2013-2014-2015-2016
THE PARLIAMENT OF THE COMMONWEALTH OF AUSTRALIA
HOUSE OF REPRESENTATIVES
ETHICAL COSMETICS BILL 2016
EXPLANATORY MEMORANDUM
and
STATEMENT OF COMPATIBILITY WITH HUMAN RIGHTS
Circulated by authority of Clare O’Neil MP,
Member for Hotham
ETHICAL COSMETICS BILL 2016
PURPOSE OF THE BILL
1. This Bill bans the practice of testing cosmetics on live animals in Australia, and the importation into and manufacture in Australia of cosmetics tested on live animals overseas.
2. This Bill amends the Industrial Chemicals (Notification and Assessment) Act 1989 (“the ICNA Act”).
3. The Bill provides new offences regarding the importation and manufacture of cosmetics and the testing of cosmetics on live animals.
4. The Bill makes a number of other amendments to the Act for consistency and to ensure the regulating body has sufficient information to monitor these requirements.
OBJECTIVES
5. The Bill proposes four new offences regarding live animal testing in addition to existing offences regarding the approval and assessment of an industrial chemical:
a. An offence to import or manufacture a cosmetic in Australian that has been tested on a live animal.
b. An offence to import or manufacture a substance where testing has been conducted on a live animal, and the dominant purpose of the testing relates to the substance’s use in a cosmetic.
c. An offence to test a cosmetic on live animals in Australia.
d. An offence to test a substance on a live animal in Australia if the dominant purpose of the testing relates to the substance’s use in a cosmetic.
6. Intention and recklessness are the default fault element for the offences in (5). Importers or manufacturers must have reasonable knowledge of the testing a substance has been subject to.
7. The offences mentioned in (5) apply to bodies corporate. This is intended to ensure that subsidiaries are assumed to have reasonable knowledge of the testing activities of their parent entities.
8. The Bill amends the assessment process for a new industrial chemical which is intended to be used in a cosmetic. To apply to register a new cosmetic ingredient, the regulator, National Industrial Chemicals Notification and Assessment Scheme (NICNAS), must be provided with a substance’s live animal testing history.
9. The applicant must list any live animal testing and indicate, for any animal testing, the end use for which that ingredient was being tested (e.g. for that ingredient’s use in a cosmetic, in a medical product, etc.) If the dominant purpose of the animal testing was for the ingredient’s use as a cosmetic, that ingredient cannot be registered in Australia. If the dominant purpose of the animal testing was for another reason (e.g. the ingredient’s use in medicine) then the offences do not apply.
10. Regardless of the dominant purpose of any animal testing, NICNAS can no longer accept evidence from animal tests to support the registration of a new cosmetic ingredient.
11. The Bill removes explicit reference to animal tests in the Act’s Schedule to create consistency. The Bill requires the regulator to define alternative non-animal tests for cosmetics which align with the data required in the Act’s Schedule.
12. The provisions in this Bill are prospective. Live animal tests on cosmetics and substances used in cosmetics that have already occurred are not subject to the Bill.
13. The key components of the Bill commence three (3) years following the Bill’s assent. This phase-in period will provide the regulator with sufficient time to develop alternative testing means and allow industry to change their current processes if required.
14. Animal testing that occurs between the assent of the Bill and commencement of provisions within the Bill is not covered by the new offences.
INTERNATIONAL TRADE OBLIGATIONS
15. The provisions in this Bill are consistent with Australia’s trade obligations. There are provisions within the Bill, should its contents explicitly breach Australia’s international obligations, that would not have effect to that extent.
FINANCIAL IMPACT
16. This Bill will have no financial impact.
NOTES ON CLAUSES
Item 1 – Short Title
17. This clause provides for the Bill, when enacted, to be cited as the Ethical Cosmetics Act 2016.
Item 2 – Commencement
18. This clause provides for the Bill to be enacted after receiving Royal Assent. Schedule 1 is to take effect three (3) years following Royal Assent. This provides a transitional period for entities affected by this Bill.
