Made available in DSpace on 2014-07-29T15:07:31Z (GMT). No. of bitstreams: 1 Thaysa dos Santos Silva.pdf: 1435457 bytes, checksum: 4745e5a89c1abe5f3e29a10d0aa47fe5 (MD5) Previous issue date: 2011-02-21 / Milk is considered one of the nutritionally complete foods, consumers and inspection organizations require that this product has innocuousness and good quality. The veterinary medicinal products, in particular antimicrobials have been widely used in stockfarming to treat and preventi diseases (mastitis). However, when they are used in an inappropriate manner, the presence of residues of antimicrobials such as sanitizers, antibiotics or chemotherapic drugs, endanger animals´ and humans´ health, predisposing the population to allergic reactions, carcinogenic activity, microbial resistance, in addition to causing economic losses to industries, producers and governments. Furthermore, the analysis of titratable acidity in milk is one of the parameters used by dairy industry for the indirect determination of its quality, being compulsory in the milk reception platforms the industries. In this study 992 samples (441 of raw, 327 of pasteurized and 224 of Ultra High Temperature (UHT) milk) were collected from April to November 2010 in the properties and places of commercialization, and analyzed in the State of Goias. The commercial kit Delvotest® SP-NP was used to carry out the antimicrobials research, a methodology according the federal law for the titratable acidity, and the software SPSS version 15.0 for data analysis. Out of the analyzed samples 8.47% (5.34% of raw milk, 1.92% of pasteurized milk and 1.21% UHT milk) were positive for the presence of antimicrobials residues. As for titratable acidity, 25.30% of the samples (12.10 % raw milk, 9.57% of pasteurized milk and 3.63% UHT milk) were not within standard values. Among these samples, 10.48% were below the recommendation and 14.82% were above. The analyzes results confirm that the quality of raw, pasteurized and UHT milk produced and consumed in Goias is not within the standard values recommended by federal law, as regards the presence of antimicrobial residue and titratable acidity, which represents risk to public health, besides causing economic losses in milk processing. / O leite é considerado um dos alimentos mais completos nutricionalmente, assim os consumidores e órgãos fiscalizadores, exigem que este produto seja inócuo e de qualidade. Os medicamentos veterinários, em particular os antimicrobianos, têm sido amplamente utilizados na pecuária para tratamento e prevenção de doenças (mastites), no entanto, quando utilizados em desrespeito às boas práticas, a presença de resíduos de antimicrobianos sejam eles sanitizantes, antibióticos ou quimioterápicos colocam em risco tanto a saúde animal como a humana, predispondo a população a eventuais reações alérgicas, ação carcinogênica e resistência microbiana, além de causar prejuízos econômicos para as indústrias, produtores e governos. Além disso, a análise de acidez titulável no leite também é um dos parâmetros utilizados pelos laticínios para a determinação indireta de sua qualidade, sendo obrigatória nas plataformas de recepção de leite dos laticínios. Neste trabalho foram analisadas 992 amostras de leite no Estado de Goiás, sendo 441 de leite cru, 327 de pasteurizado e 224 de Ultra Higth Temperature (UHT), de abril a novembro de 2010, coletadas nas propriedades fornecedoras de leite e locais de comercialização do produto. Para realização da pesquisa de antimicrobianos foi utilizado o kit comercial Delvotest® SP-NP, já para a acidez titulável utilizou-se metodologia segundo legislação federal, e para análise dos dados o software SPSS versão 15.0. Das amostras analisadas 8,47% se mostraram positivas para a presença de resíduos de antimicrobianos (5,34% de leite cru, 1,92% de leite pasteurizado e 1,21% de leite UHT), já 25,30% das amostras apresentaram-se fora do padrão para acidez titulável (12,10 % leite cru, 9,57% de leite pasteurizado e 3,63% de leite UHT). Dentre as amostras que estavam fora do padrão para acidez titulável, 10,48% estavam abaixo do recomendado e 14,82% estavam acima. Os resultados das análises da pesquisa confirmam que a qualidade do leite cru, pasteurizado e UHT produzido e consumido em Goiás, estão apresentando resultados fora dos padrões recomendados pela legislação federal, no que se refere à presença de resíduo de antimicrobiano e acidez titulável, o que gera preocupação, pois representa risco a saúde pública, além de causar prejuízos no processamento do leite.

