Present situation of food irradiation in South America and the regulatory perspectives for Brazil

This presentation shows the main aspects of the Brazilian and Argentinean regulations on food irradiation, the current situation in each country and the perspectives for legislation in Brazil     

Practical implications of developments in legislation on food irradiation in the European Union

Food irradiation legislation is very different in most member-states of the EU. For many years there was the desire by many interested groups to harmonise this legislation.

As the member-states had a different view on irradiated foods, often based on their existing regulation, it took many years and revised drafts to come to a harmonised regulation acceptable to the majority.

The background on the development of this EU-legislation and the final draft is discussed.

Some information is also given on the possible influence of WTO (SPS- and TBT-agreements) and Codex Alimentarius on this EU-legislation.     

Nanocarriers as Active Ingredients Enhancers in the Cosmetic Industry—The European and North America Regulation Challenges

“Flawless skin is the most universally desired human feature” is an iconic statement by Desmond Morris. Skin indicates one´s health and is so important that it affects a person’s emotional and psychological behavior, these facts having propelled the development of the cosmetics industry. It is estimated that in 2023, this industry will achieve more than 800 billion dollars. This boost is due to the development of new cosmetic formulations based on nanotechnology. Nanocarriers have been able to solve problems related to active ingredients regarding their solubility, poor stability, and release. Even though nanocarriers have evident benefits, they also present some problems related to the high cost, low shelf life, and toxicity. Regulation and legislation are two controversial topics regarding the use of nanotechnology in the field of cosmetics. In this area, the U.S. FDA has taken the lead and recommended several biosafety studies and post-market safety evaluations. The lack of a global definition that identifies nanomaterials as a cosmetic ingredient is a hindrance to the development of global legislation. In the EU, the legislation regarding the biosafety of nanomaterials in cosmetics is stricter. “The cost is not the only important issue, safety and the application of alternative testing methods for toxicity are of crucial importance as well”.     

How to remove barriers to medicines trade in emerging economies: the role of medicines regulatory authority in Serbia

The primary role of European pharmaceutical legislation is to safeguard public health while encouraging the development of the pharmaceutical industry, creation of single market for pharmaceuticals with removed barriers to medicines trade. This article presents some important characteristics of pharmaceutical legislation in Serbia, the potential EU candidate country, and the latest improvements of existing national pharmaceutical legislation. Additional explanation is given for the Serbian negotiations with World Trade Organization and measures taken for the harmonisation with Agreements on Technical barriers to Trade (TBT), especially with Agreement on Trade-Related Intellectual Property Rights. Current status of Serbian pharmaceutical market is described, with the highlight of domestic manufacturers??capacity to comply with European Union requirements. National medicines agency is described in the framework of European medicines quality infrastructure. The role and responsibility of national medicines authority to assure access to quality, safe and efficacious medicines on Serbian market is described. The special emphasis is given to agency’s role in harmonisation process, in terms of removing unnecessary barriers to medicines trade in Serbia.     

Determination of polycyclic aromatic hydrocarbons in drinking and surface waters from Galicia (N.W. Spain) by constant-wavelength synchronous spectrofluorimetry

We describe a fast, new method for determination of the joint concentration of the six polycyclic aromatic hydrocarbons (PAHs), designated by current legislation as indicators of the quality of drinking waters and surface waters intended for the abstraction of drinking waters. The limit of detection of the new method was 6 ng l(-1), its limit of quantification 20 ng l(-1), its precision (CV%) 2.48 and its recovery 94.05%. Its speed allowed rapid PAH screening of 404 samples of surface and drinking water from Galicia (N.W. Spain).     

European Quality Promotion Policy for improving the competitiveness of european industry

 The Community legislative policy for the free movement of industrial goods has evolved from an approach based purely on legislation and public intervention towards a more voluntary approach based on a homogeneous system combining regulatory and voluntary assessment of conformity with standards and/or customer specifications. This has led to an increased participation of the economic operators in the legislative process and a better reallocation of responsibilities between the public and private sectors. The European Union has now to go beyond legislation, standardisation and certification, in order to contribute further to increasing the competitiveness of European industry. At present, Community activities concentrate on reinforcing the Single Market and the necessary quality infrastructures, and in the proper implementation of existing legislation, in particular the application and interpretation of the CE marking requirements. These measures, however, do not solve all the problems relating either to conformity with regulatory requirements or to enhancing competitiveness. The European Quality Promotion Policy has the ambition of constituting above all an awareness policy to give political visibility and support to a European-wide range of quality instruments and actions. Simultaneously, it should be seen as a logical step on the road from conformity with safety regulations (in particular CE marking directives) to competitiveness and business excellence through quality management strategies.     