Item 3 – Schedules
19. This is a formal clause that enables the Schedules to amend the Act. It provides that each Act that is specified in a Schedule is amended or repealed as set out in the applicable items in the Schedule, and that any other item in a Schedule has effect according to its terms. The Bill contains only one Schedule.
Schedule 1
Part 1 - Main amendments
Industrial Chemicals (Notification and Assessment) Act 1989
20. Item 1 inserts Division 2, an additional set of clauses, at the end of Part 3B of the Act.
21. Proposed section 81B establishes four new offences under the Act.
Importing or manufacturing cosmetics or ingredients for cosmetics
22. Proposed paragraph 81B(1) would make it an offence for a person to import or manufacture a cosmetic that has been tested on a live animal and the testing relates to the cosmetic. A person causes an offence if the actions were undertaken in the course of carrying out a business.
23. Proposed paragraph 81B(2) would make it an offence for a person to import or manufacture a substance to be used in a cosmetic that has been tested on a live animal and the dominant purpose of the testing relates to the use of the substance in a cosmetic. A person causes this offence if these actions were undertaken in the course of carrying out a business.
24. Proposed paragraph 81B(3) clarifies the fault elements of the offences.
25. Intention is the default element for components 81B(1)(a) and 81B(2)(a).
26. Recklessness is the default fault element that applies to section 81B(1)(b), 81B(1)(c) & 81B(2)(c) through to 81B(2)(e). The prosecution will be required to prove that the defendant was aware of a substantial risk that the testing had occurred and that, in the circumstances, it was unjustifiable to take that risk.
27. Proposed paragraph 81B(4) establishes that a person who imports and manufactures a cosmetic or substance referred to in 81B(1) or 81B(2) is reckless if testing is undertaken by a person, a related entity or related body corporate.
Testing cosmetics and ingredients for cosmetics
28. Proposed paragraph 81B(5) would make it an offence for a person to test a cosmetic on a live animal in Australia.
29. Proposed paragraph 81B(6) would make it an office for a person to test a substance on a live animal in Australia if the dominant purpose of the testing relates to the substance’s use in a cosmetic.
30. Paragraph 81B(7) exempts substances from the offences created in 81B(1),(2),(5) or (6) that were approved under the ICNA Act prior to the commencement of the these amendments. A person does not cause an offence under these provisions if testing occurred prior to the commencement of these amendments.
31. New sections 81C, 81D, 81E and 81F clarify the coverage of proposed of section 81B.
32. Proposed paragraph 81C calls on NICNAS to determine rules with respect to determining the ‘dominant purpose’ of testing. NICNAS must do so by legislative instrument.
33. Proposed paragraph 81D provides a reading down provision for the application of these amendments.
34. Proposed paragraph 81E qualifies the amendments proposed in this Bill subject to Australia’s international obligations.
35. Paragraph 81F(1) qualifies coverage of the Division with regard to goods covered by the Therapeutic Goods Act 1989 and substances that fall within paragraph 5(1)(d) of the definition of cosmetic.
36. Paragraph 81F(2) clarifies that the Division considers a mixture or preparation of a substance in the same manner as it considers a substance. This Division considers the contribution of a substance as a component in the same way it applies to a substance’s use as an ingredient.
Part 2 – Related Amendments
Industrial Chemicals (Notification and Assessment) Act 1989
37. Items 2 and 3 alter the title and objective of the Act to reflect the amendments proposed in this Bill.
38. Item 5 provides a definition for “constitutional trade and commerce” and “federally regulated entity” as a result of their use in new section 81D. The item also creates a cross reference for “dominant purpose” which is established in 81C.
39. Items 4 and 6 substitutes the definition of “constitutional trade and commerce” with its occurrence in subparagraph 4(a)(iii), 21M(1) and 21M(2)(c).
40. Items 7 through 15 make consequential amendments throughout the Act for consistency with the amendments proposed in Item 1.
