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4-Week Stability Test: Your Fastest Route to Global Markets

Bringing a cosmetic product to market requires more than creativity – it requires scientific certainty about its safety and stability. Under EU Regulation (EC) No 1223/2009, every cosmetic product must remain safe and stable throughout its shelf life.

The first and most decisive step in this process is the 4-week accelerated stability test. At Annel, we combine laboratory precision with global regulatory expertise, helping brands make data-driven decisions before entering new markets.

We act as a single partner for your brand across three key regions: the EU, the United Kingdom and the United States.

1. Why the 4-Week Test Provides Peace of Mind

The 4-week accelerated stability test simulates 12–24 months of real-time ageing. It is the first analytical checkpoint determining whether a formulation is ready for long-term testing or requires costly reformulation. Four weeks in the laboratory can prevent two years of uncertainty and financial loss on the market.

Test parameters:

  • ✅ Organoleptic: colour, fragrance, texture.
  • ✅ Physicochemical: pH, viscosity, emulsion stability.
  • ✅ Packaging interaction: leakage, corrosion, mass loss.

The documentation from these tests becomes part of your Product Information File (PIF) required by EU law. A stable formulation is early scientific proof of durability – a key condition for responsible notification (CPNP / SCPN / FDA MoCRA).

2. From Analytical Rigour to Business Conclusions

At Annel, we apply rigorous analytical procedures derived from pharmaceutical stress-testing standards. This is not merely advanced technique – it is intelligent risk management for your brand.

  • 💡 Reduced reformulation costs.
  • 🚀 Faster market readiness and global submissions.
  • 📊 Forecasting of potential shelf-life limitations.

Our analysis identifies degradation points and chemical transformations that may threaten formulation integrity. We translate laboratory data into a clear business strategy.

Accelerated Stability Test for Cosmetics – simulates 12–24 months, supports EU CPNP, SCPN and MoCRA compliance

3. Compliance: One Partner, Three Markets (EU RP / UK RP / US Agent)

No cosmetic product can be placed on the market in the EU, UK or USA without a designated Responsible Person (RP) or US Agent. The RP ensures that all product-safety data including the 4-week stability results are documented, verified and compliant with applicable law.

Annel acts as your Global Responsible Person, with offices in:

  • 🇪🇺 Warsaw (EU RP)
  • 🇬🇧 London (UK RP)
  • 🇺🇸 Miami (US RP under MoCRA)

This is your key advantage: partnering with Annel ensures that your 4-week stability data are immediately integrated into a complete compliance system, including:

  • 📌 CPNP / SCPN / FDA MoCRA notifications.
  • 📄 Preparation and maintenance of the PIF.
  • 🧾 Post-market surveillance and safety reporting.
  • 🏷️ Authorised Representative roles for CE and UKCA marking (for related products such as candles).

4. Frequently Asked Questions (FAQ)

What is a 4-week accelerated stability test?
It is a short-term study that simulates up to two years of storage. By exposing samples to controlled stress conditions, it predicts how the product will behave under normal use.

Is the 4-week test mandatory?
While not explicitly required, it forms part of the stability verification set out in Annex I of Regulation (EC) No 1223/2009. It is strongly recommended by the CTPA and FDA MoCRA as evidence of product safety.

How do the results affect market registration?
✅ Positive results allow progression to long-term testing and immediate preparation of the PIF.
⚠️ Instability requires reformulation before costly CPNP or SCPN submissions.

5. Ethical and Regulatory Assurance

Quality is a measurable and auditable process, not a slogan. Annel’s commitment to excellence is confirmed by membership in leading organisations such as the Cosmetic, Toiletry & Perfumery Association (CTPA) and the Polish Association of the Cosmetics and Detergent Industry (PACDI).

All procedures comply with Good Manufacturing Practice (GMP ISO 22716) and Annex I of Regulation 1223/2009. This ensures that every stability-test result we deliver serves as scientific evidence in regulatory audits and brand documentation.

6. Partnership with Annel: Turning Data into Market Confidence

Scientific testing and regulatory compliance are not obstacles – they are your fastest route to safe market success. Ready to verify your formulation’s stability and achieve global compliance? 📞 Contact Annel today to receive a quote for our “Three Markets / One Partner” package.

📚 References

  1. 📘 Regulation (EC) No 1223/2009 — European Parliament and Council on cosmetic products.
  2. 🔬 Alsante K. M., Waterval J. (2003). A Stress Testing Benchmarking Study. Pharmaceutical Technology.
  3. 🧪 Klick S., Muijselaar P. G. (2005). Stress Testing of Drug Substances and Drug Products. Pharmaceutical Technology.
  4. 🌿 Kaloustian J. et al. (2002). Chemical, Chromatographic and Thermal Analysis of Rosemary (Rosmarinus officinalis). J. Appl. Polymer Sci., 83, 747–756.
  5. 📗 Baś W. (2020). Chemiczna analiza instrumentalna. AGH / WIMiC.
  6. 📙 Jakubiak I. (2021). Bezpieczny kosmetyk, czyli jaki? BMP Publishing.
  7. 📄 Gmelin E. (1999). Report of the Chairman of the Scientific Commissions and Working Groups. ICTAC News, 32/2.
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