Docstoc
EXCLUSIVE OFFER FOR DOCSTOC USERS
Try the all-new QuickBooks Online for FREE.  No credit card required.

2001aug_pt02

Document Sample
2001aug_pt02 Powered By Docstoc
					                                                                                               59



                     19      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 8, 7 August 2001
                                                                                                                   60


                               20      COMMERCIAL EVALUATION PERMITS
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 Permits


 PERMIT        COMPANY              COMPANY    CHEMICAL OR          HAZARDOUS   QUANTITY          USE           PERIOD
NUMBER              NAME            POSTCODE    TRADE NAME          SUBSTANCE                                  APPROVED



   476               UCB              3167     2-Propenoic acid,       NO        1 tonne        Radiation      30/04/01 to
                   Chemicals                     polymer with.                                   curable        30/04/03
                                                  alpha.alpha.                                coatings, inks
                                                 ’alpha.''-1,2,3-                               and paints
                                                propanetriyl tris
                                                    [.omega. -
                                               hydroxypoly [oxy
                                                  (methyl-1, 2-
                                                  ethanediyl)]],
                                                 ethanolamine-
                                                    terminated


   478           Clariant             3148     Hontavin PR 25         YES        1 tonne      UV absorber      15/06/01 to
              (Australia) Pty                                                                for application    15/06/03
                   Ltd                                                                         in plastics



   479            SLE                 3194        Strontium            NO        2000 kg      Luminesent       06/07/01 to
              (Australia) Pty                     Aluminate                                    Pigment          06/01/02
                   Ltd



   480             Unilever           2151      Dequest 2046           NO        2000 kg        Surface        16/07/01 to
                   Australia                   Phosphonate LR2                                  Cleaning        16/07/03
                                                                                                product



   481               Fernz            2163       D-glucoside,          NO        1000 kg       Cosmetic        11/07/01 to
                   Specialty                       eicosyl                                     ingredient       11/07/02
                   Chemicals



   482               Fernz            2163      Glycine, N-(1-         NO        1000 kg       Cosmetic        11/07/01 to
                   Specialty                      oxooctyl)-                                   ingredient       11/07/02
                   Chemicals



   483               Fernz            2163             1-             YES        900 kg        Cosmetic        18/07/01 to
                   Specialty                    Propanaminium,                                 ingredient       18/07/02
                   Chemicals                     3-amino-N-[2-
                                               [(2-hydroxyethyl)
                                                   amino]-2-
                                                oxoethyl]-N, N-



Chemical Gazette                                                                      Commonwealth of Australia Gazette
                                                                                                 No. C 8, 7 August 2001
                                                                                                   61


                                       dimethyl-, N-
                                        C12-18 acyl
                                        derivatives,
                                         chlorides



   484               Fernz     2163       Glutens,        YES    900 kg        Cosmetic        11/07/01 to
                   Specialty            hydrolyzates,                          ingredient       11/07/02
                   Chemicals          reaction products
                                         with lauryl
                                      chloride, sodium
                                             salts



   485               Fernz     2163   L-proline, 1-(1-    NO    900 kg per     Cosmetic        11/07/01 to
                   Specialty          oxohexadecyl)1-             annum        ingredient       11/07/03
                   Chemicals            sodium salt




   486               Fernz     2163   Nymphoea alba       NO    300 kg per     Cosmetic        11/07/01 to
                   Specialty             extract                  annum        ingredient       11/07/03
                   Chemicals




Chemical Gazette                                                      Commonwealth of Australia Gazette
                                                                                 No. C 8, 7 August 2001
                                                                                                       62

                             21    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 Chemical Permits are approved for 36 months.

