Part 1—Preliminary
1.1 Name of Regulations
These Regulations are the Agricultural and Veterinary Chemicals (Administration) Regulations 1995.
1.2 Commencement
These Regulations commence on the same day as the Agricultural and Veterinary Chemicals Act 1994.
1.3 Interpretation
(1) In these Regulations:
Act means the Agricultural and Veterinary Chemicals (Administration) Act 1992.
active constituent has the same meaning as in the Agvet Code of the participating Territories.
agricultural chemical product has the same meaning as in the Agvet Code of the participating Territories.
Agvet Code of the participating Territories has the same meaning as in subsection 5(1) of the Agricultural and Veterinary Chemicals Code Act 1994.
authorised officer has the meaning given by regulation 1.4.
CAS number or Chemical Abstracts Service number means the registry number:
(a) assigned to the chemical by the Chemical Abstracts Service, Columbus, Ohio, United States of America; and
(b) published by the Service in the journal Chemical Abstracts.
chemical product has the same meaning as in the Agvet Code of the participating Territories.
Collector has the meaning given by subsection 8(1) of the Customs Act 1901.
controlled chemical has the meaning given by regulation 1.3A.
generic information has the meaning given by regulation 1.5.
import decision means a response, made under paragraph 2 of Article 10 of the Rotterdam Convention, providing a response in accordance with the requirements of paragraph 4 of that Article that consists of a final decision or an interim decision (within the respective meanings given by that paragraph):
(a) consenting to import with or without specified conditions; or
(b) not consenting to import.
IUPAC name means a name assigned to a chemical by the International Union of Pure and Applied Chemistry, set out in International Standard ISO 1750—1981: Pesticides and Agrochemicals—Common Names, published in Geneva by the International Standards Organisation in 1981.
multiple entry import permit has the meaning given by regulation 3.310.
multiple exit export permit has the meaning given by regulation 3.310.
multiple permit means a multiple entry import permit or multiple exit export permit.
non‑party, in relation to a Convention, means a country that has not consented to be bound by the Convention or for which the Convention is not in force.
prescribed chemical means:
(a) an active constituent or chemical product that has been prescribed by these Regulations for the purposes of section 69CA or 69CB of the Act; or
(b) a chemical product containing an active constituent referred to in paragraph (a).
Rotterdam Convention means the Rotterdam Convention on the Prior Informed Consent Procedure for Certain Hazardous Chemicals and Pesticides in International Trade.
Note: In 2012, the text of the Convention was available at www.pic.int.
Secretariat means:
(a) in relation to the Rotterdam Convention, the secretariat established under Article 19 of that Convention; and
(b) in relation to the Stockholm Convention, the secretariat established under Article 20 of that Convention.
Stockholm Convention means the Stockholm Convention on Persistent Organic Pollutants (POPs).
Note: In 2012, the text of the Convention was available at www.pops.int.
veterinary chemical product has the same meaning as in the Agvet Code of the participating Territories.
(2) Unless the contrary intention appears, a term that is defined in an international agreement or arrangement and that is used in these Regulations has the same meaning in these Regulations when used in relation to that agreement or arrangement.
(3) A reference in these Regulations to an active constituent is a reference to an active constituent for a proposed or existing chemical product.
1.3A Meaning of controlled chemical
(1) Subject to subregulation (2), in these Regulations:
controlled chemical means:
(a) an active constituent or chemical product listed in Part 2 of Schedule 1; or
(b) a chemical product containing an active constituent referred to in paragraph (a); or
(c) the chemical product listed as an item in Part 3 of Schedule 1.
(2) To avoid doubt, if the heading of an item in Part 2 of Schedule 1 includes the words ‘and its compounds’ or other words describing all compounds, or all compounds of a particular kind (such as, for example, ‘and its salts and esters’) of the relevant chemical, all compounds, or all such compounds, of the chemical are also controlled chemicals.
1.4 Meaning of authorised officer
An officer of the Department is an authorised officer for a provision of these Regulations if the person is authorised in writing by the Secretary under the provision in which the expression occurs.
1.5 Meaning of generic information about a person
(1) In these Regulations:
generic information about a person means the following information:
(a) the person’s name;
(b) the person’s ABN;
(c) the address of the person’s principal place of business;
(d) the address of the person’s registered office, if different from the address of the person’s principal place of business;
(e) if the person is not an individual, the name of an individual who is to be the contact person;
(f) the telephone and facsimile numbers for, and e‑mail address of, the person and contact person.
(2) If a person has given generic information about himself, herself or itself to the Department, and the information changes, the person must give the new information to the Department within 30 days.
Part 1A—Annual operational plan and annual report
1A.1 Information for inclusion in annual report
The APVMA must include in its annual report a list of:
(a) the standards made under section 6E of the Schedule to the Agricultural and Veterinary Chemicals Code Act 1994 during the period to which the annual report relates; and
(b) the standards made under section 6E that were varied by the APVMA during the period to which the annual report relates.
1A.2 Information for inclusion in annual operational plan
For paragraph 55(2)(c) of the Act, the following information is prescribed:
(a) the number of reconsiderations to be commenced by the APVMA under section 31 of the Schedule to the Agricultural and Veterinary Chemicals Code Act 1994 (the Agvet Code Act) during the period to which the annual operational plan relates;
(b) the number of reconsiderations to be concluded by the APVMA under Division 4 of Part 2 of the Schedule to the Agvet Code Act during that period;
(c) brief details of how the APVMA plans to progress those reconsiderations during that period.
