Cosmetic Compliance
Intelligence & Solutions
Canadian Cosmetic Regulation
Dec 29, 2023
Hedy He
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All cosmetics sold in Canada must be safe for use and must not pose any health risk to humans. They shall comply with the Cosmetic Regulations under the Food and Drugs Act. Furthermore, Canada dictates that cosmetics must be produced, preserved, packaged, and stored under hygienic conditions.

To ensure compliance, manufacturers and importers are required to notify Health Canada about their intention to sell the product and provide a list of ingredients used. Moreover, cosmetics must meet the requirements outlined in the Consumer Packaging and Labeling Act, ensuring proper packaging and labeling practices.

Part 1 Regulatory Framework and Competent Authority

1.1 Existing Main Cosmetic Regulations in Canada

Canada's legal and regulatory system operates on three primary levels: Act, Regulation, and Guidance. The Act serves as the foundational framework for governing various aspects of society. The second level is Regulation, which is derived from the Act and provides more specific and detailed instructions on how to enforce Act. At the third level, the Guidance, which is not a legally binding act and regulation in Canada, serves as an interpretive document that consolidates the requirements outlined in relevant acts and regulations. Nonetheless, enterprises are recommended to follow the Guidance to ensure compliance. Together, these three levels form a comprehensive structure that ensures legal compliance and provides guidance within Canada's regulatory framework.

The table below lists Canada's existing main cosmetics regulations.




Effective Date



Food and Drugs Act

Food and Drugs Act is a key legislation in Canada, governing the production, import, export, provincial transportation, and sale of various products, including food, drugs, cosmetics, and contraceptive device. Originally enacted in 1920, it underwent its most recent revision on June 22, 2023.


The Act provides definitions of these products, sets forth general safety requirements for cosmetics, and confers inspectors with the authority to conduct in-site inspections, sampling and confiscation.

June 22, 2023

In force


Consumer Packaging and Labelling Act

The Consumer Packaging and Labelling Act and its subordinate Consumer Packaging and Labelling Regulations prescribe the mandatory information that must appear on the label of pre-packaged cosmetic products.


The Act and Regulations also address false and misleading representation of the product and the standardization of container size.

January 15, 2019

In force


Cosmetic Regulations (CR)

The Cosmetic Regulations, as a subordinate regulation of the Food and Drugs Act, establishes comprehensive requirements pertaining to the notification, inspection, importation, sampling, sales, labeling, packaging, and safety evidence of cosmetics.


The Regulations mandates that cosmetics available in the Canadian market must be manufactured, prepared, preserved, packed, and stored in adherence to stringent sanitary conditions.

June 17, 2019

In force


Consumer Packaging and Labelling Regulations

The Consumer Packaging and Labelling Act and Consumer Packaging and Labelling Regulations prescribe the mandatory information that must appear on the label of pre-packaged cosmetic products.


The Act and Regulations also address false and misleading representation of the product and the standardization of container size.

June 17, 2019

In force


How to Complete a Cosmetic Notification Form

Cosmetic manufacturers and importers are required to submit a cosmetic notification form within 10 days from the initial sale of their products in Canada. This Guidance is formulated to assist businesses in completing the online Cosmetic Notification form.

December 18, 2017

In force


Industry Guide for the Labelling of Cosmetics

This Guidance is designed to assist in the preparation of labels that comply with Canadian regulatory requirements for cosmetics.

July 21, 2022

In force


Guide to Cosmetic Ingredient Labelling

This Guidance is to help understand the nuances of the International Nomenclature of Cosmetic Ingredients (INCI) system of ingredient labelling. This Guidance includes tables to clarify common questions, ingredient label examples, and tips to verify proper INCI labelling.

May 1, 2012

In force


Guidelines for the   Nonprescription and Cosmetic Industry Regarding Non-therapeutic Advertising and Labelling Claims

Cosmetics are not allowed to have therapeutic claims. The Guidance is developed to help marketers differentiate non-therapeutic claims from therapeutic claims and is used by Advertising Standards Canada, the advertising industry's non-profit self-regulating body, to provide preclearance services for cosmetic broadcast advertising copy.

