Regulatory Updates

Distribution date: 23 September 2020 | Final date for Comment: 22 November 2020

This standard stipulates the maximum limit requirements, sample preparation and determination methods for lead, cadmium, mercury, hexavalent chromium and soluble heavy metals (soluble antimony, soluble arsenic, soluble barium, soluble cadmium, soluble chromium, soluble lead, soluble mercury, soluble selenium) in printing inks.

Products Covered: Printing ink ICS:87.080 HS：3215

Regulation Type: Regular notification

Distribution date: 23 September 2020 | Final date for Comment: 13 October 2020

Republic of Korea is proposing the regulation on the “Approval of Advanced Biopharmaceuticals and the Safety about Advanced Biological Products". The main contents are: As the Act on the Safety and Support of Advanced Biological Products was established, the regulations on the approval of advanced biopharmaceuticals and the regulation on safety about biological products was enacted to stipulate document requirements and evaluation criteria.

Products Covered: Advanced Biological Products (HS: 3004-90-9900)

Regulation Type: Regular notification

Distribution date: 23 September 2020 | Final date for Comment: 13 October 2020

Republic of Korea is proposing the regulation on the “Approval of Advanced Biopharmaceuticals and the Safety about Advanced Biological Products". The main contents are: As the Act on the Safety and Support of Advanced Biological Products was established, the regulations on the approval of advanced biopharmaceuticals and the regulation on safety about biological products was enacted to stipulate document requirements and evaluation criteria.

Products Covered: Advanced Biological Products (HS: 3004-90-9900)

Regulation Type: Regular notification

Distribution date: 23 September 2020

The Resolution – RDC number 348, 17 March 2020 – previously notified through G/TBT/N/BRA/990 – which establishes exceptional and temporary criteria and procedure for the processing of petitions for the market authorization of medicines, biological products, and in vitro diagnosis products; and for the post-market authorization of medicines and biological products due to the international public health emergency of the new coronavirus (Covid-19), was updated by Resolution – RDC number 415, 26 August 2020. This Resolution will enter into force on the day of its publication in the Brazilian Official Gazette.

Products Covered: HS Code(s): 2941; 3002300; 3003; 3004; 3005; (pharmaceutical products, in vitro diagnosis products, biological products).

Regulation Type: Addendum to Regular Notification

Distribution date: 23 September 2020

The Resolution – RDC number 348, 17 March 2020 – previously notified through G/TBT/N/BRA/990 – which establishes exceptional and temporary criteria and procedure for the processing of petitions for the market authorization of medicines, biological products, and in vitro diagnosis products; and for the post-market authorization of medicines and biological products due to the international public health emergency of the new coronavirus (Covid-19), was updated by Resolution – RDC number 415, 26 August 2020. This Resolution will enter into force on the day of its publication in the Brazilian Official Gazette.

Products Covered: HS Code(s): 2941; 3002300; 3003; 3004; 3005; (pharmaceutical products, in vitro diagnosis products, biological products).

Regulation Type: Addendum to Regular Notification

Distribution date: 23 September 2020

In accordance with the Cosmetics Order (1/2010), the following certificates are required when importing the toothpaste into Myanmar: For importation of toothpaste, Acknowledgement of Cosmetic Notification is only required to harmonise the ASEAN Cosmetic Regulatory Committee Meeting during May 2015 as redundancy to reduce technical barriers by releasing Import Recommendation and Health Certificate. The importer only needs to apply the Acknowledgement of Cosmetic Notification for toothpaste before market distribution at Department of Food and Drug Administration. Acknowledgement of cosmetic notification from the country of origin or any other ASEAN country and full ingredient listing and the percentage of restricted ingredients are needed to be attached.

Products Covered: Toothpaste

Regulation Type: Regular notification

Distribution date: 23 September 2020

In accordance with the Cosmetics Order (1/2010), the following certificates are required when importing the toothpaste into Myanmar: For importation of toothpaste, Acknowledgement of Cosmetic Notification is only required to harmonise the ASEAN Cosmetic Regulatory Committee Meeting during May 2015 as redundancy to reduce technical barriers by releasing Import Recommendation and Health Certificate. The importer only needs to apply the Acknowledgement of Cosmetic Notification for toothpaste before market distribution at Department of Food and Drug Administration. Acknowledgement of cosmetic notification from the country of origin or any other ASEAN country and full ingredient listing and the percentage of restricted ingredients are needed to be attached.

Products Covered: Toothpaste

Regulation Type: Regular notification

Distribution date: 23 September 2020 | Final date for Comment: 22 November 2020

This standard specifies the terms and definitions, requirements and test methods for domestic sanitary insecticide products. This standard applies to general requirements related to human health, environmental protection and safety of domestic sanitary insecticide products.

Products Covered: Domestic sanitary insecticide ICS: 65.100.10 HS: 3808

Regulation Type: Regular notification

Distribution date: 23 September 2020 | Final date for Comment: 22 November 2020

This standard specifies the terms and definitions, requirements and test methods for domestic sanitary insecticide products. This standard applies to general requirements related to human health, environmental protection and safety of domestic sanitary insecticide products.

Products Covered: Domestic sanitary insecticide ICS: 65.100.10 HS: 3808

Regulation Type: Regular notification

Distribution date: 23 September 2020 | Final date for Comment: 22 November 2020

Revision of the Mandatory Standard SI 562 part 14, dealing with trampolines for domestic use. This draft standard revision adopts the European Standard EN 71-14: December 2018, with a few changes that appear in the standard's Hebrew section as follows: Changes the normative references (section 2); Adds a new sub-section 5.13 dealing with flammability and requires that the trampolines' flammability shall also comply with the requirements of Israel's Mandatory Standard SI 562 part 2; Adds a new sub-section 5.14 dealing with the migration of certain chemical elements and requires that trampolines' materials shall also comply with the requirements of Israel's Mandatory Standard SI 562 part 3; Adds a new sub-section 5.15 dealing with the migration of certain chemical elements and requires that trampolines' components accessible to children and made of softened PVC shall also comply with the requirements of Israel's Standard SI 562 part 9 regarding phthalates; Adds to section 6 a requirement that the warnings shall be written in Hebrew as detailed in the new normative annex C. This new revised standard will enter into force one year after publication in Israel's Official Gazette.

Products Covered: Trampolines for domestic use

Regulation Type: Regular notification