Regulatory Updates

Partial amendment to the Minimum Requirements for Biological ProductsPartial amendment to the Public Notice on National Release Testing

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Distribution date: 31 July 2026 | Final date for Comment: 30 August 2026

The Minimum Requirements for Biological Products will be amended as follows:The standard for “Recombinant Herpes Zoster Vaccine (Prepared from Chinese Hamster Ovary Cells)” that is to be newly approved will be added. And regarding the standard for “Recombinant Coronavirus (SARS-CoV-2) Vaccine”, the article of “Virus seed lot” and “Virus-infected cell suspension” in the section of “Production control” will be partially amended. In addition, regarding the standard for “Inactivated Polio Vaccine”, the article of “Potency test” in the section of “Tests on final product” will be partially amended. The Public Notice on National Release Testing will be amended as follows: The criterion, fee, quantity and Institution for National Release Testing for “Recombinant Herpes Zoster Vaccine (Prepared from Chinese Hamster Ovary Cells)” that is to be newly approved will be added. And the criterion, fee, and quantity for “Freeze-dried Recombinant Herpes Zoster Vaccine (Prepared from Chinese Hamster Ovary Cells)” and “Freeze-dried Smallpox Vaccine Prepared in Cell Culture” will be partially amended. In addition, the fee and quantity for “Adsorbed Diphtheria-purified Pertussis-tetanus-inactivated polio Combined Vaccine” and “Adsorbed Diphtheria-purified Pertussis-tetanus-inactivated polio Haemophilus TYPE b Combined Vaccine” will be partially amended.

Products Covered: Pharmaceutical products (HS: 30)

Regulation Type: Regular notification

Graphic Materials Group Standard amendment – consultation document – APP205008

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Distribution date: 29 July 2026 | Final date for Comment: 27 September 2026

The New Zealand Environmental Protection Authority (EPA) is proposing to amend the Graphic Materials Group Standard 2020:We propose to amend the definition of child for the purposes of the group standard (from 0 to 12 years) to 0 to up to 8 years.We propose to amend the definition of graphic materials in the group standard to exclude negligible risk items such as pens and pencils, so these graphic materials are no longer regulated under HSNO.We propose to amend the wording in the scope (clause 4) to explicitly state that the group standard applies to products that do not trigger a hazard classification but contain one or more hazardous ingredients.We propose that a substance can be assigned to the group standard if it is classified for a human health hazard in New Zealand only because New Zealand uses lower GHS cut-off thresholds for mixtures. This would only apply where the same substance would not be classified by recognised international regulatorsWe propose that graphic materials that trigger a hazard classification in New Zealand only because New Zealand applies lower GHS cut-off thresholds for mixtures are exempt from complying with the Labelling Notice, where the same materials would not be classified by recognised international regulators.We propose that graphic materials that trigger a hazard classification in New Zealand only because New Zealand applies lower GHS cut-off thresholds for mixtures are exempt from complying with the SDS Notice, where the same materials would not be classified by recognised international regulators.

Products Covered: Paint (under heading 3208 and 3209)Graphic materials (under heading 9608 and 9609)

Regulation Type: Regular notification

Amendments to the Enforcement Ordinance of the Standards of Feed and Feed Additives (Amendment of an agricultural chemical residue standard: Acephate)

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Distribution date: 28 July 2026 | Final date for Comment: 26 September 2026

Proposal for the amendments of the maximum residue limits (MRLs) for the agricultural chemical: Acephate. Commodity (for feed)   Proposed MRL(mg/kg)   Current MRL(mg/kg)Maize                                                  0.3                                       0.5Hay                                                      0.4                                        3 Note:- Residue definition for enforcement: Sum of acephate and its metabolite methamidophos converted to acephate.- Hay includes hay and fodder (dry), straw, forage (green) and silage. The MRL is set as 90% dry matter base.

Products Covered: Maize (HS code: 10.05) and hay (HS code: 12.13, 12.14) for feed

Regulation Type: Regular notification

Food safety Human health Maximum residue limits (MRLs)

Draft National Technical Regulation on safety in the research, production, trading, storage, transportation, use and disposal of consumer fireworks and display fireworks Number of pages: be confirmed.Language: Vietnamese.

