Food Contact Materials (FCM) refer to various materials that come into contact with food, such as packaging materials, containers, kitchen utensils, etc. The safety of FCMs directly affects the quality of food and human health, making their regulation and management extremely important.

Food contact plastics entering the European market are regulated by EU regulation EU 10/2011. EU legislation is based on the "positive list" principle, where substances used to manufacture food contact plastic materials must be selected from the list in Annex I of EU regulation EU 10/2011. Only substances listed can be added as monomers, additives, or production aids in the manufacturing formula. In the actual production process, apart from substances intentionally added during the process, there are also Non-Intentionally Added Substances (NIAS).

1. Non-Intentionally Added Substances (NIAS)

As the name suggests, NIAS refers to substances that are unintentionally added by manufacturers into food contact plastics but are indeed present. These substances may be introduced as impurities from substances on the positive list, could be intermediates left from reactions, or might be decomposition products resulting from thermal instability, light instability, or oxidation. They could also be unintended by-products from the reaction process, or contaminants introduced during the manufacturing process, among other possibilities. These non-intentionally added substances are often unpredictable and unauthorized, and they may pose potential health risks.

2. Intentionally Added Substances (IAS)

Unlike NIAS, IAS are deliberately added during the production of FCMs and play a functional role either during the manufacturing process or in the final product. The main structural components of plastics or coatings such as starters and monomers (used to synthesize polymers), additives, solvents, polymer production aids, polymerization catalysts, and colorants are considered IAS. About 900 substances (IAS) including monomers, other starters, and lacquer additives are listed in Annex I of EU regulation 10/2011.

3. How are NIAS & IAS regulated and assessed in food contact materials?

Risk management of food contact materials is a systematic engineering task requiring multi-level comprehensive management. Only through detailed assessment and control can food safety be ensured from the source, better protecting consumer health. Routine monitoring and control methods for FCM include material and product risk assessments, evaluating the risks of relevant high-risk substances, mainly testing authorized substances with specific limit requirements such as polymers used monomers, common additives, etc. There are also a vast number of low-risk authorized substances and NIAS that are not tested. How to control the risks of these substances? CIRS recommends increasing NIAS screening assessments and Ingredient List Reviews to holistically assess product risks.

 4. Importance of Ingredient List Review

Ingredient List Review for food contact materials involves evaluating whether the ingredients provided are authorized under the positive list of EU regulations. This controls product risks from the design and production source to prevent irreversible damage later.

5. Importance of NIAS

According to the general safety requirements of Chapter 3 of EU Regulation EU 1935/2004, food contact materials must comply with good manufacturing practices. Under normal or reasonably foreseeable conditions, they should not transfer ingredients to food that could harm human health or cause unacceptable changes to food ingredients or degrade their sensory characteristics. Business operators should conduct risk assessments as required by Article 19 of EU Regulation 10/2011. With the rapid development of testing technology and demands, the EU authorities are also intensifying their focus on this area, and there have been several related recall cases in the EU market.

6. CIRS NIAS Testing Services

NIAS control involves risk assessment, substance screening, and process control. This helps control the content of NIAS in food contact materials, ensuring their safety. Substance screening is a very important task. Using the most advanced technologies and equipment, NIAS can be quickly and accurately identified, properly identifying unknown NIAS, and avoiding potential impacts on human health and the environment.

CIRS's NIAS testing services will help you understand which non-intentionally added substances might migrate from food contact materials into food. Tests are conducted according to the food simulants and conditions specified in EU food contact testing regulations EU 10/2011. Analytical techniques scan all migrating substances and identify them at very low detection limits. Subsequently, a toxicological assessment is conducted based on internationally recognized principles. In cases where risks are identified, it is assessed whether they violate the relevant requirements of EU food contact materials.

CIRS Testing, as an internationally recognized testing, inspection, and certification body, offers one-stop solutions for product compliance, including routine high-risk substance testing of food contact materials, ingredient analysis Ingredient List Review, and NIAS screening assessment. We welcome your inquiries.

If you need any assistance or have any questions, please get in touch with us via test@cirs-group.com.