Letter of the Federal Service for Veterinary and Phytosanitary Surveillance No. FS-NV-7/14290 as of 18 March 2020

Distribution date: 25 May 2020
Russian Federation lifted the provisional restriction on imports of milk and dairy products from the Republic of Korea heat-treated with temperatures that guarantee a destruction of the virus which causes foot-and-mouth disease in accordance with the OIE recommendations.
Products Covered: Milk and dairy products, heat-treated with temperatures that guarantee a destruction of the virus which causes foot-and-mouth disease.
Regulation Type: Regular notification
Letter of the Federal Service for Veterinary and Phytosanitary Surveillance No. FS-NV-7/14290 as of 18 March 2020

Distribution date: 25 May 2020
Russian Federation lifted the provisional restriction on imports of milk and dairy products from the Republic of Korea heat-treated with temperatures that guarantee a destruction of the virus which causes foot-and-mouth disease in accordance with the OIE recommendations.
Products Covered: Milk and dairy products, heat-treated with temperatures that guarantee a destruction of the virus which causes foot-and-mouth disease.
Regulation Type: Regular notification
TITLE: Electronic Detonators; Correction AGENCY: Mine Safety and Health Administration, Labor ACTION: Direct final rule; correction SUMMARY: The Mine Safety and Health Administration (MSHA) is correcting a footnote in the preamble of a direct final rule that appeared in the Federal Register on 14 January 2020 and that became effective on 16 March 2020. The direct final rule revised certain safety standards for explosives at metal and nonmetal mines. Effective 20 May 2020. The docket folder on Regulations.gov provides access to primary documents for this rulemaking as well as comments received: https://www.regulations.gov/docket?D=MSHA-2019-0007.

Distribution date: 25 May 2020
Products Covered: Electronic detonators
Regulation Type: Corrigendum to Regular Notification
TITLE: Electronic Detonators; Correction AGENCY: Mine Safety and Health Administration, Labor ACTION: Direct final rule; correction SUMMARY: The Mine Safety and Health Administration (MSHA) is correcting a footnote in the preamble of a direct final rule that appeared in the Federal Register on 14 January 2020 and that became effective on 16 March 2020. The direct final rule revised certain safety standards for explosives at metal and nonmetal mines. Effective 20 May 2020. The docket folder on Regulations.gov provides access to primary documents for this rulemaking as well as comments received: https://www.regulations.gov/docket?D=MSHA-2019-0007.

Distribution date: 25 May 2020
Products Covered: Electronic detonators
Regulation Type: Corrigendum to Regular Notification
Letter of the Federal Service for the Veterinary and Phytosanitary No. FS-NV-7/14160 as of 15 May 2020

Distribution date: 25 May 2020
This letter introduces a temporary restriction on import of life poultry and poultry products from North Macedonia mentioned in point 3 due to the outbreak of Newcastle disease virus.
Products Covered: Life poultry and hatching egg, poultry meat and poultry processed products not heat-treated (at least 70° C), feeds and feed additives for poultry (with the exception of feed additives of vegetable origin, chemical and microbiological synthesis), used equipment and supplies for transportation, breeding, stockkeeping, slaughtering and cutting of poultry from North Macedonia (HS Code(s): of 0105, of 0106, of 0207, of 0208, of 0209, of 0210, of 0407, of 0408, 0410000000, of 0510000000, of 0504000000, of 0505, of 0507, of 1501, of 0511, of 150300, of 1506000000, of 151610, of 151800, of 160100, of 1602, of 160300, of 190220, of 190420, of 2104, of 2106, of 2309, of 2301, of 2309, of 3101000000, of 3502, of 350400, of 3507, of 4206000000, of 9508100000, of 9705000000)
Regulation Type: Emergency notifications (SPS)
Letter of the Federal Service for the Veterinary and Phytosanitary No. FS-NV-7/14160 as of 15 May 2020

