Laboratory testing services

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.

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.

The substances of very high concern (SVHC) analysis provides comprehensive material screening for SVHC substances as listed in the Registration, Evaluation, and Authorization of Chemical Substances (REACH). The maximum allowed concentration of any substance on the SVCH list is 0.1 mass-%. If the product contains more than 0.1% w/w of an SVHC substance, ECHA has to be notified and information on the safe use of the article must be provided to customers upon request. Contact us to request a quote for screening your material for SVHCs. The price of the analysis depends on the sample type.

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).

A biological evaluation plan (BEP) is a critical part of assessing the safety of a medical device. It involves a detailed examination of various aspects such as the device's design & structure, its material composition, manufacturing process & potential contaminants, the intended use, existing test results, and clinical history. The BEP ensures that the device undergoes sufficient biocompatibility testing, with parameters selected from the ISO 10993-1 standard. As a manufacturer, you will need to have a BEP during the regulatory approval process to demonstrate the safety of your medical device. The BEP should be developed during the initial design phase of the medical device. At this stage, manufacturers can identify potential biological risks associated with the device's intended use, materials, and components. A new BEP or updates to the existing one may also be needed if changes are made to the device's design or material composition at a later point. At Measurlabs, we can provide a BEP for a range of medical devices while also guiding manufacturers throughout the process. Do not hesitate to contact us if you are developing a new device, seeking regulatory approval, making changes to an existing product, conducting post-market surveillance, or performing preclinical testing.  We are also happy to create an offer for biocompatibility testing according to the BEP, as well as a biological evaluation report (BER) to summarize the results of the biological evaluation.

Determination of total fluorine (F) content in plastic according to the EN 15408 mod. method. The fluorine content of the sample is obtained using oxygen bomb combustion treatment followed by ion chromatography (IC). Possible sample preparation, such as grinding into smaller particles, is available at an extra cost. This method can also be used to determine the total content of S, Cl, and Br. The results will be reported in mg/kg.

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 perfluorohexanesulfonic 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 of PFOS, PFOA, PFNA, and PFHxS (excl. LOQ). The results 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 overall PFAS presence. We are happy to provide a quote for both analyses to help you get a more comprehensive picture of your samples' PFAS levels.

Testing for harmful substances in metal jewelry parts according to the requirements of REACH Regulation (EC) No 1907/2006. The test package includes the following tests: Transfer of nickel from jewelry to the human body. Limit value for first-time piercing jewelry 0.2 µg/cm²/week. For other jewelry, the limit is 0.5 µg/cm²/week., Cadmium (concentration test, limit value 0.01% by weight), Lead (concentration test, limit value 0.05% by weight). NOTE: Price is applicable for single jewelry parts (for example earring hooks etc.) and pricing is based on small sample sets. Discount is provided if the number of samples is high. Please ask for an offer from our expert if the tested product includes multiple parts or materials or if you are planning to deliver a bigger sample set at once.

GC-MS analysis of 16 PAH compounds, which are listed as high-priority pollutants by the U.S. Environmental Protection Agency (EPA). The analyzed PAH compounds are: naphthalene [CAS: 91-20-3], acenaphthylene [CAS: 208-96-8], acenaphthene [CAS: 83-32-9], fluorene [CAS: 86-73-7], phenanthrene [CAS: 85-01-8], anthracene [CAS: 120-12-7], fluoranthene [CAS: 206-44-0], pyrene [CAS: 129-00-0], benz(a)anthracene [CAS: 56-55-3], chrysene [CAS: 218-01-9], benzo(b)fluoranthene [CAS: 205-99-2], benzo(k)fluoranthene [CAS: 207-08-9], benzo (a) pyrene [CAS: 50-32-8], dibenzo(ah)anthracene [CAS: 53-70-3], benzo (ghi) perylene [CAS: 191-24-2], indeno (123cd) pyrene [CAS: 193-39-5].

Analysis of PAH compounds in plastic, rubber, paper, board, and products made from these raw materials (e.g., textiles, toys, packaging materials) as required by the REACH Regulation. Test package includes the following substances: Benzo(a)pyrene [benzo(def)chrysene] [CAS: 50-32-8] , Benzo(e)pyrene [CAS: 192-97-2] , Benzo(a)anthracene [CAS: 56-55-3] , Chrysene [CAS: 218-01-9] , Benzo(b)fluoranthene [CAS: 205-99-2] , Benzo(j)fluoranthene [CAS: 205-82-3] , Benzo(k)fluoranthene [CAS: 207-08-9], Dibenzo(a,h)anthracene [CAS: 53-70-3].

