Distribution date: 25 March 2024 | Final date for Comment: 22 April 2025

The purpose of this notification is to provide the final texts of “Amendment to the List of Ingredients Prohibited in Cosmetic Products” and relevant dates of its implementation.The draft texts notified in G/TBT/N/TPKM/534 were adopted with minor changes.Besides the implementation date specified above, the amendment of the ingredient “Cells, tissues or products of human origin” took effect on 21 March 2024.

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

Regulation Type: Addendum to Regular Notification

Distribution date: 25 March 2024 | Final date for Comment: 31 March 2024

Israel's Ministry of Health announced a new draft amendment to the Pharmacists Ordinance [New Version] 5741-1981.This proposed amendment aims to reduce trade barriers by coordinating the Israeli import regime with The European Regulation (EC) No 1223/2009 on Cosmetic Products regarding prohibited substances in cosmetics, restricted substances, dyes, sunscreens and preservatives. and includes the following significant changes:Adopts of EU regulations to apply in Israel;Allows adequate cosmetics importers to import from EU member countries, UK or Switzerland, even if they do not have access to the cosmetic product information file or to its  safety assessment.

Products Covered: Cosmetics (HS code(s): 33; 34); (ICS code(s): 71.100.70)

Regulation Type: Regular notification

Distribution date: 26 March 2024 | Final date for Comment: 22 April 2025

The Government Decision No. 718/2023 for the approval of the Technical Regulation lays down the rules on making available on the market crystal glass, composition, characteristics of manufacture and labelling of the crystal categories. The Annex 2 establishes the methods for determining the chemical and physical properties of categories of crystal glass.

Products Covered: GLASS AND GLASSWARE (HS code(s): 70)

Regulation Type: Regular notification

Distribution date: 27 March 2024 | Final date for Comment: 15 May 2024

This Draft Resolution contains provisions on the validation of bioanalytical methods and analysis of study samples for regulatory submissions of industrialized medicines for human use. The bioanalytical method used to quantify the drug in matrix biological must be described in detail, and Guide nº XX, of XX 2024, which deals with the validation of bioanalytical methods and sample analysis study (ICH M10 - Bioanalytical method validation and study sample analysis /ICH M10 - validation of bioanalytical methods and analysis of study samples), and its updates.

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 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); Medicaments (ICS code(s): 11.120.10)

Regulation Type: Regular notification

Distribution date: 28 March 2024 | Final date for Comment: 22 April 2025

Resolution 567, 29 September 2021 - previously notified through G/TBT/N/BRA/910/Add.2 -which stablishes a list of radiopharmaceuticals to prove the safety and effectiveness, was changed by Resolution 853, 21 March 2024.  The final text is available only in Portuguese and can be downloaded at:  http://antigo.anvisa.gov.br/documents/10181/6332458/RDC_853_2024_.pdf/14aea960-5b08-4c30-a3fb-ee133678eb60 

Products Covered: HS CODE: 3006 (radiopharmaceuticals)

Regulation Type: Addendum to Regular Notification

Distribution date: 28 March 2024 | Final date for Comment: 22 April 2025

Draft resolution number 1108, 18 August 2022 - previously notified through  G/TBT/N/BRA/1442  - which is regarded to a proposal for a Normative Instruction that establishes the modalities and criteria applied for the optimized analysis procedure, in which the evaluations conducted by the Equivalent Foreign Regulatory Authority (EFRA) are used to analyze the market authorization and post-market authorization petitions of medicines and biological products, and a letter of adequacy of active pharmaceutical ingredient (CADIFA), in national territory, was adopted as Normative Instruction 289, 20 March 2024. The final text is available only in Portuguese and can be downloaded at:  http://antigo.anvisa.gov.br/documents/10181/6354042/IN_289_2024_.pdf/ec565fb0-e17e-4e0a-a8c0-a88935fb6cca 

Products Covered: Medicaments (excluding goods of heading 30.02, 30.05 or 30.06) consisting of two or more constituents which have been mixed together for therapeutic or prophylactic uses, not put up in measured doses or in forms or packings for retail sale. (HS code(s): 3003); Medicaments (excluding goods of heading 30.02, 30.05 or 30.06) consisting of mixed or unmixed products for therapeutic or prophylactic uses, put up in measured doses (including those in the form of transdermal administration systems) or in forms or packings for retail sale. (HS code(s): 3004)

Regulation Type: Addendum to Regular Notification

Distribution date: 28 March 2024 | Final date for Comment: 20 May 2024

The drafts define veterinary and sanitary requirements for albumin, albuminates and other derivatives of albumin, as well as for casein, caseinates and other derivatives of casein, casein glues.

Products Covered: Goods (products) subject to veterinary control

Regulation Type: Regular notification

Distribution date: 28 March 2024 | Final date for Comment: 22 April 2025

Draft resolution 1188, 03 August 2023 - previously notified through  G/TBT/N/BRA/1493 - whichcontains provisions on health requirements for safety and efficacy for post-marketing registration alterations of synthetic and semi-synthetic drugs classified as new or innovative, was adopted as Resolution 851, 20 March 2024.  The final text is available only in Portuguese and can be downloaded at:  http://antigo.anvisa.gov.br/documents/10181/6636520/RDC_851_2024_.pdf/46470423-d17a-4aef-8dbc-86af88eb65b9 

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 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); Pharmaceutics (ICS code(s): 11.120)

Regulation Type: Addendum to Regular Notification

Distribution date: 02 April 2024 | Final date for Comment: 01 June 2024

To revise the administerial rules of the Act on the Quality Control of Fertilizer for reflecting advancement of agricultural and scientific technology contributes to human health and promotes agricultural productivity.Official standards to be established:Complex fertilizer that contains following agricultural chemicals・Sodium-N’-Methoxycarbonylsulfanilamide and Potassium α-(2-methyl-4-chlorophenoxy) propionate

Products Covered: FERTILISERS (HS code(s): 31)

Regulation Type: Regular notification

Distribution date: 02 April 2024 | Final date for Comment: 22 April 2025

The Environmental Protection Agency (EPA or the Agency) is issuing this final rule under the Toxic Substances Control Act (TSCA) to address to the extent necessary the unreasonable risk of injury to health presented by chrysotile asbestos based on the risks posed by certain conditions of use. The injuries to human health include mesothelioma and lung, ovarian, and laryngeal cancers resulting from chronic inhalation exposure to chrysotile asbestos. This final rule is effective on 28 May 2024. Title 40 Code of Federal Regulations (CFR) Part 751 This final rule and previous actions notified under the symbol G/TBT/N/USA/1850 are identified by Docket Number EPA-HQ-OPPT-2021-0057. The Docket Folder is available on Regulations.gov at https://www.regulations.gov/docket/EPA-HQ-OPPT-2021-0057/document and provides access to primary and supporting documents as well as comments received. Documents are also accessible from Regulations.gov by searching the Docket Number. 

Products Covered: Chrysotile Asbestos; Asbestos (excl. products made from asbestos) (HS code(s): 2524); Friction material and articles thereof, e.g., sheets, rolls, strips, segments, discs, washers, pads, not mounted, for brakes, clutches or the like, with a basis of asbestos, other mineral substances or cellulose, whether or not combined with textile or other materials (excl. mounted friction material) (HS code(s): 6813); Environmental protection (ICS code(s): 13.020); Air quality (ICS code(s): 13.040); Protection against dangerous goods (ICS code(s): 13.300); Road vehicle systems (ICS code(s): 43.040); Products of the chemical industry (ICS code(s): 71.100)

Regulation Type: Addendum to Regular Notification