Specific migration testing – hexamethylene diisocyanate

Printing ink set-off can occur on the reverse side of printed labels, lids, cups, and packaging film, either in a stack or on the reel after printing. This creates a potential for low-molecular-weight substances to transfer to the unprinted surface of the packaging that makes contact with the packed contents. Annex of Regulation (EC) No 2023/2006 (i.e., the GMP regulation) mandates that printing inks are formulated and applied in a manner that migration into food does not lead to non-compliance with Article 3 of Regulation (EC) No 1935/2004. In the analysis, samples are first stacked and exposed to accelerated set-off for 10 days at 40 °C. This is followed by migration into food simulants and analysis of the simulant with GC-MS. Finally, the GC-MS results are evaluated according to internationally recognised scientific principles on risk assessment to assess compliance with Regulation (EC) 1935/2004. Analysis is available with the following food simulants: Abbreviation Food simulant Accreditation status Food simulant A water Non-accredited Food simulant A 10% ethanol Accredited Food simulant B 3% acetic acid Accredited Food simulant C 20% ethanol Accredited Food simulant D1 50% ethanol Accredited Food simulant D2e 95% ethanol Accredited Food simulant D2i isooctane Accredited Food simulant E Tenax Accredited The price includes a simple risk assessment based on the following EU regulations and guidelines (non-exhaustive list): Regulation (EU) No 10/2011 (Annex I and Annex II), Swiss Ordinance SR 817.023.21 (Annex 2 and Annex 10), BfR Recommendations and outcomes from the BfR Committee for Consumer Goods, EFSA Scientific Opinions for specific food contact substances (e.g., monomers, additives, and aids to polymerization), EU databases for food additives and food flavouring substances, Toxicological "read-across" approach (applying established limits from structurally similar authorized substances to substances with data gaps), EFSA’s Threshold of Toxicological Concern (TTC) approach. More extensive risk assessment is available upon request for an additional cost.

Specific migration of elements listed in Annex II of Commission Regulation (EU) 2020/1245 of 2 September 2020 amending and correcting Regulation (EU) No 10/2011. The test covers the following elements: 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. In addition, the test includes specific migration testing of ammonium ion, which is performed separately from elemental migration analysis.

Specific migration of formaldehyde [CAS 50-00-0; Ref No 17260/54880; FCM 98] from a plastic food contact material. The compound is listed under FCM 98 in Annex I of European Regulation No 10/2011. Formaldehyde is grouped with FCM 196 and FCM 344 in Group 15. Together, the compounds have a specific migration limit (SML) of 15 mg/kg (expressed as formaldehyde). We also offer testing for fiber-based food contact materials - see formaldehyde content in extracts of paper and board.

Analysis of the migration of non-intentionally added substances (NIAS) into selected food simulant. NIAS have various sources and can be grouped into side products, breakdown products, and contaminants. The service is available with the following simulants: Water, 3% acetic acid, 10%, 20%, 50%, and 95% ethanol, and isooctane - suitable for plastic materials and materials with polymer coatings, Dry food simulant (Tenax) - also suitable for materials that cannot withstand liquid simulants (e.g. paper and board). The lower displayed price covers testing with liquid simulants and the higher with Tenax. A simple risk assessment based on EU regulations for food contact materials and EFSA's Threshold of Toxicological Concern (TTC) approach is included in the cost. More extensive risk assessment is available upon request.

Analysis to determine the specific migration of fluorescent whitening agent 2,5-bis(5-tert-butyl-2-benzoxazolyl)thiophene, known by the trade name Uvitex OB [CAS: 7128-64-5], from a sample or material intended for food contact. The substance is listed under FCM 500 and Ref No. 38560 in European Commission Regulation No 2011/10 on plastic food contact materials. The specific migration limit (SML) for Uvitex OB is 0.6 mg/kg of food.

Determination of the specific migration of elements listed in Annex II of Commission Regulation (EU) No 2020/1245 (15th amendment of the Commission Regulation (EU) No 10/2011). The Annex lists the following elements and specific migration limits (SMLs) for each element: Element Symbol SML [mg/kg] Cadmium Cd Not detectable (LOD 0.002) Arsenic As Not detectable (LOD 0.01) Lead Pb Not detectable (LOD 0.01) Mercury Hg Not detectable (LOD 0.01) Chromium Cr Not detectable (LOD 0.01) Nickel Ni 0.02 Antimony Sb 0.04 Cobalt Co 0.05 Europium Eu 0.05 (sum) Gadolinium Gd Lanthanum La Terbium Tb Lithium Li 0.6 Manganese Mn 0.6 Aluminium Al 1 Barium Ba 1 Copper Cu 5 Zinc Zn 5 Iron Fe 48 Calcium Ca - Magnesium Mg - Potassium K - Sodium Na - The service is available with all conventional food simulants: Water-based simulants: water, 3% acetic acid, 10% ethanol, 20% ethanol, 50% ethanol (simulants A, B, C, and D1), Solvent simulants: 95% ethanol, isooctane (simulants D2e and D2i), Vegetable oil (simulant D2), Tenax adsorbent (simulant E). The cost of the analysis depends on the number of samples, the desired scope of testing, and the food simulant used.

Specific migration testing of terephthalic acid [CAS 100-21-0; Ref No 24910] and isophthalic acid [CAS 121-91-5; Ref No 19150] by European Union Regulation No 2011/10. Terephthalic acid (FCM 785) is grouped with FCM 191 and FCM 192 (Group 28), which together have an SML of 7.5 mg/kg (expressed as terephthalic acid). Isophthalic acid (FCM 291) is grouped with FCM 188 (Group 27), which together have an SML of 5 mg/kg (expressed as isophthalic acid).

Specific migration of octadecyl 3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate, known by the trade name Irganox 1076 [CAS 2082-79-3], from a plastic material intended for food contact. The substance is listed under FCM No 433 and Ref No 68320 in European Commission Regulation 10/2011 with an SML value of 6 mg/kg of food. Test is available for all conventional food simulants. For repeated use articles, the test is done with three subsequent migrations.

Analysis for measuring the specific migration of bis(2,4-di-tert-butylphenyl)pentaerythritol diphosphite, known as Irgafos 126 [CAS: 26741-53-7], from a food contact material. The substance is listed as FCM 652 with Ref No. 38820 in European Commission Regulation No 10/2011 with an SML value of 0.6 mg/kg of food.

Analysis to determine the specific migration of 1,1,1-trimethylolpropane [CAS 77-99-6; FCM 141] from a plastic food contact material. The substance is listed in Annex I of Regulation (EU) No 10/2011 with three reference numbers (13380, 25600, and 94960). The specific migration limit (SML value) for trimethylolpropane is 6 mg/kg.