Distribution date: 08 April 2024 | Final date for Comment: 07 June 2024

This Working Draft East African Standard specifies requirements, sampling and test methods for sunscreens skincare leave-on products. This standard does not apply to skincare products covered by EAS 786, anti-wrinkle products, anti-aging products, aromatherapy substances and hair creams, lotions and gels.

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

Regulation Type: Regular notification

Distribution date: 08 April 2024 | Final date for Comment: 07 June 2024

 the draft Technical regulation is developed in accordance with the provisions of the Law of Ukraine “On Ensuring Chemical Safety and Management of Chemical Products” to ensure a high level of protection of human health and the environment, free circulation of chemical products, promotion of alternative methods of chemical hazard assessment and innovation while increasing competitiveness, determination of requirements for chemical safety during production, placing on the market and use of chemicals, including in mixtures and products.The provisions of the draft Technical Regulation are based on the precautionary principle according to which manufacturers, importers and subsequent users have to ensure that they produce, place on the market or use chemicals that do not adversely affect human health or the environment.Chemical products cannot be placed on the market of Ukraine if they do not meet the requirements of this Technical Regulation. Chemical products that were put into circulation before the entry into force of this Resolution and do not meet all or some of the requirements of this Technical Regulation may be placed on the market within one year from the date of entry into force of this Resolution.The draft Technical Regulation is based on provisions of Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC.The revised draft Technical Regulation has incorporated suggestions received from relevant central executive authorities and includes technical modifications compared to its previous version notified in G/TBT/N/UKR/179/Rev.1. 

Products Covered: Chemical products (substances, mixtures, explosive or pyrotechnical articles). All HS codes from Chapters 28 - 38 of Section VI of the Harmonized System, excluding Chapter 30 - Pharmaceutical products

Regulation Type: Revision to Regular Notification

Distribution date: 05 April 2024

The Committee for Veterinary Control and Surveillance of the Ministry of Agriculture of Kazakhstan reports that on the basis of the official notification of the World Organisation for Animal Health (WOAH), an outbreak of highly pathogenic avian influenza was registered in the states of Massachusetts, New York, Michigan, Indiana, Nebraska, Florida, Kansas, North Carolina, North Dakota and Idaho of the United States of America. In this regard, since 15 March 2024, temporary restrictions have been introduced on the importation to the territory of Kazakhstan from the territory of the states of Massachusetts, New York, Michigan, Indiana, Nebraska, Florida, Kansas, North Carolina, North Dakota and Idaho of the United States of America of live poultry and hatching eggs, down and feathers, poultry meat and all types of poultry products that have not undergone heat treatment (at least 70 °C), feed and feed additives for birds (except for feed additives of chemical and microbiological synthesis), hunting trophies that have not undergone taxidermic treatment (feathered game), used equipment for keeping, slaughtering and butchering birds, as well as for the transit from the above territories through the territory of Kazakhstan of live birds.

Products Covered: Live poultry and hatching eggs, down and feathers, poultry meat and all types of poultry products, feed and feed additives for birds, hunting trophies, used equipment for keeping, slaughtering and butchering birds

Regulation Type: Emergency notifications (SPS)

Distribution date: 02 April 2024

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

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: 28 March 2024

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: 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

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

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: 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