Regulatory Updates

Resolution number 698, 13 May 2022

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Distribution date: 11 September 2023

Resolution number 698, 13 May 2022 - previously notified through G/TBT/N/BRA/1393 - which contains provisions on sanitizing products categorized as bleach and its market registration, was revoked by Resolution 813, 01 September 2023. The final text is available only in Portuguese and can be downloaded at:  http://antigo.anvisa.gov.br/documents/10181/6651220/RDC_813_2023_.pdf/1ac713a6-7fdb-46a6-ac4f-e7b3bc2d9830   

Products Covered: 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 34.01. (HS code(s): 3402)

Regulation Type: Addendum to Regular Notification

Human health

Draft Resolution 1154, 6 April 2023

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Distribution date: 11 September 2023 | Final date for Comment: 10 November 2023

Draft Resolution 1154, 6 April 2023 - previously notified through   G/SPS/N/BRA/2155  - was adopted as Normative Instruction 245, 1 September 2023. The regulation updates the monographs of the active ingredient I32 - ISOCYCLOSERA on the Monograph List of Active Ingredients for Pesticides, Household Cleaning Products and Wood Preservatives, published by Normative Instruction 103 on 19 October 2021 in the Brazilian Official Gazette (DOU - Diário Oficial da União).  The final text is available only in Portuguese and can be downloaded at:

Products Covered: Organic chemicals (HS code(s): 29); Environment. Health protection. Safety (ICS code(s): 13)

Regulation Type: Addendum to Regular Notification

Human health Adoption/publication/entry into force of reg. Food safety Pesticides

Draft Food (Amendment No. Y) Regulations 2023

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Distribution date: 06 September 2023

The draft Food (Amendment No. Y) Regulations 2023 (concerning microbiological standards for non-ready-to-eat food) notified in G/SPS/N/SGP/82 was gazetted as the Food (Amendment No. 3) Regulations 2023 on 4 September 2023 and will enter into force on 4 March 2024.

Products Covered: Non-ready-to-eat (RTE) meat and meat products: 02011000, 02012000, 02013000, 02021000, 02022000, 02023000, 02031100, 02031200, 02031900, 02032100, 02032200, 02032900, 02041000, 02042100, 02042200, 02042300, 02043000, 02044100, 02044200, 02044300, 02045000, 02050000, 02061000, 02062100, 02062200, 02062900, 02063000, 02064100, 02064900, 02068000, 02069000, 02071100, 02071200, 02071300, 02071410, 02071420, 02071430, 02071499, 02072400, 02072500, 02072600, 02072710, 02072799, 02074100, 02074200, 02074300, 02074400, 02074500, 02075100, 02075200, 02075300, 02075400, 02075500, 02076000, 02081000, 02085000, 02089010, 02089090, 02091000, 02099000, 02101100, 02101200, 02101930, 02101990, 02102000, 02109300, 02109910, 02109990, 05040000, 15011000, 15019000, 15021000, 15029010, 16010010, 16010090, 16022000, 16023110, 16023199, 16023290, 16023900, 16024110, 16024190, 16024210, 16024290, 16024991, 16024999, 16025000, 16029090; Non-RTE eggs and egg products: 04072100, 04072910, 04072990, 04079010, 04079020, 04079090, 04081100, 04081900, 04089100, 04089900, 21069099, 35021100, 35021900; Non-RTE oysters and blood-cockles: 03071110, 03071120, 03071200, 03077110, 03077120, 03077200

Regulation Type: Addendum to Regular Notification

Food safety Human health Adoption/publication/entry into force of reg.

Amendments to the Legal Inspection Requirements of Toys

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Distribution date: 05 September 2023

The purpose of this notification is to provide the final texts of "Amendments to the Legal Inspection Requirements of Toys" and relevant dates of its implementation. The draft texts notified in “G/TBT/N/TPKM/524” were adopted with minor changes.

Products Covered: Toys (HS code(s): 3213; 3307; 3407; 3824; 3918; 3923; 3924; 3926; 4006; 4016; 4202; 4823; 6114; 6211; 6306; 6307; 6506; 8306; 8414; 8472; 8505; 8516; 8543; 8715; 8806; 9208; 9404; 9503; 9504; 9505; 9506) 

Regulation Type: Addendum to Regular Notification

The amendment of the "Procedure for the Recognition of Infectious Animal Disease-Free Status of a Foreign Country (Zone)”

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Distribution date: 04 September 2023