The burning rate of vertically mounted materials designed for vehicles and buses must be tested with the UN/ECE R118 Annex 8 test before approval for use. Measurlabs offers this and other accredited R118 fire tests. Upon meeting the requirements outlined in Annex 8, the requirements for horizontal flame spread (annex 6) are also met. In the test method, the exposed side of the vertically mounted test specimen is burned from underneath and the burning rate is measured in mm/min.

Testing package to assess the industrial compostability of materials or products following international protocols, such as EN 13432 for packaging, EN 14995 for plastic products, and ISO 17088 for organic recycling. The compostability assessment framework comprises four complementary tests, collectively ensuring the organic recyclability of the material or product: Analysis of constituents to verify the absence of heavy metals and toxic compounds in the material., Biodegradation tests to assess how plastic breaks down, gauging its environmental impact., Disintegration tests for evaluating how plastics fragment into smaller pieces under diverse environmental conditions., Ecotoxicity assessment to ensure that the biodegradation product is not toxic to living organisms, including plants, invertebrates, and microorganisms.. This analysis package includes the necessary tests to verify your product's compostability in an industrial composting environment with a 3-month testing time, which is the typical time for biodegradable plastics to break down in an industrial compost. The maximum testing time is 6 months.

The burning rate of horizontally mounted materials designed to be used in vehicles and buses must be tested with the UN/ECE R118 annex 6 test before they can be approved for use. Measurlabs offers this and the other R118 tests with accreditation. In the test method, the exposed side of the test specimen is burned from underneath and the burning rate is measured and expressed in mm/min.

The melting behavior of fusible materials used in certain motor vehicles must be determined according to Annex 7 of UN/ECE Regulation 118. In the test, it is monitored whether the specimen ignites, creates flaming droplets, and if these droplets ignite cotton wool placed under the specimen. For the material to pass the test, there must be no formation of flaming drops that ignite the cotton wool. Measurlabs can offer accredited test reports for the UN/ECE R118 Annex 7 test, as well as the Annex 6 and Annex 8 tests. Non-isotropic materials must be tested from both sides, which means that double the number of samples is required.

The following analyses are included in this nanoparticle analysis package, intended to characterize nanoforms according to the REACH Regulation. Particle size distribution and aspect ratios by SEM-EDX Preparation with isopropanol, Sample dispersion on a slide, with centrifugation, SEM analysis and particle count by image analysis, Nanoparticle detection and classification according to the 2022 EC recommendation on the definition of nanomaterial, Reporting of PSD parameters for ~300 particles, including the following: PSD diagram, accumulated and individual., Feret min (min, d10, d25, d50, d75, d90, d95, max), Feret max (min, d10, d25, d50, d75, d90, d95, max), Equivalent circular diameter (min, d10, d25, d50, d75, d90, d95, max), Aspect ratio (calculated based on individual Feret min and Feret max measurements), Number based nano-fraction (%).. Crystal phase analysis by XRD/Rietveld method Sample preparation: drying, grinding, X-ray preparation, XRD analysis over an angular range extending from 10° to 90°, Identification of the crystalline phases present in the sample, Semi-quantitative analysis of phase distribution, using the Rietveld method, Interpretation of diffractograms. Chemical composition/purity by ICP-AES and CHNS analysis ICP-AES quantification of inorganic and metallic elements: Ag, Al, As, B, Ba, Be, Bi, Ca, Cd, Co, Cr, Cu, Fe, K, Li, Mg, Mn, Mo, Na, Ni, P, Pb, S, Se, Sb, Si, Sn, Sr, V, Zn, Ti, and Tl, Determination of C, H, N, and S with an elemental analyzer. Volume-specific surface area (VSSA) and VSSA diameter calculations (optional) BET specific surface area measurement of powder by nitrogen adsorption, True (skeletal) density measurement by He pycnometry, excluding intergranular and intragranular porosity, Both analyses include sample preparation. You can request a quote for the analysis using the form below. Please note that the OECD 125 guideline does not apply to this analysis.