Comparison of ED-XRF and LA-ICP-MS with the European reference method of acid digestion-ICP-MS for the measurement of metals in ambient particulate matter

A comparison study of the measurement of metals in ambient particulate matter collected on air filters, using energy-dispersive X-ray fluorescence (ED-XRF), laser ablation inductively coupled plasma-mass spectrometry (LA-ICP-MS) and wet chemical digestion followed by ICP-MS analysis according to the European ‘reference method’ EN14902, is presented. Whilst it is shown that the methods have a low systematic bias with respect to each other, overall they do show a high random variability, and when considered individually using regression methods, some analytes have shown bias with respect to the EN14902 method. The low systematic bias observed is not unexpected since both the ED-XRF and LA-ICP-MS methods have been calibrated using results from the EN14902 technique. The uncertainty of each analysis has been estimated and compared with the data quality objectives for uncertainty specified in the relevant European air quality legislation. This has tentatively shown that approximately 75% of the analyses using ED-XRF and LA-ICP-MS meet the requirements of the legislation. However, improvements in repeatability and calibration methods for both ED-XRF and LA-ICP-MS would be needed before these methods were truly applicable for routine use in air quality measurements of this type.     

Pesticides in water and the performance of the liquid-phase microextraction based techniques. A review

The control of pesticides in surface, drinking and groundwater is nowadays a real necessity. In the European Community, their concentration must comply with the established parametric and environmental quality standards (EQSs). Regarding the new legislation, this article updates the information concerning the monitoring of pesticides and the technical specifications for their measurement in water samples where ultra-sensitive analytical methods are required. For some compounds, like pesticides, there is still a need to improve the performance of the existing methods. High sensitive techniques like gas chromatography tandem mass spectrometry (GC–MS/MS) and liquid chromatography coupled with mass spectrometry (LC–MS) have been developed. However, for most of the substances present at trace and ultra-trace levels the extraction and preconcentration steps are so far essential for their detection. Advances at a micro scale have been made and different types of microextractions are being developed. Liquid-phase microextraction (LPME) is an example. The study of this technique has increased in the last years and some innovations have been recently reported for pesticides water analysis. This article reviews the new developed LPME-based techniques and compares its performance with the analytical specifications established for pesticides water monitoring. The results show that LPME-based techniques can be a promising tool to improve the nowadays performance of methods used in pesticides water control.     

A rapid method for the determination of brominated flame retardant concentrations in plastics and textiles entering the waste stream

Due to new European legislation, products going to waste are subject to ‘low persistent organic pollutant concentration limits’. Concentrations of restricted brominated flame retardants in waste products must be determined. A rapid extraction and clean‐up method was developed for determination of brominated flame retardants in various plastics and textiles. The optimised method used vortexing and ultrasonication in dichloromethane followed by sulfuric acid clean‐up to determine target compounds. Poly‐brominated diphenyl ethers were determined by gas chromatography with mass spectrometry and hexabromocyclododecane by liquid chromatography with tandem mass spectrometry. Good recoveries of target analytes were obtained after three extraction cycles. The method was validated using poly‐propylene and poly‐ethylene certified reference materials as well as previously characterised textiles, expanded and extruded poly‐styrene samples. Measured concentrations of target compounds showed good agreement with the certified values indicating good accuracy and precision. Clean extracts provided low noise levels resulting in low limits of quantification (0.8–1.5 ng/g for poly‐brominated diphenyl ethers and 0.3 ng/g for α‐, β‐ and γ‐hexabromocyclododecane). The developed method was applied successfully to real consumer products entering the waste stream and it provided various advantages over traditional methods, including reduced analysis time, solvent consumption, minimal sample contamination and high sample throughput, which is crucial to comply with the implemented legislation.     

