8726 Overprint Varnish:
- Respiratory protection, protective eyewear, impermeable clothing and gloves, and
occupational footwear are required for coating applicators.
Guidance in selection of personal protective equipment can be obtained from
Australian, Australian/New Zealand or other approved standards.
? A copy of the MSDS should be easily accessible to employees.
? If products and mixtures containing the notified polymer are classified as hazardous to
health in accordance with the NOHSC Approved Criteria for Classifying Hazardous
Substances, workplace practices and control procedures consistent with provisions of
State and Territory hazardous substances legislation must be in operation.
Secondary Notification
The Director of Chemicals Notification and Assessment must be notified in writing within 28
days by the notifier, other importer or manufacturer:
Under Section 64(1) of the Act; if
- the notified polymer is introduced in a chemical form that does not meet the PLC
criteria.
or
Under Section 64(2) of the Act:
- if any of the circumstances listed in the subsection arise.
Chemical Gazette Commonwealth of Australia Gazette
No. C 11, 6 November 2001
53
The Director will then decide whether secondary notification is required.
Chemical Gazette Commonwealth of Australia Gazette
No. C 11, 6 November 2001
54
16 PUBLICATION SUMMARY REPORT
Evcote P56-100
Summary Report
Reference No: PLC/252
Asia Pacific Specialty Chemicals of 15 Park Road, Seven Hills, NSW (ABN 32 000 316 138)
has submitted a synthetic polymer of low concern (PLC) notification statement in support of
their application for an assessment certificate for EvCote P56-100. The notified polymer is
intended to be used as a strength enhancer and moisture barrier coating for paper and paper
products. Less than 10 000 tonnes of the notified polymer will be manufactured per annum
for each of the first five years.
ASSESSMENT OF PUBLIC, OCCUPATIONAL HEALTH AND SAFETY AND
ENVIRONMENTAL EFFECTS
Hazard Assessment
No toxicological data were provided for the notified polymer. The polymer meets the criteria
for a synthetic polymer of low concern and is therefore not classified as a hazardous
substance in accordance with the NOHSC Approved Criteria For Classifying Hazardous
Substances.
The MSDS for the notified polymer lists a number of potential health effects based on
products of similar composition, namely irritation of the gastrointestinal tract with upper
abdominal pain, nausea, vomiting and diarrhoea if swallowed, irritation of the eye with
discomfort or blurring (resulting in eye damage if exposure is prolonged), irritation of the
skin following prolonged exposure and irritation of the upper respiratory passages following
overexposure by inhalation. These effects are related to the physical characteristics of
polymer particles. The MSDS for the aqueous polymer dispersion lists similar potential
health effects.
Occupational Health and Safety
There is little potential for significant occupational exposure during transport and storage of
the notified polymer and its dispersion except in the event of accidental spillage. It is not
anticipated that workers involved in transport and storage of the notified polymer would be
exposed during normal operations.
During crushing of the solid polymer and blending of the crushed polymer into an aqueous
dispersion in the reactor, there is potential for respiratory and ocular exposure. There is no
NOHSC exposure standard for the notified polymer itself, however the NOHSC exposure
standard for dust not otherwise specified is 10 mg/m3. As the crushing and blending
processes occur under local exhaust ventilation, respiratory exposure is unlikely and the level
of 10 mg/m3 is unlikely to be attained. Standard personal protective measures used during
plant operation including the use of overalls, safety glasses, gloves and safety footwear. The
health risk of workers during crushing and blending is expected to be low.
During packing off of the polymer into drums and packing off of the dispersion into tanks,
there is the potential for dermal and respiratory exposure to the notified polymer in the event
of accidental spillage at the filling station. Given the expected low hazard of the notified
polymer and that exposure will be controlled through the standard protective measures
Chemical Gazette Commonwealth of Australia Gazette
No. C 11, 6 November 2001
55
including overalls, safety glasses, gloves and safety footwear, the health risk to workers
during the packing off of the polymer and its dispersion is low.
During quality control testing of samples of the polymer during manufacture and application
of the dispersion to paper the main route of exposure will be dermal. Exposure to the notified
polymer and its dispersion will be controlled through the use of laboratory coats (during
quality control), overalls (during application of the dispersion to paper), safety glasses, safety
footwear and gloves. Given the expected low hazard of the notified polymer, the health risk
to workers during these processes will be low.
Conclusion
The notified polymer is of low concern to human health and safety. The standard control
measures used during plant operation and protective measures during quality control and
application of the dispersion to paper will ensure sufficient protection against the notified
polymer.
Public Health
The notified polymer is intended for use by paper manufacturers and will not be sold to the
public. Following application, the notified polymer will form a durable coating that is not
expected to be easily removable. Therefore, the health risk to the public from exposure to the
notified polymer is considered to be low.
Environmental Effects
The majority of the notified polymer will share the fate of the paper substrates to which it is
bound. Waste paper products containing the notified polymer will be disposed of in landfill,
recycled or incinerated. During recycling, the notified polymer is expected to associate with
sludge and will be disposed of in landfill or incinerated. The notifier indicates that aqueous
wastes will be treated with a polyacrylamide surfactant to remove suspended solids, which
will be disposed of in landfill, prior to the water being discharge into sewer.
In landfill, it is expected that the polymer will slowly break down and become part of the soil
matrix and is unlikely to leach due to its low water solubility. Any of the ammonium salt of
the notified polymer that passes through the treatment process and enters the sewer is
expected to dilute and disperse and eventually partition to the sediments through conversion
to the acid form. The incineration of polymer wastes would yield water vapour and oxides of
carbon.
The polymer's high molecular weight and expected low water solubility should prevent
bioaccumulation.
Given the above considerations, the overall environmental risk is expected to be low.
RECOMMENDATIONS
Control Measures
No specific precautions are required to control exposure to the notified polymer. However, in
the interests of good occupational health and safety, the following guidelines and precautions
should be observed:
Chemical Gazette Commonwealth of Australia Gazette
No. C 11, 6 November 2001
56
? Employers should implement the following engineering controls to minimise
occupational exposure:
- Exhaust ventilation during manufacture, blending, crushing and filling process
- Enclosed and automated manufacture process
? Employers should implement the following safe work practices to minimise
occupational exposure:
- During manual transfer of notified polymer and polymer dispersion into reaction
tanks and coating bath, avoid spills and splashing
- Avoid generation of dust clouds when handling the polymer in powder form
? Employers should ensure that the following personal protective equipment is used by
workers to minimise occupational exposure to the notified polymer:
- Chemical resistant gloves
- Protective clothing which protects the body, arms and legs
- Eye protection when splashes are generated
- A dust mask when dusts are generated
Guidance in selection of personal protective equipment can be obtained from
Australian, Australian/New Zealand or other approved standards.
? A copy of the MSDS should be easily accessible to employees.
If products and mixtures containing the notified polymer are classified as hazardous to health
in accordance with the NOHSC Approved Criteria for Classifying Hazardous Substances,
workplace practices and control procedures consistent with provisions of State and Territory
hazardous substances legislation must be in operation.
Chemical Gazette Commonwealth of Australia Gazette
No. C 11, 6 November 2001
57
17 PUBLICATION SUMMARY REPORT
Polymer in Afranil SLO
Summary Report
Reference No: PLC/254
BASF Australia Ltd of 500 Princes Highway, Noble Park, Victoria 3174 (ABN 62 008 437
867) has submitted a synthetic polymer of low concern (PLC) notification statement in
support of their application for an assessment certificate for Polymer in Afranil SLO. The
notified polymer is intended to be used as a foam inhibitor and pulp deaerator for paper
manufacture. Between 1 and 10 tonnes of the notified polymer will be imported per annum
for each of the first five years.
ASSESSMENT OF PUBLIC, OCCUPATIONAL HEALTH AND SAFETY AND
ENVIRONMENTAL EFFECTS
Hazard Assessment
No toxicological information has been provided for the notified polymer. However, due to its
high molecular weight and presence of only low concern reactive functional groups, it is
unlikely to be a hazardous substance in accordance with the NOHSC Approved Criteria for
Classifying Hazardous Substances. The notified polymer meets the criteria for a Polymer of
Low Concern and thus is unlikely to represent a health hazard.
Occupational Health and Safety
Exposure to the notified polymer is not expected during import and storage of the polymer
suspension which contains 1.6% notified polymer. Import containers of polymer are not
opened prior to end-use and so occupational exposure of import/storage workers to the
polymer would only be envisaged in the case of accidental puncture of containers.
For paper plant operators and personnel involved in quality analysis, the main exposure
routes will be dermal and ocular from splashes and spills. Exposure is only likely to occur
during connection and disconnection of pump lines to import containers and during manual
sampling of imported polymer for quality analysis. The low likelihood of vapour or aerosol
formation during transfer and the use of exhaust ventilation at the dryer sections of the paper
plant make inhalation exposure to the notified polymer unlikely.
