<h3>Pharmaceutical products testing</h3>Sample Control Laboratory carries out tests physico-chemical, pharmaceutical-technological and microbiological tests of pharmaceutical products, as well as appropriate tests of active pharmaceutical ingredients and medical agents.When testing and controlling pharmaceutical products, the Sample Control laboratory provides the following services:<ul><li>complete physico-chemical testing of active and auxiliary pharmaceutical ingredients</li><li>complete analysis of the finished pharmaceutical form (physico-chemical tests, pharmaceutical-technological and microbiological analyses)</li><li>analysis of the finished pharmaceutical form, e.g. packaging material, identification of the active pharmaceutical ingredient, auxiliary ingredients, etc.</li><li>analysis of the finished pharmaceutical form- determination of the content of an active pharmaceutical ingredient or other component whose content must be determined precisely by applying various methods such as titrimetric, spectrophotometric and chromatographic methods</li><li>analysis of the finished pharmaceutical form- determination of related ingredients</li><li>determination of water by the Karl Fischer method</li><li>control of galenic products according to the manufacturer's specification</li><li>preparation of an expert report according to a specific part of the documentation (at the request of the manufacturer)</li><li>development of LC (HPLC, LC-MS/MS, LC-Orbitrap), GC (GC-FID, GC-MS/MS, GC-Orbitrap), IC and spectrophotometric methods for determining the content of active and related ingredients and degradation products in active pharmaceutical ingredients and pharmaceutical products</li><li>preparation of the method validation protocol and experimental validation of LC and GC methods for determining the content of the active pharmaceutical ingredient, related ingredients and degradation products in active pharmaceutical ingredients and pharmaceutical products</li><li>drafting protocols for monitoring the stability of pharmaceutical products (accelerated and long-term stability studies)</li><li>method transfer – preparation of reports and processing of results for the active pharmaceutical ingredient</li><li>method transfer – preparation of reports and processing of results for the active pharmaceutical ingredient and related ingredients</li><li>analyses on HPLC, LC-MS/MS, LC-Orbitrap, etc.</li><li>analyses on GC, GC-FID, GC-MS/MS, GC-Orbitrap, etc.</li><li>analyses on Raman microscope/spectroscope, ion chromatograph (IC), TOC and more.</li></ul>

Pharmaceutical products testing

<h3>Packaging testing</h3>The quality and safety of packaging of various types of products is the primary concern of all consumers, businesses and inspections throughout the supply chain.Sample Control performs quality and safety testing in the packaging industry and related industries such as the food industry, manufacturers of general use items, traders (trade brand), pharmaceutical industry (medicines), etc.Our testing of food contact materials includes testing a global and specific migration of packaging, kitchen utensils and food processing machines.Food testing services are carried out for industry when developing and researching packaging and products, confirming the compliance of packaging and products, and regular testing of production processes. The packaging industry, i.e. packaging production, is constantly facing changes in regulations, packaging conveniences, design modifications, innovations, etc. Sample Control monitors developments in the field of packaging and packaging production and we ensure that our clients comply with new and/or revised regulations, innovations and other important developments in the packaging industry.Some of the services carried out by Sample Control in the field of packaging:<ul><li>Testing of materials and objects that come into immediate contact with food (migration testing),</li><li>IFS, BRC, FCCS22000, SQF requirements of packaging material migration testing,</li><li>Support in the preparation of the Declaration of Conformity (DoC),</li><li>Packaging conformity verification services according to European Union regulations,</li><li>Pharmaceutical packaging extracting and rinsing materials,</li><li>Material characterization,</li><li>Support in the manufacture of packaging materials,</li><li>Compliance with REACH and SVHC.</li></ul>

<h3>Testing of materials and objects that come into immediate contact with food</h3>Materials and articles intended to come into contact with food and beverages (Food Packaging and Food Contact Materials- FCM), are those materials and objects that are already in contact with food and drink or can reasonably be expected to come into contact with them.Such materials and articles may not alter the food and beverages with which they are in contact or endanger human health, and they are recognised as:<ul><li>Packaging that protects food,</li><li>Machines that process food,</li><li>Equipment used for storing, cooking and consuming food.</li></ul>Testing of the migration of materials and articles that come into contact with food, include overall (global) migration and/or specific migration. Testing migration in contact with food is essential to check safety and determine the conformity of materials and articles that come into immediate contact with food. Migration limits are set for food packaging materials on the basis of a toxicological risk assessment of these substances and are included in the regulations. Globally, different markets maintain their own FCM regulations to prevent the placing on the market of products that alter our food or drink, lead to a deterioration in their organoleptic characteristics or emit dangerous substances. Several legal frameworks in various countries of the world have made requests to examine the migration of materials and objects that come into immediate contact with food. Regulation (EC) 1935/2004 on food contact materials and articles lays down rules for the European Union market. The requirements in the US, by the US Food and Drug Administration (FDA), are regulated in Chapter 21 of the Code of Federal Regulations (CFR) - a review of the formulation of the material that prescribes testing of the finished product and FDA migration testing.Regulation (EC) 1935/2004 on food contact materials and articles provides that migration must not endanger human health, cause a change or deterioration of organoleptics and change the composition of food.Migration implies the transfer of chemicals from packaging to food.Regulation (EC) 10/2011 on plastic materials and articles intended to come into contact with food. establishes an overall migration limit of 60 mg/kg for the total sum of all migrating substances, as well as specific migration limits for more than 1000 monomers and additives such as formaldehyde, bisphenol A, primary aromatic amines (PAAs) or phthalates as the most prominent examples.In addition, Article 19 of Regulation (EC) 10/2011 prescribes so-called non-intentionally added substances (NIAS). These are chemicals that may appear as impurities of raw materials, products of packaging decomposition or decomposition of intentionally added chemicals and should be identified (tested), considered and their toxicological risk assessed.

<h3>Overall migration testing</h3>Overall migration covers all types of substances transferred from food packaging to food regardless of the nature and toxicological profile of the substance. Sample Control Laboratory offers overall migration testing according to internationally-compliant standard EN 1186 for all types of food packaging materials, using food simulators (model solutions) acetic acid, ethanol, isooctane, vegetable oil and Tenax®. Sample Control Laboratory performs global migration testing for various materials and objects that come into immediate contact with food in various model solutions: distilled water, acetic acid, ethanol, isooctane, vegetable oil and Tenax®.<h3>Specific migration testing</h3>The specific migration limit applies to an individual substance or to a group of similar substances. The limits established are based on the toxicological hazard that the substance causes. Different analytical techniques are used to determine the presence of these substances in food and/or model food solutions. Limitations specificfor the migration of certain substances can be found in almost all food contact regulations, ranging from a few high-risk substances to extensive lists of ingredients with migration limits. Standard EN 13130 Materials and articles in contact with foodstuffs&nbsp; - Plastics substances subject to limitation, prescribes a significant number of ingredients.Sample Control Laboratory tests specific migrations of a wide range of chemicals for all types of food packaging materials. Additional description and techniques can be found here.Specific requirements for food packaging and materials that come into contact with food largely depend on the type of material. List of groups of materials and objects that may be covered by the specific measures set out in Annex I of Regulation (EC) 1935/2004 on food contact materials and articles:<ol><li>Active and intelligent materials and objects</li><li>Adhesives</li><li>Ceramics</li><li>Cork</li><li>Rubbers</li><li>Glass</li><li>Ion-exchange resins</li><li>Metals and alloys</li><li>Paper and board</li><li>Plastics</li><li>Printing inks</li><li>Regenerated cellulose film</li><li>Silicones</li><li>Textiles</li><li>Varnishes and coatings</li><li>Waxes</li><li>Wood</li></ol>Regulation (EC) 1935/2004 on food contact materials and articles provides that migration must not endanger human health, cause a change or deterioration of organoleptics and change the composition of food.Migration implies the transfer of chemicals from packaging to food. Regulation (EC) 10/2011 on plastic materials and articles intended to come into contact with food. establishesthe overall migration limit of 60 mg/kg for the total sum of all migrating substances, as well as specific migration limits for more than 1000 monomers and additives such as formaldehyde, bisphenol A, primary aromatic amines (PAAs) or phthalates as the most prominent examples.The specific migration limit applies to an individual substance or to a group of similar substances. The limits established are based on the toxicological hazard that the substance causes. Different analytical techniques are used to determine the presence of these substances in food and/or model food solutions. Limitations specific for the migration of certain substances can be found in almost all food contact regulations, ranging from a few high-risk substances to extensive lists of ingredients with migration limits. Standard EN 13130 Materials and articles in contact with foodstuffs&nbsp; - Plastics substances subject to limitation, prescribes a significant number of ingredients.Sample Control Laboratory tests specific migrations of a wide range of chemicals for all types of food packaging materials. Below are some of the most prominent ingredients tested in the laboratory:<table><tbody><tr><td colspan="1" rowspan="1">Heavy metals and elements</td><td colspan="1" rowspan="1">Melamine</td><td colspan="1" rowspan="1">Butylhydroxytoluene (BHT)</td></tr><tr><td colspan="1" rowspan="1">Mineral oils MOSH/POSH, MOAH</td><td colspan="1" rowspan="1">Formaldehyde</td><td colspan="1" rowspan="1">Dioxolane</td></tr><tr><td colspan="1" rowspan="1">Primary aromatic amines</td><td colspan="1" rowspan="1">photo initiator 2-isopropylthioxanthone (ITX)</td><td colspan="1" rowspan="1">Caprolactam</td></tr><tr><td colspan="1" rowspan="1">Secondary aromatic amines</td><td colspan="1" rowspan="1">BADGE, BFDGE, NOGE and derivatives</td><td colspan="1" rowspan="1">Terephthalic and isophthalic acid</td></tr><tr><td colspan="1" rowspan="1">Benzophenone and 4-methylbenzophenone</td><td colspan="1" rowspan="1">Volatile compounds (chlorinated hydrocarbons)</td><td colspan="1" rowspan="1">Irganox 1010</td></tr><tr><td colspan="1" rowspan="1">Bisphenol A</td><td colspan="1" rowspan="1">Phenolic index</td><td colspan="1" rowspan="1">Epoxidised soybean oil (ESBO)</td></tr><tr><td colspan="1" rowspan="1">Phthalates</td><td colspan="1" rowspan="1">Nonil/octylphenol</td><td colspan="1" rowspan="1">BTX</td></tr><tr><td colspan="1" rowspan="1">Semicarbazide</td><td colspan="1" rowspan="1">Acetaldehyde</td><td colspan="1" rowspan="1">Nitrosamines</td></tr></tbody></table>Sample Control Laboratory tests specific migrations using various techniques: IC, GC-FID, GC-MS, GC-MS/MS, UPLC-MS/MS, LC/GC-FID, GC-Orbitrap HRAM, LC-Orbitrap HRAM.

<h3>Testing of materials and objects that come into immediate contact with food</h3>Materials and objects that come into immediate contact with food and beverages (FCM), are those materials and objects that are already in contact with food and drink or can reasonably be expected to come into contact with them.Such materials and objects may not alter the food and beverages with which they are in contact or endanger human health, and they are recognised as:<ul><li>Packaging that protects food,</li><li>Machines that process food,</li><li>Equipment used for storing, cooking and consuming food.</li></ul>Testing of the migration of materials and objects that come into immediate contact with food, include global (overall) migration and/or specific migration. Testing migration in contact with food is essential to check safety and determine the conformity of materials and objects that come into immediate contact with food. Migration limits are set for food packaging materials on the basis of a toxicological risk assessment of these substances and are included in the regulations. Globally, different markets maintain their own FCM regulations to prevent the placing on the market of products that alter our food or drink, lead to a deterioration in their organoleptic characteristics or emit dangerous substances. Several legal frameworks in various countries of the world have made requests to examine the migration of materials and objects that come into immediate contact with food. Regulation (EC) 1935/2004 on food contact materials and articles lays down rules for the European Union market. The requirements in the US, by the US Food and Drug Administration (FDA), are regulated in Chapter 21 of the Code of Federal Regulations (CFR) - a review of the formulation of the material that prescribes testing of the finished product and FDA migration testing.Regulation (EC) 1935/2004 on food contact materials and articles provides that migration must not endanger human health, cause a change or deterioration of organoleptics and change the composition of food.Migration implies the transfer of chemicals from packaging to food.Regulation (EC) 10/2011 on plastic materials and articles intended to come into contact with food. establishes an overall migration limit of 60 mg/kg for the total sum of all migrating substances, as well as specific migration limits for more than 1000 monomers and additives such as formaldehyde, bisphenol A, primary aromatic amines (PAAs) or phthalates as the most prominent examples.In addition, Article 19 of Regulation (EC) 10/2011 prescribes so-called non-intentionally added substances (NIAS). These are chemicals that may appear as impurities of raw materials, products of packaging decomposition or decomposition of intentionally added chemicals and should be identified (tested), considered and their toxicological risk assessed.Besides EU Regulation 10/2011, the Regulation on the Health Safety of Materials and Items Intended to Come into Contact with Food (NN 125/09) is also in force. Materials under this regulation include: metals and their alloys, enamel, cement, ceramics and porcelain, glass, polymer materials (plastics including coatings, lacquers, and films, cellulose, and elastomers), wood (including cork), and textiles.However, it is important to mention microbiological cleanliness of material which is determined using swab or rinse methods, testing for aerobic mesophilic bacteria, Enterobacteriaceae, Staphylococcus aureus, and Pseudomonas aeruginosa, in accordance with the Regulation on the Health Safety of Materials and Articles in Contact with Food.