                                              Table 2
                                     Low Volume Chemical Permits


PERMIT         COMPANY        COMPANY      CHEMICAL OR        HAZARDOUS           USE             DATE
NUMBER          NAME          POSTCODE     TRADE NAME         SUBSTANCE


   390            Dow             3018       4-Alkyl (C9         YES         Ingredient of      20/07/01
                Chemical                  branched) phenol                     an oven
               (Australia)                   ethoxylate                         cleaner
               Ltd/Reckitt                propoxylate ethyl
                Benckiser                      acetate
               (Australia)        2114
                   Ltd




Chemical Gazette                                                          Commonwealth of Australia Gazette
                                                                                     No. C 8, 7 August 2001
                                                                                                          63

   22 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 3

   Chemicals Eligible for Listing on the Australian Inventory of Chemical Substances


             CHEMICAL NAME                              CAS NUMBER          MOLECULAR FORMULA

  Copper [29H, 31H-phthalocyaninato- N29, N30,             150522-10-4                   Unspecified
  N31, N32]-, [[3-[(2-hydroxyethyl) methylamino]
 propyl] amino] sulfonyl sulfo derivs., sodium salts

2-propenoic acid, polymer with butyl 2-propenoate,          31360-56-2    (C8H8. C7H12O2. C3H5NO.C3H4O2.C3H3N)x
      ethenylbenzene, 2-propenamide and 2-
                   propenenitrile

 1,4-Benzenedicarboxylic acid, polymer with 1,3-            36621-48-4       (C9H4O5.C8H6O4.C5H12O2.C2H6O2)x
dihydro-1,3-dioxo-5-isobenzofurancarboxylic acid,
 2,2-dimethyl-1,3-propanediol and 1,2-ethanediol

   2-Propenoic acid, 2-methyl-, cyclohexyl ester,           27517-36-8               (C10H16O2.C5H8O2)x
   polymer with methyl 2-methyl-2-propenoate

 2-Methyl-5,6-dihydro-4H-cyclopenta[d]isothiazol-           82633-79-2                    C7H9NOS
                    3(2H)-one

          1,2-Ethanediol, polymer with [(2-                 41630-20-0               (C6H10O2.C2H6O2)x
            propenyloxy)methyl]oxirane

                   Butane, decafluoro-                       355-25-9                        C4F10

      Silicic acid (H2SiO3), strontium salt (1:1)           13451-00-8                    H2O3Si.Sr

    Fatty acids, tall oil, polymers with castor oil,       127087-72-3                   Unspecified
     glycerol, phthalic anhydride and styrene

   Fatty acids C14-18-and C16-18 unsaturated,              171236-28-5                   Unspecified
polymers with adipic acid, glycerol, 1,6 hexanediol,
3-hydroxy-2 (hydroxymethyl)- 2-methylpropanoic
acid, 1,1' methylenebis [ 4-isocyanatocyclohexane],
        neopentyl glycol and pentaerythritol

      2-Propenoic acid, polymer with sodium                129898-01-7            (C3H4O2. H3O2P.Na)x.xNa
            phosphinate, sodium salt

      2-Oxepanone, polymer with 2-ethyl-2-                  85338-68-7   (C12H18N2O2.C6H14O3.C6H10O2.C5H8O3.(C2H4
  (hydroxymethyl)-1,3-propanediol, alpha-hydro-                                          O)nH2O)x
   omega-hydroxypoly(oxy-1,2-ethanediyl) and 5-
      isocyanato-1-(isocyanatomethyl)-1,3,3-
  trimethylcyclohexane, 2-hydroxyethyl acrylate-
                      blocked

  1,2-Propanediol, polymer with ethyloxirane and           134737-27-2          (C4H8O.C3H8O2.C2H4O)x.xK
             oxirane, potassium salt

  1,4-Benzenedicarboxylic acid, di-C11-14-isoalkyl         162030-42-4                   Unspecified
                 esters C rich


Chemical Gazette                                                             Commonwealth of Australia Gazette
                                                                                        No. C 8, 7 August 2001
                                                                                              64

                   esters, C13-rich

           D-Glucitol, 1,3:2,4-bis-O-[(3,4-        135861-56-2                 C24H30O6
            dimethylphenyl)methylene]-

    1,2,3-propanetricarboxylic acid, 2-hydroxy-,   93385-14-9                 C54H104O7
               triisohexadecyl ester




Chemical Gazette                                                 Commonwealth of Australia Gazette
                                                                            No. C 8, 7 August 2001
                                                                                                  65


       23      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 has been made to the
Australian Inventory of Chemical Substances.

