Cosmetics and Personal Care

We provide full-service regulatory licensing, compliance and product development services to cosmetic and personal care product brands comply with Canadian regulatory requirements.

In Canada, the labelling of cosmetics is governed the Food and Drugs Act and the Cosmetic Regulations, the Consumer Packaging and Labelling Act and the Consumer Packaging and Labelling Regulations. WE support manufacturers and importers of cosmetic products with making sure their products meet the requirements in the Acts.

To ensure compliance in the cosmetic industry, especially in light of the Modernization of Cosmetics Regulation Act (MOCRA) in the United States, audits must address a set of globally recognized quality and regulatory standards. These criteria ensure that cosmetic products are safe, accurately labeled, manufactured under appropriate controls, and meet evolving expectations across both U.S. and international markets.

Here’s a breakdown of the most important audit criteria for cosmetics, incorporating MOCRA and relevant global requirements:

Key References:

• ISO 22716 – Cosmetics – Guidelines on Good Manufacturing Practices (globally harmonized)
• Health Canada GMP Guide for Cosmetics
• MOCRA Section 606 – Mandatory GMP Requirements (pending rulemaking)

Audit Criteria:

• Facility hygiene and environmental control
• Equipment maintenance and cleaning validation
• Raw material and finished product storage conditions
• Batch records and production traceability
• Quality control and microbiological testing
• Training and hygiene of personnel
• Change control and deviation documentation

Note: MOCRA mandates that FDA will finalize and enforce GMP regulations for cosmetics by December 2025, modeled closely on ISO 22716.

MOCRA Requirements:

• All cosmetic manufacturing facilities must register with the FDA
• Cosmetic products and their ingredients must be listed annually
• Foreign facilities must appoint a U.S. Agent

Audit Criteria:

• Facility registration records
• Product listing status and update history
• Responsible person designation
• U.S. Agent contact validation for foreign sites
• Communication procedures for FDA inspections or inquiries

MOCRA Section 608:

• Every marketed cosmetic product must be adequately substantiated for safety based on tests, studies, or other evidence.

Audit Criteria:

• Presence of safety substantiation dossiers
• Ingredient toxicological review and justifications
• Dermatological and clinical study summaries (if applicable)
• Allergen testing, particularly for leave-on products
• Safety claims substantiation vs. marketing language

MOCRA Section 605:

• Requires reporting of serious adverse events to the FDA within 15 days
• Firms must maintain records of all complaints for 6 years (or 3 years for small businesses)

Audit Criteria:

• SOPs for adverse event intake and classification
• Documentation and response records for all complaints
• Tracking systems for medically significant or unexpected reactions
• FDA MedWatch reporting readiness
• Recordkeeping policies aligned with statutory retention periods

MOCRA Section 609–610:

• Labeling must include contact information for reporting adverse events
• MOCRA will mandate fragrance allergen disclosure (rulemaking expected in 2025)

Audit Criteria:

• Compliance with current U.S. and Canadian labeling rules (INCI, bilingual requirements, etc.)
• Ingredient declarations and net content verification
• Fragrance and allergen review documentation
• Processes for updating labels based on regulatory changes
• Verification of marketing claims (e.g., “hypoallergenic,” “natural”)

ISO 22716 & Health Canada Guidelines:

• All ingredient suppliers, contract manufacturers, and packaging providers must be vetted for compliance.

Audit Criteria:

• Supplier qualification program and audit trail
• Technical and quality agreements
• Certificate of Analysis (CoA) validation and traceability
• Subcontractor GMP compliance verification
• On-site audit reports or virtual inspection evidence

Additional Considerations:

• EU Regulation (EC) No. 1223/2009 – Cosmetic Product Safety Report (CPSR), PIF
• Health Canada’s Cosmetic Ingredient Hotlist – Restrictions and prohibitions
• ASEAN Cosmetic Directive – For manufacturers targeting Asia-Pacific markets

Audit Criteria:

• Ingredient screening across global Hotlists and banned substance lists
• Regulatory gap assessments for multi-jurisdictional sales
• Product Information File (PIF) or equivalent technical documentation
• Market-specific labeling, claim, and testing adjustments

Cosmetic manufacturers, private-label brands, and importers must now treat compliance as a proactive, strategic function. MOCRA has aligned U.S. regulations with global frameworks like ISO 22716, placing greater emphasis on:

• Operational transparency
• Safety substantiation
• Regulatory readiness
• Global supplier accountability

MCS Associates helps cosmetic companies prepare and thrive in this new regulatory environment with GMP and MOCRA-aligned audits that identify risk, strengthen systems, and ensure product quality from concept to consumer.