<h3>Ispitivanje materijala i predmeta koji dolaze u neposredan dodir s hranom</h3>Materijali i predmeti koji dolaze u neposredan dodir s hranom i pićima (food contact materials- FCM), su oni materijali i predmeti koji su već u doticaju s hranom i pićem ili se razumno može očekivati da će doći u doticaj s njima.Takvi materijali i predmeti ne smiju mijenjati hranu i piće s kojima su u kontaktu niti ugroziti zdravlje ljudi, a prepoznaju se kao:<ul><li>Ambalaža koja štiti hranu,</li><li>Strojevi koji prerađuju hranu,</li><li>Oprema koja se koristi za spremanje, kuhanje i konzumaciju hrane.</li></ul>Studije ispitivanja migracije materijala i predmeta koji dolaze u neposredan dodir s hranom, uključuje globalnu (ukupnu) migraciju i/ili specifičnu migraciju. Ispitivanje migracije u kontaktu s hranom ključno je za provjeru sigurnosti i utvrđivanje sukladnosti materijala i predmeta koji dolaze u neposredan dodir s hranom. Granice migracije utvrđene su za materijale za pakiranje hrane na temelju toksikološke procjene rizika ovih tvari i one su uključene u propise. Globalno, različita tržišta održavaju vlastite FCM propise kako bi se spriječilo stavljanje na tržište proizvoda koji mijenjaju našu hranu ili piće, dovode do pogoršanja njihovih organoleptičkih karakteristika ili ispuštaju opasne tvari.Nekoliko zakonskih okvira u raznim zemljama svijeta, postavili su zahtjeve za ispitivanje migracije materijala i predmeta koji dolaze u neposredan dodir s hranom. Uredba (EZ) 1935/2004 o materijalima i predmetima koji dolaze u dodir s hranom propisuje pravila za tržište Europske unije. Zahtjevi u SAD-u, od strane američke Uprave za hranu i lijekove (FDA), regulirani su u Poglavlju 21 Kodeksa saveznih propisa (CFR)- pregled formulacije materijala koji propisuje testiranje gotovog proizvoda i FDA migracijsko testiranje.Uredba (EZ) 1935/2004 o materijalima i predmetima koji dolaze u dodir s hranom propisuje da migracija ne smije ugroziti ljudsko zdravlje, uzrokovati promjenu, odnosno pogoršanje organoleptike i promijeniti sastav hrane.Migracijom se podrazumijeva prijenos kemikalija s pakiranja na hranu.Za plastične materijale, Uredba EU 10/2011 o plastičnim materijalima i predmetima koji dolaze u dodir s hranom. utvrđuje ukupnu granicu migracije od 10 mg/dm2 ili 60 mg/kg za ukupnu sumu svih migrirajućih tvari, kao i specifične granice migracije za više od 1000 monomera i aditiva kao što su formaldehid, bisfenol A, primarni aromatski amini (PAA) ili ftalati kao najistaknutiji primjeri.Dodatno, Članak 19. Uredbe EU 10/2011 propisuje takozvane nenamjerno dodane tvari (non-intentionally added substances- NIAS). To su kemikalije koje se mogu pojaviti kao nečistoće sirovina, produkti razgradnje ambalaže ili razgradnje namjerno dodanih kemikalija te ih treba utvrditi (ispitati), razmotriti i procijeniti njihov toksikološki rizik.Osim uredbe EU 10/2011, na snazi je i Pravilnik o zdravstvenoj ispravnosti materijala i predmeta koji dolaze u neposredan dodir s hranom (NN 125/09). Materijalima u sklopu ovoga Pravilnika smatraju se: metali i njihove slitine, emajl, cement, keramika i porculan, staklo, polimerni materijali (plastika uključujući lakove, premaze i prevlake, celuloza i elastomeri) drvo (uključujući i pluto) te tekstil. &nbsp;Također, važno je spomenuti i mikrobiološku čistoću ambalaže koja se određuje metodom brisa ili ispirka, a ispituju se aerobne mezofilne bakterije, Enterobacteriaceae, Staphylococcus aureus i Pseudomonas aeruginosa sukladno Pravilniku o zdravstvenoj ispravnosti materijala i predmeta koji dolaze u neposredan dodir s hranom.

<h3>Preiskovanje materialov in predmetov, ki pridejo v neposreden stik s hrano</h3>Materiali in predmeti, ki pridejo v neposreden stik s hrano in pijačami (food contact materials- FCM), so tisti materiali in predmeti, ki so že v stiku s hrano in pijačo, alipa &nbsp;razumsko lahko pričakujemo, da bo prišlo do stika z njimi.Takšni materiali in predmeti ne smeju spreminjati hrano in pijačo, s katerimi so v kontaktu niti ogroziti zdravje ljudi, prepoznamo pa jih kot:<ul><li>Embalažo ki ščiti hrano,</li><li>Stroje ki predelujejo hrano,</li><li>Opremo, ki jo uporabljamo za shranjevanje, kuhanje in konzumacijo hrane.</li></ul>Študije preverjanja migracije materialov in predmetov, ki pridejo v neposreden stik s hrano, vključuje globalno (skupno) migracijo in/ali specifično migracijo. Preiskovanje migracije v kontaktu s hrano je ključno za preiskovanje varnosti in ugotavljanje usklajenosti materialov in predmetov ki pridejo v neposreden stik s hrano. Meje migracije so določene za materiale za pakiranje hrane na podlagi toksikološke ocenitve tveganosti teh snovi in so vključene v predpise. Globalno, različni trgi vzdržujejo lastne FCM predpise da bi preprečili pošiljanje na trg izdelkov, ki spreminjajo našo hrano ali pijačo, pripeljejo do poslabšanja njihovih organoleptičnih lastnosti ali izpuščajo nevarne snovi. V nekaj zakonskih okvirjev v različnih deželah sveta, so zastavili zahteve za preiskovanje migracij materialov in predmetov, ki pridejo v neposreden stik s hrano. Uredba (ES) 1935/2004 o materialih in predmetih ki pridejo v stik s hrano narekuje pravila za trg Evropske unije. Zahteve v ZDA, s strani ameriške Uprave za hrano in zdravila (FDA), so regulirane v Poglavlju 21 Kodeksa zveznih predpisov (CFR)- pregled formulacije materialov, &nbsp;ki narekujejo testiranje gotovega izdelka in FDA migracijsko testiranje.Uredba (ES) 1935/2004 o materialih in predmetih, ki pridejo v stik s hrano predpisuje, da migracija ne sme ogroziti človeško zdravje, povzročati spremembo, oziroma poslabšanje organoleptike in spreminjanje sestavin hrane.Migracija pomeni prenos kemikalij s pakiranja na hrano.Za plastične materiale, Uredba EU 10/2011 o plastičnih materialih in predmetih, ki pridejo v stik s hrano ugotavlja skupno mejo migracije, ki je 10 mg/kg kot skupni seštevek vseh migrirajočih snovi, kot tudi specifične meje migracije za več kot 1000 monomerjev in aditivov, kot so formaldehid, bisfenol A, primarni aromatični amini (PAA) ali ftalati kot najbolj izpostavljeni primeri.Dodatno, 19. ćlen Uredbe EU 10/2011 predpisuje takoimenovane nenamerno dodane snovi (non-intentionally added substances- NIAS). To so kemikalije, ki se lahko pojavijo kot nečistoče surovin, produkti razkrajanja embalaže ali razkrajanja namenoma dodanih kemikalij ter jih je potrebno ugotoviti (preiskati), obravnavati in oceniti njihovo toksikološko tveganje.Poleg uredbe EU 10/2011 je v veljavi tudi Pravilnik o zdravstveni ustreznosti materialov in predmetov, ki pridejo v neposreden stik s hrano (NN 125/09). Med materiali, ki jih zajema ta Pravilnik, so: metali in njihove zlitine, emajl, cement, keramika in porcelan, steklo, polimerni materiali (plastika, vključno z laki, premazi in zaščitnimi sloji, celuloza in elastomeri), les (vključno s pluto) ter tekstil.

<h3>Testing mineral oils MOSH/POSH, MOAH, PAO in packaging</h3>Today, mineral oil is found in various food products, as it can get into the product, as well as in raw materials anywhere in the food processing and retail chain. Potential sources are fuels, exhaust gases, lubricating oils, anti-dust agents, surface treatment agents, lot oils, packaging materials, etc. Manufacturers, food distributors and laboratories are trying to detect the source and point of contamination.Food groups in which we can find mineral oils include rice, cereal flour, cereals, chocolate products, spices, fats and oils as well as additionally processed foods.Mineral oils are mainly complex hydrocarbon mixtures (C10 to C50) of mainly fossil origin. The mineral oils that are tested consist of Mineral Oil Saturated Hydrocarbons (MOSH) as well as up to 50% of Mineral Oil Aromatic Hydrocarbons (MOAH).&nbsp;MOAHs are complex mixtures of compounds with different and mostly unknown toxicity. With fractions of mineral oils MOSH and MOAH, the so-called POSH (polyolefinic oligomeric saturated hydrocarbons) as well as PAO (poly alpha olefins) are increasingly coming into the spotlight. POSHs are oligomer substances that potentially migrate from plastic packaging (PE and PP). PAOs are synthetic isoparaffins with short main and long side chains used, for example, in synthetic lubricants and adhesives.Despite a number of measures aimed at avoiding mineral oils, the values of possible mineral oil residues remain at the level that we can determine by testing. Since there is a tendency to an increasing number of false positives, the question arises about the testing methods that check the presence of mineral oils. The online LC-GC-FID technique reliably detects MOSH/MOAH fractions.The new online LC-GC-FID technique, successfully implemented by Sample Control Laboratory, enables separate quantification of MOSH/POSH/PAO and MOAH within a single chromatographic series.

<h3>Global (overall) migration testing</h3>Global (total) migration includes all types of substances that transfer from food packaging to food, regardless of the nature and toxicological profile of the substances. Sample Control laboratory offers total migration testing according to the internationally harmonized standard EN 1186-3:2022 for plastic materials using the following food simulators (model solutions): distilled water, acetic acid, ethanol, isooctane, vegetable oil, and Tenax®.&nbsp;Testing of specific migration&nbsp;Specific migration limits refer to individual substances or groups of similar substances that may migrate from packaging or objects into food. Established limits are based on the toxicological hazards posed by the substances. Various analytical techniques are used to determine the presence of these substances in food and/or food simulators. Specific migration limits for certain substances can be found in nearly all regulations concerning food contact materials, ranging from a few high-risk substances to extensive lists of ingredients with migration limits.&nbsp;Sample Control laboratory conducts specific migration testing for various types of food packaging materials. Specific requirements for food packaging and materials that come into contact with food greatly depend on the type of material. The list of material groups and items that may be covered by specific measures is established in Annex I of Regulation (EC) No. 1935/2004 on materials and articles intended to come into contact with food:<ol><li>Active and intelligent materials and objects</li><li>Adhesives</li><li>Ceramics</li><li>Cork</li><li>Rubbers</li><li>Glass</li><li>Ion-exchange resins</li><li>Metals and alloys</li><li>Paper</li><li>Plastics</li><li>Printing inks</li><li>Regenerated cellulose film</li><li>Silicones</li><li>Textiles</li><li>Varnishes and coatings</li><li>Waxes</li><li>Wood</li></ol>EU Regulation 1935/2004 on materials and articles intended to come into contact with food stipulates that migration must not endanger human health, cause changes of organoleptic properties, or alter the composition of food.&nbsp;Migration refers to the transfer of chemicals from packaging to food. For plastic materials, EU Regulation 10/2011 on plastic materials and articles intended to come into contact with food sets a total migration limit of 10 mg/dm² or 60 mg/kg for the sum of all migrating substances, as well as specific migration limits for over 1000 monomers and additives, such as formaldehyde, bisphenol A, primary aromatic amines (PAA), and phthalates as prominent examples.&nbsp;Specific migration limits apply to individual substances or groups of similar substances. Established limits are based on the toxicological hazards posed by the substances. Various analytical techniques are used to determine the presence of these substances in food and/or food simulators. Specific migration limits for certain substances can be found in most food contact regulations, ranging from a few high-risk substances to extensive lists of ingredients with migration limits.&nbsp;Sample Control conducts specific migration testing for a wide spectrum of chemicals in all types of food packaging materials. Below are some of the most notable parameters tested in the laboratory:<table><tbody><tr><td colspan="1" rowspan="1">Heavy metals</td><td colspan="1" rowspan="1">Melamine</td><td colspan="1" rowspan="1">Mineral oils MOSH/POSH, MOAH</td></tr><tr><td colspan="1" rowspan="1">Formaldehyde</td><td colspan="1" rowspan="1">Primary aromatic amines</td><td colspan="1" rowspan="1">Acetaldehyde</td></tr><tr><td colspan="1" rowspan="1">Secondary aromatic amines</td><td colspan="1" rowspan="1">Phthalates</td><td colspan="1" rowspan="1">Benzophenone and 4-methylbenzophenone</td></tr><tr><td colspan="1" rowspan="1">PCBs</td><td colspan="1" rowspan="1">Bisphenol A</td><td colspan="1" rowspan="1">BTX</td></tr><tr><td colspan="1" rowspan="1">Nitrosamines</td><td colspan="2" rowspan="1">...</td></tr></tbody></table>Sample Control laboratory tests specific migration using various techniques: ICP-MS, HPLC-ICP-MS, GC-FID, GC-MS, GC-MS/MS, UPLC-MS/MS, LC/GC-FID, GC-Orbitrap HRAM, LC-Orbitrap HRAM, and HPLC-UV.