1A.3 Performance indicators for inclusion in annual report
For subparagraph 61(b)(ii) of the Act, the following performance indicators are prescribed:
(a) the number of reconsiderations commenced by the APVMA under section 31 of the Schedule to the Agricultural and Veterinary Chemicals Code Act 1994 (the Agvet Code Act) during the period to which the annual report relates;
(b) the number of reconsiderations concluded by the APVMA under Division 4 of Part 2 of the Schedule to the Agvet Code Act during that period;
(c) brief details of the progress of reconsiderations that were scheduled to progress in that period;
(ca) a summary of any action taken by the APVMA under section 99 of the Schedule to the Agvet Code Act during that period;
(d) the number of applications mentioned in each item of Part 2 of Schedule 6 of the Agricultural and Veterinary Chemicals Code Regulations 1995 that were:
(i) made under the Schedule to the Agvet Code Act during that period; and
(ii) not determined within the period required for the application by regulations made under section 165 of that Schedule;
(e) the number of reports (known as adverse experience reports) received by the APVMA during that period;
(f) the number of adverse experience reports mentioned in paragraph (e) that the APVMA determined were related to each of the following:
(i) human health;
(ii) environment;
(iii) animal health;
(iv) crop health;
(v) efficacy for agricultural chemical products or veterinary chemical products;
(g) a summary of any action taken by the APVMA during that period in relation to adverse experience reports.
Note: Adverse experience reports are received under the Adverse Experience Reporting Program (AERP) which is a post‑registration quality assurance program established by the APVMA.
Part 2—Providing information about certain active constituents and chemical products
2.05 Prescribed international agreements (Act s 69CA(1))
Each of the following is a prescribed international agreement for the purposes of subsection 69CA(1) of the Act:
(a) the Rotterdam Convention;
(b) the Stockholm Convention.
2.10 Prescribed chemicals (Act s 69CA(2))
A chemical is a prescribed active constituent or prescribed chemical product for the purposes of subsection 69CA(2) of the Act if:
(a) there is an item in Schedule 1 for the chemical; and
(b) the item describes the chemical as a prescribed active constituent or a prescribed chemical product for the purposes of that subsection.
Note: For each constituent or product, the relevant item identifies the relevant international agreement or arrangement (see the Act, subsection 69CA(3)).
2.15 Prescribed chemicals (Act s 69CB(1))
A chemical is a prescribed active constituent or prescribed chemical product for the purposes of subsection 69CB(1) of the Act if:
(a) there is an item in Schedule 1 for the chemical; and
(b) the item describes the chemical as a prescribed active constituent or prescribed chemical product for the purposes of that subsection.
2.20 Prescribed information—import (Act ss 69CA(2)(a) and 69CB(2)(a))
The following information about the import into Australia of a prescribed chemical is prescribed for the purposes of paragraphs 69CA(2)(a) and 69CB(2)(a) of the Act:
(a) generic information about the importer;
(b) the technical name and common name of the chemical;
(c) the name of any chemical product that contains the chemical;
(d) the name of the exporting country or countries;
(e) the chemical’s intended use;
(f) the total quantity of the chemical imported in any calendar year or part of any calendar year, specifying the quantity imported from each named exporting country;
(g) any additional information specified in the relevant item in Schedule 1.
2.25 Prescribed information—manufacture (Act ss 69CA(2)(b) and 69CB(2)(b))
The following information about the manufacture in Australia of a prescribed chemical is prescribed for the purposes of paragraphs 69CA(2)(b) and 69CB(2)(b) of the Act:
(a) generic information about the manufacturer;
(b) the technical name and common name of the chemical;
(c) the address of the place of manufacture;
(d) the quantity manufactured in any calendar year or part of any calendar year;
(e) the chemical’s intended use;
(f) any additional information specified in the relevant item in Schedule 1.
2.30 Prescribed information—use (Act ss 69CA2)(b) or 69CB(2)(b))
Note: This regulation is reserved for information that may be prescribed for the purposes of paragraph 69CA(2)(b) or 69CB(2)(b) of the Act.
2.35 Prescribed information—other dealings (Act ss 69CA(2)(c) or 69CB(2)(c))
Note: This regulation is reserved for information that may be prescribed for the purposes of paragraph 69CA(2)(c) or 69CB(2)(c) of the Act.
2.40 Prescribed information—export (Act ss 69CA(2)(d) and 69CB(2)(d))
The following information about the export from Australia of a prescribed chemical is prescribed for the purposes of paragraphs 69CA(2)(d) and 69CB(2)(d) of the Act:
(a) generic information about the exporter;
(b) the technical name and common name of the chemical;
(c) the name of importing country or countries;
(d) the total quantity of the prescribed chemical exported in any calendar year or part of any calendar year, specifying the quantity exported to each named importing country;
(e) any additional information specified in the relevant item in Schedule 1.
2.45 Prescribed period for giving prescribed information (Act ss 69CA(5) and 69CB(5))
(1) Subject to subregulation (2), for the purposes of subsections 69CA(5) and 69CB(5) of the Act, the period within which relevant prescribed information in respect of a prescribed chemical must be provided:
(a) starts on the date when a notice setting out:
(i) the obligation to provide information to the Department; and
(ii) the address where the information must be sent;
is published in the Gazette; and
(b) ends 30 days after that date.
(2) For the purposes of subsections 69CA(5) and 69CB(5) of the Act, the following prescribed information must be given to the Department by an importer, exporter or manufacturer on or before 28 February following the calendar year to which it relates:
(a) the total quantity of the prescribed chemical imported in a calendar year, specifying the quantity imported from each named exporting country;
(b) the total quantity of the prescribed chemical exported in a calendar year, specifying the quantity exported to each named importing country;
(c) the total quantity of the prescribed chemical manufactured in a calendar year;
(d) generic information about the importer, exporter or manufacturer.
Part 3—Prohibition on import, manufacture etc of certain active constituents and chemical products
Division 3.1—General
3.05 Prescribed international agreements (Act, s 69C)
Each of the following is a prescribed international agreement for the purposes of section 69C of the Act:
(a) the Rotterdam Convention;
(b) the Stockholm Convention.
