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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:

Under controlled stress conditions, samples are stored at elevated temperature (typically 40 ± 2 °C) and humidity (75 ± 5 % RH).

  • 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 of the European Parliament and of the 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. 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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