Distribution date: 24 July 2020 | Final date for Comment: 14 May 2025

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 | 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 | 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

Purpose: This Notification provides for the matters to be observed by customized cosmetics sellers for the safety of procedures such as mixing customized cosmetics or dividing them into smaller quantities. The contents and raw materials used in customized cosmetics shall comply with the safety standards for cosmetics. The quality and safety of the final product shall be ensured by reviewing in advance the allowable range of mixture or division into smaller quantities. The shelf life for customized cosmetics shall be no longer than those of contents and raw materials. Customized cosmetics shall not be mixed or dividedin advance without identifying the skin type or preference of consumers.

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

Purpose: This Notification provides for the matters to be observed by customized cosmetics sellers for the safety of procedures such as mixing customized cosmetics or dividing them into smaller quantities. The contents and raw materials used in customized cosmetics shall comply with the safety standards for cosmetics. The quality and safety of the final product shall be ensured by reviewing in advance the allowable range of mixture or division into smaller quantities. The shelf life for customized cosmetics shall be no longer than those of contents and raw materials. Customized cosmetics shall not be mixed or dividedin advance without identifying the skin type or preference of consumers.

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

Regulation Type: Regular notification

Distribution date: 27 July 2020 | Final date for Comment: 14 May 2025

This Technical Regulation establishes definitions, requirements, specifications, guarantees, tolerances, registration, packaging and labelling of organic fertilizers and biofertilizers, for agricultural use. It revokes the Technical Regulation No. 25, 23 July 2009.

Products Covered: Animal or vegetable fertilisers, whether or not mixed together or chemically treated; fertilisers produced by the mixing or chemical treatment of animal or vegetable products. (HS code(s): 3101); Fertilizers (ICS code(s): 65.080)

Regulation Type: Regular notification

Distribution date: 27 July 2020 | Final date for Comment: 14 May 2025

This Technical Regulation establishes definitions, requirements, specifications, guarantees, tolerances, registration, packaging and labelling of organic fertilizers and biofertilizers, for agricultural use. It revokes the Technical Regulation No. 25, 23 July 2009.

Products Covered: Animal or vegetable fertilisers, whether or not mixed together or chemically treated; fertilisers produced by the mixing or chemical treatment of animal or vegetable products. (HS code(s): 3101); Fertilizers (ICS code(s): 65.080)

Regulation Type: Regular notification

Distribution date: 27 July 2020 | Final date for Comment: 12 September 2020

This Draft resolution incorporates the following changes for the active ingredient C49 - CARFENTRAZONA-ETÍLICA (carfentrazone-ethyl) from the Relation of Monographies of Active Ingredients of Pesticides, Household Cleaning Products and Wood Preservers, all in the modality of post-emergency use (application):-includes the millet  and sorghum cultures with MRL of 0,05 mg/kg and safety security period of 84 days.

Products Covered: HS Code(s): 100820, 1007; ICS Code(s): 13, 65

Regulation Type: Regular notification