                                              Table 4
                   Amendments to the Australian Inventory of Chemical Substances

The following amendments to the Inventory has been made:


   CHEMICAL NAME                   EXISTING CAS            NEW CAS                   MOLECULAR
                                     NUMBER                NUMBER                     FORMULA

       n-Decyl glucoside               6801-91-8            54549-25-6                     C16H32O6

 D-Glucopyranoside, dodecyl            6801-92-9            27836-64-2                     C18H36O6




Chemical Gazette                                                     Commonwealth of Australia Gazette
                                                                                No. C 8, 7 August 2001
                                                                                                66


           24        TWELFTH SIDS INITIAL ASSESSMENT MEETING (SIAM 12)

The twelfth OECD SIDS Initial Assessment Meeting (SIAM) was held in Paris, France from
27 to 29 June 2001. The purpose of the meeting was to review assessment reports and
recommendations on chemicals being co-operatively assessed as part of the OECD High
Production Volume (HPV) Chemicals Program.

The meeting was attended by Member countries, the Business and Industry Advisory Council
and the European Commission

The HPV Program now focuses on the hazards of the chemicals. A number of assessments
prepared by industry were presented and discussed at this meeting.

Members agreed to recommendations for 13 of the 15 chemicals discussed at the meeting
(Table 1). Recommendations relate to whether the SIDS data set is complete and whether the
chemical is a candidate for further work.

Table 1
CAS Number                    Chemical                          Sponsor
79-06-1                       Acrylamide                        UK
84-74-2                       Dibutyl phthalate                 Netherlands
100-21-0                      Terephthalic acid                 Italy/US
141-97-9                      Ethyl acetoacetate                Germany
25154-52-3                    Nonyl phenol                      UK
84852-15-3                    Phenol, 4-nonyl-,branched         UK
126-73-8                      Tributyl phosphate                US
75-68-3                       1-Chloro-1, 1-difluoroethane      France/ICCA*
91-15-6                       1,2-Benzenedicarbonitrile         Japan/Germany/ICCA
105-60-2                      Epsilon-Caprolactam               Germany/ICCA
822-06-0                      Hexamethylene diisocyanate        Germany/ICCA
1717-00-6                     1,1-Dichloro-1-fluoroethane       US/ICCA
34590-94-8                    Dipropylene glycol methyl ether   US/ICCA
   ICCA = Industry Council of Chemical Associations

Recommendations for the following chemicals were not agreed to and these chemicals will
need to be reconsidered at a future SIAM meeting:

                   127-19-5        N,N-Dimethylacetamide
                   123-77-3        Diazenedicarboxamide

If you would like more information on SIAM 12, please contact Sneha Satya by phone
on (02) 9577 9490 or by email sneha.satya@nicnas.gov.au

More information on the OECD SIDS program can be obtained from the OECD website at:
http://www.oecd.org/ehs/hpv.htm

The SIDS reports are published by UNEP and can be accessed at:
http://irptc.unep.ch/irptc/sids/sidspub.html


Chemical Gazette                                                   Commonwealth of Australia Gazette
                                                                              No. C 8, 7 August 2001
                                                                                                       67


                         25      CANDIDATE LIST OF CHEMICALS

The Candidate List of chemicals along with the Standby section of the List was published in the
Chemical Gazette of 1 February 2000 following screening of nominations received from members of
the public and government and non-governmental bodies.
Chemicals contained in the standby section of the Candidate List were reviewed in June 2001 to
determine whether the awaited data has become available. Where new information has come to hand
this has been reviewed and the status of all the chemicals on the List redetermined.
Table 1 gives the Candidate List of chemicals following the review of the standby section. The
Candidate List will be used by NICNAS as a basis for selecting chemicals from time to time for
declaration and assessment as priority existing chemicals. Some chemicals from the previously
published Candidate List have since been declared as Priority Existing Chemicals and hence no longer
appear on the Candidate List.
Table 2 gives the chemicals remaining on the Standby section of the List following the review. This
list will be reviewed periodically and chemicals transferred to the main section of the Candidate List
or the Not Selected List depending on the outcomes of awaited assessments and/or testing.
Table 3 lists the chemicals removed from the main or standby sections of the Candidate List and the
reasons for the removal.


