Strengthening Environmental Protection for a Healthier Canada Act (S.C. 2023, c. 12)

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

  • (a.01) declaring that any drug is adulterated if the Minister believes that a prescribed substance contained in that drug presents a serious risk to the environment;

• (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) Subsection 30(1) of the Act is amended by adding the following after paragraph (b):

  • (b.01) respecting, for the purposes of managing risks to the environment, any of the following:

    • (i) the labelling and packaging and the offering, exposing and advertising for sale of food, drugs, cosmetics and devices,

    • (ii) the size, dimensions, fill and other specifications of packages of food, drugs, cosmetics and devices,

    • (iii) the sale or the conditions of sale of any food, drug, cosmetic or device, and

    • (iv) the use of any substance as an ingredient in any food, drug, cosmetic or device;

• (4) Paragraph 30(1)(e) of the Act is replaced by the following:

  • (e) respecting the method of manufacture, preparation, preserving, packaging, storing and testing of any food, drug, cosmetic or device in the interest of, or for the prevention of injury to, the health of the purchaser or consumer or to manage risks to the environment;

• Marginal note: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):

  • Marginal note: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) Subsection 30(1.2) of the Act is amended by adding the following after paragraph (d):

  • (d.01) requiring holders of a therapeutic product authorization to provide the Minister with information, in respect of any serious risk to the environment, that the holders receive or become aware of and that is relevant to the therapeutic product to which the authorization relates, regarding

    • (i) risks that have been communicated outside Canada, and the manner of the communication,

    • (ii) changes that have taken place to labelling outside Canada, and

    • (iii) recalls, reassessments and suspensions or revocations of authorizations, including licences, in respect of a therapeutic product, that have taken place outside Canada;

• Marginal note:2014, c. 24, s. 6(1)

  (8) Paragraph 30(1.2)(e) of the Act is replaced by the following:

  • (e) respecting modifications of labels and modifications and replacements of packages referred to in sections 21.2 and 21.302;

• Marginal note:2014, c. 24, s. 6(2)

  (9) Paragraph 30(1.2)(f.3) of the Act is replaced by the following:

  • (f.3) respecting the compilation of information, the conducting of tests and studies and the monitoring that are referred to in paragraphs 21.32(a) and 21.33(a), and the provision to the Minister of the information or results referred to in paragraphs 21.32(b) and 21.33(b);

Repeal

Marginal note:Repeal

68 The Perfluorooctane Sulfonate Virtual Elimination Act, chapter 13 of the Statutes of Canada, 2008, is repealed.

Coming into Force

Marginal note:Order in council

69 Section 64 and subsections 67(2), (5) and (6) come into force on a day to be fixed by order of the Governor in Council.