Distribution date: 26 April 2024

Proposed reforms to the regulation of Electronic Nicotine Delivery systems (ENDs) and Electronic Non-Nicotine Delivery systems (ENNDs) notified in G/TBT/N/AUS/151 and G/TBT/N/AUS/151.add1 are being implemented in 2024.  Adopted reforms include implementing changes to Australia’s borders to restrict the importation of vapes. From 1 January 2024, the importation of all single use disposable vapes is prohibited, subject to very limited exceptions. Additionally, from 1 March 2024: importation of all vapes without an import licence and permit from the Office of Drug Control is prohibited, subject to limited exceptions. to obtain an import permit, importers are required to notify the Therapeutic Goods Administration (TGA) that a vape is:only for smoking cessation or the management of nicotine dependence, and that the vape complies with relevant product standards (Australian manufacturers must also make a notification to that effect before first releasing vapes for supply); ora vaping device that is only for use with medicinal cannabis, and the device complies with the essential principles in the Therapeutic Goods (Medical Devices) Regulations 2002 (the pre-existing requirement to obtain an import permit for vaping substances containing cannabis has not changed).the standard that previously only applied to nicotine vapes applies to all therapeutic vapes for smoking cessation and the management of nicotine dependence, irrespective of nicotine content. New flavour restrictions have also been added to this standard.vaping devices that are not exclusively for the administration of a medicine are no longer excluded from the therapeutic goods regulatory framework. A new medical device standard applies to these devices as an alternative to essential principles that ordinarily apply to medical devices. individuals are no longer able to access the personal importation scheme to import therapeutic vapes for personal use, apart from a limited exemption for travellers to Australia under which modest quantities are permitted.  The updated minimum quality and safety standard, which applies to both ENDS and ENNDS for smoking cessation or the management of nicotine dependence, includes requirements for: product labelling (including an over sticker or in an information sheet provided with the product)child resistant packagingrequirement for the product label to list all active ingredients and state the nicotine concentration of the vapeprohibited ingredientslimited flavours permitted (mint, menthol and tobacco only)quality management system requirements for vaping devices and vaping device accessories that do not comply with the essential principles that ordinarily apply to medical devicesdocumentation that needs to be kept by the Australian sponsor of the product demonstrating compliance with the requirements of the minimum quality and safety standards.  The new medical device standard provides minimum certification requirements for therapeutic vaping devices and therapeutic vaping device accessories that were excluded goods as 1 January 2024.  Other proposed measures that have been previously notified in G/TBT/N/AUS/151 and G/TBT/N/AUS/151.add1 are also being pursued. On 21 March 2024, the Australian Government introduced the Therapeutic Goods and Other Legislation Amendment (Vaping Reforms) Bill 2024 into the Parliament of Australia. The Bill proposes strict domestic controls on all vaping goods. It proposes prohibiting the importation, domestic manufacture, supply, commercial possession, and advertisement of single use disposable vapes and non-therapeutic vaping goods. Therapeutic vaping goods will continue to be available and subject to regulation under the Therapeutic Goods Act 1989, in line with other medicines and therapeutic goods. Further details about the reforms is available at: Vaping hub | Therapeutic Goods Administration (TGA)

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). One of the possible reform options would also affect the importation of vaping devices that do not contain nicotine (ENNDs).  TOBACCO AND MANUFACTURED TOBACCO SUBSTITUTES (HS 24); PHARMACEUTICAL PRODUCTS (HS 30)

Regulation Type: Addendum to Regular Notification

Distribution date: 26 April 2024

The Environmental Protection Agency (EPA) is correcting a final rule that appeared in the Federal Register of Thursday, 28 March 2024, which finalized the rule under the Toxic Substances Control Act (TSCA) to address to the extent necessary the unreasonable risk of injury to health presented by chrysotile asbestos based on the risks posed by certain conditions of use. The injuries to human health include mesothelioma and lung, ovarian, and laryngeal cancers resulting from chronic inhalation exposure to chrysotile asbestos.  This correction is effective on 28 May 2024. 89 Federal Register (FR) 31655, Title 40 Code of Federal Regulations (CFR) Part 751:https://www.govinfo.gov/content/pkg/FR-2024-04-25/html/2024-08871.htmhttps://www.govinfo.gov/content/pkg/FR-2024-04-25/pdf/2024-08871.pdf This final rule; correction and previous actions notified under the symbol G/TBT/N/USA/1850 are identified by Docket Number EPA-HQ-OPPT-2021-0057. The Docket Folder is available on Regulations.gov at https://www.regulations.gov/docket/EPA-HQ-OPPT-2021-0057/document and provides access to primary and supporting documents as well as comments received. Documents are also accessible from Regulations.gov by searching the Docket Number.