Table 1: Candidate List of Chemicals
Chemical                                          CAS No
Various Azo dyes
1,3 butadiene                                     106-99-0
2-hydroxy 2’,4,4’-trichlorodiphenyl ether        3380-34-5

Bismuth oxychloride                               7787-59-9
t-butyl alcohol                                   75-65-0
Chlorinated styrenes including                    29082-74-4
octachlorostyrene
Chromium (VI) compounds
   Lead chromate                                 7758-97-6
   Lead sulphochromate                            1344-37-2
   Zinc chromate                                 13530-65-9
N,N Dimethylformamide                            68-12-2
Epichlorohydrin                                  106-89-8
Ethylene oxide                                    75-21-8
Formaldehyde                                      50-00-0
Hydroquinone                                     123-31-9
Isocyanates including:
   2,4 TDI                                        584-84-9


Chemical Gazette                                                          Commonwealth of Australia Gazette
                                                                                     No. C 8, 7 August 2001
                                                                                             68


   2,4’-MDI                                     5873-54-1
   2,6-TDI                                      91-08-7
   4,4’-MDI                                     101-68-8
   Polymethylene polyphenylene isocyanate       9016-87-9
Isopropyl alcohol, isopropanol                  67-63-0
Mercury compounds
Methyl ethyl ketone peroxide                    1338-23-4
Methyl ethyl ketone                             78-93-3
Methyl tert butyl ether                         1634-04-4
Methylene chloride                              75-09-2
Naphthalene polychlorinated                     70776-03-3
Peracetic acid                                  79-21-0
Phenolphthalein                                 77-09-8
Polychlorinated biphenyl ethers
Sodium cyanide                                  143-33-9
Sodium hydroxide                                1310-73-2
Sodium hypochlorite                             7681-52-9
Styrene                                         100-42-5
Tetrachlorobenzyltoluenes including:
   - dichloro [(dichlorophenyl)methyl] methyl   76253-60-6
    benzene (Ugilec 141)
   (chlorophenyl)(chlorotolyl) methane, mixed   No CAS Number
   isomers (Ugilec 121)
1,1,1,2-tetrafluoroethane                       811-97-2
Tetrafluoroethylene                             116-14-3
Toluene                                         108-88-3
Triethanolamine                                 102-71-6
Xylene – mixed                                  1330-20-7
   o-xylene                                     95-47-6
   p-xylene                                     106-42-3
   m-xylene                                     108-38-3




Chemical Gazette                                                Commonwealth of Australia Gazette
                                                                           No. C 8, 7 August 2001
                                                                                       69


Table 2: Standby Section of Candidate List
Chemical                                     CAS No
Alkyl phenol ethoxylates including
   Nonyl phenol ethoxylate                   9016-45-9
   Nonyl phenol ethoxylate blend             63496-57-1
   Octylphenolethoxylate                     9036-19-5
Carbon disulphide                            75-15-0
N-methyl pyrrolidone                         872-50-4
Methyl methacrylate                          80-62-6
Mobil jet oil:
   1-Naphthalenamine                         134-32-7
   1-Naphthalenamine, N-phenyl               90-30-2
   2-Naphthalenamine                         91-59-8
   2-Naphthalenamine, N-phenyl               135-88-6
   Tricresol phosphate                       1330-78-5
Naphthalene                                  91-20-3
Nickel                                       7440-02-0
Nickel oxide                                 1313-99-1
Nickel sulfate                               7786-81-4
Phthalates including:
   diethylhexyl phthalate (DEHP)             117-81-7
   Diethylphthalate (DEP)                    84-66-2
   Dibutylphthalate                          84-74-2
   di isodecyl phthalate (DIDP)              26761-40-0
   di isononyl phthalate (DINP)              28553-12-0
   butylbenzyl phthalate (BBP)               85-68-7
   dimethyl phthalate (DMP)                  131-11-3
   dicyclohexyl phthalate                    84-61-7
   di-n-hexyl phthalate                      84-75-3
   di-n-pentyl phthalate                     131-18-0
   di-n-propyl phthalate                     131-16-8
   di(2-ethylhexyl) adipate                  103-23-1
1,1,2,2-tetrabromoethane                     79-27-6
Triethyl tetramine                           112-24-3




