Compliance Verification Project 2022-2023: Cosmetic Regulations
Consumer Product Enforcement Summary Report
Fiscal Year 2022-2023
Summary
The Consumer Product Safety Program (CPSP) administers and enforces the Food and Drugs Act (FDA) and Cosmetic Regulations (CR).
The purpose of this Compliance Verification (CV) project was to verify industry's compliance of tattoo inks and permanent make-up pigments with Sections 16 and 18 of the FDA and other specific requirements of the CR.
For this project, compliance of select tattoo inks and permanent make-up pigments with the FDA and CR was determined through a sampling and testing process. Relevant products were sampled from both physical and online establishments by Health Canada inspectors. Compliance with the requirements listed under the FDA and CR was then verified through testing at both of Health Canada's Product Safety Laboratory and Regulatory Operations and Enforcement Branch Microbiology Laboratory.
Prior to initiating inspections, the CPSP carried out a market survey to determine the presence of tattoo ink and permanent make-up pigment companies in Canada. This effort resulted in a list of companies that included tattoo parlours, retailers, importers, and manufacturers. These companies were provided a letter informing them that tattoo inks and permanent make-up pigments are regulated as cosmetics in Canada and are subject to the requirements of the FDA and its CR. Targets were then selected from that list of companies.
Over the course of the 2022 to 2023 fiscal year, chemical and microbial testing of 30 different products was carried out, where 27 of the 30 samples were imported products. The testing resulted in 3 stop distributions and 23 commitments to address non-compliance. There were 4 instances in which no corrective action was required.
Results
Readers should consult the individual recall and safety notices, if applicable, for details of the products subject to this enforcement action.
| Brand | Product Name | Source of Sample | Country of Origin | Determination | Corrective Action(s) |
|---|---|---|---|---|---|
| Airless Color | Permanent Make-up Airless Color Cappuccino | Distribution IB | France | Canadian importer was not listed on notification | Commitment by Distribution IB |
| Allegory | Allegory Blak | Black Watch Tattoos (Life-Inx Supply Co.) | United States of America | Labelling issues identified | Commitment by Allegory Ink |
| BaodeLi | BaodeLi Tattoo Ink – All Purpose Black | Amazon Canada | Germany | Did not meet microbial limit requirements | Stop Distribution by BaodeLi |
| Biotouch | Biotouch Pure Micro-pigment (Ash Mudpie) | Biotouch Canada | United States of America | Labelling issues identified | Commitment by Biotouch Canada |
| Bloodline Tattoo Inks | UV Blacklight Yellow | Studio One Tattoo Supplies | United States of America | Did not meet microbial limit requirements | Stop Distribution by Bloodline Tattoo Inks |
| Doreme | Doreme – Chocolate Kiss #237 | Investus Inc. Canada | South Korea | Labelling issues identified | Commitment by Investus Inc. Canada |
| Dynamic | Dynamic MD1 (Magenta) | Prévention Hygie | United States of America | Labelling issues identified and product has not been notified | Commitment by Prévention Hygie |
| Electrum Ink | Electrum Ink – Kirby | HYVE Beauty | United States of America | Labelling issues identified and product has not been notified | Commitment by HYVE Beauty |
| Empire Inks | Empire Inks – Dark David Vega Transparent Gray | Empire Tattoo Supplies | United States of America | Labelling issues identified and product has not been notified | Commitment by Empire Tattoo Supplies |
| Eternal Ink | Dark Brown Tattoo Ink | Extreme Tattoo Equipment | United States of America | Labelling issues identified and product has not been notified | Commitment by Extreme Tattoo Equipment |
| Eternal Ink | Lining Black | Worldwide Tattoo Supply Canada | United States of America | Labelling issues identified | Commitment by Worldwide Tattoo Supply Canada |
| Ever After Pigments | Ever After Pigments – Maleficent | HYVE Beauty | United States of America | Labelling issues identified and product has not been notified | Commitment by HYVE Beauty |