October 1, 2016

In force


Guidance on Heavy Metal Impurities in Cosmetics

Many heavy metals are not acceptable as ingredients in cosmetic products sold in Canada as they may cause injury to the health of the user. Yet they may still be found in cosmetics as impurities because they are widely persistent in the natural environment. The purpose of this Guidance is to determine and communicate appropriate limits of impurities in cosmetic products, with the focus on heavy metals with known significant toxicological properties: lead, arsenic, cadmium, mercury and antimony.

July 26, 2012

In force


Classification of Products at the Cosmetic-Drug Interface

This Guidance provides a principled approach on the classification of products at the cosmetic-drug interface.

January 6, 2022

In force


Guidance Document: Animal Testing Ban on Cosmetics

This Guidance is to inform the cosmetics industry about the new ban on cosmetic testing on animals in Canada.

December 4, 2023

In force

1.2 Competent Authority

Health Canada, as an agency of the Canadian government, plays a vital role in safeguarding and enhancing the health of Canadians. It contributes to minimizing health risk factors for Canadians through regulations on drugs, food, medical devices, health supplements, cosmetics, etc.

Regarding cosmetic regulation, Health Canada has specific responsibilities, which include accepting cosmetic notifications, establishing ingredient usage requirements, and conducting post-market surveillance, etc.

Part 2 Cosmetic Products

2.1 Cosmetic Definition

Under the Food and Drugs Act, cosmetic is defined as "any substance or mixture of substances, manufactured, sold or represented for use in cleansing, improving or altering the complexion, skin, hair or teeth and includes deodorants and perfumes." This also includes:

  • cosmetics used by professional esthetic services

  • bulk institutional products such as hand soap in school rest rooms

  • "handmade" cosmetics sold through home-based businesses or craft sales


Cosmetic Products

  • Soap

  • Deodorants/antiperspirants

  • Make-up

  • Hair dyes

  • Tattoo inks

  • Tooth whiteners

  • Mouthwash

  • Nail adhesives

  • Hotel amenities

Not Cosmetic Products

  • Sunburn protectants (cosmetics can contain sunscreens if no sunscreen protection claims present)

  • Anti-caries toothpastes

  • Antidandruff shampoo

  • Skin whiteners/lighteners

  • Injectables (collagen, botox)

  • Intentionally swallowed products (vitamins, etc.)

Some products that share characteristics of both "cosmetic" and "drug" are harder to be classified. Health Canada evaluates and determines whether they should be classified as a cosmetic on a case-by-case basis. In making this determination, Health Canada takes into consideration the following factors:

1. Representation: The product is represented for sale to serve a or more cosmetic function(s) such as cleansing, moisturizing, lubricating, perfuming or altering the hair, skin or teeth of humans.

2. Composition: While the product's classification cannot be solely decided according to its composition, the presence or concentration of certain ingredients may render the product unsuitable for classification as a cosmetic.

3. Level of Action: Typically, cosmetics are intended for external application and are not designed to penetrate below the skin to achieve their desired cosmetic effect.

Furthermore, in making the determination, the below points need attention:

  • Cosmetics can be applied to the skin surrounding the eyes, but products specifically intended for direct application into the eyes do not fall under the cosmetic classification.

  • Products administered through ingestion, inhalation, or injection (such as intramuscular, subcutaneous, or intravenous routes, with the exception of tattoo ink) are not classified as cosmetics.

2.2 General Safety Requirements

Health Canada sets safety rules through the Food and Drugs Act and the Cosmetic Regulations. All cosmetics sold in Canada must ensure:

1) Compliant Ingredient Use

Cosmetics must be free from contaminants and substances that could potentially harm consumers when used as directed. Health Canada maintains the Cosmetic Ingredient Hotlist, which outlines prohibited and restricted ingredients in cosmetics.

Enterprises must notify Health Canada of the composition of their cosmetics, allowing for monitoring and verification against the Cosmetic Ingredient Hotlist. If any safety concerns arise, the cosmetic product may be prohibited from the market.

2) Hygienic Production and Storage Conditions

Cosmetics must be manufactured, prepared, preserved, packed, and stored under hygienic conditions to ensure consumer safety. While specific methods for proving product safety are not prescribed by legislation, it is the responsibility of manufacturers to determine and demonstrate the safety of their products.

While Canada does not mandate the obtain of a production license or strictly enforce Good Manufacturing Practices (GMP), companies are encouraged to adhere to ISO Cosmetics GMP Standard: 22716. It is essential to establish quality control systems for impurities and microorganisms, as well as maintain appropriate packaging and storage conditions.

