SR 2001/112 有害物质(最低危害标准)条例2001(Hazardous Substances (Minimum Degrees of Hazard) Regulations 2001)

　　Hazardous Substances （Minimum Degrees of Hazard） Regulations 2001

　　（SR 2001/112）

        1 Title

　　These regulations are the Hazardous Substances （Minimum Degrees of Hazard）

Regulations 2001.

　　2 Commencement

　　These regulations come into force on 2 July 2001.

　　3 Interpretation

        In these regulations, unless the context otherwise requires,—

　　Act means the Hazardous Substances and New Organisms Act 1996

　　ASTM, when followed by letters and numbers, means the document identified by

those letters and numbers that is published by the American Society for Testing and

Materials

　　data includes values that are directly measured, calculated, or estimated for
any of the measures given

　　deflagrate, in relation to a substance that is initiated or ignited, means

the production in that substance of a chemical reaction that proceeds through, or 

along the surface of, the substance at subsonic velocity, where that chemical

reaction,—

　　（a） results in the steady production of hot gases at high pressures; and

　　（b） if the substance is sufficiently confined, results in an increase in

pressure, rate of reaction, and temperature that may produce a detonation of the

substance

　　detonate, in relation to a substance that is initiated, means the production

in that substance of a chemical reaction that proceeds through that substance at

supersonic velocity, resulting in the production of heat and a supersonic shock wave

through the surrounding medium

　　gas means a substance that—

　　（a） is completely gaseous at 20°C and at 101.3 kPa absolute pressure; or

　　（b） has a vapour pressure of more than 300 kPa absolute pressure at 50°C

　　ISO means the International Standards Organisation; and—

　　（a） ISO 9328 （II）： 1991 means the ISO Standard called Steel plates and

strips for pressure purposes—technical delivery conditions, Part II; and

　　（b） ISO 10156: 1996 means the ISO Standard called Gases and gas mixtures—

determination of fire potential and oxidising ability for the selection of cylinder

valve outlets

　　liquid means—

　　（a） a substance with a melting point of less than or equal to 20°C at

101.3 kPa absolute pressure; or

　　（b） a viscous substance, without a defined melting point, if—

　　（i） more than the quantity of the substance specified in ASTM D 4359–90,

called Test method for determining whether a material is a liquid or a solid,

collects on a watch glass when tested in the manner specified in that test; or

　　（ii） a penetrometer penetrates into the substance the distance defined in

the test for determining fluidity prescribed in Appendix A.3 of the European

Agreement concerning the International Carriage of Dangerous Goods by Road （ADR），

published in 1994 by the United Nations, when the method specified in that test is

followed

　　pyrotechnic effect, in relation to a substance that is initiated, means the

production in that substance of a self-sustaining exothermic chemical reaction

resulting in heat, sound, light, gas, smoke, or motion, or a combination of these

　　solid means a substance that is neither a liquid nor a gas

　　Test Series, when followed by a letter or number, means 1 or more tests as

prescribed in the UN Manual of Tests and Criteria

　　UN Manual of Tests and Criteria means the third revised edition of the

Recommendations on the Transport of Dangerous Goods Manual of Tests and Criteria,

published in 1999 by the United Nations （New York and Geneva）

　　UN Model Regulations means the 11th revised edition of the Recommendations on
the Transport of Dangerous Goods Model Regulations, published in 1999 by the United

Nations （New York and Geneva）。

　　4 Substances not considered hazardous

        （1） A substance is not hazardous for the purposes of the Act unless it

meets the minimum degrees of hazard for at least 1 of the intrinsic hazardous

substance properties specified in regulation 7.

　　（2） This regulation is subject to regulations 5 and 6.

　　5 Medicines

        （1） A medicine is not hazardous for the purposes of the Act unless Parts

13, 14, or 15 of the Act apply.

　　（2） Despite subclause （1）， a new medicine must be treated as hazardous

if it meets any of the minimum degrees of hazard prescribed in these regulations

and—

　　（a） it is a substance to which section 3（1）（b） of the Medicines Act

1981 applies; or

　　（b） an application is made to register that medicine as a trade name

product under the Agricultural Compounds and Veterinary Medicines Act 1997.

　　（3） In this regulation,—

　　medicine has the same meaning as in section 3（1） of the Medicines Act 1981,
except that it does not include a gas contained at a pressure greater than 170 kPa in
a container larger than 100 mL, at any time after that gas becomes so contained and

before the time the gas is first administered to a person for a therapeutic purpose

　　new medicine means—

　　（a） any medicine that has not been generally available in New Zealand—

　　（i） before the commencement of the Medicines Act 1981; or

　　（ii） at any time during the period of 5 years immediately before the date

on which it is proposed to become so available:

　　（b） any medicine that, immediately before the commencement of Part 2 of the
Medicines Act 1981, was a therapeutic drug to which section 12 of the Food and Drug

Act 1969 applied, and in respect of the sale or distribution of which the Minister of
Health had not given his or her consent under that section:

　　（c） any medicine that becomes a medicine for the first time after the

commencement of the Medicines Act 1981:

　　（d） any medicine that is referred to the Minister of Health under section

24（5） of the Medicines Act 1981.