<h3>Preiskovanje globalne (skupne) migracije</h3>Globalna (skupna) migracija obsega vse vrste snovi, ki se prenašajo s pakiranja hrane na hrano ne glede na naravo in toksikološki profil snovi. Sample control laboratorij ponuja preiskovanje skupne migracije po mednarodno usklajeni normi EN 1186 za vse vrste materialov za pakiranje hrane, z uporabo simulatorjev hrane (modelne raztopine) ocetno kislino, etanol, izooktan, rastlinsko olje in Tenax®. Laboratorij Sample control opravlja preiskovanje globalne migracije za razne materiale in predmete, ki pridejo v neposreden stik s hrano v raznih modelnih raztopinah: v destilirani vodi, ocetni kislini, etanolu, izooktanu, rastlinskem olju in Tenax-u®.<h3>Preiskovanje specifične migracije</h3>Specifična meja migracije se uporablja za posamično snov ali za skupino podobnih snovi. Ugotovljene meje se temeljijo na toksikološki nevarnosti , ki jo povzroča snov. Za ugotavljanje prisotnosti teh snovi v hrani in/ali modelnih raztopinah hrane, uporabljamo različne analitične tehnike. Omejitve specifičneza migracijo določenih snovi lahko najdemo v skoraj vseh predpisih o kontaktu s hrano, v razponu od nekaj visokotveganih snovi do obsežnih seznamov sestavin z mejami migracij. Standard EN 13130 Materiali in izdelki v kontaktu z živili - Plastične sestavine za katere obstajajo omejitve, predpisuje znatno število sestavin.Laboratorij Sample control opravlja preiskovanje specifičnih migracij širokega spektra kemikalij za vse vrste materialov za pakiranje hrane. Dodaten opis in tehnike lahko najdete tukaj.Specifične zahteve za pakiranje hrane in materialov, ki pridejo v stik s hrano, so v veliki meri odvisne od vrste materialov. Seznam skupin materialov in predmetov, ki bi lahko bili zajeti s posebnimi ukrepi, se nahaja v Prilogi I Uredbe (ES) 1935/2004 o materialih in predmetih, ki pridejo v stik s hrano:<ol><li>Aktivni in inteligentni materiali in predmeti</li><li>Adhezivi</li><li>Keramika</li><li>Plutovina</li><li>Gume</li><li>Steklo</li><li>Ionsko izmenjevalne smole</li><li>Kovine in zlitine</li><li>Papir</li><li>Plastika</li><li>Tinte za tiskanje</li><li>Regenerirana celuloza</li><li>Silikoni</li><li>Tekstil</li><li>Laki in prevleke</li><li>Voski</li><li>Les</li></ol>Uredba (ES) 1935/2004 o materialih in predmetih, ki pridejo v stik s hrano narekuje, da migracija ne sme ogroziti človeško zdravje, povzročati spremembo, odziroma poslabšanje organoleptike in spremembo sestave hrane.Migracija pomeni prenos kemikalij s pakiranja na hrano. Za plastične materiale, Uredba (ES) 10/2011 o plastičnih materialih in predmetih koji pridejo v stik s hrano, ugotavlja skupno mejo migracije, ki je &nbsp;60 mg/kg za skupni seštevek vseh migrirajočih snovi, kot tudi specifične meje migracij za več kot 1000 monomerjev in aditivov, kot so formaldehid, bisfenol A, primarni aromatični amini (PAA) ali ftalati kot najbolj izpostavljeni primeri.Specifična meja migracije se uporablja za posamično snov ali za skupino podobnih snovi. Ugotovljene meje se temeljijo na toksikološki nevarnosti, ki jo snov povzroča. Za ugotavljanje prisotnosti teh snovi v hrani in/ali modelnih raztopinah hrane, uporabljamo različne analitične tehnike. Omejitve specifične za migracijo določenih snovi lahko najdemo v skoraj vseh predpisih o kontaktu s hrano, v razponu od nekaj visokotveganih snovi do obsežnih seznamov sestavin z mejami migracije. Standard EN 13130 Materiali in izdelki v kontaktu z živili - Plastične sestavine, za katere obstajajo omejitve, vsebuje znatno število sestavin.Sample control opravlja preiskovanje specifičnih migracij širokega spektra kemikalij za vse vrste materialov za pakiranje hrane. V nadaljevanju so nekateri med najbolj izpostavljenimi sestavinami, ki jih preverjamo v laboratoriju:<table><tbody><tr><td colspan="1" rowspan="1">Težke kovine in elementi</td><td colspan="1" rowspan="1">Melamin</td><td colspan="1" rowspan="1">Mineralna olja MOSH/POSH, MOAH</td></tr><tr><td colspan="1" rowspan="1">Formaldehid</td><td colspan="1" rowspan="1">Acetaldehid</td><td colspan="1" rowspan="1">Primarni aromatični amini</td></tr><tr><td colspan="1" rowspan="1">Sekundarni aromatični amini</td><td colspan="1" rowspan="1">Benzofenon in 4-metilbenzofenon</td><td colspan="1" rowspan="1">Bisfenol A</td></tr><tr><td colspan="1" rowspan="1">PCBs</td><td colspan="1" rowspan="1">Ftalati</td><td colspan="1" rowspan="1">BTX</td></tr><tr><td colspan="1" rowspan="1">Nitrozamini</td><td colspan="2" rowspan="1">...</td></tr></tbody></table>Laboratorij Sample control specifične migracije preiskuje z različnimi tehnikami: IC, GC-FID, GC-MS, GC-MS/MS, UPLC-MS/MS, LC/GC-FID, GC-Orbitrap HRAM, LC-Orbitrap HRAM.

<h3>Ispitivanje globalne (ukupne) migracije</h3>Globalna (ukupna) migracija obuhvaća sve vrste tvari koje se prenose s pakiranja hrane na hranu bez obzira na prirodu i toksikološki profil tvari. Sample Control laboratorij nudi ispitivanje ukupne migracije prema međunarodno usklađenoj normi EN 1186-3:2022 za plastične materijale koristeći slijedeće simulatore hrane (modelne otopine): destiliranu vodu, octenu kiselinu, etanol, izooktan, biljno ulje i Tenax®.ISPITIVANJE SPECIFIČNE MIGRACIJESpecifična granica migracije odnosi se na pojedinačnu tvar ili na skupinu sličnih tvari koje mogu migrirati iz ambalaže ili nekog predmeta u hranu. Utvrđene granice temelje se na toksikološkoj opasnosti koju tvar uzrokuje. Za utvrđivanje prisutnosti tih tvari u hrani i/ili modelnim otopinama hrane, koriste se različite analitičke tehnike. Ograničenja specifična za migraciju određenih tvari mogu se pronaći u gotovo svim propisima o kontaktu s hranom, u rasponu od nekolicine visokorizičnih tvari do opsežnih popisa sastojaka sa granicama migracije.Laboratorij Sample control provodi ispitivanje specifičnih migracija za različite<s> </s>vrste materijala za pakiranje hrane.Specifični zahtjevi za pakiranje hrane i materijale koji dolaze u dodir s hranom uvelike ovise o vrsti materijala. Popis skupina materijala i predmeta koji mogu biti obuhvaćeni posebnim mjerama utvrđen u Prilogu I Uredbe (EZ) 1935/2004 o materijalima i predmetima koji dolaze u dodir s hranom:<ul><li>Aktivni i inteligentni materijali i predmeti</li><li>Adhezivi</li><li>Keramika</li><li>Pluto</li><li>Gume</li><li>Staklo</li><li>Ionsko izmjenjivačke smole</li><li>Metali i legure</li><li>Papir</li><li>Plastika</li><li>Tinte za tiskanje</li><li>Regenerirana celuloza</li><li>Silikoni</li><li>Tekstil</li><li>Lakovi i prevlake</li><li>Voskovi</li><li>Drvo</li></ul>Uredba EU 1935/2004 o materijalima i predmetima koji dolaze u dodir s hranom propisuje da migracija ne smije ugroziti ljudsko zdravlje, uzrokovati promjenu, odnosno pogoršanje organoleptike i promijeniti sastav hrane.Migracijom se podrazumijeva prijenos kemikalija s pakiranja na hranu. Za plastične materijale, Uredba EU 10/2011 o plastičnim materijalima i predmetima koji dolaze u dodir s hranom utvrđuje granicu ukupne migracije od 10 mg/dm2 ili 60 mg/kg za sumu svih migrirajućih tvari, kao i specifične granice migracije za više od 1000 monomera i aditiva kao što su formaldehid, bisfenol A, primarni aromatski amini (PAA) ili ftalati kao najistaknutiji primjeri.Specifična granica migracije primjenjuje se na pojedinačnu tvar ili na skupinu sličnih tvari. Utvrđene granice temelje se na toksikološkoj opasnosti koju tvar uzrokuje. Za utvrđivanje prisutnosti tih tvari u hrani i/ili modelnim otopinama hrane, koriste se različite analitičke tehnike. Ograničenja specifična za migraciju određenih tvari mogu se pronaći u većini propisa o kontaktu s hranom, u rasponu od nekolicine visokorizičnih tvari do opsežnih popisa sastojaka s granicama migracije.Sample Control provodi ispitivanje specifičnih migracija širokog spektra kemikalija za sve vrste materijala za pakiranje hrane. U nastavku su neki od najistaknutijih parametrara koji se ispituju u laboratoriju:<table><tbody><tr><td colspan="1" rowspan="1">Teški metali</td><td colspan="1" rowspan="1">Melamin</td></tr><tr><td colspan="1" rowspan="1">Mineralna ulja MOSH/POSH, MOAH</td><td colspan="1" rowspan="1">Formaldehid</td></tr><tr><td colspan="1" rowspan="1">Primarni aromatski amini</td><td colspan="1" rowspan="1">Acetaldehid</td></tr><tr><td colspan="1" rowspan="1">Sekundarni aromatski amini</td><td colspan="1" rowspan="1">Ftalati</td></tr><tr><td colspan="1" rowspan="1">Benzofenon i 4-metilbenzofenon</td><td colspan="1" rowspan="1">PCB</td></tr><tr><td colspan="1" rowspan="1">Bisfenol A</td><td colspan="1" rowspan="1">BTX</td></tr><tr><td colspan="1" rowspan="1">Nitrozamini</td><td colspan="1" rowspan="1">...</td></tr></tbody></table>Laboratorij Sample control specifične migracije ispituje raznim tehnikama: ICP-MS, HPLC-ICP-MS, GC-FID, GC-MS, GC-MS/MS, UPLC-MS/MS, LC/GC-FID, GC-Orbitrap HRAM, LC-Orbitrap HRAM, HPLC-UV.

<h3>Testing of heavy metals and elements in materials and articles that come into immediate contact with food (FCM)</h3>The migration of substances from materials and articles that come into immediate contact with food may pose a health risk if not controlled. Testing in accordance with the regulations for materials and objects that come into immediate contact with food are necessary to ensure their safety.In general, materials such as plastics used for food packaging contain low concentrations of heavy metals and elements. There are several possible sources of heavy metals and elements, including compounds, printing, food processing, filling and recycling. Metal ions or metal-containing substances may be present as non-intentionally added substances (NIAS), so studies identifying inorganic NIASs are crucial for the safety of food contact products or materials.There are several relevant guidelines to consider, for example, in Europe, Resolution CM/Res (2013), the Technical Guide on metals and alloys used in food contact materials, is widely recognised and used as a reference for the safety and quality of food packaging made of metals and alloys, and specific discharge limits are set for each element. Regulation (EC) 10/2011 (Regulation (EU) 2020/1245), introduced migration restrictions for additional substances containing metals migrating from plastic materials and objects. Plastic materials and articles may not release the following substances in quantities exceeding the limits of a specific migration: aluminium, antimony, arsenic, barium, cadmium, calcium, chromium, cobalt, copper, europium, gadolinium, iron, lanthanum, lead, lithium, magnesium, manganese, mercury, nickel, potassium, sodium, terbium and zinc. Annex II of Regulation (EU) 10/2011 now clearly defines migration limits based on EFSA opinion, which allowed for a single analytical conformity check.Sample Control Laboratory, in addition to the classic AAS (Atomic Absorption Spectrophotometer) technique with flame and graphite furnace, tests the elements using the modern method on ICP-MS and HPLC-ICP-MS, in order to achieve the lowest limits of detection for the analysis of trace elements. The laboratory tests the following elements in materials and articles that come into immediate contact with food:<table><tbody><tr><td colspan="1" rowspan="1">Aluminium (Al)</td><td colspan="1" rowspan="1">Antimony (Sb)</td><td colspan="1" rowspan="1">Arsenic (As)</td><td colspan="1" rowspan="1">Copper (Cu)</td><td colspan="1" rowspan="1">Barium (Ba)</td></tr><tr><td colspan="1" rowspan="1">Beryllium (Be)</td><td colspan="1" rowspan="1">Caesium (Cs)</td><td colspan="1" rowspan="1">Zinc (Zn)</td><td colspan="1" rowspan="1">Europium (Eu)</td><td colspan="1" rowspan="1">Gadolinium (Gd)</td></tr><tr><td colspan="1" rowspan="1">Gallium (Ga)</td><td colspan="1" rowspan="1">Cadmium (Cd)</td><td colspan="1" rowspan="1">Calcium (Ca)</td><td colspan="1" rowspan="1">Potassium (K)</td><td colspan="1" rowspan="1">Cobalt (Co)</td></tr><tr><td colspan="1" rowspan="1">Chromium (Cr)</td><td colspan="1" rowspan="1">Tin (Sn)</td><td colspan="1" rowspan="1">Lanthanum (La)</td><td colspan="1" rowspan="1">Lithium (Li)</td><td colspan="1" rowspan="1">Magnesium (Mg)</td></tr><tr><td colspan="1" rowspan="1">Manganese (Mn)</td><td colspan="1" rowspan="1">Molybdenum (Mo)</td><td colspan="1" rowspan="1">Sodium (Na)</td><td colspan="1" rowspan="1">Nickel (Ni)</td><td colspan="1" rowspan="1">Lead (Pb)</td></tr><tr><td colspan="1" rowspan="1">Rubidium (Rb)</td><td colspan="1" rowspan="1">Selenium (Se)</td><td colspan="1" rowspan="1">Silver (Ag)</td><td colspan="1" rowspan="1">Strontium (Sr)</td><td colspan="1" rowspan="1">Thallium (Tl)</td></tr><tr><td colspan="1" rowspan="1">Terbium (Tb)</td><td colspan="1" rowspan="1">Vanadium (V)</td><td colspan="1" rowspan="1">Mercury (Hg)</td><td colspan="1" rowspan="1">Iron (Fe)</td><td colspan="1" rowspan="1">...</td></tr></tbody></table>

<h3>Testing mineral oils MOSH/POSH, MOAH, PAO in packaging</h3>&nbsp;Mineral oil hydrocarbons (MOH) are chemical compounds primarily derived from crude oil, but they can also be synthetically produced (from coal, natural gas, and biomass). POSH are not part of MOH but can be present in polyolefin plastics (such as polyethylene (PE) and polypropylene (PP)).&nbsp;In food products, these hydrocarbons can be found as a result of environmental contamination, during the manufacturing process, or through food additives and materials that come into contact with food. Food manufacturers and distributors, as well as analytical laboratories, face significant challenges when trying to clarify the source and point of contamination.&nbsp;The presence of saturated (MOSH – Mineral Oil Saturated Hydrocarbons) and aromatic (MOAH – Mineral Oil Aromatic Hydrocarbons) mineral oil hydrocarbons in paper and cardboard packaging for food and hygiene products is a contemporary issue. Food groups in which mineral oils can be found include rice, grain flour, cereals, chocolate products, spices, fats, oils, and further processed foods.&nbsp;Mineral oils can currently be found in various food products. They can enter the final product, as well as the raw materials, at any point in the food production, processing, and distribution chain. The main source of mineral oil compounds in paper and cardboard that can migrate into food products is the inks used for printing, which are applied directly to the packaging or introduced during recycling processes that do not fully remove them.&nbsp;Migration of mineral oil hydrocarbons from packaging into packed products occurs through direct contact or via the gas phase, with evaporation from the packaging and subsequent condensation in the packed product.&nbsp;Sample Control is one of the leading laboratories in this part of Europe for testing mineral oil hydrocarbons in both food and materials and articles intended for food contact. The LC-GC-FID technique successfully employed by Sample Control allows for the separate quantification of MOSH/MOAH within a single chromatographic display.

