{"id":4415,"date":"2026-08-13T08:48:06","date_gmt":"2026-08-13T08:48:06","guid":{"rendered":"https:\/\/nano-test.de\/?p=4415"},"modified":"2026-08-13T08:54:47","modified_gmt":"2026-08-13T08:54:47","slug":"bisphenol-und-phthalat-analysen-ppwr-und-10-2011-eu","status":"publish","type":"post","link":"https:\/\/nano-test.de\/en\/2026\/08\/13\/bisphenol-und-phthalat-analysen-ppwr-und-10-2011-eu\/","title":{"rendered":"Bisphenol and Phthalate Analyzes | PPWR and 10\/2011\/EU"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-post\" data-elementor-id=\"4415\" class=\"elementor elementor-4415\" data-elementor-post-type=\"post\">\n\t\t\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-42427b3 ts-col-stretched-none ts-bg-color-over-image elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"42427b3\" data-element_type=\"section\" data-e-type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-59d46fe8 ts-bg-color-over-image\" data-id=\"59d46fe8\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-583325ad elementor-widget elementor-widget-text-editor\" data-id=\"583325ad\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<h2><span style=\"color: #000000;\">Introduction: The regulatory importance of bisphenols and phthalates<\/span><\/h2><p><span style=\"color: #000000;\">The chemical safety of packaging materials that come into contact with food is strictly regulated by the European Union Packaging Ordinance (PPWR) and a number of specific regulations, above all Regulation (EU) No 10\/2011 on plastic materials. Two of the most important components of this regulatory framework are the groups of substances known as bisphenols and B phthalates. Bisphenols are monomers used in particular in polycarbonate plastics and epoxy resin coatings, while phthalates are plasticizers that give PVC-based packaging flexibility. Both groups of substances have undergone intensive toxicological examinations on the basis of their endocrine-effective properties (which negatively affect the hormone system) and for many of them specific migration limits (SML) limiting their migration to foods have been set. Nano-Test Laboratories perform bisphenol and phthalate analyzes in full compliance with GLP principles with validated LC-MS\/MS and GC-MS\/MS procedures and provide our customers with legal compliance assessments and comprehensive technical advice.<\/span><\/p><h2><span style=\"color: #000000;\">Bisphenols: chemical structure, regulatory status and SML values<\/span><\/h2><p><span style=\"color: #000000;\">Bisphenols are synthetic organic compounds in which two hydroxyphenyl groups are connected to each other via a bridge atom or a bridge group. The best known and most commonly used compound of this group, Bisphenol A (BPA), is used as a monomer in the manufacture of polycarbonate plastics and as a starting material in the synthesis of epoxy resins. However, after the endocrine properties of BPA have been scientifically proven, the restrictions on the use of BPA in the European Union have been increasingly tightened. This has prompted manufacturers to use alternatively structurally similar alternative compounds (BPS, BPF, BPAF, etc.) instead of BPA; However, the fear that these alternatives could also have similar toxicological profiles has resulted in the supervisory authorities having also included these connections in the scope of surveillance.<\/span><\/p><h3><span style=\"color: #000000;\">The main regulated bisphenols and their SML values<\/span><\/h3><p><span style=\"color: #000000;\">The following table summarizes the bisphenol compounds that occur most frequently in packaging materials, their chemical structure, their regulatory status and the current SML values:<\/span><\/p><table><thead><tr><th><span style=\"color: #000000;\">Connection<\/span><\/th><th><span style=\"color: #000000;\">Abbreviation \/ CAS No.<\/span><\/th><th><span style=\"color: #000000;\">SML (mg\/kg food or simulant)<\/span><\/th><th><span style=\"color: #000000;\">Regulatory Status<\/span><\/th><th><span style=\"color: #000000;\">Typical scope<\/span><\/th><\/tr><tr><td><span style=\"color: #000000;\"><strong>Bisphenol A<\/strong><\/span><\/td><td><span style=\"color: #000000;\">BPA \/ 80-05-7<\/span><\/td><td><span style=\"color: #000000;\">0,05<\/span><\/td><td><span style=\"color: #000000;\">subject to SML according to 10\/2011\/EU; prohibited in baby bottles; in the EU in the process of a complete ban on food contact;<\/span><br><span style=\"color: #000000;\">limited in REACH Annex XVII; On the SVHC Candidate List (Endocrine Disruptor)<\/span><\/td><td><span style=\"color: #000000;\">Polycarbonate-Plastics, Epoxy Resin Coatings, Canned Inner Coatings<\/span><\/td><\/tr><tr><td><span style=\"color: #000000;\"><strong>Bisphenol S<\/strong><\/span><\/td><td><span style=\"color: #000000;\">BPS \/ 80-09 -1<\/span><\/td><td><span style=\"color: #000000;\">0,05<\/span><\/td><td><span style=\"color: #000000;\">Subject to SML according to 10\/2011\/EU; is increasingly being used as a BPA alternative; toxicological examination is still ongoing<\/span><\/td><td><span style=\"color: #000000;\">BPA alternative; Thermal paper coatings, sulfone polymers, epoxy resins<\/span><\/td><\/tr><tr><td><span style=\"color: #000000;\"><strong>Bisphenol f<\/strong><\/span><\/td><td><span style=\"color: #000000;\">BPF \/ 620-92-8<\/span><\/td><td><span style=\"color: #000000;\">Under observation<\/span><\/td><td><span style=\"color: #000000;\">Is not yet subject to any SML according to 10\/2011\/EU; on the EFSA's surveillance list; BPA alternative<\/span><\/td><td><span style=\"color: #000000;\">Epoxy resins, coatings, adhesives<\/span><\/td><\/tr><tr><td><span style=\"color: #000000;\"><strong>Bisphenol AF<\/strong><\/span><\/td><td><span style=\"color: #000000;\">BPAF \/ 1478-61-1<\/span><\/td><td><span style=\"color: #000000;\">Is subject to surveillance<\/span><\/td><td><span style=\"color: #000000;\">Used in fluorinated polymers; BPA alternative; official examination is still ongoing<\/span><\/td><td><span style=\"color: #000000;\">Manufacture of fluoropolymers, special coatings<\/span><\/td><\/tr><\/thead><\/table><p><span style=\"color: #000000;\"><em>Note: The European Commission is currently working on a draft prohibiting the use of BPA in all materials that come into contact with food. Nano-Test closely follows these regulatory developments and proactively informs its customers.<\/em><\/span><\/p><h2><span style=\"color: #000000;\">Phthalates: regulatory framework for plasticizers<\/span><\/h2><p><span style=\"color: #000000;\">Phthalates (phthalic acid esters) are plasticizers used in particular in polyvinyl chloride (PVC)-based packaging materials to impart flexibility and processability. Since they are not covalently bound to PVC, they can go to the surface (migration) over time and go into food from there. Some of the phthalates are classified as endocrine-effective substances and as reproductive toxic substances, which is why their use in materials that come into contact with food is strictly restricted. For low molecular weight phthalates (such as DBP, BBP, DEHP), far-reaching restrictions also apply under the REACH regulation.<\/span><\/p><h3><span style=\"color: #000000;\">The main regulated phthalates and SML values<\/span><\/h3><p><span style=\"color: #000000;\">The following table summarizes the most common phthalate compounds in packaging materials, their chemical structure and SML values in accordance with Regulation (EU) No 10\/2011:<\/span><\/p><table><thead><tr><th><span style=\"color: #000000;\">Connection<\/span><\/th><th><span style=\"color: #000000;\">Abbreviation \/ CAS No.<\/span><\/th><th><span style=\"color: #000000;\">SML (mg\/kg food or simulant)<\/span><\/th><th><span style=\"color: #000000;\">Regulatory Status<\/span><\/th><th><span style=\"color: #000000;\">Typical scope<\/span><\/th><\/tr><\/thead><tbody><tr><td><span style=\"color: #000000;\"><strong>Di (2-ethylhexyl)phthalate<\/strong><\/span><\/td><td><span style=\"color: #000000;\">DEHP \/ 117-81-7<\/span><\/td><td><span style=\"color: #000000;\">1,5<\/span><\/td><td><span style=\"color: #000000;\">subject to SML according to 10\/2011\/EU; REACH Annex XIV (requiring approval); on the SVHC candidate list; prohibited in toys<\/span><\/td><td><span style=\"color: #000000;\">PVC plasticizer; Seals, Closures, Flexible Foils, Medical Devices<\/span><\/td><\/tr><tr><td><span style=\"color: #000000;\"><strong>Dibutyl phthalate<\/strong><\/span><\/td><td><span style=\"color: #000000;\">DBP \/ 84-74-2<\/span><\/td><td><span style=\"color: #000000;\">0,3<\/span><\/td><td><span style=\"color: #000000;\">Subject to SML according to 10\/2011\/EU; REACH Annex XIV; on the SVHC candidate list; prohibited in cosmetics<\/span><\/td><td><span style=\"color: #000000;\">Adhesives, printing inks, PVC films, coatings<\/span><\/td><\/tr><tr><td><span style=\"color: #000000;\"><strong>Butylbenzylphthalate<\/strong><\/span><\/td><td><span style=\"color: #000000;\">BBP \/ 85-68-7<\/span><\/td><td><span style=\"color: #000000;\">30<\/span><\/td><td><span style=\"color: #000000;\">Subject to SML according to 10\/2011\/EU; REACH Annex XIV; On the SVHC candidate list<\/span><\/td><td><span style=\"color: #000000;\">Vinyl coatings, printing inks, laminating adhesives<\/span><\/td><\/tr><tr><td><span style=\"color: #000000;\"><strong>Di-isononylphthalate<\/strong><\/span><\/td><td><span style=\"color: #000000;\">DINP \/ 28553 -12-0<\/span><\/td><td><span style=\"color: #000000;\">9 (as sum of DINP and DIDP)<\/span><\/td><td><span style=\"color: #000000;\">Subject to SML according to 10\/2011\/EU; restricted