3) Compliant Label

Cosmetic product labels must comply with specific requirements outlined in various acts and regulations, including the Food and Drugs Act, Cosmetic Regulations, and Consumer Packaging and Labeling Act.

2.3 Cosmetic Notification

Section 30 of the Cosmetic Regulations stipulates that manufacturers or importers are obligated to submit a Cosmetic Notification Form (CNF) to Health Canada within 10 days from the first sale of a cosmetic in Canada. In the case of imported products, it is advisable to notify Health Canada before the importation takes place. Failure to notify may result in the denied entry into Canada or removed from sale.

The notifier can be the manufacturer, importer, distributor, or an authorized third party. While it is not mandatory for the notifier to be a Canadian company, the notification information must include the contact information of a Canadian manufacturer, importer, or distributor.

There are no fees associated with submitting the notification. After the CNF has been completed, no publicly available platform will disclose information on the corresponding products. For comprehensive instructions on completing the CNF, please refer to the How to Complete a Cosmetic Notification Form.

1. Notification Information

Information Required for Notification

1. Notification type

2. Brand and product name

3. First sale date (actual or expected)

4. Other product names

5. Product description

6. Application area

7. Product function

8. Product dosage form

9. The name and address of the manufacturer on the label and the actual manufacturer

10. The name and address of the Canadian manufacturer or importer or distributor

11. Name and position of the notifier

12. Product labels (under certain circumstances, such as cosmetics with safety warning labeling requirements)

13. Product formula (ingredient name and concentration/concentration range)

2. Notification Review

The CNF can be submitted online to Health Canada. Once submitted, the company can proceed with placing the product on the market. However, it is important to note that submitting the CNF does not imply that the product has been approved for sale, classified as a cosmetic, or complied with all legal requirements. The CNF will undergo subsequent review by Health Canada.

During the review process, Health Canada may have inquiries regarding the product notification information or encounter issues with the product itself, such as unknown ingredients, missing information, safety concerns, and improper classification, etc. In such cases, Health Canada will contact the notifier for additional information to ensure the product's safety. The table below provides an overview of common reasons for non-compliance and possible outcomes of the notification review.

Common Reasons for Non-compliance

  • The ingredient use does not comply with the requirements in Cosmetic Ingredient Hotlist

  • The product contains ingredients beyond the scope of cosmetic ingredients, which makes the product ineligible to be classified as cosmetics (e.g. containing medicinal ingredients)

  • Therapeutic representation in the product's name, label or website

  • Incorrect calculations of ingredient concentrations

  • The cosmetic name or ingredient list on the form is not consistent with the submitted label

Possible Notification Review Results for Notifiers

  • Provide more information to demonstrate the product safety

  • Provide labels

  • Re-label the product

  • Reformulate the product

  • Remove the product from sale

  • Recall the product

  • Submit a product license application to a different Health Canada program such as the Health Products and Food Branch or the Pest Management Regulatory Agency

Once the identified issues have been addressed and resolved, Health Canada will issue a Cosmetic Number (CN), a unique 7-digit identifier, to the notifier via email. While the review process may take several months, companies are permitted to place the product on the market upon completing the CNF submission without waiting for the CN to be issued. The CN primarily serves as a reference for future amendments of the CNF or discontinuation of sale, allowing enterprises to expedite processing by entering the CN in the online system.

3. Notification Amendments and Discontinuations

It is important to keep the most accurate and up-to-date information in the CNF. Manufacturers and importers must amend and resubmit the CNF to Health Canada within 10 days when there are changes on the product that affect the information provided. Examples of such changes include

  • modifications to the cosmetic formulation;

  • changes in the product name;

  • discontinuation of sale;

  • new company name, address, or contact information.

2.4 Cosmetic Labeling

Cosmetic labeling is regulated by two Acts and their associated Regulations:

1. Food and Drugs Act and its subordinate Cosmetic Regulations:

  • The Act and Regulations specify the necessary information that must be included on the label, as well as the specific requirements

2. Consumer Packaging and Labelling Act and its subordinate Consumer Packaging and Labelling Regulations:

  • The Act and Regulations specify the labeling requirements for net quantity. Additionally, they emphasize that the label must not contain any false or misleading claims.

