Guidance document: Animal testing ban on cosmetics

Table of Contents

• Introduction
• Who this guide is for
• 1.0 Background
• 2.0 Prohibition on the conduct of cosmetic animal testing
  • 2.1 Explanation of the prohibition
• 3.0 Prohibition on the sale of cosmetics relying on animal testing data
  • 3.1 Explanation of the prohibition
  • 3.2 Circumstances where the use of animal testing data is permitted
• 4.0 Prohibition on false claims on labels and in advertising
  • 4.1 Explanation of the prohibition
  • 4.2 Examples of animal testing claims and how Health Canada would interpret them
• 5.0 Supplying evidence upon request of the Minister
• Appendix A: Illustrative examples
  • Example 1
  • Example 2
  • Example 3
  • Example 4
  • Example 5

Introduction

This document is a guide to inform the cosmetics industry about the new ban on cosmetic testing on animals in Canada set out in the Food and Drugs Act. In addition, this guide communicates Health Canada's interpretation of the new requirements in the Food and Drugs Act that were introduced through the Budget Implementation Act, 2023, No. 1 and received Royal Assent on June 22, 2023. The legislation comes into force on December 22, 2023.

This document does not constitute part of the Food and Drugs Act or its regulations and, in the event of any inconsistency or conflict between the Food and Drugs Act or regulations and this document, the Food and Drugs Act or the regulations take precedence. This document is an administrative document that is intended to facilitate compliance by the regulated party with the Food and Drugs Act, the regulations and the applicable administrative policies.

Who this guide is for

• members of the cosmetic industry

1.0 Background

Health Canada's mandate is focused on human health and safety. The Food and Drugs Act and the Cosmetic Regulations require that all cosmetics sold in Canada be safe for the user and it is the responsibility of industry to ensure the safety of their cosmetics.

Section 16 of the Food and Drugs Act provides, among other things, that no person can sell any cosmetic that has in or on it any substance that may cause injury to the health of the user. Prior to the coming into force of the prohibition on cosmetic animal testing in 2023, the Food and Drugs Act and the Cosmetic Regulations did not prescribe the type of data that industry could rely upon to establish the safety of their cosmetics or could submit to Health Canada to demonstrate their safety. While the Food and Drugs Act and Cosmetic Regulations did not require that cosmetics be tested on animals or that safety data derived from animal testing be used to demonstrate the safety of a cosmetic product, they did not prohibit the testing of cosmetics on animals or the submission of data derived from animal testing to demonstrate the safety of a cosmetic.

The Government took the steps to ban the testing of cosmetics on animals and the reliance on data derived from new animal testing to demonstrate the safety of cosmetics, with some exceptions, because it recognizes that, in many circumstances, it is now possible to satisfy the safety requirements for cosmetics without resorting to new animal testing (for example by relying on alternative test protocols (e.g., testing on cell cultures), computer-based models, or existing information on similar chemicals). The prohibitions set out in the Food and Drugs Act help to support the global shift toward reducing reliance on animal testing by encouraging the cosmetic industry to focus on new alternative testing methodologies.

To comply with the new requirements in the Food and Drugs Act, industry must:

• Not test, in Canada, any cosmetic on animals to satisfy the cosmetic requirements of the Food and Drugs Act or safety requirements relating to cosmetics under the laws of another country;
• Ensure that the safety of any new cosmetic product sold in Canada can be established by relying strictly on permissible data (i.e., data not derived from animal testing or data satisfying the relevant exceptions); and,
• Ensure that any claims relating to the absence of animal testing on the label of a cosmetic, or in an advertisement for a cosmetic, can be substantiated.

The prohibitions do not interfere with legislative regimes for non-cosmetic products in Canada where animal testing is needed to demonstrate safety. For example, the testing of ingredients for the purposes of pharmaceutical drug development and the general testing of chemicals to determine the impacts on human health and the environment.

2.0 Prohibition on the conduct of cosmetic animal testing

2.1 Explanation of the prohibition

16.2 No person shall conduct a test on an animal that could cause pain, suffering or injury, whether physical or mental, to the animal if the purpose of the test is to meet, with respect to a cosmetic, a requirement under a provision of this Act or the regulations or to meet a requirement that relates to the safety of cosmetics under the law that applies in a foreign state.