<h3>Preiskovanje mineralnih olj MOSH/POSH, MOAH, PAO v embalaži</h3>Ogljikovodiki iz mineralnih olj (MOH) so kemične spojine, ki jih pretežno pridobivamo iz surove nafte, pridobivamo pa jih tudi sintetično (iz premoga, zemeljskega plina in biomase). POSH niso del MOH, vendar so lahko prisotni v poliolefinski plastiki (kot sta polietilen (PE) in polipropilen (PP)).Najdemo jih v živilskih izdelkih kot posledico kontaminacije iz okolja, med proizvodnim procesom ali prek aditivov za živila in materialov, ki pridejo v stik s hrano. Proizvajalci hrane in distributerji ter analitični laboratoriji se soočajo z ogromnimi izzivi, ko poskušajo razjasniti vir in točko kontaminacije.Prisotnost nasičenih (MOSH - Mineral Oil Saturated Hydrocarbons) in aromatskih (MOAH - Mineral Oil Aromatic Hydrocarbons) ogljikovodikov mineralnih olj v papirni in kartonski embalaži za živilske in higienske izdelke je danes aktualen problem. Skupine hrane, v katerih najdemo mineralna olja, so riž, žitna moka, kosmiči, čokoladni izdelki, začimbe, maščobe in olja ter dodatno predelana hrana.Mineralna olja danes najdemo v različnih živilskih izdelkih. Sam izdelek, pa tudi surovine, lahko vstopijo kjerkoli v verigi proizvodnje, predelave in prodaje hrane. Glavni vir mineralnih oljnih spojin v papirju in kartonu, ki lahko migrirajo v živilski izdelek, so tiskarska črnila, ki se nanesejo neposredno na embalažo ali pa se vnesejo s postopki recikliranja, med katerimi se ne odstranijo v celoti.Migracija ogljikovodikov mineralnega olja iz embalaže v pakirane izdelke poteka z neposrednim stikom ali preko plinske faze, izhlapevanjem iz embalaže in ponovno kondenzacijo v embaliranem izdelku.Sample Control je eden vodilnih laboratorijev v tem delu Evrope za testiranje ogljikovodikov iz mineralnih olj, tako v hrani kot v materialih in predmetih, ki prihajajo v stik s hrano. Tehnika LC-GC-FID, ki jo uspešno uporablja laboratorij Sample control, omogoča ločeno kvantifikacijo MOSH/MOAH znotraj enega kromatografskega prikaza.

<h3>Ispitivanje mineralnih ulja MOSH/POSH, MOAH, PAO u ambalaži</h3>Ugljikovodici iz mineralnih ulja (MOH) su kemijski spojevi koji se uglavnom dobivaju iz sirove nafte, no proizvode se i sintetski (iz ugljena, priprodnog plina i biomase). POSH nisu dio MOH-a, ali mogu biti prisutni u poliolefinskoj plastic (poput polietilena (PE) i polipropilena (PP)).U prehrambenim proizvodima mogu se naći kao posljedica kontaminacije iz okoliša, tijekom procesa proizvodnje ili putem prehrambenih aditiva i materijala koji dolaze u kontakt s hranom. Proizvođači hrane i distributeri, kao i analitički laboratoriji suočeni su s ogromnim izazovima kada pokušavaju razjasniti izvor i točku onečišćenja.Prisutnost zasićenih (MOSH – Mineral Oil Saturated Hydrocarbons) i aromatskih (MOAH – Mineral Oil Aromatic Hydrocarbons) ugljikovodika mineralnih ulja u papirnatoj i kartonskoj ambalaži za prehrambene i higijenske proizvode aktualan je problem današnjice. Skupine hrane u kojima možemo naći mineralna ulja uključuju rižu, brašno žitarica, žitarice, čokoladne proizvode, začine, masti i ulja kao i dodatno prerađenu hranu.Mineralna ulja danas se mogu naći u raznim prehrambenim proizvodima. U sam proizvod, kao i u sirovine, mogu ući bilo gdje u lancu proizvodnje, prerade i prodaje hrane. Glavni izvor spojeva mineralnih ulja u papiru i kartonu, koje mogu migrirati u prehrambeni proizvod,&nbsp; su tiskarske boje koje se nanose izravno na ambalažu ili se unose procesima recikliranja tijekom kojih se ne uklanjaju u potpunosti.Migracija ugljikovodika mineralnih ulja iz ambalaže u pakirane proizvode odvija se izravnim kontaktom ili putem plinske faze, isparavanjem iz ambalaže i ponovnom kondenzacijom u pakiranom proizvodu.Sample control je jedan od vodećih laboratorija u ovom dijelu Europe za ispitivanje ugljikovodika iz mineralnih ulja, kako u hrani tako i u materijalima i predmetima koji dolaze u kontakt s hranom. LC-GC-FID tehnika koju laboratorij Sample control uspješno primjenjuje, omogućuje odvojeno kvantificiranje MOSH/MOAH unutar jednog kromatografskog prikaza.

<h3>Testing of primary aromatic amines in materials and articles that come into immediate contact with food (FCM)</h3>Testing of the migration of primary aromatic amines from materials and articles that come into immediate contact with food products is carried out because some primary aromatic amines are known to have carcinogenic properties, while others are suspected to be carcinogenic. These substances can therefore pose a health risk if they migrate from food contact materials to food. Primary aromatic amines are used in the production of azo pigments such as certain yellow, orange and red dyes, but they can also be present in inks as impurities of pigments or decomposition products. Primary aromatic amines have been detected in plastic materials that come into contact with food, but also in paper and cardboard food packaging. In Europe, all food contact materials and objects must comply with Regulation (EC) 1935/2004 and Regulation (EC) 10/2011 on plastic materials and articles intended to come into contact with food. Regulation (EC) No. 10/2011 has been amended and supplemented to include the primary aromatic amines listed in 'the Azocolourants entry' of the REACH Regulation (EC) No. 1907/2006. They should not migrate or be released from plastic materials and articles into food or model solution during testing. They should not be detectable by tests with a detection limit of 0.002 mg/kg of food or a model food solution applicable to each individual primary aromatic amine, in accordance with Article 11(4).Sample Control Laboratory tests primary aromatic amines using the&nbsp; UPLC-MS/MS or LC-Orbitrap HRAM technique.

<h3>Testing of heavy metals in materials and articles that come into immediate contact with food (FCM)</h3>The migration of substances from materials and articles that come into immediate contact with food may pose a health risk if not controlled. Testing in accordance with the regulations for materials and objects that come into immediate contact with food are necessary to ensure their safety.In general, materials such as plastics used for food packaging contain low concentrations of heavy metals and elements. There are several possible sources of heavy metals and elements, including compounds, printing, food processing, filling and recycling. Metal ions or metal-containing substances may be present as non-intentionally added substances (NIAS), so studies identifying inorganic NIASs are crucial for the safety of food contact products or materials.There are several relevant guidelines to consider, for example, in Europe, Resolution CM/Res (2013), the Technical Guide on metals and alloys used in food contact materials, is widely recognised and used as a reference for the safety and quality of food packaging made of metals and alloys, and specific discharge limits are set for each element. Regulation (EC) 10/2011 (Regulation (EU) 2020/1245), introduced migration restrictions for additional substances containing metals migrating from plastic materials and objects. Plastic materials and articles may not release the following substances in quantities exceeding the limits of a specific migration: aluminium, antimony, arsenic, barium, cadmium, calcium, chromium, cobalt, copper, europium, gadolinium, iron, lanthanum, lead, lithium, magnesium, manganese, mercury, nickel, potassium, sodium, terbium and zinc. Annex II of Regulation (EU) 10/2011 now clearly defines migration limits based on EFSA opinion, which allowed for a single analytical conformity check.Sample Control Laboratory, in addition to the classic AAS (Atomic Absorption Spectrophotometer) technique with flame and graphite furnace, tests the elements using the modern method on ICP-MS and HPLC-ICP-MS, in order to achieve the lowest limits of detection for the analysis of trace elements. The laboratory tests the following elements in materials and articles that come into immediate contact with food:<table><tbody><tr><td colspan="1" rowspan="1">Aluminium (Al)</td><td colspan="1" rowspan="1">Antimony (Sb)</td><td colspan="1" rowspan="1">Arsenic (As)</td><td colspan="1" rowspan="1">Copper (Cu)</td><td colspan="1" rowspan="1">Barium (Ba)</td></tr><tr><td colspan="1" rowspan="1">Sodium (Na)</td><td colspan="1" rowspan="1">Iron (Fe)</td><td colspan="1" rowspan="1">Zinc (Zn)</td><td colspan="1" rowspan="1">Europium (Eu)</td><td colspan="1" rowspan="1">Gadolinium (Gd)</td></tr><tr><td colspan="1" rowspan="1">Mercury (Hg)</td><td colspan="1" rowspan="1">Cadmium (Cd)</td><td colspan="1" rowspan="1">Calcium (Ca)</td><td colspan="1" rowspan="1">Potassium (K)</td><td colspan="1" rowspan="1">Cobalt (Co)</td></tr><tr><td colspan="1" rowspan="1">Chromium (Cr)</td><td colspan="1" rowspan="1">Tin (Sn)</td><td colspan="1" rowspan="1">Lanthanum (La)</td><td colspan="1" rowspan="1">Lithium (Li)</td><td colspan="1" rowspan="1">Magnesium (Mg)</td></tr><tr><td colspan="1" rowspan="1">Manganese (Mn)</td><td colspan="1" rowspan="1">Terbium (Tb)</td><td colspan="1" rowspan="1">Lead (Pb)</td><td colspan="1" rowspan="1">Nickel (Ni)</td><td colspan="1" rowspan="1">...</td></tr></tbody></table>

<h3>Preiskovanje težkih kovin v materialih in predmetih, ki pridejo v neposreden stik s hrano (FCM)</h3>Migracija snovi iz materialov in predmetov, ki pridejo v neposreden stik s hrano, lahko predstavlja zdravstveno tveganje če jo ne kontroliramo. Preiskovanja v skladu s predpisi za materiale in predmete, ki pridejo v neposreden stik s hrano, so nujna da bi zagotovili varnost le-teh.Splošno, materiali kot je plastika, ki se uporablja za pakiranje hrane,&nbsp;vsebujejo nizke koncentracije težkih kovin in elementov. Obstaja nekaj možnih virov težkih kovin in elementov, vključno s spojinami, tiskanjem, obdelavo hrane, polnjenjem in recikliranjem. Kovinski ioni ali snovi, ki vsebujejo kovine, so lahko prisotne kot nenamerno dodane snovi (NIAS), zato so preiskovanja, s katerimi identificiramo anorganske NIAS, usodna za varnost izdelka ali materialov, ki pridejo v stik s hrano.Imamo nekaj relevantnih smernic, ki jih je potrebno upoštevati, na primer v Evropi Rezolucija CM/Res (2013), Tehnični vodič o kovinah in zlitinah, ki jih uporabljamo v materialih, ki pridejo v stik s hrano, je široko priznan in se uporablja kot referenca za varnost in kakovost embalaže za hrano, izdelane iz kovin in zlitin, ter so za vsaki element postavljene specifične meje izpuščanja. Z uredbo (ES) 10/2011 (Uredba (EU) 2020/1245), so uvedene omejitve migracije za dodatne snovi, ki vsebujejo kovine, ki migrirajo iz plastičnih materialov in predmetov. Materiali in predmeti iz plastike ne smejo izpuščati naslednje snovi v količinah, ki prehajajo meje specifične migracije: aluminij, antimon, arsen, barij, kadmij, kalcij, krom, kobalt, baker, Evropij, gadolinij, železo, lantan, svinec, litij, magnezij, mangan, živo srebro, nikelj, kalij, natrij, terbij in cink. V Aneksu II Uredbe (EU) 10/2011 so sedaj jasno definirane meje migracije na podlagi mnenja EFSA, ki so omogočile obenoteno analitično preiskovanje usklajenosti.Laboratorij Sample control, razen s klasično AAS (Atomski absorbcijski spektrofotomer), z grafitno in plamensko tehniko, preiskuje elemente z uporabo sodobne metode na ICP-MS in HPLC-ICP-MS, da bi dosegel najnižje meje detekcije za analizo elementov v sledeh. Laboratorij preiskuje naslednje elemente v materialih in predmetih, ki pridejo v neposreden stik s hrano:<table><tbody><tr><td colspan="1" rowspan="1">Aluminij (Al)</td><td colspan="1" rowspan="1">Antimon (Sb)</td><td colspan="1" rowspan="1">Arsen (As)</td><td colspan="1" rowspan="1">Bakar (Cu)</td><td colspan="1" rowspan="1">Barij (Ba)</td></tr><tr><td colspan="1" rowspan="1">Natrij (Na)</td><td colspan="1" rowspan="1">Željezo (Fe)</td><td colspan="1" rowspan="1">Cink (Zn)</td><td colspan="1" rowspan="1">Europij (Eu)</td><td colspan="1" rowspan="1">Gadolinij (Gd)</td></tr><tr><td colspan="1" rowspan="1">Živa (Hg)</td><td colspan="1" rowspan="1">Kadmij (Cd)</td><td colspan="1" rowspan="1">Kalcij (Ca)</td><td colspan="1" rowspan="1">Kalij (K)</td><td colspan="1" rowspan="1">Kobalt (Co)</td></tr><tr><td colspan="1" rowspan="1">Krom (Cr)</td><td colspan="1" rowspan="1">Kositar (Sn)</td><td colspan="1" rowspan="1">Lantan (La)</td><td colspan="1" rowspan="1">Litij (Li)</td><td colspan="1" rowspan="1">Magnezij (Mg)</td></tr><tr><td colspan="1" rowspan="1">Mangan (Mn)</td><td colspan="1" rowspan="1">Terbij (Tb)</td><td colspan="1" rowspan="1">Olovo (Pb)</td><td colspan="1" rowspan="1">Nikal (Ni)</td><td colspan="1" rowspan="1">...</td></tr></tbody></table>

