Uma análise histórico-crítica sobre o desenvolvimento das normas brasileiras relacionadas a queijos artesanais / [A critical-historical analysis of the continuous development of Brazilian legislation related to artisanal cheeses]

Diferentes tipos de queijos artesanais são produzidos, comercializados e consumidos no Brasil, o que impulsiona o constante desenvolvimento de normas por órgãos oficiais, como o Mapa. A criação do Suasa e do Sisbi-POA foi fundamental para esse setor, por permitir um sistema de equivalência na fiscalização e por ampliar a distribuição. Ainda, o Mapa passou a permitir que queijos artesanais produzidos com leite cru pudessem ser maturados em um período inferior a 60 dias, desde que comprovada sua inocuidade. A redução do tempo de maturação é um tema controverso e polêmico, já que não há critérios específicos que estudos científicos devem contemplar, o que permite múltiplas interpretações de dados. Com a criação e a regulamentação do selo Arte, a fiscalização dos produtos artesanais foi designada aos órgãos de agricultura, pecuária e de saúde pública, em complementação à atribuição já prevista pelo Mapa e pelo Sisbi-POA. Ainda, o selo Arte atribui aos órgãos de inspeção uma função orientadora, atividade que deveria ser prioritariamente executada por agências de extensão e associações. As normas que balizam a produção e comercialização de produtos artesanais devem ser frequentemente atualizadas, devido aos constantes avanços científicos na área e para assegurar a oferta de produtos com qualidade e inócuos aos consumidores.(AU)

Different artisanal cheeses are produced, commercialized and consumed in Brazil, leading to a constant development of related rules by the MAPA and other official agencies. The establishment of two national programs (SUASA and SISBI-POA) allowed an equivalence in inspection system and an expanded distribution. Also, MAPA allowed ripening time lower than 60 days for artisanal raw milk cheeses, based on scientific studies that assure their safety. However, lowering the ripening period is still controversial, once there are no proper established criteria for such scientific studies, leading to potential multiple interpretation of data. The newly established ARTE certification transferred the inspection responsibilities of artisanal products to secretaries of agriculture, livestock and health, in support of what was already predicated by MAPA and SISBI-POA. Based on ARTE certification, the inspection service must also provide orientation guidance to producers, which should be done specifically by extension organs and associations. The norms that guide the production and commercialization of these artisanal products often need to be updated, but based on well-established methodologies and procedures, to ensure the distribution of suitable products to consumers.(AU)

Twenty Years of the Dietary Supplement Health and Education Act--How Should Dietary Supplements Be Regulated?

The Dietary Supplement Health and Education Act (DSHEA) of 1994 defines the FDA's statutory authority to regulate dietary supplement products in the United States. The dietary supplement industry has rapidly expanded since 1994, presenting an obvious need for "DSHEA 2.0." Current regulations surrounding dietary supplements have been increasingly and reasonably scrutinized, given their widespread use by over one-half of the US population as well as highly publicized safety concerns over the past 20 y. As the market continues to expand and evolve, so too must the laws that protect consumers from potential harm and misleading communication. This article is meant to begin a scientific dialogue on how regulations may be improved to provide both ease of access and safer products to the consumer by focusing on 4 topics: premarket approval, label claims, current Good Manufacturing Practices, and adverse event reporting.

Food chemistry and U.S. food regulations.

The Agriculture and Food Chemistry Division (AGFD) was founded in 1908 shortly after passage of the first U.S. food regulations in 1906. Modern food regulations started with the passage of the Food Drug and Cosmetic Act in 1938. This Act has been amended several times to keep pace with developments in food chemistry. In 1958 the Food Additives Amendment was enacted to control substances added to food. Since 1958 scientific techniques have been developed to evaluate the safety and carcinogenicity of substances in the food supply. In the 1970s and 1980s AGFD symposia and books addressed compounds of concern in foods. In the 1990s food safety and nutrition regulations followed new developments in food and nutrition chemistry. Recently, the well-studied toxin acrylamide was discovered in food and presented regulators with new questions on safety and control in the food supply. Discoveries and developments in chemistry such as those in nanotechnology will continue to present challenges to food regulators.

Safety assessment of 2-ethyl-3,(5 or 6) dimethylpyrazine as a food ingredient.

