As global requirements for the safety of food contact materials (FCM) become increasingly stringent, the identification, assessment, and control of Non-Intentionally Added Substances (NIAS) have become critical components of compliance and product safety. As your professional compliance partner, Xico Testing leverages deep regulatory understanding and cutting-edge analytical techniques to provide comprehensive, precise, and reliable one-stop NIAS testing and risk assessment services.

I. Why Focus on NIAS?

NIAS refers to substances not intentionally added during the production, processing, storage, or use of food contact materials but may be present in the final product. They originate from various sources, including:

• Raw Material Impurities: Trace impurities in starting substances and additives.
• Process By-products: Decomposition products, reaction intermediates, by-products during production.
• Environmental Contaminants: Pollutants introduced during production, transportation, storage.
• Interaction Products: New substances formed between different material layers (e.g., inks, adhesives, coatings and substrates) or with food simulants.

II. Regulatory Requirements

China: According to GB 4806.1 "National Food Safety Standard General Safety Requirements for Food Contact Materials and Articles" (draft for comments), manufacturers must assess and control the safety of NIAS in products, ensuring their migration does not harm health or alter food characteristics. The compliance statement must include a list of NIAS requiring further assessment.

European Union: The regulatory framework for NIAS is the most systematic and stringent.

• Framework Regulation (EC) No 1935/2004: Establishes the basic safety principle that all migrants, including NIAS, must not endanger health.
• Plastic Regulation (EU) No 10/2011: Clearly defines NIAS and mandates risk assessments for all potential migrants (including NIAS).
• Latest Amendments (EU) 2025/351: Strengthen source control, specifying "high purity" raw material requirements. For non-genotoxic NIAS already assessed, a specific migration limit reference value of 0.05 mg/kg is set.
• Other Materials: Specific regulations exist for rubber, coatings, paper products, etc. (Res AP (2004) 4, 93/11/EEC, Res AP (2004), Res AP (2002) 1, CM/Res (2013) 9) that impose restrictions on specific NIAS (e.g., nitrosamines).

Risk Assessment Guidelines: We strictly adhere to the best practice guidelines for NIAS risk assessment published by the EU and other authorities, using scientific methods for exposure assessment and toxicological evaluation.

III. NIAS Testing and Assessment Service Solutions

We offer a full-process service from substance identification and quantitative analysis to safety assessment, precisely addressing the challenges of "predictable" and "unpredictable" NIAS.

Sample Characterization and Plan Design

• Deeply understand your product composition (materials, layer structures, inks, adhesives, etc.), production processes, and usage conditions.
• Tailor the most cost-effective testing and assessment plan based on target market regulations.

2. Targeted Quantitative Analysis (for Predictable NIAS)

• Predict potential NIAS based on product composition and process knowledge (e.g., degradation products of specific additives, oligomers, known impurities).
• Using chromatographic equipment such as Gas Chromatography-Mass Spectrometry (GC-MS), Headspace-GC-MS (HS-GC-MS), Liquid Chromatography-Tandem Mass Spectrometry (LC-MS-MS), and spectrometric equipment like Inductively Coupled Plasma Spectrometry (ICP) for targeted testing of analytes, employing corresponding standards for accurate quantification.
• Flexible testing modes: simulate actual use conditions for migration tests or conduct extraction studies under the most stringent conditions to assess maximum potential risk.

3. Non-targeted Screening Analysis (for Unpredictable NIAS)

• Using chromatographic equipment such as Gas Chromatography-Mass Spectrometry (GC-MS), Headspace-GC-MS (HS-GC-MS), Liquid Chromatography-Tandem Mass Spectrometry (LC-MS-MS), and Liquid Chromatography-Quadrupole-Time of Flight Mass Spectrometer (LC-Q-TOF) for non-targeted screening.
• Conduct full scan analysis to capture unknown compound signals in migrants or extracts without pre-setting target substances.
• Combine extensive substance libraries, industry databases, and expert experience to preliminarily identify and prioritize significant peaks for risk assessment.

4. Substance Identification and Confirmation

• For unknown peaks exceeding concern levels, we provide in-depth identification services, including:
• Determining molecular formulas through accurate mass numbers.
• Interpreting mass spectral fragmentation patterns to infer structures.
• If necessary, purchasing or synthesizing standards for final confirmation.

5. Safety Assessment and Compliance Support

• Exposure Assessment: Calculate daily human exposure based on migration or extraction data combined with food consumption factors.
• Toxicological Assessment:
• Use existing data for risk assessment of substances with defined structures and toxicological data.
• Apply the Threshold of Toxicological Concern (TTC), an internationally recognized scientific tool, for tiered assessment of most data-lacking substances. We determine if exposure levels are below the relevant safety thresholds (e.g., 1.5 μg/kg bw/day, 0.15 μg/kg bw/day) based on the Cramer classification (I, II, III) or specific categories (e.g., potential genotoxic substances).
• For substance categories not suitable for TTC (e.g., nitrosamines, certain heavy metals, high bioaccumulative substances), we recommend and assist in conducting targeted assessments.
• Reports and Declarations: Provide detailed test reports and scientific risk assessment conclusions to support your compliance statement (DoC) regarding NIAS, proving that products meet the basic safety requirements of relevant regulations.

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. 

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