Distribution date: 01 October 2024 | Final date for Comment: 21 April 2025

Resolution – RDC number 621, 09 March 2022 - previously notified through G/TBT/N/BRA/1376- which contains provisions on petitions for license requests, license renewals, post-qualification modifications, testing outsourcing, suspensions and cancellations  of Pharmaceutical Equivalence Centers, was revoked by Resolution 927, 20 September 2024.  The final text is available only in Portuguese and can be downloaded at:  https://antigo.anvisa.gov.br/documents/10181/6874029/RDC_927_2024_.pdf/63167a0c-94c3-48ea-b226-035dbad5b698 

Products Covered: HS (3003-3004) - Medicaments

Regulation Type: Addendum to Regular Notification

Distribution date: 01 October 2024 | Final date for Comment: 21 April 2025

Resolution 317, 22 October 2019 - previously notified through G/TBT/N/BRA/885/Add.1 - which establishes criteria and deadlines for market authorization and notification of medicines; and provides other measures, was revoked by Resolution 912, 19 September 2024 The final text is available only in Portuguese and can be downloaded at:  https://antigo.anvisa.gov.br/documents/10181/6873824/RDC_912_2024_.pdf/6c82f302-9728-4f0e-9b39-bbdfb0bc5870 

Products Covered: HS CODE: 30

Regulation Type: Addendum to Regular Notification

Distribution date: 01 October 2024 | Final date for Comment: 21 April 2025

Normative Instruction number 162, 01 July 2022 - previously notified through G/TBT/N/BRA/1417 - which establishes the acceptable daily intake (ADI), the acute reference dose (DRfA) and maximum residue limits (MRL) for active pharmaceuticals ingredients (API) of veterinary drugs in foods of animal origin, was changed by Normative Instruction 317, 19 September 2024.  The final text is available only in Portuguese and can be downloaded at:  https://antigo.anvisa.gov.br/documents/10181/6870061/IN_317_2024_.pdf/b92930b4-679d-47af-a479-e181977c94dc 

Products Covered: Pharmaceutical goods specified in Note 4 to this Chapter. (HS code(s): 3006)

Regulation Type: Addendum to Regular Notification

Distribution date: 01 October 2024 | Final date for Comment: 21 April 2025

Resolution – RDC number 620, 09 March 2022 - previously notified through G/TBT/N/BRA/1324 - which contains provisions on the Certification of Good Practices for conducting Bioavailability/Bioequivalence studies of medicaments and defines which Bioavailability/Bioequivalence studies of medicines must be carried out in certified research centers, was revoked by Resolution 926, 20 September 2024.  The final text is available only in Portuguese and can be downloaded at:  https://antigo.anvisa.gov.br/documents/10181/6874029/RDC_926_2024_.pdf/448b8051-83fd-4b61-a18a-2351d5db9e36 

Products Covered: HS (3003-3004) - Medicaments

Regulation Type: Addendum to Regular Notification

Distribution date: 01 October 2024 | Final date for Comment: 21 April 2025

Resolution - RDC n. 187, November 8th, 2017 - previously notified through G/TBT/N/BRA/758 - which establishes the minimum requirements for the registration of Hyperimmune Serum in order to guarantee the quality, safety and efficacy of these products, was revoked by Resolution 914, 19 September 2024.  The final text is available only in Portuguese and can be downloaded at:  https://antigo.anvisa.gov.br/documents/10181/6873824/RDC_914_2024_.pdf/754dff2a-fbe5-4a89-81ad-476ea4b77ac3 

Products Covered: 3002 - Blood

Regulation Type: Addendum to Regular Notification

Distribution date: 01 October 2024 | Final date for Comment: 21 April 2025

Draft Resolution  1262, 13 June 2024 - previously notified through G/TBT/N/BRA/1549 - which contains provisions on criteria for updating the composition of COVID-19 vaccines to be used in Brazil, was adopted as Resolution 905, 18 September 2024.  The final text is available only in Portuguese and can be downloaded at:  https://antigo.anvisa.gov.br/documents/10181/6770142/RDC_905_2024_.pdf/83622cba-e755-4e32-baee-5ab9e8696b1d 

Products Covered: Health care technology (ICS code(s): 11)

Regulation Type: Addendum to Regular Notification

Distribution date: 02 October 2024 | Final date for Comment: 21 April 2025

The Food and Drug Administration (FDA or we) is announcing the withdrawal, without prejudice to a future filing, of a food additive petition (FAP 2A4832) proposing that the food additive regulations for chlorine dioxide be amended to provide for an additional method for producing the additive.The food additive petition was withdrawn on 4 March 2024.

