Biomedical subjects

R Franz

Publications and source records attributed to R Franz.

At least 19 recordsLinked to original sources

PubMed2005

Evaluation of migration models that might be used in support of regulations for food-contact plastics.

Materials and articles intended to come into contact with food must be shown to be safe because they might interact with food during processing, storage and the transportation of foodstuffs. Framework Directive 89/109/EEC and its related specific Directives provide this safety basis for the protection of the consumer against inadmissible chemical contamination from food-contact materials. Recently, the European Commission charged an international group of experts to demonstrate that migration modelling can be regarded as a valid and reliable tool to calculate 'reasonable worst-case' migration rates from the most important food-contact plastics into the European Union official food simulants. The paper summarizes the main steps followed to build up and validate a migration estimation model that can be used, for a series of plastic food-contact materials and migrants, for regulatory purposes. Analytical solutions of the diffusion equation in conjunction with an 'upper limit' equation for the migrant diffusion coefficient, D(P), and the use of 'worst case' partitioning coefficients K(P,F) were used in the migration model. The results obtained were then validated, at a confidence level of 95%, by comparison with the available experimental evidence. The successful accomplishment of the goals of this project is reflected by the fact that in Directive 2002/72/EC, the European Commission included the mathematical modelling as an alternative tool to determine migration rates for compliance purposes.

Diffusion↗

PubMed2005

Feasibility study for the development of certified reference materials for specific migration testing. Part 2: estimation of diffusion parameters and comparison of experimental and predicted data.

This paper describes the second part of a project whose main objective was to develop the know-how to produce certified reference materials (CRMs) for specific migration testing. Certification parameters discussed are the diffusion coefficient, D(P), the respective polymer-specific coefficient, A(P), of the migrant polymer combinations and the partitioning coefficient, K(P,F), describing the partitioning of the migrant between the polymer and a food simulant. The parameters were determined for 16 preliminary candidate CRMs. Each parameter was determined by one laboratory. The six materials most suitable as reference materials were selected and the parameters then determined by four laboratories. The coefficients resulting from this small-scale interlaboratory comparison study can be regarded as the most reliable values available to date. These coefficients were applied for a comparison of experimental and predicted migration data. The experimental migration data arose from the same project and were determined by one laboratory for the first 16 materials and subsequently by four laboratories for the six materials selected in the second phase. Overall, experimental and predicted migration data fit together quite well. Roughly half of the predicted data were within +/-10%; almost all predicted data were within +/-40% compared with the experimental data.

Benzophenones↗

PubMed2005

Migration modelling from food-contact plastics into foodstuffs as a new tool for consumer exposure estimation.

One important aspect within the European Union's public healthcare is the exposure of consumers to undesirable chemicals in the diet. Food-contact materials (FCM) are one potential contamination source and therefore of particular interest for food exposure assessment. On the other hand, scientific investigations concerning the migration potential and behaviour of food-packaging materials have demonstrated that diffusion in and migration from FCM are foreseeable physical and, in principle, mathematically describable processes. Because of this situation and the current state-of-the-art in migration science, a research project was initiated within the 5th Framework Programme of the European Commission. This project, with the acronym 'FOODMIGROSURE' (European Union Contract No. 'QLK1-CT2002-2390') started on 1 March 2003, was due to last 3 years and had the participation of nine European project partners (see the project website: www.foodmigrosure.org). The aim of the project was to extend currently existing migration models (which have been demonstrated to be applicable for less complex matrices such as food simulants) to foodstuffs themselves. In this way, the project aims to provide a novel and economic tool for estimation of consumer exposure to chemicals migrating from food-contact plastic materials under any actual contact conditions. In addition, the project aims to increase knowledge of the mechanisms of diffusion of organic compounds in foodstuffs and provide data on the partitioning effects between FCM and foods. Today the latter aspect is increasingly regarded as a fundamental influence parameter for migration into foods. Based on the project achievements, a much better scientific basis is available to allow scientifically appropriate amendments of European Union Directive 85/572/EEC as well as to support further developments with the so-called Plastics Directive 2002/72/EC. The paper introduces the project and presents an overview of the project work progress.