Since wash water is recycled, the notified polymer will be present in the final manufactured
paper only at very low levels. Therefore the possibility of exposure of workers involved in
any manual handling of finished paper is very low. Drum recyclers may be exposed to the
polymer residue via mainly the dermal route when reconditioning import containers.
A combination of personal protective equipment worn by workers and engineering controls in
the form of enclosed transfer lines and general and local ventilation will control exposure to
the polymer during end use. These controls will be adequate also to limit exposure to other
potentially hazardous components of the imported polymer solution such as formaldehyde, a
carcinogen and skin sensitiser, present in the imported solution at < 0.05%. Formaldehyde
has a NOHSC exposure standard of 1.2 mg/m3 TWA, 2.5 mg/m3 STEL. Where exposure
control measures have not been specified and exposure is likely eg. for container
reconditioners, personal protective equipment should be worn to limit exposure to the
polymer and other potentially hazardous components of the imported solution.
Chemical Gazette Commonwealth of Australia Gazette
No. C 11, 6 November 2001
58
Given these controls, the low possibility of exposure and the low health hazard associated
with the notified polymer the health risk for these workers would be assessed as low.
Public Health
The product containing the notified chemical is used by industrial users at very low
concentrations and is not available to the public. Hence the risk to public health is not
expected to be significant.
Environmental Effects
When used in the manner prescribed, the polymer is unlikely to lead to adverse effects in the
environment. Release estimates indicate the notified polymer will be present in mill effluent
at a concentration in the sub parts per billion range and assumes that 1% of the notified
polymer is released with mill effluent.
The notified polymer makes up 1.6% of the end use product, which is stated as miscible with
water in the MSDS. Even assuming a worst case scenario that all notified polymer used
during a daily production is released with effluent, the concentration in effluent would be less
than 1 part per billion which would be further diluted on release to receiving waters.
While no ecotoxicological data are available for the notified polymer, releases of this
concentration are not expected to lead to adverse environmental impacts.
RECOMMENDATIONS
Control Measures
Occupational Health and Safety
? No special precautions are required for the notified polymer. However, in the interests
of good occupational hygiene practice, employers should ensure that the following
personal protective equipment is used by workers to minimise occupational exposure
to the notified polymer in the product Afranil SLO:
- Impervious coveralls and footwear
- PVC, rubber or nitrile gloves
- Chemical goggles
Guidance in selection of personal protective equipment can be obtained from
Australian, Australian/New Zealand or other approved standards.
? A copy of the MSDS should be easily accessible to employees.
If products and mixtures containing the notified polymer are classified as hazardous to
health in accordance with the NOHSC Approved Criteria for Classifying Hazardous
Substances, workplace practices and control procedures consistent with provisions of
State and Territory hazardous substances legislation must be in operation.
Chemical Gazette Commonwealth of Australia Gazette
No. C 11, 6 November 2001
59
Secondary Notification
The Director of Chemicals Notification and Assessment must be notified in writing within 28
days by the notifier, other importer or manufacturer:
(1) Under Subsection 64(1) of the Act; if
- the notified polymer is introduced in a chemical form that does not meet the PLC
criteria.
or
(2) Under Subsection 64(2) of the Act:
- if any of the circumstances listed in the subsection arise.
The Director will then decide whether secondary notification is required.
Chemical Gazette Commonwealth of Australia Gazette
No. C 11, 6 November 2001
60
18 PUBLICATION SUMMARY REPORT
MVA 2453L
Summary Report
Reference No: PLC/255
MBT (Australia) Pty Ltd of 11 Stanton Rd Seven Hills NSW 2147 (ACN 000 450 288) has
submitted a synthetic polymer of low concern (PLC) notification statement in support of their
application for an assessment certificate for MVA 2453L. The notified polymer is intended to
be used as a concrete additive. Up to 100 tonnes of the notified chemical will be imported per
annum for each of the first five years.
ASSESSMENT OF PUBLIC, OCCUPATIONAL HEALTH AND SAFETY AND
ENVIRONMENTAL EFFECTS
Hazard Assessment
The notified polymer meets the criteria for a synthetic polymer of low concern and is unlikely
to be a human health hazard. According to the MSDS, the imported aqueous solution is not
hazardous according to the NOHSC Approved Criteria for Classifying Hazardous
Substances.
Occupational Health and Safety
Transport workers are only likely to be exposed to the notified polymer in the event of a
breach of bulk containers or drums in which the 44% polymer solution is imported.
The notified polymer solution is transferred to a holding tank in which the solution is
adjusted with water and to which other additions may be made. The finished solution is
pumped out into tanker trucks for transport to plants followed by transfer to a holding tank
and addition to concrete. The concrete is then transported to work sites for use in
construction. The notifier has stated that there is virtually nil handling of the polymer solution
or finished product as closed systems for pumping and electronic dispensation are employed.
This is reflected in the maximum estimated release of 10 g/day. For the low exposure to
workers gloves and goggles will be used for personal protection. The MSDS for the imported
polymer solutions suggests the use of nitrile rubber or PVC gauntlets, chemical worker's
goggles and overalls. Given the low level of polymer released coupled with its low hazard,
the risk of adverse health effects to workers involved in formulation of the concrete additive,
its transport, storage and addition to the wet concrete is considered to be low. Worker
exposure (mainly dermal) to concrete used in construction is potentially high unless gloves
are employed. However, the concentration of the notified polymer in finished concrete is
0.05% and there is negligible risk of adverse health effects to workers from exposure to the
polymer.
Public Health
The product containing the notified chemical is not available to the public. Dermal exposure
to the chemical through contact with wet concrete is not expected to pose a significant health
risk due to the low concentration and low irritancy of the chemical/product. Also the
chemical will be bound within the cement matrix of the concrete and will not be bioavailable.
The risk to public health is not expected to be significant.
Chemical Gazette Commonwealth of Australia Gazette
No. C 11, 6 November 2001
61
Environmental Effects
The majority of the notified polymer will be incorporated into a matrix of concrete. Once
the concrete is solidified, the notified polymer is expected to pose minimum risk to the
environment.
There is little potential for the notified polymer to be released into the environment from
spillage, drum residues and equipment washing as these processes take place within closed
systems and residues are overwhelmingly likely to be reused. Spillages are expected to be
dispersed and not restricted to a single site. This would minimise the degree of risk to the
environment at any given time. If the spilt imported material or raw product cannot be
recycled then it is likely it will end up in landfill adsorbed to the inert material used for the
spill clean-up (such as sand), where it is likely to leach out in a diffuse manner at low
concentrations.
The main environmental hazard would arise from release of the notified polymer during
storage or transport. The use of bunded containment minimises the risk of release at storage
sites. The MSDS appears to adequately address spills and disposal.
A further environmental hazard could arise from release of untreated polymer-contaminated
water into the aquatic compartment. However, this risk is greatly reduced by the likely
recycling of major volumes of truck wash water for subsequent batches of cement.
The low expected environmental exposure of the notified polymer, when integrated into
concrete, suggests the overall environmental risk should be limited.
RECOMMENDATIONS
Control Measures
Occupational Health and Safety
No specific precautions are required to control exposure to the notified polymer. However, in
the interest of good OHS practice the following measures should be implemented:
? Employers should implement the following engineering controls to minimise
occupational exposure to the notified polymer as introduced and as diluted for use:
- automated pumping
? Employers should ensure that the following personal protective equipment is used by
workers to minimise occupational exposure to the notified polymer as introduced or
as diluted for use:
- nitrile rubber or PVC gauntlets, chemical worker's goggles and overalls
Guidance in selection of personal protective equipment can be obtained from
Australian, Australian/New Zealand or other approved standards.
? A copy of the MSDS should be easily accessible to employees.
Chemical Gazette Commonwealth of Australia Gazette
No. C 11, 6 November 2001
62
? If products and mixtures containing the notified polymer are classified as hazardous to
health in accordance with the NOHSC Approved Criteria for Classifying Hazardous
Substances, workplace practices and control procedures consistent with provisions of
State and Territory hazardous substances legislation must be in operation.
Secondary Notification
The Director of Chemicals Notification and Assessment must be notified in writing within 28
days by the notifier, other importer or manufacturer:
(1) Under Section 64(1) of the Act; if
- the notified polymer is introduced in a chemical form that does not meet the PLC
criteria.
or
(2) Under Section 64(2) of the Act:
- if any of the circumstances listed in the subsection arise.
The Director will then decide whether secondary notification is required.
Chemical Gazette Commonwealth of Australia Gazette
No. C 11, 6 November 2001
63
19 PUBLICATION SUMMARY REPORT
Evcote PWRH-100
Summary Report
Reference No: PLC/256
Asia Pacific Specialty Chemicals Limited (APS) of 15 Park Road Seven Hills NSW 2147
(ABN 32 000 316 138) has submitted a synthetic polymer of low concern (PLC) notification
statement in support of their application for an assessment certificate for EvCote PWRH-100.
