Revision of the Standards and Specifications for Foods and Food Additives under the Food Sanitation Act (revision of agricultural chemical residue standards)
Distribution date: 03 June 2020 | Final date for Comment: 02 August 2020
Proposed maximum residue limits (MRLs) for the following agricultural chemical Pesticide: Diquat
Products Covered: -Meat and edible meat offal (HS: 02.01, 02.02, 02.03, 02.04, 02.05, 02.06, 02.07, 02.08 and 02.09) -Fish and molluscs (HS: 03.02, 03.03, 03.04 and 03.07) -Dairy produce and birds' eggs (HS: 04.01, 04.07 and 04.08) -Animal originated products (HS: 05.04) -Edible vegetables and certain roots and tubers (HS: 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: 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: 09.01, 09.02, 09.03, 09.04, 09.05, 09.06, 09.07, 09.08, 09.09 and 09.10) -Cereals (HS: 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: 12.01, 12.02, 12.04, 12.05, 12.06, 12.07, 12.10 and 12.12)-Animal fats and oils (HS: 15.01, 15.02 and 15.06)
Regulation Type: Regular notification
TITLE: Children's Toys and Child Care Articles: Determinations Regarding ASTM F963 Elements and Phthalates for Unfinished Manufactured Fibers AGENCY: U.S. Consumer Product Safety Commission ACTION: Final rule SUMMARY: The Consumer Product Safety Commission (CPSC) is issuing a final rule determining that certain unfinished manufactured fibers do not contain the ASTM F963 elements or specified phthalates that exceed the limits set forth under the CPSC's statutes and regulations for children's toys and child care articles. Based on these determinations, the specified unfinished manufactured fibers would not be required to have third party testing for compliance with the requirements of the ASTM F963 elements or phthalates for children's toys and child care articles. The rule is effective on 1 July 2020. The docket folder on Regulations.gov provides access to primary documents for this rulemaking as well as the comments received: https://www.regulations.gov/docket?D=CPSC-2019-0023.
Distribution date: 03 June 2020 | Final date for Comment: 11 May 2025
Products Covered: Toys and child care articles
Regulation Type: Addendum to Regular Notification
TITLE: Children's Toys and Child Care Articles: Determinations Regarding ASTM F963 Elements and Phthalates for Unfinished Manufactured Fibers AGENCY: U.S. Consumer Product Safety Commission ACTION: Final rule SUMMARY: The Consumer Product Safety Commission (CPSC) is issuing a final rule determining that certain unfinished manufactured fibers do not contain the ASTM F963 elements or specified phthalates that exceed the limits set forth under the CPSC's statutes and regulations for children's toys and child care articles. Based on these determinations, the specified unfinished manufactured fibers would not be required to have third party testing for compliance with the requirements of the ASTM F963 elements or phthalates for children's toys and child care articles. The rule is effective on 1 July 2020. The docket folder on Regulations.gov provides access to primary documents for this rulemaking as well as the comments received: https://www.regulations.gov/docket?D=CPSC-2019-0023.
Distribution date: 03 June 2020 | Final date for Comment: 11 May 2025
Products Covered: Toys and child care articles
Regulation Type: Addendum to Regular Notification
Notice of Modification to the List of Permitted Preservatives to Enable the Use of Benzoic Acid and its Salts in Oyster Flavoured Sauce - Reference Number: NOM/ADM-0147
Distribution date: 04 June 2020 | Final date for Comment: 01 August 2020
On occasion, Health Canada may identify the need to make changes to the Lists of Permitted Food Additives in order to correct minor errors, to adjust wording in the interest of clarity, to ensure consistency in terminology, or to make changes that are required as a consequence of amendments to the Food and Drug Regulations (Regulations) or emerging scientific developments related to the effectiveness and/or safety of an approved food additive. Health Canada's Food Directorate received a request seeking approval for the use of sodium benzoate as a preservative used at a maximum level of 1,000 ppm in oyster-flavoured sauce. Oyster-flavoured sauce is regulated as an unstandardized fish product in Canada, and consequently, is not permitted to contain either benzoic acid or salts of benzoic acid due to the exception captured under subitem B.1(2) of Part 2 of the List of Permitted Preservatives. The Food Directorate conducted an internal review of its files to understand the rationale behind the establishment of the exception, and found no scientific evidence, from a health and safety perspective, to soundly rationalize the establishment of the exception. In addition, emerging scientific developments have demonstrated the effective anti-microbiological activities of benzoic acid and its salts when used for the preservation of meat, poultry and fish products. Therefore, Health Canada has enabled the use of benzoic acid and its potassium and sodium salts described in the information document by modifying Part 2 of the List of Permitted Preservatives, effective 5 May 2020. The purpose of this communication is to publically announce the Department's decision in this regard and to provide the appropriate contact information for any inquiries or feedback on this modification.
