Distribution date: 01 July 2024

The proposed maximum residue limits (MRLs) for Ormetoprim notified in G/SPS/N/JPN/1223 (dated 7 August 2023) were adopted and published on 20 December 2023. The specified MRLs are available as below:

Products Covered: ・Meat and edible meat offal (HS codes: 02.01, 02.02, 02.03, 02.06, 02.07 and 02.09)・Fish and crustaceans, molluscs and other aquatic invertebrates (HS codes: 03.02, 03.03 and 03.04)・Animal originated products (HS code: 05.04)・Animal or vegetable fats and oils (HS codes: 15.01 and 15.02)

Regulation Type: Addendum to Regular Notification

Distribution date: 01 July 2024

The proposed maximum residue limits (MRLs) for Cyphenothrin notified in G/SPS/N/JPN/1222 (dated 7 August 2023) were adopted and published on 20 December 2023. The specified MRLs are available as below:

Products Covered: ・Meat and edible meat offal (HS codes: 02.03, 02.06 and 02.09)・Animal originated products (HS code: 05.04)・Animal or vegetable fats and oils (HS code: 15.01)    

Regulation Type: Addendum to Regular Notification

Distribution date: 28 June 2024 | Final date for Comment: 31 December 2024

The manufacture, supply, processing and installation of engineered stone slabs, panels, and benchtops will be prohibited in all Australian states and territories from 1 July 2024. Prohibited ‘engineered stone’ will be defined in the legislation as an artificial product that contains 1% or more crystalline silica (determined as a weight/weight (w/w) concentration), is created by combining natural stone materials with other chemical constituents (such as water, resins or pigments) and becomes hardened.  However, engineered stone does not include concrete and cement products, bricks, pavers and other similar blocks, ceramic wall and floor tiles, grout, mortar and render, plasterboard, porcelain products, sintered stone and roof tiles.  Other engineered stone products are not affected by the prohibition. To have effect, the prohibition will need to be implemented in jurisdictional work health and safety laws. Australia has a harmonised work health and safety system achieved by the adoption in each jurisdiction (other than Victoria) of the model Work Health and Safety laws developed by Safe Work Australia, a tripartite body representing all jurisdictions as well as employer and worker representatives. All jurisdictions other than the state of Victoria have implemented the model laws, and Victoria has similar laws. In this case the model law amendments reflect the agreed national policy to be implemented in each state and territory and the Commonwealth. The Commonwealth government has indicated an intention to introduce an import prohibition to complement the prohibition on use. Timing is still to be determined.

Products Covered: The measure will apply to:Engineered stone slabs, panels, and benchtops. Prohibited ‘engineered stone’ will be defined as an artificial product that contains 1% or more crystalline silica (determined as a weight/weight (w/w) concentration), is created by combining natural stone materials with other chemical constituents (such as water, resins or pigments) and becomes hardened. Engineered stone does not include concrete and cement products, bricks, pavers and other similar blocks, ceramic wall and floor tiles, grout, mortar and render, plasterboard, porcelain products, sintered stone and roof tiles.  This captures the following HS codes:6802: Worked monumental or building stone (except slate) and articles thereof, other than goods of 6801.00.00; mosaic cubes and the like, of natural stone (including slate), whether or not on a backing; artificially coloured granules, chippings and powder, of natural stone (including slate)6802.29.00: Other stone6802.99.00: Other stone6810: Articles of cement, of concrete or of artificial stone, whether or not reinforced6810.19.00: Other6810.91.00: Prefabricated structural components for building or civil engineering6810.99.00: Other6814: Worked mica and articles of mica, including agglomerated or reconstituted mica, whether or not on a support of paper, paperboard or other materials6814.10.00: Plates, sheets and strips of agglomerated or reconstituted mica, whether or not on a support6814.90.00: Other

Regulation Type: Regular notification

Distribution date: 26 June 2024 | Final date for Comment: 23 August 2024

Health Canada is proposing amendments to the Pest Control Products Regulations in response to the spring 2022 consultations on the targeted review of the Pest Control Products Act (PCPA). The proposed amendments would:make it easier to access confidential test data (CTD) for research and re-analysis purposes;increase transparency for maximum residue limit (MRL) applications for imported food products;give the Minister of Health the explicit authority to require submission of information on cumulative effects on the environment (CEE);require the Minister of Health to consider CEE during risk assessments where information and methodology are available; andstrengthen consideration of species at risk (SAR) by giving the Minister of Health the explicit authority to require registrants and applicants to submit information on species at risk.The proposed amendments were pre-published on June 15, 2024, and are open to comments for 70 days.

