Foodstuffs and medicines as legal categories in the EU and China. Functional foods as a borderline case

The thesis discusses the regulation of foodstuffs and medicines, and particularly the regulation of functional foods. Legal systems investigated are the EU and China. Both are members of the WTO and Codex Alimentarius, which binds European and Chinese rules together. The study uses three Chinese berries as case examples of how product development faces regulation in practice. The berries have traditional uses as herbal medicines. Europe and China have similar nutrition problems to be resolved, such as obesity, cardiovascular disease, and diabetes. The three berries might be suitable raw materials for functional foods. Consumer products with health-enhancing functions, such as lowering blood pressure, might legally be classifi ed either as foodstuffs or medicines. The classifi cation will depend on functions and presentation of the product. In our opinion, food and medicine regulation should come closer together so the classifi cation issue would no longer be an issue. Safety of both foodstuffs and medicines is strictly regulated. With medicines, safety is a more relative concept, where benefi ts of the product are compared to side-effects in thorough scientifi c tests and trials. Foods, on the other hand, are not allowed to have side-effects. Hygiene rules and rules on the use of chemicals apply. In China, food safety is currently at focus as China has had several severe food scandals. Newly developed foods are called novel foods, and are specifi cally regulated. The current European novel food regulation from 1997 treats traditional third country products as novel. The Chinese regulation of 2007 also defi nes novel foods as something unfamiliar to a Chinese consumer. The concepts of novel food thus serve a protectionist purpose. As regards marketing, foods are allowed to bear health claims, whereas medicines bear medicinal claims. The separation is legally strict: foods are not to be presented as having medicinal functions. European nutrition and health claim regulation exists since 2006. China also has its regulation on health foods, listing the permitted claims and how to substantiate them. Health claims are allowed only on health foods. The European rules on medicines include separate categories for herbal medicines, traditional herbal medicines, and homeopathic medicines, where there are differing requirements for scientifi c substantiation. The scientifi c and political grounds for the separate categories provoke criticism. At surface, the Chinese legal system seems similar to the European one. To facilitate trade, China has enacted modern laws. Laws are needed as the country moves from planned economy to market economy: ‘rule of law’ needs to replace ‘rule of man’. Instead of being citizens, Chinese people long were subordinates to the Emperor. Confucius himself advised to avoid confl ict. Still, Chinese people do not and cannot always trust the legal system, as laws are enforced in an inconsistent manner, and courts are weak. In China, there have been problems with confl icting national and local laws. In Europe, the competence of the EU vs. the competence of the Member States is still not resolved, even though the European Commission often states that free trade requires harmonisation. Food and medicine regulation is created by international organisations, food and medicine control agencies, standards agencies, companies and their organisations. Regulation can be divided in ‘hard law’ and ‘soft law’. One might claim that hard law is in crisis, as soft law is gaining importance. If law is out of fashion, regulation certainly isn’t. In the future, ‘law’ might mean a process where rules and incentives are created by states, NGOs, companies, consumers, and other stakeholders. ‘Law’ might thus refer to a constant negotiation between public and private actors. Legal principles such as transparency, equal treatment, and the right to be heard would still be important.

Straightforward synthesis of 2,2,4,4,5,7,7-d7-cholestane: a new deuterated standard in petroleum analysis

A short and efficient synthesis of heptadeuterated 2,2,4,4,5,7,7-d7-cholestane (1) from cholesterol (3) is described. The deuterated material will be useful for the analysis of different sources of petroleum in analytical geochemistry laboratories as internal standard for quantification of steranes via gas chromatography-mass spectrometry (GC-MS).

