{"id":4431,"date":"2026-08-20T07:08:02","date_gmt":"2026-08-20T07:08:02","guid":{"rendered":"https:\/\/nano-test.de\/?p=4431"},"modified":"2026-08-20T07:25:49","modified_gmt":"2026-08-20T07:25:49","slug":"primary-aromatic-amine-paa-analyses-ppwr-and-10-2011-eu","status":"publish","type":"post","link":"https:\/\/nano-test.de\/en\/2026\/08\/20\/primary-aromatic-amine-paa-analyses-ppwr-and-10-2011-eu\/","title":{"rendered":"Analysis of primary aromatic amines (PAA) | PPWR"},"content":{"rendered":"\t\t
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Introduction: The regulatory importance and health risks of primary aromatic amines<\/span><\/h2>\nPrim\u00e4re aromatische Amine (PAA) sind organische Verbindungen, deren chemische Struktur eine prim\u00e4re Aminogruppe (-NH\u2082) enth\u00e4lt, die direkt an einen oder mehrere aromatische Ringe gebunden ist. Diese Stoffgruppe ist f\u00fcr die Sicherheit von Verpackungsmaterialien, die mit Lebensmitteln in Kontakt kommen, von besonderer regulatorischer Bedeutung. PAAs k\u00f6nnen durch den Abbau von Azofarbstoffen entstehen, die bei der Verpackungsherstellung verwendet werden, oder aus unvollst\u00e4ndigen Aush\u00e4rtungsreaktionen von Klebstoffen auf Polyurethanbasis stammen. Die Europ\u00e4ische Beh\u00f6rde f\u00fcr Lebensmittelsicherheit (EFSA)<\/a> und die Internationale Agentur f\u00fcr Krebsforschung (IARC)<\/a> haben viele PAA-Verbindungen als genotoxische Karzinogene eingestuft. Aus diesem Grund begrenzt die Verordnung (EU) Nr. 10\/2011 der Europ\u00e4ischen Union \u00fcber Kunststoffmaterialien die Migration von PAA aus Kunststoffmaterialien, die mit Lebensmitteln in Kontakt kommen, streng auf ein extrem niedriges Niveau. Mit der Einf\u00fchrung der PPWR wurde diese Kontrolle weiter versch\u00e4rft; PAA-Analysen sind zu einem unverzichtbaren Bestandteil der Konformit\u00e4tsbewertungen f\u00fcr Verpackungshersteller geworden. Nano-Test Laboratory Services f\u00fchrt PAA-Analysen unter Verwendung validierter LC-MS\/MS-Methoden durch, die den GLP-Grunds\u00e4tzen vollst\u00e4ndig entsprechen; wir bieten unseren Kunden Bewertungen der Einhaltung gesetzlicher Vorschriften sowie umfassende technische Beratung.<\/span>\n

Chemical structure, sources, and legal framework of PAAs<\/span><\/h2>\nPrimary aromatic amines are not a single chemical compound, but a broad family of substances that share a common structural feature. Within this family, certain compounds have been identified whose names are explicitly listed in Regulation (EU) No 10\/2011 and whose migration is prohibited.<\/span>\n

Main sources of PAAs in packaging materials<\/span><\/h3>\nThe following table summarizes the reasons for the occurrence of PAAs in packaging materials, their formation mechanisms, and the types of packaging where these mechanisms are typically observed:<\/span>\n\n\n\n\n\n\n\n\n
Mechanism of formation<\/span><\/th>\nFormation process<\/span><\/th>\nTypical packaging type \/ application<\/span><\/th>\nExplanation<\/span><\/th>\n<\/tr>\n<\/thead>\n
Breakdown of azo dyes<\/strong><\/span><\/td>\nCleavage of the nitrogen-nitrogen double bond (N=N)<\/span><\/td>\nPrinted plastic films, colored packaging, paper\/cardboard packaging<\/span><\/td>\nUnder reducing conditions (e.g., in the acidic or reducing environment of food), azo dyes can release PAAs by breaking the azo bond in their structure.<\/span><\/td>\n<\/tr>\n
Incomplete curing of polyurethane adhesives<\/strong><\/span><\/td>\nConversion of aromatic isocyanates to PAA upon reaction with water<\/span><\/td>\nMulti-layer laminate packaging, flexible films,<\/span>\nBags<\/span><\/td>\nIf polyurethane adhesives based on aromatic isocyanates are not fully cured, they can undergo hydrolysis when in contact with water and form PAAs (e.g., MDA \u2013 methylenedianiline).<\/span><\/td>\n<\/tr>\n
Contaminations in raw materials<\/strong><\/span><\/td>\nPAA residues that arise during the production process of monomers or additives<\/span><\/td>\nPolymer raw materials, masterbatches, technical additives<\/span><\/td>\nSome technical chemicals can contain small amounts of PAA impurities that originate from production processes.<\/span><\/td>\n<\/tr>\n
Inks and coatings<\/strong><\/span><\/td>\nBreakdown of pigments and binders used in ink recipes<\/span><\/td>\nExternally printed packaging, labels, coated cardboard<\/span><\/td>\nIn particular, the migration of dyes (transfer of the print to the surface of the packaging that comes into contact with food) can lead to PAA contamination.<\/span><\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n