in children's products<\/span><\/td><td><span style=\"color: #000000;\">PVC plasticizer; Flexible packaging, seals, closures<\/span><\/td><\/tr><tr><td><span style=\"color: #000000;\"><strong>Di isodesyl phthalate<\/strong><\/span><\/td><td><span style=\"color: #000000;\">DIDP \/ 26761-40-0<\/span><\/td><td><span style=\"color: #000000;\">9 (as sum of DINP and DIDP)<\/span><\/td><td><span style=\"color: #000000;\">subject to SML according to 10\/2011\/EU; restricted in children's products<\/span><\/td><td><span style=\"color: #000000;\">PVC plasticizer; Flexible packaging, seals<\/span><\/td><\/tr><tr><td><span style=\"color: #000000;\"><strong>Di-n-octylphthalate<\/strong><\/span><\/td><td><span style=\"color: #000000;\">Dnop \/ 117-84-0<\/span><\/td><td><span style=\"color: #000000;\">5 (as sum of DNOP and DNP)<\/span><\/td><td><span style=\"color: #000000;\">10\/ 2011\/EU is subject to SML<\/span><\/td><td><span style=\"color: #000000;\">PVC plasticizer; Special Applications<\/span><\/td><\/tr><\/tbody><\/table><p><span style=\"color: #000000;\"><em>Note: In the current consolidated version of Regulation 10\/2011\/EU, the SML values for DEHP, DBP, BBP and DINP are defined on the basis of the specific substances. In addition, combined conformity criteria for the total of these phthalates (e.g. the sum of DEHP + DBP + BBP) must be taken into account.<\/em><\/span><\/p><h2><span style=\"color: #000000;\">Analytical methodology in the nano test laboratory<\/span><\/h2><p><span style=\"color: #000000;\">In the nano-test laboratory, bisphenol and phthalate analyzes are carried out using analytical methods, which are optimized, validated and fully compliant with the GLP principles according to the chemical properties of the target substance.<\/span><\/p><h3><span style=\"color: #000000;\">Selection of the analytical platform and method comparison<\/span><\/h3><p><span style=\"color: #000000;\">The following table provides a comparison of the most important analytical platforms used in bisphenol and phthalate analyses and their areas of application:<\/span><\/p><table><thead><tr><th><span style=\"color: #000000;\">Analytical Platform<\/span><\/th><th><span style=\"color: #000000;\">Technical properties<\/span><\/th><th><span style=\"color: #000000;\">Destination connections<\/span><\/th><th><span style=\"color: #000000;\">Advantages<\/span><\/th><\/tr><\/thead><tbody><tr><td><span style=\"color: #000000;\"><strong>LC-MS\/MS (QQQ)<\/strong><\/span><\/td><td><span style=\"color: #000000;\">Triple quadrupole; ESI ionization; MRM mode; High selectivity and sensitivity<\/span><\/td><td><span style=\"color: #000000;\">Bisphenols (BPA, BPS, BPF, BPAF and other analogs); Polar Phthalate Metabolites<\/span><\/td><td><span style=\"color: #000000;\">Ideal for polar and moderately polar connections; low LOQ values (in the PPB range); No derivatization required<\/span><\/td><\/tr><tr><td><span style=\"color: #000000;\"><strong>GC-MS\/MS (QQQ)<\/strong><\/span><\/td><td><span style=\"color: #000000;\">Triple quadrupole; egg ionization; MRM mode; High chromatographic selectivity<\/span><\/td><td><span style=\"color: #000000;\">Phthalates (DEHP, DBP, BBP, DINP, DIDP, DNOP); Low Polar Connections<\/span><\/td><td><span style=\"color: #000000;\">Reference method for volatile and semi-volatile connections; extensive library support; isomer separation possible<\/span><\/td><\/tr><tr><td><span style=\"color: #000000;\"><strong>HPLC DAD \/ UV-VIS<\/strong><\/span><\/td><td><span style=\"color: #000000;\">Photodiode array detector; Suitable for compounds with chromophores groups<\/span><\/td><td><span style=\"color: #000000;\">Specific bisphenols; Samples with high concentration<\/span><\/td><td><span style=\"color: #000000;\">Simple and fast screening; cost-efficient; Suitable for pre-screening<\/span><\/td><\/tr><\/tbody><\/table><h3><span style=\"color: #000000;\">Analytical workflow: from migration attempt to quantitative determination<\/span><\/h3><p><span style=\"color: #000000;\">The following table describes in detail the end-to-end workflow for bisphenol and phthalate analyzes in the nano-test laboratory:<\/span><\/p><table><thead><tr><th><span style=\"color: #000000;\">Step<\/span><\/th><th><span style=\"color: #000000;\">Process<\/span><\/th><th><span style=\"color: #000000;\">Technical Details<\/span><\/th><\/tr><\/thead><tbody><tr><td><span style=\"color: #000000;\"><strong>1. Test setup<\/strong><\/span><\/td><td><span style=\"color: #000000;\">Determination of the simulancy and test conditions<\/span><\/td><td><span style=\"color: #000000;\">Appropriate food simulants and test conditions are selected in accordance with the application scenario specified by the customer in accordance with Annex III and V of Regulation (EU) No 10\/2011. For bisphenols and phthalates, Simulan D1 (50% ethanol) or Simulan D2 (vegetable oil) are usually used.