　　6 Food

        （1） A food is not hazardous for the purposes of the Act unless Parts 13,

14, or 15 of the Act apply.

　　（2） In this regulation,—

　　food has the same meaning as in section 2 of the Food Act 1981, except that

it does not include a food additive if that food additive has not been mixed with or 

added to any other food or drink

　　food additive has the same meaning as in section 2（1） of the Food

Regulations 1984 （SR 1984/262）。

　　7 Minimum degrees of hazard

        （1） The minimum degrees of hazard for substances with explosive properties

are the degrees of hazard specified in Schedule 1.

　　（2） The minimum degrees of hazard for substances with flammable properties

are the degrees of hazard specified in Schedule 2.

　　（3） The minimum degrees of hazard for substances with oxidising properties

are the degrees of hazard specified in Schedule 3.

　　（4） The minimum degrees of hazard for substances with toxic properties are

the degrees of hazard specified in Schedule 4.

　　（5） The minimum degrees of hazard for substances with corrosive properties

are the degrees of hazard specified in Schedule 5.

　　（6） The minimum degrees of hazard for substances with ecotoxic properties

are the degrees of hazard specified in Schedule 6.

　                             　Schedule 1

　　Minimum degrees of hazard for substances with explosive properties

　　1 Minimum degrees of hazard for substances other than manufactured articles

          A substance （other than a manufactured article） with explosive properties
is not hazardous for the purpose of the Act unless—

　　（a） the substance is listed as class 1 in the Dangerous Goods List in

Chapter 3.2 of the UN Model Regulations; or

　　（b） the substance propagates a detonation in accordance with paragraph

12.4.1.4 of the UN Manual of Tests and Criteria when tested as prescribed by Test

Series 2 type （a） in paragraph 12.4 of that manual; or

　　（c） the substance propagates a detonation in accordance with paragraph

12.5.1.4 of the UN Manual of Tests and Criteria when tested as prescribed by Test

Series 2 type （b） in paragraph 12.5 of that manual; or

　　（d） the substance produces a pressure rise from 690 to 2070 kPa gauge

pressure or more, as determined in accordance with paragraph 12.6.1.4 of the UN

Manual of Tests and Criteria, when tested as prescribed by Test Series 2 type （c）

in paragraph 12.6 of that manual; or

　　（e） the substance is specifically manufactured to detonate, deflagrate, or 

produce a pyrotechnic effect.

　　2 Minimum degrees of hazard for manufactured articles

          A manufactured article containing, incorporating, or including a hazardous

substance with explosive properties is not hazardous for the purposes of the Act

unless—

　　（a） the article is listed as class 1 in the Dangerous Goods List in Chapter
3.2 of the UN Model Regulations; or

　　（b） the article produces some effect of projection, fire, smoke, heat, or 

loud noise external to the article when tested as a stack of articles as prescribed

in Test Series 6 type （c） in paragraph 16.6 of the UN Manual of Tests and Criteria.

　　                              Schedule 2

　　Minimum degrees of hazard for substances with flammable properties

　　1 Interpretation

        In this schedule, unless the context otherwise requires,—

　　flammable ingredient means a substance that meets 1 or more of the minimum

degrees of hazard for a flammable gas, a flammable liquid, or a flammable solid, or 

any combination of them

　　flammable range—

　　（a） means the range between 2 ratios of gas or vapour to air, the lower of

which contains too much air, and the upper of which contains too little air, to

support combustion; and

　　（b） includes a minimal range effectively equivalent to a single value

　　flashpoint means the lowest temperature at which a flammable liquid, when

tested in a closed cup flash point test, gives off vapour that ignites

　　SADT means self-accelerating decomposition temperature, being the lowest

temperature at which self-accelerating decomposition of the substance occurs in the

packaging in which it is tested when tested as prescribed in Test Series H in section
28 of the UN Manual of Tests and Criteria.

