Primary aromatic amines (PAAs) migration testing from food packaging materials to ensure regulatory compliance with Regulation (EU) No 10/2011 for plastic food contact materials

Testing for primary aromatic amines (PAAs) migration from food packaging materials into foodstuffs is important as some PAAs are known to have carcinogenic properties, whilst others are suspected carcinogens. These substances therefore may pose a health risk if they transfer from food contact materials to food. Primary aromatic amines are used in the manufacture of azo pigments such as certain yellow, orange, and red colorants, but can also be present in inks as impurities of pigments or breakdown products.

PAAs have been detected in plastic food contact materials but also in paper and board food packaging. In Europe, all materials and articles intended to come into contact with food need to comply with the European Framework Regulation (EC) 1935/2004. The Commission Regulation (EU) No 10/2011 on plastic food contact materials and articles establishes specific requirements for the manufacture and marketing of plastic materials and articles. Regulation (EU) No 10/2011 was amended to include primary aromatic amines listed in ‘the Azocolourants entry’ of the REACH Regulation (EC) No 1907/2006. These should not migrate or be released from plastic materials and articles into food or food simulant when testing. They should not be detectable using analytical equipment with a limit of detection of 0,002 mg/kg food or food simulant applied to each individual primary aromatic amine, in accordance with Article 11(4).

Food Contact Migration Studies and Determination of PAAs
We provide expert analytical determination of PAAs as part of our food contact materials migration testing services. Our analytical experts can apply several analytical strategies to determine the levels of PAAs in food simulants including a liquid chromatography-tandem mass spectrometry (LC-MS/MS) approach or spectrophotometry methods. Our selection of approach considers the regulatory requirements for extremely low and specific detection and typical challenges related to false positives, complex sample matrices (e.g., multiple migrated components or cloudiness of the resulting simulant). With the selectivity of the LC-MSMS method we are able to directly quantify the concentration of a specific PAA using external standards of the corresponding PAA. The accuracy can be demonstrated by performing standard additions to migrated simulants.

Helping You to Mitigate Risks
Due to the health risks associated with primary aromatic amines in food contact materials coupled with regulated restrictions on the levels of these substance it is imperative to demonstrate that levels in your food contact products fall below the restricted alert and allowable levels. Our team can help you to accurately determination levels of individual PAAs enabling you to risk assess your food contact materials or products.

Food Contact Compliance Testing
Our wider range of food contact material testing includes testing for compliance in your region of interest, overall and specific migration, chemical composition, non-intentionally added substances (NIAS) studies. Alongside testing for PAAs we also perform specific testing for PFAS, heavy metals and trace elemental impurities, phthalates, fluorochemicals and others.

To support product development, we also perform physical testing, processability evaluation and quality assurance and certification in relation to circularity and sustainability. Our global team of assurance and testing experts provide complete food contact regulatory compliance support including, migration protocol development, third party certifications, migration studies, placement and monitoring of toxicology studies to support a submission, as well as guidance for use of recycled content in food contact applications.

With decades of experience, we can support you with Total Quality Assurance for fast track and cost-effective approaches to enter new markets, aid the introduction of new products and aid adapt to changes in existing regulations. Our extensive knowledge of all aspects of food law and food contact laws, and our strong communication network with local and regional governmental authorities is a competitive advantage for our clients.

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