The notified polymer is intended to be used as a strength enhancer and moisture barrier
coating for paper and paper products. Greater than 10000 tonnes of the notified chemical will
be manufactured over the first five years and <100 tonnes of the solid notified polymer may
be imported during the first year.
ASSESSMENT OF PUBLIC, OCCUPATIONAL HEALTH AND SAFETY AND
ENVIRONMENTAL EFFECTS
Hazard Assessment
No toxicological information was provided for the notified polymer. The notified polymer
has a high molecular weight and is unlikely to penetrate biological membranes. It contains
carboxylic acid groups and very low concentrations of residual monomers. The polymer
meets the PLC criteria and is unlikely to be a hazardous substance according to the NOHSC
Approved Criteria for Classifying Hazardous Substances.
The notified polymer is not a dangerous good for road and rail transport.
The Material Safety Data Sheet (MSDS) for the notified polymer lists a number of potential
health effects based on products of similar composition, namely irritation of the
gastrointestinal tract with upper abdominal pain, nausea, vomiting and diarrhoea if
swallowed, irritation of the eye with discomfort or blurring resulting in eye damage if
exposure is prolonged, irritation of the skin following prolonged exposure and irritation of the
upper respiratory passages following overexposure by inhalation. The MSDS for the aqueous
polymer dispersion lists potential health effects as irritation of the gastrointestinal tract,
nausea, vomiting and diarrhoea if the liquid is swallowed, irritation to the eye causing redness
and pain following eye exposure, skin irritation following prolonged exposure of the skin to
the liquid and irritation of the upper respiratory tract following mist inhalation. The adverse
health effects relate to the physical characteristics of the solid polymer particles rather than its
toxicological effects.
Occupational Health and Safety
During polymer manufacture, crushing of the solid polymer and blending of the crushed
polymer into an aqueous dispersion there is potential for respiratory, ocular and dermal
exposure to the coarse particles of the notified polymer. There is no NOHSC exposure
standard for the notified polymer itself, however the NOHSC exposure standard for nuisance
dust is 10 mg/m3. The manufacturing, crushing and blending processes are largely enclosed,
with local exhaust ventilation provided. Workers handling the notified polymer will wear
personal protective equipment including overalls, safety glasses, gloves, safety footwear and
respiratory protection. These controls will also provide protection against exposure to other
constituents of the polymer dispersion. These controls and the low toxicological impact
render the health risk from the notified polymer during manufacture, crushing and blending
of polymer low.
Chemical Gazette Commonwealth of Australia Gazette
No. C 11, 6 November 2001
64
Inhalation exposure to airborne particulates and skin contamination from drips and spills is
possible when packing off the polymer and the dispersion into containers. The expected low
hazard of the notified polymer and the use protective equipment to mitigate exposure render
the health risk to workers during the packing off of the polymer and its dispersion low.
During quality control testing of samples of the polymer, intermittent dermal contact can
occur. Laboratory workers are protected by wearing laboratory coats, safety glasses and
gloves. The health risk to workers during this process is low.
Dermal exposure to spills when adding the dispersion into coating systems can occur during
the paper treatment process, which is largely enclosed and automated. Plant operators are
protected from dermal exposure by wearing overalls, safety glasses and gloves. Once the
notified polymer is impregnated onto the paper and has dried, it becomes unavailable for
exposure. Therefore, due to the low potential for exposure and the low health hazard of the
notified polymer, the health risk to paper treatment workers is low.
There is no occupational exposure expected for transport and storage workers except in the
event of accidental spillage.
The notified polymer is of low hazard to human health and safety. The standard control
measures in place during plant operation and protective measures during quality control and
application of the dispersion to paper will ensure sufficient protection against the notified
polymer. Therefore, the notified polymer is of low concern to human health and safety and no
additional risk reduction measures are necessary.
Public Health
The notified polymer is not available for sale to the general public. Although members of the
public will make dermal contact with the dried form of the notified polymer when handling
treated paper items, the risk to public health from the notified polymer is likely to be low
because the notified polymer is unlikely to be bioavailable.
Environmental Effects
The aqueous dispersion containing up to 25% of the notified polymer will be sold to paper
manufacturers who will apply it as a coating or impregnate it into a range of paper products.
These paper products will then be distributed to the general public. Once applied and dried,
the polymer is expected to be durable and not easily removed from the paper to which it has
applied. Therefore, little release of the `free' polymer is anticipated and the great majority of
environmental release of the polymer will be as a result of disposal to landfill, incineration or
recycling of waste paper products. Additionally, there may be some minor release to the
aquatic compartment from the paper/carton recycling processes.
In landfill, the polymer will exist as a stable polyester and is unlikely to be mobile in the soil
environment and would be expected to very slowly degrade to gas such as carbon dioxide
through abiotic and biotic processes. The environmental risk of the notified polymer in
landfill is expected to be low. Incineration of the polymer would yield water and oxides of
carbon. In the case of aquatic discharge, the polymer is likely to associate with sediments.
The high molecular weight and expected low water solubility of the polymer should prevent
bioaccumulation.
Given the above considerations, the overall environmental risk is expected to be low.
Chemical Gazette Commonwealth of Australia Gazette
No. C 11, 6 November 2001
65
RECOMMENDATIONS
Control Measures
No specific precautions are required to control exposure to the notified polymer. However, in
the interests of good occupational health and safety, the following guidelines and precautions
should be observed:
? Employers should implement the following engineering controls to minimise
occupational exposure:
- Exhaust ventilation during manufacture, blending, crushing and filling process
- Enclosed and automated manufacture process
? Employers should implement the following safe work practices to minimise
occupational exposure:
- During manual transfer of notified polymer and polymer dispersion into reaction
tanks and coating bath, avoid spills and splashing
- Avoid generation of dust clouds when handling the polymer in powder form
? Employers should ensure that the following personal protective equipment is used by
workers to minimise occupational exposure to the notified polymer:
- Chemical resistant gloves
- Protective clothing which protects the body, arms and legs
- Eye protection when splashes are generated
- A dust mask when dusts are generated
Guidance in selection of personal protective equipment can be obtained from
Australian, Australian/New Zealand or other approved standards.
? A copy of the MSDS should be easily accessible to employees.
? If products and mixtures containing the notified polymer are classified as hazardous to
health in accordance with the NOHSC Approved Criteria for Classifying Hazardous
Substances, workplace practices and control procedures consistent with provisions of
State and Territory hazardous substances legislation must be in operation.
Secondary Notification
The Director of Chemicals Notification and Assessment must be notified in writing within 28
days by the notifier, other importer or manufacturer:
(1) Under subsection 64(1) of the Act; if
- the notified polymer is introduced in a chemical form that does not meet the PLC
criteria.
or
(2) Under subsection 64(2) of the Act:
- if any of the circumstances listed in the subsection arise.
The Director will then decide whether secondary notification is required.
Chemical Gazette Commonwealth of Australia Gazette
No. C 11, 6 November 2001
66
20 PUBLICATION SUMMARY REPORT
Evcote PWR-100
Summary Report
Reference No: PLC/257
Asia Pacific Specialty Chemicals Limited (APS) of 15 Park Road Seven Hills NSW 2147
(ABN 32 000 316 138) has submitted a synthetic polymer of low concern (PLC) notification
statement in support of their application for an assessment certificate for Ev Cote PWR-100.
The notified polymer is intended to be used as a strength enhancer and moisture barrier
coating for paper and paper products. Greater than 10000 tonnes of the notified chemical will
be manufactured over the first five years and <100 tonnes of the solid notified polymer may
be imported during the first year.
ASSESSMENT OF PUBLIC, OCCUPATIONAL HEALTH AND SAFETY AND
ENVIRONMENTAL EFFECTS
Hazard Assessment
No toxicological information was provided for the notified polymer. The notified polymer
has a high molecular weight and is unlikely to penetrate biological membranes. It contains
carboxylic acid groups and very low concentrations of residual monomers. The polymer
meets the PLC criteria and is unlikely to be a hazardous substance according to the NOHSC
Approved Criteria for Classifying Hazardous Substances.
The notified polymer is not a dangerous good for road and rail transport.
The Material Safety Data Sheet (MSDS) for the notified polymer lists a number of potential
health effects based on products of similar composition, namely irritation of the
gastrointestinal tract with upper abdominal pain, nausea, vomiting and diarrhoea if
swallowed, irritation of the eye with discomfort or blurring resulting in eye damage if
exposure is prolonged, irritation of the skin following prolonged exposure and irritation of the
upper respiratory passages following overexposure by inhalation. The MSDS for the aqueous
polymer dispersion lists potential health effects as irritation of the gastrointestinal tract,
nausea, vomiting and diarrhoea if the liquid is swallowed, irritation to the eye causing redness
and pain following eye exposure, skin irritation following prolonged exposure of the skin to
the liquid and irritation of the upper respiratory tract following mist inhalation. The adverse
health effects relate to the physical characteristics of the solid polymer particles rather than its
toxicological effects.