3.10 Effect of grant of permissions or multiple permits
The grant of a permission or multiple permit under this Part does not excuse the holder from compliance with other requirements in the Act, in these Regulations and in other Commonwealth, State or Territory legislation relating to the controlled chemical to which the permission or permit relates.
3.15 Notice to be given if additional information required
(1) An authorised officer or the Minister may, by written notice, require an applicant to give additional information in relation to the applicant’s application.
(2) The notice must include a statement to the effect that:
(a) the application will not be considered further until the applicant gives to the authorised officer or Minister the information; and
(b) the application will be taken to have been withdrawn if the applicant does not give the information within 28 days after the day on which the notice is received by the applicant or within such further period as the authorised officer or Minister allows in writing.
(3) If an applicant does not give the additional information within the required period, the application is taken to have been withdrawn.
(4) In this regulation:
applicant means:
(a) an applicant for a permission or multiple permit under this Part; or
(b) an applicant for reconsideration under regulation 3.510.
3.20 Matters that may be considered when making decision
In making a decision whether to grant an application for a permission or multiple permit under this Part, the authorised officer may take into consideration:
(a) whether the applicant has previously been granted a permission or permit of that kind; and
(b) whether the applicant complied with any conditions or restrictions specified in the permission or permit; and
(c) whether the applicant has failed to comply with any of the following:
(i) the Act;
(ii) these Regulations;
(iii) the Agricultural and Veterinary Chemicals Act 1994;
(iv) the Agricultural and Veterinary Chemicals Code Act 1994;
(v) any Act relating to the collection of a levy on agricultural and veterinary chemical products;
(vi) the Industrial Chemicals (Notification and Assessment) Act 1989;
(vii) regulations under any Act mentioned or referred to in subparagraphs (iii) to (vi).
Division 3.2—Import
Subdivision 3.2.1—Absolute prohibition
3.45 Prohibited importation
(1) The importation into Australia of a controlled chemical is prohibited if the relevant item in Schedule 1 states that its importation is prohibited in all cases.
(2) For the purposes of subsection 69C(1) of the Act, the condition that a person must not import a chemical in contravention of subregulation (1) is prescribed.
Subdivision 3.2.2—Prohibition subject to conditions
3.50 Chemicals to which this Subdivision applies
(1) This Subdivision applies to a controlled chemical if the relevant item in Schedule 1 states that its importation is prohibited except with written permission.
(2) In this Subdivision, a controlled chemical to which this Subdivision applies is called an import‑prohibited chemical.
3.55 Prohibition
(1) The importation into Australia of an import‑prohibited chemical is prohibited unless:
(a) an authorised officer or the Minister has given permission in writing to import the chemical; and
(b) the permission is produced to a Collector; and
(c) any condition or restriction specified in the relevant item in Schedule 1 is satisfied.
Note 1: The permission to import required under this regulation must be produced to a Collector for the purposes of complying with regulation 5I of the Customs (Prohibited Imports) Regulations 1956 in relation to the importation of chemicals under those Regulations that are active constituents or chemical products.
Note 2: A multiple entry import permit is a permission for purposes of this regulation (see subregulation 3.310(2)).
(2) For the purposes of subsection 69C(1) of the Act, the following conditions or restrictions are prescribed for each such chemical:
(a) a person must not import the chemical:
(i) without the written permission of an authorised officer or the Minister; or
(ii) contrary to a condition or restriction specified in the permission;
(b) a person who imports the chemical must not fail to produce the permission if asked to do so by a Collector;
(c) any condition or restriction set out in the relevant item in Schedule 1.
Note: A person who imports such a chemical in contravention of a prescribed condition or restriction may be punished by a fine of up to 300 penalty units (see subsection 69C(5) of the Act).
(3) This regulation applies despite:
(a) the APVMA’s written consent to import referred to in subsection 69B(1B) of the Act; and
(b) any approval to import under any other legislation.
3.60 Applications for permission to import import‑prohibited chemicals
(1) A person may apply to the Department for permission to import an import‑prohibited chemical.
(2) An application must be in the approved form and must include the following information:
(a) generic information about the applicant;
(b) the technical name, common name and CAS number (if known) of the chemical;
(c) the quantity to be imported;
(d) the name of the exporting country;
(e) the intended use in Australia.
Note 1: The applicant may be required to give additional information (see regulation 3.15).
Note 2: An authorised officer must give written notice of his or her decision on the application (see regulation 3.505).
3.65 When permission may be granted
(1) An authorised officer may grant an application for permission to import an import‑prohibited chemical if the officer is satisfied that:
(a) in the case of a chemical whose importation is stated in an item in Schedule 1 to be prohibited except with written permission under paragraph 3.65(1)(a)—the chemical is being imported for the purpose of environmentally sound disposal in accordance with paragraph (1)(d) of Article 6 of the Stockholm Convention; or
(b) in any other case—the chemical is being imported for a use or purpose that is permitted under the relevant Convention.
Note: In deciding whether to grant the application, the officer may take into consideration the matters mentioned in regulation 3.20.
(2) If the officer is not satisfied as to the matters mentioned
in subregulation (1), the officer must refuse to grant the application.
(3) To avoid doubt, an authorised officer may refuse to grant an application despite the fact that the applicant has the APVMA’s written consent, referred to in subsection 69B(1B) of the Act, to import the import‑prohibited chemical.
Division 3.3—Manufacture
Subdivision 3.3.1—Absolute prohibition
3.100 Prohibited manufacture
(1) The manufacture in Australia of a controlled chemical is prohibited if the relevant item in Schedule 1 states that its manufacture is prohibited in all cases.