Flow-batch analyser for preparation of calibration standard mixtures in simultaneous multicomponent spectrometric analysis

The application of multivariate calibration techniques to multicomponent analysis by UV-VIS molecular absorption spectrometry is a powerful tool for simultaneous determination of several chemical species. However, when this methodology is accomplished manually, it is slow and laborious, consumes high amounts of reagents and samples, is susceptible to contaminations and presents a high operational cost. To overcome these drawbacks, a flow-batch analyser is proposed in this work. This analyser was developed for automatic preparation of standard calibration and test (or validation) mixtures. It was applied to the simultaneous determination of Cu2+, Mn2+ and Zn2+ in polyvitaminic and polymineral pharmaceutical formulations, using 4-(2-piridilazo) resorcinol as reagent and a UV-VIS spectrophotometer with a photodiode array detector. The results obtained with the proposed system are in good agreement with those obtained by flame atomic absorption spectrometry, which was employed as reference method. With the proposed analyser, the preparation of calibration and test mixtures can be accomplished about four hours, while the manual procedure requires at least two days. Moreover, it consumes smaller amounts of reagents and samples than the manual procedure. After the preparation of calibration and test mixtures, 60 samples h-1 can be carried out with the proposed flow-batch analyser.

Estimation of standard enthalpy of formation of alkanes in gaseous state by calculating size, structural and electronic parameters in the molecules

A quantitative analysis is made on the correlation ship of thermodynamic property, i.e., standard enthalpy of formation (ΔH fº) with Kier's molecular connectivity index(¹Xv),vander waal's volume (Vw) electrotopological state index (E) and refractotopological state index (R) in gaseous state of alkanes. The regression analysis reveals a significant linear correlation of standard enthalpy of formation (ΔH fº) with ¹Xv, Vw, E and R. The equations obtained by regression analysis may be used to estimate standard enthalpy of formation (ΔH fº) of alkanes in gaseous state.

Sistema de exercício online para apoio a aprendizagem de Medicina Legal na Universidade de Brasília

O propósito deste estudo retrospectivo foi avaliar o padrão de utilização do sistema de exercícios on-line, facultativos, assíncronos, para o apoio à aprendizagem da disciplina Medicina Legal e Deontologia Médica na Universidade de Brasília. Os sujeitos foram 38 alunos que cursaram a disciplina no segundo semestre de 2005. O sistema oferecia conteúdos textuais e imagens que podiam ser acessados anonimamente. Para a resolução dos exercícios do tipo "verdadeiro" ou "falso", alguns com imagens, era necessário que os alunos se identificassem por senha, o que permitiu o monitoramento. Os resultados mostraram que 32 alunos (84%) realizaram exercícios on-line, com uma média de 183 respostas por aluno, entre os que aderiram; 52% dos exercícios foram resolvidos nas últimas 24 horas antes da prova; 62,3% dos exercícios foram resolvidos entre 19h e 01h. Conclui-se que os alunos, num sistema facultativo, concentram seus esforços na véspera da prova, o que diminui a eficiência do sistema, sugerindo que técnicas de motivação para o uso regular desse tipo de sistema devem ser implementadas.

Objeção de Consciência e Aborto Legal: Atitudes de Estudantes de Medicina

RESUMO Introdução No Brasil, o aborto é permitido em caso de risco de morte da mulher, gravidez decorrente de estupro e anencefalia fetal. Objetivo O objetivo deste trabalho foi avaliar as atitudes de estudantes de Medicina em relação à objeção de consciência ao aborto legal. Métodos Todos os estudantes das escolas médicas do Piauí foram convidados a responder a um questionário eletrônico e anônimo com perguntas sobre características sociodemográficas, objeção de consciência ao aborto e obrigações éticas em caso de recusa. Resultados A taxa de resposta foi de 66,7% (n = 1.174). Enquanto 13,2% dos estudantes apresentariam objeção de consciência por risco de morte da mulher, 31,6% objetariam quando houvesse anencefalia fetal e 50,8% em caso de estupro. Na recusa do aborto por estupro, 54% não encaminhariam a mulher a outro profissional e 72,5% não explicariam a ela as opções de tratamento. Religião foi a única característica associada à recusa para o aborto. Conclusões A objeção de consciência no aborto por estupro foi mais frequente do que nas outras circunstâncias previstas pela legislação brasileira. Os estudantes com religião estiveram mais associados à recusa.