The following table outlines the five essential pieces of information that must be included on the label. It is crucial that they are clear and easily identifiable under normal purchase and use conditions.

Required Items

Labeling Requirements


Inner Label

Outer Label

The identity of the cosmetic in terms of its common or generic name or in terms of its function, unless the identity is obvious

1. Marked on the main display panel of the product;

2. For main display panels larger than 10 square centimeters, the minimum letter height should be 1.6 mm. For main display panels smaller than 10 square centimeters, the minimum letter height should be 0.8 mm.

1. Bilingual (English and French);

2. For products that have both inner and outer label, the product name and function on the inner label can be marked in English and/or French.



Net quantity

1. Marked on the main display panel of the product;

2. Expressed in metric units;

3. A space should be maintained between numbers and metric characters;

4. In clear contrast to other contents on the packaging;

5. Depending on the size of the main display panel, specific requirements for character's height apply. Please refer to section 5.1.1 of the Industry Guide for the Labeling of Cosmetics for detailed information.

Bilingual (English and French)



The name of the manufacturer and the address of their principal place of business

1. For products produced overseas, enterprises can choose any of the following information for labeling:

  • The name and address of the overseas distributor;

  • The name and address of the Canadian distributor, use "imported by" or "imported for" as the guide word;

  • The name and address of the Canadian distributor and a statement of the product's country of origin.

2. Not marked on the bottom;

3. For main display panels larger than 10 square centimeters, the minimum letter height should be 1.6 mm. For main display panels smaller than 10 square centimeters, the minimum letter height should be 0.8 mm.

English and/or French



List of ingredients

1. The International Nomenclature of Cosmetic Ingredients (INCI) name shall be used for each ingredient. If an ingredient does not have an INCI name, its chemical name shall be used;

2. Ingredients with concentrations above 1% shall be listed in descending order. Ingredients with concentrations below 1% can be listed in any order;

3. Flavors and fragrances shall be labeled by using the terms "parfum" or "aroma" (fragrance allergen labeling is not currently mandatory);

4. Colorants shall be labeled by using CI numbers;

5. For main display panels larger than 10 square centimeters, the minimum letter height should be 1.6 mm. For main display panels smaller than 10 square centimeters, the minimum letter height should be 0.8 mm.

1. If the ingredients are listed in the Schedule of the Cosmetics Regulations, they must be labeled with the EU trivial name and/or the English and French equivalents provided in the Schedule;

2. Except for INCI names and EU trivial names, other ingredient names shall be bilingual (English and French).



Avoidable hazards and cautions

1. If the use of the product presents avoidable hazards, the label must bear warnings on how to use the product to eliminate the hazard, including instructions for use, precautions and related symbols;

2. Avoidable hazards and cautions is also applicable to certain products that have specific safety warning labeling requirements, such as hair dyes containing specific ingredients, products containing mercury as preservative, genital deodorants in pressurized containers, pressurized metal containers, flammable products in pressurized metal containers, mouthwash, etc.;

3. For main display panels larger than 10 square centimeters, the minimum letter height should be 1.6 mm. For main display panels smaller than 10 square centimeters, the minimum letter height should be 0.8 mm.

Bilingual (English and French)



2.5 Cosmetic Claims

A claim can be a word, a sentence, a picture, a symbol, a paragraph or an implication on product labels, package inserts or advertisements, including company websites. Together, these claims are used to create a net impression of what the product is and does.

Regarding cosmetic claims, enterprises shall pay attention to the following points:

1. Claims must be true and verifiable

It must accurately convey the attributes, features and benefits of the product. Companies must be able to substantiate claims made on labels and advertisements and keep the substantiation data and evidence. This may include ingredient properties, research data, test results, etc.

2. Claims shall not contain false or misleading statements

False or misleading statements include situations such as:

  • The labeled net quantity is inconsistent with the actual quantity;

  • The claim indicates that a product contains a specific ingredient that is not actually present.

3. No manufacturer shall make the below claim on a label of or in an advertisement for a cosmetic, unless the manufacturer has evidence that validates the claim:

  • the ability of the cosmetic or any of its ingredients can influence the chemistry of the skin, hair or teeth; or

  • the formulation, manufacture or performance of the cosmetic implies that the user of the cosmetic will not suffer injury to their health.