　　2 Minimum degrees of hazard

        （1） A substance with flammable properties is not hazardous for the purposes
of the Act unless—

　　（a） the substance is a gas or a gas mixture that is sufficiently flammable

to be capable of ignition when mixed with air in a proportion within a flammable

range at 20°C and at a pressure of 101.3 kPa absolute; or

　　（b） the substance—

　　（i） is or contains a gas compressed, liquefied, or dissolved under pressure
（with or without a liquid, paste, or powder）； and

　　（ii） is packed under pressure in a way that is designed to be released—

　　（A） as solid or liquid particles in suspension in a gas; or

　　（B） as a foam, paste, or powder; or

　　（C） in a liquid state; or

　　（D） in a gaseous state; and

　　（iii） comprises 45% or more by mass of flammable ingredients; or

　　（c） the substance is a liquid that has a flash point of less than or equal

to 93°C; or

　　（d） the substance—

　　（i） is described in paragraph 2.4.2.4 of the UN Model Regulations as being

an explosive substance that has been dissolved or suspended in water or other liquid

substances to form a homogeneous mixture in order to suppress its explosive

properties; or

　　（ii） is listed in paragraph 2.3.1.4 of the UN Model Regulations with one of
the serial numbers UN 1204, UN 2059, UN 3064, or UN 3343; or

　　（iii） is listed in the Dangerous Goods List in Chapter 3.2 of the UN Model

Regulations as having a class, division, or subsidiary risk of liquid desensitised

explosive; or

　　（e） the substance is a solid that meets the criteria specified in paragraph
33.2.1.4.4 of the UN Manual of Tests and Criteria when tested in accordance with the

test method for readily combustible solids as prescribed in Test Series N.1 in

paragraph 33.2.1.4 of that manual; or

　　（f） the substance is a solid that—

　　（i） is listed in the Dangerous Goods List in Chapter 3.2 of the UN Model

Regulations; and

　　（ii） has one of the serial numbers UN 1331, UN 1343, UN 1944, UN 1945, or 

UN 2254; or

　　（g） the substance—

　　（i） has an SADT of less than or equal to 75°C in a quantity of 50 kg and a
heat of decomposition greater than 300 joules per gram; or

　　（ii） is listed in paragraph 2.4.2.3.2.3 of the UN Model Regulations as

having a class, division, or subsidiary risk of self-reactive; or

　　（h） the substance—

　　（i） meets 1 or more of the minimum degrees of hazard for substances with

explosive properties specified in Schedule 1; and

　　（ii） has been desensitised to the extent that it would, when tested as

prescribed in Test Series 6 type （c） in paragraph 16.6 of the UN Manual of Tests

and Criteria, not show a projection, fire, smoke, heat, or noise effect external to

the substance itself; or

　　（i） the substance—

　　（i） is described in paragraph 2.4.2.4 of the UN Model Regulations as being

an explosive substance that has been wetted with water or alcohols or diluted with

other substances to form a homogeneous mixture in order to suppress its explosive

properties; or

　　（ii） is listed in paragraph 2.4.2.4 of the UN Model Regulations; or

　　（iii） is listed in the Dangerous Goods List in Chapter 3.2 of the UN Model

Regulations as having a class, division, or subsidiary risk of a solid desensitised

explosive; or

　　（j） the substance—

　　（i） is a solid in powder form that, when tested as prescribed in Test

Series N.2 in paragraph 33.3.1.4 of the UN Manual of Tests and Criteria, ignites in

one of the tests; or

　　（ii） is a liquid that, when tested in as prescribed in Test Series N.3 in

paragraph 33.3.1.5 of the UN Manual of Tests and Criteria, ignites in the first part

of the test （paragraph 33.3.1.5.3.1） or ignites or chars the filter paper in the

second part of the test （paragraph 33.3.1.5.3.2）； or

　　（iii） is a solid that, when tested as prescribed in Test Series N.4 in

paragraph 33.3.1.6 of the UN Manual of Tests and Criteria, gives a positive result in
a test using a 100 mm sample cube at 140°C; or

　　（k） the substance, when tested as prescribed in Test Series N.5 in

paragraph 33.4.1.4 of the UN Manual of Tests and Criteria, reacts with water at

ambient temperatures to produce a gas that ignites spontaneously; or

　　（l） the substance, when tested as prescribed in Test Series N.5 in

paragraph 33.4.1.4 of the UN Manual of Tests and Criteria, reacts with water at

ambient temperatures to produce a flammable gas at a rate greater than or equal to 1

litre per kilogram of substance per hour.

　　（2） When tested in accordance with any of subclause （1）（e）， （g），

（h）， （j）（i）， （j）（iii）， （k）， or （l）， a substance must be—

　　（a） in the finest particle form in which that substance is reasonably

capable of being used or rendered; or

　　（b） if it is likely or known that more than 10% of the mass of the

substance will crumble into a finer particle form, in that finer form.

　　                       Schedule 3

　　Minimum degrees of hazard for substances with oxidising properties 　　
   
        1 Interpretation

         In this schedule, unless the context otherwise requires,—

　　organic peroxide means a substance containing 1 or more chemical compounds

that—

　　（a） contains the bivalent oxygen [-0-0-] structure; and

　　（b） may be considered as a derivative of hydrogen peroxide where one or 

both of the hydrogen atoms has been replaced by an organic radical; and

　　（c） may cause or contribute to combustion by the release of chemical energy
 or compounds that may cause or contribute to fire, explosion, or chemical

decomposition

　　oxidising substance means a substance that, while not necessarily combustible
in itself, may cause or contribute to the combustion of other substances or 

materials.