Chemical Gazette                                          Commonwealth of Australia Gazette
                                                                     No. C 8, 7 August 2001
                                                                                             70


Table 3: Chemicals Removed from the Candidate List of 1 February 2000
Chemical                     CAS No     Removed     Reason
                                        from
Acrylamide                   79-06-1    Candidate   Declared a PEC
                                        List
Bis (2-Methoxyethyl) Ether   111-96-6   Standby     Moved to Not
                                        Section     Selected List
                                                    because of
                                                    limited use in
                                                    Australia
Bismuth Oxychloride          7787-59-   Standby     Moved to
                             9          Section     Candidate List
                                                    because of public
                                                    health concerns
                                                    over its use in
                                                    cosmetics
Limonene including           7705-14-   Candidate   Declared a PEC
  D-limonene                 8          List
                             5989-27-
                             5
Polybrominated flame                    Candidate   Declared a PEC
retardants                              List
Short chain chlorinated                 Candidate   Declared a PEC
paraffins                               List
1,1,2,2,-tetrachloroethane   79-34-5    Standby     Moved to Not
                                        Section     Selected List
                                                    because of
                                                    limited use in
                                                    Australia
Trisphosphates                          Candidate   Declared a PEC
                                        List




Chemical Gazette                                                Commonwealth of Australia Gazette
                                                                           No. C 8, 7 August 2001
                                                                                                71


                   26   REQUEST TO VARY BENZENE PEC REPORT

In accordance with section 60E(6) of the Industrial Chemicals (Notification and Assessment)
Act 1989, as amended, notice is hereby given by the Director that a decision has been made
on each request to vary the draft Priority Existing Chemicals report on benzene.

A copy of the decisions can be obtained from:

NICNAS
Chemical Assessment Division
92-94 Parramatta Road
Camperdown
Sydney NSW 2050

Or from Deborah Willcocks on telephone (02) 9577 9377, fax (02) 9577 9465 or email
deborah.willcocks@nicnas.gov.au.




Chemical Gazette                                                   Commonwealth of Australia Gazette
                                                                              No. C 8, 7 August 2001
                                                                                                  72


        27         CONSULTATION ON PROPOSED PRIORITY EXISTING CHEMICALS

The NICNAS Candidate List of chemicals for possible assessment has been updated and is
published in a separate notice in this edition of the Chemicals Gazette. Chemicals from this
Candidate List are selected from time to time, for assessment as Priority Existing Chemicals
(PEC). Chemicals are recommended to the Minister, Employment, Workplace Relations and
Small Business, who decides whether they should be assessed as PECs.

Below are chemicals NICNAS is considering recommending for assessment. Prior to making
any recommendations to the Minister, NICNAS is seeking any comments from any person or
organisation on the proposed assessment.

Formaldehyde (CAS Numer 50-00-0)
Formaldehyde has many uses and is also emitted as a result of industrial processes. The
National Occupational Health and Safety Commission has advised the occupational exposure
standard for formaldehyde needs to be reviewed, and the NICNAS assessment would assist in
this task. Formaldehyde is also a priority air toxic in Australia. A full risk assessment would
be undertaken addressing all uses/emission types in Australia for environment, public health
and occupational health and safety concerns.

Sodium cyanide (CAS Number 143-33-9)
Sodium cyanide has limited uses in Australia, however is used in large quantities in gold
mining. It is acutely toxic to humans and the environment. A full risk assessment would be
conducted addressing all sources in Australia for environment, public health and occupational
health and safety concerns. Current controls by industry would be assessed to identify
whether these are adequate.

