Regulatory Updates
Notice of Consultation on the Prescription Drug List (PDL): Nicotine Tablets (2 pages, English and French)
Distribution date: 24 February 2025 | Final date for Comment: 29 April 2025
The purpose of this Notice of Consultation is to provide an opportunity for the public and other interested stakeholders to comment on the proposal to revise the listing for "Nicotine or its salts" on the human use part of the Prescription Drug List (PDL). The proposal is to allow the non-prescription use of orally disintegrating or sublingual tablets by:adding a new part "g" to the qualifier of the listing to specifically exempt orally disintegrating or sublingual tablets containing 4 milligrams or less of nicotine per dosage unit.
Products Covered: Prescription status of medicinal ingredients for human use (ICS: 11.120; HS 3004.90)
Regulation Type: Regular notification
Notice of Consultation on the Prescription Drug List (PDL): Nicotine Buccal Pouches (2 pages, English and French)
Distribution date: 24 February 2025 | Final date for Comment: 29 April 2025
The purpose of this Notice of Consultation is to provide an opportunity for the public and other interested stakeholders to comment on the proposal to revise the listing for "Nicotine or its salts" on the human use part of the Prescription Drug List (PDL).The proposal is to clarify the non-prescription use of nicotine buccal pouches by:amending part "d" of the qualifier of the listing to be specific to sprays and inhalers only, andadding a new part "f" to the qualifier that is specific to nicotine buccal pouches.
Products Covered: Prescription status of medicinal ingredients for human use (ICS: 11.120; HS 3004.90)
Regulation Type: Regular notification
Draft Commission Delegated Regulation amending Regulation (EU) 2019/1009 of the European Parliament and of the Council as regards conformity assessment procedures for EU fertilising products
Distribution date: 24 February 2025 | Final date for Comment: 25 April 2025
Annex IV of Regulation (EU) 2019/1009 lays down conformity assessment procedures for the assessment of fertilising products. Module A1 is amended as to introduce the requirement that detonation resistance tests for ammonium nitrate fertilisers of high nitrogen content shall be carried out only by laboratories with proven technical capacity. Module D1 is amended as to set a general audit frequency for recovered component materials, independent from the required output material sampling.
Products Covered: Fertilising products
Regulation Type: Regular notification
Draft Order of the Ministry of Agrarian Policy and Food of Ukraine “On Approval of Hygienic Requirements for Edible Caseins and Caseinates”
Distribution date: 21 February 2025 | Final date for Comment: 22 April 2025
The draft Order proposes the approval of Hygienic requirements for edible caseins and caseinates, which define the information required for labeling the final product.The draft Order is also notified under the SPS Agreement.
Products Covered: Edible caseins and caseinates, (HS code(s): 3501)
Regulation Type: Regular notification
Resolución No. 00001310 del 18 de febrero de 2025 "Por la cual se suspende temporalmente la emisión de documentos zoosanitarios de importación (DZI) para algunos productos de origen animal procedentes de la República Federal de Alemania por la presencia del virus de la fiebre aftosa" (Resolution No. 00001310 of 18 February 2025 temporarily suspending the issuance of animal health import documents for certain products of animal origin from the Federal Republic of Germany on account of the presence of foot and mouth disease virus).
Distribution date: 21 February 2025
Resolution temporarily suspending the issuance of animal health import documents for animal products of the bovine and porcine species coming from Germany.
Products Covered: Product UseBovine albumin Laboratory materialBile, whether or not dried; glands Laboratory materialand other animal products usedin the preparation ofpharmaceutical productsBile, whether or not dried; glands Diagnosticsand other animal products usedin the preparation ofpharmaceutical productsMatured (unpasteurized) cheese Human consumptionPorcine liver extract Commercial/animal consumptionPorcine pancreatin Human medicinePorcine haemoglobin Animal consumption
Regulation Type: Emergency notifications (SPS)
Draft Order of the Ministry of Agrarian Policy and Food of Ukraine “On Approval of Hygienic Requirements for Edible Caseins and Caseinates”
Distribution date: 21 February 2025 | Final date for Comment: 22 April 2025
The draft Order proposes the approval of Hygienic requirements for edible caseins and caseinates, which define the information required for labeling the final product. This information shall include, in particular, information about food additives and/or milk protein content (where applicable). The draft Order also provides for the prohibition of the use of caseins and caseinates for food purposes that do not meet the requirements for the maximum permissible levels of some pollutants and impurities (lead, foreign matter such as wood or metal particles, hair or insect fragments). The criteria applicable to edible caseinates and caseins are outlined in the Annex to Hygienic requirements.The draft Order is also notified under the TBT Agreement.
Products Covered: Edible caseins and caseinates (HS code(s): 3501)
Regulation Type: Regular notification
DRS 603-2: 2025, Ammonium chloride fertilizer — Specification — Part 2: Liquid
Distribution date: 19 February 2025 | Final date for Comment: 17 March 2025
This Draft Rwanda Standard specifies the requirements, sampling and test methods for liquid ammonium chloride fertilizer. It covers the liquid ammonium chloride fertilizer in concentrate and diluted formulations.
Products Covered: (HS code(s): 28); Fertilizers (ICS code(s): 65.080)
Regulation Type: Regular notification
Order Repealing Certain Marketing Authorizations Issued Under the Food and Drugs Act
Distribution date: 17 February 2025
The proposed order notified under the title “Marketing Authorization repealing certain Marketing Authorizations issued under the Food and Drugs Act” in G/TBT/N/CAN/713 (dated February 2, 2024) was adopted on January 31, 2025 and published in the Canada Gazette, Part II on February 12, 2025. The order repeals sixteen redundant food marketing authorizations; fifteen of which relate to permitted food additives, and one regarding the fortification of Milk, Goat's Milk and Margarine with vitamin D. Text of the final regulations is publicly available, in both English and French, via the links provided above.
Products Covered: Food products in general (ICS: 67.040)
Regulation Type: Addendum to Regular Notification
Regulations Amending the Pest Control Products Fees and Charges Regulations (Annual Charge)
Distribution date: 17 February 2025 | Final date for Comment: 06 March 2025
Following careful deliberation taking into consideration requests from stakeholders, the comment period for the proposed Regulations Amending the Pest Control Products Fees and Charges Regulations (Annual Charge) (https://gazette.gc.ca/rp-pr/p1/2024/2024-12-21/html/reg8-eng.html) has been extended by 15 additional days, until 6 March 2025.
Products Covered: Pest control products, including but not limited to HS 3808 (ICS: 65.100).
Regulation Type: Addendum to Regular Notification
National Standard of the P.R.C., Feed additives—Part 2: Vitamins,provitamins and chemically well-defined substances having similar effect— L-Calcium ascorbate
Distribution date: 17 February 2025 | Final date for Comment: 18 April 2025
This document specifies the requirements, test methods, inspection rules, labeling，packaging, transportation storage and shelf life for feed additive L-Calcium ascorbateaThis document applies to L-Calcium ascorbate made from L-ascorbic acid and calcium salts.
Products Covered: L-Calcium ascorbatea(HS code(s): 293627); (ICS code(s): 65.020.30)
Regulation Type: Regular notification
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