Distribution date: 08 March 2023 | Final date for Comment: 07 May 2023

The notified Draft Andean Technical Regulations for domestic hygiene products with disinfectant properties establishes the technical requirements and the administrative and conformity assessment procedures for domestic hygiene products with disinfectant properties that are marketed in the territories of member countries, with a view to protecting the health of product users by minimizing health risks.

Products Covered: Code | Product description | Comments 3301.12.00 | - - Of orange | Only domestic hygiene products with disinfectant properties 3301.13.00 | - - Of lemon | Only domestic hygiene products with disinfectant properties 3301.19.10 | - - - Of lime (Citrus aurantifolia, Citrus latifolia) | Only domestic hygiene products with disinfectant properties 3301.19.90 | - - - Other | Only domestic hygiene products with disinfectant properties 3301.24.00 | - - Of peppermint (Mentha piperita) | Only domestic hygiene products with disinfectant properties 3301.25.00 | - - Of other mints | Only domestic hygiene products with disinfectant properties 3301.29.10 | - - - Of anise | Only domestic hygiene products with disinfectant properties 3301.29.20 | - - - Of eucalyptus | Only domestic hygiene products with disinfectant properties 3301.29.30 | - - - Of lavender or of lavandin | Only domestic hygiene products with disinfectant properties 3301.29.90 | - - - Other | Only domestic hygiene products with disinfectant properties 3301.30.00 | - Resinoids | Only domestic hygiene products with disinfectant properties 3301.90.10 | - - Aqueous distillates and aqueous solutions of essential oils | Only domestic hygiene products with disinfectant properties 3301.90.20 | - - Extracted oleoresins | Only domestic hygiene products with disinfectant properties 3301.90.90 | - - Other | Only domestic hygiene products with disinfectant properties 3307.41.00 | -- - "Agarbatti" and other odoriferous preparations which operate by burning | Only domestic hygiene products with disinfectant properties 3307.49.00 | - Other | Only domestic hygiene products with disinfectant properties 3401.19.10 | --- - In the form of bars, cakes, moulded pieces or shapes | Only domestic hygiene products with disinfectant properties 3401.19.90 | - - - Other | Only domestic hygiene products with disinfectant properties 3401.20.00 | - Soap in other forms | Only domestic hygiene products with disinfectant properties 3402.31.00 | - - Linear alkylbenzene sulphonic acids and their salts | Only domestic hygiene products with disinfectant properties 3402.39.10 | - - - Fatty alcohol sulphates or sulphonates | Only domestic hygiene products with disinfectant properties 3402.39.90 | - - - Other | Only domestic hygiene products with disinfectant properties 3402.41.10 | - - - Fatty amine salts | Only domestic hygiene products with disinfectant properties 3402.41.90 | - - - Other | Only domestic hygiene products with disinfectant properties 3402.42.10 | Obtained by condensing ethylene oxide with mixtures of linear alcohols with eleven or more carbon atoms | Only domestic hygiene products with disinfectant properties 3402.42.90 | - - - Other | Only domestic hygiene products with disinfectant properties 3402.49.10 | - - - Alkylbetaine or sulphobetaine proteins | Only domestic hygiene products with disinfectant properties 3402.49.90 | - - - Other | Only domestic hygiene products with disinfectant properties 3402.50.00 | - Preparations put up for retail sale | Only domestic hygiene products with disinfectant properties 3402.90.91 | - - - Surface-active preparations based on sodium nonyloxybenzene sulphonate | Only domestic hygiene products with disinfectant properties 3402.90.99 | - - - Other | Only domestic hygiene products with disinfectant properties 3405.40.00 | - Scouring pastes and powders and other scouring preparations | Only domestic hygiene products with disinfectant properties 3808.94.19 | - - - - Other | Only domestic hygiene products with disinfectant properties

Regulation Type: Revision to Regular Notification

Distribution date: 08 March 2023 | Final date for Comment: 07 May 2023

The notified Draft Andean Technical Regulations for domestic hygiene products with disinfectant properties establishes the technical requirements and the administrative and conformity assessment procedures for domestic hygiene products with disinfectant properties that are marketed in the territories of member countries, with a view to protecting the health of product users by minimizing health risks.