<h3>Ispitivanje teških metala u materijalima i predmetima koji dolaze u neposredan dodir s hranom (FCM)</h3>Migracija tvari iz materijala i predmeta koji dolaze u neposredan dodir s hranom može predstavljati zdravstveni rizik ako se ne kontrolira. Ispitivanje u skladu s propisima za materijale i predmete koji dolaze u neposredan dodir s hranom, neophodna su kako bi se osigurala sigurnost istih.Općenito, materijali kao što je plastika koja se koristi za pakiranje hrane sadrže niske koncentracije teških metala. Postoji nekoliko mogućih izvora kontaminacije teških metala uključujući spojeve, tiskanje, obradu hrane, punjenje i recikliranje.Postoji nekoliko relevantnih smjernica koje je potrebno uzeti u obzir. Na primjer, u Europi, Rezolucija CM/Res (2013), Tehnički vodič o metalima i legurama koji se koriste u materijalima koji dolaze u dodir s hranom, široko je priznat i koristi se kao referenca za sigurnost i kvalitetu ambalaže za hranu izrađenu od metala i metalnih legura. Uredbom EU 10/2011 uvedena su ograničenja migracije za metale koji mogu migrirati iz plastičnih materijala i predmeta koji dolaze u neposredan dodir s hranom.Laboratorij Sample Control određuje količinu teških metala na ICP-MS-u i HPLC-ICP-MS-u, kako bi se postigle najniže granice detekcije teških metala. Laboratorij ispituje slijedeće elemente u materijalima i predmetima koji dolaze u neposredan dodir s hranom, a definirani su u Prilogu II, Tablici 1. Uredbe (EU) 10/2011:<table><tbody><tr><td colspan="1" rowspan="1">Aluminij (Al)</td><td colspan="1" rowspan="1">Antimon (Sb)</td><td colspan="1" rowspan="1">Arsen (As)</td><td colspan="1" rowspan="1">Bakar (Cu)</td><td colspan="1" rowspan="1">Barij (Ba)</td></tr><tr><td colspan="1" rowspan="1">Natrij (Na)</td><td colspan="1" rowspan="1">Željezo (Fe)</td><td colspan="1" rowspan="1">Cink (Zn)</td><td colspan="1" rowspan="1">Europij (Eu)</td><td colspan="1" rowspan="1">Gadolinij (Gd)</td></tr><tr><td colspan="1" rowspan="1">Živa (Hg)</td><td colspan="1" rowspan="1">Kadmij (Cd)</td><td colspan="1" rowspan="1">Kalcij (Ca)</td><td colspan="1" rowspan="1">Kalij (K)</td><td colspan="1" rowspan="1">Kobalt (Co)</td></tr><tr><td colspan="1" rowspan="1">Krom (Cr)</td><td colspan="1" rowspan="1">Kositar (Sn)</td><td colspan="1" rowspan="1">Lantan (La)</td><td colspan="1" rowspan="1">Litij (Li)</td><td colspan="1" rowspan="1">Magnezij (Mg)</td></tr><tr><td colspan="1" rowspan="1">Mangan (Mn)</td><td colspan="1" rowspan="1">Terbij (Tb)</td><td colspan="1" rowspan="1">Olovo (Pb)</td><td colspan="1" rowspan="1">Nikal (Ni)</td><td colspan="1" rowspan="1">...</td></tr></tbody></table>

<h3>Testing of non-intentionally added substances (NIAS)</h3>Non-intentionally added substances (NIAS) in materials and items that come into immediate contact with food pose a potential safety problem for the food packaging industry. Precise testing, identification and quantification of NIAS is necessary to assess the safety and conformity of materials and objects that come into immediate contact with food.NIAS include impurities, reaction products or decomposition products originating from the production or extraction process of substances used in the manufacture of plastic materials and objects that come into immediate contact with food. Regulation (EC) 10/2011 on plastic materials and articles that come into immediate contact with food states that any potential health risks in the final product or food packaging material should be assessed by the manufacturer in accordance with internationally recognised risk assessment principles.Unlisted substances are another category of chemical substances that must be taken into account in the assessment of risk arising from contact with food. Unlisted substances are generally classified as substances that are not specified because they are considered not to be harmful for arbitrary or commercial reasons, however, they are still subject to assessment.The central place in the risk assessment according to NIAS and the first step towards proving compliance with NIAS is to determine which substances are present in materials and articles that come into immediate contact with food. Taking into account that NIAS applies to all materials that come into immediate contact with food, it is essential to address any risk to consumer health.NIAS testing is performed by the Sample Control Laboratory using various approach techniques to try to identify all potential compounds that have migrated to food or model solution. With a wide range of sample preparation techniques and test techniques such as GC-Orbitrap HRAM, LC-Orbitrap HRAM, UPLC-MS/MS, GC-MS/MS, HPLC-ICP-MS, we can very accurately determine the compounds that have migrated and are recognised as NIAS.

<h3>Testing of primary aromatic amines in materials and articles that come into immediate contact with food (FCM)</h3>Testing of the migration of primary aromatic amines from materials and articles that come into immediate contact with food products is carried out because some primary aromatic amines are known to have carcinogenic properties, while others are suspected to be carcinogenic. These substances can therefore pose a health risk if they migrate from food contact materials to food. Primary aromatic amines are used in the production of azo pigments such as certain yellow, orange and red dyes, but they can also be present in inks as impurities of pigments or decomposition products. Primary aromatic amines have been detected in plastic materials that come into contact with food, but also in paper and cardboard food packaging. In Europe, all food contact materials and objects must comply with Regulation (EC) 1935/2004 and Regulation (EC) 10/2011 on plastic materials and articles intended to come into contact with food. Regulation (EC) No. 10/2011 has been amended and supplemented to include the primary aromatic amines listed in 'the Azocolourants entry' of the REACH Regulation (EC) No. 1907/2006. They should not migrate or be released from plastic materials and articles into food or model solution during testing. They should not be detectable by tests with a detection limit of 0.002 mg/kg of food or a model food solution applicable to each individual primary aromatic amine, in accordance with Article 11(4).Sample Control Laboratory tests primary aromatic amines using the&nbsp; UPLC-MS/MS or LC-Orbitrap HRAM technique.

<h3>Ispitivanje primarnih aromatskih amina u materijalima i predmetima koji dolaze u neposredan dodir s hranom (FCM)</h3>Ispitivanje migracije primarnih aromatskih amina iz materijala i predmeta koji dolaze u neposredan dodir s hranom u prehrambene proizvode, provodi se jer se zna da neki primarni aromatski amini imaju kancerogena svojstva, dok se za druge sumnja da su kancerogeni. Ove tvari stoga mogu predstavljati rizik za zdravlje ako s materijala koji dolaze u dodir s hranom prijeđu na hranu. Primarni aromatski amini koriste se u proizvodnji azo pigmenata kao što su određena žuta, narančasta i crvena bojila, ali također mogu biti prisutni u tintama kao nečistoće pigmenata ili produkti razgradnje. Primarni aromatski amini su otkriveni u plastičnim materijalima koji dolaze u dodir s hranom, ali i u papirnoj i kartonskoj ambalaži za hranu. U Europi svi materijali i predmeti koji dolaze u dodir s hranom moraju biti u skladu s Uredbom EU 10/2011 o plastičnim materijalima i predmetima koji dolaze u dodir s hranom. Uredba<s> </s>EU br. 10/2011 je izmijenjena i dopunjena kako bi uključila primarne aromatske amine navedene u „unosu azobojila” Uredbe REACH (EZ) br. 1907/2006. Oni ne bi trebali migrirati iz plastičnih materijala i predmeta u modelnu otopinu tijekom testiranja. Ne bi ih se smjelo moći detektirati ispitivanjima uz utvrđenu granicom detekcije od 0,002 mg/kg hrane ili modelne otopine hrane koja se primjenjuje na svaki pojedinačni primarni aromatski amin, u skladu s člankom 11. stavkom 4.Laboratorij Sample Control ispituje primarne aromatske amine tehnikom UPLC-MS/MS ili LC-Orbitrap HRAM.

<h3>Preiskovanje primarnih aromatičnih aminov v materialih in predmetih, ki pridejo v neposreden stik s hrano (FCM)</h3>Preiskovanje migracije primarnih aromatičnih aminov iz materialov in predmetov, ki pridejo v neposreden stik s hrano v prehrambnih izdelkih, se opravlja ker ne vemo, ali nekateri primarni &nbsp;aromatični amini imajo kancerogena lastnosti, za druge pa obstaja sum da so kancerogeni. Te snovi zaradi tega lahko predstavljajo tveganje za zdravje, če iz materialov, ki pridejo v stik s hrano, prestopijo na hrano. Primarni aromatični amini se uporabljajo pri proizvodnji azo pigmentov, kot so določena rumena, oranžna in rdeča barvila, lahko pa se nahajajo tudi v tintah kot nečistoče pigmentov ali produkti razkrajanja. Primarni aromatični amini so ugotovljeni v plastičnih materialih, ki pridejo v stik s hrano, pa tudi v papirni in kartonski embalaži za hrano. V Evropi vsi materiali in predmeti, ki pridejo v stik s hrano, morajo biti v skladu z Uredbo (ES) 1935/2004 in Uredbo (ES) 10/2011 o plastičnih materialih in predmetih, ki pridejo v stik s hrano. Uredba (ES) št. 10/2011 je spremenjena in dopolnjena da bi vključila primarne aromatične amine navedene v „vnosu azobarvil” Uredbe REACH (ES) št. 1907/2006. Videti je, da ti naj ne bi migrirali niti se sproščevali iz plastičnih materialov in predmetov v hrano ali modelno raztopino med testiranjem. Ne bi smela biti možna detekcija s preiskavami z ugotovljeno mejo detekcije, ki je 0,002 mg/kg hrane ali modelne raztopine hrane ki se uporablja za vsaki posamični primarni aromatični amin, v skladu z 11. členom, 4.odstavkom.Laboratorij Sample control preiskuje primarne aromatične amine s tehniko UPLC-MS/MS ali LC-Orbitrap HRAM.

<h3>IFS, BRC, FCCS22000, SQF requirements of packaging material migration testing</h3>Different standards prescribe requirements for packaging, in particular the packaging of food and consumer goods (in particular cosmetic products, certain items and preparations that come into immediate contact with the skin and/or mucous membranes, detergents...).IFS Food and BRCGS Food Safety include specific requirements relating to food packaging materials and items and their relationship to the product.IFS HPC and BRCGS Consumer Products are standards that lay down specific requirements for manufacturers of household and personal care products (including cosmetic products, etc.).IFS PACsecure version 2 and BRCGS Packaging Issue 6 are standards that prescribe specific requirements for packaging manufacturers.Compliance is carried out according to the standards listed below:<table><tbody><tr><td colspan="1" rowspan="1">Standard</td><td colspan="1" rowspan="1">Requirement</td></tr><tr><td colspan="1" rowspan="1">IFS Food Version 7</td><td colspan="1" rowspan="1">IFS Food Version 7</td></tr><tr><td colspan="1" rowspan="1">IFS HPC version 2</td><td colspan="1" rowspan="1">4.2.1 Raw materials (including packaging materials),… 4.2.2 Finished product specifications</td></tr><tr><td colspan="1" rowspan="1">IFS PACsecure version 2</td><td colspan="1" rowspan="1">5.6 Product and process analyses</td></tr><tr><td colspan="1" rowspan="1">BRCGS Food Safety Issue 8</td><td colspan="1" rowspan="1">5.5 Product packaging</td></tr><tr><td colspan="1" rowspan="1">BRCGS Consumer Products: General Merchandise (Issue 4)</td><td colspan="1" rowspan="1"></td></tr><tr><td colspan="1" rowspan="1">BRCGS Consumer Products: Personal Care and Household (Issue 4)</td><td colspan="1" rowspan="1"></td></tr><tr><td colspan="1" rowspan="1">BRCGS Packaging Issue 6</td><td colspan="1" rowspan="1">3.4.3 Statement of compliance</td></tr><tr><td colspan="1" rowspan="1">FSSC22000 Version 5.1</td><td colspan="1" rowspan="1">FSSC 22000 2.5.11(a) i ISO 22000:2018 8.5.1.3(e) characteristics of packaging and functional effect on food</td></tr><tr><td colspan="1" rowspan="1">SQF Edition 9</td><td colspan="1" rowspan="1">2.3.2.6 Verification of packaging</td></tr></tbody></table>The conformity check carried out by Sample Control includes, among other things, the following:<ul><li>checking availability and checking the specifications of all packaging materials,</li><li>checking the compliance of all packaging materials with the product or type of food (compliance with regulations),</li><li>checking and/or conducting migration tests for packaging materials,</li><li>the effect of the packaging material on the products packaged in it (includes testing on the taste of the product, smell, preservation and other factors).</li></ul>A list of specific tests that Sample Control performs in the field of packaging, can be seen at:<ul><li>Testing of materials and objects that come into immediate contact with food (migration testing),</li><li>Cosmetic products packaging testing.</li></ul>

<h3>Testing of non-intentionally added substances (NIAS)</h3>Non-intentionally added substances (NIAS) in materials and items that come into immediate contact with food pose a potential safety problem for the food packaging industry. Precise testing, identification and quantification of NIAS is necessary to assess the safety and conformity of materials and objects that come into immediate contact with food.NIAS include impurities, reaction products or decomposition products originating from the production or extraction process of substances used in the manufacture of plastic materials and objects that come into immediate contact with food. Regulation (EC) 10/2011 on plastic materials and articles that come into immediate contact with food states that any potential health risks in the final product or food packaging material should be assessed by the manufacturer in accordance with internationally recognised risk assessment principles.Unlisted substances are another category of chemical substances that must be taken into account in the assessment of risk arising from contact with food. Unlisted substances are generally classified as substances that are not specified because they are considered not to be harmful for arbitrary or commercial reasons, however, they are still subject to assessment.The central place in the risk assessment according to NIAS and the first step towards proving compliance with NIAS is to determine which substances are present in materials and articles that come into immediate contact with food. Taking into account that NIAS applies to all materials that come into immediate contact with food, it is essential to address any risk to consumer health.NIAS testing is performed by the Sample Control Laboratory using various approach techniques to try to identify all potential compounds that have migrated to food or model solution. With a wide range of sample preparation techniques and test techniques such as GC-Orbitrap HRAM, LC-Orbitrap HRAM, UPLC-MS/MS, GC-MS/MS, HPLC-ICP-MS, we can very accurately determine the compounds that have migrated and are recognised as NIAS.