Occupational Health and Safety
During polymer manufacture, crushing of the solid polymer and blending of the crushed
polymer into an aqueous dispersion there is potential for respiratory, ocular and dermal
exposure to the coarse particles of the notified polymer. There is no NOHSC exposure
standard for the notified polymer itself, however the NOHSC exposure standard for nuisance
dust is 10 mg/m3. The manufacturing, crushing and blending processes are largely enclosed,
with local exhaust ventilation provided. Workers handling the notified polymer will wear
personal protective equipment including overalls, safety glasses, gloves, safety footwear and
respiratory protection. These controls will also provide protection against exposure to other
constituents of the polymer dispersion. These controls and the low toxicological impact
Chemical Gazette Commonwealth of Australia Gazette
No. C 11, 6 November 2001
67
render the health risk from the notified polymer during manufacture, crushing and blending
of polymer low.
Inhalation exposure to airborne particulates and skin contamination from drips and spills is
possible when packing off the polymer and the dispersion into containers. The expected low
hazard of the notified polymer and the use protective equipment to mitigate exposure render
the health risk to workers during the packing off of the polymer and its dispersion low.
During quality control testing of samples of the polymer, intermittent dermal contact can
occur. Laboratory workers are protected by wearing laboratory coats, safety glasses and
gloves. The health risk to workers during this process is low.
Dermal exposure to spills when adding the dispersion into coating systems can occur during
the paper treatment process, which is largely enclosed and automated. Plant operators are
protected from dermal exposure by wearing overalls, safety glasses and gloves. Once the
notified polymer is impregnated onto the paper and has dried, it becomes unavailable for
exposure. Therefore, due to the low potential for exposure and the low health hazard of the
notified polymer, the health risk to paper treatment workers is low.
There is no occupational exposure expected for transport and storage workers except in the
event of accidental spillage.
The notified polymer is of low hazard to human health and safety. The standard control
measures in place during plant operation and protective measures during quality control and
application of the dispersion to paper will ensure sufficient protection against the notified
polymer. Therefore, the notified polymer is of low concern to human health and safety and no
additional risk reduction measures are necessary.
Public Health
The notified polymer is not available for sale to the general public. Although members of the
public will make dermal contact with the dried form of the notified polymer when handling
treated paper items, the risk to public health from the notified polymer is likely to be low
because the notified polymer is unlikely to be bioavailable.
Environmental Effects
The aqueous dispersion containing up to 25% of the notified polymer will be sold to paper
manufacturers who will apply it as a coating or impregnate it into a range of paper products.
These paper products will then be distributed to the general public. Once applied and dried,
the polymer is expected to be durable and not easily removed from the paper to which it has
applied. Therefore, little release of the `free' polymer is anticipated and the great majority of
environmental release of the polymer will be as a result of disposal to landfill, incineration or
recycling of waste paper products. Additionally, there may be some minor release to the
aquatic compartment from the paper/carton recycling processes.
In landfill, the polymer will exist as a stable polyester and is unlikely to be mobile in the soil
environment and would be expected to very slowly degrade to gas such as carbon dioxide
through abiotic and biotic processes. The environmental risk of the notified polymer in
landfill is expected to be low. Incineration of the polymer would yield water and oxides of
carbon. In the case of aquatic discharge, the polymer is likely to associate with sediments.
Chemical Gazette Commonwealth of Australia Gazette
No. C 11, 6 November 2001
68
The high molecular weight and expected low water solubility of the polymer should prevent
bioaccumulation.
RECOMMENDATIONS
Control Measures
No specific precautions are required to control exposure to the notified polymer. However, in
the interests of good occupational health and safety, the following guidelines and precautions
should be observed:
? Employers should implement the following engineering controls to minimise
occupational exposure:
- Exhaust ventilation during manufacture, blending, crushing and filling process
- Enclosed and automated manufacture process
? Employers should implement the following safe work practices to minimise
occupational exposure:
- During manual transfer of notified polymer and polymer dispersion into reaction
tanks and coating bath, avoid spills and splashing
- Avoid generation of dust clouds when handling the polymer in powder form
? Employers should ensure that the following personal protective equipment is used by
workers to minimise occupational exposure to the notified polymer:
- Chemical resistant gloves
- Protective clothing which protects the body, arms and legs
- Eye protection when splashes are generated
- A dust mask when dusts are generated
Guidance in selection of personal protective equipment can be obtained from Australian,
Australian/New Zealand or other approved standards.
? A copy of the MSDS should be easily accessible to employees.
If products and mixtures containing the notified polymer are classified as hazardous to health
in accordance with the NOHSC Approved Criteria for Classifying Hazardous Substances,
workplace practices and control procedures consistent with provisions of State and Territory
hazardous substances legislation must be in operation.
Secondary Notification
The Director of Chemicals Notification and Assessment must be notified in writing within 28
days by the notifier, other importer or manufacturer:
(1) Under subsection 64(1) of the Act; if
- the notified polymer is introduced in a chemical form that does not meet the PLC
criteria.
or
(2) Under subsection 64(2) of the Act:
- if any of the circumstances listed in the subsection arise.
Chemical Gazette Commonwealth of Australia Gazette
No. C 11, 6 November 2001
69
The Director will then decide whether secondary notification is required.
Chemical Gazette Commonwealth of Australia Gazette
No. C 11, 6 November 2001
70
21 PUBLICATION SUMMARY REPORT
1h-pyrazole-1-ethanol, 4, 5-diamino-, sulfate (1:1) salt (Pyrazole DHE)
Summary Report
Reference No: EX/30 (NA/755)
Schwarzkopf Pty Ltd. of 20 Rodborough Road, Frenchs Forest NSW 2086 has submitted a
notification statement in support of their application for an extension of the Assessment
Certificate for 1H-pyrazole-1-ethanol, 4,5-diamino-, sulfate (1:1) salt (Pyrazole DHE). The
notified chemical will be used in the formulation of hair dye products. Approximately 200
kg/year will be imported over the nest five years.
The original assessment certificate is held by Cosmetic Products (Wella) Pty Ltd of 1 Wella
Way, Somersby NSW, who has agreed to this extension.
The new information in this current application supplied by Schwarzkopf Pty Ltd affects
primarily the occupational exposure, public exposure and environmental sections of NA/755.
The chemical will be imported as a final product in 50mL heavy wall glass containers. The
concentration of the notified chemical in the hair dye products will be 0.9%. There is a
decrease in the import volume of the notified chemical in the application for an extension of
the original certificate.
ASSESSMENT OF PUBLIC, OCCUPATIONAL HEALTH AND SAFETY AND
ENVIRONMENTAL EFFECTS
The notified chemical was of very low acute oral toxicity in rats. It was a slight skin irritant
in rabbits but non-irritant in human volunteers. In its pure form, the notified chemical caused
severe damage to the eyes of the rabbit, but was non-irritant when applied as a 5% aqueous
solution. The notified chemical was extremely sensitising to the skin of guinea pigs in the
Maximisation test but non-sensitising in the B黣hler test.
The notified chemical was considered non-mutagenic to the bacterial strains tested and non-
genotoxic in an in vivo mouse micronucleus assay. However, it was clastogenic in vitro in a
chromosomal aberration assay only in the absence of metabolic activation.
The notified chemical is classified as a hazardous substance according to the NOHSC
Approved Criteria for Classifying Hazardous Substances based on the findings of the
persistent conjunctival effects in an eye irritation study, and the potential for skin
sensitisation observed in an adjuvant type test. The overall classification is Irritant (Xi) and
the risk phrase R41- Risk of Serious Damage to Eyes and R43- May Cause Sensitisation by
Skin Contact, are assigned.
The imported product and formulated end-use products will require the appropriate risk
phrases under hazardous substances regulations.
Occupational Health and Safety
Transport and Storage
Exposure to the notified chemical is not expected during transport or storage as long as the
packaging remains intact. Exposure after a spill would be controlled by use of the
Chemical Gazette Commonwealth of Australia Gazette
No. C 11, 6 November 2001
71
recommended practices for spillage clean up given in the MSDS supplied by the notifier.
The risk of adverse health effects for transport and storage workers is considered low.
Formulation
The greatest potential for exposure to the notified chemical is during opening, emptying and
mixing of the powdered chemical and during disposal of empty used bags. There exists
potential for exposure by inhalation and/or skin and eye contact with dust particles with the
associated health effects of skin sensitisation and eye irritation. The notified chemical
comprises up to 80% of the imported dye powder for dark dye shades. At concentrations of >
1% chemical, Pyrazole DHE is a hazardous substance. There may also be potential for
genotoxic effects as revealed in a chromosome aberration study. Given the low molecular
weight (240) of the notified chemical, significant absorption through the skin cannot be
excluded.