化学与禁毒

禁毒工作的许多方面都体现了化学知识的具体应用,如毒品检验、查缉技术、禁毒立法和毒品预防教育等。化学在禁毒工作中发挥了基础性的支撑作用,将先进的化学理论和技术方法应用于禁毒研究,有助于解决实践工作中遇到的各种难题。     

Evaluation of the chemical composition of Brazilian commercial Cymbopogon citratus (D.C.) stapf samples

The concentration and the chemical composition of the essential oils obtained from different samples of Cymbopogon citratus were evaluated. Among the 12 samples investigated (11 dried leaf samples and fresh plant leaves), seven presented essential oil concentrations within the threshold established by the Brazilian legislation. The moisture content was also determined and the majority of the samples presented humidity contents near 12%. The GC and GC/MS analyses of the essential oils led to identification of 22 compounds, with neral and geranial as the two major components. The total percentage of these two compounds varied within the investigated sample oils from 40.7% to 75.4%. In addition, a considerable variation in the chemical composition of the analyzed samples was observed. The process of grinding the leaves significantly decreased (by up to 68%) the essential oil content, as well as the percentage of myrcene in the oils.     

Integration of metrological principles and performance evaluation in a proficiency testing scheme in support of the Council Directive 98/83/EC

Proficiency testing as a means of external quality assessment plays the role of independent evidence of laboratories’ performance. To enable laboratories to fulfil the requirements stated in legislation, methodology for evaluation of laboratories’ performance in proficiency testing schemes should incorporate principles of measurement results which are fit for intended use and incorporate evaluation of laboratories’ performances based on independent reference value. A proficiency testing scheme was designed to support Drinking Water Directive (98/83/EC) specifically. The methodology for performance evaluation, which takes into account a “fitness for purpose”-based standard deviation for proficiency assessment, is proposed and discussed in terms of requirements of the Drinking Water Directive. A ζ′-score, modified by application of target uncertainty was developed in a way that fulfils requirements defined in the legislation. As an illustration, results are reported for nitrate concentration in water. The approach presented can also be applied to other fields of measurements.     

Identification of hallucinogenic fungi from the genera Psilocybe and Panaeolus by amplified fragment length polymorphism

Unambiguous identification of the hallucinogenic fungi of the genera Psilocybe and Panaeolus is required by national and international drug control legislation. We report on a DNA-based test using the technique of amplified fragment length polymorphism (AFLP). AFLP can differentiate species of the two genera Psilocybe and Panaeolus by using different primer sets. The identification of hallucinogenic fungi using a DNA-based test, which can be used in conjunction with morphological features, will assist in forensic investigations.     

Regional cooperation in proficiency testing: strategy planning and practical experiences in Western Balkan countries

The article describes the project of regional cooperation in proficiency testing within CARDS 2006 (assistance programme to the Western Balkans), which was coordinated by European Committee for Standardization, European Commission and European Free Trade Association and conducted by the University of Ljubljana, Faculty of Electrical Engineering, Laboratory of Metrology and Quality. The later is the holder of the national standard for thermodynamic temperature as well as an accredited proficiency testing provider and also accredited as a calibration, testing and inspection laboratory. It is also responsible for graduate study programme Quality Engineering. Proficiency testing was considered as a core activity of the entire project, but additionally as a very appropriate platform for knowledge transfer of EU technical legislation in selected sectors, metrology, testing and quality assurance in general. The project had a high added value for participating laboratories in countries of Western Balkans, because it required an active role of all participating laboratories, assured participation of staff from national metrology institutions, all national accreditation bodies, and was supported by national quality infrastructures, such as standardization, governmental institutions etc. in the entire Western Balkans region. The activities stimulated progress in the area of conformity assessment, added knowledge to the implementation of technical directives and development of the technical part of national legislation and therefore facilitated the process toward the accession to the European Union. The main objective was therefore to organize proficiency testing in those sectors (construction, consumer protection and environment) that were vital in the pre-accession process of countries seeking full implementation of EU technical legislation.     

Speciation and legislation – Where are we today and what do we need for tomorrow?