Attitude to Health↗

PubMed2004

European survey on post-consumer poly(ethylene terephthalate) (PET) materials to determine contamination levels and maximum consumer exposure from food packages made from recycled PET.

Typical contamination and the frequency of misuse of poly(ethylene terephthalate) (PET) bottles are crucial parameters in the risk assessment of post-consumer recycled (PCR) PET intended for bottle-to-bottle recycling for direct food contact applications. Owing to the fact that misuse of PET bottles is a rare event, sustainable knowledge about the average concentration of hazardous compounds in PCR PET is accessible only by the screening of large numbers of samples. In order to establish average levels of contaminants in PET source materials for recycling, PET flakes from commercial washing plants (689 samples), reprocessed pellets (38) and super-clean pellets (217) were collected from 12 European countries between 1997 and 2001. Analysis of these materials by headspace gas chromatography revealed average and maximum levels in PCR PET of 18.6 and 86.0 mg kg-1 for acetaldehyde and 2.9 and 20 mg kg-1 for limonene, respectively. Acetaldehyde and limonene are typical compounds derived from PET itself and from prior PET bottle contents (flavouring components), respectively. Maximum levels in PCR PET of real contaminants such as misuse chemicals like solvents ranged from 1.4 to 2.7 mg kg-1, and statistically were shown to result from 0.03 to 0.04% of recollected PET bottles that had been misused. Based on a principal component analysis of the experimental data, the impact of the recollecting system and the European Union Member State where the post-consumer PET bottles had been collected on the nature and extent of adventitious contaminants was not significant. Under consideration of the cleaning efficiency of super-clean processes as well as migration from the bottle wall into food, it can be concluded that the consumer will be exposed at maximum to levels < 50 ng total misuse chemicals day-1. Therefore, PCR PET materials and articles produced by modern superclean technologies can be considered to be safe in direct food applications in the same way as virgin food-grade PET.

Acetaldehyde↗

PubMed2004

Feasibility study for the development of certified reference materials for specific migration testing. Part 1: initial migrant concentration and specific migration.

The paper describes a project with the main objective of developing the know how to produce certified reference materials (CRMs) for specific migration testing. Certification parameters discussed are the initial concentration of the migrant in the polymer (C(P),0) and the specific migration into a food simulant under certain temperature/time conditions. Sixteen preliminary candidate CRMs were defined and produced. The most important polymers (low- and high-density polyethylene (LDPE and HDPE), polypropylene (PP), polystyrene (PS), polyethylene terephtalate (PET), plasticized polyvinyl chloride (PVC), rigid PVC, polyamides (PA)) and additives as well as monomers representing different physicochemical properties as target substances for migration were chosen. The stability and homogeneity of the migrants in the materials were tested and methods for the determination of the certification parameters were developed and validated. > From the 16 materials produced, the six most suitable CRM candidates (LDPE//Irganox 1076/Irgafos 168, LDPE//1,4-diphenyl-1,3-butadiene (DPBD), HDPE//Chimassorb 81/Uvitex OB, PP homo//Irganox 1076/Irgafos 168, HIPS, 1% mineral oil//styrene, PA 6//caprolactam) were selected. The feasibility of CRM production for the six candidate materials was demonstrated and a trial certification exercise was performed with participation of all four partner laboratories. All six materials showed suitable properties for future production as certified reference materials.

Consumer Product Safety↗

PubMed2003

Development and validation of analytical methods for monomeric and oligomeric migrants from nylon 12 packaging materials.

Analytical methods for the determination of laurolactam--the monomer of nylon 12--as well as the cyclic dimer and trimer were established. High performance liquid chromatography using ultraviolet (HPLC-UV) and mass spectrometric detection (HPLC-MS) were both found suitable to identify and quantify monomer, cyclic dimer and trimer well below the specific migration limit (SML) of laurolactam, being 5 mg/kg of food (simulant). Gas chromatography with flame ionisation detection (GC-FID) showed to be an appropriate method for the detection of only laurolactam in aqueous and fatty food simulants. Food simulants could be analysed directly by all three methods, or after a change of solvents. For olive oil, a method for sample clean-up by size-exclusion chromatography (SEC) was established.

