Packaging testing services

General compliance testing package for single-use plastic food contact materials (FCMs) by regulation (EU) 10/2011 and (EC) 1935/2004, article 3. This testing package includes the following tests: Overall migration testing for all food types (simulants A, B, and D2), Sensory testing (odor and taste) according to DIN 10955, Specific migration of ammonium ion and elements listed in Annex II of EU 10/2011, Specific migration of non-intentionally added substances (NIAS) to simulant D2e (95% ethanol) with GC-MS screening analysis. When relevant, this general testing package can be combined with additional tests and test packages, such as: Specific migration tests of substances with specific migration limitations (SMLs), Specific migration of primary aromatic amines (PAAs), Extended screening analyses of non-intentionally added substances (NIAS).

Overall migration (OML) testing with simulants A, B, and D2 is used to ensure the compliance of food packaging, cling film, freezer bags, nitrile gloves, takeaway boxes, and all other materials or articles that are intended for contact with all types of foods. Overall migration is the sum of all the non-volatile compounds that migrate from the food contact material into food. According to Regulation (EU) No 10/2011, materials and articles intended for contact with all types of food shall be tested with food simulants A (10% ethanol), B (3% acetic acid), and D2 (olive oil). To comply with the regulation, overall migration must not exceed 10 mg/dm2 (or 60 mg/kg). If testing with simulant D2 is not technically feasible, it is substituted with simulants D2e (95% ethanol) and D2i (isooctane). In case the contact temperature exceeds 100 °C, testing overall migration with simulant E (Tenax) is also necessary (not included in the cost). Our experts will provide guidance for selecting the appropriate simulants and migration conditions. Do not hesitate to ask for more information or a quote for testing repeated-use articles (the displayed price applies to single-use materials).

Phthalates are a group of chemicals widely used as plasticizers, which make plastics more flexible and durable. They have also been used as additives in products such as cosmetics and personal care items. Several phthalates have been identified as endocrine-disrupting agents or as chemicals toxic to reproduction. Exposure to phthalates can occur through: Oral exposure Food: Exposure occurs via migration from food packaging., Children's toys: Children often put toys in their mouths.., Inhalation: Breathing in dust from vinyl flooring or fragrances (like perfumes) can cause exposure to phthalates via inhalation., Skin contact: Phthalates present in cosmetics, lotions, and soaps can be absorbed through the skin.. For other listed matrices apart from cosmetics, the analysis package covers the following substances included in the REACH Authorization List: Substance Abbreviation CAS number Diisobutyl phthalate DIBP 84-69-5 Dibutyl phthalate DBP 84-74-2 Benzyl butyl phthalate BBP 85-68-7 Bis(2-ethylhexyl) phthalate DEHP 117-81-7 Di(n-octyl) phthalate DNOP 117-84-0 Diisononyl phthalate DINP 68515-48-0 Diisodecyl phthalate DIDP 26761-40-0 Products that contain restricted phthalates in concentrations higher than 0.1% may be removed from the market. The analysis package for cosmetic products contains the following phthalates: Substance Abbreviation CAS number Bis(2-ethylhexyl) phthalate DEHP 117-81-7 Benzyl butyl phthalate BBP 85-68-7 Dibutyl phthalate DBP 84-74-2 Diisononyl phthalate DINP 68515-48-0 Di(n-octyl) phthalate DNOP 117-84-0 Diisodecyl phthalate DIDP 26761-40-0 All the above-mentioned substances are prohibited in cosmetic products (Annex II of Regulation (EC) No 1223/2009).

Determination of selected PFAS compounds using the LC-MS technique. The analysis package includes the determination of 32 substances including Perfluorooctane sulphonic acid (PFOS), Perfluorooctanoic acid (PFOA), and Perfluorhexanesulfonic acid (PFHxS), the use of which is prohibited under the Stockholm Convention on Persistent Organic Pollutants. The following 32 substances are included in the PFAS analysis package: Substance Abbreviation Perfluorodecanesulfonic acid PFDS 10:2 Fluorotelomer sulfonic acid 10:2 FTS 1H,1H,2H,2H-Perfluorohexanesulfonic acid 4:2 FTS 6:2 Fluorotelomer sulfonic acid 6:2FTS (H4PFOS) 8:2 Fluorotelomer sulfonic acid 8:2 FTS ADONA F-53 B major F-53 B minor HFPO-DA (GenX) Perfluorheptanoic acid PFHpA Perfluorhexanesulfonic acid PFHxS Perfluoro-3,7-dimethyloctane acid PF-3,7-DMOA Perfluorobutanesulfonic acid PFBS Perfluorobutanoic acid PFBA Perfluorodecanoic acid PFDA Perfluorododecane sulfonic acid PFDoDS Perfluorododecanoic acid PFDoDA Perfluoroheptane sulphonate PFHpS Perfluorohexadecanic acid PFHxDA Perfluorohexanoic acid PFHxA Perfluorononanesulfonic acid PFNS Perfluorononanoic acid PFNA Perfluorooctadecanic acid PFODA Perfluorooctane sulphonic acid PFOS Perfluorooctanoic acid PFOA Perfluoropentane acid PFPeA Perfluoropentanesulfonic acid PFPS Perfluorotetradecanoic acid PFTeDA Perfluorotridecane acid PFTrDA Perfluorotridecane sulfonic acid PFTrDS Perfluoroundecane sulfonic acid PFUnDS Perfluoroundecanoic acid PFUnDA In addition, the following results will be reported: Sum PFOS / PFOA / PFNA / PFHxS excl. LOQ. The results of the analysis will be reported in µg/kg. Another popular PFAS testing strategy is the total organic fluorine (TOF) analysis, which measures the total amount of organic fluorinated compounds as a proxy for PFAS. Ask the method expert for more information.