　　2 Minimum degrees of hazard

        （1） A substance with oxidising properties is not hazardous for the purposes
of the Act unless—

　　（a） the substance is listed in the Dangerous Goods List in Chapter 3.2 of

the UN Model Regulations as having a class, division, or subsidiary risk of 5.1

（oxidising substances）； or

　　（b） the substance is a solid that—

　　（i） is an oxidising substance; and

　　（ii） when mixed with dried cellulose, either spontaneously ignites or shows
a mean burning time equal to or faster than the mean burning time of a 3:7 reference

mixture by mass of potassium bromate and cellulose under the same conditions when the
mixture is tested in accordance with the test method for oxidising solids as

prescribed in Test Series O.1 in paragraph 34.4.1 of the UN Manual of Tests and

Criteria; or

　　（c） the substance is a liquid that—

　　（i） is an oxidising substance; and

　　（ii） when mixed with dried cellulose, either spontaneously ignites or shows
a mean pressure rise time that is equal to or faster than the mean pressure rise time
of the reference mixture of 65% aqueous nitric acid solution and cellulose under the

same conditions when that solution is tested in accordance with the test method for

oxidising liquids as prescribed in Test Series O.2 in paragraph 34.4.2 of the UN

Manual of Tests and Criteria; or

　　（d） the substance is a gas that—

　　（i） is an oxidising substance; and

　　（ii） will cause or contribute to combustion at a faster rate than air when

tested in accordance with the test method for determining the oxidising power of

gases and gas mixtures as prescribed in ISO 10156:1996; or

　　（e） the substance is listed in—

　　（i） paragraph 2.5.3.2.4 of the UN Model Regulations as an organic peroxide;
or

　　（ii） the Dangerous Goods List in Chapter 3.2 of the UN Model Regulations as
having a class or division of 5.2 （organic peroxides）； or

　　（f） the substance—

　　（i） is an organic peroxide or contains organic peroxides; and

　　（ii） has more than 1% available oxygen from the organic peroxides when

containing not more than 1% hydrogen peroxide by mass; or

　　（g） the substance—

　　（i） is an organic peroxide or contains organic peroxides; and

　　（ii） has more than 0.5% available oxygen from the organic peroxides when

containing not less than 1% and not more than 7% hydrogen peroxide by mass.

　　（2） If a substance is a mixture and is made up of 1 or more chemical

elements or compounds, any one of which meets 1 or more of the minimum degrees of

hazard specified in subclause （1）（b）， （c）， （f）， or （g）， then the

mixture is hazardous for the purposes of the Act unless it can be shown that the

exact mixture itself does not meet any of the minimum degrees of hazard specified in

subclause （1）。

　　（3） When tested in accordance with subclause （1）（b）， a substance must

be—

　　（a） in the finest particle form in which that substance is reasonably

capable of being used or rendered; or

　　（b） if it is likely or known that more than 10% of the mass of the

substance will crumble into a finer particle form, in that finer form.

　　（4） For the purposes of subclause （1）（f） and （g）， the available

oxygen content as a percentage by mass must be determined in accordance with the

following formula:

　　O% = 16 Σ （ ni [ ci/mi ]）

　　where—

　　O%is the percentage of available oxygen content to be determined

　　Σis the symbol for summation where there is more than 1 organic peroxide

　　niis the number of peroxygen groups per molecule of each organic peroxide

　　ciis the percentage concentration by mass of each organic peroxide

　　miis the molecular mass of each organic peroxide.

　　                       Schedule 4

　　Minimum degrees of hazard for substances with toxic properties

　　1 Interpretation

        In this schedule, unless the context otherwise requires,—

　　developmental effect, in relation to an organism, includes structural

abnormality, altered growth, functional deficiency, or interference with the normal

development of an organism （including the death of a developing organism）， that

is—

　　（a） manifested at any point in the organism's life span; and

　　（b） caused by—

　　（i） the exposure of a parent to the substance before conception; or

　　（ii） the exposure of the developing offspring to the substance during

prenatal development or postnatal development up to the time of sexual maturation

　　dust and mist, in relation to a substance in the atmosphere, means that 90%

of the substance is in the form of particles with a aerodynamic diameter of less than
10 microns

