Distribution date: 07 January 2022 | Final date for Comment: 08 March 2022

The Food and Drug Administration (FDA) proposes to revise the list of ingredients prohibited in cosmetic products. Details of the regulated scope are specified in the attached documents.

Products Covered: Cosmetics

Regulation Type: Regular notification

Distribution date: 07 January 2022 | Final date for Comment: 07 May 2025

This resolution contains provisions on the identification of regularized medical devices at Anvisa, through the Unique Device Identification (UDI) system.

Products Covered: HS (3006)

Regulation Type: Regular notification

Distribution date: 07 January 2022 | Final date for Comment: 07 May 2025

This Normative Instruction approves the list of Technical Standards for the certification of conformity of devices under the Sanitary Surveillance regime.

Products Covered: HS (3006)

Regulation Type: Regular notification

Distribution date: 07 January 2022 | Final date for Comment: 07 May 2025

The article 3º of the Normative Instruction number 101, 30 August 2021  – previously notified through G/TBT/N/BRA/1248 – which establishes specific criteria for grouping materials for health use into families for market authorization and notification purposes, was rectified. The rectified text is available only in Portuguese and can be downloaded at:  https://www.in.gov.br/web/dou/-/retificacao-370943345

Products Covered: HS (3001-3006) - grouping materials for health use

Regulation Type: Addendum to Regular Notification

Distribution date: 10 January 2022 | Final date for Comment: 11 March 2022

The Amendment to the Regulation on Designation, and Approval Procedure and Method of Pharmaceutical Products for National Lot Release: Clarifies details, including quantity of samples, period for the procedure, etc., of SARS-CoV-2 viral vector vaccines and other newly authorized pharmaceutical products subject to national lot release; Clarifies products subject to be classified as carrying risk level 3 (subject to summary protocol review and test on entire items) as products (A) which have received national lot release inappropriately, (B) of which master formula is not provided during on-site inspection, or (C) for which false test results were submitted; and Modifies quantity for samples of items including anti-tetanus immunoglobulin.

Products Covered: Pharmaceuticals

Regulation Type: Regular notification

Distribution date: 11 January 2022 | Final date for Comment: 07 May 2025

The measure has been adopted with an amendments in the conformity assessment procedure. 

Products Covered: 3505 3506 3919 4811 5906

Regulation Type: Addendum to Regular Notification

Distribution date: 12 January 2022 | Final date for Comment: 07 May 2025

Resolution – RDC Nº 283, 17 May 2019 – previously notified through G/TBT/N/BRA/871 – which establishes establishes technical requirements for investigation, control and elimination of nitrosamines potentially carcinogenic in active pharmaceutical ingredients (IFA) which are angiotensin II receptor antagonists; and is applied to companies that manufacture, import and fractionate active pharmaceutical ingredients (IFA), was changed by the Resolution – RDC number 593, 23 December 2021. The final text is available only in Portuguese and can be downloaded at: http://antigo.anvisa.gov.br/documents/10181/6279847/RDC_593_2021_.pdf/cc6bd605-bdb2-4a8d-94d6-0529ef37ad85

Products Covered: HS Codes: 2941; 30. (active pharmaceutical ingredients)

Regulation Type: Addendum to Regular Notification

Distribution date: 14 January 2022 | Final date for Comment: 07 May 2025

Regulation (EU) 2019/1793 lays down rules concerning the temporary increase of official controls upon entry into the Union on certain food and feed of non-animal origin from certain third countries (in Annex I); special import conditions for certain food and feed from certain third countries due to the contamination risk by mycotoxins, including aflatoxins, pesticide residues, pentachlorophenol and dioxins and microbiological contamination (in Annex II - increased official border controls and official certificate accompanied by the results of sampling and analysis in the third country). This Implementing Regulation amends Annexes I and II to Implementing Regulation (EU) 2019/1793 by introducing the following changes: - Transfer from Anne I to Annex II of black pepper from Brazil, aubergines, peppers other than sweet and yardlong beans from Dominican Republic and mandarins and oranges from Turkey;- Transfer from Annex II to Annex I of groundnuts and products produced from ground nuts from Argentina and hazelnuts and products produced from hazelnuts from Azerbaijan;- Deletion from Annex I of hazelnuts and products produced from hazelnuts Turkey; - Decrease in the frequency of identity and physical checks laid down in Annex I for sweet peppers from China;- Increase in the frequency of identity and physical checks laid down in Annex II for peppers of the genus capsicum from India and pitahaya from Viet Nam; - Amending to the entry for the countries listed in Annex I and Annex II concerning groundnuts with adding groundnuts paste; Inclusion in Annex I Galia melons from Honduras, drumsticks (moringa oleifera) from India, rice from India and Pakistan, gotukola and mukunuwenna from Sri Lanka, and grapefruits, cumin seeds and dried oregano from Turkey;- Inclusion in Annex I locust beans (carob), mucilages and thickeners, whether or not modified, derived from locust beans and locust bean seeds from Morocco, tomato ketchup and other tomato sauces from Mexico and pepper of genus Capsicum (other than sweet) from Uganda; - Inclusion in Annex II xantan gum from China; locust beans (including mucilages and thickeners derived from locust beans), Guar gum, several spices, Calcium carbonate and food supplements containing botanicals from India, food supplements containing botanicals and instant noodles from South Korea, locust beans (including mucilages and thickeners derived from locust beans) from Malaysia and Turkey and instant noodles from Viet Nam; - Deleted requirement for laboratory checks for possible contamination with pesticides for Sesamum seeds from India.In addition, this Implementing Regulation amends Article 14 of Implementing Regulation (EU) 2019/1793, in particular the transitional period.

Products Covered: HS Code(s): 1106, 1207, 1208, 1211, 1515, 2007, 2103, 2106, 2305, 2836, 12024, 12129, 13023, 20081, 100610, 100620, 100630, 190230, 200599, 200897, 200899, 253090, 391290, 0710, 0801, 0805, 0813, 070960, 07099, 0905, 0906, 0907, 0908, 0910, 08022, 08025, 081090, 09042, 09093, 08071

Regulation Type: Regular notification

Distribution date: 20 January 2022 | Final date for Comment: 07 May 2025

The Separate Customs Territory of Taiwan, Penghu, Kinmen and Matsu would like to notify that the "Amendments to Regulations of New and Existing Chemical Substances Registration," as per G/TBT/N/TPKM/457 on 28 May 2021, was promulgated on 23 November 2021 and came into effect on the same day.

Products Covered: Chemical Substances

Regulation Type: Addendum to Regular Notification

Distribution date: 20 January 2022 | Final date for Comment: 07 May 2025

The Resolution – RDC number 591, 21 December 2021 – previously notified through G/TBT/N/BRA/1297 – which contains provisions on the identification of regularized medical devices at Anvisa, through the Unique Device Identification (UDI) system, was republished.   The final text is available only in Portuguese and can be downloaded at: https://www.in.gov.br/en/web/dou/-/resolucao-de-diretoria-colegiada-rdc-n-591-de-21-de-dezembro-de-2021-372477718

Products Covered: HS (3006)

Regulation Type: Addendum to Regular Notification