<\/span><\/td><\/tr><tr><td><span style=\"color: #000000;\"><strong>2. Migration test<\/strong><\/span><\/td><td><span style=\"color: #000000;\">Controlled contact<\/span><\/td><td><span style=\"color: #000000;\">The packaging sample is contacted with the selected simulan at a set temperature and over a specified period using standard contact cells or by means of immersion. The contact conditions are continuously monitored in calibrated drying cabinets.<\/span><\/td><\/tr><tr><td><span style=\"color: #000000;\"><strong>3. Extraction and Sample Preparation<\/strong><\/span><\/td><td><span style=\"color: #000000;\">Isolation of the target analytes<\/span><\/td><td><span style=\"color: #000000;\">Liquid-liquid extraction or SPE (solid phase extraction) for aqueous simulants; Appropriate solvent extraction and purification for the oily Simulan D2. Matrix effects are corrected by adding internal standards (such as isotope-labeled BPA-D16, DEHP-D4).<\/span><\/td><\/tr><tr><td><span style=\"color: #000000;\"><strong>4. Instrumental Analysis<\/strong><\/span><\/td><td><span style=\"color: #000000;\">Quantitative determination using LC-MS\/MS or GC-MS\/MS<\/span><\/td><td><span style=\"color: #000000;\">Bisphenols are analyzed by LC-MS\/MS; Phthalates using GC-MS\/MS. Two MRM transits (quantitative and confirmation) are tracked for each target connection. The LOQ values were validated to be at least one tenth of the SML limits.<\/span><\/td><\/tr><tr><td><span style=\"color: #000000;\"><strong>5. Evaluation and Reporting<\/strong><\/span><\/td><td><span style=\"color: #000000;\">Comparison with the SML and declaration of conformity<\/span><\/td><td><span style=\"color: #000000;\">The quantitative results obtained are compared with the legal SML value of the respective substance. In cases where combined limit values apply (e.g. sum of DINP and DIDP), the total values are also calculated. A GLP compliant, comprehensive analysis report is created.<\/span><\/td><\/tr><\/tbody><\/table><h2><span style=\"color: #000000;\">The integrated service model of nano-test for bisphenol and phthalate analyses<\/span><\/h2><p><span style=\"color: #000000;\">As Nano-Test Labor Services, we do not offer bisphenol and phthalate analyzes as individual examinations, but as an integral part of the PPWR and 10\/2011\/EU conformity process. Our service model is based on the following four pillars:<\/span><\/p><table><thead><tr><th><span style=\"color: #000000;\">Service pillars<\/span><\/th><th><span style=\"color: #000000;\">Scope<\/span><\/th><th><span style=\"color: #000000;\">Benefits for the customer<\/span><\/th><\/tr><tr><td><span style=\"color: #000000;\"><strong>Regulatory consulting<\/strong><\/span><\/td><td><span style=\"color: #000000;\">Determining which bisphenol and phthalate compounds must be analyzed according to the product composition and the conditions of use; Selecting the right simulation and test conditions<\/span><\/td><td><span style=\"color: #000000;\">Cost optimization through the right test strategy; Avoidance of missing or unnecessary analyses<\/span><\/td><\/tr><tr><td><span style=\"color: #000000;\"><strong>Analytical Testing Services<\/strong><\/span><\/td><td><span style=\"color: #000000;\">Quantitative determination using GLP-compliant validated LC-MS\/MS and GC-MS\/MS methods<\/span><\/td><td><span style=\"color: #000000;\">Responsible and traceable analytical data accepted by the supervisory authorities<\/span><\/td><\/tr><tr><td><span style=\"color: #000000;\"><strong>Conformity assessment<\/strong><\/span><\/td><td><span style=\"color: #000000;\">Preparation of a declaration of conformity or non-conformity by comparing the results with SML values and combined limit values<\/span><\/td><td><span style=\"color: #000000;\">A clear and binding assessment of the legal status of the product<\/span><\/td><\/tr><tr><td><span style=\"color: #000000;\"><strong>Support with technical documentation<\/strong><\/span><\/td><td><span style=\"color: #000000;\">Provision of comprehensive analysis reports suitable for government requests and the data required for the Declaration of Conformity (DOC)<\/span><\/td><td><span style=\"color: #000000;\">Support for the customer in the complete and correct creation of their own declaration of conformity<\/span><\/td><\/tr><\/thead><\/table><p><span style=\"color: #000000;\">In the event of an exceeding of the limit value or non-conformity, the specialist team at Nano-Test also offers its customers technical advice on the cause analysis to determine the source of the problem and the planning of corrective measures. As bisphenol and phthalate contaminations are usually due to a specific raw material or additive in the supply chain, the correct identification of the source is crucial for a permanent solution to the problem.