　　expert means—

　　（a） a member of a scientific committee set up by an international,

national, or professional scientific body to review scientific data; or

　　（b） a person considered by his or her scientific peers to be an expert in

the relevant field of scientific study

　　genotoxic effect means alterations to the structure, information content, or 

segregation of DNA, including—

　　（a） DNA damage caused by interference with its normal replication

processes; and

　　（b） temporary non-physiological alterations to its replication

　　LD50 means the median lethal dose, being a statistically derived single dose

of a substance that can be expected to cause death in 50% of animals

　　mean Draize score,—

　　（a） in relation to acute skin irritation tests, means the mean value in at

least 2 of 3 tested animals—

　　（i） from Draize grades measured at intervals of 24 hours, 48 hours, and 72

hours after the patch is removed; or

　　（ii） where reactions are delayed, from Draize grades on 3 consecutive days

after the onset of dermal reactions; and

　　（b） in relation to acute eye irritation tests, means the mean value of at

least 2 of 3 tested animals from Draize grades measured at intervals of 24 hours, 48

hours, and 72 hours after instillation of the substance

　　mutagenic effect means a permanent change in the amount or structure of the

genetic material in a cell, being a permanent change that is—

　　（a） manifested at the phenotypic level; or

　　（b） an underlying DNA modification （including specific base pair changes

and chromosomal translocations）

　　reliable information means information that is derived from—

　　（a） a valid and relevant animal study conducted in accordance with

internationally accepted test guidelines and principles of good laboratory practice;

or

　　（b） an epidemiological study in humans that is statistically sound and has

undergone peer review; or

　　（c） any other study whose relevance and validity can be demonstrated

according to internationally accepted criteria and scientific practice

　　reproductive effect includes—

　　（a） interference with reproductive ability or capacity, including

alteration to the male or female reproductive system; or

　　（b） an effect on the onset of puberty, gamete production and transport,

reproductive cycle normality, sexual behaviour, fertility, parturition, or premature

reproductive senescence; or

　　（c） an effect on or through lactation; or

　　（d） modifications in other functions that are dependent on the integrity of
the reproductive system

　　sensitisation means an immunologically mediated response where, after

exposure to a substance to which an organism or human being has been previously

exposed, the organism or human being is, or 1 or more organs in an organism or human

being are, more readily and adversely affected by that substance

　　significant adverse biological effect means a toxicologically significant

change in an organ or in an animal observed during the study where the probability

that the change is different from any recognised background history of change or from
the value in a recognised unexposed control organ or animal group in the test animal

strain is greater than 0.95 （equivalent to P （probability） of 0.05 or less）

　　valid, in relation to a study, means—

　　（a） the design of the study methodology accurately reflects the matters the
study seeks to measure; and

　　（b） the study findings can be extrapolated from the sample used in the

study to a broader population.

　　2 Minimum degrees of hazard

       （1） A substance with toxic properties is not hazardous for the purposes of

the Act unless—

　　（a） data for the substance indicates an LD50 of 5 000 milligrams or less of
the substance per kilogram of bodyweight as a result of acute exposure of animals to

the substance by oral or dermal routes; or

　　（b） data for the substance indicate any mortality, as a result of acute

exposure of animals by—

　　（i） oral or dermal routes to 2 000 milligrams or less of the substance per

kilogram of bodyweight; or

　　（ii） the inhalation route to—

　　（A） 5 000 parts or less of the substance per million in air, if the

substance is a gas; or

　　（B） 20 milligrams or less of the substance per litre of air, if the

substance is a vapour; or

　　（C） 5 milligrams or less of the substance per litre of air, if the substance is
a dust or mist; or

　　（c） clinical signs （other than diarrhoea, piloerection, or an ungroomed

appearance） indicate to an expert a significant adverse biological effect as a

result of acute exposure of animals by—

　　（i） oral or dermal routes to 2 000 milligrams or less of the substance per

kilogram of bodyweight; or

　　（ii） the inhalation route to—

　　（A） 5 000 parts or less of the substance per million in air, if the

substance is a gas; or

　　（B） 20 milligrams or less of the substance per litre of air, if the

substance is a vapour; or

　　（C） 5 milligrams or less of the substance per litre of air, if the

substance is a dust or mist; or

　　（d） reliable information for the substance, including reliable information

from animal studies other than those from which LD50 data was obtained, where

exposure was by a route other than oral, dermal, or inhalation, indicates to an

expert the potential for significant acute toxic effects in humans after exposure to

the substance; or

　　（e） data for the substance, in the opinion of an expert, indicates evidence
in humans of significant acute toxic effects as a result of exposure to the

substance; or

　　（f） data for the substance indicates a mean Draize score of 1.5 or more for
either of the skin irritation effects known as erythema or oedema, as a result of

exposure to the substance; or

　　（g） data for the substance indicates a mean Draize score of 1 or more for

either of the eye irritation effects known as corneal opacity or iritis, as a result

of exposure to the substance; or

　　（h） data for the substance indicates a mean Draize score of 2 or more for

either of the eye irritation effects known as conjunctival redness or chemosis, as a