Products Covered: Chlorine (HS code(s): 280110); Food technology (ICS code(s): 67)

Regulation Type: Addendum to Regular Notification

Distribution date: 03 October 2024 | Final date for Comment: 21 April 2025

Further to our notification on 10 April 2024, the Department for Business and Trade: Office for Product Safety and Standards would like to prohibit a further 13 CMR substances in addition to those previously listed in the draft Statutory Instrument text that accompanied our earlier notification. Under Regulation (EC) No. 1223/2009 (the GB Cosmetics Regulation), Government is prohibiting a set of chemicals that have been classified as CMRs under Regulation (EC) No. 1272/2008 (the GB Classification Labelling, and Packaging (CLP) Regulation). We will amend technical Annex II to the GB Cosmetics Regulation to reflect the CLP classification. 

Products Covered: Cosmetics products are defined by Article 2(1)(a) of Regulation (EC) No 1223/2009.   ESSENTIAL OILS AND RESINOIDS; PERFUMERY, COSMETIC OR TOILET PREPARATIONS (HS code(s): 33); Cosmetics. Toiletries (ICS code(s): 71.100.70)

Regulation Type: Addendum to Regular Notification

Distribution date: 03 October 2024 | Final date for Comment: 21 April 2025

Ecuadorian Technical Regulation (PRTE) No. 031 (2R) "Brake fluid for hydraulic systems". 1 This information can be provided by including a website address, a PDF attachment, or other information on where the text of the final measure/change to the measure/interpretative guidance can be obtained. G/TBT/N/ECU/531/Add.1 - 2 - The Republic of Ecuador hereby advises that Ecuadorian Technical Regulation (PRTE) No. 031 (2R) "Brake fluid for hydraulic systems" will enter into force on 1 April 2025. It should be noted that, with respect to this Regulation, Ecuador has followed all the transparency and notification guidelines determined by the WTO. Thus, on 6 June 2024, in document G/TBT/N/ECU/531, the draft second revision (2R) of Ecuadorian Technical Regulation (PRTE) No. 031 "Brake fluid for hydraulic systems" was notified for 60 days on the WTO ePing platform for comments. No comments were received during this period. Ministerio de Producción, Comercio Exterior, Inversiones y Pesca, MPCEIP (Ministry of Production, Foreign Trade, Investment and Fisheries) Subsecretaría de la Calidad (Under-Secretariat for Quality) TBT enquiry point: Primary enquiry point: Patricio Fernando Alvarez Chávez Secondary enquiry point: Cristian Eduardo Yépez Jaramillo Plataforma Gubernamental de Gestión Financiera; Av. Amazonas entre Unión Nacional de Periodistas y Alfonso Pereira Piso 8 Bloque amarillo Quito EC170522 Tel.: (+593 2) 394 8760; Ext. 2254; Ext. 2252 Email: [email protected]; [email protected]; [email protected]; [email protected] Website: http://www.produccion.gob.ec __________

Products Covered: Líquidos para frenos hidráulicos y demás líquidos preparados para transmisiones hidráulicas, sin aceites de petróleo ni de mineral bituminoso o con un contenido inferior al 70 % en peso de dichos aceites (Código(s) del SA: 3819)

Regulation Type: Addendum to Regular Notification

Distribution date: 04 October 2024 | Final date for Comment: 03 December 2024

Proposal of maximum residue limits (MRLs) for the following agricultural chemical:Pesticide: 1-Naphthaleneacetic acid.

Products Covered: Natural honey (HS code: 04.09)Edible vegetables and certain roots and tubers (HS codes: 07.09 and 07.10)Edible fruit and peel of citrus fruit (HS codes: 08.04, 08.05, 08.07, 08.08, 08.09, 08.10, 08.11 and 08.14)Tea and spices (HS codes: 09.02, 09.04, 09.05, 09.06, 09.07, 09.08, 09.09 and 09.10)Oil seeds and oleaginous fruits, miscellaneous grains, seeds and fruit (HS code: 12.07)

Regulation Type: Regular notification