<\/span><\/p><p><span style=\"color: #000000;\">In order to ensure the bisphenol and phthalate compliance of your packaging that you export to the European market, according to PPWR and 10\/2011\/EU and to carry out your analyzes with a reliable and experienced partner, you can contact our expert team for detailed Get information about the accredited laboratory services and technical advice from Nano-Test.<\/span><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-bb6a7bd elementor-widget elementor-widget-text-editor\" data-id=\"bb6a7bd\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<h2><span style=\"color: #000000;\">Introduction: The NIAS concept and the regulatory context<\/span><\/h2><p><span style=\"color: #000000;\">Die Gew\u00e4hrleistung der chemischen Sicherheit von <a href=\"https:\/\/nano-test.de\/en\/service\/verpackung\/\">Verpackungsmaterialien<\/a>, die mit <a style=\"color: #000000;\" href=\"https:\/\/nano-test.de\/en\/service\/lebensmittelanalysen\/\">Lebensmitteln<\/a> in Kontakt kommen, beschr\u00e4nkt sich nicht nur auf die Kontrolle von Stoffen, die w\u00e4hrend des Herstellungsprozesses absichtlich zugesetzt werden (Intentionally Added Substances \u2013 IAS). Artikel 3 der Rahmenverordnung (EG) Nr. 1935\/2004 der Europ\u00e4ischen Union und die Verordnung (EU) Nr. 10\/2011 \u00fcber Kunststoffmaterialien verpflichten die Hersteller, unbeabsichtigt zugesetzte Stoffe (Non-Intentionally Added Substances \u2013 NIAS) zu ermitteln und eine Risikobewertung durchzuf\u00fchren. NIAS k\u00f6nnen aus Verunreinigungen in den Ausgangsstoffen, aus w\u00e4hrend der Produktion entstehenden Reaktionsnebenprodukten, Abbauprodukten oder Umweltkontaminanten stammen. Mit der Einf\u00fchrung der PPWR ist diese Verpflichtung noch deutlicher geworden, sodass Verpackungshersteller die NIAS-Bewertung mit einem systematischen Ansatz angehen m\u00fcssen. Nano-Test Labor Services bieten im Bereich der NIAS-Bewertung ein umfassendes und GLP-konformes Dienstleistungsportfolio an, das von Screening- und Identifizierungsuntersuchungen mit fortschrittlichen Analysetechniken bis hin zur toxikologischen Risikobewertung reicht.<\/span><\/p><h2><span style=\"color: #000000;\">Definition, sources and classification of NIAS<\/span><\/h2><p><span style=\"color: #000000;\">NIAS ist ein weit gefasster Begriff, der alle chemischen Stoffe umfasst, die nicht absichtlich der Rezeptur eines Verpackungsmaterials zugesetzt wurden, aber im Endprodukt vorkommen k\u00f6nnen. Die Quellen dieser Stoffe sind vielf\u00e4ltig und k\u00f6nnen w\u00e4hrend des gesamten Lebenszyklus der <a style=\"color: #000000;\" href=\"https:\/\/nano-test.de\/en\/service\/verpackung\/\">Packaging<\/a> entstehen. Ein korrektes Verst\u00e4ndnis von NIAS ist von entscheidender Bedeutung f\u00fcr die Entwicklung einer wirksamen Analysestrategie und die Durchf\u00fchrung einer Risikobewertung.<\/span><\/p><h3><span style=\"color: #000000;\">Classification of NIAS sources<\/span><\/h3><p><span style=\"color: #000000;\">The following table systematically summarizes the most important mechanisms of formation, sources and typical examples for each source:<\/span><\/p><table><thead><tr><th><span style=\"color: #000000;\">NIAS source<\/span><\/th><th><span style=\"color: #000000;\">Mechanism of formation<\/span><\/th><th><span style=\"color: #000000;\">Typical NIAS examples<\/span><\/th><\/tr><\/thead><tbody><tr><td><span style=\"color: #000000;\"><strong>Contaminations in the starting materials<\/strong><\/span><\/td><td><span style=\"color: #000000;\">Residues from the manufacturing process of monomers, additives or residues of solvents originating from the production process<\/span><\/td><td><span style=\"color: #000000;\">Monomer isomers, solvent residues, catalyst residues, contaminations in chemicals of technical quality<\/span><\/td><\/tr><tr><td><span style=\"color: #000000;\"><strong>Reaction by-products<\/strong><\/span><\/td><td><span style=\"color: #000000;\">Undesired compounds formed during polymerization, cross-linking or curing reactions undesired compounds<\/span><\/td><td><span style=\"color: #000000;\">Oligomers (dimers, trimers), polymerization by-products, degradation products<\/span><\/td><\/tr><tr><td><span style=\"color: #000000;\"><strong>Decomposition products<\/strong><\/span><\/td><td><span style=\"color: #000000;\">Thermal, photochemical or hydrolytic degradation of the polymer or additives<\/span><\/td><td><span style=\"color: #000000;\">Degradation products of antioxidants, degradation products of UV stabilizers, depolymerization oligomers<\/span><\/td><\/tr><tr><td><span style=\"color: #000000;\"><strong>Contaminations from recycling&lt;\/ strong&gt;<\/strong><\/span><\/td><td><span style=\"color: #000000;\">Foreign