result of exposure to the substance; or

　　（i） data for the substance indicates positive evidence of respiratory

sensitisation in animals as a result of exposure to the substance; or

　　（j） data for the substance indicates positive evidence of sensitisation by

skin contact in animals as a result of exposure to the substance of either—

　　（i） 30% or more sensitisation response in an adjuvant type test method; or

　　（ii） 15% or more sensitisation response in a non-adjuvant type test method;
or

　　（k） data for the substance, in the opinion of an expert, indicates evidence
in humans of specific respiratory hypersensitivity （including asthma, rhinitis, and

alveolitis） as a result of exposure to the substance; or

　　（l） data for the substance, in the opinion of an expert, indicates evidence
in humans of sensitisation by skin contact as a result of exposure to the substance;

or

　　（m） data for the substance indicates evidence of mutagenic effects as a

result of mammalian in vivo exposure to the substance; or

　　（n） data for the substance indicates evidence of—

　　（i） genotoxic effects as a result of mammalian in vivo exposure to the

substance; and

　　（ii） mutagenic effects as a result of in vitro exposure to the substance;

or

　　（o） data for the substance indicates evidence of mutagenic effects as a

result of in vitro exposure of mammalian cells to the substance and the substance has
a structure–activity relationship to known germ cell mutagens, where—

　　（i） structure–activity relationship means a significant correlative

relationship between the chemical structure of the substance and the chemical

structure of a known germ cell mutagen; and

　　（ii） the relationship relates to that germ cell mutagen activity; or

　　（p） reliable information for the substance indicates to an expert that

exposure to the substance causes the development of cancer or an increase in the

incidence of benign or malignant tumours in an organ or an organism; or

　　（q） reliable information for the substance indicates to an expert that

exposure to the substance causes an adverse reproductive effect; or

　　（r） reliable information for the substance indicates to an expert that

exposure to the substance causes an adverse developmental effect; or

　　（s） data for the substance indicates, in the opinion of an expert, evidence
of a significant adverse biological effect or a significant toxic effect （other than
an effect referred to in any of paragraphs （a） to （r）） on the function or 

morphology of an organ, or on the biochemistry or haematology of an organism or human
being as a result of exposure to the substance and, in the case of a significant

adverse biological effect, the change is relevant to human health.

　　（2） A substance is not required to be tested in accordance with subclause

（1）（a） if the substance—

　　（a） has been tested in accordance with subclause （1）（b）； and

　　（b） does not meet the minimum degree of hazard specified in subclause （1）

（b）。

　                             　Schedule 5

　　Minimum degrees of hazard for substances with corrosive properties

　　1 Interpretation

        In this schedule, unless the context otherwise requires, mean Draize score,

in relation to acute eye irritation tests, means the mean value in at least 2 of 3

tested animals from Draize grades measured at intervals of 24 hours, 48 hours, and 72
hours after instillation of the substance.

　　2 Minimum degrees of hazard

        A substance with corrosive properties is not hazardous for the purposes of

the Act unless—

　　（a） the substance corrodes, at a rate exceeding 6.25 millimetres per year

at a test temperature of 55°C,—

　　（i） steel type P235 （ISO 9328 （II）：1991）； or

　　（ii） steel type SAE 1020 （Society of Automotive Engineers）； or

　　（iii） non-clad aluminium types SAE 7075-T6 or AZ5GU-T6; or

　　（b） data for the substance indicates that the substance has a pH level of 2
 or less, or 11.5 or more; or

　　（c） data for the substance indicates destruction of dermal tissue, being

visible necrosis through the epidermis and into the dermis, as a result of exposure

to the substance, that has not fully reversed within an observation period of 14

days; or

　　（d） data for the substance indicates destruction of ocular tissue, being

adverse effects on the cornea, iris, or conjunctiva, as a result of exposure to the

substance, that has not fully reversed within an observation period of 21 days; or

　　（e） data for the substance indicates a mean Draize score of 3 or more for

the eye irritation effect known as corneal opacity, as a result of exposure to the

substance; or

　　（f） data for the substance indicates a mean Draize score of 1.5 or more for
the eye irritation effect known as iritis, as a result of exposure to the substance.