4. Any terms of therapeutic effects are prohibited

Health Canada authorized Advertising Standards Canada (ASC) to develop Guidelines for the Nonprescription and Cosmetic Industry Regarding Non-therapeutic Advertising and Labelling Claims. This Guidelines provides examples of prohibited therapeutic claims for six cosmetic product categories: antiperspirants, hair care products, nail care products, intimate products, oral care products, and skin care/color cosmetics.

Product category

Therapeutic claims that cannot appear on the labels or in advertising of cosmetic products


  • Hyperhidrosis

  • Persistent protection whose mechanism of action modifies organic function

  • Problem/Excessive perspiration

Hair Care

  • Anti-dandruff products

  • Controls/Eliminates/Prevents dandruff

  • Stimulates hair growth

Nail Care

  • Promotes nail growth (physiological)

  • Antifungal

Intimate Products

  • Enhances sperm motility/Improves chances of conception

  • Contains spermicide/spermicidal

  • Helps maintain normal pH level

Oral Care

  • Removes permanent stains

  • Prevents plaque/tartar build-up/deposit/formation by chemical or antimicrobial action

  • Anti-plaque/Anti-tartar

Skin Care/Makeup

  • Repairs (damaged) skin

  • Repairs the skin’s moisture barrier

Other Claims

  • Prescription strength/Rx/Pr

  • Active/Effective/Medicinal/Therapeutic ingredient

Notes: The lists are not exhaustive, and should be used only as a guide.

Please refer to Cosmelist for detailed information.

2.6 Animal Testing Ban

The Budget Implementation Act, Bill C-47 was passed by the Senate on June 22, 2023, and officially came into effect on December 22, 2023. This significant legislation marks the legal prohibition of cosmetic testing on animals in Canada. The following amendments have been implemented as part of this crucial legislation:

1) testing cosmetics on animals in Canada;

2) selling cosmetics that rely on animal testing data to prove the product's safety, with some exceptions; and;

3) false or misleading labeling related to the testing of cosmetics on animals.

The amendments allow the sale of cosmetics that rely on data derived from animal testing, provided that the data satisfies any of the following four conditions:

  • the animal testing was conducted before the prohibition on sale came into force;

  • the animal testing data has been published by the Government of Canada on its website or in a scientific journal (e.g., referenced in a published Chemicals Management Plan assessment);

  • the animal testing data is publicly available and not conducted or sponsored by the manufacturer, importer, or seller; or

  • the animal testing was required to meet either a legislative requirement in Canada other than the cosmetic requirements under the Food and Drugs Act, or a requirement unrelated to cosmetics (e.g., pharmaceutical drugs) under another country's legislation, and the ingredient has a valid non-cosmetic use.

2.7 Advance Notice of Importation (ANI)

Upon arrival at the Canadian border, the Canada Border Services Agency (CBSA) refers cosmetics to Health Canada, which assesses them to see if they are compliant with Canadian cosmetics regulations. If the labeling of a specific batch of imported cosmetics fails to meet regulatory requirements, the following actions should be taken by importers:

  • Advance Notice of Importation (ANI) Submission: Importers must submit an ANI form to Health Canada before importing the cosmetics.

  • Changes or Relabeling: Importers are required to make necessary changes or relabel the products within three months after importation.

However, submitting an ANI form does not guarantee cosmetics and drugs entry into Canada. Health Canada will recommend entry refusal of cosmetics that cannot achieve compliance through modification or relabeling.

2.8 Post-market Surveillance

1. Compliance & Enforcement (C&E) Activities: Working with Product Safety Inspectors

C&E activities encompass the measures undertaken by regulatory authorities to ensure that manufacturers, importers, distributors, and other stakeholders comply with the established rules, regulations, and requirements governing the cosmetic industry.

Product safety inspectors play a key role in performing C&E activities. According to the Food and Drugs Act and its subordinate Cosmetic Regulations, product safety inspectors are empowered to:

  • Conduct inspections at premises where cosmetics are sold, manufactured, or stored, including collecting samples for testing or take photographs as evidence;

  • Make recommendations regarding the refusal of imports and provide an opportunity for non-compliant products to be rectified to achieve compliance under their supervision;

  • Seize non-compliant cosmetic products.

