Specific migration testing – elements in Annex II of Commission Regulation (EU) No 10/2011

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 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.

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 2011/10. 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: 50% ethanol, 95% ethanol, and iso-octane - 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 if food packaging and beverage bottles can be considered reusable in the framework of the Single-Use Plastic (SUP) Directive (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 declare that reusability can evaluated using 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 to have been designed for multiple uses without losing their effectiveness and properties. Additionally, food packaging and beverage bottles tested for single-use are not compliant for reuse according to Regulation (EU) No 10/2011. Hence, the test package includes overall migration testing for repeated use to ensure that the article remains inert when reused. By default, testing is done to establish compliance with all types of foods (i.e., moist and dry foods, acidic and non-acidic, fatty foods). Note: this test package is only applicable for articles that have already been tested for food contact as single-use articles. This does not constitute a full test package for compliance according to Regulation (EU) No 10/2011. Please consult our experts for further support.

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.

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.