Products Covered: Code | Product description | Comments 3301.12.00 | - - Of orange | Only domestic hygiene products with disinfectant properties 3301.13.00 | - - Of lemon | Only domestic hygiene products with disinfectant properties 3301.19.10 | - - - Of lime (Citrus aurantifolia, Citrus latifolia) | Only domestic hygiene products with disinfectant properties 3301.19.90 | - - - Other | Only domestic hygiene products with disinfectant properties 3301.24.00 | - - Of peppermint (Mentha piperita) | Only domestic hygiene products with disinfectant properties 3301.25.00 | - - Of other mints | Only domestic hygiene products with disinfectant properties 3301.29.10 | - - - Of anise | Only domestic hygiene products with disinfectant properties 3301.29.20 | - - - Of eucalyptus | Only domestic hygiene products with disinfectant properties 3301.29.30 | - - - Of lavender or of lavandin | Only domestic hygiene products with disinfectant properties 3301.29.90 | - - - Other | Only domestic hygiene products with disinfectant properties 3301.30.00 | - Resinoids | Only domestic hygiene products with disinfectant properties 3301.90.10 | - - Aqueous distillates and aqueous solutions of essential oils | Only domestic hygiene products with disinfectant properties 3301.90.20 | - - Extracted oleoresins | Only domestic hygiene products with disinfectant properties 3301.90.90 | - - Other | Only domestic hygiene products with disinfectant properties 3307.41.00 | -- - "Agarbatti" and other odoriferous preparations which operate by burning | Only domestic hygiene products with disinfectant properties 3307.49.00 | - Other | Only domestic hygiene products with disinfectant properties 3401.19.10 | --- - In the form of bars, cakes, moulded pieces or shapes | Only domestic hygiene products with disinfectant properties 3401.19.90 | - - - Other | Only domestic hygiene products with disinfectant properties 3401.20.00 | - Soap in other forms | Only domestic hygiene products with disinfectant properties 3402.31.00 | - - Linear alkylbenzene sulphonic acids and their salts | Only domestic hygiene products with disinfectant properties 3402.39.10 | - - - Fatty alcohol sulphates or sulphonates | Only domestic hygiene products with disinfectant properties 3402.39.90 | - - - Other | Only domestic hygiene products with disinfectant properties 3402.41.10 | - - - Fatty amine salts | Only domestic hygiene products with disinfectant properties 3402.41.90 | - - - Other | Only domestic hygiene products with disinfectant properties 3402.42.10 | Obtained by condensing ethylene oxide with mixtures of linear alcohols with eleven or more carbon atoms | Only domestic hygiene products with disinfectant properties 3402.42.90 | - - - Other | Only domestic hygiene products with disinfectant properties 3402.49.10 | - - - Alkylbetaine or sulphobetaine proteins | Only domestic hygiene products with disinfectant properties 3402.49.90 | - - - Other | Only domestic hygiene products with disinfectant properties 3402.50.00 | - Preparations put up for retail sale | Only domestic hygiene products with disinfectant properties 3402.90.91 | - - - Surface-active preparations based on sodium nonyloxybenzene sulphonate | Only domestic hygiene products with disinfectant properties 3402.90.99 | - - - Other | Only domestic hygiene products with disinfectant properties 3405.40.00 | - Scouring pastes and powders and other scouring preparations | Only domestic hygiene products with disinfectant properties 3808.94.19 | - - - - Other | Only domestic hygiene products with disinfectant properties

Regulation Type: Revision to Regular Notification

Distribution date: 09 March 2023 | Final date for Comment: 08 May 2023

https://www.sknbs.org/wp-content/uploads/2022/10/Labelling-of-Goods-Regulations-2022-Draft.html

Products Covered: (HS code(s): 04; 08; 09; 10; 11; 12; 15; 17; 18; 22; 29; 30; 31; 33; 34; 36; 38); PACKAGING AND DISTRIBUTION OF GOODS (ICS code(s): 55)

