Food and Drugs Act (R.S.C., 1985, c. F-27)

AMENDMENTS NOT IN FORCE

• — 2023, c. 12, s. 64

  • 64 The Food and Drugs Act is amended by adding the following after section 11:

    • Risk to environment

      11.1 It is prohibited for a person to sell, or to manufacture, prepare, preserve, package or store for sale, any drug that contains a prescribed substance, unless the Minister has conducted an assessment, in accordance with the regulations made under paragraph 30(1)(l.1), of the risk to the environment presented by the substance.

• — 2023, c. 12, s. 67

  • • 67 (1) [In force]

    • (2) Subsection 30(1) of the Act is amended by adding the following after paragraph (a.01):

      • (a.02) prescribing the substances that are subject to an assessment under section 11.1;

    • (3) and (4) [In force]

    • 1999, c. 33, s. 347

      (5) Paragraph 30(1)(l.1) of the Act is replaced by the following:

      • (l.1) respecting the assessment of the risk to the environment or human life and health of the release into the environment of any food, drug, cosmetic or device;

      • (l.2) respecting, for the purpose of managing risks to the environment identified as part of an assessment under this Act, measures in respect of selling or importing, manufacturing, preparing, preserving, packaging or storing for sale any food, drug, cosmetic or device;

      • (l.3) authorizing the Minister to waive any requirement respecting the assessment under this Act of the risk to the environment presented by a food, drug, cosmetic or device;

    • (6) Section 30 of the Act is amended by adding the following after subsection (1):

      • Relevant factor

        (1.01) Before recommending to the Governor in Council that a regulation be made under paragraph (1)(a.02), the Minister must take into account the degree of uncertainty respecting the risks to the environment associated with the use of a substance as an ingredient in a drug, including its release into the environment.

    • (7) to (9) [In force]

• — 2023, c. 26, s. 501(2)

  • • 501 (2) Section 21.321 of the Act is repealed.

• — 2023, c. 26, s. 502(2)

  • • 502 (2) Subsection 21.8(2) of the Act is repealed.

• — 2024, c. 17, s. 325(2)

  • • 325 (2) Paragraph 30(1)(r) of the Act is repealed.

• — 2024, c. 17, s. 327

  • • 327 (1) Section 30.05 of the Act is amended by adding the following after subsection (1):

      • Exemption — person

        (1.1) Subject to subsection (2) and any regulations made under paragraph 30(1)(j.1), the Minister may, by order, on any conditions that the Minister considers necessary, exempt a person — or any food, therapeutic product or activity, or any class of foods, therapeutic products or activities, in relation to a person — from the application of all or any of the provisions of Part I, section 37 or the regulations. The order cannot relate to cosmetics.

    • (2) The portion of subsection 30.05(2) of the Act before paragraph (a) is replaced by the following:

      • Preconditions

        (2) The Minister may make an order under subsection (1) or (1.1) only if the Minister believes on reasonable grounds that

    • (3) Section 30.05 of the Act is amended by adding the following after subsection (3):

      • Statutory Instruments Act

        (4) An order made under subsection (1.1) that applies to only one person is not a statutory instrument within the meaning of the Statutory Instruments Act.

      • Availability — person-specific orders

        (5) The Minister must ensure that any order made under subsection (1.1) is publicly available but may exclude personal information and confidential business information from the order.

• — 2024, c. 17, s. 330

  • 330 The heading before section 30.2 and sections 30.2 to 30.4 of the Act are repealed.

• — 2024, c. 17, s. 331(2)

  • • 331 (2) Subsection 30.5(1) of the Act is replaced by the following:

      • Incorporation by reference

        • 30.5 (1) A regulation made under this Act with respect to a food or therapeutic product and an order made under subsection 30.63(1) may incorporate by reference any document, regardless of its source, either as it exists on a particular date or as it is amended from time to time.