<h3>Preiskovanje nenamerno dodanih snovi (NIAS)</h3>Nenamerno dodane snovi (Non-intentionally added substances- NIAS) v materialih in predmetih, ki pridejo v neposreden stik s hrano, predstavljajo potencialni varnostni problem za industrijo pakiranja hrane. Natančno preiskovanje, identifikacija in kvantificiranje NIAS-a je potrebno za ocenitev varnosti in usklajenosti materialov in predmetov ki pridejo v neposreden stik s hrano.NIAS vključuju nečistoče, produkte reakcije ali produkte razgraditve, ki izvirajo iz procesa proizvodnje ali ekstrakcije snovi, ki jiih uporabljamo v proizvodnji plastičnih materialov in predmetov, ki pridejo v neposreden stik s hrano. Uredba (ES) 10/2011 o plastičnih materialih in predmetih, ki pridejo v neposreden stik s hrano z navodilom, da bi potencialna zdravstvena tveganja v končnih izdelkih ali predmetih za pakiranje hrane moral oceniti proizvajalec v skladu z medarodno priznanimi načeli za ocenitev tveganja.Neuvrščene snovi so še ena kategorija kemičnih&nbsp; snovi, ki jih moramo upoštevati v študijah ocenitve tveganosti v kontaktu s hrano. Neuvrščene snovi se splošno klasificirajo kot snovi, ki niso navedene ker splošno velja, da niso škodljive zaradi svojevoljnih ali komercialnih razlogov, toda še vedno sodijo med tiste, za katere je potrebna ocenitev.Osrednje mesto v oceni tveganja po NIAS-u in prvi korak pri dokazovanju usklajenosti z NIAS-om je ugotoviti, katere snovi so prisotne v materialih in predmetih, ki pridejo v neposreden stik s hrano. Če upoštevamo, da se NIAS uporablja za vse materiale, ki pridejo v neposreden stik s hrano, je ključno razrešiti sleherno tveganje za zdravje potrošnikov.Preiskovanje NIAS-a laboratorij Sample control opravlja z uporabo različnih tehnik pristopa, da bi&nbsp; poskušal določiti vse potencialne spojine, ki so migrirale v hrano ali modelno raztopiino. S široko ponudbo tehnik priprave vzorca in s preiskovalnimi tehnikami kot so GC-Orbitrap HRAM, LC-Orbitrap HRAM, UPLC-MS/MS, GC-MS/MS, HPLC-ICP-MS, lahko zelo natančno določimo spojine ki so migrirale ter jih prepoznamo kot NIAS.

<h3>Ispitivanje nenamjerno dodanih tvari (NIAS)</h3>Nenamjerno dodane tvari (Non-intentionally added substances- NIAS) u materijalima i predmetima koji dolaze u neposredan dodir s hranom predstavljaju potencijalni sigurnosni problem za industriju pakiranja hrane. Precizno ispitivanje, identifikacija i kvantificiranje NIAS-a potrebno je za procjenu sigurnosti i sukladnosti materijala i predmeta koji dolaze u neposredan dodir s hranom.NIAS uključuju nečistoće, produkte reakcije ili produkte razgradnje koji potječu iz procesa proizvodnje ili ekstrakcije tvari koje se koriste u proizvodnji plastičnih materijala i predmeta koji dolaze u neposredan dodir s hranom. Uredba (EZ) 10/2011 o plastičnim materijalima i predmetima koji dolaze u neposredan dodir s hranom navodi da bi potencijalne zdravstvene rizike u konačnim proizvodima ili predmetima za pakiranje hrane trebao procijeniti proizvođač u skladu s međunarodno priznatim načelima procjena rizika.Neuvrštene tvari još su jedna kategorija kemijskih tvari koje se moraju uzeti u obzir u studijama procjene rizika u kontaktu s hranom. Neuvrštene tvari se općenito klasificiraju kao tvari koje nisu navedene jer se smatra da nisu štetne zbog proizvoljnih ili komercijalnih razloga, međutim, još uvijek podliježu procjeni.Središnje mjesto u procjeni rizika prema NIAS-u i prvi korak prema dokazivanju usklađenosti s NIAS-om jest utvrditi koje su tvari prisutne u materijalima i predmetima koji dolaze u neposredan dodir s hranom. Uzimajući u obzir da se NIAS primjenjuje na sve materijale koji dolaze u neposredan dodir s hranom, ključno je riješiti svaki rizik za zdravlje potrošača.Ispitivanje NIAS-a laboratorij Sample control provodi primjenom različitih tehnika pristupa kako bi se pokušali odrediti svi potencijalni spojevi koji su migrirali u hranu ili modelnu otopinu. Široki rasponom tehnika pripreme uzorka i ispitnim tehnika kao što su GC-Orbitrap HRAM, LC-Orbitrap HRAM, UPLC-MS/MS, GC-MS/MS, HPLC-ICP-MS, možemo vrlo precizno odrediti spojeve koji su migrirali te prepoznati kao NIAS.

<h3>Raman microscopy: a solution for advanced characterisation of packaging and polymers!</h3>Polymeric materials play a fundamental role in our daily lives. They prevent our food from coming into contact with bacteria or being oxidised, and the increase the resistance of our glass. More than 330 million tons of polymers are produced annually.To ensure that all these important functions are possible, a simple polymer is not enough. Therefore, polymeric materials have become more complex and now contain many different chains of macromolecules combined into multi-layered systems.Using Raman microscopy, it is possible to obtain all kinds of information such as the chemical composition of the material, its morphological and mechanical properties, the distribution of specific compounds, the structure of the material, etc. In order to localise the presence of a particular compound in complex mixtures such as in the case of solid capsules containing active compounds, it is necessary to process its spectra. The main advantages of Raman microscopy are reliability, generally easy data interpretation, non-destructive sample analysis, the possibility of mapping the surface of the sample as well as in-depth analysis of the profile.The use of Raman microscopy allows you to obtain complete characterisation data for all polymeric films, from the characterisation of multi-layered materials to the analysis of defects or errors.Sample Control Laboratory uses Thermo Scientific™ DXR3xi Raman microscope which provides chemical and structural images for various polymer samples at the test level. Find out <a target="_self" rel="noopener noreferrer nofollow" href="https://www.sample-control.hr/en/services/ramen-microscopy">more about Raman microscopy here.</a>

<h3>IFS, BRC, FCCS22000, SQF requirements of packaging material migration testing</h3>Different standards prescribe requirements for packaging, in particular the packaging of food and consumer goods (in particular cosmetic products, certain items and preparations that come into immediate contact with the skin and/or mucous membranes, detergents...).IFS Food and BRCGS Food Safety include specific requirements relating to food packaging materials and items and their relationship to the product.IFS HPC and BRCGS Consumer Products are standards that lay down specific requirements for manufacturers of household and personal care products (including cosmetic products, etc.).IFS PACsecure version 2 and BRCGS Packaging Issue 6 are standards that prescribe specific requirements for packaging manufacturers.Compliance is carried out according to the standards listed below:<table><tbody><tr><td colspan="1" rowspan="1">Standard</td><td colspan="1" rowspan="1">Requirement</td></tr><tr><td colspan="1" rowspan="1">IFS Food Version 7</td><td colspan="1" rowspan="1">IFS Food Version 7</td></tr><tr><td colspan="1" rowspan="1">IFS HPC version 2</td><td colspan="1" rowspan="1">4.2.1 Raw materials (including packaging materials),… 4.2.2 Finished product specifications</td></tr><tr><td colspan="1" rowspan="1">IFS PACsecure version 2</td><td colspan="1" rowspan="1">5.6 Product and process analyses</td></tr><tr><td colspan="1" rowspan="1">BRCGS Food Safety Issue 8</td><td colspan="1" rowspan="1">5.5 Product packaging</td></tr><tr><td colspan="1" rowspan="1">BRCGS Consumer Products: General Merchandise (Issue 4)</td><td colspan="1" rowspan="1"></td></tr><tr><td colspan="1" rowspan="1">BRCGS Consumer Products: Personal Care and Household (Issue 4)</td><td colspan="1" rowspan="1"></td></tr><tr><td colspan="1" rowspan="1">BRCGS Packaging Issue 6</td><td colspan="1" rowspan="1">3.4.3 Statement of compliance</td></tr><tr><td colspan="1" rowspan="1">FSSC22000 Version 5.1</td><td colspan="1" rowspan="1">FSSC 22000 2.5.11(a) i ISO 22000:2018 8.5.1.3(e) characteristics of packaging and functional effect on food</td></tr><tr><td colspan="1" rowspan="1">SQF Edition 9</td><td colspan="1" rowspan="1">2.3.2.6 Verification of packaging</td></tr></tbody></table>The conformity check carried out by Sample Control includes, among other things, the following:<ul><li>checking availability and checking the specifications of all packaging materials,</li><li>checking the compliance of all packaging materials with the product or type of food (compliance with regulations),</li><li>checking and/or conducting migration tests for packaging materials,</li><li>the effect of the packaging material on the products packaged in it (includes testing on the taste of the product, smell, preservation and other factors).</li></ul>A list of specific tests that Sample Control performs in the field of packaging, can be seen at:<ul><li>Testing of materials and objects that come into immediate contact with food (migration testing),</li><li>Cosmetic products packaging testing.</li></ul>

<h3>IFS, BRC, FCCS22000, SQF zahtjevi za testiranje migracije ambalaže za pakiranje</h3>Različiti standardi propisuju zahtjeve za ambalažu, posebice ambalažu hrane i predmeta široke potrošnje (posebno kozmetičkih proizvoda, određeni predmeti i sredstva koja pri uporabi dolaze u neposredan dodir s kožom i/ili sluznicom, deterdženti…).IFS Food i BRCGS Food Safety uključuju specifične zahtjeve koji se odnose na materijale i predmete za pakiranje hrane i njihov odnos na proizvod.IFS HPC i BRCGS Consumer Products su standardi koji propisuju specifične zahtjeve za proizvođače proizvoda za kućanstvo i osobnu njegu (uključujući kozmetičke proizvode i sl.).IFS PACsecure version 2 i BRCGS Packaging Issue 6 su standardi koji propisuju specifične zahtjeve za proizvođače ambalaže.Sukladnost se provodi prema niže navedenim standardima:<table><tbody><tr><td colspan="1" rowspan="1">Standard</td><td colspan="1" rowspan="1">Zahtjev</td></tr><tr><td colspan="1" rowspan="1">IFS Food Version 7</td><td colspan="1" rowspan="1">IFS Food Version 7</td></tr><tr><td colspan="1" rowspan="1">IFS HPC version 2</td><td colspan="1" rowspan="1">4.2.1 Raw materials (including packaging materials),… 4.2.2 Finished product specifications</td></tr><tr><td colspan="1" rowspan="1">IFS PACsecure version 2</td><td colspan="1" rowspan="1">5.6 Product and process analyses</td></tr><tr><td colspan="1" rowspan="1">BRCGS Food Safety Issue 8</td><td colspan="1" rowspan="1">5.5 Product packaging</td></tr><tr><td colspan="1" rowspan="1">BRCGS Consumer Products: General Merchandise (Issue 4)</td><td colspan="1" rowspan="1"></td></tr><tr><td colspan="1" rowspan="1">BRCGS Consumer Products: Personal Care and Household (Issue 4)</td><td colspan="1" rowspan="1"></td></tr><tr><td colspan="1" rowspan="1">BRCGS Packaging Issue 6</td><td colspan="1" rowspan="1">3.4.3 Statement of compliance</td></tr><tr><td colspan="1" rowspan="1">FSSC22000 Version 5.1</td><td colspan="1" rowspan="1">FSSC 22000 2.5.11(a) i ISO 22000:2018 8.5.1.3(e) characteristics of packaging and functional effect on food</td></tr><tr><td colspan="1" rowspan="1">SQF Edition 9</td><td colspan="1" rowspan="1">2.3.2.6 Verification of packaging</td></tr></tbody></table>Provjera sukladnosti koje provodi Sample control, između ostalog, uključuje:<ul><li>provjeru dostupnosti i provjeru specifikacija svih materijala za pakiranje,</li><li>provjeru usklađenosti svih materijala za pakiranje s proizvodom ili vrstom hrane (sukladnost propisima),</li><li>provjeru i/ili provođenje migracijskih testova za materijale za pakiranje,</li><li>učinak materijala za pakiranje na proizvode koji se u njemu pakiraju (uključuje i ispitivanje na okus proizvoda, miris, očuvanje i druge čimbenike).</li></ul>Popis specifičnih ispitivanja koje Sample control provodi u području ambalaže, mogu se vidjeti na:<ul><li>Ispitivanje materijala i predmeta koji dolaze u neposredan dodir s hranom (testiranje migracije),</li><li>Ispitivanje ambalaže kozmetičkih proizvoda.</li></ul>