Products Covered: Chrysotile Asbestos; Asbestos (excl. products made from asbestos) (HS code(s): 2524); Friction material and articles thereof, e.g., sheets, rolls, strips, segments, discs, washers, pads, not mounted, for brakes, clutches or the like, with a basis of asbestos, other mineral substances or cellulose, whether or not combined with textile or other materials (excl. mounted friction material) (HS code(s): 6813); Environmental protection (ICS code(s): 13.020); Air quality (ICS code(s): 13.040); Protection against dangerous goods (ICS code(s): 13.300); Road vehicle systems (ICS code(s): 43.040); Products of the chemical industry (ICS code(s): 71.100)

Regulation Type: Corrigendum to Regular Notification

Distribution date: 24 April 2024 | Final date for Comment: 23 June 2024

The draft Order provides for the approval of amendments to the Procedure for Confirmation of Compliance of Medicinal Products Manufacturing Conditions with the Requirements of Good Manufacturing Practice, approved by the Order of the Ministry of Health of Ukraine No. 1130 of 27 December 2012. The amendments to the Procedure will provide legislative regulation of the mechanism for extending the validity of the GMP Conclusion, as well as the possibility of extending the validity of the GMP certificate until the end of 2024 issued by the authorized body of an EU member state, the United Kingdom or a state that has a mutual recognition agreement with the EU or Ukraine.Approval of the amendments to the Procedure will align it with EU requirements.

Products Covered: Medicinal products 

Regulation Type: Regular notification

Distribution date: 24 April 2024 | Final date for Comment: 23 June 2024

These regulations introduce a ban on the supply and sale of wet wipes containing plastic. The draft legislation defines a wet wipe as ‘a piece of pre-moistened or pre-wetted non-woven material which is conceived, designed and placed on the market for single-use (disposable) and intended for personal care e.g., personal hygiene or domestic use e.g., household cleaning purposes. Prewetted wipes typically contain an impregnation liquid which has been added to the wipe before it is placed on the market.’These regulations will apply to all businesses in England. These restrictions will not apply to:The manufacture or import of wet wipes containing plastic.Supply and sale of wet wipes containing plastic, for the purpose of some business-to-business sale, as specified in the regulations.The supply and sale of wet wipes containing plastic by a retail pharmacy business, subject to conditions.The supply of wet wipes containing plastic for use for medical purposes by or under the direction of a healthcare professional or by a healthcare professional for medical purposes.Breach of these prohibitions will be an offence under the regulations. The regulations confer powers on enforcement authorities to impose civil sanctions, including monetary penalties and stop notices, in addition to criminal prosecution.The draft legislation provides a transition period of 18 months for businesses.

Products Covered: Beauty or make-up preparations and preparations for the care of the skin (other than medicaments), including sunscreen or suntan preparations; manicure or pedicure products. (CCCN 3304990000) Organic surface-active agents (other than soap); surface-active preparations, washing preparations (including auxiliary washing preparations) and cleaning preparations, whether or not containing soap, other than those of heading 3401. (HS 3402) Insecticides, rodenticides, fungicides, herbicides, anti-sprouting products and plant-growth regulators, disinfectants and similar products, put up in forms or packings for retail sale or as preparations or articles (for example, sulphur-treated bands, wicks and candles, and fly-papers) HS 3808)

Regulation Type: Regular notification

Distribution date: 23 April 2024

MAPA/SDA Nº 1092, 16 April 2024, amends item I of article 7 of MAPA/SDA Ordinance No. 765, 6 April 2023 that approves identity and quality requirements for boiled ham, superior cooked ham, tender cooked ham and poultry cooked ham. 