The topic of this diploma thesis is the Consumer protection in the food supplements area. The work has been devided into three parts. The first part is devoted to the overview about categorization of the products with the impact on health. This part of this work also includes the elementary terms, which are: food, food supplements, medicinal products, cosmetics products and medical devices. The second chapter is devoted to the matter of food supplements as such. The third chapter deals with the terms health and nutrition claims. The last chapter includes the survey between the consumers of the food suplements and also the survey between the pharmacies.

Alors qu’un nombre non négligeable de produits contenant des nanomatériaux est déjà présent sur les marchés, nous manquons de recul tant en ce qui concerne les risques pour la santé et l’environnement que les bénéfices qu’ils peuvent apporter à la société sur le long terme. La présente thèse aborde la question suivante : quel régime règlementaire est en mesure de procurer le plus haut niveau de protection contre les risques avérés ou suspectés des nanotechnologies tout en soutenant simultanément la compétitivité et l'innovation ? Bien que l’Union européenne et les Etats-Unis se soient efforcés de trouver des solutions nuancées en fonction des besoins, des capacités, des enjeux inhérents à chaque secteur concerné et de leurs traditions juridiques respectives, l’on ne peut que constater l’émergence d’une réglementation des nanotechnologies à géométrie variable. / While a significant number of products containing nanomaterials is already in widespread use, we have little understanding of risks and benefits they can bring to the society in the long term. The objective of this PhD thesis is to answer the following question: which regulatory framework can ensure a high level of protection against real or suspected risks of nanotechnologies while promoting competitiveness and innovation ? Although the European Union and the United States have attempted to find nuanced solutions according to the needs, capacities and challenges, which are proper to each sector concerned and their respective legal traditions, the emerging regulatory framework for nanotechnologies is characterised by a high degree of fragmentation.

La recherche dans le domaine des maladies sans traitement existant obéit à plusieurs impératifs définis par le législateur européen dans le règlement (CE) n° 141/2000 du 16 décembre 1999 concernant les médicaments orphelins. Les patients atteints de maladies rares et négligées ont le droit à « la même qualité de traitement que les autres » ce qui suppose de prendre les mesures d'incitation nécessaires pour « promouvoir la recherche, le développement et la commercialisation de traitements adéquats ». C'est un « domaine prioritaire ». Après avoir désigné les médicaments concernés, l'Union européenne veut « éviter la dispersion de ressources limitées » notamment par la promotion d'une « coopération transnationale ». Dans une démarche téléologique, cette recherche décrit les effets de la législation européenne sans ignorer la réception de ce droit par les États membres. Des fondements théoriques à même d'assurer une meilleure performativité du droit et des propositions concrètes en vue de conformer le droit positif à l'intention du législateur et aux attentes des parties prenantes sont proposés. En se focalisant sur le seul levier de la propriété intellectuelle, ce droit spécial et incitatif ne semble pas en mesure d'apporter aux patients la plupart des traitements attendus. La régulation de la concurrence et la compétence nationale sur le prix des médicaments perpétuent un seuil de rentabilité éloignant de nombreuses recherches de la phase du développement. L'accès aux médicaments orphelins demeure très restreint. Un changement de paradigme dans la construction de ce droit apparaît nécessaire afin qu'un modèle économique favorable se mette en place. Il convient que le profit des pharmaciens de l'industrie ne dépende plus de la conquête de parts de marché, mais de l'intérêt de leurs inventions pour les besoins de santé non satisfaits. / Research in the field of diseases without an existing treatment is governed by several requirements defined by the European legislator in Regulation (CE) No 141/2000 of 16 December 1999 on orphan medicinal products. Patients with rare and neglected diseases have the right to "the same quality of treatment as other patients" which means taking the necessary incentives to stimulate research, development and bringing to the market of appropriate medications". It is a "priority area". After designating the drugs concerned, the European Union wants to "avoid the dispersion of limited resources", in particular by promoting "cross national co-operation". In a teleological approach, this research analyses the positive law endeavouring to implement the objectives of Orphan Drug Law. It describes the effects of European legislation without ignoring the receipt of this law by the Member States. Theoretical foundations that can ensure a better performativity of the law, as well as concrete proposals to conform the positive law to the intention of the legislator and to the stakeholders' wills are proposed. By focusing solely on the leverage of intellectual property rights, this special and incentive law does not seem to be able to provide patients with many of the expected treatments. Competition regulation and setting of the price which is a national competency perpetuate a high profitability threshold, often withholding research projects from reaching the development phase. Access to orphan drugs remains very limited. A paradigm shift in the construction of this law appears necessary in order for a favorable economic model to emerge. The profit of the industry's pharmacists should no longer depend on the conquest of market shares, but on the value of their inventions for unmet health needs.