This prohibition applies to the testing of substances, ingredients, and finished cosmetic products when the purpose of the testing is to meet a requirement related to cosmetics under the Food and Drugs Act or its regulations (i.e., the Cosmetic Regulations). For example, this means no one can undertake animal testing in Canada for the purpose of ensuring that a cosmetic product is safe for use in a specific population group, such as infants. Similarly, testing is also prohibited for the purpose of meeting a safety-related requirement under a foreign law as it relates to a cosmetic. For example, this means that a manufacturer cannot test a cosmetic on animals in Canada for the purpose of using the resulting data to substantiate the safety of the cosmetic to satisfy regulatory requirements in another country.

Note that this requirement does not prohibit testing conducted on animals for purposes other than to satisfy requirements regarding cosmetics under the Food and Drugs Act or requirements regarding the safety of cosmetics under a foreign legislation, such as testing an ingredient for use in a pharmaceutical or other non-cosmetic product. For more information on this, see section 3.2.3 on mixed-use ingredients.

3.0 Prohibition on the sale of cosmetics relying on animal testing data

3.1 Explanation of the prohibition

The prohibition is anchored to the requirement under s.16 of the Food and Drugs Act that only cosmetic products that are safe can be sold in Canada. In ensuring the safety of their cosmetic product, industry cannot rely on animal testing data, except in the circumstances allowed for by the exceptions in paragraphs 16.1(2)(a) through (f).

This provision does not introduce a requirement that industry submit safety evidence to Health Canada prior to the sale of their cosmetic and, as such, it does not modify Health Canada's post-market approach to regulating cosmetics.

Paragraphs 16.1(2)(a) through (f) describe circumstances where data derived from animal testing may be used by industry to substantiate the safety of their cosmetic product. A further explanation of each of these circumstances is discussed in section 3.2 of this document.

3.2 Circumstances where the use of animal testing data is permitted

Paragraphs 16.1(2)(a) through (f) of the Food and Drugs Act identify several circumstances where anyone who sells a cosmetic can continue to rely on animal testing data to demonstrate the safety of their cosmetic. These exceptions aim to strike a balance between the objective of reducing reliance on animal testing and supporting innovation by not restricting the use of existing information, and do not create incentives to conduct new animal testing for the purposes of selling a cosmetic product in Canada. An explanation of each exception is provided below.

3.2.1 Government-published data

Paragraph 16.1(2)(a) allows for the use of animal testing data published by the Government of Canada. The Government of Canada does not undertake animal testing for the purposes of establishing the safety of cosmetics under the Food and Drugs Act but may conduct animal testing on chemical ingredients under programs such as the Chemicals Management Plan. Nevertheless, industry may elect to use any animal testing data published by the Government of Canada to substantiate the safety of their cosmetic, which would primarily be relevant in assessing the impacts of certain chemicals on health.

3.2.2 Publicly available data

Paragraph 16.1(2)(b) allows for the use of data derived from animal testing that is publicly available if the testing was not conducted by, or on behalf of, the manufacturer, importer or seller of the cosmetic or ingredient that is the subject of the testing. Information that is 'publicly available' is intended to encompass academic journals, scientific reviews and other science-related publications, as well as digital spaces including social media, apps, or websites. This could include animal testing data that was published by governments other than the Government of Canada, academics conducting safety assessments or scientific research, or data published by a third party or non-profit group.

3.2.3 Mixed-use ingredients

Paragraph 16.1(2)(c) allows for the use of data resulting from animal testing on 'mixed-use ingredients.' There are instances where a cosmetic contains an ingredient that is also found in a product regulated under a different regulatory framework that requires animal testing, such as pharmaceuticals. These ingredients are referred to as 'mixed-use ingredients.' Examples of mixed-use ingredients could include:

• an emollient that is found in a prescription pharmaceutical cream as well as a cosmetic skin cream;
• alpha hydroxy acids found in chemical peels that may be classified either as natural health products, prescription drugs or cosmetics; and
• formaldehyde found in glues and paints, but also nail polishes and nail hardeners.

Industry may rely on animal testing data for a mixed-use ingredient only when they can demonstrate that there is a legitimate non-cosmetic use for the ingredient in question. To demonstrate that legitimate non-cosmetic use, industry must meet the tests described in subparagraphs 16.1(2)(c)(i), (ii) and (iii):

• the animal testing data being relied upon was derived from a test conducted in order to meet a requirement unrelated to cosmetics either in Canada or in a foreign country;
• the mixed-use ingredient is present in a non-cosmetic product that is or was sold in Canada or in a foreign country; and
• the animal testing was necessary in order for the product to be sold in Canada or in a foreign country.

