Navigating the Key Regulations in Cosmetics Manufacturing

The cosmetics industry has evolved far beyond lotions and lipsticks. Today, it is a highly regulated sector, where compliance frameworks shape not only how products are manufactured but also how they are marketed and sold.

For brands, understanding and applying the right regulations is no longer optional; it is the foundation of consumer safety, legal compliance, and long-term success.

At the heart of cosmetics regulation are three major frameworks: ISO 22716, Regulation (EC) No. 1223 / 2009, and guidance from national regulators like the Health Products Regulatory Authority (HPRA) in Ireland. Together, they set the standards that every responsible manufacturer must meet.

Regulatory Insights for Safer Cosmetics.

ISO 22716: Good Manufacturing Practice for Cosmetics

ISO 22716 is the globally recognised guideline for Good Manufacturing Practices (GMP) in cosmetics. Unlike pharmaceutical GMPs, which are more stringent and product-specific, ISO 22716 translates GMP principles into the cosmetics context.

The standard provides detailed guidance on:

• Personnel: Training and hygiene of staff working in production.

  
  

• Premises and equipment: Facility design, maintenance, and equipment calibration to prevent contamination.

  
  

• Production controls: Procedures for consistent mixing, filling, and packaging.

  
  

• Raw materials and packaging: Storage, traceability, and quality checks to ensure input integrity.

  
  

• Finished product testing: Controls to confirm safety, stability, and compliance with specifications.

  
  

• Documentation: Standard operating procedures (SOPs), batch records, and audit trails that ensure traceability and accountability.

While ISO 22716 is technically voluntary, regulators in the EU and beyond increasingly expect manufacturers to demonstrate alignment with it.

Certification to ISO 22716 is also a powerful market signal, reassuring retailers and consumers alike that quality and safety are embedded in daily operations.

Regulation (EC) No. 1223 / 2009: The European Benchmark

For companies selling into the European Union, Regulation (EC) No 1223/2009 is the central piece of legislation governing cosmetics.

It sets clear requirements for placing products on the EU market, including:

• Responsible Person (RP): Every cosmetic product must have a designated RP based in the EU, legally accountable for compliance.

• Product Information File (PIF): A dossier maintained for each product, including the Cosmetic Product Safety Report (CPSR), proof of claimed effects, and GMP compliance.

• Notification: Products must be registered on the EU Cosmetic Products Notification Portal (CPNP) before sale.

• Labelling: Mandatory information such as ingredients, warnings, batch numbers, and expiry details must appear on packaging.

• Adverse event reporting: Serious undesirable effects (SUEs) must be reported to authorities.

• Bans and restrictions: Certain substances are prohibited or restricted in cosmetic formulations, with regular updates published by the European Commission.

Regulation 1223/2009 is widely considered the gold standard in cosmetics regulation and has influenced frameworks in other regions.

Non-compliance not only risks enforcement action but also blocks access to the lucrative EU market.

HPRA Guidelines: National Oversight in Practice

While EU regulation provides the overarching framework, national regulators such as the Health Products Regulatory Authority (HPRA) in Ireland ensure compliance on the ground.

The HPRA focuses on:

• Inspections: Routine and for-cause inspections of cosmetics manufacturers, distributors, and importers.

• Enforcement: Addressing non-compliance through recalls, fines, or product seizures.

• Guidance: Providing practical advice on GMP alignment, labelling requirements, and safety reporting obligations.

In practice, HPRA inspectors look for evidence that ISO 22716 principles are being applied and that companies maintain complete, up-to-date PIFs for every product. They also expect firms to demonstrate robust adverse event monitoring and prompt communication with regulators.

For Irish-based manufacturers, compliance with both EU Regulation 1223/2009 and HPRA expectations is non-negotiable.

For international companies, understanding HPRA’s approach offers a window into how EU rules are enforced at the member-state level.

Why These Regulations Matter

When viewed together, ISO 22716, Regulation (EC) No 1223/2009, and HPRA guidelines form a comprehensive compliance ecosystem:

• ISO 22716 provides the operational framework for manufacturing quality.

• Regulation 1223/2009 sets the legal obligations for market entry and product safety.

• HPRA and national authorities enforce compliance and translate regulatory expectations into practice.

These frameworks protect not only consumers but also brands. A robust regulatory foundation reduces the risk of recalls, builds consumer trust, and opens access to global markets.

Common Gaps in Compliance

Despite clear frameworks, regulators continue to identify recurring weaknesses in cosmetics companies:

• Incomplete or outdated Product Information Files.

• Weak supplier qualification and raw material testing.

• Poor documentation practices, with gaps in batch records or SOPs.

• Labelling errors, from missing warnings to incorrect ingredient declarations.

• Limited understanding of adverse event reporting requirements.

These are not minor technical oversights. They directly impact product safety and can result in regulatory enforcement.

Building a Compliance Culture

The most successful cosmetics companies view regulation not as an obstacle but as a platform for trust and growth. Compliance with ISO 22716 and Regulation 1223/2009 should not be “one-time” tasks but ongoing commitments.

Regular training, robust quality systems, and active oversight from senior leadership are key. Just as importantly, documentation should be treated as a living system, updated whenever formulations, suppliers, or processes change.

📌 Looking to strengthen your compliance foundations?

Pharmalliance Consulting Ltd now offers a specialised cGMP Fundamentals Program: Cosmetics, designed to help teams understand and apply core GMP principles.

Our program provides practical, regulator-aligned training on ISO 22716 and global GMP principles tailored for cosmetics manufacturing. It's a simple way to ensure your team understands not only what compliance requires, but also why it matters.