Product Safety and Compliance

At Lyrome Inc. product safety is the foundation of everything we make. This page describes how our products are formulated, manufactured, tested, and monitored, and how we respond to any concerns raised by customers or regulators.
If you have a safety concern about one of our products, please contact us immediately at care@lyrome.com.

1. Our Commitment

Every Lyrome product is developed with the goal of being safe, effective, and honest. This means:

• Formulations reviewed for ingredient safety before manufacturing
• Manufacturing in a facility that operates under Good Manufacturing Practice standards
• Ingredient disclosure using standard International Nomenclature of Cosmetic Ingredients (INCI) names
• Marketing claims we can substantiate
• A clear channel for customers to report adverse reactions and for us to act on them

2. Manufacturing

Lyrome products are manufactured by contract partners that operate under recognized cosmetic Good Manufacturing Practice (GMP) standards.

Our current primary manufacturer is Vicora Cosmetics Inc., a Health Canada licensed cosmetic manufacturing facility located in Ontario, Canada. Vicora holds relevant Canadian regulatory registrations and operates under ISO 22716 aligned processes for cosmetic GMP.

Every batch of product is subject to in-process quality checks and finished-product release criteria before it is shipped to us. Batch codes and manufacturing dates are recorded and traceable.

3. Ingredient Safety

Before a formulation is approved, ingredients are reviewed against internationally recognized safety standards, including:

• Health Canada’s Cosmetic Ingredient Hotlist
• The United States Food and Drug Administration’s list of prohibited and restricted cosmetic ingredients
• The European Union Cosmetics Regulation (Annexes I through VI)

Where relevant, we consult ingredient safety assessments published by bodies such as the Cosmetic Ingredient Review (CIR) and the European Scientific Committee on Consumer Safety (SCCS).

We disclose full ingredient lists using standard INCI nomenclature on our product packaging and on individual product pages.

4. Safety Substantiation

For each product we maintain a safety file that includes:

• Complete formula and ingredient specifications
• Manufacturer documentation and Certificates of Analysis
• Ingredient safety data
• Stability and preservative efficacy (challenge) test results
• Packaging compatibility information
• Cosmetic Product Safety Assessment where required by applicable jurisdiction

These records are retained for the periods required by Canadian, US, and EU regulations and are available to regulatory authorities on request.

5. Claims and Testing

Any claim we make about a product or our packaging, website, or marketing materials is intended to be truthful and substantiated. Where a claim depends on testing, we hold documentation of the relevant test on file.

Our products are cosmetics. They are intended to cleanse, beautify, moisturize, or otherwise care for the skin. They are not intended to diagnose, treat, cure, or prevent any disease. Statements about our products have not been evaluated by the FDA or Health Canada as therapeutic claims.

6. Regulatory Registrations

Canada

Lyrome products are notified to Health Canada as required under the Cosmetic Regulations. Manufacturing takes place in a Health Canada compliant facility.

United States

Under the Modernization of Cosmetics Regulation Act (MoCRA) of 2022, cosmetic manufacturers and Responsible Persons are required to register facilities and list products with the FDA. Lyrome and its manufacturing partners work to maintain compliance with MoCRA facility registration, product listing, and adverse event reporting requirements. Where a Responsible Person designation is required on packaging, we identify the appropriate legal entity on the product label.

European Union and United Kingdom

Products sold in the EU are notified in the Cosmetic Products Notification Portal (CPNP) through our authorized distributor. A Responsible Person located in the EU is designated for each product, in accordance with EU Regulation 1223/2009 and the United Kingdom Cosmetics Regulation.

Other markets

As we expand into additional markets, including the Gulf Cooperation Council (GCC) region, we work with local regulatory partners to ensure compliance with each market’s cosmetic product requirements.

Where a customer or authority requests documentation, we will respond within the timeframes required by the relevant regulation.

7. Certifications

Where products carry certifications such as Halal, Vegan, or Cruelty-Free, those certifications are held with the relevant certifying bodies and can be verified on request. Certification status is displayed on the individual product page and, where applicable, on packaging.

8. Patch Testing

We recommend performing a patch test before first use of any skincare product, particularly if you have sensitive skin or a history of allergic reactions to cosmetics.

How to patch test:

• Apply a small amount of product to the inside of your forearm.
• Leave undisturbed for 24 hours.
• If you experience redness, itching, burning, or any other irritation, do not use the product and rinse the area with water.

Even products formulated for sensitive skin can cause a reaction in some individuals. Everyone’s skin is different.

9. Reporting an Adverse Reaction

If you experience an adverse reaction after using a Lyrome product, please stop using it immediately and contact us at care@lyrome.com.

When you contact us, please include:

• Your name and contact information
• The product name and, if available, the batch code (printed on the bottom or back of the packaging)
• Where and when the product was purchased
• A description of your reaction, including when it started and how it developed
• Photos, if you are comfortable sharing them
• Whether you consulted a healthcare professional and, if so, their advice

We treat every report seriously. We will:

• Acknowledge your report within two business days
• Ask any follow-up questions we need to understand what happened
• Record the report in our safety file for the relevant product
• Report to regulatory authorities where required by law, including FDA serious adverse event reporting under MoCRA and cosmetovigilance reporting in the EU
• Offer a refund or credit for the affected product

Reporting an adverse reaction does not waive any legal rights you may have.

10. Product Recalls and Withdrawals

In the unlikely event that a safety issue requires a product to be withdrawn from sale or recalled, we will:

• Notify affected customers directly where we have their contact information
• Post a notice on lyrome.com
• Notify relevant regulatory authorities in each affected market
• Provide clear instructions on how to return or dispose of the product
• Issue a full refund

If you believe you have a product that is subject to a recall, contact care@lyrome.com for guidance.

11. Storage and Shelf Life

For best results, store Lyrome products:

• Away from direct sunlight
• At normal room temperature (avoid extreme heat or freezing)
• Tightly closed when not in use

Each product carries a Period After Opening (PAO) symbol on the packaging indicating how many months the product remains at its intended quality after opening. For unopened products, the batch code allows us to trace the manufacturing date on request.

12. Packaging and Sustainability

We work to select packaging that protects product integrity while minimizing environmental impact where practical. Packaging materials are selected in consultation with our manufacturer for compatibility with the formula. Recyclability varies by material and by local recycling programs.

13. Not Intended for Children

Our products are formulated for adult use. Keep out of reach of children. If a child ingests or is exposed to the product, seek medical advice.

14. Questions or Concerns

For any safety related question, contact:

Lyrome Inc.
Unit 12 Mississauga, Ontario,
L5L 3S3, Canada
Email: care@lyrome.com