substances that enter the recycled raw material or residues from previous use<\/span><\/td><td><span style=\"color: #000000;\">Printing ink components, adhesive residues, residues of previous products, MOSH\/MOAH<\/span><\/td><\/tr><tr><td><span style=\"color: #000000;\"><strong>Environmental contaminants<\/strong><\/span><\/td><td><span style=\"color: #000000;\">Substances that occur during production, storage or transport from the environment<\/span><\/td><td><span style=\"color: #000000;\">PAH (polycyclic aromatic hydrocarbons), PCB, pesticide residues<\/span><\/td><\/tr><\/tbody><\/table><p><span style=\"color: #000000;\"><em>Note: The scope of the NIAS assessment is determined on a case-by-case basis based on the composition of the packaging material, the manufacturing process and the intended conditions of use. The guidelines published by the EFSA provide the basic methodological framework for the NIAS assessment.<\/em><\/span><\/p><h2><span style=\"color: #000000;\">Analytical strategy in NIAS assessment<\/span><\/h2><p><span style=\"color: #000000;\">The NIAS assessment represents one of the most complex areas of analytical chemistry due to the need to screen and identify a variety of known and unknown substances simultaneously. In the Nano-Test laboratory, the NIAS assessment is carried out using the following multi-stage and systematic approach.<\/span><\/p><h3><span style=\"color: #000000;\">Step-by-step NIAS assessment strategy<\/span><\/h3><p><span style=\"color: #000000;\">The NIAS assessment process applied by Nano-Test consists of four main phases, which are summarized in the following table:<\/span><\/p><table><thead><tr><th><span style=\"color: #000000;\">Phase<\/span><\/th><th><span style=\"color: #000000;\">Step<\/span><\/th><th><span style=\"color: #000000;\">Explanation<\/span><\/th><\/tr><\/thead><tbody><tr><td><span style=\"color: #000000;\"><strong>1. Pre-evaluation and data collection<\/strong><\/span><\/td><td><span style=\"color: #000000;\">Review of information on formulation and manufacturing process<\/span><\/td><td><span style=\"color: #000000;\">Theoretical determination of all raw materials, additives, production parameters, and potential NIAS sources (impurities, reaction by-products, decomposition products). In this phase, supplier declarations and safety data sheets (SDS) provided by the customer are also evaluated.<\/span><\/td><\/tr><tr><td><span style=\"color: #000000;\"><strong>2. Non-targeted screening (non-targeted screening)<\/strong><\/span><\/td><td><span style=\"color: #000000;\">Comprehensive screening using high-resolution mass spectrometry (HRMS)<\/span><\/td><td><span style=\"color: #000000;\">The extract obtained after a suitable extraction and\/or migration test is analyzed with LC-QTOF-MS and GC-QTOF-MS systems. The obtained data are evaluated with advanced data processing software to perform a library match and identify unknown peaks.<\/span><\/td><\/tr><tr><td><span style=\"color: #000000;\"><strong>3. Identification and semiquantitative determination<\/strong><\/span><\/td><td><span style=\"color: #000000;\">Structural elucidation of identified NIAS candidates<\/span><\/td><td><span style=\"color: #000000;\">The structural characterization of unknown compounds is based on the exact mass obtained from the HRMS data, the isotope distribution and the MS\/MS fragmentation pattern. As far as possible, validation is based on reference standards. The semi-quantitative estimate is based on an approach based on internal standards or structural analogues.<\/span><\/td><\/tr><tr><td><span style=\"color: #000000;\"><strong>4. Toxicological Risk Assessment<\/strong><\/span><\/td><td><span style=\"color: #000000;\">Evaluation of the identified NIAS with regard to food safety<\/span><\/td><td><span style=\"color: #000000;\">For each identified NIAS, a risk assessment is performed using the EFSA's Threshold of Toxicological Concern (TTC) approach or substance-specific toxicological data. The Cramer classification and genotoxicity warnings (QSAR) are taken into account.<\/span><\/td><\/tr><\/tbody><\/table><h3><span style=\"color: #000000;\">Nano Test NIAS Analysis Platforms<\/span><\/h3><p><span style=\"color: #000000;\">The main analytical platforms used in the Nano Test Laboratory for the NIAS assessment, as well as their specific roles in NIAS analysis, are shown in the following table:<\/span><\/p><table><thead><tr><th><span style=\"color: #000000;\">Analytical Platform<\/span><\/th><th><span style=\"color: #000000;\">Technical properties<\/span><\/th><th><span style=\"color: #000000;\">Role in NIAS analysis<\/span><\/th><th><span style=\"color: #000000;\">Target network profile<\/span><\/th><\/tr><\/thead><tbody><tr><td><span style=\"color: #000000;\"><strong>LC-QTOF-MS<\/strong><\/span><\/td><td><span