Regulatory Updates

Distribution date: 06 May 2024

National Agency for Petroleum, Natural Gas and Biofuels – ANP issued Resolution Nº 968, 30 April 2024, that establishes the specifications of diesel oils intended for vehicles or equipment equipped with Diesel cycle engines and the obligations regarding quality control to be met by economic agents that sell the product in Brazilian territory.The following Resolutions and Resolutions items and articles are revoked: I - ANP Resolution No. 50, 31 December 2013; II - ANP Resolution No. 13, 6 March 2015; III - item IV of the caput of art. 37 and art. 46 of ANP Resolution No. 828, 1 September 2020; IV - art. 30 of ANP Resolution No. 859, 6 December 2021; V - art. 12 of ANP Resolution No. 909, 18 November 2022;  VI - the sole paragraph of art. 1st of ANP Resolution No. 920, 4 April 2023, previously notified through G/TBT/N/BRA/1481.

Products Covered: Biodiesel and mixtures thereof, not containing or containing < 70 % by weight of petroleum oils or oils obtained from bituminous minerals (HS code(s): 3826)

Regulation Type: Addendum to Regular Notification

Distribution date: 06 May 2024

Draft resolution number 1135, 23 December 2022 - previously notified through  G/TBT/N/BRA/1468  - which is regarded to a regulatory proposal for the establishment of specific criteria and procedures for defining the Equivalent Foreign Regulatory Authorities of the sanitary inspection process of manufacturers of active pharmaceutical ingredients, Cannabis products for medicinal purposes, medicines and biological products, was adopted as Normative Instruction 292, 02 May 2024  The final text is available only in Portuguese and can be downloaded at:  https://antigo.anvisa.gov.br/documents/10181/6531690/IN_292_2024_.pdf/33b87ce6-cb6b-4136-b7e8-9adc4d54285d 

Products Covered: Pharmaceutics (ICS code(s): 11.120)

Regulation Type: Addendum to Regular Notification

Distribution date: 02 May 2024 | Final date for Comment: 01 July 2024

The United Kingdom has announced its intention to introduce a voluntary option for businesses to use digital labelling, as an alternative to physical labelling, for certain marking and information requirements. This will apply to most manufactured products. Where the Regulations require businesses to provide a product’s UK conformity marking, manufacturer details, importer details, responsible person details (or in the case of the Aerosols Dispensers Regulations 2009, the person responsible for the marketing of the aerosol dispenser) and UK Declaration of Conformity, this will allow businesses to provide access to such marking and information through a digital link. The United Kingdom also intends to make permanent the current temporary labelling easements relating to a product’s UK conformity marking and importer details (G/TBT/N/GBR/49). Where the Regulations require businesses to provide a product’s UK conformity marking and importer details on a product, this will allow businesses to provide the same marking and details on the product’s packaging, on a label affixed to the product or the product’s packaging, or on an accompanying document. In respect of the existing importer details easement, this will be made permanent and expanded to provide more flexibility for all importers.These labelling easements will also be extended to cover a product’s manufacturer details. Where the Regulations require businesses to provide manufacturer or responsible person details (or marketer details in the case of the Aerosols Dispensers Regulations 2009) on the product, this will also allow businesses to provide these details on the product’s packaging, on a label affixed to the product or the product’s packaging, or on an accompanying document. This legislation applies to Great Britain (England, Scotland and Wales).

Products Covered: Products covered fall under the 18 product regulations under the responsibility of the Department for  Business  and Trade, the Ecodesign  for Energy-Related  Products  Regulations 2010 (Department  for  Energy Security  and  Net Zero),  the  Explosives Regulations  2014 (Department for Work and Pensions (Health and Safety Executive)), and the Restriction of  the Use  of  Certain Hazardous  Substances  in Electrical  and  Electronic Equipment Regulations 2012 (Department for Environment, Food and Rural Affairs). A full list of these regulations is attached to this notification.These regulations cover a range of manufactured products including mobile phones, lifts, industrial machinery, toys, and household appliances. Such products are included within, but are not limited to, the following HS codes: 36, 39, 73, 76, 85, 95, 96.

Regulation Type: Regular notification

Distribution date: 01 May 2024 | Final date for Comment: 30 June 2024

The Regulations will require certain categories of businesses, including importers who are established and supply packaged products Fin the UK, to label packaging as ‘Recycle’ or ‘Do Not Recycle’ together with a logo, as specified in the Regulations. Businesses that manufacture or import unfilled packaging for supply to another business will be required to provide information on its recyclability.  This will inform correct labelling by the businesses that subsequently fill that packaging. A common methodology to determine recyclability will be publicly available. This will inform businesses which label to apply. The Regulations will include details of the types of packaging that must be labelled, flexibility regarding medical and veterinary products, and exemptions for certain packaging items such as small packaging.  