(2) For the purposes of subsection 69C(1) of the Act, the condition that a person must not manufacture a chemical in contravention of subregulation (1) is prescribed.
Subdivision 3.3.2—Prohibition subject to conditions
3.105 Chemicals to which this Subdivision applies
(1) This Subdivision applies to a controlled chemical if the relevant item in Schedule 1 states that its manufacture is:
(a) prohibited except with written permission; or
(b) prohibited except if specified conditions are met.
(2) In this Subdivision, a controlled chemical to which this Subdivision applies is called a manufacture‑prohibited chemical.
3.110 Prohibition
(1) The manufacture in Australia of a manufacture‑prohibited chemical is prohibited unless:
(a) an authorised officer or the Minister has given permission in writing to manufacture the chemical (if such permission is required); and
(b) any condition or restriction specified in the relevant item in Schedule 1 is satisfied.
(2) For the purposes of subsection 69C(1) of the Act, the following conditions or restrictions are prescribed for each such chemical:
(a) a person must not manufacture the chemical:
(i) without the written permission of an authorised officer or the Minister (if such permission is required); or
(ii) contrary to a condition or restriction specified in the permission;
(b) a person who manufactures the chemical must not fail to produce any required permission if asked to do so by:
(i) an authorised officer; or
(ii) an officer of another Agency, or an officer or employee of a State or Territory government, authorised in writing by the Secretary for the purposes of this paragraph;
(c) any condition or restriction specified in the relevant item in Schedule 1.
Note: A person who manufactures such a chemical in contravention of a prescribed condition or restriction may be punished by a fine of up to 300 penalty units (see subsection 69C(5) of the Act).
(3) This regulation applies despite any approval to manufacture under any other legislation.
3.115 Applications for permission to manufacture manufacture‑prohibited chemicals
(1) A person may apply to the Department for permission to manufacture a manufacture‑prohibited chemical.
(2) An application must be in the approved form and must include the following information:
(a) generic information about the applicant;
(b) the technical name, common name and CAS number (if known) of the chemical;
(c) the quantity to be manufactured.
Note 1: The applicant may be required to give additional information (see regulation 3.15).
Note 2: An authorised officer must give written notice of his or her decision on the application (see regulation 3.505).
3.120 When permission may be granted
(1) An authorised officer may grant an application for permission to manufacture a manufacture‑prohibited chemical if:
(a) the manufacture of the chemical is stated in an item in Schedule 1 to be prohibited except with written permission under subregulation 3.120(1); and
(b) the officer is satisfied that there is in effect for Australia a production‑specific exemption for the chemical under Article 4 of the Stockholm Convention.
(2) An authorised officer may grant an application for permission to manufacture a manufacture‑prohibited chemical if:
(a) the manufacture of the chemical is stated in an item in Schedule 1 to be prohibited except with written permission under subregulation 3.120(2); and
(b) the officer is satisfied that, in accordance with paragraph 9 of Article 10 of the Rotterdam Convention, the chemical to be manufactured is to be exported and not used in Australia.
(3) An authorised officer may grant an application for permission to manufacture a manufacture‑prohibited chemical if:
(a) neither subregulation (1) nor (2) applies; and
(b) the chemical is to be manufactured for a use or purpose that is permitted under the relevant Convention.
Note: In deciding whether to grant the application, the officer may take into consideration the matters mentioned in regulation 3.20.
(4) If the officer is not satisfied as to the matters mentioned in subregulation (1), (2) or (3), the officer must refuse to grant the application.
Division 3.4—Use
3.145 Absolute prohibition
(1) The use in Australia of a controlled chemical is prohibited if the relevant item in Schedule 1 states that its use is prohibited in all cases.
(2) For the purposes of subsection 69C(1) of the Act, the condition that a person must not use a chemical in contravention of subregulation (1) is prescribed.
3.150 Prohibition subject to conditions
(1) This regulation applies to a controlled chemical if:
(a) the relevant item in Schedule 1 identifies the relevant international agreement or arrangement as the Stockholm Convention; and
(b) that item states that use is prohibited unless paragraphs 3.150(2)(a) to (d) are complied with.
(2) The use in Australia of a controlled chemical to which this regulation applies is prohibited unless:
(a) the chemical is an approved active constituent or a registered chemical product; and
(b) the use is in accordance with the instructions for its use that the APVMA has approved; and
(c) the use is in accordance with a use‑specific exemption that is in effect for Australia under Article 4 of the Stockholm Convention; and
(d) the use is permitted under the law of the State or Territory in which the chemical is to be used.
Division 3.5—Dealing with chemicals
Subdivision 3.5.1—Absolute prohibition
3.175 Prohibited dealing
(1) Any dealing (other than importation, manufacture, use or exportation) in Australia of a controlled chemical is prohibited if the relevant item in Schedule 1 states that dealing in the chemical is prohibited in all cases.
(2) For the purposes of subsection 69C(1) of the Act, the condition that a person must not deal in a chemical in contravention of subregulation (1) is prescribed.
Subdivision 3.5.2—Prohibition subject to conditions
3.180 Chemicals to which this Subdivision applies
(1) This Subdivision applies to a controlled chemical if the relevant item in Schedule 1 states that Subdivision 3.5.2 applies to it.
(2) In this Subdivision, a controlled chemical to which this Subdivision applies is called a dealing‑prohibited chemical.
3.185 Prohibition
(1) Any dealing (other than importation, manufacture, use or exportation) of a dealing‑prohibited chemical in Australia is prohibited unless an authorised officer or the Minister has given permission in writing to deal with the chemical in the relevant way.