Given this risk of adverse health effects during this stage of the formulation process, local
exhaust ventilation and dust extraction need to be maintained over mixing areas to capture
dust and aerosols at source, and minimise exposure to airborne particulates generated from
the notified chemical and any other ingredients. The wearing of an air purifying dust
respirator (with P3 particulate filter) and other protective equipment throughout the
formulation process, such as impervious gloves, overalls and eye protection, is needed. The
NOHSC exposure standard for inspirable dust will need to be adhered to in the workplace.
Exposure to the chemical at 0-4.5% may occur after dilution, when mixing with other hair
dye ingredients, during connection/disconnection of containers to transfer lines and during
cleaning and maintenance of equipment. Inhalation exposure is not expected as any aerosols
would be within enclosed automated operation systems. Skin and/or eye contact will be the
main routes of exposure. As the notified chemical is hazardous at > 1%, a risk of skin
sensitisation, and possibly eye irritation, exists during formulation and packaging,
particularly with the darker shades which contain the higher concentrations. The prompt
clean up of spills and the wearing of impervious gloves, overalls and chemical splash goggles
are needed to reduce these risks when handling the dye solutions.
Exposure to dusts and aerosols may also occur during laboratory testing, however, given the
smaller quantities handled, the potential for skin sensitisation and eye irritancy is reduced.
Local exhaust ventilation and the routine wearing of laboratory coats, impervious gloves and
safety glasses would be expected to further reduce these risks.
Measures should also be implemented in the disposal of the notified chemical to ensure that
exposure is avoided.
End use
Workers in hairdressing salons could handle this chemical on a frequent basis. The product
concentration of 0-4.5% is diluted in use, to a maximum of 0-2.25%. At 2.25%, the chemical
is still a hazardous substance (skin sensitiser) and hairdressers will need to wear gloves when
making up, applying and rinsing off this chemical.
Public Health
The public will be exposed to the notified chemical at up to 4.5% in hair dye products. At
this concentration, it is expected that the products will not cause skin or eye irritation, but
may cause skin sensitisation in certain susceptible individuals. Exposure of individuals, in
Chemical Gazette Commonwealth of Australia Gazette
No. C 11, 6 November 2001
72
the at home use, to the notified chemical should be controlled by following the instructions
supplied on product labels. Exposure is expected to be low and for short periods only; thus, it
is considered that Pyrazole DHE will not pose a significant hazard to public health when used
in the proposed manner.
Variations to this assessment specific to the Schwarzkopf Pty Ltd extension
Public exposure to hair dye products containing the notified chemical is likely to be
intermittent (based on the use pattern), and widespread (sold to the public and limited only by
the commercial success of the products). When used, the colour gel containing the notified
chemical (1.0%) will be diluted 4:5 with developer, leading to maximal exposure
concentrations of 0.5%. At these concentrations, it is expected that the products will not
cause skin or eye irritation, but may cause skin sensitisation in certain susceptible individuals.
Use of hair dye products strictly in accordance with the product information, should minimise
the potential skin sensitisation hazard. There will be minimal public exposure from transport
and storage.
Environmental Effects
The notified chemical is expected to pose a low environmental hazard if used as specified by
the notifier.
The annual amount of waste notified chemical produced during the reformulation is 19.0 kg.
The majority of this waste will enter the sewer. The remainder will likely be disposed of to
landfill (ie in bags/containers), where is likely to leach out. The empty end-use containers
will generally go to landfill, equating to about 10 kg of unreacted notified chemical waste
annually. All these inputs into the environment are likely to be at very low concentrations
and in a very diffuse manner.
As the notifier has not provided the percentage uptake of the dye by the hair it has been
presumed that all the dye (containing the notified chemical) will end up in the sewer. The use
of the hair dye would be dispersed over Australia, so a PEC for the notified chemical could
be calculated as follows:
Amount of notified chemical imported per year,
subsequently entering sewer 500 kg
Population of Australia 18 million
Amount of water used per person per day 150 L
Number of days in a year 365
Estimated PEC 0.00005 mg/L (0.05 ppb)
The scenario where a whole formulation batch is dropped and subsequently enters the sewer
would represent a worst case PEC. The resultant PEC is:
Quantity of notified chemical entering the on-site
treatment plant 4.5 kg
Volume of water handled by the treatment plant 40 000 L
Sewer concentration 112.5 mg/L
Amount of effluent handled daily by MTP 250 ML
Dilution in receiving water 1:10
Worst case daily PEC 0.045 mg/L (0.045 ppm)
Chemical Gazette Commonwealth of Australia Gazette
No. C 11, 6 November 2001
73
The ecotoxicity studies indicated that the most sensitive species to the notified chemical is
algae (EbC50 = 5.33 mg/L). All of the PECs calculated are several orders of magnitude below
the calculated EbC50 level for algae, therefore the use as proposed poses a low hazard.
Variation to this assessment specific to the Schwarzkopf Pty Ltd extension
The following calculations assume that the new chemical will be used nationwide and that it
is released to the sewer system. It is also assumed that 150 L of sewerage are generated each
day by each person.
Import rate 200kg/annum
Release rate 200kg/annum
19 x 106
Population (national)
1 x 1012 L/annum
Volume of sewerage per annum
0.2 礸 /L (0.2ppb)
Mean concentration of sewerage
On release to receiving waters (after treatment at the sewage treatment plant), it is usually
assumed that the effluent is diluted by a factor of 10. This gives a final PEC in receiving of
0.02 礸 /L (0.02 ppb).
However, it should be noted that no removal through other mechanisms has been considered
in the above calculations. Biodegradation of the chemical or adsorption to sediment will
lower the above PEC estimates to the extent these processes occur.
Conclusion
The notified chemical is not likely to present a hazard to the environment when it is stored,
transported and used in the proposed manner.
RECOMMENDATIONS
Pyrazole DHE is a skin sensitiser; workers handling it or products containing it will need to
be strictly protected against skin contact. To minimise occupational exposure to Pyrazole
DHE the following guidelines and precautions should be observed:
Safety goggles should be selected and fitted in accordance with Australian Standard
?br>
(AS) 1336 to comply with Australian/New Zealand Standard (AS/NZS) 1337;
industrial clothing should conform to the specifications detailed in AS 2919 and AS
3765.1; impermeable gloves or mittens should conform to AS 2161.2; all
occupational footwear should conform to AS/NZS 2210; respiratory protection should
conform to AS/NZS 1715, and AS 1716;
Local exhaust ventilation should conform to AS 1668.2;
?br>
Dust levels in the workplace should be maintained below the NOHSC exposure
?br>
standard for nuisance dusts, 10 mg/m3 (TWA) measured as inspirable fraction.
Employers are responsible for ensuring the exposure standard is not exceeded;
Spillage of the notified chemical should be avoided. Spillages should be cleaned up
?br>
promptly and put into containers for disposal;
Chemical Gazette Commonwealth of Australia Gazette
No. C 11, 6 November 2001
74
Good personal hygiene should be practised to minimise the potential for ingestion;
?br>
and
A copy of the MSDS should be easily accessible to employees.
?br>
If the conditions of use are varied, then greater exposure to the public may occur. In such
circumstances, further information may be required to assess the hazards to public health.
The notified chemical may be recommended to the National Occupational Health and Safety
Commission for consideration for inclusion in the NOHSC List of Designated Hazardous
Substances.
Chemical Gazette Commonwealth of Australia Gazette
No. C 11, 6 November 2001
75
22 ACCESS TO FULL PUBLIC REPORT
NICNAS publishes a Full Public Report for each new chemical assessed. These reports are
available for public inspection at the library of the National Occupational Health & Safety
Commission at their Canberra office by appointment only. Please call the library on (02)
6279 1161 or (02) 6279 1163 to arrange to view the Full Public Report.
Reports can also be viewed and downloaded free of charge from our website at
www.nicnas.gov.au. Copies of these reports may also be requested, free of charge, by
contacting the Administration Section of NICNAS by phone: (02) 9577 9579 or fax: (02)
9577 9465.
Chemical Gazette Commonwealth of Australia Gazette
No. C 11, 6 November 2001
76
23 COMMERCIAL EVALUATION PERMIT
The permits listed in Table 1 were issued to import or manufacture the following chemicals
for commercial evaluation under section 21G of the Industrial Chemicals (Notification and
Assessment) Act 1989.
