Chemical Regulatory Updates – Latest Global Changes

Normative Instruction number 162, 01 July 2022

Distribution date: 01 October 2024

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

Human health

Draft resolution (Consulta Pública) 657, 24 June 2019

Distribution date: 01 October 2024

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establishes criteria and deadlines for market authorization and notification of medicines; and provides other measures, was revoked by Resolution 912, 19 September 2024 The final text is available only in Portuguese and can be downloaded at: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

Human health

Resolution – RDC number 621, 09 March 2022

Distribution date: 01 October 2024

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modifications, testing outsourcing, suspensions and cancellations of Pharmaceutical Equivalence Centers, was revoked by Resolution 927, 20 September 2024.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

Human health

Draft Resolution 758, 19 December 2019.

Distribution date: 01 October 2024

Resolution 841, 18 December 2023 - previously notified through G/TBT/N/BRA/954/Add.2 - which establishes contains provisions on on the definition, classification, technical requirements for labeling and packaging, parameters for microbiological control, as well as technical requirements and procedures for the regularization of personal hygiene products, cosmetics and perfumes. was revoked by Resolution 907, 19 September 2024 The final text is available only in Portuguese and can be downloaded at: https://antigo.anvisa.gov.br/documents/10181/6856654/RDC_907_2024_.pdf/2016b944-8f47-4273-b152-b58dd76b67dc

Products Covered: HS Codes: 3303; 3304; 3305; 3306;3307; 340111; 340130; 9616; 9619 (personal hygiene products, cosmetics, and perfumes)

Regulation Type: Addendum to Regular Notification

Labelling Human health

DEAS 425-1:2023, Skin powders — Specification — Part 1: Body and face powder, Second Edition

Distribution date: 26 September 2024 | Final date for Comment: 25 November 2024

This Draft East African Standard specifies the requirements, sampling and test methods for body and face powders which cover talcum powders, toilet powders, deodorant powders and dusting powders, for adult use only. This draft standard does not cover powders with therapeutic claims.

Products Covered: ESSENTIAL OILS AND RESINOIDS; PERFUMERY, COSMETIC OR TOILET PREPARATIONS (HS code(s): 33); Cosmetics. Toiletries (ICS code(s): 71.100.70)