Distribution date: 25 October 2023

Draft resolution 1136, 26 December 2022 - previously notified through G/TBT/N/BRA/1467  - which is regarded to a proposal to define the general guidelines for the pilot implementation of the optimized analysis procedure, based on risk criteria, to confirm the suitability of the documentation submitted to Anvisa for marketing authorization and post-marketing authorization changes to medicines., was adopted as Resolution 823, 19 October 2023. The final text is available only in Portuguese and can be downloaded at:  http://antigo.anvisa.gov.br/documents/10181/6531732/RDC_823_2023_.pdf/097b9a99-6230-4f87-ba03-2c0738c4860f  

Products Covered: Medicaments (ICS code(s): 11.120.10)

Regulation Type: Addendum to Regular Notification

Distribution date: 24 October 2023

The draft of January 2021 has been simplified according to received comments, and some deletion has been made for the classification of tooth paste and requirements of testing reports.

Products Covered: Toothpaste

Regulation Type: Addendum to Regular Notification

Distribution date: 20 October 2023

In the notifications G/TBT/N/IND/298, dated 13 September 2023 and G/TBT/IND/298/Corr.1, dated 12 October 2023, Item 6 should read (changes in bold): 6.Description of content: Ethylene oxide is used in organic synthesis, especially in the production of ethylene glycol. It forms starting material for the manufacture of acrylonitrile and non-ionic surfactants. It is also used as a fumigant for foodstuffs and in textiles and pharmaceutical industry. So, for protection of human health and environment, the BIS standard of Ethylene oxide needs to be made mandatory.The locally manufactured or imported Ethylene Oxide shall conform to the Indian Standard (IS 5573: 1984) and shall bear the standard mark under license from the Bureau of Indian Standards (BIS) as per Scheme-I of Schedule-II of the Bureau of Indian Standards (Conformity Assessment) Regulations, 2018. The use of standard mark is governed by the provisions of Bureau of Indian Standards Act, 2016 and the Rules and Regulations made thereunder. Bureau of Indian Standards shall be the certifying and enforcing authority

Products Covered: Ethylene Oxide (HS CODE – 29101000)

Regulation Type: Corrigendum to Regular Notification

Distribution date: 16 October 2023

Products Covered: Nicotine pouches for oral purpose, containing 20 mg nicotine a pouch or more.

Regulation Type: Addendum to Regular Notification

Distribution date: 13 October 2023

El proyecto de decreto supremo tiene como propósito modificar el artículo 11 del Reglamento de la Ley N° 29662, aprobado por Decreto Supremo N° 028-2014-SA, a efectos de adecuar el procedimiento administrativo de autorización para el uso regulado del asbesto crisotilo a las disposiciones establecidas en el Texto Único Ordenado de la Ley N° 27444, Ley del Procedimiento Administrativo General, aprobado por Decreto Supremo N° 004-2019-JUS, y a la normativa vigente sobre mejora de la calidad regulatoria. Ministerio de Comercio Exterior y Turismo - MINCETURCalle Uno Oeste Nº 50 - Urb. Corpac - Lima 27 - PerúTel.: (+51-1) 513-6100, Ext. 1223 y 1239Email: [email protected] Dirección General de Salud Ambiental e Inocuidad Alimentaria - DIGESALas Amapolas # 350 Urb. San Eugenio, Lince, Lima.Tel.: (+51-1) 631-4430Email: [email protected] 

Products Covered: 6812991000: Amianto en fibras trabajado; mezclas a base de amianto o a base de amianto y carbonato de magnesio. ; 6812930000: Amianto (asbesto) y elastómeros comprimidos, para juntas o empaquetaduras, en hojas o rollos. ; Construcción: En protecciones ignifugas de estructuras; en placas de falso techo; en tuberías de fibrocemento para agua – evacuación de humos; en placas acústicas; en placas de fibrocemento en cubiertas, medianeras revestimientos; en placas para aislamiento de calor; en material de revestimiento de carreteras; en fijación de juntas y baldosas; en mezclado de pinturas y en material plástico; en trenzado para aislar tuberías. ; Industria: Material de fricción en ascensores; material textil-amianto: fieltro industriales y comerciales, tejidos ignífugos, ropa de protección térmica; material de aislamiento eléctrico; filtros de bebidas; Filtros en transporte de gas; plástico y cauchos reforzados con amianto. ; Medios de Transporte: Material de fricción; Pastillas de frenos; Frenos de tambor; Discos de Embragues. ; Ferrocarril y Metro: Como aislante en vagones y ventanas; como aislante en el sistema eléctrico; como aislante de radiadores eléctricos. ; Barcos: Aislante en bodegas; salas de máquinas; ductos de agua caliente. ; Otros Usos. Centrales eléctricas y nucleares, aislamiento de hornos industriales, calderas, turbinas rejillas de laboratorio, material poroso de relleno de botellas de acetileno. ; Productos de Consumo Público. Secadoras de cabello, estufas catalíticas, fundas de tablas de planchar, tostadoras de pan. ;