Table 1
Commercial Evaluation Category Permits
PERMIT COMPANY COMPANY CHEMICAL HAZARDOUS QUANTITY USE PERIOD
NUMBER NAME POSTCODE OR TRADE SUBSTANCE APPROVED
NAME
19/09/01
Binder in
2086 No Less than
Rioch RSE-825
492
photocoping
1500kg per
Australia Pty
toner
year
Ltd
2086 No Less than Binder in 19/09/01
Rioch
493 RSE-801
Australia Pty 500kg per photocopying
Ltd year toner
Rioch 2086 No Less than Charge 19/09/01
494 RCR-8
Australia Pty 60kg per control in
Ltd year toner
BASF Akzo
495
Nobel
Chemical in
Automotive
No 1800kg Car primer 26/10/01
3020 RX 3211
OEM Pty Ltd
& Akzo
Nobel Pty Ltd
Chemical Gazette Commonwealth of Australia Gazette
No. C 11, 6 November 2001
77
24 LOW VOLUME CHEMICAL PERMITS
The permits listed in Table 2 were issued to import or manufacture the following chemicals
under section 21U of the Industrial Chemicals (Notification and Assessment) Act 1989. Low
Volume Category Permits are approved for 36 months.
Table 2
Low Volume Category Permits
PERMIT COMPANY COMPANY CHEMICAL HAZARDOUS USE DATE
NUMBER NAME POSTCODE OR TRADE SUBSTANCE
NAME
398 Kodak 3058 CIN Yes Component of 19/01/01
Australasia 10090712 ink
Pty Ltd formulations
403 Canon 2113 NT-9 No Developer 04/10/01
Australia component
Pty Ltd for electro-
photocopying
machine
404 Konica 2113 H-9605 No Component of 04/10/01
Australia photo-
processing
chemicals
405 3M 1790 Polyurethane No Component of 05/10/01
Australia a foam used
Pty Ltd in OEM
applications
406 Lord 3043 Polymer in No Rubber 05/10/01
Chemical Ty-Ply ?RC bonding agent
Products
Pty Ltd
Chemical Gazette Commonwealth of Australia Gazette
No. C 11, 6 November 2001
78
25 EARLY INTRODUCTION PERMITS FOR NON-HAZARDOUS INDUSTRIAL
CHEMICALS
The permits listed in Table 3 were issued to import or manufacture the following chemicals
prior to the issue of their respective assessment certificates under section 30A of the Act.
Table 3
Early Introduction Permits
PERMIT COMPANY CHEMICAL OR TRADE USE
NUMBER NAME NAME
180 3M Australia Pty Urethane Polymer Component of a
Ltd fabric/fibre stain
protector
181 Degussa Australia Dynapol H 700 Paint component
Pty Ltd
182 DuPont (Australia) RC 25433 Paint component
Ltd
183 ISP (Australasia) Pty Allianz LT120 Hair fixture resin for hair
Ltd styling products
184 BASF Akzo Nobel Polymer in RW 3210 Paint component
Automotive OEM
Coatings Pty Ltd &
185 Akzo Nobel Pty Ltd Polymer in RW 3210 Paint component
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No. C 11, 6 November 2001
79
26 NOTICE OF CHEMICALS ELIGIBLE FOR LISTING ON THE AUSTRALIAN
INVENTORY OF CHEMICAL SUBSTANCES UNDER AN AMNESTY
Notice is given in accordance with section 20E of the Industrial Chemicals (Notification and
Assessment) Amendment Act (No. 2), 1992, that the following chemicals have been added to
the Australian Inventory of Chemical Substances.
Table 4
Chemicals Eligible For Listing On The Australian Inventory Of Chemical Substances
CHEMICAL NAME CAS NUMBER MOLECULAR FORMULA
1-Propanaminium, 3-butoxy-2-hydroxy-N- (2-
C12H27NO6S
108797-84-8
hydroxy-3-sulfopropyl)-N, N-dimethyl-, inner salt
1-Propanaminium, 3-[(2-ethylhexyl) oxy]-2-
108797-85-9 C16H35NO6S
hydroxy-N- (2-hydroxy-3-sulfopropyl)-N, N-
dimethyl-, inner salt
1-Butanol, 2,2-bis [(2-propenyloxy) methyl]-,
71486-80-1 C12H22O3.C12H18N2O2.C3H6O
reaction products with allyl alc. and 5-isocyanato-1-
(isocyanatomethyl)-1,3,3-trimethylcyclohexane
Poly [imino(1,2-dioxo-1,2-ethanediyl)imino-1,2-
36812-63-2 (C4H6N2O2) n
ethanediyl]
Ethanethiol, 2,2'-thiobis-, reaction products with
(C5H10Cl2O2.C4H10S3.C3H5Cl3.Unspecif
109159-22-0
reduced 1,1'-[methylenebis(oxy)]bis[2- ied ) x
chloroethane]-sodium sulfide
(Na2 (Sx)-1,2,3-trichloropropane polymer
Hexane, 1,6-diisocyanato-, homopolymer, 2-ethyl-1-
Unspecified
199745-10-3
hexanol- and 2-oxepanone homopolymer 2-[(1-oxo-
2-propenyl) oxy] ethyl ester-blocked
1,2-Ethanediamine, polymer with 2,2'-[(1-
27615-34-5 (C21H24O4.C2H8N2) x
methylethylidene) bis (4,1-
phenyleneoxymethylene)] bis [oxirane]
Chemical Gazette Commonwealth of Australia Gazette
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27 NOTICE OF CHEMICALS ELIGIBLE FOR LISTING ON THE AUSTRALIAN
INVENTORY OF CHEMICAL SUBSTANCES FIVE YEARS AFTER ISSUING OF
ASSESSMENT CERTIFICATES
Notice is given in accordance with section 14(1) of the Industrial Chemicals (Notification
and Assessment) Act 1989, that the following chemicals have been added to the Australian
Inventory of Chemical Substances.
Table 5
Chemicals Eligible for Listing on the Australian Inventory of Chemical Substances
CHEMICAL NAME CAS NUMBER MOLECULAR FORMULA
(C8H14O2.C7H12O2.C4H6O2) x
32409-51-1
2-Propenoic acid, 2-methyl-, polymer with butyl 2-
propenoate and 2-methylpropyl 2-methyl-2-propenoate
162568-28-7 Unspecified
1,2,3-Propanetricarboxylic acid, 2-hydroxy-, reaction
products with 1H-imidazole-1-propanamine, 2-
oxepanone homopolymer decy ester, polyethylene-
polypropylene glycol and poly-TDI
(C6H12N4.CH4N2O.CH2O) x
69898-35-7
Urea, polymer with formaldehyde and 1,3,5,7-
tetraazatricyclo[3.3.1.13,7]decane, butylated
99869-40-6
1,6-Hexanediol, polymer with 1,1'-methylenebis[4- (C15H10N2O2.C6H14O2.C3H8O3.3 (C3H6O.C2H4O)
x)x
isocyanatobenzene] and methyloxirane polymer with
oxirane ether with 1,2,3-propanetriol (3:1)
C28H34O8S2
92761-26-7
Bicyclo[2.2.1]heptane-1-methanesulfonic acid, 3,3'-
(1,4-phenylenedimethylidyne)bis[7,7-dimethyl-2-oxo-
(C21H28O4.C16H26O3.C8H6O4) x
173659-63-7
1,3-Benzenedicarboxylic acid, polymer with 3-
(dodecenyl)dihydro-2,5-furandione and 1,1'-[(1-
methylethylidene)bis(4,1-phenyleneoxy)]bis[2-
propanol]
C28H52N2O4.C8H18.C4H10O2
129757-67-1
Decanedioic acid, bis(2,2,6,6-tetramethyl-4-
piperidinyl) ester, reaction products with tert-Bu
hydroperoxide and octane
C30H25FN8O16S5.4Na
130201-56-8
2,7-Naphthalenedisulfonic acid, 3-[(2,5-
disulfophenyl)azo]-5-[[4-[[3-[[[2-
(ethenylsulfonyl)ethyl]amino]carbonyl]phenyl]amino]-
6-fluoro-1,3,5-triazin-2-yl]amino]-4-hydroxy
tetrasodium salt
C56H46F2N18O20S6.xK.xLi.xNa
149850-34-0
2-Naphthalenesulfonic acid, 7,7'-[(2-methyl-1,5-
pentanediyl)bis[imino(6-fluoro-1,3,5-triazine-4,2-
diyl)imino]]bis[4-hydroxy-3-[[2-sulfo-4-[(4-
sulfophenyl)azo]phenyl]azo]-, lithium potassium
sodium salt
C30H25Br2ClN8O11S3.xNa
155522-14-8
2,7-Naphthalenedisulfonic acid, 5-[[4-chloro-6-
(ethylphenylamino)-1,3,5-triazin-2-yl]amino]-3-[[5-
[(2,3-dibromo-1-oxopropyl)amino]-2-
sulfophenyl]azo]-4-hydroxy-, sodium salt
153519-44-9 Unspecified
1,3-Benzenediol, 4-[4,6-bis(2,4-dimethylphenyl)-1,3,5-
triazin-2-yl]-, reaction products with
[(dodecyloxy)methyl]oxirane and oxirane mono[(C10-
16-alkyloxy)methyl] derivs.