Note that the relevant country must be the same in each of the three criteria. For example, an animal test conducted in Canada to meet Canadian requirements must have the associated non-cosmetic product sold in Canada. Similarly, for the criteria to be satisfied, a test conducted in the United States to meet requirements in the United States must have the associated non-cosmetic product sold in the United States. If all the criteria found in subparagraphs 16.1(2)(c)(i), (ii) and (iii) are met, then the data for the ingredient that was the result of animal testing, and was subsequently used in a cosmetic product, is acceptable.

3.2.4 Previously-generated data

Paragraph 16.1(2)(d) allows for the use of animal testing data when it was generated prior to this prohibition against the reliance on animal testing data coming into force. This exemption acknowledges that, at one point or another, virtually every ingredient was tested on animals and that the scientific knowledge that has already been generated should not be disregarded. Industry may rely on existing scientific data derived from animal testing provided that the test that created the data was done prior to December 22, 2023.

3.2.5 Cosmetics that were sold before the prohibition

Paragraph 16.1(2)(e) allows for the use of animal testing data for cosmetic products that were already on the market when subsection 16.1(1) came into force. This means that cosmetic products already on the market before December 22, 2023, are allowed to continue to rely on any animal testing data to demonstrate their safety. However, industry should note that if they reformulate their product, they will no longer be able to rely on this exception regarding reliance on animal testing data. If industry relies on this exception and the label or advertisements of their products claim that the cosmetic is not tested on animals, industry must have the appropriate evidence to support this claim (see sections 4.1 and 4.2).

3.2.6 Additional circumstances

Paragraph 16.1(2)(f) of the Food and Drugs Act allows the Governor in Council to prescribe any additional circumstances where the use of animal testing data by industry to demonstrate the safety of a cosmetic would be permitted. Any new exceptions would be introduced through the formal regulatory amendment process.

4.0 Prohibition on false claims on labels and in advertising

4.1 Explanation of the prohibition

The first part of this prohibition is intended to prevent false or misleading claims, whether on a label or in an advertisement, that relate to animal testing. A misleading claim could be made by any person, including manufacturers, notifiers, importers, sellers or anyone acting on their behalf (e.g., beauty influencers under contract with the manufacturer, importer or seller). In this case, cosmetic means the finished cosmetic product. The scope of the prohibition applies to any testing conducted for any purpose and is not limited to testing conducted to satisfy safety requirements.

The prohibition would cover claims made either through words (e.g., 'cruelty-free') or images (e.g., bunny logos, symbols of animals). The prohibition applies to existing claims on products as of December 22, 2023, and any claims made on products in the future. For examples of how Health Canada would apply this prohibition, see section 4.2 of this document.

Subsection 16.3(2) authorizes the Minister to request evidence that the claim is accurate and the person who made the claim must provide the Minister with the evidence. Subsection 16.3(1) refers to persons having evidence that no such animal testing occurred. A person who, while acting on behalf of another, made the claim while not being in possession of such evidence may need to obtain the evidence to respond to the Minister's request.

4.2 Examples of animal testing claims and how Health Canada would interpret them

Health Canada does not intend to impose any standards for cruelty-free claims relating to animal testing. Industry can continue to determine how they want to state claims on their labels, so long as their claims can be substantiated. Health Canada may ask for evidence to substantiate a cruelty-free labelling claim, for example, in cases where a complaint is made against a particular cosmetic product.

Health Canada interprets claims under two categories: a) fixed-date claims and b) claims with no fixed date:

1. Fixed-date claims are those that either include a date (e.g., 'Cruelty-free since 2025') or explicitly claim to be starting from a given point in time and moving forward.^Footnote 1 Fixed-date claims will be assessed for accuracy from the earlier of: the date the claim is first made, or the date indicated in the claim, but no earlier than December 22, 2023.

   Other examples of fixed-date claims include: 'Not tested on animals since YYYY;' or claims (symbols or words) from known third-party certification organizations (i.e., Leaping Bunny, PETA Beauty without Bunnies) that are explicit about the forward-looking characteristic of their certification.

2. Claims with no fixed date are those that are general and don't include a date (such as, 'Not tested on animals,' 'Cruelty-free,' or 'Never tested on animals'). Unless the claim explicitly indicates that it is occurring from a point forward (on the claim itself or publicly on the third-party certification website/program), Health Canada will interpret it as being a claim with no fixed date. Health Canada will assess the veracity of claims with no fixed date as of December 22, 2023.