Products Covered: Benzoic Acid and its Salt (ICS Codes: 67.200.20, 67.120.30)
Regulation Type: Regular notification
Notice of Modification to the List of Permitted Preservatives to Enable the Use of Benzoic Acid and its Salts in Oyster Flavoured Sauce - Reference Number: NOM/ADM-0147
Distribution date: 04 June 2020 | Final date for Comment: 01 August 2020
On occasion, Health Canada may identify the need to make changes to the Lists of Permitted Food Additives in order to correct minor errors, to adjust wording in the interest of clarity, to ensure consistency in terminology, or to make changes that are required as a consequence of amendments to the Food and Drug Regulations (Regulations) or emerging scientific developments related to the effectiveness and/or safety of an approved food additive. Health Canada's Food Directorate received a request seeking approval for the use of sodium benzoate as a preservative used at a maximum level of 1,000 ppm in oyster-flavoured sauce. Oyster-flavoured sauce is regulated as an unstandardized fish product in Canada, and consequently, is not permitted to contain either benzoic acid or salts of benzoic acid due to the exception captured under subitem B.1(2) of Part 2 of the List of Permitted Preservatives. The Food Directorate conducted an internal review of its files to understand the rationale behind the establishment of the exception, and found no scientific evidence, from a health and safety perspective, to soundly rationalize the establishment of the exception. In addition, emerging scientific developments have demonstrated the effective anti-microbiological activities of benzoic acid and its salts when used for the preservation of meat, poultry and fish products. Therefore, Health Canada has enabled the use of benzoic acid and its potassium and sodium salts described in the information document by modifying Part 2 of the List of Permitted Preservatives, effective 5 May 2020. The purpose of this communication is to publically announce the Department's decision in this regard and to provide the appropriate contact information for any inquiries or feedback on this modification.
Products Covered: Benzoic Acid and its Salt (ICS Codes: 67.200.20, 67.120.30)
Regulation Type: Regular notification
Draft Resolution number 812, 12 May 2020 Comment form: http://formsus.datasus.gov.br/site/formulario.php?id_aplicacao=56188
Distribution date: 11 June 2020 | Final date for Comment: 10 July 2020
This draft resolution changes the Resolution – RDC number 73, 7 April 2016, which establishes technical requirements for post-registration changes and cancellation procedures for registering medicines.
Products Covered: HS Code(s): 3003; 3004; 3005; 2941 (pharmaceutical products).
Regulation Type: Regular notification
Draft Resolution number 812, 12 May 2020 Comment form: http://formsus.datasus.gov.br/site/formulario.php?id_aplicacao=56188
Distribution date: 11 June 2020 | Final date for Comment: 10 July 2020
This draft resolution changes the Resolution – RDC number 73, 7 April 2016, which establishes technical requirements for post-registration changes and cancellation procedures for registering medicines.
Products Covered: HS Code(s): 3003; 3004; 3005; 2941 (pharmaceutical products).
Regulation Type: Regular notification
Resolution – RDC number 378, 28 April 2020
Distribution date: 11 June 2020 | Final date for Comment: 11 May 2025
This resolution extraordinarily and temporarily establishes technical requirements for the import, marketing, and donation of lung ventilators, vital signs monitor, infusion pump sets, oximetry machine, and used capnographs, indispensable for intensive care units, due to the international public health emergency related to the Covid-19.
Products Covered: HS Code(s): Medical devices (2936, 2937, 3001, 3002, 3003, 3004, 3006)
Regulation Type: Regular notification
Resolution – RDC number 378, 28 April 2020
Distribution date: 11 June 2020 | Final date for Comment: 11 May 2025
This resolution extraordinarily and temporarily establishes technical requirements for the import, marketing, and donation of lung ventilators, vital signs monitor, infusion pump sets, oximetry machine, and used capnographs, indispensable for intensive care units, due to the international public health emergency related to the Covid-19.
Products Covered: HS Code(s): Medical devices (2936, 2937, 3001, 3002, 3003, 3004, 3006)
Regulation Type: Regular notification
Resolution – RDC number 375, 17 April 2020
Distribution date: 11 June 2020 | Final date for Comment: 11 May 2025
This resolution extraordinarily and temporarily establishes the submission procedure for clinical studies required to validate medical devices of Classes III and IV identified as essential to healthcare services, due to the international public health emergency related to the SARS-CoV-2.
Products Covered: HS Code(s): medical devices (2936, 2937, 3001, 3002, 3003, 3004, 3006)
Regulation Type: Regular notification
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