Distribution date: 01 March 2021 | Final date for Comment: 30 April 2021

The Therapeutic Goods Administration (TGA) is seeking comments on a proposed standard for vaporiser nicotine products. Vaporiser nicotine products are nicotine-containing products intended to be used in vaping devices such as e-cigarettes, e-cigars and other electronic nicotine delivery systems (ENDs). This includes vape liquids, e-liquids and e-juices that contain nicotine and/or nicotine salts. This does not include other nicotine replacement therapies (NRTs) containing nicotine, such as patches, gum, lozenges, mouth spray and inhalators nor nicotine-containing products that are not intended for use in ENDs, such as chewing tobacco and snuff. The proposed standard relates only to unapproved goods – that is, medicines that have not been approved by the TGA and are not registered in the Australian Register of Therapeutic Goods (ARTG). While it is anticipated that a number of vaporiser nicotine products may seek approval by the TGA as medicines in the coming years, it is also anticipated that there will be a significant number of prescriptions written for unapproved goods for smoking cessation. The proposed standard is in the form of a Therapeutic Goods Order (a TGO) and would be TGO 110. TGOs are legal standards made under section 10 of the Therapeutic Goods Act 1989 (Act) which specify safety and quality rules for medicines imported into, exported from or supplied in Australia. TGOs can apply to approved or unapproved products, or both, and may be limited to a certain type of medicine. TGOs cannot specify requirements for vaping devices. The public consultation on the Therapeutic Goods (Standard for Vaporiser Nicotine) (TGO 110) Order 2021 (draft TGO 110) is open until 31 March 2021, available via the link in section 8 below. We will review all feedback received and, if appropriate, revise the requirements in the draft TGO 110 before it is finalised. 

Products Covered: Nicotine-containing products intended to be used in vaping devices such as e-cigarettes, e-cigars and other electronic nicotine delivery systems (ENDs).

Regulation Type: Regular notification

Distribution date: 01 March 2021 | Final date for Comment: 30 April 2021

This standard specifies the requirements, sampling, test methods, inspection rules, and labelling, packaging, transportation, storage and shelf-life requirements of feed additive lactic acid. This document applies to the feed additive lactic acid with L-lactic acid as its main components, prepared by fermentation method with starch or sugar as raw materials.

Products Covered: Feed Additive—Lactic Acid

Regulation Type: Regular notification

Distribution date: 01 March 2021 | Final date for Comment: 30 April 2021

This standard specifies the technical requirements, sampling, test methods, inspection rules, and labelling, packaging, transportation, storage and shelf-life requirements of feed additive natural xanthophyll (saponified marigold extract). This document applies to the feed additive natural xanthophyll prepared by saponification of marigold extract, and its main coloring substances are lutein and zeaxanthin.

Products Covered: Feed Additive Natural Xanthophyll (Saponified Marigold Extract)

Regulation Type: Regular notification

Distribution date: 03 March 2021 | Final date for Comment: 16 March 2021

The comment period is being extended till 16 March 2021, following request from Members.

Products Covered: All tobacco and manufactured tobacco substitutes, including but not limited to HS codes starting with, 2402 and 2403 and nicotine delivery systems, including components of such systems, including but not limited to HS codes starting with 2403, 3824 and 8543.

Regulation Type: Addendum to Regular Notification

Distribution date: 03 March 2021 | Final date for Comment: 14 May 2025

This resolution establishes criteria for prescription, exemption, control, packaging, and labelling of medicines based on substances categorized as antimicrobial for use under prescription, isolated or associated. They will be listed in a specific Normative Instruction.

Products Covered: Antibiotics (HS code(s): 2941); Medicaments consisting of two or more constituents mixed together for therapeutic or prophylactic uses, not in measured doses or put up for retail sale (excl. goods of heading 3002, 3005 or 3006) (HS code(s): 3003); Medicaments consisting of mixed or unmixed products for therapeutic or prophylactic uses, put up in measured doses "incl. those for transdermal administration" or in forms or packings for retail sale (excl. goods of heading 3002, 3005 or 3006) (HS code(s): 3004); Wadding, gauze, bandages and the like, e.g. dressings, adhesive plasters, poultices, impregnated or covered with pharmaceutical substances or put up for retail sale for medical, surgical, dental or veterinary purposes (HS code(s): 3005); Pharmaceutical preparations and products of subheadings 3006.10.10 to 3006.60.90 (HS code(s): 3006); Pharmaceutics (ICS code(s): 11.120)

Regulation Type: Regular notification

Distribution date: 03 March 2021 | Final date for Comment: 14 May 2025

This normative instruction defines the list of substances categorized as antimicrobial for use under prescription, isolated or associated.

Products Covered: Antibiotics (HS code(s): 2941); Medicaments consisting of two or more constituents mixed together for therapeutic or prophylactic uses, not in measured doses or put up for retail sale (excl. goods of heading 3002, 3005 or 3006) (HS code(s): 3003); Medicaments consisting of mixed or unmixed products for therapeutic or prophylactic uses, put up in measured doses "incl. those for transdermal administration" or in forms or packings for retail sale (excl. goods of heading 3002, 3005 or 3006) (HS code(s): 3004); Wadding, gauze, bandages and the like, e.g. dressings, adhesive plasters, poultices, impregnated or covered with pharmaceutical substances or put up for retail sale for medical, surgical, dental or veterinary purposes (HS code(s): 3005); Pharmaceutical preparations and products of subheadings 3006.10.10 to 3006.60.90 (HS code(s): 3006); Pharmaceutics (ICS code(s): 11.120)

Regulation Type: Regular notification

Distribution date: 04 March 2021 | Final date for Comment: 14 May 2025

Prohibition of import, export and transit of mercury and amalgam listed in The Minamata Convention on Mercury and contained in the Schedule annexed to Chief Executive’s Decision No. 231/2020 in the Macao Special Administrative Region.

Products Covered: Mercury and Amalgam 2805.40.00, 2843.90.19, 2853.90.19

Regulation Type: Regular notification

Distribution date: 04 March 2021 | Final date for Comment: 14 May 2025

Prohibition of import and transit of disposable foamed plastic tableware to the Macao Special Administrative Region.

Products Covered: Disposable Foamed Plastic Tableware, including: Disposable foamed plastic food box (ex. 3923.10.00); Disposable foamed plastic bowls and cups (ex. 3923.90.00, ex. 3924.10.00); Disposable foamed plastic plates (ex. 3924.10.00).

Regulation Type: Regular notification

Distribution date: 08 March 2021 | Final date for Comment: 07 May 2021

The purpose of this Regulation is to establish a legal regime to ensure that all processes involving the activities of production, use, import, export, transit, handling and application of fertilizers are carried out without prejudice to public, animal and environmental health.

Products Covered: Animal or vegetable fertilisers, whether or not mixed together or chemically treated; fertilisers produced by the mixing or chemical treatment of animal or vegetable products. (HS code(s): 3101); Fertilizers (ICS code(s): 65.080)

Regulation Type: Regular notification

Distribution date: 08 March 2021 | Final date for Comment: 07 May 2021

This Draft Uganda Standard specifies requirements, sampling method and test methods for granulated superphosphate fertilizers.

Products Covered: - Superphosphates : (HS code(s): 31031); Fertilizers (ICS code(s): 65.080)

Regulation Type: Regular notification