N-nitrosamines and N-nitrosatable substances are present, usually in trace quantities, in various environmental media, certain food products, cosmetics, and rubber products. In particular, those found in rubber products are thought to originate from certain additives used in the vulcanization of rubber. Regulatory reference / standard Applicable materials Compliance limits Applicable reference method Commission Directive 93/11/EEC Elastomer or rubber teats and soothers N-nitrosamines released: 0.01 mg/kg N-nitrosatable substances released: 0.1 mg/kg EN 12868 EN 14350 Drinking accessories made of rubber and other elastomers BfR recommendation XXI/1 Commodities based on natural and synthetic rubber in contact with food N-nitrosamines: not detected above 1 µg/dm2 (sum of substances) - N-nitrosamines and N-nitrosatable substances are controlled by Commission Directive 93/11/EEC. In addition, recommendation XXI by Germany’s Federal Institute for Risk Assessment (BfR) has set the migration limit of N-nitrosamines from elastomers to food at ≤ 1.0 µg/dm². The test package covers analysis of the release of the following N-nitrosamines (free and after nitrosation) into artificial saliva simulant or a food simulant: Substance Abbreviation CAS No N-Nitrosodimethylamine NDMA 62-75-9 N-Nitrosodi-n-propylamine NDPA 621-64-7 N-Nitrosodi-n-butylamine NDBA 924-16-3 N-Nitrosopiperidine NPIP 100-75-4 N-Nitrosopyrrolidine NPYR 930-55-2 N-Nitrosomorpholine NMOR 59-89-2 N-Nitrosobenzylamine NDBzA 937-32-6 N-Nitrosodi-n-amylamine NDiNA 2050-92-2 N-Nitroso-methylphenylamine NMPhA 937-35-9 N-Nitrosoethylphenylamine NEPhA 612-64-6

Specific migration of mineral oil hydrocarbons (MOH), including mineral oil saturated hydrocarbons (MOSH) with polyolefin oligomeric hydrocarbons (POSH) and mineral oil aromatic hydrocarbons (MOAH) from food contact materials (FCM) into a food simulant. Analysis is possible with food simulants 10%, 20%, 50%, and 95% ethanol, 3% acetic acid, iso-octane, olive oil, and Tenax. The price includes testing with one simulant. The results are reported as the concentrations of fractions of MOSH/POSH and MOAH, with grouping based on the number of carbon atoms in the substances. The reported fractions are listed in the table below: MOSH/POSH (C10-C50), total MOAH (C10-C50), total MOSH/POSH (≥C10-≤C16) MOAH (≥C10-≤C16) MOSH/POSH (>C16-≤C20) MOAH (>C16-≤C25) MOSH/POSH (>C20-≤C25) MOAH (>C25-≤C35) MOSH/POSH (>C25-≤C35) MOAH (>C35-≤C50) MOSH/POSH (>C35-≤C40) MOSH/POSH (>C40-≤C50) POSH are not part of MOH but can be present in polyolefin plastics, such as polyethylene (PE) and polypropylene (PP). MOSH and POSH have very similar structures and they tend to elute together in chromatography. Thus in polyolefin plastics and materials with polyolefin layers, it is usually impossible to separate MOSH and POSH with normal analysis techniques. The analysis includes a compliance assessment according to the following references: MOSH fraction: in-house risk assessment POSH fraction: Plastics Europe documentation Polyolefin oligomers: research project for risk assessment. MOAH fraction: Standing Committee on Plants, Animals, Food and Feed Section Novel Food and Toxicological Safety of the Food Chain 19 October 2022

Determination of the specific migration of elements listed in Annex II of Commission Regulation (EU) No 10/2011. The test covers the following elements or parameters: Lithium (Li), Sodium (Na), Magnesium (Mg), Aluminum (Al), Potassium (K), Calcium (Ca), Chromium (Cr), Manganese (Mn), Iron (Fe), Cobalt (Co), Nickel (Ni), Copper (Cu), Zinc (Zn), Arsenic (As), Cadmium (Cd), Antimony (Sb), Barium (Ba), Lanthanum (La), Europium (Eu), Gadolinium (Gd), Terbium (Tb), Mercury (Hg), Lead (Pb), Sum of lanthanides – Eu, Gd, La, Tb.

We offer extractables and leachables (E&L) testing by USP <1663> and USP <1664> to identify and quantify potential contaminants that could migrate from pharmaceutical packaging systems into the drug product. Extractables are organic and inorganic chemicals released from pharmaceutical packaging into an extraction solvent under laboratory conditions. The specific testing conditions (e.g., solvents, temperature) are chosen to simulate potential stresses on the packaging and differ depending on the extraction study's purpose. Leachables are organic and inorganic chemical compounds that migrate from pharmaceutical packaging materials, components, or systems into the drug product under simulated use conditions. These conditions are tailored to represent the drug product's shelf life, storage, and administration, enabling a realistic assessment of potential patient exposure. Examples of analytical techniques used to characterize potential contaminants include: HS-GC: Detects volatile organic compounds., GC-MS: Identifies semi-volatile organic compounds., LC-MS: Characterizes non-volatile organic compounds., ICP-MS: Analyzes inorganic elements (metals).. E&L tests are always customized to the specific product that is studied. Contact our experts through the form below to get a quote for your material.