Important PAA compounds subject to the regulation<\/span><\/h3>\nRegulation (EU) No 10\/2011 lists certain PAA compounds for which the migration from plastic materials that come into contact with food must not be detectable (limit: 0,01 mg\/kg food or simulant). The following table shows the most important PAA compounds from this list along with their CAS numbers and typical sources:<\/span>\n\n\n\n\n\n\n\n\n\n\n\n\n
Primary aromatic amine<\/span><\/th>\nAbbreviation \/ CAS No.<\/span><\/th>\nToxicological classification<\/span><\/th>\nTypical source \/ Related azo dye<\/span><\/th>\n<\/tr>\n<\/thead>\n
4,4\u2032-Methylenedianiline<\/strong><\/span><\/td>\nMDA \/ 101-77-9<\/span><\/td>\nCarcinogen (IARC Group 2B); Mutagen<\/span><\/td>\nPolyurethane adhesives; Isocyanate hydrolysis<\/span><\/td>\n<\/tr>\n
Benzidine<\/strong><\/span><\/td>\nBZD \/ 92-87-5<\/span><\/td>\nCarcinogen (IARC Group 1); genotoxic<\/span><\/td>\nAzo dyes (based on benzidine); prohibited pigments<\/span><\/td>\n<\/tr>\n
2-Naphthylamin<\/strong><\/span><\/td>\n2-NA \/ 91-59-8<\/span><\/td>\nCarcinogen (IARC Group 1); genotoxic<\/span><\/td>\nAzo dyes (based on 2-naphthylamine); prohibited pigments<\/span><\/td>\n<\/tr>\n
4-Aminobiphenyl<\/strong><\/span><\/td>\n4-ABP \/ 92-67-1<\/span><\/td>\nCarcinogen (IARC Group 1);<\/span>\ngenotoxic<\/span><\/td>\nAzo dyes (based on 4-aminobiphenyl); prohibited pigments<\/span><\/td>\n<\/tr>\n
o-Toluidine<\/strong><\/span><\/td>\n2-Methylaniline \/ 95-53-4<\/span><\/td>\nCarcinogen (IARC Group 1); genotoxic<\/span><\/td>\nAzo dyes; printing inks<\/span><\/td>\n<\/tr>\n
4-Chloranilin<\/strong><\/span><\/td>\n4-CA \/ 106-47-8<\/span><\/td>\nSuspected of carcinogenicity; Mutagen<\/span><\/td>\nAzo dyes; pigment impurities<\/span><\/td>\n<\/tr>\n
Aniline<\/strong><\/span><\/td>\nANL \/ 62-53-3<\/span><\/td>\nCarcinogen (IARC Group 2A); toxic<\/span><\/td>\nAzo dyes; a variety of pigments and additives<\/span><\/td>\n<\/tr>\n
2,4-Toluenediamine<\/strong><\/span><\/td>\n2.4-TDA \/ 95-80-7<\/span><\/td>\nSuspected of carcinogenicity; mutagen<\/span><\/td>\nPolyurethane adhesives; Isocyanate hydrolysis<\/span><\/td>\n<\/tr>\n<\/tbody>\n<\/table>\nNote: In Regulation (EU) No 10\/2011, the overall migration limit for PAAs is defined as \"not detectable\", and the analytical detection limit is set at 0.01 mg\/kg (per food or simulant). This limit applies to the sum of all listed PAA compounds. Nano-Test can determine more than 20 PAA compounds simultaneously by expanding the analysis scope according to customer needs.<\/em><\/span>\n

PAA analysis methodology in the Nano-Test laboratory<\/span><\/h2>\nThe analysis of primary aromatic amines is an analytical procedure that requires high sensitivity and selectivity due to the low migration limits of these compounds (0.01 mg\/kg). In the Nano-Test laboratory, PAA analyses are performed using LC-MS\/MS methods that are optimized and fully validated for these requirements.<\/span>\n