Regulation Type: Regular notification

Distribution date: 09 March 2023 | Final date for Comment: 02 May 2025

The Draft resolution number 730, 14 October 2019 (previously notified through G/TBT/N/BRA/928), which proposes the updating of the Resolution – RDC number 185, 22 October 2001, which establishes the risk classification, market authorization and technical requirements for labelling and usage instructions of medical devices, was adopted as Resolution - RDC number 751, 15 September 2022.  Resolution - RDC number 751, 15 September 2022, which provides for risk classification, reporting and registration regimes, and labeling requirements and instructions for use of medical devices, was now modified by Resolution - RDC number 777, 1st March 2023. The final text is available only in Portuguese and can be downloaded at:  http://antigo.anvisa.gov.br/documents/10181/5672055/RDC_777_2023_.pdf/de9823a6-80e9-427b-926f-d9651078fcea 

Products Covered: HS Code(s): 2936, 2937, 3001, 3002, 3003, 3004, 3006 (medical devices)

Regulation Type: Addendum to Regular Notification

Distribution date: 09 March 2023 | Final date for Comment: 05 April 2023

The Draft Resolution number 1.137, of 27 December 2022 - previously notified through G/TBT/N/BRA/1466 - which contains provisions on rules for preparing, harmonizing, updating, publishing and making available drug inserts for patients and health professionals, had its period for comments extended by 30 days through Order Number 25, from  6 March 2023. The final text is available only in Portuguese and can be downloaded at: https://www.in.gov.br/en/web/dou/-/despacho-n-25-de-6-de-marco-de-2023-468130801

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

Regulation Type: Addendum to Regular Notification

Distribution date: 09 March 2023 | Final date for Comment: 05 May 2023

The Draft resolution number 1136, 26 December 2022, previously notified through G/TBT/N/BRA/1467 - which regards 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, had its period for comments extended for 60 days by Order number 27, from 06 March 2023. The final text is available only in Portuguese and can be downloaded at:  https://www.in.gov.br/en/web/dou/-/despacho-n-27-de-06-de-marco-de-2023-468130483 

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

Regulation Type: Addendum to Regular Notification

Distribution date: 09 March 2023 | Final date for Comment: 02 May 2025

The Resolution – RDC number 646, 24 March 2022 – previously notified through G/TBT/N/BRA/1341 – Which contains provisions on the obligation to describe the composition in Portuguese on the labelling of personal hygiene products, cosmetics and perfumes, was modified  by  Resolution – RDC number 773, 15 February 2023.   The final text is available only in Portuguese and can be downloaded at:  http://antigo.anvisa.gov.br/documents/10181/6555105/RDC_773_2023_.pdf/e7497be6-fcfe-42da-9222-4afea0fc8c66 

Products Covered: HS (3303, 3304, 3305, 3306, 3307) - Toiletries, cosmetics and perfumes

Regulation Type: Addendum to Regular Notification

Distribution date: 10 March 2023 | Final date for Comment: 02 May 2025

Proposed maximum residue limits (MRLs) for the following agricultural chemical:Veterinary drug: Diminazene.

Products Covered: Meat and edible meat offal (HS codes: 02.01, 02.02 and 02.06)Dairy produce (HS code: 04.01)Animal originated products (HS code: 05.04)Animal fats and oils (HS code: 15.02)

Regulation Type: Regular notification

Distribution date: 10 March 2023 | Final date for Comment: 02 May 2025

Proposal of maximum residue limits (MRLs) for the following agricultural chemical:Veterinary drug: Mafoprazine.

Products Covered: Meat and edible meat offal (HS codes: 02.03, 02.06 and 02.09)Animal originated products (HS code: 05.04)Animal fats and oils (HS code: 15.01)      

Regulation Type: Regular notification

Distribution date: 10 March 2023 | Final date for Comment: 02 May 2025

Proposal of maximum residue limits (MRLs) for the following agricultural chemical:Pesticide: Metobromuron.

Products Covered: Edible vegetables and certain roots and tubers (HS codes: 07.01 and 07.13)Cereals (HS code: 10.01) Oil seeds and oleaginous fruits, miscellaneous grains, seeds and fruit (HS code: 12.01) 

Regulation Type: Regular notification