<h3>IFS, BRC, FCCS22000, SQF zahteve za testiranje migracije embalaže za pakiranje</h3>Različni standardi narekujejo zahteve za embalažo, zlasti embalažo hrane in predmetov široke uporabe (posebno kozmetičnih izdelkov, določeni predmeti in sredstva ki pri uporabi pridejo v neposreden stik s kožo in/ali sluznico, detergenti…).IFS Food in BRCGS Food Safety vključujejo specifične zahteve, &nbsp;ki se nanašajo na materiale in predmete za pakiranje hrane in njihovo razmerje z izdelkom.IFS HPC in BRCGS Consumer Products so standardi, ki narekujejo specifične zahteve za proizvajalce&nbsp;&nbsp; izdelkov za gospodinjstvo in osebno nego (vključno s kozmetičnimi izdeleki in pd.).IFS PAC secure version 2 in BRCGS Packaging Issue 6 so standardi, v katerih so predpisane specifične zahteve za proizvajalce&nbsp;&nbsp; embalaže.Usklajenost se opravlja v skladu s spodaj navedenimi standardi:<table><tbody><tr><td colspan="1" rowspan="1">Standard</td><td colspan="1" rowspan="1">Zahteva</td></tr><tr><td colspan="1" rowspan="1">IFS Food Version 7</td><td colspan="1" rowspan="1">IFS Food Version 7</td></tr><tr><td colspan="1" rowspan="1">IFS HPC version 2</td><td colspan="1" rowspan="1">4.2.1 Raw materials (including packaging materials),… 4.2.2 Finished product specifications</td></tr><tr><td colspan="1" rowspan="1">IFS PACsecure version 2</td><td colspan="1" rowspan="1">5.6 Product and process analyses</td></tr><tr><td colspan="1" rowspan="1">BRCGS Food Safety Issue 8</td><td colspan="1" rowspan="1">5.5 Product packaging</td></tr><tr><td colspan="1" rowspan="1">BRCGS Consumer Products: General Merchandise (Issue 4)</td><td colspan="1" rowspan="1"></td></tr><tr><td colspan="1" rowspan="1">BRCGS Consumer Products: Personal Care and Household (Issue 4)</td><td colspan="1" rowspan="1"></td></tr><tr><td colspan="1" rowspan="1">BRCGS Packaging Issue 6</td><td colspan="1" rowspan="1">3.4.3 Statement of compliance</td></tr><tr><td colspan="1" rowspan="1">FSSC22000 Version 5.1</td><td colspan="1" rowspan="1">FSSC 22000 2.5.11(a) in ISO 22000:2018 8.5.1.3(e) characteristics of packaging and functional effect on food</td></tr><tr><td colspan="1" rowspan="1">SQF Edition 9</td><td colspan="1" rowspan="1">2.3.2.6 Verification of packaging</td></tr></tbody></table>Preiskovanje usklajenosti, ki jo opravlja Sample control, med drugim, vključuje:<ul><li>preverjanje dostopnosti in preverjanje specifikacij vseh materialov za pakiranje,</li><li>preverjanje usklajenosti vseh materialov za pakiranje z izdelekom ali vrsto hrane (usklajenost s predpisi),</li><li>preiskovanje in/ali opravljanje migracijskih testov za materiale za pakiranje,</li><li>učinek materialov za pakiranje na izdeleke ki se vanj pakirajo (vključuje tudi preiskovanje na okus izdelka, vonj, ohranitev in druge dejavnike).</li></ul>Seznam specifičnih preverjanj, ki jih Sample control opravlja na področju embalaže, lahko vidimo na:<ul><li>preiskovanju materialov in predmetov, ki pridejo v neposreden stik s hrano (testiranje migracije),</li><li>preiskovanju embalaže kozmetičnih izdelkov.</li></ul>

<h3>Material characterisation</h3>Raman microscopy: a solution for advanced characterisation of packaging and polymers!Polymeric materials play a fundamental role in our daily lives. They prevent our food from coming into contact with bacteria or being oxidised, and the increase the resistance of our glass. More than 330 million tons of polymers are produced annually.To ensure that all these important functions are possible, a simple polymer is not enough. Therefore, polymeric materials have become more complex and now contain many different chains of macromolecules combined into multi-layered systems.Using Raman microscopy, it is possible to obtain all kinds of information such as the chemical composition of the material, its morphological and mechanical properties, the distribution of specific compounds, the structure of the material, etc. In order to localise the presence of a particular compound in complex mixtures such as in the case of solid capsules containing active compounds, it is necessary to process its spectra. The main advantages of Raman microscopy are reliability, generally easy data interpretation, non-destructive sample analysis, the possibility of mapping the surface of the sample as well as in-depth analysis of the profile.The use of Raman microscopy allows you to obtain complete characterisation data for all polymeric films, from the characterisation of multi-layered materials to the analysis of defects or errors.Sample Control laboratory has accredited the method for material identification using Raman spectroscopy. For this purpose, the Thermo Scientific™ DXR3xi Raman microscope is used, which not only provides data on the chemical composition of materials but also delivers chemical and structural images for various polymer samples at a research level. Find out <a target="_self" rel="noopener noreferrer nofollow" href="https://www.sample-control.hr/en/services/raman-spectroscopy-and-microscopy">more about Raman microscopy here.</a>

<h3>Karakterizacija materijala</h3>Ramanova mikroskopija: rješenje za naprednu karakterizaciju pakiranja i polimera!Polimerni materijali igraju temeljnu ulogu u našem svakodnevnom životu. Oni sprječavaju da naša hrana dođe u kontakt s bakterijama ili da se oksidira, povećavaju otpornost naših stakala. Godišnje se proizvede više od 330 milijuna tona polimera.Kako bi se osiguralo da su sve ove važne funkcije moguće, jednostavan polimer nije dovoljan. Stoga su polimerni materijali postali sve složeniji i sada sadrže mnogo različitih lanaca makromolekula kombiniranih u višeslojne sustave.Korištenjem Ramanove mikroskopije moguće je dobiti razne informacije kao što su kemijski sastav materijala, njegova morfološka i mehanička svojstva, distribucija specifičnih spojeva, struktura materijala itd. Kako bi se lokalizirala prisutnost određenog spoja u složenim smjesama kao što je u slučaju čvrstih kapsula koje sadrže aktivne spojeve potrebno je obraditi njegove spektre. Glavne prednosti Ramanove mikroskopije su pouzdanost, općenito laka interpretacija podataka, nedestruktivna analiza uzorka, mogućnosti mapiranja površine uzorka kao i dubinska analiza profila.Korištenje Ramanove mikroskopije omogućuje dobivanje potpunih podataka karakterizacije za sve polimerne filmove, od karakterizacije višeslojnih materijala do analize nedostataka ili grešaka.Sample Control laboratorij akreditirao je metodu za identifikaciju materijala Ramanovom spektroskopijom. Za provođenje ove metode koristi se Thermo Scientific™ DXR3xi Ramanov mikroskop koji, osim podataka o kemijskom sastavu materijala, također daje kemijske i strukturne slike za razne uzorke polimera na istraživačkoj razini. Više o <a target="" rel="noopener noreferrer nofollow" href="https://www.sample-control.hr/usluge/raman-spektroskopija-i-mikroskopija">Ramanovoj mikroskopiji pronađite ovdje</a>.

<h3>Karakterizacija materijala</h3>Ramanova mikroskopija: rešitev za napredno karakterizacijo pakiranja in polimerjev!Polimerni materiali igrajo temeljno vlogo v našem vsakdanjem življenju. Preprečujejo, da naša hrana pride v stik z bakterijami ali da oksidira, ter zvečujejo pdpornost naših stekel. Letna proizvodnja je več kot 330 milijonov ton polimerjev.Da bi zagotovili, da bodo vse te pomembne funkcije možne, enostaven polimer ni dovolj. Zato so polimerni materiali postali vedno bolj sestavljeni in sedaj vsebujejo mnogo različnih verig makromolekul, kombiniranih v večplastne sisteme.Z uporabo Ramanove mikroskopije lahko dobimo razne informacije, kot so kemična sestava materiala, njegove morfološke in mehanične lastnosti, distribucija specifičnih spojin, struktura materiala itd. Da bi lokalizirali prisotnost določene spojine v sestavljenih zmeseh, kot je v primeru trdnih kapsul, ki vsebujejo aktivne spojine, je potrebno obdelati njene spektre. Glavne prednosti Ramanove mikroskopije so zanesljivost, splošno podatki so lahki za interpretacijo, nedestruktivna analiza vzorca, možnosti mapiranja površja vzorca kot tudi globinska analiza profila.Uporaba Ramanove mikroskopije omogoča pridobivanje popolnih podatkov karakterizacije za vse polimerne filme, od karakterizacije večplastnih materialov do analize pomanjkljivosti ali napak.Sample control laboratorij uporablja Thermo Scientific™ DXR3xi Ramanov mikroskop, ki &nbsp;daja kemične in strukturne slike za razne vzorce polimerjev na raziskovalni ravni. Več o&nbsp;<a target="" rel="noopener noreferrer nofollow" href="https://www.sample-control.hr/usluge/raman-spektroskopija-i-mikroskopija">Ramanovi mikroskopiji najdite tukaj.</a>

<h3>Preiskovanje embalaže</h3>Kakovost in varnost pakiranja raznih tipov izdelka je primarna skrb vseh potrošnikov, podjetij in inšpekcij v celotni oskrbovalni verigi.Sample Control opravlja preiskovanje kakovosti in varnosti v industriji embalaže in sorodnih industrijah kot je prehrambna industrija, pri proizvajalcih predmetov za splošno uporabo, trgovcih (trgovska blagovna znamka), v farmacevtski industriji (zdravila) in tn.Naša preiskovanja materialov, ki pridejo v stik s hrano, vključujejo testiranje globalne in specifične migracije embalaže, kuhinjskega pribora in strojev za predelavo hrane.Storitve preverjanja hrane opravljamo za industrijo med razvijanjem in raziskovanjem embalaže in izdelka, potrditvijo usklajenosti embalaže in izdelka ter redno testiramo proizvajalne procese. Industrija pakiranja, oziroma izdelovanja embalaže, se nenehno sooča s spremembami v predpisih, praktičnostih pakiranja, spremembami oblikovanja, inovacijami in podobno. Sample control spremlja novosti v področju pakiranja in izdelovanja embalaže ter zagotavljamo, da se naši klienti pridržujejo novih in/ali revidiranih predpisov, inovacij in drugih stvari, ki so pomembne&nbsp; v razvoju industrije pakiranja.Nekatere med storitvami, ki jih opravlja Sample control na področju embalaže:<ul><li>Preiskovanje materialov in predmetov, ki pridejo v neposreden stik s hrano (testiranje migracije),</li><li>IFS, BRC, FCCS22000, SQF zahteve za testiranje migracije embalaže za pakiranje,</li><li>Podpora pri izdelavi Izjave o usklajenosti (Declaration of Compliance- DoC),</li><li>Storitve preverjanja usklajenosti pakiranja v skladu z regulativami Evropske unije,</li><li>Materiali za ekstrahiranje in izpiranje za farmacevtsko pakiranje,</li><li>Karakterizacija materialov,</li><li>Podpora pri izdelavi materiala za pakiranje,</li><li>Usklajenost z REACH in SVHC.</li></ul>

<h3>Ispitivanje ambalaže</h3>Kvaliteta i sigurnost pakiranja raznih tipova proizvoda, primarna je briga svih potrošača, poduzeća i inspekcija u cijelom lancu opskrbe.Sample Control provodi ispitivanje kvalitete i sigurnosti u industriji ambalaže i srodnim industrijama poput prehrambenoj industriji, kod proizvođača predmeta opće uporabe, trgovaca (trgovačka robna marka), u farmaceutskoj industriji (lijekovi) itd.Naša ispitivanja materijala koji dolaze u kontakt s hranom uključuju testiranje globalne i specifične migracije ambalaže, kuhinjskog pribora i strojeva za preradu hrane.Usluge ispitivanja hrane provodimo za industriju prilikom razvoja i istraživanja ambalaže i proizvoda, potvrde usklađenosti ambalaže i proizvoda te redovnom testiranju proizvodnih procesa. Industrija pakiranja, odnosno proizvodnja ambalaže, stalno se suočava s promjenama u propisima, praktičnostima pakiranja, izmjeni dizajna, inovacijama i sl.. Sample control prati novosti u području pakiranja i proizvodnji ambalaže te osiguravamo da se naši klijenti pridržavaju novim i/ili revidiranim propisima, inovacijama i drugim važnim razvojem industrije pakiranja.Neke od usluga koje provodi Sample control u području ambalaže:<ol><li>Ispitivanje materijala i predmeta koji dolaze u neposredan dodir s hranom (testiranje migracije),</li><li>IFS, BRC, FCCS22000, SQF zahtjevi za testiranje migracije ambalaže za pakiranje,</li><li>Podrška kod izrade Izjave o sukladnosti (Declaration of Compliance- DoC),</li><li>Usluge provjere sukladnosti pakiranja prema regulativama Europske unije,</li><li>Materijali za ekstrahiranje i ispiranje za farmaceutsko pakiranje,</li><li>Karakterizacija materijala,</li><li>Podrška u proizvodnji materijala za pakiranje,</li><li>Usklađenost s REACH i SVHC.</li></ol>

<h3>Cosmetic products safety assessment</h3><h4>Preparation of Product Information File, Safety Assessment and laboratory testing of cosmetic product</h4>When placing products on the EU market, the preparation of a Product Information File (PIF) is necessary, and an integral part of the documentation is the Safety Assessment Report. Our regulatory department can compile complete documentation in accordance with Regulation (EU) 1223/2009 on cosmetic products, and it can prepare documentation for any market in the world to which the product export is planned.Furthermore, before placing the product on the market, extensive tests need to be performed, and test results are an integral part of the Product Information File. Sample Control is accredited and authorised to test cosmetic products, in order to make all analyses necessary when placing products on the EU market, as well as in other markets of the world.Within the laboratory it is possible to perform over 2000 different analyses, depending on the needs (product type, composition, target market...). Generally speaking, the basic analyses that need to be done for the cosmetic product are listed below.<h4>Analysis of the wholesomeness of the product</h4>When placing the product on the market, an analysis of the wholesomeness of the product is necessary, which most often implies testing: organoleptic characteristics of the product, microbiological quality of the product, pH value and peroxide number, the proportion of heavy metals, potential impurities that may be present in the product from raw materials and/or packaging (the test parameters depend on the type of raw materials and the packaging in which the product is placed).<h4>Preservative Efficacy Testing (Challenge tests)</h4>For formulations with a high proportion of the aqueous phase, that is, for formulations that are suitable for the development of microorganisms, it is necessary to test the efficacy of preservation, which can determine whether the product is suitable for or resistant to the development of microorganisms. In addition, it can be determined to what extent the preservative used is effective in combating the growth of individual microorganisms. This analysis is of paramount importance when deciding on the type of packaging for a cosmetic product.<h4>Stability testing</h4>Before placing a cosmetic product on the market, extensive tests of the stability of the cosmetic product should be performed to determine whether the product will be stable within the intended shelf-life under normal conditions of use, storage and transportation.Among other performed tests (the influence of temperature freezing, vibrations in transport, compatibility with packaging, UV radiation, etc.), a real-time test is carried out to determine the stability of the product. Thus, for example, if the foreseen shelf-life is one year, the product is monitored for a period of one year on the parameters that are deemed relevant, and in view of the characteristics of the product.When the product is to be marketed in the shortest possible period of time, it is possible to foresee the shelf-life of the product with accelerated stability tests, whereby the product is exposed to extreme conditions, depending on the geographical area where the product is planned to be sold, as well as on the characteristics of the product itself (e.g. for an estimated shelf-life of 2 years, the test is performed over a period of 3 months).<h4>Clinical trials of products and proof of cosmetic claims</h4>Depending on the method of communication of the brand, that is, the requirements of the client, it is possible to perform various tests to prove claims about the effectiveness that are communicated for the product. For example, if it is communicated that the product is allergen-free and has been dermatologically tested, it is necessary to carry out an analysis on all known allergens that can be expected in the product and dermatological tolerability tests. Furthermore, if it is communicated that the product has a sun protection factor, then it is necessary to prove it by appropriate testing. It is also possible to perform the following tests to prove effectiveness: measuring biochemical parameters such as strength and elasticity, hydration levels, cellulite intensity, wrinkle intensity, luminosity and intensity of skin pigmentation before and after use of the product, and testing user satisfaction.<h4>Responsible person for the cosmetic product</h4>Only cosmetic products for which a legal or natural person in the European Union has been designated as a 'responsible person' may be placed on the market.In the event that the client does not know the EU legislation from which certain obligations and responsibilities arise, or the client (legal or natural person) is not based in the EU or for some other reason does not want to be the responsible person for cosmetic products, a partner of Sample Control may assume the role of responsible person and all obligations defined in Regulation (EU) 1223/2009 on cosmetic products.The responsible person must:<ul><li>check the safety assessment and safety report of the cosmetic product;</li><li>keep documentation with product data (10 years);</li><li>electronically submit a cosmetic product notification to the European Commission (CPNP application);</li><li>electronically submit a cosmetic product notification for products containing substances in the form of nanomaterials to the European Commission (CPNP application);</li><li>ensure the declaration of cosmetic products in accordance with legal regulations;</li><li>collect data on the serious undesirable effects of the cosmetic product (resulting from the use of the cosmetic product).</li></ul>