Analytical workflow: From migration testing to quantitative determination<\/span><\/h3>\nThe following table describes the entire workflow for PAA analyses in the Nano-Test laboratory:<\/span>\n\n\n\n\n\n\n\n\n\n
Step<\/span><\/th>\nProcedure<\/span><\/th>\nTechnical Details<\/span><\/th>\n<\/tr>\n<\/thead>\n
1. Experimental planning<\/strong><\/span><\/td>\nDefinition of simulants and test conditions<\/span><\/td>\nAn appropriate food simulant is selected according to Annexes III and V of Regulation (EU) No 10\/2011. The simulant most frequently used for PAA analyses is Simulant B (3 % acetic acid), which represents acidic foods and best simulates the risk of reduction of azo dyes. Simulant A (10 % ethanol) and Simulant C (20 % ethanol) can also be used.<\/span><\/td>\n<\/tr>\n
2. Migration test<\/strong><\/span><\/td>\nControlled contact<\/span><\/td>\nThe packaging sample is brought into contact with the selected simulant using standard contact cells or by means of the immersion method at the specified temperature and duration. The test conditions are chosen to reflect the worst-case application scenario.<\/span><\/td>\n<\/tr>\n
3. Sample preparation<\/strong><\/span><\/td>\nExtraction and purification<\/span><\/td>\nThe simulant extract is purified by solid-phase extraction (SPE) or liquid-liquid extraction after appropriate pH adjustment. To ensure the stability of PAA compounds, an antioxidant is added. Matrix effects are corrected by adding isotopically labeled internal standards (e.g., aniline-d5, MDA-d4).<\/span><\/td>\n<\/tr>\n
4. LC-MS\/MS analysis<\/strong><\/span><\/td>\nQuantitative Determination<\/span><\/td>\nAfter separation on a reverse-phase LC column, the purified extract is analyzed using ESI ionization in a triple quadrupole mass spectrometer. For each PAA compound, two MRM transitions are monitored. The LOQ value was validated at \u2264 0.005 mg\/kg to enable a reliable assessment of the SML limit of 0.01 mg\/kg. <\/span><\/td>\n<\/tr>\n
5. Evaluation and Reporting<\/strong><\/span><\/td>\nComparison with the SML and declaration of conformity<\/span><\/td>\nThe quantitative results obtained are compared with the total PAA limit of 0.01 mg\/kg. For compounds not detected, the result is reported as \u201c< LOQ\u201d. A comprehensive, GLP-compliant analysis report is generated.<\/span><\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n

Parameters for quality control and method validation<\/span><\/h3>\nThe following table summarizes the key quality control parameters and acceptance criteria applied for PAA analyses at Nano-Test Laboratory:<\/span>\n\n\n\n\n\n\n\n\n\n\n\n
Quality Control Parameters<\/span><\/th>\nFrequency of Application<\/span><\/th>\nAcceptance criteria<\/span><\/th>\n<\/tr>\n<\/thead>\n
Procedure blank<\/strong><\/span><\/td>\nAt least 1 per analysis run<\/span><\/td>\nAll target PAA compounds < LOQ<\/span><\/td>\n<\/tr>\n
Spike recovery in matrix<\/strong><\/span><\/td>\nPer run for each simulant type<\/span><\/td>\n80 % \u2013 120 % recovery<\/span><\/td>\n<\/tr>\n
Recovery Rate of Internal Standard<\/strong><\/span><\/td>\nAdded to each sample<\/span><\/td>\n60 % \u2013 140 % recovery<\/span><\/td>\n<\/tr>\n
Control standard (mixed PAA solution)<\/strong><\/span><\/td>\nAt least 1 per analysis run<\/span><\/td>\nWithin \u00b120 % of Expected Concentration<\/span><\/td>\n<\/tr>\n
Duplicate analysis<\/strong><\/span><\/td>\n1 per 10 samples<\/span><\/td>\nRelative percent deviation (RPD) \u2264 20 %<\/span><\/td>\n<\/tr>\n
Accuracy (recovery)<\/strong><\/span><\/td>\nAt 3 different concentration levels during validation<\/span><\/td>\nBetween 80 % and 120 %<\/span><\/td>\n<\/tr>\n
Limit of quantification (LOQ)<\/strong><\/span><\/td>\nDetermined during validation<\/span><\/td>\n\u2264 0.005 mg\/kg (SML limit below 0.01 mg\/kg)<\/span><\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n