Bismuth Oxychloride (7787-59-9)
Bismuth oxychloride is used in cosmetics, such as pressed powders and lipsticks.
Neurotoxicity has been reported for some bismuth salts, and the assessment would identify
whether there is any data on bismuth oxychloride specifically. A full risk assessment would
be conducted for public and occupational health relevant to use in the cosmetics industry.

Contact for comments
Written comments on the above proposals are required by Monday 3 September to:

Deborah Willcocks
Team Leader, Existing Chemicals
GPO Box 58
Sydney 2001

Companies or others wishing to discuss the proposal should call Deborah Willcocks on (02)
9577 9377




Chemical Gazette                                                     Commonwealth of Australia Gazette
                                                                                No. C 8, 7 August 2001
                                                                                                            73


 28   OPTIONS FOR LOW VOLUME CHEMICAL INTRODUCTION UNDER THE
   NATIONAL INDUSTRIAL CHEMICALS NOTIFICATION AND ASSESSMENT
                        SCHEME (NICNAS)

                                           Advice for Notifiers

NICNAS has a number of options for introducers of low volume new industrial chemicals. These
include:

Category                            Requirements to NICNAS                   Form            NICNAS
                                                                                             fee
<10kg/12 months exemption           Self assessment of risk and advice to    Form 15         None
(cosmetic chemicals)                NICNAS
<10kg/12 months exemption (non-     Self assessment of risk; advice to       Form 21 4a      None
cosmetic chemicals)                 NICNAS encouraged
Research, development or analysis   None                                     None            None
<50kg/12 months exemption
Research, development or analysis   Information relevant to apparatus,       Form 6          None
– manufacture in a fixture          program, type of chemical, procedures
                                    for safe disposal of chemical and
                                    degradation products to be provided
Low Volume Chemical (LVC)           Approved application with mandatory      Form 1-LVC      $2600
Permit                              data requirements; follow-up reporting
                                    under certain circumstances
Commercial Evaluation Category      Approved application with mandatory      Form 1-CEC      $2600
(CEC) Permit                        data requirements; User Agreement
                                    Form(s); Final Report                    Form 8

Chemicals in the above categories are not added to the Australian Inventory of Chemical Substances.

<10kg/12 months Exemption

Under the <10kg/12 months exemption, a new industrial chemical, including a cosmetic ingredient
can be introduced without first obtaining an assessment certificate or permit. The introducer must
have conducted a self-assessment of risk for the chemical and concluded that it would not pose an
unreasonable risk to occupational health and safety, public health or the environment. If the
introducer concludes that the risk is unreasonable, they cannot use this exemption and will need to
notify the chemical to NICNAS for assessment in another category.

Introducers of cosmetic chemicals need to advise NICNAS using the approved form. There are
special conditions to protect public health. These include that the chemical cannot be used as a
preservative, colouring agent or ultraviolet filter, cannot be prohibited or restricted in the EU or USA,
must comply with other Australian laws, and must be safe if used on susceptible populations at >1%
in cosmetic products. Companies should retain a dossier on occupational health and safety, public
health and environmental matters to substantiate the risk assessment, for 5 years after introduction and
provide this to NICNAS upon request.

Research, development or analysis

Introducers of chemicals used for research, development or analysis need to submit an application or
information to NICNAS only if the chemical is imported at >50 kg/12 months or if the chemical is
manufactured in Australia. Chemicals introduced under this category can be used in research
institutions or laboratories, including industrial laboratories. They may be used in experimental
toxicology tests or in human volunteer studies, for example for skin irritation. The NICNAS
definition of “research” does not include research for the purpose of determining market acceptance
or consumer preferences. Chemical products or articles incorporating research or development


Chemical Gazette                                                               Commonwealth of Australia Gazette
                                                                                          No. C 8, 7 August 2001
                                                                                                         74

chemicals cannot be sold. For example, if the new chemical was tested in a sealant in a car part, the
car part could not be sold.

Permits

Chemicals introduced under LVC Permit may be introduced at up to 100kg/12 months and each
permit is granted for 36 months. The 100kg is a national maximum, so should you apply for a LVC
Permit when an existing permit is in force, NICNAS can only grant the new permit for the difference
in volume. Chemicals introduced under LVC Permit may be used for research, development or
analysis, toxicology tests or in human volunteer studies, for example for skin irritation, or for
determining market acceptance or consumer preferences, as well as entering the routine marketplace.