Avaliação econômica de sistemas agroflorestais implantados para recuperação de reserva legal no Pontal do Paranapanema, São Paulo

O Pontal do Paranapanema, extremo oeste do Estado de São Paulo, é conhecido em todo o Brasil devido aos conflitos pela posse da terra, protagonizados pelo Movimento dos Trabalhadores Rurais Sem Terra (MST), que transformou significativamente a paisagem da região, onde atualmente se observam pequenas ilhas de assentamentos rurais imersos numa matriz de grandes pastagens. O Código Florestal prevê que esses assentamentos, assim como qualquer propriedade rural, deve manter 20% de sua área com cobertura vegetal arbórea. Essa área, conhecida como Reserva Florestal Legal, deve ser restaurada, caso não exista. Assim, esta pesquisa se desenvolveu no assentamento Santa Zélia, Município de Teodoro Sampaio, São Paulo, numa área de 15 ha de Reserva Legal. Seis famílias desse assentamento foram responsáveis pela restauração da área, através de módulos agroflorestais (Taungya) temporários. Dois indicadores foram utilizados para avaliação econômica da produção agrícola na área: Valor Presente Líquido (VLP) e Relação Benefício-Custo (RB/C). Os resultados indicaram valores positivos em todas as famílias analisadas, levando à conclusão de que sistemas agroflorestais podem ser adotados na recuperação de áreas de reserva legal em propriedades rurais. Sua maior ou menor viabilidade econômica irá depender de um manejo mais intenso na área para produção agrícola e de preços satisfatórios para venda no mercado.

Quantificação das áreas de preservação permanente e de reserva legal em propriedades da bacia do Rio Pomba-MG

Para a efetivação das áreas de preservação permanente (APPs) e de reserva legal (ARL) nas propriedades rurais, dando cumprimento à legislação, é de extrema importância que elas sejam quantificadas, determinando-se o porcentual que ocupam nas propriedades e o que representam essas áreas na atividade econômica dos produtores rurais. Dessa forma, este trabalho teve por objetivo quantificar as APPs e ARL com relação à área total das propriedades rurais pesquisadas. Determinaram-se também a área com vegetação nativa em cada propriedade e as APPs que estavam de acordo com a legislação. Utilizou-se de uma amostra composta por 47 propriedades, divididas em seis estratos, tendo como critério de estratificação o tamanho da área de cada uma delas. A coleta de dados foi realizada com o uso de GPS e a quantificação, com a utilização do SIG ArcView 3.3. Com base nos resultados, observou-se que as 47 propriedades estudadas ocupavam uma área de 1.854.35 ha, dos quais 811,35 ha, referentes a 43,75% do total, eram APPs e ARLs, de acordo com as legislações federal e estadual. Além disso, em apenas 21,09% dessas áreas não ocorria o uso indevido do solo, evidenciando-se o não-cumprimento da lei e a necessidade de medidas efetivas para a sua adequação.

Mathematical analysis of maximum power generated by photovoltaic systems and fitting curves for standard test conditions

The rural electrification is characterized by geographical dispersion of the population, low consumption, high investment by consumers and high cost. Moreover, solar radiation constitutes an inexhaustible source of energy and in its conversion into electricity photovoltaic panels are used. In this study, equations were adjusted to field conditions presented by the manufacturer for current and power of small photovoltaic systems. The mathematical analysis was performed on the photovoltaic rural system I-100 from ISOFOTON, with power 300 Wp, located at the Experimental Farm Lageado of FCA/UNESP. For the development of such equations, the circuitry of photovoltaic cells has been studied to apply iterative numerical methods for the determination of electrical parameters and possible errors in the appropriate equations in the literature to reality. Therefore, a simulation of a photovoltaic panel was proposed through mathematical equations that were adjusted according to the data of local radiation. The results have presented equations that provide real answers to the user and may assist in the design of these systems, once calculated that the maximum power limit ensures a supply of energy generated. This real sizing helps establishing the possible applications of solar energy to the rural producer and informing the real possibilities of generating electricity from the sun.