2-Ethyl-3,(5 or 6)-dimethylpyrazine (CAS No. 27043-05-6), a heterocyclic, nitrogen-containing compound, is used in the food industry as a flavor ingredient for its characteristic roasted odor and flavor, reminiscent of roasted cocoa or nuts. Pyrazines, including 2-ethyl-3,(5 or 6)-dimethylpyrazine, are widely distributed in foods and because of their natural unavoidable occurrence in cooked food; therefore, pyrazine compounds, including 2-ethyl-3,(5 or 6)-dimethylpyrazine, are commonly consumed in the daily diet. 2-Ethyl-3,(5 or 6)-dimethylpyrazine is oxidized in rats almost exclusively via its aliphatic side-chain to carboxylic acid derivatives. The LD(50) of 2-ethyl-3,(5 or 6)-dimethylpyrazine in rats was reported as 460 mg/kg and it is reported to be irritating to the skin, eyes and the upper respiratory tract. Two 90-day rat feeding studies have been conducted on 2-ethyl-3,(5 or 6)-dimethylpyrazine, with the one reporting a no effect level of 12.5mg/kg/day (both sexes) and a second study reporting a NOAEL of 2-ethyl-3,(5 or 6)-dimethylpyrazine 17 and 18 mg/kg/day for male and female rats, respectively. Although no genotoxicity studies were found on 2-ethyl-3,(5 or 6)-dimethylpyrazine, structurally similar pyrazine derivatives were reported as clastogenic in mammalian cells and non-mutagenic in bacterial assays. The relevance of the positive results in assays with Saccharomyces cerevisiae and Chinese hamster ovary cells in vitro is unclear. The data and information available, including a prolonged history of safe use, indicate that at the current level of intake, the food flavoring use of 2-ethyl-3,(5 or 6)-dimethylpyrazine is safe.

Legislação brasileira referente à rotulagem nutricional de alimentos / Brazilian food labeling regulations

O objetivo deste trabalho é apresentar uma reflexão sobre a evolução histórica da legislação brasileira de alimentos sob o aspecto da rotulagem nutricional, contextualizando as principais leis das últimas quatro décadas, destacando os avanços e identificando os pontos críticos que ainda necessitam de aprimoramento. De uma forma geral pode-se afirmar que, ao longo dos últimos 40 anos, o Brasil aperfeiçoou a sua legislação, incorporando evidências científicas nos regulamentos buscando melhorar a qualidade dos alimentos e promover a Saúde Pública, levando em consideração a realidade brasileira. Contudo, com a publicação da Resolução n° 360 da Diretoria Colegiada da Agência Nacional de Vigilância Sanitária em 2003, que retira a obrigatoriedade da declaração dos conteúdos de ferro, cálcio e colesterol dos rótulos, pode-se afirmar que ocorreu uma involução em relação à saúde pública, embora a Resolução tenha mérito em relação à harmonização da legislação com os países membros do Mercosul, permitindo o livre comércio entre estes. Esforços devem ser envidados para que as empresas mantenham a declaração dos nutrientes que deixaram de ser obrigatórios. Ademais, é importante atualizar regulamentos já ultrapassados, incorporar conhecimento novo, preencher lacunas e recomendar ações integradas e contínuas de educação alimentar subsidiadas por pesquisas científicas. A rotulagem nutricional de alimentos é um apoio valioso para os consumidores, dando-lhes a oportunidade de conhecer a composição do alimento, a segurança quanto à ingestão de nutrientes e energia, bem como informações importantes para a manutenção de sua saúde. A legislação na área de alimentos deve ser vista como estratégia para auxiliar na redução dos índices de obesidade, das deficiências nutricionais e das doenças crônicas não-transmissíveis associadas ao padrão de consumo.

The objective of this work is to present a reflection on the historical evolution of the Brazilian food legislation and to emphasize nutritional labeling. The main regulations which have been under way for the four past decades were highlighted as well as some topics in the regulations which should be improved. From a general point of view, during this period, advances in the legislation have been observed, considering that scientific reports were incorporated in the regulations intending to improve food quality and to promote public health on account of the specific demands of the Brazilian reality. Nevertheless, according to the Regulation nr.360 of the Collegiate Directorate of the Agência Nacional de Vigilância Sanitária in 2003, which states that the declaration of iron, calcium and cholesterol contents is not obligatory anymore, an involution could be assumed regarding public health. Yet, the regulation has its merit by uniformizing the legislation of the countries which compose the Mercosul, providing free trading. Efforts should be made in order to maintain on food labels the nutrients whose declaration is not obligatory anymore. Moreover, it seems to be important to update the regulations, to fill in gaps and to recommend integrated actions of education in food, based on scientific evidences. Food labels have been an useful tool to consumers by giving them the opportunity to know about the composition, nutrient and energy contents as well as informations regarding health maintenance. Food legislation should be considered a strategy to help reduce obesity, nutritional deficiencies and even to prevent the most common chronic noncommunicable diseases associated with intake patterns.

Observations at the interface of mutation research and regulatory policy.

Between 1970 and 1975 developments in environmental mutagenesis proceeded with amazing speed. These developments were both structural and conceptual in nature. A new infrastructure was built and new concepts about how best to protect consumers from exposures to mutagens emerged. The internal dynamics within the Food and Drug Administration played an important role and is discussed with regard to modifications in testing protocols as well as changes in the overall approach used to protect consumers. It is clear that this exciting period in the early days of environmental mutagenesis has provided a base for growth and development of the field and continues to affect and guide future developments.