Chromatography, Gas↗

PubMed2003

Alternative fatty food simulants and diffusion kinetics of nylon 12 food packaging.

The migration of laurolactam and cyclic di- and trimer of nylon 12 was assessed using three different films and five food simulants (olive oil, isooctane, 95% ethanol, 50% ethanol, water). Substitute test conditions for migration into olive oil according to European Union Directive EC/97/48 were applied using 95% ethanol and isooctane. Results showed that 95% ethanol overestimated while isooctane underestimated the respective migration into olive oil. Water was the best olive oil substitute, as migration of laurolactam into water and olive oil using the same temperature gave similar results. Additionally, diffusion kinetics of laurolactam were investigated by migration kinetic studies using isooctane and olive oil. Diffusion coefficients determined with isooctane were significantly higher than those found using olive oil. It was proved that isooctane had an interaction and olive oil was inert to the polymer. The diffusion conductance parameter, A(p), for nylon 12 determined using olive oil ranged from 0.3 to 0.6.

Dietary Fats↗

PubMed2002

Programme on the recyclability of food-packaging materials with respect to food safety considerations: polyethylene terephthalate (PET), paper and board, and plastics covered by functional barriers.

Stimulated by new ecology-driven European and national regulations, news routes of recycling waste appear on the market. Since food packages represent a large percentage of the plastics consumption and since they have a short lifetime, an important approach consists in making new packages from post-consumer used packages. On the other hand, food-packaging regulations in Europe require that packaging materials must be safe. Therefore, potential mass transfer (migration) of harmful recycling-related substances to the food must be excluded and test methods to ensure the safety-in-use of recycled materials for food packaging are needled. As a consequence of this situation, a European research project FAIR-CT98-4318, with the acronym 'Recyclability', was initiated. The project consists of three sections each focusing on a different class of recycled materials: polyethylene terephthalate (PET), paper and board, and plastics covered by functional barriers. The project consortium consists of 28 project members from 11 EU countries. In addition, the project is during its lifetime in discussion with the US Food and Drug Administrations (FDA) to consider also US FDA regulatory viewpoints and to aim, as a consequence, to harmonizable conclusions and recommendations. The paper introduces the project and presents an overview of the project work progress.

Consumer Product Safety↗

PubMed2002

Recycled poly(ethylene terephthalate) for direct food contact applications: challenge test of an inline recycling process.

Of all the plastics used for packaging, due to its low diffusivity and chemical inertness, poly(ethylene terephthalate) (PET) is one of the favoured candidate plastics for closed-loop recycling for new packaging applications. In the work reported here, a PET-recycling process was investigated with respect to its cleaning efficiency and compliance of the PET recyclate with food law. The key technology of the investigated PET-recycling process to remove contaminants consists of a predecontamination-extruder combination. At the end of the recycling process, there is either a pelletizing system or downstream equipment to produce preforms or flat sheets. Therefore, the process has two process options, an inline production of PET preforms and a batch option producing PET pellets. In the case of possible misuse of PET bottles by the consumer, the inline process produces higher concentrations in the bottle wall of the recyclate containing preforms. Owing to the dilution of the PET output material by large amounts of uncontaminated PET, the batch option is the less critical process in terms of consumer protection. Regarding an appropriate testing procedure for the evaluation of a bottle-to-bottle recycling process, both process options have their own specific requirements with respect to the design of a challenge test. A novel challenge test approach to the inline mode of a recycling process is presented here.

Conservation of Natural Resources↗

PubMed2002

[Miniature assistance module for robot-assisted heart surgery].

During the robotic enhanced minimally invasive cardiac surgery the approach to and the space for handling instruments in the operating field are usually reduced, compared to the conventional surgery. Additional well knewn problems are the restricted capability available for accessories into and out of the closed chest and the limited assistance during the cardiac procedure. This paper is presenting two solutions of Miniature Modules for supporting the surgeon inside the closed chest. A self-sufficient Cargo Module is developed as a transportation and depot device. It provides an "inside equipment store" for the surgeon. With the Assist Module the surgical equipment, tissue and vessels can be positioned on a desired place in the operating field. This module provides the surgeon an "assistant" inside the closed chest.

Coronary Artery Bypass↗

PubMed2001