Distribution date: 25 May 2020
This letter introduces a temporary restriction on import of life poultry and poultry products from North Macedonia mentioned in point 3 due to the outbreak of Newcastle disease virus.
Products Covered: Life poultry and hatching egg, poultry meat and poultry processed products not heat-treated (at least 70° C), feeds and feed additives for poultry (with the exception of feed additives of vegetable origin, chemical and microbiological synthesis), used equipment and supplies for transportation, breeding, stockkeeping, slaughtering and cutting of poultry from North Macedonia (HS Code(s): of 0105, of 0106, of 0207, of 0208, of 0209, of 0210, of 0407, of 0408, 0410000000, of 0510000000, of 0504000000, of 0505, of 0507, of 1501, of 0511, of 150300, of 1506000000, of 151610, of 151800, of 160100, of 1602, of 160300, of 190220, of 190420, of 2104, of 2106, of 2309, of 2301, of 2309, of 3101000000, of 3502, of 350400, of 3507, of 4206000000, of 9508100000, of 9705000000)
Regulation Type: Emergency notifications (SPS)
SI 5438 part 9 - Chemicals used for treatment of water intended for human consumption: Aluminium sulfate

Distribution date: 25 May 2020 | Final date for Comment: 24 July 2020
Revision of the Mandatory Standard SI 5438 part 9, dealing with aluminium sulfate for treatment of water intended for human consumption. This draft standard revision adopts both the European Standard EN 878: March 2016 and the American Standard ANSI/AWWA B403-16, with a few changes and national deviations that appear in the standard's Hebrew section as follow: Chapter A - National deviations to the European route of compliance: Changes the standard's normative references (section 2); Adds a note to Table 5 of section 4.3 dealing with a limit of impurities; Deletes the column relating to Type 3 of Table 6 of section 4.4 dealing with chemical parameters; Adds new sub-sections 5.1.2.2.1 and 5.1.2.2.2 detailing the sampling from tank and tankers; Adds alternative test methods to section 5.2 dealing with analysis; Adds a new requirement to comply with Israel Mandatory Standards SI 2302 parts 1 and 2 to section 6 dealing with lebelling, transportation and storage; Adds a new requirement to comply with Israel Standards SI 819 part to section 6.1 dealing with means of delivery; Deletes section 6.2 dealing with lebelling in accordance with the EU legislation; Replace section 6.4 dealing with marking; Amends Annex B. Chapter B - National deviations to the American route of compliance: Changes section 1.3 dealing application; Changes the standard's normative references (section 2); Deletes definition 10 (reclaimed water) and definition 13 (wastewater) of section 3 dealing with definition; Changes section 4 dealing with requirements; Changes the specific impurity limits appearing in sub-section 4.3.2; Changes the product specifications appearing in sub-section 4.3.3; Changes section 5.2 dealing with test procedures; Changes the formula appearing in sub-section 5.5.9 dealing with calculations; Adds new sub-section 5.12 dealing with nickel content; Changes the marking requirements appearing in section 6.1 dealing with marking; Adds a new requirement to comply with Israel Standards SI 819 part to section 6.1 dealing with packaging and shipping; Adds new sub-section 6.2.6.4 and requires that the product will include SDS (Safety Data Sheet). All requirement of the new revised standard will be declared mandatory, except the following: The marking requirements for "iron-free" and "low-iron" and for "marking of Aluminum concentration marking requirement (by weight)" appearing in section 6.4 of the European Standard route of compliance; The requirement for "marking of Aluminum concentration marking requirement (by weight)" appearing in section 6.1 of the American route of compliance.
Products Covered: Aluminium sulfate for treatment of water intended for human consumption
Regulation Type: Regular notification
SI 5438 part 9 - Chemicals used for treatment of water intended for human consumption: Aluminium sulfate