Products Covered: Pest Control Products, HS 3808, (ICS: 65.100)

Regulation Type: Regular notification

Distribution date: 26 June 2024 | Final date for Comment: 26 July 2024

The Minimum Requirements for Biological Products will be amended as follows:Regarding the standard for “Freeze-dried Live Attenuated Rubella Vaccine” and “Freeze-dried Live Attenuated Measles-Rubella Combined Vaccine”, the requirements in case of using human diploid cells will be added. The Public Notice on National Release Testing will be amended as follows: The criterion for “Freeze-dried Live Attenuated Rubella Vaccine” and “Freeze-dried Live Attenuated Measles-Rubella Combined Vaccine” will be partially amended. 

Products Covered: Pharmaceutical products (HS: 30)

Regulation Type: Regular notification

Distribution date: 25 June 2024

Resolution - RDC number 708, 01 July 2022 - previously notified through  G/TBT/N/BRA/1410  - which contains provisions on post - approval changes of herbal medicines and traditional herbal products, was changed by Resolution 882, 14 June 2024 The final text is available only in Portuguese and can be downloaded at:  http://antigo.anvisa.gov.br/documents/10181/6354796/RDC_882_2024_.pdf/f26f6e81-3ea2-41ab-8d6c-04f9808b5238 

Products Covered: Medicaments (excluding goods of heading 30.02, 30.05 or 30.06) consisting of two or more constituents which have been mixed together for therapeutic or prophylactic uses, not put up in measured doses or in forms or packings for retail sale. (HS code(s): 3003); Medicaments (excluding goods of heading 30.02, 30.05 or 30.06) consisting of mixed or unmixed products for therapeutic or prophylactic uses, put up in measured doses (including those in the form of transdermal administration systems) or in forms or packings for retail sale. (HS code(s): 3004)

Regulation Type: Addendum to Regular Notification

Distribution date: 24 June 2024 | Final date for Comment: 23 August 2024

El objeto de este reglamento técnico es establecer las disposiciones administrativas y requisitos para la regulación y control del material vegetal, derivados y productos de interés sanitario que contienen cáñamo. Asimismo, aplica a los derivados y productos de interés sanitario con cáñamo: alimentos, cosméticos, suplementos a la dieta, productos higiénicos, plaguicidas de uso doméstico o profesional, productos químicos peligrosos, equipos y material biomédico.

Products Covered: ICS  12079901

Regulation Type: Regular notification

Distribution date: 21 June 2024 | Final date for Comment: 23 August 2024

This Draft Resolution contains provisions on criteria for indication, inclusion and exclusion of medicines in the List of Reference Medicines.

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 for transdermal administration" or in forms or packings for retail sale (excl. goods of heading 3002, 3005 or 3006) (HS code(s): 3004)

Regulation Type: Regular notification

Distribution date: 21 June 2024 | Final date for Comment: 05 August 2024

This Draft Resolution contains provisions on criteria for updating the composition of COVID-19 vaccines to be used in Brazil. Vaccines intended to prevent Covid-19 to be sold or used in Brazil must comply with the composition recommended by the World Health Organization (WHO).

Products Covered: Health care technology (ICS code(s): 11)

Regulation Type: Regular notification

Distribution date: 20 June 2024

Ukraine notifies the adoption of the Order of the Ministry of Health of Ukraine No 787 "On Approval of Amendments to the Procedure for Confirmation of Compliance of Medicinal Products Manufacturing Conditions with the Requirements of Good Manufacturing Practice" of 06 May 2024.The Order was registered in the Ministry of Justice of Ukraine on 21 May 2024 and published on 14 June 2024.The Order entered into force on 14 June 2024.

Products Covered: Medicinal products 

Regulation Type: Addendum to Regular Notification