Distribution date: 19 May 2020 | Final date for Comment: 10 May 2025

The proposed maximum residue limits (MRLs) for Gentamicin notified in G/SPS/N/JPN/668 (dated 8 August 2019) were adopted and published on 15 January 2020. The specified MRLs are available as below:

Products Covered:

Regulation Type: Addendum to Regular Notification

Distribution date: 19 May 2020 | Final date for Comment: 10 May 2025

The proposed maximum residue limits (MRLs) for Gentamicin notified in G/SPS/N/JPN/668 (dated 8 August 2019) were adopted and published on 15 January 2020. The specified MRLs are available as below:

Products Covered:

Regulation Type: Addendum to Regular Notification

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

Distribution date: 19 May 2020 | Final date for Comment: 10 May 2025

Products Covered: PHARMACEUTICAL PRODUCTS (HS code(s): 30); (ICS code(s): 11.100)

Regulation Type: Addendum to Regular Notification

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

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

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

Distribution date: 25 May 2020 | Final date for Comment: 10 May 2025

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)

Distribution date: 25 May 2020 | Final date for Comment: 10 May 2025

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)

Distribution date: 25 May 2020 | Final date for Comment: 10 May 2025

Products Covered: Electronic detonators

Regulation Type: Corrigendum to Regular Notification