style=\"color: #000000;\">High Resolution (\u201a30,000 FWHM), High Mass Accuracy (\u00b13 ppm), MS\/MS Fragmentation<\/span><\/td><td><span style=\"color: #000000;\">Target-free screening and identification of polar and moderately polar NIAS<\/span><\/td><td><span style=\"color: #000000;\">Oligomers, degradation products, antioxidants and their metabolites, plasticizers, lubricants<\/span><\/td><\/tr><tr><td><span style=\"color: #000000;\"><strong>GC-QTOF-MS<\/strong><\/span><\/td><td><span style=\"color: #000000;\">High Resolution, Egg and Ci Ionization, Extensive Library (NIST, Wiley)<\/span><\/td><td><span style=\"color: #000000;\">Targets Free Screening and Identification of Volatile and Semi-Flecked NIAS<\/span><\/td><td><span style=\"color: #000000;\">Volatile organic compounds (VOCs), low molecular weight oligomers, solvent residues<\/span><\/td><\/tr><tr><td><span style=\"color: #000000;\"><strong>LC-MS\/MS (QQQ)<\/strong><\/span><\/td><td><span style=\"color: #000000;\">Triple-quadrupole, MRM mode, high selectivity and sensitivity<\/span><\/td><td><span style=\"color: #000000;\">Targeted quantitative determination and validation of identified NIAS<\/span><\/td><td><span style=\"color: #000000;\">Specific NIAS compounds (BPA, phthalates, PAA, etc.)<\/span><\/td><\/tr><tr><td><span style=\"color: #000000;\"><strong>Headspace GC-MS<\/strong><\/span><\/td><td><span style=\"color: #000000;\">Headspace sampling, optimized for volatile connections<\/span><\/td><td><span style=\"color: #000000;\">Screening and Quantification of Volatile NIAS<\/span><\/td><td><span style=\"color: #000000;\">Residual monomers (styrene, butadiene), solvents, volatile degradation products<\/span><\/td><\/tr><\/tbody><\/table><h2><span style=\"color: #000000;\">Toxicological risk assessment and TTC approach<\/span><\/h2><p><span style=\"color: #000000;\">The ultimate goal of the NIAS assessment is to determine whether the identified substances pose a risk to consumer health. The \u201cThreshold of Toxicological Concern\u201d (TTC) approach adopted by EFSA offers a scientifically based risk assessment tool for substances whose structure is known but for which only limited toxicological data are available.<\/span><\/p><p><span style=\"color: #000000;\">Nano Test uses the following systematic approach in this crucial phase of NIAS assessment:<\/span><\/p><h3><span style=\"color: #000000;\">Cramer Classification and TTC Thresholds<\/span><\/h3><p><span style=\"color: #000000;\">The following table summarizes the toxicological potential of the substances according to the Cramer classification system and the corresponding TTC thresholds:<\/span><\/p><table><thead><tr><th><span style=\"color: #000000;\">Cramer class<\/span><\/th><th><span style=\"color: #000000;\">Toxicity potential<\/span><\/th><th><span style=\"color: #000000;\">TTC threshold (\u03bcg\/kg body weight\/day)<\/span><\/th><th><span style=\"color: #000000;\">Typical chemical structures<\/span><\/th><\/tr><tr><td><span style=\"color: #000000;\"><strong>Class I<\/strong><\/span><\/td><td><span style=\"color: #000000;\">Low toxicity potential<\/span><\/td><td><span style=\"color: #000000;\">30<\/span><\/td><td><span style=\"color: #000000;\">Simple aliphatic hydrocarbons, normal metabolic products<\/span><\/td><\/tr><tr><td><span style=\"color: #000000;\"><strong>Class II<\/strong><\/span><\/td><td><span style=\"color: #000000;\">Mean toxicity potential<\/span><\/td><td><span style=\"color: #000000;\">9<\/span><\/td><td><span style=\"color: #000000;\">Compounds with functional groups without aromatic rings, esters, ethers<\/span><\/td><\/tr><tr><td><span style=\"color: #000000;\"><strong>Class III<\/strong><\/span><\/td><td><span style=\"color: #000000;\">High toxicity potential<\/span><\/td><td><span style=\"color: #000000;\">1, 5<\/span><\/td><td><span style=\"color: #000000;\">Aromatic compounds, heterocyclic structures, conjugated systems<\/span><\/td><\/tr><tr><td><span style=\"color: #000000;\"><strong>Genotoxic substances<\/strong><\/span><\/td><td><span style=\"color: #000000;\">Suspected DNA-reactive genotoxicity<\/span><\/td><td><span style=\"color: #000000;\">0.0025 (for a lifetime risk of cancer of 1:10\u2075)<\/span><\/td><td><span style=\"color: #000000;\">Aflatoxin-like structures, N-nitroso compounds, DNA intercalators<\/span><\/td><\/tr><\/thead><\/table><p><span style=\"color: #000000;\"><em>Note: EFSA does not recommend using the TTC approach for genotoxic carcinogens. Minimizing exposure (Alara principle) is of fundamental importance for such substances. In addition, the TTC approach may not be suitable for substance groups with potentially neurotoxic effects, such as organophosphates and carbamates.