　　                         Schedule 6

　　Minimum degrees of hazard for substances with ecotoxic properties

   　　1 Interpretation

        In this schedule, unless the context otherwise requires,—

　　BCF means bioconcentration factor, being the steady state concentration of a

substance in an aquatic organism divided by the concentration of the substance in the
surrounding water
 
　　   bioaccumulative, in relation to a substance, means the substance has a BCF

greater than or equal to 500 or, if BCF data is not available, a log Kow greater than
 or equal to 4; and, for the purposes of this definition, measured log Kow values take
precedence over estimated values

　　biocidal action, in relation to a substance, means the substance causes

mortality, inhibited growth, or inhibited reproduction in an organism

　　BOD5 means 5-day biochemical oxygen demand, being the mass of oxygen consumed
by micro-organisms during oxidation of the substance in water over a period of 5

days, expressed in units of milligrams of oxygen consumed per milligram of the

substance

　　COD means chemical oxygen demand, being the equivalent mass of oxygen from an
oxidising agent, of a strength at least equal to the oxidising strength of potassium

permanganate or potassium dichromate, that is consumed during oxidation of the

substance in water, expressed in units of milligrams of oxygen consumed per milligram
of the substance

　　EC50 means the median effect concentration, being a statistically derived

concentration of a substance that can be expected to cause—

　　（a） an adverse effect in 50% of organisms; or

　　（b） a 50% reduction in growth or in the growth rate of organisms

　　Kow means the steady state ratio of the solubility of a substance in n-

octanol to the solubility of that substance in water

　　LC50 means the median lethal concentration, being a statistically derived

concentration of a substance that can be expected to cause death in 50% of organisms

exposed for a specified time

　　LD50 means a median lethal dose, being a statistically derived single dose of
a substance that can be expected to cause death in 50% of organisms

　　LOEC means the lowest observed effect concentration, being the lowest

concentration of a substance that produces a significant ecotoxic effect in an

organism or in an organism population

　　MATC means the maximum acceptable toxicant concentration, being the geometric
mean of the NOEC and LOEC where the NOEC and LOEC are derived from the same study

　　NOEC means the no observed effect concentration, being the highest

concentration of a substance that does not produce a significant ecotoxic effect in

an organism or in an organism population

　　rapidly degradable, in relation to a substance in water, means that—

　　（a） 28 days after a solution containing the substance is inoculated with

micro-organisms, there is at least—

　　（i） a 70% reduction in dissolved organic carbon in the solution; or

　　（ii） a 60% depletion of oxygen in the solution, when compared with the

maximum depletion of oxygen that would occur if the substance were completely

degraded; or

　　（iii） a 60% generation of carbon dioxide in the solution, when compared

with the maximum generation of carbon dioxide that would occur if the substance were

completely degraded; or

　　（b） if only COD and BOD5 data is available, the ratio of BOD5 to COD is

greater than or equal to 0.5:1; or

　　（c） at least 70% of the substance can be degraded biotically or 

abiotically, in the aquatic environment within 28 days

　　significant ecotoxic effect means an ecotoxicologically significant change in
an organism or in an organism population observed during the study where the

probability that the change is different from any recognised background history of

change or from the value in a recognised unexposed control organism population is

greater than 0.95 （equivalent to P （probability） of 0.05 or less）。

　　2 Minimum degrees of hazard

        （1） A substance with ecotoxic properties is not hazardous for the purposes

of the Act unless—

　　（a） the substance is ecotoxic to aquatic organisms because—

　　（i） data for the substance indicates that the fish LC50 is 100 milligrams

 or less of the substance per litre of water over a 96-hour exposure period, as a

result of exposure to the substance; or

　　（ii） data for the substance indicates that the crustacean EC50 is 100

milligrams or less of the substance per litre of water over a 48-hour exposure

period, as a result of exposure to the substance; or

　　（iii） data for the substance indicates that the algal or other aquatic

plant EC50 is 100 milligrams or less of the substance per litre of water over a 72-

hour or 96-hour exposure period, as a result of exposure to the substance; or

　　（iv） data for the substance indicates that the chronic fish NOEC, or 

chronic crustacean NOEC, or algal or other aquatic plant chronic NOEC, is 1 milligram
 or less of the substance per litre of water, as a result of exposure to the

substance; or

　　（v） in the absence of the NOEC data prescribed in subparagraph （iv） data

for the substance indicates that it is not rapidly degradable and is bioaccumulative;
or

　　（b） the substance is ecotoxic to soil organisms because—

　　（i） data for the substance indicates that a plant or soil invertebrate EC50
is 100 milligrams or less of the substance per kilogram of dry weight of soil over a

14-day exposure period, as a result of exposure to the substance; or

　　（ii） data for the substance indicates a 25% reduction in microbial

respiration or microbial nitrification at 100 milligrams or less of the substance per
kilogram of dry weight of soil after a 28-day exposure period, as a result of

exposure to the substance; or

　　（c） the substance is ecotoxic to terrestrial vertebrates because—

　　（i） data for the substance indicates an acute avian or mammalian oral or 

dermal LD50 of 2 000 milligrams or less of the substance per kilogram of body weight,
as a result of exposure to the substance; or

　　（ii） data for the substance indicates an acute avian or mammalian LC50 of 5
000 parts or less of the substance per million in the diet, as a result of exposure

to the substance; or

　　（iii） data for the substance indicates a chronic avian or mammalian MATC of
100 parts or less of the substance per million in the diet, as a result of exposure

to the substance; or

　　（d） the substance is ecotoxic to terrestrial invertebrates because data for
the substance indicates an acute oral or contact LD50 of 25 micrograms or less of the
substance per terrestrial invertebrate, as a result of exposure to the substance; or

　　（e） the substance is designed for biocidal action.

