Container-content interactions refer to physical or chemical exchanges between the packaging (container) and the product it contains (content). These interactions can affect the quality, safety, and efficacy of the product.
Indeed, the container and content must not interact in a harmful way. The packaging must protect the product from external factors (light, moisture, oxygen, etc.) and maintain its stability, while contributing to its identity in certain markets.
Their evaluation is therefore crucial in order to:
- Ensure consumer or patient safety
- Prevent the migration of hazardous substances
- Ensure product stability and compliance with regulatory standards
The major risk lies in the migration of hazardous substances from the container in quantities sufficient to compromise the safety of the product or alter its organoleptic properties (taste, smell, color).Various European markets are concerned by this assessment: The main regulated markets that EQUITOX targets for the assessment of these interactions are as follows:
Food Sector
Materials that come into contact with foodstuffs are governed by Regulation (EC) No. 1935/2004, as well as Regulation (EU) No. 10/2011 specifically for plastic materials and articles intended to come into contact with foodstuffs. These texts set specific (SML) or generic (GML) migration limits to ensure consumer safety.
Cosmetics sector
The requirements of Regulation (EC) No. 1223/2009 on the safety of cosmetic products impose strict criteria for assessing interactions between packaging and formulas. This includes preventing the migration of hazardous substances and ensuring that the final product remains compliant with safety standards.
Medical Devices (MD)
Medical devices are governed by Regulation (EU) 2017/745 and ISO standards. Among these, ISO 10993-18 defines the requirements for the chemical analysis of extractable and leachable substances that may migrate from device materials to the patient or user. ISO 10993-1 provides a framework for the overall biological evaluation of devices. This approach ensures that potential interactions between the device and the packaging do not pose any unacceptable health risks throughout the product’s life cycle.
Analytical and methodological challenges
The impact of container-content interactions on the safety of various regulated products requires the use of robust and relevant analytical methods. It is essential to be able to identify and quantify substances that may migrate from packaging materials into products. However, the composition of packaging materials not always well known, and there is a risk of unintentionally added substances (NIAS) being present, which makes chemical analysis all the more crucial. In particular, these analyses must:
- Be carried out under the right extraction conditions,
- Use suitable solvents and reference substitutes,
- Apply validated analytical methods that guarantee optimal sensitivity, accuracy, and stability (e.g., GC-MS, LC-MS/MS, ICP-MS, etc.).
The crucial role of modeling
When analytical solutions reach their limits, modeling can play a role in predicting which substances are likely to migrate and estimating the extent of this migration/leaching. To do this, modeling tools must take into account the nature and specific characteristics of packaging materials (containers). They must also consider the chemical, physical, mechanical, and usage properties of the products (contents). Finally, robust databases will ensure the reliability of the tool and will require regular updates to guarantee relevant predictions.
New challenges related to recycled materials
Recent regulations such as the Green Deal, the AGEC law, and the 3R decree (reduce, reuse, recycle) introduce additional requirements for recycled materials. These developments add considerable complexity to the assessment of container-content interactions, particularly in the interpretation of test results and the implementation of appropriate methodologies.
Our support services for the assessment of container-content interactions
At EQUITOX, we leverage our expertise in the assessment of container-content interactions to support our clients across all regulated markets: medical devices, cosmetics, food, and more broadly any sector subject to strict product safety requirements
📩 Feel free to contact us for more information: contact@equitox.eu
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