Distribution date: 10 August 2023 | Final date for Comment: 28 August 2023

This Draft Resolution contains provisions on definition, classification, technical requirements for labeling and packaging, parameters for microbiological control, as well as technical requirements and procedures for the regulation of personal hygiene

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

Regulation Type: Regular notification

Distribution date: 10 August 2023 | Final date for Comment: 28 August 2023

This Draft Resolution contains provisions on health requirements for safety and efficacy for post-marketing registration alterations of synthetic and semi-synthetic drugs classified as new or innovative.

Products Covered: 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 u

Regulation Type: Regular notification

Distribution date: 10 August 2023 | Final date for Comment: 25 September 2022

This draft resolution contains provisions on the conditions and procedures for registering pre-pandemic influenza vaccines, updating to a pandemic strain and authorization for the use, marketing and monitoring of pandemic influenza vaccines.&nbs

Products Covered: PHARMACEUTICAL PRODUCTS (HS code(s): 30); Pharmaceutics (ICS code(s): 11.120)

Regulation Type: Regular notification

Distribution date: 10 August 2023 | Final date for Comment: 03 March 2025

This normative instruction contains provisions on the inclusion of declaration of new formula in hygiene product labeling personal, including disposables, cosmetics and perfumes when formula modification.  

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

Regulation Type: Regular notification

Distribution date: 10 August 2023 | Final date for Comment: 03 March 2025

RDC – Resolution n. 530, August 11th, 2021 - previously notified through G/TBT/N/BRA/1238 - which provides for the list of substances that personal hygiene products, cosmetics, and perfumes must not contain except under the conditions, and with the est

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

Regulation Type: Addendum to Regular Notification

Distribution date: 09 August 2023 | Final date for Comment: 08 October 2023

Draft Resolution 1155, 6 April 2023 - previously notified through   G/SPS/N/BRA/2154  - was adopted as Normative Instruction 234, 1 August 2023. The regulation includes the active ingredient P71: PYRIOPHENONE on the Monograph List of Active I

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

Regulation Type: Addendum to Regular Notification

Distribution date: 09 August 2023 | Final date for Comment: 08 October 2023

Draft Resolution 1157, 6 April 2023 - previously notified through  G/SPS/N/BRA/2157  - was adopted as Normative Instruction 233, 1 August 2023. The regulation amends the monographs of the active ingredients B41 - Boscalid, C07 - Kasugamycin, C10 -

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

Regulation Type: Addendum to Regular Notification

Distribution date: 09 August 2023 | Final date for Comment: 08 October 2023

Draft resolution 1153, 6 April 2023 - previously notified through   G/SPS/N/BRA/2152  - was adopted as Normative Instruction 239, 1 August 2023.  The regulation includes item A58.2 - HYDROALCOHOLIC EXTRACT OF NEEM in the monograph of the

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

Regulation Type: Addendum to Regular Notification

Distribution date: 08 August 2023 | Final date for Comment: 03 September 2023

The draft amendments to the Pharmacopoeia of the Eurasian Economic Union provides for 46 general pharmacopoeia articles added, in terms of biological tests, biological medicinal products and radiopharmaceuticals.

Products Covered: Medical products

Regulation Type: Regular notification

Distribution date: 07 August 2023 | Final date for Comment: 22 January 2024

This document announces the Agency's receipt of several cancelations of pesticide petitions requesting the modification of regulations for residues of pesticide chemicals in or on various commodities.

Products Covered: Multiple commodities

Regulation Type: Regular notification