<\/em><\/span><\/p><h2><span style=\"color: #000000;\">Nano-Test's integrated NIAS assessment service<\/span><\/h2><p><span style=\"color: #000000;\">As Nano-Test Labor Services, we offer the NIAS assessment with a multidisciplinary and integrated approach. Our service model consists of the components summarized in the following table:<\/span><\/p><p><span style=\"color: #000000;\">Die NIAS-Bewertung ist nicht nur ein analytischer Test, sondern ein vielschichtiger Prozess, der fundiertes chemisches und toxikologisches Fachwissen erfordert. Als Nano-Test handeln wir in jeder Phase dieses Prozesses im Einklang mit den GLP-Grunds\u00e4tzen, wissenschaftlicher Sorgfalt und einem kundenorientierten Beratungsansatz.Um die NIAS-Konformit\u00e4t Ihrer Verpackungen, die Sie auf den europ\u00e4ischen Markt exportieren, im Rahmen der <a href=\"https:\/\/environment.ec.europa.eu\/topics\/waste-and-recycling\/packaging-waste_en\">PPWR<\/a> und der entsprechenden EU-Vorschriften sicherzustellen und Ihre Screening- sowie Risikobewertungsprozesse mit einem zuverl\u00e4ssigen Partner durchzuf\u00fchren, k\u00f6nnen Sie sich an unser Expertenteam wenden, um detaillierte Informationen zu den <strong>NIAS-Bewertungsdienstleistungen<\/strong> von Nano-Test zu erhalten.<\/span><\/p><p>\u00a0<\/p><table><thead><tr><th><span style=\"color: #000000;\">Performance component<\/span><\/th><th><span style=\"color: #000000;\">Scope<\/span><\/th><th><span style=\"color: #000000;\">Benefit for the customer<\/span><\/th><\/tr><\/thead><thead><tr><th>\u00a0<\/th><th>\u00a0<\/th><th>\u00a0<\/th><\/tr><\/thead><tbody><tr><td><span style=\"color: #000000;\"><strong>Formulation and Process Analysis<\/strong><\/span><\/td><td><span style=\"color: #000000;\">Detailed investigation of the raw materials used, additives and the production process; Theoretical mapping of potential NIAS sources<\/span><\/td><td><span style=\"color: #000000;\">Correct elaboration of the analysis strategy, avoidance of unnecessary analyses<\/span><\/td><\/tr><tr><td><span style=\"color: #000000;\"><strong>Untargeted Screening (HRMS)<\/strong><\/span><\/td><td><span style=\"color: #000000;\">Comprehensive, target-free chemical screening using LC-QTOF-MS and GC-QTOF-MS<\/span><\/td><td><span style=\"color: #000000;\">Detection of unexpected contaminants and unknown NIAS<\/span><\/td><\/tr><tr><td><span style=\"color: #000000;\"><strong>Structural Enlightenment and Half-Quantification<\/strong><\/span><\/td><td><span style=\"color: #000000;\">Structural characterization based on HRMS data and semi-quantitative estimate based on internal standards<\/span><\/td><td><span style=\"color: #000000;\">Reliable identification of unknown peaks and determination of their approximate concentrations<\/span><\/td><\/tr><tr><td><span style=\"color: #000000;\"><strong>Toxicological risk assessment<\/strong><\/span><\/td><td><span style=\"color: #000000;\">Comprehensive Risk Assessment Using TTC Approach, Cramer Classification and QSAR Toxicity Prediction (in Silico)<\/span><\/td><td><span style=\"color: #000000;\">Scientifically based assessment of the food safety risk of identified NIAS<\/span><\/td><\/tr><tr><td><span style=\"color: #000000;\"><strong>Compliance with regulatory requirements<\/strong><\/span><\/td><td><span style=\"color: #000000;\">Comprehensive report for the DOC (Declaration of Conformity), which contains all analytical results and the risk assessment<\/span><\/td><td><span style=\"color: #000000;\">Complete documentation for official applications and customer audits<\/span><\/td><\/tr><\/tbody><\/table>\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":"<p>Einleitung: Die regulatorische Bedeutung von Bisphenolen und Phthalaten Die chemische Sicherheit von Verpackungsmaterialien, die mit Lebensmitteln in Kontakt kommen, wird durch die Verpackungsverordnung der Europ\u00e4ischen Union (PPWR) sowie durch eine Reihe spezifischer Vorschriften, allen voran die Verordnung (EU) Nr. 10\/2011 \u00fcber Kunststoffmaterialien, streng geregelt. Zwei der wichtigsten Bestandteile dieses regulatorischen Rahmens sind die als Bisphenole \u2026 <a href=\"https:\/\/nano-test.de\/en\/2026\/08\/13\/bisphenol-und-phthalat-analysen-ppwr-und-10-2011-eu\/\" class=\"more-link\" title=\"Continue reading &amp;lt;span class=\" screen-reader-text>Bisphenol- und Phthalat-Analysen | PPWR und 10\/2011\/EU\u201c&gt;Continue reading <span class=\"screen-reader-text\">Bisphenol and Phthalate Analyzes | PPWR and 10\/2011\/EU<\/span><\/a><\/p>\n","protected":false},"author":4,"featured_media":4417,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[42],"tags":[],"class_list":["post-4415","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-verpackung-blog"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v28.8 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Bisphenol- und Phthalat-Analysen | 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