Hevonen irtaimen kaupan tapauksena - laatuvirhe ja siihen varautuminen

Tutkimuksessa tarkastellaan hevoskauppaa ja sen erityispiirteitä suhtees-sa irtaimen kauppaa säätelevään lainsäädäntöön. Tavoitteena on tuoda esiin hevosesta johtuvia erityispiirteitä ja pohtia sovellettavan lainsäädän-nön soveltuvuutta hevosen kauppaan. Tarkastelu kohdentuu erityisesti hevoselle ominaisiin laatuvirheen muotoihin, kuten sairauksiin ja fyysisiin vikoihin. Lisäksi tarkastellaan, miten esiin nostettuihin erityispiirteisiin on varauduttu hevoskauppaan tarkoitetuissa kauppasopimusmalleissa. Hevoskauppaan pätee sama lainsäädäntö kuin minkä tahansa muun ir-taimen tavaran kauppaan. Virheeseen varautuminen yksityiskohtaisesti sopimalla korostuu hevoskaupassa, koska täydellistä ja virheetöntä hevosta ei ole olemassakaan. Myyjän näkökulmasta onnistuneessa kauppaprosessissa neuvotellaan virheen mahdollisuus niin pieneksi kuin se on mahdollista. Tähän instrumentit antavat lainsäädäntö ja erityisesti sopimusoikeudelliset keinot. Ostajan näkökulmasta onnistuneessa kaupassa hän on kyennyt asiantuntijoihin tukeutuen tunnistamaan ennalta hevosen viat ja muut epämieluisat ominaisuudet. Nämä tiedostaen ostaja määrittää, mitä virheitä on valmis hyväksymään. Hevoskaupassa riidan välittömät ja välilliset kustannukset suhteessa maksettuun kauppahintaan voivat nousta korkeiksi. Hevoskaupassa usein ainoa kirjallinen dokumentti on omistajanvaihdosilmoitus, eikä kauppasopimuksen laatiminen kirjallisena ole itsestäänselvyys. Yksinomaan hevoskauppaan liittyvien juridisten kysymysten tekeminen näkyväksi on tärkeää. Irtaimen kauppaa säätelevä lainsäädäntö ei kuitenkaan tunnista riittävällä tarkkuudella hevosen erityispiirteitä persoonaesineenä, vaan väliin tarvi-taan vakiosopimusten kaltaisia apuvälineitä kaupan osapuolten tueksi.

The Evolution of Securities Lending and Risk Mitigation: A Finnish Market Case Study

Although securities lending is an important function of the financial markets, it has not received that much academic attention. This study examines the evolution of European securities lending and risk management with an emphasis on the development of collateral management, the function responsible for reducing credit risk. The effects of the recent financial instabilities are also considered. The evolution of the Finnish securities lending market is examined in more detail through a case-study. This study can be classified as a constructive qualitative case study. The initial practical knowledge comes from the author's own experience and additional insight and theoretical background is acquired through a literature review. The case study is based on research, semi-structured interviews and a brief analysis of numerical data. The main observation of this study was that securities lending is now recognized as more of an investment management discipline than an operational support function. The recent financial instabilities have resulted in an increased focus on risk and transparency. In securities lending this is directly reflected in collateral management guidelines and procedures. Collateral management has become increasingly technologically developed and automated. Collateral optimization initiatives have been started to make the process more efficient, liquid, and cost effective. Although securities lending is generally an OTC-market with no standard market place, centralized exchange-like models have been introduced. Finnish securities lending has now shifted towards the more common global OTC model. Although the Finnish securities lending industry has developed, and the main laws governing it (tax legislation) have changed, there is still need for development. There are still not many Finnish participants involved and due to legal issues most securities loans are collateralized with cash and not securities (e.g. government bonds).