Larger volumes of new industrial chemicals may be introduced under the Commercial Evaluation
Category (CEC) Permit. Maximum introduction times and volumes are 2 years and 2000kg, as long
as the introducer can adequately justify to NICNAS that these times and volumes are needed. There
are tight controls for chemicals that NICNAS allows to be introduced under the CEC Permit. For
example, the chemical can only be introduced to test its potential for commercial application, and only
for the purpose and conditions specified in the NICNAS application. Tests for determining market
acceptance or consumer preferences fall within the definition of commercial evaluation. As the
chemical is being introduced for commercial evaluation, at large volumes and without being assessed,
NICNAS requires there be a close association between the introducer and other companies or
individuals involved in doing the commercial evaluation. Both groups need to be identified in the
NICNAS application and both groups are responsible for adhering to the permit conditions. The
applicant has additional responsibilities for passing on relevant occupational health and safety, public
health and environmental information. They need to ensure that the subsequent users have read the
permit conditions so they may act upon them and have received the material safety data sheet.

End users need to provide feedback to the applicant on relevant occupational health and safety, public
health and environmental matters concerning the use of the chemical during the commercial
evaluation. The applicant includes this information in the Final Report to NICNAS.

LVC or CEC Permit holders may apply to NICNAS at any time during the life of the permit, for a
change in permit conditions. The permit holder will need to provide reasons for the request and
provide any new health and safety information gathered from use of the chemical so far.

The NICNAS Director may cancel a LVC Permit or CEC Permit if NICNAS has been provided with
misleading information.

In addition, for both permits, penalties apply to permit holders who contravene a permit condition
without reasonable excuse.

Repeated Applications

Under the <10kg/12 months exemption and research, development or analysis manufacture in a
fixture exemption, there is no need to apply annually to NICNAS as long as introduction continues to
meet the original criteria.

Should introduction stop and recommence outside the original time period, the introducer should
advise NICNAS again.

NICNAS accepts repeated applications for LVC Permits. In contrast, NICNAS looks critically at
repeated applications for CEC Permits, and the Director would be unlikely to grant more than one
repeat CEC permit. NICNAS expect commercial evaluation to be complete within two and at most
four years. The applicant needs to provide the CEC Permit Final Report and advise of any relevant
changes in circumstances for a LVC Permit, when applying for a repeat permit.

Chemical Gazette                                                            Commonwealth of Australia Gazette
                                                                                       No. C 8, 7 August 2001
                                                                                                   75


                       29    NICNAS INNOVATION AND COMPLIANCE

                                     Information for the Public

The NICNAS Innovation and Compliance Team deals with:

          compliance – enquiries, case reports and audits concerning new and industrial
          chemicals and company registration

          regulatory reform - main projects are Commercial Evaluation Category Permit and
          Low Regulatory Concern Chemicals reform

          international activities for new chemicals – main projects are within the OECD New
          Chemicals Task Force on international worksharing and a bilateral arrangement with
          Environment Canada

          maintaining the Australian Inventory of Chemical Substances (AICS) - AICS updates,
          searches, CD-ROM, confidential AICS listing, enquiries.

Please contact NICNAS on phone (02) 9577 9400 or 1800 638 528, fax (02) 9577 9465, or
comply@nicnas.gov.au if you have any enquiries on the above topics or wish to contact
NICNAS on a compliance matter concerning yourself or others.

Visit www.nicnas.gov.au for more information on NICNAS; retrieve and use the form
“Report of non-compliance with NICNAS Requirements” to advise on suspected non-
compliance.

Megan Smith
Group Leader
Innovation and Compliance
Phone (02) 9577 9462 or email megan.smith@nicnas.gov.au




Chemical Gazette                                                      Commonwealth of Australia Gazette
                                                                                 No. C 8, 7 August 2001

				
DOCUMENT INFO
Shared By:
Categories:
Tags:
Stats:
views:4
posted:3/1/2012
language:English
pages:17