Explore CHIMEI’s Food Contact Materials Excellence!
Welcome to the latest edition of the CHIMEI Newsletter!
Here at CHIMEI, we are committed to providing high-quality food contact materials (FCM) that meet stringent regulatory standards across the globe. In this issue, we delve into the regulatory landscape, explore key standards like EU 10/2011, and highlight our comprehensive FCM portfolio designed to meet diverse needs.
Global Regulatory Landscape for Food Contact Materials
Navigating the complex regulatory environment for FCM is crucial for manufacturers and suppliers. Around the world, several authorities set the standards for ensuring the safety of materials that come into contact with food. The European Union (EU), the United States Food and Drug Administration (FDA), China's GB standards, and Japan's JOSPHA-PL are among the most influential regulatory bodies.
Each of these regions has established its own set of guidelines and testing methods to ensure consumer safety. For instance, the FDA regulates FCM under the Federal Food, Drug, and Cosmetic Act, while China's GB standards are overseen by the National Health Commission.
EU 10/2011: A Closer Look
The EU 10/2011 regulation is a cornerstone in the European regulatory framework for plastics intended to come into contact with food. This regulation specifies the types of materials that can be used, the conditions under which they can be used, and the limits on the migration of substances from the materials into food.
A critical aspect of EU 10/2011 is its focus on ensuring that any substance migrating from the material into food does not pose a risk to human health, alter the composition of the food, or deteriorate its characteristics.
Understanding OML and SML
When discussing FCM regulations, two key terms often arise: Overall Migration Limit (OML) and Specific Migration Limit (SML).
OML refers to the total amount of non-volatile substances that can migrate from the material into food. It ensures the general safety of the material.
SML, on the other hand, pertains to the migration of specific substances that are known to pose potential health risks at certain levels. These limits are crucial for ensuring that materials meet safety standards specific to individual substances.
Specific Migration Limits in EU 10/2011
Under EU 10/2011, each substance used in the manufacture of FCM must comply with its designated SML. This ensures that any migrating substance remains within a safe threshold, protecting consumers from potential health risks. These limits are established based on scientific assessments and are regularly updated to reflect new scientific evidence.
Diverse Testing Conditions under EU 10/2011
EU 10/2011 outlines various testing conditions to simulate real-world scenarios. These conditions consider factors such as time, temperature, and the type of food to which the material will be exposed. Different simulants are used to mimic various food types, ensuring that the materials are tested under conditions that reflect their intended use.
CHIMEI’s Comprehensive FCM Portfolio
At CHIMEI, we offer an extensive range of food contact materials that comply with international standards. Our portfolio includes:
Our commitment to safety, quality, and innovation ensures that our FCM solutions meet the rigorous demands of global regulations, providing confidence and peace of mind to our partners and consumers.
Thank you for partnering with CHIMEI. We look forward to continuing to serve your needs with our reliable and compliant food contact materials. For more information, please contact our regulatory affairs team or visit our website.