Estudo da linfadenectomia radical comparada à linfadenectomia standard no tratamento cirúrgico do adenocarcinoma da papila de Vater

OBJETIVO: avaliar a morbidade e a mortalidade cirúrgica em pacientes submetidos a gastroduodenopancreatectomia (GDP) com linfadenectomia padrão e radical para adenocarcinoma de papila, analisando os fatores prognósticos com relação à sobrevida global e livre de doença. MÉTODOS: foram analisados retrospectivamente no período de 1999 a 2007, no Serviço de Cirurgia Abdômino-Pélvica do INCa-RJ, 50 casos de GDP para adenocarcinoma da papila duodenal divididos em dois grupos de acordo com a linfadenectomia (grupo A: linfadenectomia padrão e grupo B: linfadenectomia radical). RESULTADOS: A mediana de idade foi semelhante nos dois grupos, assim como a distribuição entre os sexos. Na comparação entre as linfadenectomias somente o número de linfonodos ressecados (grupo A: 12,3 e grupo B: 26,5) e o tempo operatório (grupo A: 421 e grupo B: 474) foram significativamente diferentes. Não ocorreram diferenças estatisticamente significativas nos dois grupos com relação a morbi-mortalidade operatória e tempo de internação. A sobrevida livre de doença (grupo A: 35 meses e grupo B: 51 meses) e sobrevida global (grupo A: 38 meses e grupo B: 53 meses) foi maior no grupo da linfadenectomia radical, porém não foram significantes estatisticamente. CONCLUSÃO: no presente estudo não ocorreram casos de linfonodos metastáticos para outros grupos nodais sem o acometimento linfonodal das cadeias pancreato-duodenais (13 e 17), sugerindo um padrão de disseminação linfonodal. Apesar da linfadenectomia radical apresentar taxas de sobrevida livre de doença e sobrevida global maiores esses dados não foram significativos estatisticamente. Novos estudos devem ser realizados para avaliar o real papel da linfadenectomia radical no adenocarcinoma da papila duodenal.

Epidemiological profile and postoperative complications of women undergoing gynecological surgery in a reference center in the northern brazilian legal amazon

Objective: To evaluate the epidemiological profile and the operative complications of patients undergoing gynecological operations for benign diseases in a tertiary public hospital in the state of Roraima, Brazil. Methods: We conducted a retrospective survey through the analysis of 518 records of patients submitted to gynecological operations between January and June 2012. We included the three major operations during this period (n = 175): hysterectomy, colpoperineoplasty and suburethral sling placement. We excluded 236 cases of tubal ligation and 25 cases where it was not possible to access to medical records. Results: The mean age was 47.6 years; the education level of most patients was completed junior high (36.6%); 77% were from the State capital, 47.4% were in stable relationships and 26.3% were housewives. The majority of patients had given birth three or more times (86.6%), with previous vaginal delivery in 50.2%, and cesarean delivery, 21%. The main diagnostic indications for surgical treatment were uterine myoma (46.3%), urinary incontinence (27.4%) and genital dystopias (17.7%). We found three cases (1.7%) of high-grade intraepithelial lesions on Pap smear. The most common procedure was total hysterectomy (19.8%), 15.5% vaginally. The most common complication was wound infection (2.2%). Conclusion: Women undergoing gynecological operations due to benign disease had a mean age of 47 years, most had levels of basic education, came from the capital, were in stable relationships, predominantly housewives, multiparous and showed low operative complication rates.

Establishment of a health and safety management system according to the OHSAS 18001 standard

The thesis develops guidelines for the implementation of the health and safety management system according to the OHSAS 18001 standard, as well as the feasible threat analysis, project proposal schedule, future system quality improvements and organizational change evaluation. The theoretical part clarifies determination of occupational health and safety, its management system, the OHSAS 18001 standard and integrated management system compounded of triple ISO 14001, ISO 9001 and OHSAS 18001 standards. The literature includes such important aspects as human factor, organizational policies, possible benefits, threats, organizational safety culture, Deming’s quality improvement cycle, system implementation, maintenance and cost matters. The empirical part demonstrates real-life situation by using Andritz Pulp & Paper Oy as a case study. Prior the thesis proposal, Andritz Group is analysed including separate business areas, acquisition and integration strategies, current status of the health and safety management and parallel experiences of the largest business area Andritz Hydro. The proposal is aimed at improving the current health and safety system for the permanent and sub-contracted employees at Andritz Pulp & Paper both in Finland and in various projects globally.