The Separate Customs Territory of Taiwan, Penghu, Kinmen and Matsu notified the first amendment to the "Procedure for the Recognition of Infectious Animal Disease-Free Status of a Foreign Country" on 23 November 2021 (G/SPS/N/TPKM/543/Rev.1/Add.1). Since 1 August 2023, the Council of Agriculture (COA) and the Bureau of Animal and Plant Health Inspection and Quarantine (BAPHIQ), COA have been reorganized and renamed as the Ministry of Agriculture (MOA) and the Animal and Plant Health Inspection Agency (APHIA), MOA. In addition, the abbreviation of the World Organisation for Animal Health (OIE) was changed as the WOAH. Therefore, with the changes (marked in red), the amendment of the "Procedure for the Recognition of Infectious Animal Disease-Free Status of a Foreign Country (Zone)" was updated and promulgated on 25 August 2023. 

Products Covered: Animals and Animal Products (HS codes: 01, 02, 0401, 0402, 0407, 0408, 0410, 0502, 0504, 0505, 0506, 0507, 0510, 0511, 1214, 1502, 1506, 1601, 1602, 1902, 1904, 1905, 2104, 2301, 2308, 2309, 3001, 3002, 3101, 3105, 3502, 4101, 4102, 4103, 4205, 4301, 4601, 5101, 5102, 5103, and 6701)

Regulation Type: Addendum to Regular Notification

Animal diseases Animal health Adoption/publication/entry into force of reg. Bovine Spongiform Encephalopathy (BSE)

Microbe phosphate fertilizer (The new standards for fertilizer)

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Distribution date: 01 September 2023

Draft to establish, Ministerial Order and Notification amending the Ministerial Order and Notification of the Ministry of Agriculture, Forestry and Fisheries pertaining to Act on the Quality Control of Fertilizer notified in G/TBT/N/JPN/771 has been adopted and published on dated 1 September 2023.

Products Covered: Fertilizer (HS: 3101)

Regulation Type: Addendum to Regular Notification

National Standard of the P.R.C., Safety and technical standards for cleaning products

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Distribution date: 28 August 2023 | Final date for Comment: 27 October 2023

This document specifies terms and definitions, raw material requirements, product requirements, test methods and labeling requirements for cleaning products.The document applies to cleaning products (except cosmetics, disinfection products and detergents for food) produced and sold (including imported) in the People's Republic of China.This document does not apply to cleaning products used in aerospace, nuclear, military and semiconductor (including integrated circuits).

Products Covered: Laundry soap (ordinary laundry soap, compound laundry soap, other laundry soap), soap powder, soap liquid, other soap products, synthetic laundry powder (ordinary laundry powder, concentrated laundry powder, industrial laundry powder, other laundry powder), liquid detergent (household and fabric detergent, household cleaning care agent, other liquid detergent), industrial cleaning agent, public facilities and environmental sanitation detergent, other synthetic detergent, intermediate surfactant products. (HS code(s): 3401; 3402); (ICS code(s): 71.100.40)

Regulation Type: Regular notification

Draft Resolution of the Cabinet of Ministers of Ukraine “On Amendments to Paragraph 20 of the Technical Regulation on Detergents”

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Distribution date: 25 August 2023

Ukraine notifies the adoption of the Resolution of Cabinet of Ministers of Ukraine  No 872 “On Amendments to Paragraph 20 of the Technical Regulation on Detergents” of August 19, 2023.The Resolution was published  on August 23, 2023 and  will enter into force on October 01, 2023.  

Products Covered: Detergents

Regulation Type: Addendum to Regular Notification

Human health

National Standard of the P.R.C., Safety specification for electrical equipment for measurement, control and laboratory use

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Distribution date: 25 August 2023 | Final date for Comment: 24 October 2023

This document stipulates general safety requirements for electrical equipment for measurement, control and laboratory use.This document applies to electrical equipment for measurement, control and laboratory use, including industrial automation equipment.

Products Covered: electrical equipment for measurement, control and laboratory use (HS code(s): 8543); (ICS code(s): 19.080; 71.040.10)

Regulation Type: Regular notification

Resolution – RDC number 471, 23 February 2021

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Distribution date: 24 August 2023

Normative instruction 244, 21 August 2023, the list of substances classified as antimicrobial for use under prescription, alone or in association, which the resolution 471, 23 February 2023, which contains provisions on criteria for the prescription, dispensing, control, packaging and labeling of drugs based on substances classified as antimicrobials for use under prescription, alone or in combination. The final text is available only in Portuguese and can be downloaded at:  http://antigo.anvisa.gov.br/documents/10181/6644859/IN_244_2023_.pdf/c111ee17-6f8f-42ab-9bcc-8dd86bbcdf63 

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: Addendum to Regular Notification

Human health

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