(2) For the purposes of subsection 69C(1) of the Act, the following conditions or restrictions are prescribed for each such chemical:
(a) a person must not deal with the chemical:
(i) without the written permission of an authorised officer or the Minister; or
(ii) contrary to a condition or restriction specified in the permission;
(b) a person who deals with the chemical must not fail to produce the permission if asked to do so by:
(i) an authorised officer; or
(ii) an officer of another Agency, or an officer or employee of a State or Territory government, authorised in writing by the Secretary for the purposes of this paragraph;
(c) any condition or restriction specified in the relevant item in Schedule 1.
Note: A person who deals with such a chemical in contravention of a prescribed condition or restriction may be punished by a fine of up to 300 penalty units (see subsection 69C(5) of the Act).
(3) This regulation applies despite any approval to deal with the chemical under any other legislation.
3.190 Applications for permission to deal with dealing‑prohibited chemicals
(1) A person may apply to the Department for permission to deal with a dealing‑prohibited chemical.
(2) An application to deal with a dealing‑prohibited chemical must be in the approved form and must include the following information:
(a) generic information about the applicant;
(b) the technical name, common name and CAS number (if known) of the chemical;
(c) information that the applicant considers supports the application.
Note 1: The applicant may be required to give additional information (see regulation 3.15).
Note 2: An authorised officer must give written notice of his or her decision on the application (see regulation 3.505).
3.195 When permission may be granted
(1) An authorised officer may grant an application for permission to deal with a dealing‑prohibited chemical if the officer is satisfied that the dealing is in accordance with Australia’s obligations under the relevant international agreement or arrangement.
Note: In deciding whether to grant the application, the officer may take into consideration the matters mentioned in regulation 3.20.
(2) If the officer is not satisfied as to the matter mentioned in subregulation (1), the officer must refuse to grant the application.
Division 3.6—Export
Subdivision 3.6.1—Absolute prohibition
3.200 Prohibited export
(1) The export from Australia of a controlled chemical is prohibited if the relevant item in Schedule 1 states that its export is prohibited in all cases.
(2) For the purposes of subsection 69C(1) of the Act, the condition that a person must not export a chemical in contravention of subregulation (1) is prescribed.
Subdivision 3.6.2—Prohibition subject to conditions
3.205 Chemicals to which this Subdivision applies
(1) This Subdivision applies to a controlled chemical if the relevant item in Schedule 1 states that its export is prohibited except with written permission.
(2) In this Subdivision, a controlled chemical to which this Subdivision applies is called an export‑prohibited chemical.
3.210 Prohibition
(1) The export from Australia of an export‑prohibited chemical is prohibited unless:
(a) an authorised officer or the Minister has given permission in writing to export the chemical; and
(b) the permission is produced to a Collector; and
(c) any condition or restriction specified in the relevant item in Schedule 1 is satisfied.
Note 1: The permission to export required under this regulation must be produced to a Collector for the purposes of complying with regulation 4A of the Customs (Prohibited Exports) Regulations 1958 in relation to the exportation of chemicals under those Regulations that are active constituents or chemical products.
Note 2: A multiple exit export permit is a permission for the purposes of this regulation (see subregulation 3.310(3)).
(2) For the purposes of subsection 69C(1) of the Act, the following conditions or restrictions are prescribed for each such chemical:
(a) a person must not export the chemical:
(i) without the written permission of an authorised officer or the Minister; or
(ii) contrary to a condition or restriction specified in the permission;
(b) a person who exports the chemical must not fail to produce the permission if asked to do so by a Collector;
(c) any condition or restriction set out in the relevant item in Schedule 1.
Note: A person who exports such a chemical in contravention of a prescribed condition or restriction may be punished by a fine of up to 300 penalty units (see subsection 69C(5) of the Act).
(3) This regulation applies despite:
(a) the APVMA’s certificate setting out its findings (if any) in relation to the export of a chemical product under section 69D of the Act; and
(b) any approval to export under any other legislation.
3.215 Applications for permission to export export‑prohibited chemicals
(1) A person may apply to the Department for permission to export an export‑prohibited chemical.
(2) An application must be in the approved form and must include the following information:
(a) generic information about the applicant;
(b) the technical name, common name and CAS number (if known) of the chemical;
(c) the quantity to be exported;
(d) the name of the importing country;
(e) the name of any transit country (if known);
(f) the intended use in the importing country.
Note 1: The applicant may be required to give additional information (see regulation 3.15).
Note 2: An authorised officer must give written notice of his or her decision on the application (see regulation 3.505).
3.220 Additional information required for certain exports
(1) This regulation applies to an export‑prohibited chemical if the relevant item in Schedule 1 states that the chemical is subject to a notification of final regulatory action by Australia under Article 5 of the Rotterdam Convention.
(2) An application for permission to export a chemical to which this regulation applies must, in addition to the information required under regulation 3.215, include the following information:
(a) expected date of export;
(b) category (pesticide or industrial use) under which the chemical is being exported;
(c) the name and address of the importer;
(d) precautionary measures to reduce exposure to, and emission of, the chemical;
(e) in the case of a mixture or preparation, the concentration of the prescribed active constituent or constituents.
Note The above information forms part of the export notification required under Article 12 of the Rotterdam Convention.
3.225 When permission must be granted
An authorised officer must grant an application for permission to export an export‑prohibited chemical if:
(a) the relevant item in Schedule 1 identifies the relevant international agreement or arrangement as the Rotterdam Convention; and
(b) the export is to a non‑party to that Convention.
3.230 When permission may be granted
(1) An authorised officer may grant an application for permission to export an export‑prohibited chemical whose export is stated in an item in Schedule 1 to be prohibited except with written permission under paragraph 3.230(1)(a), (b) or (c) if the officer is satisfied that the export is:
(a) for the purpose of environmentally sound disposal in accordance with paragraph (1)(d) of Article 6 of the Stockholm Convention; or
(b) to a party that is permitted to use the chemical under Annex A or B of the Stockholm Convention; or
(c) to a State not Party to the Stockholm Convention (within the meaning of paragraph 2 of Article 3 of that Convention) that has provided an annual certification to Australia in accordance with that paragraph.