Chemical Gazette Commonwealth of Australia Gazette
No. C 11, 6 November 2001
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C18H11ClN2O2
88949-37-5
Pyrrolo[3,4-c]pyrrole-1,4-dione, 3-(4-chlorophenyl)-
2,5-dihydro-6-phenyl-
C27H27N3O2
147315-50-2
2-(4,6-Diphenyl-1,3,5-triazine-2-yl)-5-
[(hexyl)oxy]phenol
C20H16N2O2
84632-66-6
2,5-Dihydro-3,6-bis(4-methylphenyl)pyrrolo[3,4-
c]pyrrole-1,4-dione
C35H34N12O9S2.2Na
130201-55-7
Disodium 4,4'-(6-morpholino-1,3,5-triazine-2,4-
diyldiimino)bis[m-(2-
acetamidophenylazo)benzenesulfonate]
C18H14N4O6S.xNa
156738-27-1
Benzenesulfonic acid, 4-[[4-[(4-
hydroxyphenyl)azo]phenyl]amino]-3-nitro-, sodium
salt
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28 NOTICE OF AMENDMENTS TO THE AUSTRALIAN INVENTORY OF
CHEMICAL SUBSTANCES
Notice is given in accordance with section 20 of the Industrial Chemicals (Notification and
Assessment) Act 1989 (the Act) that the following amendment have been made to the
Australian Inventory of Chemical Substances (AICS).
1. The following chemical has been added to AICS.
Table 6 Amendment to AICS
CHEMICAL NAME CAS NUMBER MOLECULAR FORMULA
Rosin, maleated, polymer with branched 4-
185765-80-4 Unspecified
nonylphenol, formaldehyde and
pentaerythritol
2. Some chemicals were listed in AICS under valid and invalid CAS numbers. Invalid CAS
numbers are now deleted from AICS. Table 5 lists the invalid CAS Numbers against the valid
CAS numbers.
Table 7 Invalid CAS numbers, now deleted from AICS, and the corresponding valid
CAS numbers
INVALID CAS NUMBER VALID CAS NUMBER
1338-46-1 67701-03-5
1406-70-8 58-95-7
5893-66-3 55671-32-4
8051-63-6 68155-24-8
10535-02-1 5280-66-0
12225-04-6 3905-19-9
12238-65-2 3068-39-1
12262-18-9 3251-84-1
12389-15-0 6047-12-7
12619-52-2 31455-16-0
12710-07-5 14117-96-5
12769-01-6 5045-40-9
22374-99-8 150-88-9
22886-75-5 12503-89-8
25776-41-4 52625-13-5
26793-72-6 68584-99-6
26857-24-9 25232-42-2
28068-35-1 38945-70-9
29754-80-1 7023-61-2
30373-82-1 25498-49-1
30496-13-0 79-94-7
31830-07-6 56449-05-9
31957-38-7 25119-99-7
32075-38-0 137-20-2
32917-01-4 12225-86-4
33115-06-9 37280-83-4
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83
35885-17-7 9004-99-3
36443-64-8 57671-19-9
36655-14-8 73507-68-3
37332-31-3 123465-33-8
37359-39-0 30351-73-6
39355-08-3 8012-95-1
39355-58-3 61791-14-8
51176-98-8 26898-17-9
51750-73-3 7783-13-3
52238-52-5 5280-66-0
52309-41-8 25322-69-4
53523-20-9 9003-35-4
54173-86-3 56011-02-0
54990-32-8 68584-99-6
55599-33-2 7631-86-9
56731-19-2 30125-47-4
56802-99-4 11084-85-8
57485-98-0 82338-76-9
57851-91-9 9003-35-4
58517-33-2 25155-30-0
58660-13-2 9086-52-6
61180-55-0 12174-11-7
61512-60-5 109414-04-2
61512-64-9 21405-81-2
61931-54-2 15958-61-9
63172-75-8 65307-72-4
63690-56-2 5743-47-5
64945-73-9 37337-65-8
66105-29-1 68553-03-7
67953-88-2 54579-44-1
68345-29-9 26761-25-1
68412-30-6 58944-89-1
68412-90-8 69331-40-4
68412-91-9 59419-62-4
68609-75-6 68133-63-1
68610-03-7 62503-58-6
68859-51-8 29204-84-0
68859-68-7 36888-99-0
68916-24-5 9000-24-2
68988-66-9 8005-52-5
69771-45-5 15993-42-7
70865-24-6 12237-01-3
70992-41-5 27136-15-8
75497-74-4 3618-72-2
76168-74-6 40716-47-0
79331-93-4 9011-15-8
89591-46-8 68110-24-7
94351-85-6 15233-33-7
97143-76-5 33918-18-2
98073-10-0 119831-19-5
102979-97-5 100208-47-7
102979-98-6 97660-74-7
102980-36-9 102980-18-7
103513-11-7 9049-71-2
103819-01-8 68439-50-9
104133-13-3 60892-41-3
104133-20-2 102980-22-3
104339-47-1 57629-28-4
Chemical Gazette Commonwealth of Australia Gazette
No. C 11, 6 November 2001
84
111977-68-5 67989-30-4
118658-97-2 68030-74-0
120145-59-7 110053-35-5
159339-88-5 146126-21-8
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29 NICNAS MOVES - NEW CONTACT DETAILS
The National Industrial Chemicals Notification and Assessment Scheme (NICNAS) is
moving from Camperdown to Marrickville during the week of 5 November 2001.
Our new contact details follow ?please note that our GPO Box and freecall numbers, as well
as our web site, remain unchanged.
Street address:
334-336 Illawarra Road
Marrickville NSW 2204
Postal address:
GPO BOX 58
Sydney NSW 2001
Australia
tel +61 2 8577 8800
fax +61 2 8577 8888
freecall 1800 638 528
email info@nicnas.gov.au
web www.nicnas.gov.au
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30 OZONE PROTECTION PROGRAM, ENVIRONMENT AUSTRALIA,
REQUEST FOR INFORMATION ON OZONE-DEPLETING SUBSTANCES USED
AS PROCESS AGENTS
Under the Montreal Protocol on Substances that Deplete the Ozone Layer, the import, export
and manufacture of certain ozone depleting substances (ODS) has been prohibited. An
exception to this prohibition is the import, export or manufacture of ODS as process agents,
under certain circumstances.
Process agents are chemicals that are used, because of their unique chemical and/or physical
properties, to facilitate an intended chemical reaction and/or inhibit an unintended chemical
reaction. ODS are typically used as process agents in the production of chlorine, chlorinated
rubber, pharmaceuticals and agricultural and veterinary chemicals. To date, the Montreal
Protocol's panel of experts have verified that the ODS carbon tetrachloride (CTC),
chlorobromomethane (CBM) and chlorofluorocarbons 11, 12 and 113 (CFC 11, CFC 12,
CFC 113) are currently used internationally as process agents.
In accordance with industry and government consultation undertaken in 1998, the
Commonwealth Government reported internationally that Australia does not use ODS as
process agents. The 10th Meeting of the Parties to the Montreal Protocol in December 1998
agreed: a list of process agent applications of ODS; country-specific limits on the level of
"make-up quantity" (quantity of ODS needed annually in the process agent application to
maintain operations) and emissions allowable from ODS used in those process agent
applications; and annual reporting obligations. Australia's annual "make-up quantity" and
emission limits are currently zero.
Environment Australia is the Commonwealth agency responsible for implementing
Australia's international obligations under the Montreal Protocol, and as such would
appreciate any information relating to the use of these substances as process agents in
Australia. All information received by Environment Australia will be used to: fulfil
Australia's international reporting obligations; determine whether there are legitimate process
agent uses of ozone depleting substances within Australia; register these uses with the
Secretariat of the Montreal Protocol; and determine whether Australia needs to seek
amendment to its Protocol limits on "make-up quantity" and emission.
Users of these substances who believe that they may have relevant information should
contact Mr Ben Stapley of Environment Australia on (02) 6274 1601 by 1 December 2001.
Environment Australia has prepared a questionnaire to assist Australian industry in providing
the relevant information. This will be provided on request.
If you would like further information or wish to discuss any aspect of this request, please
contact Mr Stapley.
Chemical Gazette Commonwealth of Australia Gazette
No. C 11, 6 November 2001
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31 CHANGES TO THE INDUSTRIAL CHEMICALS (NOTIFICATION AND
ASSESSMENT) ACT 1989
Changes have been made within legislation administered by the Minister for Employment,
Workplace Relations and Small Business to reflect the application of the Criminal Code Act
1995. These include changes to the Industrial Chemicals (Notification and Assessment) Act
1989. The Criminal Code contains a standard approach to the formulation of criminal
offences. Changes are found in the Employment, Workplace Relations and Small Business
Legislation Amendment (Application of Criminal Code) Act 2001, which commenced on 2
October 2001.
The Department of Employment, Workplace Relations and Small Business provides the
following explanation.
Outline of Amendments and Rationale
The Employment, Workplace Relations and Small Business Legislation Amendment
(Application of Criminal Code) Act 2001 (the EWRSB Act) commenced on 2 October 2001.