Regulation Type: Addendum to Regular Notification

Distribution date: 13 October 2023 | Final date for Comment: 12 December 2023

The Industrial Chemicals Environmental Management Standard (IChEMS) has been developed by all Australian governments to efficiently and effectively manage the risks of industrial chemicals to the environment, while providing consistent requirements for businesses across Australia. The IChEMS Register records standards for the environmental management of chemicals, including risk management measures for specific industrial uses. In turn, the Australian federal government and each state and territory government will enact legislation to implement the standards in their jurisdictions. The proposed decision will assign the following group of chemicals, and mixtures and articles containing the group of chemicals, to Schedule 7 of the IChEMS Register. This will prohibit their import, manufacture, use and export in Australia, with exceptions for unintentional trace contamination, research, environmentally sound disposal, and for articles in use prior to the date of effect of the decision.Short-chain chlorinated paraffins 

Products Covered: The following group of chemicals, and chemical mixtures or articles (finished goods) containing the following group of chemicals, when used for an industrial purpose (excluding agricultural, veterinary or therapeutic purposes):Short-chain chlorinated paraffins (SCCPs)

Regulation Type: Regular notification

Distribution date: 12 October 2023

In the notification G/TBT/N/IND/297. dated 13 September 2023, the Column no. 6 may be replaced as below: Anhydrous ammonia (NH3) is an efficient and widely used source of nitrogen fertilizer. It is relatively easy to apply and is readily available to producers. Anhydrous means “without water”. When used as an agricultural fertilizer, NH3 is compressed into a liquid. So, for protection of human health and environment, the BIS standard of anhydrous ammonia needs to be made mandatory. The locally manufactured or imported Anhydrous ammonia shall conform to the Indian Standard IS 662 : 2020 and shall bear the standard mark under license from the Bureau of Indian Standards (BIS) as per Scheme-I of Schedule-II of the Bureau of Indian Standards (Conformity Assessment) Regulations, 2018. The use of standard mark is governed by the provisions of Bureau of Indian Standards Act, 2016 and the Rules and Regulations made thereunder. Bureau of Indian Standards shall be the certifying and enforcing authority

Products Covered: Anhydrous Ammonia (HS CODE – 28141000)

Regulation Type: Corrigendum to Regular Notification

Distribution date: 12 October 2023

In the notification No G/TBT/N/IND/300. dated 13 September 2023, the Column no. 6 may be replaced as below: Industrial Grade Urea is used in production of Water-soluble fertilizers, Dyes and Pigment industries, cattle feed. It also used in manufacturing of Urea Formaldehyde resin, production of Diesel exhaust fluid for pollution abatement, plywood and adhesive industries. So, for protection of human health and environment, the BIS standard of Industrial Grade Urea needs to be made mandatory. The locally manufactured or imported Industrial Grade Urea shall conform to the Indian Standard IS 1781: 2022, and shall bear the standard mark under license from the Bureau of Indian Standards (BIS) as per Scheme-I of Schedule-II of the Bureau of Indian Standards (Conformity Assessment) Regulations, 2018. The use of standard mark is governed by the provisions of Bureau of Indian Standards Act, 2016 and the Rules and Regulations made thereunder. Bureau of Indian Standards shall be the certifying and enforcing authority.

Products Covered: Industrial Grade Urea (HS CODE 31021000)

Regulation Type: Corrigendum to Regular Notification

Distribution date: 12 October 2023

The following communication, dated 25 September 2023, is being circulated at the request of the delegation of India. In the notification No G/TBT/N/IND/299. dated 13 September 2023, the Column no. 6 may be replaced as below: Captafol is a fungicide. It is used to control almost all fungal diseases of plants except powdery mildews. It is also used to control certain seed‑ and soil‑borne organisms. So, for protection of human health and environment, the BIS standard of Captafol needs to be made mandatory. The locally manufactured or imported Captafol (Technical Grade) shall conform to the Indian Standard (IS 10300: 2023) and shall bear the standard mark under license from the Bureau of Indian Standards (BIS) as per Scheme-I of Schedule-II of the Bureau of Indian Standards (Conformity Assessment) Regulations, 2018. The use of standard mark is governed by the provisions of Bureau of Indian Standards Act, 2016 and the Rules and Regulations made thereunder. Bureau of Indian Standards shall be the certifying and enforcing authority.

Products Covered: Captafol  (HS CODE – 29308000)

Regulation Type: Corrigendum to Regular Notification

Distribution date: 12 October 2023

In the notification No G/TBT/N/IND/301. dated 13 September 2023, the Column no. 6 and 8 may be replaced as below: Column 6: Monocrotophos, technical, exists in two isomeric forms, namely, cis isomer and trans isomer. Of these two isomeric forms, only the cis isomer is effective. This is a systemic as well as contact insecticide and employed in the preparation of pesticidal formulations for the control of insect and acarine pests of agricultural crops. So, for protection of human health and environment, the BIS standard of Monocrotophos needs to be made mandatory. The locally manufactured or imported Monocrotophos Technical and Monocrotophos SL shall conform to the Indian Standard (IS 8025: 1990) & (IS 8074: 1990) respectively and shall bear the standard mark under license from the Bureau of Indian Standards (BIS) as per Scheme-I of Schedule-II of the Bureau of Indian Standards (Conformity Assessment) Regulations, 2018. The use of standard mark is governed by the provisions of Bureau of Indian Standards Act, 2016 and the Rules and Regulations made thereunder. Bureau of Indian Standards shall be the certifying and enforcing authority. Column 8: Quality Control Order for making Indian Standard of Monocrotophos, Technical - (IS 8025: 1990) and Monocrotophos SL- (IS 8074: 1990), as mandatory are enclosed.

Products Covered: Monocrotophos (HS CODE – 38089199)

Regulation Type: Corrigendum to Regular Notification