Common symptoms your customers may experience when using expired or PAO-passed cosmetics

Common symptoms your customers may experience when using expired or PAO-passed cosmetics

Cosmetic durability is a critical safety requirement under Regulation (EC) 1223/2009. Once a product exceeds its expiry date or its PAO (Period After Opening), the formula may degrade, oxidise or become microbiologically contaminated — resulting in irritation, allergic reactions or infections.

For brands, the consequences may include customer complaints, negative reviews, Amazon listing removals, regulatory warnings and in severe cases full product withdrawal.

These risks are entirely avoidable when a brand follows correct compliance procedures: accurate labelling, justified PAO, stability and microbiological testing and complete Product Information File (PIF) documentation. As an experienced Responsible Person (RP) for the EU, UK and USA, Annel ensures cosmetic safety, validated durability claims and legally compliant labelling.

Expired or PAO-passed cosmetics — symptoms and real risks

Infographic explaining symptoms caused by expired or PAO-passed cosmetics

1. Skin irritation and inflammatory reactions

  • redness
  • burning or tingling
  • dryness or tightness
  • immediate discomfort after application

Case insight: Annel supported a brand whose vitamin C serum oxidised rapidly, leading to irritation complaints. After stability testing and packaging optimisation, all issues were resolved.

Cosmetic regulatory services

2. Allergic reactions and sensitisation

  • rashes
  • swelling
  • urticaria (hives)
  • clusters of small bumps

Annel’s compliance solution: Every formulation undergoes a CPSR assessing allergens, impurities, toxicological profiles and degradation behaviour.

Responsible Person (RP) service

3. Microbial contamination and infections

  • mascaras
  • eye creams
  • open-jar moisturisers
  • lip balms

Possible infections include:

  • conjunctivitis
  • eyelid inflammation
  • skin infections

How Annel prevents this: Microbiological analysis, preservative challenge testing and packaging compatibility studies confirm microbial stability throughout the PAO period.

4. Reduced performance and loss of efficacy

  • serums showing no visible results
  • reduced SPF performance
  • colour changes
  • unusual smell or texture

Understanding durability requirements: minimum durability vs PAO

Minimum Durability Date (“Best before end”): Required for products with a shelf life shorter than 30 months.

EU Commission Cosmetics FAQ

PAO (Period After Opening): Required for products intended to last more than 30 months (for example 6M, 12M, 24M).

Incorrect PAO may lead to:

  • Amazon listing removals
  • marketplace rejections
  • compliance audit findings
  • consumer complaints

Label review & Article 19 compliance

Why brands must justify durability and PAO with testing

  • stability testing (accelerated and real-time)
  • microbiological evaluation & preservative challenge test
  • packaging compatibility studies
  • toxicological assessment
  • environmental condition analysis

SCCS Notes of Guidance

Brand risk overview and how Annel prevents each issue

Risk
Consumer Impact
Root Cause
How Annel Prevents It
Instability
irritation, redness
oxidation, ingredient breakdown
stability testing; packaging compatibility assessment
Contamination
infections
insufficient preservation
preservative challenge test; microbiological analysis
Incorrect PAO
returns, complaints
incorrect durability validation
PAO justification; label compliance audit
Missing documentation
legal liability
incomplete PIF
full PIF creation and RP oversight

Quick checklist for cosmetic brands before launch

  • Stability testing completed
  • Microbiological testing & preservative challenge test completed
  • PAO justified with supporting data
  • Expiry date validated
  • INCI list compliant with UK & EU requirements
  • Claims substantiation prepared
  • Packaging compatibility confirmed
  • CPSR completed and approved
  • Full PIF assembled
  • Responsible Person assigned
  • GMP documentation available
  • Marketplace compliance confirmed

Download your PAO compliance checklist

Why cosmetic brands choose Annel

  • Full regulatory support for the UK, EU and USA
  • Expertise in private label, OEM and online brands
  • ISO-accredited laboratory partnerships
  • Fast labelling and compliance checks
  • Amazon compliance support
  • Comprehensive PIF & CPSR preparation
  • Legal protection as Responsible Person

Protect your cosmetic brand with expert regulatory support

If you require assistance with PAO validation, stability testing, label compliance or full RP services:

Annel supports brands of all sizes — from start-ups to global manufacturers.