Regulatory Updates

Distribution date: 24 July 2020 | Final date for Comment: 22 September 2020

­The Public Notice aims to provide detailed guidance on the documentation and storage of safety data for each product under the cosmetics legislation. ­ The Public Notice stipulates that cosmetic manufacturers and responsible cosmetic sellers shall compile safety data (such as product dossier, summary of manufacturing process, information on the ingredient, final product and adverse effect) in accordance with the current cosmetics legislation and manage them for each product. It should be noted that the draft regulation does not mandate conducting additional tests or analysis. Responsible cosmetic sellers may internally determine whether it is appropriate to use an infant’s and children’s cosmetics on target consumers based on the safety data they compiled for the product concerned.

Products Covered: Cosmetics (HS code 3303, 3304, 3305, 3307)

Regulation Type: Regular notification

Distribution date: 24 July 2020 | Final date for Comment: 22 September 2020

­The Public Notice aims to provide detailed guidance on the documentation and storage of safety data for each product under the cosmetics legislation. ­ The Public Notice stipulates that cosmetic manufacturers and responsible cosmetic sellers shall compile safety data (such as product dossier, summary of manufacturing process, information on the ingredient, final product and adverse effect) in accordance with the current cosmetics legislation and manage them for each product. It should be noted that the draft regulation does not mandate conducting additional tests or analysis. Responsible cosmetic sellers may internally determine whether it is appropriate to use an infant’s and children’s cosmetics on target consumers based on the safety data they compiled for the product concerned.

Products Covered: Cosmetics (HS code 3303, 3304, 3305, 3307)

Regulation Type: Regular notification

Distribution date: 24 July 2020 | Final date for Comment: 22 September 2020

The Draft amendments to the Rules of the Good Manufacturing Practice in the Eurasian Economic Union applies to medicinal products put into circulation on the territory of the Eurasian Economic Union and envisages the need to establish a unified approach to the procedures for qualification and validation of medicinal products, in order to prove that the parameters of critical processes (equipment) meet the specified requirements, as well as in case of significant changes in premises, equipment and processes that may affect the quality of finished products, which makes it possible to ensure stable output of products with a given level of quality at pharmaceutical enterprises.

Products Covered: Medicaments consisting of two or more constituents mixed together for therapeutic or prophylactic uses, not in measured doses or put up for retail sale (excl. goods of heading 3002, 3005 or 3006) (HS code(s): 3003); Medicaments consisting of mixed or unmixed products for therapeutic or prophylactic uses, put up in measured doses "incl. those in the form of transdermal administration" or in forms or packings for retail sale (excl. goods of heading 3002, 3005 or 3006) (HS code(s): 3004); Pharmaceutics (ICS code(s): 11.120)

Regulation Type: Regular notification

Distribution date: 24 July 2020 | Final date for Comment: 22 September 2020

The Draft amendments to the Rules of the Good Manufacturing Practice in the Eurasian Economic Union applies to medicinal products put into circulation on the territory of the Eurasian Economic Union and envisages the need to establish a unified approach to the procedures for qualification and validation of medicinal products, in order to prove that the parameters of critical processes (equipment) meet the specified requirements, as well as in case of significant changes in premises, equipment and processes that may affect the quality of finished products, which makes it possible to ensure stable output of products with a given level of quality at pharmaceutical enterprises.

Products Covered: Medicaments consisting of two or more constituents mixed together for therapeutic or prophylactic uses, not in measured doses or put up for retail sale (excl. goods of heading 3002, 3005 or 3006) (HS code(s): 3003); Medicaments consisting of mixed or unmixed products for therapeutic or prophylactic uses, put up in measured doses "incl. those in the form of transdermal administration" or in forms or packings for retail sale (excl. goods of heading 3002, 3005 or 3006) (HS code(s): 3004); Pharmaceutics (ICS code(s): 11.120)