Analysis of fragrance allergens as specified in Commission Regulation (EC) No 1223/2009 on cosmetic products. This wide GC-MS/MS screening covers substances added to Annex III of the cosmetic products regulation by Regulation (EC) No 2023/1545, which added dozens of new entries to the allergen list. Some prohibited substances, such as Lilial and Lyral, are also tested for. The following substances are included in the analysis: Substance Reference number in Regulation 1223/2009 Status Benzyl alcohol 45 Restricted (Annex III) 6-Methyl Coumarin 46 Restricted (Annex III) Amyl cinnamal 67 Restricted (Annex III) Cinnamyl alcohol 69 Restricted (Annex III) Citral, Geranial, Neral 70 Restricted (Annex III) Eugenol 71 Restricted (Annex III) Hydroxycitronellal 72 Restricted (Annex III) Isoeugenol 73 Restricted (Annex III) Amylcinnamyl alcohol 74 Restricted (Annex III) Benzyl salicylate 75 Restricted (Annex III) Cinnamal 76 Restricted (Annex III) Coumarin 77 Restricted (Annex III) Geraniol 78 Restricted (Annex III) Anise alcohol 80 Restricted (Annex III) Benzyl cinnamate 81 Restricted (Annex III) Farnesol 82 Restricted (Annex III) Linalool 84 Restricted (Annex III) Benzyl benzoate 85 Restricted (Annex III) Citronellol 86 Restricted (Annex III) Hexyl cinnamal 87 Restricted (Annex III) Limonene 88 Restricted (Annex III) Methyl 2-Octynoate 89 Restricted (Annex III) alpha-Isomethyl ionone 90 Restricted (Annex III) Evernia prunastri extract 91 Restricted (Annex III) Evernia furfuracea extract 92 Restricted (Annex III) Musk xylene 96 Restricted (Annex III) Musk ketone 97 Restricted (Annex III) Methyl eugenol 102 Restricted (Annex III) Alpha-Terpinene 131 Restricted (Annex III) Terpinolene 133 Restricted (Annex III) Acetyl Hexamethyl indan (Phantolide) 134 Restricted (Annex III) 4-tert.- Butyldihydrocinnamaldehyde (Bourgenoal) 155 Restricted (Annex III) Sum of rose ketones: Alpha-Damascone, cis-Rose ketone 1, trans-Rose ketone 1, Rose ketone 4 (Damascone), Rose ketone 3 (delta-Damascone), trans-Rose ketone 3, cis-Rose ketone 2 (cis-beta-Damascone), trans-Rose ketone 2 (trans-beta-Damascone) 157 Restricted (Annex III) 3-Propylidenephthalide 175 Restricted (Annex III) Acetyl hexamethyl tetralin (Tonalide) 182 Restricted (Annex III) Methyl-N-methylanthranilate 323 Restricted (Annex III) Methyl Salicylate 324 Restricted (Annex III) Acetyl Cedrene 327 Restricted (Annex III) Amyl Salicylate 328 Restricted (Annex III) Anethole (analyzed as trans-Anethole) 329 Restricted (Annex III) Benzaldehyde 330 Restricted (Annex III) Camphor 331 Restricted (Annex III) Beta-Caryo-phyllene 332 Restricted (Annex III) Carvone 333 Restricted (Annex III) Dimethyl Phenethyl Acetate (analyzed as Dimethylbenzyl Carbinyl Acetate) 334 Restricted (Annex III) Hexadecanolactone 335 Restricted (Annex III) Hexamethylindanopyran 336 Restricted (Annex III) Linalyl Acetate 337 Restricted (Annex III) Menthol 338 Restricted (Annex III) Trimethylcyclopentenyl Methylisopentenol 339 Restricted (Annex III) Salicylaldehyde 340 Restricted (Annex III) Santalol (analyzed as alpha-Santalol, beta-Santalol, Santalol (sum of isomers)) 341 Restricted (Annex III) Sclareol 342 Restricted (Annex III) Terpineol (analyzed as alpha-Terpineol, beta-Terpineol, gamma-Terpineol, Terpineol (sum of isomers)) 343 Restricted (Annex III) Tetramethyl acetyloctahydronaphthalenes 344 Restricted (Annex III) Trimethylbenzenepropanol 345 Restricted (Annex III) Vanillin 346 Restricted (Annex III) Versalide 362 Restricted (Annex III) Eugenyl Acetate 368 Restricted (Annex III) Geranyl Acetate 369 Restricted (Annex III) Isoeugenyl Acetate 370 Restricted (Annex III) Pinene (analyzed as alpha-Pinene, beta-Pinene, Pinene (sum of isomers)) 371 Restricted (Annex III) Musk Ambrette 414 Prohibited (Annex II) Moskene 421 Prohibited (Annex II) Musk Tibetene 422 Prohibited (Annex II) 4-(4-Hydroxy-4-methylpentyl) cyclohex-3-ene1-carbaldehyde (Lyral) 1380 Prohibited (Annex II) 2,6-Dihydroxy-4-methyl-benzaldehyde (atranol) 1381 Prohibited (Annex II) 3-Chloro-2,6-Dihydroxy-4-methyl-benzaldehyde (chloroatranol) 1382 Prohibited (Annex II) 2-(4-tert-butylbenzyl) propionaldehyde (Lilial) 1666 Prohibited (Annex II) Traseolide (musk fragrance) - Not listed Cashmeran (musk fragrance) - Not listed Celestolid (musk fragrance) - Not listed In most cases, the presence of individual fragrance allergens must be indicated on cosmetics packaging if their concentration exceeds 0.001% in leave-on products or 0.01% in rinse-off products. More detailed restrictions are outlined in annexes to the consolidated version of Regulation (EC) 1223/2009.