| Fusion | Fusion Tattoo Ink – Jeff Gogue's Super Red | Northern Tattoo Supply Inc. | United States of America | Labelling issues identified and product has not been notified | Commitment by Northern Tattoo Supply Inc. |
| Good Geisha | Tobiko Pigment | Good Geisha | Canada | No compliance issues identified | None |
| Halcyon Professional | Li Pigments (Beach Blonde) | Halcyon Professional | United States of America | Labelling issues identified and product has not been notified | Commitment by Halcyon Professional |
| Helios | Helios Reserve Private Stock – Black Outlining Ink | Northern Tattoo Supply Inc. | United States of America | Labelling issues identified and product has not been notified | Commitment by Northern Tattoo Supply Inc. |
| Industry Inks | Industry Inks Crimson Red | Anarchy Tattoo Supplies | United States of America | Labelling issues identified | Commitment by Industry Inks |
| Ink & Arch | Professional Tattoo Ink Pigment 222 - Yellowish Brown | Ink & Arch Microblading and Cosmetic Tattoo Studio | Canada | Labelling issues identified | Commitment by Ink & Arch Microblading and Cosmetic Tattoo Studio |
| Intenze | Intenze Advanced Tattoo Ink – Cherry Bomb | Steri-Studio | United States of America | Labelling issues identified and product has not been notified | Commitment by Steri-Studio |
| Lauro Paolini | Noir “Black” by Lauro Paolini | Quebec Tattoo Supply | Italy | Labelling issues identified and product has not been notified | Commitment by Quebec Tattoo Supply |
| Micro- Pigmentation Centre (Chanco Beauty) | Micro- Pigmentation Centre – Med Collection Areola Pink | Micro-Pigmentation Centre (Chanco Beauty) | Canada | Labelling issues identified and product has not been notified | Commitment by Micro-Pigmentation Centre (Chanco Beauty) |
| National | National – Triple Black Ink | Studio One Tattoo Supplies | United States of America | Did not meet microbial limit requirements | Stop Distribution by National Tattoo Supply |
| Radiant | Radiant Colors tattoo ink (Banana Bright & Strong) | Source Tattoo Supply | United States of America | Labelling issues identified and product has not been notified | Commitment by Source Tattoo Supply |
| Raw Premium Pigment | Raw Premium Pigment – Smoke | Empire Tattoo Supplies | United States of America | Labelling issues identified and product has not been notified | Commitment by Empire Tattoo Supplies |
| Shadink Tattoo Ink | Shadink -Medium Yan Solo Signature Series (Gray Wash) | Shadink Tattoo Ink | United States of America | Labelling issues identified | Commitment by Shadink Tattoo Ink |
| Silverback Ink | Silverback Ink – Stupid Black | Mithra Tattoo Supplies | United States of America | No compliance issues identified | None |
| Solid Ink | Banana | FYT Supplies | United States of America | No compliance issues identified | None |
| Startbrite Colors | Startbrite Colors – Tribal Black | Quebec Tattoo Supply | United States of America | Labelling issues identified and product has not been notified | Commitment by Quebec Tattoo Supply |
| TruccArt | Truccart Tattoo Pigment 4 For Eyebrow (Dark Ash Brown) | Natali Products Inc. | Germany | Labelling issues identified | Commitment by Natali Products Inc. |
| World Famous | World Famous – Dead Sea | Canada Tattoo Supply | United States of America | No compliance issues identified | None |
Disclaimer: Inspectors apply a systematic bias during the selection of establishments and samples. Inspectors do not select products randomly; instead, they select the ones that are more likely not to meet health and safety requirements due to observed characteristics. Due to this biased nature of sampling and the fact that sample sizes within CV projects are very small, Health Canada does not consider the findings of CV projects to reflect overall market compliance, unless otherwise stated. Note that these summary reports relate only to the product(s) actually tested and the specific criteria measured in this project. Testing by Health Canada does not represent approval or endorsement of the product(s).
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