　　（2） A substance referred to in subclause （1）（e） is not hazardous for

the purposes of this schedule if—

　　（a） the substance is designed for biocidal action against a virus,

protozoan, bacterium, or an internal organism in humans or in other vertebrates; and

　　（b） the substance does not meet any of the minimum degrees of hazard

specified in subclause （1）（a） to （d）。

　　　                 Explanatory note

　　This note is not part of the regulations, but is intended to indicate their

general effect.

　　These regulations, which come into force on 2 July 2001, prescribe, for each

intrinsic hazardous substance property, the minimum degrees of hazard that must be

met before a substance is considered hazardous for the purposes of the Hazardous

Substances and New Organisms Act 1996.

　　Contents

　　1 General

　　2 Status of reprints

　　3 How reprints are prepared

　　4 Changes made under section 17C of the Acts and Regulations Publication Act
1989

　　5List of amendments incorporated in this reprint （most recent first）

　　Notes

　　1 General

        This is a reprint of the Hazardous Substances （Minimum Degrees of Hazard）

Regulations 2001. The reprint incorporates all the amendments to the regulations as

at 1 June 2001, as specified in the list of amendments at the end of these notes.

　　Relevant provisions of any amending enactments that have yet to come into

force or that contain relevant transitional or savings provisions are also included,

after the principal enactment, in chronological order.

　　2 Status of reprints

        Under section 16D of the Acts and Regulations Publication Act 1989, reprints

are presumed to correctly state, as at the date of the reprint, the law enacted by

the principal enactment and by the amendments to that enactment. This presumption

applies even though editorial changes authorised by section 17C of the Acts and

Regulations Publication Act 1989 have been made in the reprint.

　　This presumption may be rebutted by producing the official volumes of

statutes or statutory regulations in which the principal enactment and its amendments
are contained.

　　3 How reprints are prepared

       A number of editorial conventions are followed in the preparation of reprints.
For example, the enacting words are not included in Acts, and provisions that are

repealed or revoked are omitted. For a detailed list of the editorial conventions,

see http://www.pco.parliament.govt.nz/editorial-conventions/ or Part 8 of the Tables

of New Zealand Acts and Ordinances and Statutory Regulations and Deemed Regulations

in Force.

　　4 Changes made under section 17C of the Acts and Regulations Publication Act

1989

        Section 17C of the Acts and Regulations Publication Act 1989 authorises the

making of editorial changes in a reprint as set out in sections 17D and 17E of that

Act so that, to the extent permitted, the format and style of the reprinted enactment
is consistent with current legislative drafting practice. Changes that would alter

the effect of the legislation are not permitted.

　　A new format of legislation was introduced on 1 January 2000. Changes to

legislative drafting style have also been made since 1997, and are ongoing. To the

extent permitted by section 17C of the Acts and Regulations Publication Act 1989, all
legislation reprinted after 1 January 2000 is in the new format for legislation and

reflects current drafting practice at the time of the reprint.

　　In outline, the editorial changes made in reprints under the authority of

section 17C of the Acts and Regulations Publication Act 1989 are set out below, and

they have been applied, where relevant, in the preparation of this reprint:

　　omission of unnecessary referential words （such as “of this section” and

“of this Act”）

　　typeface and type size （Times Roman, generally in 11.5 point）

　　layout of provisions, including:

　　indentation

　　position of section headings （eg, the number and heading now appear above

the section）

　  format of definitions （eg, the defined term now appears in bold type,

without quotation marks）

　　format of dates （eg, a date formerly expressed as “the 1st day of January

1999” is now expressed as “1 January 1999”）

　  position of the date of assent （it now appears on the front page of each

Act）

　　punctuation （eg, colons are not used after definitions）

　　Parts numbered with roman numerals are replaced with arabic numerals, and all
cross-references are changed accordingly

　　case and appearance of letters and words, including:

　　format of headings （eg, headings where each word formerly appeared with an

initial capital letter followed by small capital letters are amended so that the

heading appears in bold, with only the first word （and any proper nouns） appearing

with an initial capital letter）

　　small capital letters in section and subsection references are now capital

letters

　　schedules are renumbered （eg, Schedule 1 replaces First Schedule）， and all
cross-references are changed accordingly

　　running heads （the information that appears at the top of each page）

　　format of two-column schedules of consequential amendments, and schedules of

repeals （eg, they are rearranged into alphabetical order, rather than

chronological）。

　　5 List of amendments incorporated in this reprint （most recent first）