2. Other C&E Activities

In addition to the responsibilities of product safety inspectors, there are various other C&E activities that contribute to the enforcement of cosmetic regulations. These activities include:



Following-up on cosmetic notifications or incident reports received

Triggers for C&E activities:

  • Incorrect product classification

  • Missing notification information

  • Clarification required (i.e. unknown ingredient)

  • Verification of Cosmetic Ingredient Hotlist or Cosmetic Regulations conditions of an ingredient

  • Safety data request

Following-up on an imported product into Canada (referral from CBSA)


Product recall monitoring



Compliance Verification Projects

Projects to verify compliance of cosmetic products

Market survey

  • Sampling and compliance verification

  • Sample testing at the Product Safety Laboratory (PSL) or a third party lab

Outcome of the projects

  • Enforcement actions where non-compliance was detected

  • Determination of priorities, timelines and scope of future projects

Publish of results summary report

Part 3. Cosmetic Ingredient Use

3.1 Cosmetic Ingredient Hotlist

Health Canada maintains an extensive Cosmetic Ingredient Hotlist that outlines specific requirements for cosmetic products regarding ingredient usage, maximum concentration limits, and necessary warnings. However, it's important to note that the Hotlist primarily focuses on intentionally used ingredients and does not encompass common impurities or contaminants present at trace levels in finished products, such as heavy metals.

The Hotlist comprises two distinct tables:

1. Prohibited Ingredients

  • These ingredients are strictly forbidden in cosmetic products sold in Canada.

2. Restricted Ingredients

  • These ingredients are permitted under specific conditions or with the inclusion of cautionary statements. For example:

               Camphor: The maximum concentration is 3%.

               Ethyl methacrylate: Cautionary statement: "Avoid skin contact."

The Hotlist undergoes regular review and revisions through the review of the following items:

Identification of Ingredients for Review

Outcome of Review

1) New scientific information

2) New regulatory decisions (domestic and international)

3) Consumer complaints/injuries

4) Media

5) Industry request

6) Other concerns

1) Addition of the ingredient to Hotlist as Prohibited

2) Addition of the ingredient to Hotlist as Restricted:

  • Concentration

  • Method of application (e.g. aerosol vs liquid)

  • Type of product used (e.g. rinse off vs leave-on product)

  • Addition of cautionary statement

  • Request for Evidence of Safety (EoS)

3) Revision of existing entry on Hotlist

4) No concern with current use in cosmetics

While the Hotlist serves as an administrative tool for communicating substances that may pose risks when used in cosmetics, it should be noted that it is not an exhaustive list. The general prohibition applies as soon as the potential for injury is identified.

3.2 Other Ingredient Prohibitions

Besides the Hotlist, the Canadian government has issued other regulatory documents that prohibit the use of certain ingredients in general products, including cosmetics.




Effective Date



Controlled Drugs and Substances Act

Unless authorized, individuals are prohibited to possess substances listed in Schedule I, II, or III. Additionally, individuals are strictly prohibited to request, acquire, or seek authorization for substances listed in Schedule I, II, III, or IV.

August 30, 2023

In force


Prohibition of Asbestos and Products Containing Asbestos Regulations

The Regulations prohibits the manufacture, import and sale of consumer products containing asbestos.

December 30, 2018

In force


Microbeads in Toiletries Regulations

The Regulations prohibits the manufacture, import, and sale of toiletries that contain plastic microbeads used for exfoliation or cleansing. Covered toiletry products include bath and body products, skin cleansers, and toothpaste.

March 18, 2021

In force


Prohibition of Certain Toxic Substances Regulations

The Regulations prohibits the manufacture, use, sale, offer for sale and import of certain toxic substances, as well as products (including cosmetics) containing them, with a limited number of exemptions.

March 18, 2021

In force


Volatile Organic Compound Concentration Limits for Certain Products Regulations

The Regulations sets concentration limits for volatile organic compounds (VOCs) in around 130 product categories and subcategories. It is prohibited to manufacture or import products exceeding the category-specific VOC limits, unless a permit is obtained. Covered product types include personal care, automotive and household maintenance products, adhesives, adhesive removers, sealants, caulks, and miscellaneous items.

January 5, 2022

In force


Ministerial Prohibitions

Ministerial prohibitions prohibit any person from manufacturing or importing the substance in any amount.


In force