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Distribution date: 27 July 2026 | Final date for Comment: 25 September 2026

The draft National Technical Regulation establishing mandatory safety requirements applicable to the research, production, trading, storage, transportation, use and disposal of consumer fireworks and display fireworks. The draft National Technical Regulation applies to agencies, organizations and individuals engaged in activities relating to consumer fireworks, display fireworks, pyrotechnic compositions and related accessories in the territory of Viet Nam. In the case of imported consumer fireworks and display fireworks, the requirements relating to trading, storage, use and disposal under the draft National Technical Regulation shall apply.The draft National Technical Regulation provides, inter alia, requirements relating to:the location and construction of production establishments and storage facilities;production workshops, testing sites, machinery, electrical equipment and technical infrastructure;fire and explosion prevention, lightning protection, environmental protection and occupational safety;research and production of consumer fireworks, display fireworks and pyrotechnic compositions;packaging and labelling;storage during production and trading;transportation;use of consumer fireworks and display fireworks;disposal of consumer fireworks and display fireworks;technical specifications, sampling requirements and test methods; andmanagement responsibilities, inspection and surveillance. The draft measure also establishes conformity assessment requirements. Consumer fireworks and display fireworks must be subject to declaration of conformity in accordance with the legislation on product and goods quality.

Products Covered: Consumer fireworks and display fireworks, including high-altitude display fireworks, low-altitude display fireworks and other types of consumer fireworks, pyrotechnic compositions for fireworks and display fireworks and accessories used in the research, production, storage, transportation, use and disposal of the above products (including ignition circuits, slow/fast burning fuses, electric igniters, and colour-effect components). HS Code: 3604.10.00

Regulation Type: Regular notification

The Environmental Protection (Wet Wipes Containing Plastic) (Scotland) Regulations 2024

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Distribution date: 27 July 2026

The regulations were adopted at a date later than the proposed date given within the original notification of 23 July 2024. Consequently, the date the regulation will enter into force has also been amended. The content and scope of the regulation have not materially changed.

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: Addendum to Regular Notification

Amendment to the Enforcement Ordinance of the Standards of Feed and Feed Additives (Amendment of an agricultural chemical residue standard: Phenthoate)

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Distribution date: 27 July 2026

Proposal for the amendment of the maximum residue limits (MRLs) for the agricultural chemical: Phenthoate. Commodity (for feed)       Proposed MRL(mg/kg)       Current MRL(mg/kg)Wheat                                                     0.5                                          0.4 Note:- Residue definition for enforcement: Phenthoate.

Products Covered: Wheat (HS code:10.01) for feed

Regulation Type: Regular notification

Food safety Human health Maximum residue limits (MRLs)

Proyecto de Tercera Revisión del Reglamento Técnico Ecuatoriano PRTE INEN 051 (3R) “Ollas a presión para uso doméstico”

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Distribution date: 22 July 2026 | Final date for Comment: 20 September 2026

The notified Ecuadorian Technical Regulation applies to the following products, whether domestic or imported, marketed in Ecuador: Portable household pressure cookers with a gross volume of up to 25 l and a working pressure exceeding 4 kPa but of less than 150 kPa, with integrated or independent heating systems.

Products Covered: Artículos de uso doméstico y sus partes, de acero inoxidable (exc. bidones, latas o botes, cajas y recipientes simil. de la partida 7310; papeleras; palas, sacacorchos y demás artículos con carácter de herramientas; artículos de cuchillería, así como las cucharas, cucharones, tenedores, etc. de las partidas 8211 a 8215, ambas inclusive; objetos de adorno; artículos de higiene o de tocador) (Código(s) del SA: 732393)

Regulation Type: Revision to Regular Notification

Draft Circular promulgating the National Technical Regulation on Products and Goods of Building Materials (2 pages, in Vietnamese) and draft QCVN XX:202X/BXD - National Technical Regulation on Products and Goods of Building Materials

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Distribution date: 20 July 2026 | Final date for Comment: 18 September 2026

The draft Circular promulgates national technical regulation QCVN xx:202x/BXD, replacing Circular No. 04/2023/TT-BXD and QCVN 16:2023/BXD. This draft Circular is planned to take effect from January 1, 2027. It include a transitional provision which applies to Certificates of Conformity, Registered or Designated Conformity Assessment Organizations, Conformity Assessment Files with completed sampling, and domestically produced or imported building materials and products.The draft technical regulation (QCVN) lays down mandatory technical requirements, limit values, test methods and sampling procedures for high-risk and medium-risk building-material products and goods manufactured domestically, imported, placed on the market and used in Viet Nam.The main amendments and additions include:- reclassifying and restructuring the list of covered products according to risk level;- updating essential technical characteristics, limit values, referenced standards, test methods and sampling procedures;- adding certain new materials and filling/embankment materials derived from industrial by-products;- specifying principles for conformity assessment and declaration of conformity, using Method 2, Method 5 or Method 7 depending on the product and risk level;- for high-risk products, declaration of conformity is based on certification by a certification body designated by the Ministry of Construction; for medium-risk products, declaration of conformity may be based on certification by an accredited/designated certification body or on self-assessment supported by test results issued by an accredited/designated testing body;- establishing responsibilities of relevant organizations and individuals, together with transitional provisions for existing certificates, conformity-assessment dossiers, products already manufactured or imported, and conformity-assessment bodies.This draft national technical regulation does not specify the procedures for quality management of construction materials and products manufactured specifically for a construction project and not independently circulated in the market. The quality of these products is managed according to construction laws, design documents, technical specifications, and applicable standards for the project.Exemption or reduction of state inspection of imported goods does not change the responsibility to ensure that the goods comply with the technical requirements of this regulation, except where the law provides otherwise.This draft national technical regulation applies to:- Organizations and individuals producing, importing, trading, distributing, and using construction materials and products within the scope of this Standard.- Testing organizations and certification organizations conducting conformity assessment activities for construction materials and products.- State management agencies, product and goods quality inspection agencies, and other relevant organizations and individuals.