A copy of the Bill as introduced (there were no amendments made to the Bill as introduced)
and the Explanatory Memorandum can be found at:
http://www.dewrsb.gov.au/workplacerelations/legislation/EWRSBLA(ACC)/default.asp
The Act was one of a series proposed across portfolios to align Commonwealth offences in
general with Chapter 2 of the Criminal Code Act 1995. Chapter 2 of the Criminal Code sets
out the general principles of criminal responsibility and applies to the portfolio Acts it
amends from its commencement.
The amendments were made to ensure that the relevant offences continued to have much the
same meaning and to operate in much the same manner as they did before Chapter 2 applied.
The Criminal Code contains a standard approach to the formulation of criminal offences.
The following is a link to the Criminal Code Act 1995 (Note - it is over 160 pages to print
out, but Chapter 2 of the Code is the most relevant):
http://www.austlii.edu.au/au/legis/cth/consol_act/cca1995115/
The major forms of amendment effected to the Industrial Chemicals (Notification and
Assessment) Act 1989 by the EWRSB Act are:
? applying Chapter 2 of the Criminal Code. One consequence of this is that the provisions
of Part 2.5 of Chapter 2 which deal with the vicarious liability of corporations will apply
rather than the provisions of subsection 109(1) and 109(2);
?better identifying exceptions and defences. For example `reasonable excuse' has been
removed from the body of offences and restated as a defence for which the defendant
bears an evidential burden (see ss 13.3(3) of the Criminal Code);
?deleting references to sections 7, 7A, and 86 of the Crimes Act 1914 (which deal with
attempt, incitement and conspiracy) and replacing these with references to equivalent
Criminal Code provisions where appropriate;
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? applying strict liability to individual offences or specified physical elements of offences
where appropriate. This means that the prosecution does not have to prove a mental
element in relation to the offence or element of the offence (such as intention to do
something). The defence of reasonable mistake of fact is available for strict liability
offences (see section 9.2 of the Criminal Code);
?reconstructing provisions in order to clarify physical elements of conduct, circumstance
and result. For example subsections 21L(4) and 21W(5) relating to breaching conditions
of a permit have been restructured to better identify the physical elements of conduct (in
this case doing or omitting to do an act) and result (the act or omission contravenes a
permit); and
?removing or replacing inappropriate fault elements. For example, omitting `knowingly or
recklessly' from provisions such as ss. 21(1); 30C(4); section 56; ss 67(2); and section
80B. This is because under the Criminal Code it will not be possible to apply a fault
element of knowledge or recklessness to a physical element of conduct. Only intention
can apply to conduct.
Contact Megan Smith, Innovation and Compliance, NICNAS on Freecall 1800 638 528 if
clarification is needed.
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No. C 11, 6 November 2001
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32 NEW TRANSITIONAL ARRANGEMENTS TOWARDS APPROVAL OF
APPROVED FOREIGN SCHEME
The Transitional Arrangements Towards Approval of Approved Foreign Schemes
(Transitional Arrangements) were first published in the Chemical Gazette No. C 4, 7 April
1998.
NICNAS experience gained to date within the Transitional Arrangements and by
participating in international activity, namely within the OECD New Chemicals Task Force,
suggests benefits to NICNAS and industry by expanding the Transitional Arrangements. For
example, NICNAS has established firm links with Canada and European Union member
states on information sharing which will make it easier for industry to obtain assessment
reports from these sources. In addition, there are potential benefits for industry and NICNAS
by expanding the Transitional Arrangements to include the Limited Notification Category.
Finally, Canada and Australia share similar criteria for defining a Synthetic Polymer of Low
Concern (PLC). Consequently, we can introduce resource savings for both industry and
NICNAS where the applicant provides evidence to NICNAS that a polymer has been notified
and assessed in Canada under the Canadian Environment Protection Act (CEPA) as a Low
Concern Polymer. In this circumstance, NICNAS could waive the application fee for an Early
Introduction Permit (EIP).
The Minister has approved the New Transitional Arrangements Towards Approval of
Approved Foreign Schemes (New Transitional Arrangements). The new arrangements
provide industry with increased opportunities to either access an assessment rebate by
submitting assessment reports prepared by national authorities or be eligible for a waiver in
EIP fee.
New Transitional Arrangements
The New Transitional Arrangements supersede all previous notices with respect to
Transitional Arrangements Towards Approval of Approved Foreign Schemes.
The following options are now available to applicants notifying new industrial chemicals to
NICNAS.
Option 1 Up to 40% Rebate in Notification Fee for Provision of an Acceptable
Assessment Report issued by a National Authority
Option 1 applies to chemicals or polymers for notification under subsections 23(4) to 23(9) of
the Industrial Chemicals (Notification and Assessment) Act 1989 (Cwlth) (the Act) that is,
notification under the Standard or Limited Notification category.
Criteria for an Acceptable Assessment Report
The assessment report must:
date from post-1994. Preferably, the report should be in English, however, authorised
translations are acceptable. Electronic reports are also acceptable;
originate from the national authority of an OECD Member country, preferably Canada or any
European Union Member State;
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include confidential information, for example, chemical identity. Sanitised documents are not
acceptable;
include a summary and assessment of physicochemical properties;
include a summary and assessment of toxicological and environmental effects data, as
appropriate;
include a health and environmental risk assessment; and
be accompanied by a letter of validation from the overseas authority that the report is the full
and final report issued for that chemical.
Conditions
In all instances, acceptance of an assessment report is subject to the approval of the Director
of Chemicals Notification and Assessment.
Applicants are still required to follow the notification procedures as described in Section 23
of the Act and submit a notification statement about the chemical or polymer that contains the
information required as per the Schedule. Where not already covered by the notification
requirements of section 23, the following information should also be submitted to the
Director of Chemicals Notification and Assessment.
Details of the overseas authority, that is, when and where notified;
A copy of all the particulars about the chemical that were given under the foreign scheme and
are available to the applicant; and
Any other information about the chemical available to the applicant, that is, assessment
information or was given under another foreign scheme.
NICNAS statutory timeframes for assessment remain unchanged.
Rebate
NICNAS will decide the level of rebate on a case-by-case basis. The maximum rebate is 40%
of the notification fee, however the fee rebate will be less than 40% if data on toxicological
and environmental effects is absent or incomplete.
Method of Application and Fees
Applications for Assessment Certificates under the New Transitional Arrangements are to be
made on FORM 1-FS. Notification fees must be paid in full. The rebate is determined at the
end of the assessment period.
Obtaining Assessment Reports from the Canadian Authority
Applicants should first contact NICNAS to obtain a proforma authorising Environment
Canada to transmit the Canadian assessment report to NICNAS. This will expedite the
process of obtaining the Canadian assessment report.
Option 2: A Free Early Introduction Permit (EIP) for Synthetic Polymers of Low
Concern (PLC) Assessed as Low Concern Polymers in Canada.
Option 2 applies to polymers notified and assessed as a Low Concern Polymer under CEPA.
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No. C 11, 6 November 2001
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Eligibility Criteria
The polymer has been assessed as a Low Concern Polymer under CEPA. The PLC
notification statement and EIP application to NICNAS includes a Validation Letter from
Environment Canada to this effect.
The PLC notified to NICNAS meets the requisite criteria for early introduction described
under section 30A of the Act.
Conditions
In all instances, recognition of the Validation Letter from Environment Canada is subject to
the approval of the Director of Chemicals Notification and Assessment. NICNAS and
Environment Canada will assume that the presence of a copy of the letter indicates that the
applicant is entitled to use it.
In all instances, the granting of an EIP is subject to the approval of the Director of Chemicals
Notification and Assessment.
Polymers that have had conditions or restrictions imposed by CEPA are ineligible to access
Option 2.
Applicants are still required to follow the notification procedures as described in Section 23
of the Act and submit a notification statement about the PLC that contains the information
required as per the Schedule.
NICNAS statutory timeframes for both assessment of the EIP application and PLC
assessment certificate remain unchanged.
Method of Application and Fees
Application for an EIP under the Transitional Arrangements is to be made on FORM 1-EIP.
The $500 fee need not be provided, as long as the Eligibility Criteria and Conditions are met.
Accessing the CEPA `No Suspicion of Toxic' Validation Letter
Applicants need to contact their Canadian company counterpart to obtain a copy of the
Environment Canada Validation Letter. This letter states that:
? the Schedule VI information on the polymer completes the applicant's obligations
under the CEPA New Substances Notification Regulations (that is, meets Low
Concern Polymer criteria);
? the assessment outcome is `No Suspicion of Toxic'; and
? depending on trigger threshold volumes, the polymer is eligible for addition to the
Domestic Substances List.
For further details on the New Transitional Arrangements please contact Bob Graf or Roshini
Jayewardene in NICNAS New Chemicals on freecall 1800 638 528.
Chemical Gazette Commonwealth of Australia Gazette
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