Note 1: The export of an active constituent or chemical product for the purpose of environmentally sound disposal must also comply with the Hazardous Waste (Regulation of Exports and Imports) Act 1989 and any regulations made under that Act.
Note 2: Under paragraph 2(b)(iii) of Article 3 of the Stockholm Convention, the annual certification of a non‑party must:
(a) specify the intended use of the chemical; and
(b) include a statement that, with respect to that chemical, the importing State is committed to:
(i) protect human health and the environment by taking the necessary measures to minimize or prevent releases;
(ii) comply with the provisions of paragraph 1 of Article 6; and
(iii) comply, where appropriate, with the provisions of paragraph 2 of Part II of Annex B; and
(c) include any appropriate supporting documentation, such as legislation, regulatory instruments, or administrative or policy guidelines.
Note 3: Paragraph 2(d) of Article 3 of the Stockholm Convention states:
‘For the purposes of this paragraph, the term “State not Party to this Convention” shall include with respect to a particular chemical, a State or regional economic integration organization that has not agreed to be bound by the Convention with respect to that chemical.’.
(2) An authorised officer may grant an application for permission to export an export‑prohibited chemical if:
(a) the relevant item in Schedule 1 identifies the relevant international agreement or arrangement as the Rotterdam Convention; and
(b) the export is to a party to that Convention; and
(c) the officer is satisfied that the export complies with the requirements of that Convention.
(3) An authorised officer may grant an application for permission to export an export‑prohibited chemical if:
(a) neither subregulation (1) nor (2) applies; and
(b) the chemical is being exported for a use or purpose in the importing country that is permitted under the relevant Convention.
Note: In deciding whether to grant the application, the officer may take into consideration the matters mentioned in regulation 3.20.
(4) To avoid doubt, an authorised officer may refuse to grant an application despite the fact that the APVMA has given a certificate setting out its findings (if any) in relation to the export of the chemical product under section 69D of the Act.
3.235 Required conditions
(1) This regulation applies to the export of an export‑prohibited chemical if:
(a) the relevant item in Schedule 1 identifies the relevant international agreement or arrangement as the Rotterdam Convention; and
(b) the export is to a party to that Convention.
(2) It is a condition of a permission for the export that the exporter will:
(a) include the Harmonized System customs code for the chemical (if assigned) on shipping documentation; and
(b) ensure that the labelling of the chemical complies with relevant international standards (including standards requiring information regarding risks and hazards to human health and the environment); and
(c) if the chemical is to be used for occupational purposes, give to the importer a safety data sheet that:
(i) is in accordance with an internationally recognised format; and
(ii) sets out up‑to‑date information; and
(iii) if practicable, is in one of the official languages of the country to which the chemical is to be exported; and
(d) give to the Department, on or before 28 February following each calendar year, a statement of the total quantity of the chemical exported in the calendar year, naming each importing country and specifying how much of the chemical was exported to each importing country.
3.240 Deciding application for permission to export when import decision available
(1) This regulation applies to the export of an export‑prohibited chemical if the relevant item in Schedule 1 identifies the relevant international agreement or arrangement as the Rotterdam Convention.
(2) In making a decision whether to grant an application for permission to export the chemical to a party to the Convention, an authorised officer must take into consideration:
(a) any import decision notified to the Secretariat by the party; and
(b) if the chemical is described in the relevant item in Schedule 1 as a severely hazardous pesticide formulation, any applicable condition or restriction specified in that item; and
(c) whether the applicant has provided any additional information required under regulation 3.220.
Note: Under Article 10 of the Convention, the Secretariat must, every 6 months, inform all parties of the import responses it has received. It does so by way of a six‑monthly information circular.
3.245 Deciding application for permission to export when import decision not known
(1) This regulation applies to the export of an export‑prohibited chemical if:
(a) the relevant item in Schedule 1 identifies the relevant international agreement or arrangement as the Rotterdam Convention; and
(b) the export is to a party to that Convention; and
(c) the party’s import decision is not known.
(2) An authorised officer must not grant an application for permission to export the chemical, unless he or she is satisfied that the export will not be in breach of Australia’s obligations under Article 11 of the Rotterdam Convention.
Note: The import decision of a party may not be known because:
(a) the party failed to transmit to the Secretariat its decision; or
(b) the party transmitted an import response stating that a final import decision is under consideration or requesting more information or assistance in making its decision (see paragraph 4 (b) of Article 10 of the Rotterdam Convention).
3.250 When permission must be refused
(1) An authorised officer must refuse to grant an application for permission to export an export‑prohibited chemical if the officer is not satisfied as to the matters mentioned in subregulation 3.230(1).
(2) An authorised officer must refuse an application for permission to export an export‑prohibited chemical if:
(a) the relevant item in Schedule 1 identifies the relevant international agreement or arrangement as the Rotterdam Convention; and
(b) the export is to a party to that Convention; and
(c) any of the following applies:
(i) the officer is not satisfied that the export complies with the Rotterdam Convention;
(ii) the party has notified to the Secretariat an import decision not to consent to the import;
(iii) the party has notified to the Secretariat an import decision to consent to the import only subject to specified conditions and the authorised officer is not satisfied that those conditions have been met or will be met.
Note: A list of the parties to the Rotterdam Convention is available at http://www.pic.int.
(3) An authorised officer must refuse to grant an application for permission to export an export‑prohibited chemical if:
(a) neither subregulation (1) nor (2) applies; and
(b) the chemical is being exported for a use or purpose in the importing country that is not permitted under the relevant Convention.