Distribution date: 25 May 2020 | Final date for Comment: 24 July 2020
Revision of the Mandatory Standard SI 5438 part 9, dealing with aluminium sulfate for treatment of water intended for human consumption. This draft standard revision adopts both the European Standard EN 878: March 2016 and the American Standard ANSI/AWWA B403-16, with a few changes and national deviations that appear in the standard's Hebrew section as follow: Chapter A - National deviations to the European route of compliance: Changes the standard's normative references (section 2); Adds a note to Table 5 of section 4.3 dealing with a limit of impurities; Deletes the column relating to Type 3 of Table 6 of section 4.4 dealing with chemical parameters; Adds new sub-sections 5.1.2.2.1 and 5.1.2.2.2 detailing the sampling from tank and tankers; Adds alternative test methods to section 5.2 dealing with analysis; Adds a new requirement to comply with Israel Mandatory Standards SI 2302 parts 1 and 2 to section 6 dealing with lebelling, transportation and storage; Adds a new requirement to comply with Israel Standards SI 819 part to section 6.1 dealing with means of delivery; Deletes section 6.2 dealing with lebelling in accordance with the EU legislation; Replace section 6.4 dealing with marking; Amends Annex B. Chapter B - National deviations to the American route of compliance: Changes section 1.3 dealing application; Changes the standard's normative references (section 2); Deletes definition 10 (reclaimed water) and definition 13 (wastewater) of section 3 dealing with definition; Changes section 4 dealing with requirements; Changes the specific impurity limits appearing in sub-section 4.3.2; Changes the product specifications appearing in sub-section 4.3.3; Changes section 5.2 dealing with test procedures; Changes the formula appearing in sub-section 5.5.9 dealing with calculations; Adds new sub-section 5.12 dealing with nickel content; Changes the marking requirements appearing in section 6.1 dealing with marking; Adds a new requirement to comply with Israel Standards SI 819 part to section 6.1 dealing with packaging and shipping; Adds new sub-section 6.2.6.4 and requires that the product will include SDS (Safety Data Sheet). All requirement of the new revised standard will be declared mandatory, except the following: The marking requirements for "iron-free" and "low-iron" and for "marking of Aluminum concentration marking requirement (by weight)" appearing in section 6.4 of the European Standard route of compliance; The requirement for "marking of Aluminum concentration marking requirement (by weight)" appearing in section 6.1 of the American route of compliance.
Products Covered: Aluminium sulfate for treatment of water intended for human consumption
Regulation Type: Regular notification
Enforcement decree of the Act on advanced regenerative medicine and advanced biological products regarding safety and support

Distribution date: 19 May 2020 | Final date for Comment: 18 July 2020
- As the “Act on Safety and Support of Advanced Regenerative Medicine and Advanced Biological Products” is established, “Enforcement Decree of the Act on Safety and Support of Advanced Regenerative Medicine and Advanced Biological Products” is enacted to prescribe the matters delegated by the Act and those necessary for its implementation. - Article 31: to prescribe facility standards required for the notification of importing business of advanced biological products. - Article 32: to prescribe facilities, equipment, human resources, and quality management system required for the approval of human cell management business, etc. - Article 34-36: 1) to stipulate that long-term follow-up investigations may be conducted on certain advanced biological products containing stem cell treatments, animal tissue and cells, gene therapy products and other advanced biological products that need to be monitored for adverse events over a specific period after administration. 2) to prescribe matters related to the designation as a subject of such investigations, the withdrawal of the designation, etc.
Products Covered: Biological Products
Regulation Type: Regular notification
Partial amendment to the Minimum Requirements for Biological Products Amendment to establish, amend and delete articles under the Minimum Requirements for Biological Products was adopted and published on 13 May 2020. The outline of amendment are available as attached file.

Distribution date: 19 May 2020
Products Covered: PHARMACEUTICAL PRODUCTS (HS code(s): 30); (ICS code(s): 11.100)
Regulation Type: Addendum to Regular Notification
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