In international legislation concerning trace elements in food, in the environment or in occupational health most regulations are based on the total element contents, and are frequently given as maximum limits or guideline levels. In contrast, only few regulations pay attention to the molecular species in which the elements are bound. The international legislation concerning contaminants in food is presently being established in the Codex Alimentarius, which is an independent United Nations organisation under the joint FAO/WHO Food Standards Programme. Development of the Codex General Standard for Contaminants and Toxins in Food provides the framework for future international legislation on metals as contaminants in food. For certain food additives, which include some essential minerals, speciation is an integral part of the set of specification criteria, because only certain defined chemical compounds are permitted as sources of the essential element. The development of more species-specific analytical and toxicological data, and improved communication with legislators will be necessary before it will become possible to lay down species-specific regulations in all the cases where the specialised scientist will consider it reasonable.     

Brominated flame retardants in the European chemicals policy of REACH-Regulation and determination in materials

The EU REACH legislation will require the registration of 30,000 currently marketed chemicals, including the main commercial BFRs in use (Deca-BDE, HBCD and TBBP-A). Much of the data needed for registration are already available, thanks to risk assessments of continued production and use already undertaken in the EU. Within the authorisation, substitution by less hazardous chemicals is encouraged. Both qualitative and quantitative methods for the analysis of flame-retarded polymers are needed in order that the identity and concentration of the BFRs can be established and compliance with regulations including the RoHS Directive demonstrated. These are reviewed.     

Detection of cocaine in the airborne particles of the Italian cities Rome and Taranto

Cocaine was first detected in the air of two Italian cities, Rome and Taranto, where it reached concentrations sometimes exceeding 100 pg/m(3), by HRGC-MS analysis of carbonaceous aerosol samples. By contrast, the drug was virtually absent in Algiers (Algeria). In Italy, atmospheric concentrations of cocaine were, on average, similar to those of other toxic pollutants like polychlorobiphenyls or nitrated polynuclear aromatic hydrocarbons, and higher than those of polychlorodibenzo-p-dioxins/polychlorodibenzofurans. The cocaine concentrations seemed to correlate with regional consumption of the drug in Rome and Taranto. By contrast, it correlated neither with nicotine or caffeine, nor with benzo[a]pyrene, the sole organic compound associated with aerosols that is quoted according to Italian legislation.     

Quantitation of suspected allergens in fragrances part II. Evaluation of comprehensive gas chromatography-conventional mass spectrometry

The European legislation requires that fragranced products are evaluated for their content in 24 compounds that are suspected to be skin sensitizers. Their quantitation in fragrance concentrates may not be achieved with GC-flame ionization detection (FID), due to the complexity of these mixtures and even comprehensive GC-FID does not provide sufficient resolution. This paper reports the first example of quantitation based on the hyphenation of comprehensive GC with a low-cost quadrupole MS. A detection frequency of 30.7 Hz can be obtained by monitoring a single ion. This allows a satisfactory evaluation of the area sum over the 2-3 modulations of a given compound and linear calibration curves are obtained. Analyses are completed within 35 min.     

Sampling, sample treatment and quality assurance issues for the determination of phosphorus species in natural waters and soils

Phosphorus is an important macronutrient and the accurate determination of phosphorus species in environmental matrices such as natural waters and soils is essential for understanding the biogeochemical cycling of the element, studying its role in ecosystem health and monitoring compliance with legislation. This paper provides a critical review of sample collection, storage and treatment procedures for the determination of phosphorus species in environmental matrices. Issues such as phosphorus speciation, the molybdenum blue method, digestion procedures for organic phosphorus species, choice of model compounds for analytical studies, quality assurance and the availability of environmental CRMs for phosphate are also discussed in detail.     

Uncertainty evaluation for the quantification of low masses of benzo[a]pyrene: Comparison between the Law of Propagation of Uncertainty and the Monte Carlo method

A proper evaluation of the uncertainty associated to the quantification of micropollutants in the environment, like Polycyclic Aromatic Hydrocarbons (PAHs), is crucial for the reliability of the measurement results. The present work describes a comparison between the uncertainty evaluation carried out according to the GUM uncertainty framework and the Monte Carlo (MC) method. This comparison was carried out starting from real data sets obtained from the quantification of benzo[a]pyrene (BaP), spiked on filters commonly used for airborne particulate matter sampling. BaP was chosen as target analyte as it is listed in the current European legislation as marker of the carcinogenic risk for the whole class of PAHs.