Division 3.7—Multiple entry import and multiple exit export permits
3.305 Definitions
In this Division:
import‑prohibited chemical means a controlled chemical to which Subdivision 3.2.2 applies.
export‑prohibited chemical means a controlled chemical to which Subdivision 3.6.2 applies.
3.310 Purpose
(1) The purpose of this Division is to allow persons who from time to time import import‑prohibited chemicals, or export export‑prohibited chemicals, to apply for a permission to import (multiple entry import permit) or export (multiple exit export permit) those chemicals over a period of time, instead of having to apply for a permission for each import or export.
(2) A multiple entry import permit is a permission for the purposes of regulation 3.55.
(3) A multiple exit export permit is a permission for the purposes of regulation 3.210.
3.315 Fit and proper person
(1) For the purposes of regulation 3.340, an authorised officer must have regard to the following matters in determining whether a person is a fit and proper person:
(a) any conviction of the applicant for an offence against the Act or these Regulations;
(b) if the applicant is an individual:
(i) any conviction of the applicant for an offence under a law of the Commonwealth, of a State or of a Territory that is punishable by imprisonment for a period of one year or longer; and
(ii) whether the applicant is bankrupt;
(c) if the applicant is a corporation:
(i) any conviction of the applicant for an offence under a law of the Commonwealth, of a State or of a Territory that is punishable by a fine of 50 penalty units or more, being an offence committed at a time when a person who is a director, officer or shareholder of the company was a director, officer or shareholder of the company; and
(ii) whether the applicant is an externally administered body corporate (within the meaning of the Corporations Act 2001);
(d) whether the applicant has previously held a multiple permit or a permission under this Part;
(e) whether the applicant complied with any conditions or restrictions specified in the permit or permission.
(2) To avoid doubt, the matters mentioned in subregulation (1) are in addition to:
(a) any matters that an authorised officer is required to take into consideration under a provision of this Division; and
(b) any other matters that are relevant.
3.320 Multiple entry import permits
Note: Regulation 3.320 is reserved.
3.325 When multiple entry import permits may be granted
Note: Regulation 3.325 is reserved.
3.330 Multiple exit export permits
(1) This regulation applies if:
(a) the relevant item in Schedule 1 identifies the relevant international agreement or arrangement as the Rotterdam Convention; and
(b) either:
(i) the export is to a non‑party to that Convention; or
(ii) the chemical to be exported is a severely hazardous pesticide formulation that is of a form different from, or is of a concentration lower than, the relevant formulation given in Schedule 1.
(2) A person may apply to the Department for a multiple exit export permit.
(3) An application must be in the approved form and must include generic information about the applicant and the following information in respect of each export‑prohibited chemical to be exported under the permit:
(a) the technical name, common name and CAS number (if known) of each chemical;
(b) the non‑parties to which exports are to be made (if applicable);
(c) the formulation to be exported (if applicable);
(d) the quantity of chemical to be exported under the permit or, if that quantity is not known, an estimate of the quantity to be exported.
3.335 When multiple exit export permits may be granted—general
(1) An authorised officer may grant an application for a multiple exit export permit if the officer is satisfied that the exports to be made under the permit comply with the requirements of the Rotterdam Convention.
Note: In deciding whether to grant the application, the officer may take into consideration the matters mentioned in regulation 3.20.
(2) An authorised officer must refuse to grant an application if:
(a) the officer is not satisfied as to the matter mentioned in subregulation (1); or
(b) the applicant has at any time failed to comply with any condition or restriction specified in a permission or permit.
3.340 Grant of multiple exit export permits in special circumstances
Despite any thing else in this Division, an authorised officer may grant a multiple exit export permit to a person if the authorised officer is satisfied that:
(a) the relevant items in Schedule 1 for the export‑prohibited chemicals to be exported under the permit identify the relevant international agreement or arrangement as the Rotterdam Convention; and
(b) the person has, over an aggregate period of at least 1 year, exported export‑prohibited chemicals; and
(c) the person has complied with the requirements of the Act and these Regulations in relation to those exports; and
(d) the person is a fit and proper person.
Note: In deciding whether to grant the permit, the officer may take into consideration the matters mentioned in regulation 3.20.
3.345 Annual reports
(1) The holder of a multiple permit must give to the Department an annual report about imports or exports made under the permit.
(2) The report:
(a) must state the name of the holder, the identification number and date of issue, of the permit; and
(b) must include the following information in respect of the chemicals imported or exported under the permit:
(i) the technical name and common name of the chemical;
(ii) the name of the exporting or importing countries;
(iii) the date of each import or export;
(iv) the name of any transit country (if known);
(v) any additional information required as a condition or restriction specified on the permit;
(vi) the quantity of each kind of chemical imported from or exported to each named exporting or importing country; and
(c) must be signed by the holder of the permit; and
(d) must be given on or before 28 February of each year.
3.350 Period of validity and renewal of permit
(1) A multiple permit is valid until the end of 31 March next occurring after the permit is granted.
(2) An application for renewal of a permit may be made in writing by the holder of the permit not more than 60 days before the day on which the permit ceases to be valid under subregulation (1).
(3) An authorised officer may grant an application for renewal if the authorised officer is satisfied that:
(a) the holder has not imported or exported a chemical in contravention of the permit; and
(b) the holder has complied with any conditions or restrictions specified in the permit; and
(c) the holder continues to be a fit and proper person (if applicable); and
(d) the holder has complied with the annual reporting requirements under regulation 3.345.
Division 3.8—Conditions or restrictions of permissions or multiple permits
3.405 Conditions
A permission or multiple permit granted under this Part may specify conditions or restrictions to be complied with by the holder and may, in respect of any such condition or restriction, specify a time (being a time before or after the act permitted) at or before which the holder must comply with the condition or restriction.