Regulation Type: Regular notification

Distribution date: 24 July 2020

This addendum aims to inform that the National Institute of Metrology, Quality and Technology - INMETRO, issued Ordinance no. 237, of 02 July 2020, previously notified through G/TBT/N/BRA/375/Add.8 , which to amends Conformity Assessment Requirements for School Articles, approved by Inmetro Ordinance 481 of 07 December 2010. This regulation enters into force on the day of publication in Brazilian Official Gazette. The full text is available only in Portuguese and can be downloaded at:

Products Covered: ): pencil sharpeners (HS 8214.10); backpacks and briefcases (HS 4202); drawing sets (HS 9017); Ball point pens; felt tipped and other porous -tipped pens and markers; fountain pens, stylograph pens and other pens; duplicating stylos; propelling or sliding pencils (HS 9608); student rubber (HS 4016); child scissors (HS 8214); student glue (HS 3505) and others school items.

Regulation Type: Addendum to Regular Notification

Distribution date: 24 July 2020

This addendum aims to inform that the National Institute of Metrology, Quality and Technology - INMETRO, issued Ordinance no. 237, of 02 July 2020, previously notified through G/TBT/N/BRA/375/Add.8 , which to amends Conformity Assessment Requirements for School Articles, approved by Inmetro Ordinance 481 of 07 December 2010. This regulation enters into force on the day of publication in Brazilian Official Gazette. The full text is available only in Portuguese and can be downloaded at:

Products Covered: ): pencil sharpeners (HS 8214.10); backpacks and briefcases (HS 4202); drawing sets (HS 9017); Ball point pens; felt tipped and other porous -tipped pens and markers; fountain pens, stylograph pens and other pens; duplicating stylos; propelling or sliding pencils (HS 9608); student rubber (HS 4016); child scissors (HS 8214); student glue (HS 3505) and others school items.

Regulation Type: Addendum to Regular Notification

Distribution date: 23 July 2020 | Final date for Comment: 07 September 2020

This draft normative instruction proposes the revision of Resolution – RDC no. 107, 5 September 2016, which approves, the "List of Low-risk medicinal produts subject to simplified notification".

Products Covered: HS Code(s): 3003; 3004; 3005; 2941 (pharmaceutical products).

Regulation Type: Regular notification

Distribution date: 23 July 2020 | Final date for Comment: 07 September 2020

This draft normative instruction proposes the revision of Resolution – RDC no. 107, 5 September 2016, which approves, the "List of Low-risk medicinal produts subject to simplified notification".

Products Covered: HS Code(s): 3003; 3004; 3005; 2941 (pharmaceutical products).

Regulation Type: Regular notification

Distribution date: 20 July 2020 | Final date for Comment: 29 August 2020

This Draft resolution incorporates the following changes for the active ingredient C09 - CIMOXANIL (cymoxanil) from the Relation of Monographies of Active Ingredients of Pesticides, Household Cleaning Products and Wood Preservers, all in the modality of foliar use (application): -includes the chicory, stevia reubadiana, mustard, chinese-cabbage, and brussels sprouts with MRL of 0.01 mg/kg and safety security period of 3 days; -includes the chayote, and gherkin cultures with MRL of 0.1 mg/kg and safety security period of 3 days.

Products Covered: HS Code(s): 07052, 120750, 070420, 071140, 12119029, 07049010, 0709991000; ICS Code(s): 13, 65

Regulation Type: Regular notification

Distribution date: 20 July 2020 | Final date for Comment: 29 August 2020

This Draft resolution incorporates the following changes for the active ingredient C09 - CIMOXANIL (cymoxanil) from the Relation of Monographies of Active Ingredients of Pesticides, Household Cleaning Products and Wood Preservers, all in the modality of foliar use (application): -includes the chicory, stevia reubadiana, mustard, chinese-cabbage, and brussels sprouts with MRL of 0.01 mg/kg and safety security period of 3 days; -includes the chayote, and gherkin cultures with MRL of 0.1 mg/kg and safety security period of 3 days.

Products Covered: HS Code(s): 07052, 120750, 070420, 071140, 12119029, 07049010, 0709991000; ICS Code(s): 13, 65

Regulation Type: Regular notification