The integrated service model of Nano-Test for PAA analyses<\/span><\/h2>\nAs Nano-Test Laboratory Services, we do not offer PAA analyses as standalone tests but as an integrated part of the compliance process according to PPWR and 10\/2011\/EU. Our service model consists of the components summarized in the following table:<\/span>\n\n\n\n\n\n\n\n\n\n
Service column<\/span><\/th>\nScope<\/span><\/th>\nBenefits for the customer<\/span><\/th>\n<\/tr>\n<\/thead>\n
Consultation on regulatory requirements<\/strong><\/span><\/td>\nIdentification of PAA compounds to be analyzed based on the product composition as well as the adhesives and inks used; selection of suitable simulants and test conditions<\/span><\/td>\nCost optimization through the right test strategy; avoidance of incomplete or unnecessary analyses<\/span><\/td>\n<\/tr>\n
Analytical Testing Services<\/strong><\/span><\/td>\nGLP-compliant, validated LC-MS\/MS method for the simultaneous quantitative determination of more than 20 PAA compounds<\/span><\/td>\nAnalysis data accepted by the regulatory authorities, are well-founded and traceable<\/span><\/td>\n<\/tr>\n
Conformity assessment<\/strong><\/span><\/td>\nIssuance of a declaration of conformity\/non-conformity by comparing the results with the SML limit of 0.01 mg\/kg total PAA, resulting in an explanation of conformity or non-conformity<\/span><\/td>\nA clear and binding assessment of the legal status of the product<\/span><\/td>\n<\/tr>\n
Support with technical documentation<\/strong><\/span><\/td>\nProvision of a comprehensive analysis report and a declaration of conformity (DOC)<\/span><\/td>\nSupport for the customer in the complete and correct creation of their own declaration of conformity<\/span><\/td>\n<\/tr>\n
Consulting in Case of Non-Conformity<\/strong><\/span><\/td>\nDetermination of the cause of the problem in the case of exceeding the limit value (glue, ink, pigment or raw material) and recommendations for corrective measures<\/span><\/td>\nPermanently eliminating the problem and avoiding recurring non-conformities<\/span><\/td>\n<\/tr>\n<\/tbody>\n<\/table>\nPolyurethan-Klebstoffe, die in mehrschichtigen Laminatverpackungen verwendet werden, und Azofarbstoffe, die in bedruckten Verpackungen zum Einsatz kommen, sind die h\u00e4ufigsten Ursachen f\u00fcr PAA-Migration<\/a>. Bei Nano-Test liefern wir mehr als nur Analysedaten; wir bieten unseren Kunden auch technische Beratung zur Ursachenanalyse potenzieller Quellen f\u00fcr festgestellte PAA-Kontaminationen, zur Optimierung der Klebstoffaush\u00e4rtung und zur Auswahl alternativer Rohstoffe.<\/span>\n\nTo ensure that your European market packaging complies with the PAA regulations in accordance with PPWR and 10\/2011\/EU, and to conduct your analyzes with a reliable and experienced partner, please contact our team of experts for detailed information on the accredited laboratory services and to obtain technical advice from nano-test.<\/span>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<\/div>\n\t\t","protected":false},"excerpt":{"rendered":"

Einleitung: Die regulatorische Bedeutung und die Gesundheitsrisiken prim\u00e4rer aromatischer Amine Prim\u00e4re aromatische Amine (PAA) sind organische Verbindungen, deren chemische Struktur eine prim\u00e4re Aminogruppe (-NH\u2082) enth\u00e4lt, die direkt an einen oder mehrere aromatische Ringe gebunden ist. Diese Stoffgruppe ist f\u00fcr die Sicherheit von Verpackungsmaterialien, die mit Lebensmitteln in Kontakt kommen, von besonderer regulatorischer Bedeutung. PAAs k\u00f6nnen \u2026 Analysen von prim\u00e4ren aromatischen Aminen (PAA) | PPWR\u201c>Continue reading Analysis of primary aromatic amines (PAA) | PPWR<\/span><\/a><\/p>\n","protected":false},"author":4,"featured_media":4432,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[42],"tags":[],"class_list":["post-4431","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-verpackung-blog"],"yoast_head":"\nAnalysen von prim\u00e4ren aromatischen Aminen (PAA) | PPWR | Nano-Test\u00ae<\/title>\n<meta name=\"description\" content=\"Wir f\u00fchren Analysen auf prim\u00e4re aromatische Amine (PAA) f\u00fcr Ihre Lebensmittelverpackungen gem\u00e4\u00df der PPWR und der Verordnung (EU) Nr. 10\/2011 durch; wir bescheinigen Ihnen die vollst\u00e4ndige Einhaltung des SML-Grenzwerts von 0,01 mg\/kg.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/nano-test.de\/2026\/08\/20\/primary-aromatic-amine-paa-analyses-ppwr-and-10-2011-eu\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Analysen von prim\u00e4ren aromatischen Aminen (PAA) | PPWR | Nano-Test\u00ae\" \/>\n<meta property=\"og:description\" content=\"Wir f\u00fchren Analysen auf prim\u00e4re aromatische Amine (PAA) f\u00fcr Ihre Lebensmittelverpackungen gem\u00e4\u00df der PPWR und der Verordnung (EU) Nr. 10\/2011 durch; 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