3.410 Revocation etc of permission or multiple permits
(1) An authorised officer may revoke, vary or suspend a permission or multiple permit granted under this Part.
(2) The authorised officer must give to the holder of a permission or permit written notice of the revocation, variation or suspension of the permission or permit within 10 days after doing so.
(3) The notice must include:
(a) a brief statement of the reasons for the revocation, variation or suspension; and
(b) a statement that the applicant may apply to the Minister for reconsideration of the decision.
(4) A failure to comply with subregulation (2) or (3) does not affect the validity of the revocation, variation or suspension.
Division 3.9—Review of decisions
3.505 Notice of authorised officer’s decision
(1) An authorised officer must give, to an applicant for a permission or multiple permit under this Part, written notice of the officer’s decision on the application within 10 days after making the decision.
(2) A notice of a decision to refuse to grant a permission or permit must include:
(a) a brief statement of the reasons for the refusal; and
(b) a statement that the applicant may apply to the Minister for reconsideration of the decision.
(3) A failure to comply with subregulation (1) or (2) in relation to a decision does not affect the validity of the decision.
3.510 Reconsideration of decisions by Minister
(1) An application for reconsideration of the following decisions may be made to the Minister by the applicant for, or the holder of, a permission or multiple permit:
(a) an authorised officer’s decision to refuse to grant a permission or permit;
(b) an authorised officer’s decision to revoke, vary or suspend a permission or permit.
(2) The application must be made in writing within 15 days after the applicant receives notice of the decision.
(3) The Minister may:
(a) grant or refuse to grant a permission or permit; or
(b) vary or affirm a decision to revoke, vary or suspend a permission or permit; or
(c) set aside, and substitute his or her decision for, a decision to revoke, vary or suspend a permission or permit.
3.515 Notice of Minister’s decision
(1) The Minister must give, to a person who applies for reconsideration of a decision, written notice of the Minister’s decision on the person’s application within 10 days after making the decision.
(2) The notice must include a statement that the person may apply to the Administrative Appeals Tribunal for a review of the decision.
(3) A failure to comply with subregulation (1) or (2) in relation to a decision does not affect the validity of the decision.
3.520 Review of decisions by AAT
An application may be made to the Administrative Appeals Tribunal for a review of the Minister’s decision on an application for reconsideration under this Division.
3.550 Export of chemical products—fees for certificates
(1) Subject to subregulation (2), the following fees are prescribed for subsection 69D(1) of the Act:
(a) $125 as the standard fee for a certificate;
(b) if the certificate requires technical or scientific assessment to be undertaken by the APVMA, a further $105 for the assessment.
(2) No fee is payable for a certificate (the subsequent certificate) if an applicant applies for the subsequent certificate on the same day when the applicant applied for another certificate (the original certificate), and the original and subsequent certificates are:
(a) the same in all respects; or
(b) the same in all respects except for one or more of the following:
(i) the addressee of the certificate;
(ii) the country to which the chemical product is to be exported;
(iii) the authority of the country to which the chemical product is to be exported.
(3) For subsection 69D(1) of the Act, the following fees are further prescribed if the applicant requires the APVMA to take a certificate (whether original or subsequent) to the Department of Foreign Affairs and Trade so that a consular act can be performed in relation to the certificate:
(a) for signing and affixing a seal to the certificate, the fee imposed under the Consular Fees Regulations 1990 for that consular act;
(b) for preparing and issuing an Apostille (being a certificate of the kind referred to in Article 3 of the Requirement of Legalisation for Foreign Public Documents), the fee imposed under the Consular Fees Regulations 1990 for that consular act.
Note 1: At the time of the commencement of this regulation, the fees imposed under the Consular Fees Regulations 1990 for the consular acts mentioned in paragraphs (3)(a) and (b) were $20 and $60, respectively.
Note 2: The Department of Foreign Affairs and Trade will not sign and affix a seal to, or prepare and issue an Apostille for, an APVMA certificate unless the certificate has an original signature, stamp or seal.
Part 3A—Infringement notices
3A.01 Infringement notices
(1) For the definition of prescribed civil penalty provision in section 4 of the Act, each civil penalty provision mentioned in Schedule 5 is prescribed.
(2) For subsection 69EKA(3) of the Act:
(a) the amount (in penalty units) mentioned for an individual in an item of Schedule 5 is the amount that applies for an alleged contravention by the individual of the provision mentioned in the item in the circumstances (if any) mentioned in the item; and
(b) the amount (in penalty units) mentioned for a corporation in an item of Schedule 5 is the amount that applies for an alleged contravention by the corporation of the provision mentioned in the item in the circumstances (if any) mentioned in the item.
Part 4—Miscellaneous
4.10 Annual returns—active constituents
(1) For the purposes of paragraph 69E(2)(a) of the Act, active constituents that are not made into, or included in, chemical products are prescribed.
(2) For the purposes of paragraph 69E(2)(b) of the Act, the prescribed quantity is as follows:
(a) for active constituents for proposed or existing veterinary chemical products or active constituents included in veterinary chemical products—3kg;
(b) for active constituents for proposed or existing agricultural chemical products or active constituents included in agricultural chemical products—10kg.
4.15 Method of securing samples
(1) This regulation applies to an inspector who exercises:
(a) the monitoring power mentioned in paragraph 69EAC(1)(g) of the Act to take and keep samples of any thing on any premises; or
(b) the investigation power mentioned in paragraph 69EBA(1)(g) of the Act to take a sample and keep samples of any thing on any premises.
(2) The inspector must ensure that:
(a) the sample is contained and sealed in an appropriate vessel or package; and
(b) the vessel or package is so marked as to clearly identify the sample; and
(c) the vessel or package cannot be opened, or the identification of the sample removed, without breaking the seal; and
(d) the sample is stored and transported in such a way that the composition of the sample is not altered.