41. Item 7 proposes paragraph 21(7) which removes the exemptions for introducing a new chemical in 21(1A), (2), (3), (4) and (6) if a new industrial chemical has been tested on live animals and the dominant purpose of the testing relates to the new industrial chemical’s use in a cosmetic. This paragraph only applies in the course of carrying on a business.
42. Items 8 to 11 make amendments to section 23 which deals with an application for a non-self-assessed assessment certification for any chemical.
43. Item 8 proposes a new subsection, 23(1B), which would prevent an application for an assessment certificate from being made if a new industrial chemical was intended to be used in a cosmetic and testing had been conducted, on or after the commencement of this subsection, on a live animal (whether or not in Australia) and if the dominant purpose of the testing relates to the new industrial chemical’s use in a cosmetic.
44. If an applicant believes that Item 8 does not apply to their application, Item 10 provides through proposed paragraph 23(9B) a requirement for the applicant to provide a history of testing for an industrial chemical if the chemical has been tested on a live animal (whether or not in Australia, and whether before or after the commencement of this subsection). The notification statement for the new industrial chemical must contain information about when the testing occurred and, the purpose or purposes of the testing. Item 10 also has the effect of preventing information obtained through live animal testing from being used on an application. No information to support an application can be obtained through live animal tests.
45. Item 11 has the effect of clarifying 23(12). Subsection 23(12A) proposes that the information required to complete an assessment certificate in section 23 must not require testing on live animals if the new industrial chemical is to be used in a cosmetic. The Director must, in 23(12B), provide a list of tests to obtain the required information through means which do not involve live animal testing.
46. Item 12 proposes amendments to section 23A relating to an application for a self-assessed assessment certificate for certain chemicals. Proposed paragraph 23A(4) prevents a self-assessed assessment from occurring if a new industrial chemical is to be used in a cosmetic and testing has been conducted, on or after the commencement of this subsection, on a live animal (whether or not in Australia) and the dominant purpose of the testing relates to the new industrial chemical’s use in a cosmetic
47. Proposed paragraph 23A(5) requires that an application’s approved form must require an applicant to provided information about whether the new industrial chemical has been tested on a live animal (whether or not in Australia, and whether before or after the commencement of this subsection). Information must cover when the testing occurred and the purpose of the testing. 23A(5) also has the effect of preventing information obtained through live animal testing from being used on the application. No information to support an application can be obtained through live animal tests.
48. Item 13 inserts a clause at the end of section 24, 24(5), which has the effect of preventing the Director from issuing a waiver for a new industrial chemical if that waiver would prevent a person from suppling information or data regarding the testing of a substance or cosmetic.
49. Items 8 through to 13 have the effect of creating consistency across all assessment and notification processes.
50. Item 14 replaces the existing heading with a simplified title: “Cosmetics”.
51. Item 15 and 16 remove specific animal tests from Part C of the Schedule and allow the Director to specify the test required to obtain similar data without live animal testing.
STATEMENT OF COMPATIBILITY WITH HUMAN RIGHTS
Prepared in accordance with Part 3 of the Human Rights (Parliamentary Scrutiny) Act 2011
Ethical Cosmetics Bill 2016
This bill is compatible with the human rights and freedoms recognised or declared in the international instruments listed in section 3 of the Human Rights (Parliamentary Scrutiny) Act 2011.
Overview of the bill
This Bill will amend the Industrial Chemicals (Notification and assessment) Act 1989 (“the ICNA Act”) to prevent live animal testing for cosmetics and live animal testing for substances if the dominant purpose of testing was for that substance’s use in a cosmetic.
Human rights implications
This Bill does not impact any human rights. With respect to Article 25 of the Universal Declaration of Human Rights, the Bill does not impact or limit the right to health. The Bill does not impact substances which would be considered medical products under the Therapeutic Goods Act 1989. Viable non-animal testing practices are well established and changes to health and safety testing practices proposed in this Bill would not pose any significant change to ensuring a person’s health or safety.
Conclusion
The Bill does not raise any human rights issues and as such is compatible with the Human Rights (Parliamentary Scrutiny) Act 2011.
Clare O’Neil MP,
Member for Hotham