Distribution date: 26 May 2021 | Final date for Comment: 25 July 2021

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

Products Covered: - Edible vegetables and certain roots and tubers (HS Codes: 07.01, 07.02, 07.03, 07.04, 07.05, 07.06, 07.07, 07.08, 07.09, 07.10, 07.13 and 07.14)- Edible fruit, nuts and peel of citrus fruit (HS Codes: 08.01, 08.02, 08.03, 08.04, 08.05, 08.06, 08.07, 08.08, 08.09, 08.10, 08.11 and 08.14)- Coffee, tea, mate and spices (HS Codes: 09.01, 09.02, 09.03, 09.04, 09.05, 09.06, 09.07, 09.08, 09.09 and 09.10)- Cereals (HS Codes: 10.01, 10.02, 10.03, 10.04, 10.05, 10.06, 10.07 and 10.08)- Oil seeds and oleaginous fruits, miscellaneous grains, seeds and fruit (HS Codes: 12.01, 12.02, 12.04, 12.05, 12.06, 12.07, 12.10 and 12.12)- Cacao and cacao preparations (HS Code: 18.01)    

Regulation Type: Regular notification

Distribution date: 26 May 2021 | Final date for Comment: 13 May 2025

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

Products Covered: - Meat and edible meat offal (HS Codes: 02.01, 02.02, 02.04, 02.05, 02.06, 02.07, 02.08 and 02.09) - Animal originated products (HS Code: 05.04) - Animal fats and oils (HS Codes: 15.01, 15.02 and 15.06)       

Regulation Type: Regular notification

Distribution date: 28 May 2021 | Final date for Comment: 27 July 2021

Regulations of New and Existing Chemical Substances Registration (hereinafter referred to as the Regulations) were promulgated on 11 December 2014 and amended on 11 March 2019. After reviewing the practice of annual reporting and standard registration of existing chemical substances through collecting stakeholders’ opinions, the draft amendments to the Regulations is introduced under the consideration of the impacts of the COVID-19 pandemic, and in accordance with the Toxic and Concerned Chemical Substances Control Act amended on 16 January 2019. The highlights of the amendments are as follows: The name and the provisions of the Toxic and Concerned Chemical Substances Control Act, with which the Regulations are established in accordance, is amended. The controlled chemicals, as prescribed in the Occupational Safety and Health Act, as well as the concerned chemical substances, as defined by the Toxic and Concerned Chemical Substances Control Act, are not applicable to the Regulations. To reduce the highly overlapping contents of appendixes, the appendixes of the Regulations are combined and amended accordingly. The valid and confidential periods of the registration approval are unified as 5 years. Furthermore, for a new chemical substance that has been included in the inventory of existing chemical substances, the maximum confidential period is 15 years. The deadline for standard registration of existing chemical substances is extended to 4 years. In addition, the on-site isolated intermediates of existing chemical substances are exempted from standard registration. Completion numbers for the standard registration of existing chemical substances are issued to those who apply and complete information items regarding registrants and substances. The registrants shall complete the remaining information items proactively or before the appointed due date. The articles governing the notification of report supplementation and correction are also specified. The review periods and the number of extensions of review periods for applications are also amended. The article stating that registrants must retain all application documents for future reference is deleted.

Products Covered: Chemical Substances

Regulation Type: Regular notification

Distribution date: 31 May 2021 | Final date for Comment: 13 May 2025

ANVISA Draft Resolution number 805, 27 March 2020 – previously notified through G/TBT/N/BRA/997 – which establishes administrative procedure for the concession of Good Manufacturing Practices Certification for medicines, medical devices, personal hygiene products, cosmetics, perfumes, sanitizers, active pharmaceutical ingredients, and food; and Good Practices of Storage and Distribution Certification for medicines, medical devices, and active pharmaceutical ingredients, was adopted as Resolution – RDC number 497, 20 May 2021. The final text is available only in Portuguese and can be downloaded at: http://antigo.anvisa.gov.br/documents/10181/5833170/RDC_497_2021_.pdf/28c1740f-a816-4e86-92f7-fd64f3ac90fb

Products Covered: HS Code(s): 2106, 29, 2936, 2937, 2941, 3303, 3304, 3305, 3306, 3307, 340111, 340130, 3402, 340119, 340120, 330290, 9616, 9619.

Regulation Type: Addendum to Regular Notification

Distribution date: 31 May 2021 | Final date for Comment: 13 May 2025

Products Covered: Pressure vessels

Regulation Type: Addendum to Regular Notification

Distribution date: 01 June 2021 | Final date for Comment: 31 July 2021

This draft Commission Decision aims at identifying resorcinol as a substance of very high concern due to its endocrine disrupting properties whose effects to human health give rise to an equivalent level of concern according to Article 57(f) of Regulation (EC) No 1907/2006 (REACH).

Products Covered: Chemical substance Resorcinol

Regulation Type: Regular notification

Distribution date: 03 June 2021 | Final date for Comment: 11 June 2021

Following consultation, the United Kingdom Government has now developed a draft of the regulation for Mandatory Validation of Covid 19 In vitro Diagnostic antigen and Molecular tests. This text will amend the Medical Device Regulations 2002, using powers provided in the Medicines and medical Devices Act 2021. The legal text is available on request. 

Products Covered: HS3822

Regulation Type: Addendum to Regular Notification

Distribution date: 03 June 2021 | Final date for Comment: 24 June 2021

ANVISA Public Consultation No. 1043, 8 April 2021 - previously notified through G/TBT/N/BRA/1166 - which establishes technical requirements for the import, commercialization, and donation of used reprocessed medical devices, was extended for 30 days. The extension text is available only in Portuguese and can be downloaded at:https://www.in.gov.br/web/dou/-/despacho-n-59-de-20-de-maio-de-2021-321789910

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

Regulation Type: Addendum to Regular Notification

Distribution date: 07 June 2021 | Final date for Comment: 13 May 2025

The purpose of this Notice of Intent to Amend is to announce that Health Canada will add Epinephrine topical solution for hemostasis when sold at a concentration equal to or greater than 1 mg/ml (1:1000) to the Prescription Drug List (PDL). Both the Human and the Veterinary parts of the List will be updated.

Products Covered: Prescription status of medicinal ingredients for human use (ICS: 11.120; HS 3004.90)

Regulation Type: Addendum to Regular Notification

Distribution date: 08 June 2021 | Final date for Comment: 07 August 2021

This Draft Uganda Standard specifies the requirements and methods of sampling and test for polyamines used for water treatment intended for human use.

Products Covered: Polyamines

Regulation Type: Regular notification