A biological evaluation report (BER) or biological risk assessment report (BRA) collects and evaluates the results of biological evaluation studies and concludes the medical device's biological risk. It is a comprehensive analysis considering chemical and biological test results as well as toxicological evaluation of the extractables that could be released from the device during its usage. The biological evaluation report is needed as a part of the regulatory approval and often requires strong expertise in the biological risk evaluation of medical devices, taking into account the requirements of ISO 10993- standard family and local regulations (FDA, MDR). The biological evaluation plan (BEP) and sufficient testing need to be completed before the BER can be prepared. Measurlabs can support medical device manufacturers with BER preparation. We can also provide the required testing and a BEP if these have not yet been completed.

The purpose of cleaning validation studies is to show that reusable medical devices can be reprocessed effectively between uses so that patients are not exposed to pathogens. Depending on the device’s intended use and classification, appropriate reprocessing steps may include cleaning, disinfection, and/or sterilization. For cleaning validation more specifically, the testing procedure consists of three steps: Simulated contamination with artificial soils that accurately reflect clinically relevant soils, such as blood and other bodily fluids. , Cleaning (manual and/or automated), carefully following the manufacturer's instructions for parameters such as detergents, cleaning tools, water quality, and temperature. , Inspection, both visually and using quantitative methods relevant to the test soil (e.g., proteins, total organic carbon, or hemoglobin), to assess whether residual contaminants remain on the device.. Successful cleaning validation is often sufficient for non-critical reusable devices, such as blood pressure cuffs, monitors, and clutches. Semi-critical and critical devices will require further disinfection and/or sterilization validation studies, which we can also offer. The displayed example price covers a manual cleaning validation study with 6 reprocessing cycles and cleanability evaluations with visual inspection & protein content measurement. Test protocol formulation and reporting are also included.

Analysis package for mycotoxins listed in Commission Regulation (EU) No 2023/915, including the following determinations: Aflatoxin B1, B2, G1, G2, Ochratoxin A, T-2, HT-2 toxins, Deoxynivalenol, Zearalenone. Testing of the listed mycotoxins is usually required for almost all types of cereals and cereal products, including foods for infants and young children. We can also offer additional mycotoxin analyses, including for ergot alkaloids and patulin. Do not hesitate to ask for more information or request a quote.

Determination of volatile organic compounds (VOC) in water using the GC-MS technique. The analysis determines the concentrations of 67 volatile compounds including BTEX, DIPE, ETBE, MTBE, TAEE, TAME, and TBA. The results of the analysis are reported in µg/l.

With this label check, the information provided on a food label is reviewed against the requirements of Regulation (EU) No 1169/2011 on food information to consumers. Applicable implementing regulations are also considered (e.g., (EU) No 2018/775 on indicating the primary ingredient's country of origin). According to EU regulations, mandatory food information for almost all prepackaged foods includes the following: The name of the food, The list of ingredients, Any ingredient or processing aid that may cause allergies or intolerances, Quantity of certain ingredients or categories of ingredients, Net quantity of the food, The date of minimum durability ('best before' or 'use by' date), Any special storage conditions and/or conditions of use, The name or business name and address of the food business operator, The country of origin or place of provenance, Instructions for use where it would be difficult to make appropriate use of the food in the absence of such instructions, The actual alcoholic strength by volume for beverages containing more than 1.2 % by volume of alcohol, Nutrition declaration. The label check can be combined with laboratory analyses covering parameters related to EU or national legislation. If this is the case, the analysis results are reviewed as part of the check. Nutritional and vitamin content analysis results are evaluated based on this Commission guidance document. Other parameters that can be assessed in the review process include, for example, the following: Contaminants and undesirable substances, as listed in Regulation (EU) No 2023/915, Pesticide residues as in Regulation (EU) No 396/2005, Food additives as in Regulation (EC) No 1333/2008, Food flavourings as in Regulation (EC) No 1334/2008, Acrylamide as in Regulation (EU) No 2017/2158. Photographic evidence of the product label, including all the required details, is provided with the test report. Contact us for more information about the food label check and a quote for related testing services.

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.