5.0 Supplying evidence upon request of the Minister

Health Canada may request that evidence be submitted, as part of the compliance and enforcement measures for the ban on cosmetic animal testing.

Health Canada will consider different types of evidence to demonstrate that industry:

• has not engaged in any animal testing to establish the safety of their cosmetic product;
• can demonstrate the safety of their product without relying on non-permissible data; or,
• has not made any false claims on their labels or in their advertising.

Below are some of the types of evidence that Health Canada considers acceptable:

• An affidavit attesting that no animal testing was conducted by the manufacturer and that they can establish the safety of the cosmetic relying solely on permissible data;
• Evidence of a continuous monitoring system to ensure all suppliers and manufacturers associated with the product are not testing on animals;
• Evidence of a recent independent audit by a reputable third-party organization^Footnote 2 that concludes that no animal testing has been conducted; and,
• Standard Operating Procedures that demonstrate that all products, raw materials and ingredients are checked for any new animal testing regularly.

Health Canada may accept other types of evidence as well. Health Canada will consider each piece of evidence individually on its own merit to determine whether any evidence provided by the manufacturer or importer is sufficient for its purpose.

Appendix A: Illustrative examples

Example 1

Product A, a skin cream, has been sold in Canada for 2 years prior to the coming into force of the new requirements on December 22, 2023. The product relies on animal testing data to demonstrate its safety. Once the new requirements come into effect, paragraph 16.1(2)(e) enables Product A to continue to be sold in Canada, as products already on the market before December 22, 2023, may continue to rely on their existing animal testing data to demonstrate safety.

Note: If Product A is reformulated, it could be considered a new product. If it is a new product, it would be subject to the new requirements and its sellers must be able to demonstrate the safety of their product with reliance only on allowable data.

Example 2

Product B, a shampoo, has been sold in Canada for 7 years prior to the coming into force of the new requirements. It has a claim on the label that the product is not tested on animals. After the new requirements come into effect on December 22, 2023, a complaint is filed with Health Canada that questions the validity of that claim. Health Canada requests from the manufacturer evidence that the product has not been tested on animals since December 22, 2023, despite the product's 7-year marketing history in Canada. The manufacturer provides appropriate evidence.

Note: Health Canada can forward the complaints it receives in relation to claims based on actions that occurred prior to December 22, 2023, to the Competition Bureau for their consideration.

Example 3

Product C, a facial cleanser, is sold in Canada beginning in January 2024. The product contains an ingredient that is also found in a pharmaceutical that is marketed in another country (i.e., a mixed-use ingredient). To demonstrate the safety of the product, the manufacturer relies on non-animal testing data for some ingredients and animal testing data to demonstrate the safety of the mixed-use ingredient as permitted under paragraph 16.1(2)(c). The manufacturer maintains records that demonstrate that the animal testing data was required for the mixed-use ingredient under the other country's legislative requirements for pharmaceuticals and that a pharmaceutical containing that ingredient is sold in that country. The manufacturer does not have a labelling claim on Product C that the product is not tested on animals because one ingredient does rely on animal testing data to demonstrate its safety. The sale of the product would not be prohibited under sections 16.1 or subsection 16.3(1).

Example 4

Product D, a lipstick, is marketed by a make-up manufacturer. To sell in a foreign jurisdiction, the manufacturer conducted animal testing in that country and used, in that jurisdiction, the resulting data to demonstrate Product D's safety. The manufacturer possesses sufficient alternative non-animal testing data to demonstrate the safety of Product D in Canada. The product's labels and advertisements do not claim that Product D is not tested on animals. The sale of the product would not be prohibited under sections 16.1 or subsection 16.3(1).

Example 5

A manufacturer plans to introduce Product E, a deodorant, into Canada in January 2024 after the new requirements came into force. The product contains an ingredient that relies on animal testing data to demonstrate its safety. At this point in time, there is no alternative non-animal data that the manufacturer can rely on to demonstrate safety and the animal testing data does not satisfy any of the exceptions under paragraphs 16.1(2)(a) through (f). The manufacturer would not be able to introduce Product E into Canada.

Note: Should the manufacturer be able to rely on non-animal data or satisfy any of allowable exceptions for the use of animal data in the future, then the product would not be prohibited under subsection 16.1(1).