Products Covered: 3923 Articles for the conveyance or packing of goods, of plastics; stoppers, lids, caps and other closures, of plastics, 4819 packaging made of paper and cardboard,7010 Carboys, bottles, flasks, jars, pots, phials, ampoules and other containers, of glass, of a kind used for the conveyance or packing of goods, preserving jars, stoppers, lids and other closures, of glass,6305 Sacks and bags, of a kind used for the packing of goods, of all types of textile materials8309 Stoppers, caps and lids, incl. crown corks, screw caps and pouring stoppers, capsules for bottles, threaded bungs, bung covers, seals and other packing accessoriesEx 6909 Ceramic wares for laboratory, chemical or other technical uses; ceramic troughs, tubs and similar receptacles of a kind used in agriculture; ceramic pots, jars and similar articles of a kind used for the conveyance or packaging of goods 7310 Tanks, casks, drums, cans, boxes and similar containers, for any material (other than compressed or liquefied gas), of iron or steel, of a capacity not exceeding 300 l, whether or not lined or heat-insulated, but not fitted with mechanical or thermal equipment7612 Aluminium casks, drums, cans, boxes and similar containers (including rigid or collapsible tubular containers), for any material (other than compressed or liquefied gas), of a capacity not exceeding 300 litres, whether or not lined or heat-insulated, but not fitted with mechanical or thermal equipmentEx 3919, Ex 3920, Ex 3921 – wrappings if made of plasticsEx 4804, Ex 4805, Ex 4808, Ex 4813, Ex 4823 – wrappings if made of paperTo note that the above listed products are only in scope of the labelling requirements if they are used as ‘primary packaging’ (regulation 7.1.a) or ‘shipment packaging’ (regulation 7.1.d) of the draft regulations. primary packaging, which is packaging conceived so as to constitute a sales unit to the final user or consumer at the point of purchase;Shipment packaging, which is packaging in addition to primary packaging on items which are sold online or by mail order which are either delivered direct to the purchaser or collected by the purchaser from a shop or other collection point after they have been purchased. 

Regulation Type: Regular notification

Distribution date: 29 April 2024 | Final date for Comment: 28 June 2024

This document specifies the general safety requirements for non-traditional machines, and  the safety requirements for electro-discharge machines, electrochemical machines, additive manufacturing machines, laser processing machines.This document applies to the design and manufacture of electro-discharge machines, electrochemical machines, additive manufacturing machines and laser processing machines.

Products Covered: non-traditional machines (HS code(s): 8456); (ICS code(s): 25.080.99)

Regulation Type: Regular notification

Distribution date: 29 April 2024 | Final date for Comment: 28 June 2024

This document specifies the requirement of cylinder assemblies, nozzles, selector valves, check valves, manifolds, connection hoses, safety relief devices, actuation devices, control system, signal feedback devices, pressure reducing devices, actuation line vent valves, pipes and fittings, hook and bracket, room vents, flow calculation method and test, test methods, inspection rules, operation instructions, fire extinguishing agent filling and marking, packing, storage and transport to gas fire extinguishing systems and components.This document applies to system design, manufacture and test for chemical extinguishing system, like HFC227ea, and inert gas extinguishing systems, including IG-01(Argon), IG-100(Nitrogen), IG-55(Nitrogen, Argon), and IG-541 (Nitrogen, Argon, Carbon dioxygen).This document doesn’t apply to system design, manufacture and test for carbon dioxide extinguishing systems and halon extinguishing systems.

Products Covered: gas fire extinguishing system and components(HS code(s): 842410); (ICS code(s): 13.220.10)

Regulation Type: Regular notification

Distribution date: 29 April 2024 | Final date for Comment: 28 June 2024

This document defines the chemical name, molecular formula and relative molecular weight and structural formula of Neohesperidin dihydrochalcone, specifies the technical requirements, sampling, inspection rules, labeling, packaging, transportation, storage and shelf life of Neohesperidin dihydrochalcone as a feed additive, and describes test methods.This document applies to the feed additive Neohesperidin dihydrochalone, which is obtained by catalytic hydrogenation, crystallization, centrifugation, washing, drying and crushing after dissolving in sodium hydroxide solution, using neohesperidin as raw material.

Products Covered: neohesperidin dihydrochalcone (HS code(s): 293890); (ICS code(s): 65.120)

Regulation Type: Regular notification

Distribution date: 29 April 2024 | Final date for Comment: 28 June 2024

This document defines the chemical name, molecular formula and relative molecular weight of Copper chloride hydroxide, specifies the technical requirements, sampling, inspection rules, labeling, packaging, transportation, storage and shelf life of Copper chloride hydroxide as a feed additive, and describes test methods.This document applies to the feed additive Copper chloride hydroxide produced by chemical synthesis from copper-containing raw materials.

Products Covered: copper chloride hydroxide (HS code(s): 230990); (ICS code(s): 65.120)

Regulation Type: Regular notification

Distribution date: 29 April 2024 | Final date for Comment: 28 June 2024

This document defines the chemical name, molecular formula, relative molecular mass and structural formula of Ferric glycine complex, specifies the technical requirements, sampling, inspection rules, labeling, packaging, transportation, storage and shelf life of Ferric glycine complex as a feed additive, and describes  test methods.This document applies to the chemical synthesis of feed additive Ferric glycine complex with glycine and ferrous sulfate as main raw materials.

Products Covered: ferric glycine complex (HS code(s): 230990); (ICS code(s): 65.120)

Regulation Type: Regular notification

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