Specific migration testing – ammonium ion and elements of Annex II in Commission Regulation (EU) 2020/1245

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 of hexamethylene diisocyanate [CAS: 822-06-0] from a sample or material intended for food contact. The substance is listed under FCM 372 and Ref No. 18640 in European Commission Regulation No 10/2011 on plastic food contact materials. The specific migration limit (SML) of hexamethylene diisocyanate is ND (not detected), which means migration must not be observed with a 0.01 mg/kg detection limit. Note that we also offer an isocyanate testing package for measuring the residual content of hexamethylene diisocyanate and three additional isocyanates.

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 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.

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).

This analysis package is intended to determine whether food packaging and beverage bottles can be considered reusable in the framework of the Single-Use Plastic (SUP) Directive (EU) 2019/904. The following tests are included: Overall migration testing for repeated use with 10% ethanol, 3% acetic acid, and olive oil (simulants A, B, and D2), Dishwasher resistance testing according to EN 12875-1 with 25 wash cycles. The EU Commission’s interpretations of the SUP legislation state that reusability can be evaluated using the test method EN 12875-1 (Mechanical dishwashing resistance of utensils). If plastic articles can be washed 25 times in a dishwasher, they can be considered reusable, as they maintain their usability and properties throughout multiple uses. The test package also includes overall migration testing for repeated use to ensure that the article remains inert when used multiple times. By default, testing is done to establish compliance with all types of foods (i.e., moist and dry, acidic and non-acidic, and fatty foods). Note: The price applies to articles that have already been cleared for food contact as single-use articles. If a full set of tests for compliance according to Regulation (EU) No 10/2011 is needed, our experts are happy to provide a quote.

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.