Products Covered: High-risk and medium-risk building-material products and goods, covering 36 product types in the following main categories: cement; additions for cement and concrete (phosphogypsum, granulated blast-furnace slag, electric-furnace phosphorus slag and fly ash); chrysotile asbestos; construction glass; natural and agglomerated/artificial stone slabs; ceramic tiles; autoclaved aerated concrete products and wall panels; roofing products; sanitary appliances; emulsion wall paints; wood-based panels; pipes and fittings for water supply and drainage; gypsum boards and panels; and filling/embankment materials derived from industrial by-products (coal-fired power plant ash and slag, steel slag and phosphogypsum mixtures).Detailed HS codes are specified in Appendices II and III to Circular No. 41/2026/TT-BXD

Regulation Type: Regular notification

Proyecto de Primera Revisión del Reglamento Técnico Ecuatoriano PRTE INEN 264 (1R) "Calzado de seguridad, protección y trabajo" 

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Distribution date: 20 July 2026 | Final date for Comment: 18 September 2026

The notified Ecuadorian Technical Regulation applies to the following products, whether domestic or imported, marketed in Ecuador: • Safety footwear;• Protective footwear;• Occupational footwear.The notified Ecuadorian Technical Regulation does not apply to:• Footwear for firefighters;• Electrical insulating footwear;• Footwear protecting against chain saw injuries;• Footwear protecting against chemicals and molten metal splash; and Protective footwear for motorcycle riders.

Products Covered: 64011000, 64019200, 64019900, 64021900, 64029100, 64029910, 64029990, 64034000, 64035100, 64035900, 64039190, 64039990, 64041900, 64051000, 64052000, 64059000Calzado impermeable con suela y parte superior de caucho o plástico, cuya parte superior no esté unida a la suela por costura o por medio de remaches, clavos, tornillos, espigas o dispositivos simil. ni se haya formado con diferentes partes unidas de la misma manera, con puntera metálica de protección (exc. el calzado con patines fijos, para hielo o de ruedas, espinilleras y demás artículos de protección utilizados en el deporte) (Código(s) del SA: 640110); Calzado impermeable con suela y parte superior de caucho o de plástico, cuya parte superior no esté unida a la suela por costura o por remaches, clavos, tornillos, espigas o dispositivos simil. ni se haya formado con diferentes partes unidas de la misma manera, que cubran el tobillo sin cubrir la rodilla (exc. con puntera metálica de protección o con patines fijos, para hielo o de ruedas, y calzado con características de juguete) (Código(s) del SA: 640192); - Los demás calzados: (Código(s) del SA: 64029); Calzado con suela y parte superior de cuero natural, que cubra el tobillo (exc. con puntera metálica de protección, así como calzado de deporte, calzado ortopédico y calzado con características de juguete) (Código(s) del SA: 640351)

Regulation Type: Revision to Regular Notification

Revision of the Specifications and Standards for Foods, Food Additives, Etc. under the Food Sanitation Act (Revision of agricultural chemical residue standards)

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Distribution date: 20 July 2026 | Final date for Comment: 18 September 2026

Proposal of maximum residue limits (MRLs) for the following agricultural chemical:Pesticide: Kasugamycin.

Products Covered: Natural honey (HS code: 04.09)Edible vegetables and certain roots and tubers (HS codes: 07.01, 07.02, 07.03, 07.04, 07.05, 07.06, 07.07, 07.08, 07.09, 07.10 and 07.13)Edible fruit and nuts, peel of citrus fruit (HS codes: 08.02, 08.04, 08.05, 08.07, 08.08, 08.09, 08.10, 08.11 and 08.14)Tea, mate and spices (HS codes: 09.02, 09.03, 09.04, 09.05, 09.06, 09.07, 09.08, 09.09 and 09.10)Cereals (HS code: 10.06)Oil seeds and oleaginous fruits, miscellaneous grains, seeds and fruit (HS codes: 12.01, 12.07 and 12.12)

Regulation Type: Regular notification

Food safety Human health Maximum residue limits (MRLs)

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