<h3>Procjena sigurnosti kozmetičkih proizvoda</h3><h4>Izrada dokumentacije s podacima o proizvodu, procjena sigurnosti te laboratorijska ispitivanja kozmetičkog proizvoda</h4>Pri stavljanju proizvoda na tržište EU, neophodna je izrada dokumentacije s podacima o proizvodu (PIF), a sastavni dio dokumentacije je Izvješće o procijenjenoj sigurnosti. Naš regulatorni odjel u mogućnosti je složiti kompletnu dokumentaciju u skladu s Uredbom (EU) 1223/2009 o kozmetičkim proizvodima, te je u mogućnosti načiniti dokumentaciju za bilo koje tržište u svijetu, na koje se proizvod planira izvoziti.Nadalje, prije stavljanja proizvoda na tržište, potrebno je provesti opsežna ispitivanja, a rezultati ispitivanja sastavni su dio dokumentacije s podacima o proizvodu. Sample Control akreditiran je i ovlašten za ispitivanje kozmetičkih proizvoda, kako bi se načinile sve analize neophodne pri stavljanju proizvoda na tržište EU, ali i na ostala tržišta svijeta.Unutar laboratorija moguće je načiniti preko 2000 različitih analiza, ovisno o potrebama (vrsti proizvoda, sastavu, ciljanom tržištu…). Generalno govoreći, osnovne analize koje je potrebno načiniti za kozmetički proizvod navedene su u nastavku.<h4>Analiza zdravstvene ispravnosti proizvoda</h4>Prilikom stavljanja proizvoda na tržište, neophodna je analiza zdravstvene ispravnosti proizvoda, što najčešće podrazumijeva ispitivanje: organoleptičkih karakteristika proizvoda, mikrobiološke kakvoće proizvoda, pH vrijednosti te peroksidnog broja, udjela teških metala, potencijalnih nečistoća koje mogu biti prisutne u proizvodu iz sirovina i/ili ambalaže (parametri ispitivanja ovise o vrsti sirovina i ambalaži u kojoj se nalazi proizvod).<h4>Ispitivanje učinkovitosti konzerviranja (Challenge testovi)</h4>Za formulacije s visokim udjelom vodene faze, odnosno za formulacije koje su pogodne za razvoj mikroorganizama, neophodno je provesti testove učinkovitosti konzerviranja, kojima se može utvrditi je li proizvod pogodan ili otporan za razvoj mikroorganizama. Osim toga, može se utvrditi u kojoj je mjeri korišteni konzervans učinkovit u suzbijanju rasta pojedinih mikroorganizama. Ova analiza od iznimne je važnosti kada se odlučuje o vrsti ambalaže za kozmetički proizvod.<h4>Provođenje testova stabilnosti</h4>Prije stavljanja kozmetičkog proizvoda na tržište, potrebno je provesti opsežna ispitivanja stabilnosti kozmetičkog proizvoda kako bi se utvrdilo hoće li proizvod biti stabilan u predviđenom roku trajanja pri normalnim uvjetima korištenja, skladištenja i transporta.Između ostalih testova koji se provode (utjecaj temperaturnog smrzavanja, vibracija pri transportu, kompatibilnosti s ambalažom, UV zračenja, itd.), provodi se i test u realnom vremenu kako bi se utvrdila stabilnost proizvoda. Tako npr. ako je predviđeni rok trajanja godinu dana, proizvod se prati u vremenskom razdoblju od godine dana na parametre koji se procijene relevantnim, s obzirom na karakteristike proizvoda.Kada se s proizvodom želi izaći na tržište u što kraćem vremenskom roku, moguće je predvidjeti rok valjanosti proizvoda akceleriranim testovima stabilnosti pri čemu se proizvod izlaže ekstremnim uvjetima, ovisno o geografskom području gdje se proizvod planira prodavati, kao i o samim karakteristikama proizvoda (npr. za predviđeni rok trajanja od 2 godine, ispitivanje se provodi 3 mjeseca).<h4>Klinička ispitivanja proizvoda i dokazivanje kozmetičkih tvrdnji</h4>Ovisno o načinu komunikacije brenda, odnosno zahtjevima klijenta, moguće je provoditi različite testove kako bi se dokazale tvrdnje o učinkovitosti koje se komuniciraju za proizvod. Primjerice, ako se komunicira da je proizvod bez alergena i da je dermatološki testiran, potrebno je provesti analizu na sve poznate alergene koji se mogu očekivati u proizvodu te dermatološke testove podnošljivosti. Nadalje, ako se komunicira da proizvod ima faktor zaštite od sunca, tada je to odgovarajućim testiranjima potrebno i dokazati. Moguće je i provođenje sljedećih testova za dokazivanje učinkovitosti: mjerenje biokemijskih parametara kao čvrstoće i elastičnosti, razine hidratacije, intenziteta celulita, intenziteta bora, luminoznosti te intenziteta pigmentacije kože prije i poslije korištenja proizvoda, te ispitivanje zadovoljstva korisnika.<h4>Odgovorna osoba za kozmetički proizvod</h4>Na tržište se smiju stavljati samo oni kozmetički proizvodi za koje je pravna ili fizička osoba u Europskoj uniji imenovana „odgovornom osobom”.U slučaju da klijent ne poznaje zakonsku regulativu EU iz koje proizlaze određene obveze i odgovornosti, ili klijent (pravna ili fizička osoba) nema sjedište u EU ili pak zbog nekog drugog razloga ne želi biti odgovorna osoba za kozmetičke proizvode, partner tvrtke Sample Control može preuzeti ulogu odgovorne osobe i sve obveze definirane Uredbom (EU) 1223/2009 o kozmetičkim proizvodima.Odgovorna osoba dužna je:<ul><li>provjeriti procjenu sigurnosti i izvješće o sigurnosti kozmetičkog proizvoda;</li><li>voditi dokumentaciju s podacima o proizvodu (10 godina);</li><li>izvršiti elektroničkim putem notifikaciju kozmetičkih proizvoda Europskoj komisiji (CPNP prijava);</li><li>izvršiti elektroničkim putem notifikaciju kozmetičkih proizvoda koji sadrže tvari u obliku nanomaterijala Europskoj komisiji (CPNP prijava);</li><li>osigurati deklariranje kozmetičkih proizvoda u skladu sa zakonskim propisima;</li><li>prikupljati podatke o ozbiljnim neželjenim učincima kozmetičkog proizvoda (koji su posljedica uporabe kozmetičkog proizvoda).</li></ul>

<h3>Ocenitev varnosti kozmetičnih izdelkov</h3><h4>Izdelava dokumentacije s podatki o izdelku, ocenitev varnosti ter laboratorijska preiskovanja kozmetičnega izdelka</h4>Pri uvajanju izdelka na trg EU, je nujna izdelava dokumentacije s podatkih o izdelku (PIF),&nbsp; sestavni del dokumentacije pa je Poročilo o ocenjeni varnosti. Naš regulatorni oddelek lahko pripravi kompletno dokumentaciju v skladu z Uredbo (EU) 1223/2009 o kozmetičnih izdelkih, ter lahko naredi &nbsp;kompletno dokumentacijo za kateri koli trg v svetu, kamor se načrtuje izvoz izdelka.Nadalje, pred uvajanjem izdelka na trg je potrebno opraviti obsežna preiskovanja, rezultati preiskovanja pa so sestavni del dokumentacije s podatki o izdelku. Sample Control je akreditiran in pooblaščen za preiskovanje kozmetičnih izdelkov, da bi se nanaredile vse analize nujne pri pošiljanju izdelka na trg EU, pa tudi na ostale trge po svetu.Znotraj laboratorija je možno narediti več kot 2000 različnih analiz, odvisno od potreb (vrsta izdelka, sestava, ciljani trg…). Če govorimo generalno, osnovne analize ki jih je potrebno narediti za kozmetični izdelek so navedene v nadaljevanju.<h4>Analiza zdravstvene neoporečnosti izdelka</h4>Pri pošiljanju izdelka na trg, nujna je analiza zdravstvene neoporečnosti izdelka, to pa najbolj pogosto pomeni preiskovanje: organoleptičnih lastnosti izdelka, mikrobiološke kakovosti izdelka, pH vrednosti ter peroksidne številke, deleža težkih kovin, potencialnih nečistoč ki so lahko prisotne v izdelku iz surovin in/ali embalaže (parametri preverjanja so odvisni od vrste surovin in embalaže, v kateri se nahaja izdelek).<h4>Preiskovanje učinkovitosti konzerviranja (Challenge testi)</h4>Za formulacije z visokim deležom vodne faze, oziroma za formulacije, ki so ustrezne za razvoj mikroorganizmov, nujno je opraviti teste učinkovitosti konzerviranja, s katerimi lahko ugotovimo ali je izdelek primeren ali odporen za razvoj mikroorganizmov. Razen tega lahko ugotovimo v kolikšni meri je uporabljeni konzervans učinkovit v zatiranju rasti posameznih mikroorganizmov. Ta analiza je izjemno pomembna ko se odloča o vrsti embalaže za kozmetični izdelek.<h4>Opravljanje testov stabilnosti</h4>Pred pošiljanjem kozmetičnega izdelka na trg, potrebno je opraviti obsežna preiskovanja stabilnosti kozmetičnega izdelka, da bi ugotovili ali bo izdelek bil stabilen v predvidenem roku trajanja pri normalnih pogojih uporabe, skladiščenja in transporta.Med ostalimi testi ki jih opravljamo (vpliv temperaturnega zamrzovanja, vibracija pri transportu, kompatibilnosti z embalažo, UV sevanja, itd.), opravljamo tudi testiranje v realnem času da ugotovili stabilnost izdelka. Tako npr. vkolikor je predvideni rok trajanja eno leto, izdelek spremljamo v časovnem obdobju enega leta na parametre, ki jih ocenimo kot relevantne, glede na lastnosti izdelka.Ko izdelek nameravamo poslati na trg v čim krajšem časovnem roku, možno je napovedovanje roka veljavnosti izdelka z akceleriranimi testi stabilnosti, pri čemer se izdelek izpostavlja ekstremnim pogojem, odvisno od geografskega področja kjer se načrtuje prodaja izdelka, kot tudi same lastnosti izdelka (npr. za predvideni rok trajanja dveh let, preiskovanje se opravlja 3 meseca).<h4>Klinična preverjanja izdelka in dokazovanje kozmetičnih trditev</h4>Odvisno od načina komunikacije brenda, oziroma zahtev klienta, možno je opravljati različne teste da bi dokazali trditve o učinkovitosti, ki jih komuniciramo za izdelek. Na primer, če se komunicira da je izdelek brez alergenov in da je dermatološko testiran, potrebno je opraviti analizo na vse znane alergene, ki jih lahko pričakujemo v izdeleku ter dermatološke teste znosnosti. Nadalje, če komuniciramo, &nbsp;da izdelek ima faktor zaščite od sonca, potem je to z ustreznimi testiranji potrebno tudi dokazati. Možno je tudi opravljanje naslednjih testov za dokazovanje učinkovitosti: merjenja biokemičnih parametrov kot sta trdnost in elastičnost, ravni hidratacije, intenzitete celulita, intenzitete gub, luminoznosti ter intenzitete pigmentacije kože pred in po uporabi izdelka, ter preiskovanje zadovoljstva uporabnika.<h4>Oseba odgovorna za kozmetički izdelek</h4>Na trg lahko pošljemo &nbsp;samo tiste kozmetične izdelke, za katere je pravna ali fizična oseba v Evropski uniji imenovana za „odgovorno osebo”.V primeru da klient ne pozna zakonsko regulativo EU iz katere izhajajo določene obveze in odgovornosti, ali klijent (pravna ali fizična oseba) nima sedeža v EU ali pa zaradi nekega drugega razloga ne želi biti odgovorna oseba za kozmetične izdeleke, partner podjetja Sample Control lahko prevzame vlogo odgovorne osebe in vse obveze definirane z Uredbo (EU) 1223/2009 o kozmetičnih izdelkih.Odgovorna oseba je dolžna:<ul><li>preveriti oceno varnosti in poročilo o varnosti kozmetičnega izdelka;</li><li>voditi dokumentacijo s podatki o izdelku (10 let);</li><li>po elektronski poti opraviti notifikacijo kozmetičnih izdelkov Evropski komisiji (CPNP prijava);</li><li>po elektronski poti opraviti notifikacijo kozmetičnih izdelkov, ki vsebujejo snovi v obliki nanomaterialov, Evropski komisiji (CPNP prijava);</li><li>zagotoviti deklariranje kozmetičnih izdelkov v skladu z zakonskimi predpisi;</li><li>zbirati podatke o resnih nezaželenih učinkih kozmetičnega izdelka (ki so posledica uporabe kozmetičnega izdelka).</li></ul>

Pharmaceutical products testing

Pharmaceutical products testing

Cosmetic products safety assessment

Packaging testing

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