Products Covered: Prepared or preserved meat, offal or blood (excl. sausages and similar products, and meat extracts and juices) (HS code(s): 1602); Meat, meat products and other animal produce (ICS code(s): 67.120)

Regulation Type: Addendum to Regular Notification

Distribution date: 22 April 2024

Kazakhstan notified in G/SPS/N/KAZ/159 (5 January 2024) the Letter of the Committee for Veterinary Control and Surveillance of the Ministry of Agriculture of the Republic of Kazakhstan on the introduction of temporary restrictions on the importation to the territory of Kazakhstan from the Komi Republic of the Russian Federation of live poultry and hatching eggs, down and feathers, poultry meat and all types of poultry products that have not undergone heat treatment, feed and feed additives for birds, hunting trophies that have not undergone taxidermic treatment, used equipment for keeping, slaughtering and butchering birds, as well as for transit from the above territory through the territory of the Republic of Kazakhstan of live birds.The notified measure was modified by the Letter of the Committee for Veterinary Control and Surveillance of the Ministry of Agriculture of Kazakhstan.

Products Covered: Live poultry and hatching eggs, down and feathers, poultry meat and all types of poultry products, feed and feed additives for birds, hunting trophies, used equipment for keeping, slaughtering and butchering birds

Regulation Type: Addendum to Emergency Notification (SPS)

Distribution date: 19 April 2024

The Russian Federation lifted temporary restrictions on imports of birds' eggs from seven enterprises of the Hajdú-Bihar county of Hungary on 16 April 2024.

Products Covered: Live poultry, bird eggs, meat and edible offal of poultry, machinery for preparing animal feeding stuffs, poultry incubators and brooders. HS Codes: 0105; 0407, 0408; 0207;0208,0209,0210,0410 00 000 0,0504 00 000 0,0505,0511,1501,1506 00 000 0,1516 10,1518 00,1601 00,1602, 1603 00,1902 20,1904 20,products from group 20, from 2104, from 2106, 4206 00 000 0, 0106; 508 10 000 0,0106,9705 00 000 0; 9508 10 000 0,0106; 2102, 2309, 2936, 3504, 3507, 3808, 3824; 3923,3926,4415 4416 00 000 0, 4421, 7020 00, 7309 00, 7310, 7326, 7616, 8436 10 000 0, 8436 21 000 0, 8436 29 000 0, 8436 80 900 0, 8606 91 800 0, 8609 00, 8716 39 800;

Regulation Type: Addendum to Emergency Notification (SPS)

Distribution date: 19 April 2024

Kazakhstan notified in G/SPS/N/KAZ/146 (12 September 2023) the Letter of the Committee for Veterinary Control and Surveillance of the Ministry of Agriculture of the Republic of Kazakhstan on the introduction of temporary restrictions on the importation to the territory of Kazakhstan from the territory of Republics of Bashkortostan and Mari El, Vologda region of the Russian Federation of live poultry and hatching eggs, down and feathers, poultry meat and all types of poultry products, feed and feed additives for birds, hunting trophies, used equipment for keeping, slaughtering and butchering birds susceptible to highly pathogenic avian influenza virus (HPAI), as well as transit through the territory of Kazakhstan of live birds susceptible to highly pathogenic avian influenza virus (HPAI).The notified measure was modified by the Letter of the Committee for Veterinary Control and Surveillance of the Ministry of Agriculture of Kazakhstan.

Products Covered: Live poultry and hatching eggs, down and feathers, poultry meat and all types of poultry products, feed and feed additives for birds, hunting trophies, used equipment for keeping, slaughtering and butchering birds 

Regulation Type: Addendum to Emergency Notification (SPS)

Distribution date: 15 April 2024 | Final date for Comment: 14 June 2024

Ministry of Health, Labour and Welfare will revise Appendix 2-2 in the Standards for Cosmetics under the provision of Article 42, Paragraph 2 of the Law on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices.

Products Covered: Cosmetics (HS: 33)

Regulation Type: Regular notification

Distribution date: 15 April 2024 | Final date for Comment: 24 May 2024

Products Covered: Cosmetics (HS code(s): 33; 34); (ICS code(s): 71.100.70)

Regulation Type: Addendum to Regular Notification