domingo, 27 de octubre de 2013

Corrupcion politica

http://noticias.lainformacion.com/policia-y-justicia/crimen-organizado/comunicado-corrupcion-presidencial-argentina-vinculada-a-los-bancos-suizos_MFqv8HLUAJG9OSM3r7krM7/

La profesion de lobbista en España es regulada

http://www.prnoticias.com/index.php/comunicacion/26-prcomunicacion/20124599-politicos-y-profesionales-de-public-affaires-se-ponen-de-acuerdo-hay-que-regular-el-lobby

martes, 22 de octubre de 2013

Bruxelles va réglementer les étiquettes mensongères de l'industrie alimentaire

L'industrie alimentaire va devoir procéder à un grand ménage dans ses étiquettes et retirer plus de deux mille allégations de santé trompeuses ou mensongères, a annoncé, jeudi 28 juillet, la Commission européenne.

"Réduit le taux de cholestérol", "solidifie les os", "facilite la circulation sanguine" : ces promesses ont fleuri sur les étiquettes des denrées alimentaires commercialisées dans l'Union européenne, mais beaucoup sont "trompeuses", a souligné Frédéric Vincent, porte-parole du commissaire John Dalli, responsable de la santé et des consommateurs.

UNE ÉTIQUETTE SUR CINQ SCIENTIFIQUEMENT FONDÉE
L'Agence européenne pour la sécurité des aliments (EFSA en anglais) a été chargée de rendre un avis scientifique sur ces assertions. Elle a achevé l'exercice jeudi et le verdict est sévère : sur les 2 760 allégations nutritionnelles étudiées, 510 seulement se sont avérées scientifiquement fondées.

La liste initiale comptait 44 000 allégation fournies par les Etats. Elle a été ramenée à 4 600 transmises à l'EFSA, puis réduite à 2 760 avec le retrait spontané de 300 allégations par l'industrie et la mise à l'écart de plus de 1 500 allégations de santé liées aux plantes qui seront examinées ultérieurement.

L'analyse par l'EFSA n'a pas porté sur les produits mais sur leurs composants dont les bienfaits sont vantés. "Le rejet d'une allégation ne signifie pas que le produit n'est pas bon, seulement que les promesses figurant sur l'étiquette ne sont pas correctes", a insisté Frédéric Vincent.

LES COMPLÉMENTS ALIMENTAIRES DANS LA LIGNE DE MIRE

La Commission européenne va préparer un projet de règlement sur la base des avis de l'EFSA. Elle va le soumettre aux Etats et espère une décision en 2012. Une fois le règlement adopté, les industriels auront six mois pour retirer des étiquettes les allégations de santé non validées.

La Commission s'est livrée à un exercice similaire avec l'industrie de la diététique et des compléments alimentaires, pour la contraindre à apporter la preuve scientifique des prétentions dont elle pare ses produits pour pouvoir les commercialiser. Une proposition de règlement a été soumises aux Etats et au Parlement européen. "Il s'agit de réguler un marché actuellement opaque", ont souligné les services du commissaire John Dalli.

Improving food safety in Latin America and the Caribbean

Urgent measures are needed across Latin America and the Caribbean to improve the availability of safe food, both to reduce the level of disease and to facilitate the export of the region’s numerous food products to the rest of the world, 200 regional food-safety experts and regulators agreed today.

At least 6000 outbreaks of a number of different foodborne diseases occurred in Latin America and the Caribbean between 1993 and 2002, according to figures announced here by the Food and Agriculture Organization of the United Nations (FAO) and the World Health Organization (WHO).

Such outbreaks, as well as the greater burden of the many single cases of foodborne disease, resulted in an estimated 57,000 deaths in the region from food- and waterborne diarrhoea in 2004. However, even this estimated disease burden is considered to be greatly underestimating the true magnitude of the foodborne disease problem in the Region, the meeting heard. Organized by FAO and WHO, and hosted by the Government of Costa Rica, the meeting ran from 6 to 9 December 2005.

The experts, representing government food regulatory authorities, food producers, consumer associations and international organizations, agreed on a comprehensive plan which include measures to improve the safety and quality of food both for the peoples of the region and for export.

Regulation to focus on critical points in the food chain

Measures to be taken include assuring safety throughout the entire food chain, by enforcing science-based regulations and applying risk analysis focussing on those critical points in the food chain which require closer monitoring by the relevant government authorities; and improving coordination both among countries in the Region, and between food regulators and food producers in each country.

Despite some relative success in some countries, multiple agencies with fragmented responsibilities, combined with a lack of human and financial resources, are making efforts to achieve uniform high food standards across the region difficult.

For example, not all countries in the Region have harmonized their food legislation with Codex Alimentarius standards. This makes exporting food to the rest of the world, more difficult. Codex Alimentarius is the FAO/WHO body setting food safety and quality standards for consumer protection and facilitation of domestic and international trade.

Food legislation is currently enforced by a number of ministries, including, depending on the country, those for agriculture, health, economy, tourism, trade, and industry, among others. With more than one implementing agency, there is often the risk that the relevant regulations overlap. In addition, these regulations are often out-dated and are not science-based.

Moreover, food safety and quality reference laboratories do not exist in all countries of the Region. The 200 experts underlined the necessity of ensuring that all countries in the Region have own food-testing facilities, or have access to suitable ones in the region.

Promote exports and food security

Food exports from the region are worth some US$66 billion, or 12% of the world’s total food trade, and this figure could increase rapidly over the coming decades if food safety and quality standards are improved, according to FAO and WHO. Several food safety problems including microbiological contamination, are causing costly rejections of export products from the region.

“Without adequate food safety regulatory frameworks and enforcing capabilities, the people of Latin America and the Caribbean will continue to suffer millions of cases of food-borne illness and their food exports will continue to suffer from costly rejections,” said Dr Jorgen Schlundt, WHO’s Director for Food Safety.

“We therefore welcome and will do everything we can to support the development of strong food safety authorities in all the countries of the region, including strengthened food-borne disease surveillance, in order to know where to put increased efforts to lower the disease burden,” he added.

Dr Kraisid Tontisirin, FAO’s Director of Food and Nutrition, said: “Food safety is the bedrock for everything else in the area of nutrition and food security, and for trading food internationally. For example, FAO is actively working with Member countries in the region to assure the safety of fresh fruits and vegetable and the safety and quality of coffee. In so doing, we are enhancing the food security of the region and its ability to export its food. Ensuring safe and nutritious food is an important precondition to food security, and helps countries in the region in their efforts to achieve the Millennium Development Goals.”

DEVICE REGULATION & THE HARMONISATION PROCESS IN LATIN AMERICA

There are 23 countries in Latin America (Argentina, Belize, Bolivia, Brazil, the Caribbean [Antilles], Chile, Colombia, Costa Rica, Cuba, Ecuador, El Salvador, French Guiana, Guatemala, Guyana, Honduras, Mexico, Nicaragua, Panama, Paraguay, Peru, Suriname, Uruguay and Venezuela) with a total population of approximately 517 million people. The main language in this region is Spanish, although Brazil – with a consumer market of 100 million people – speaks Portuguese.
Latin America is an important region for the medical devices consumer market, particularly with regard to imported products as there are few local industries working with cutting-edge technology, particularly taking into account the proportion of the population in the region.
With regard to the regulations covering medical devices, Latin America offers certain challenge to companies, particularly foreign corporations wishing to build up a presence in the various countries in this region. This is because there are many different procedures and regulations to be followed when gaining approval for medical devices due to the autonomy of the Latin American nations and the lack of international pacts among them in this sector.
It is worthwhile stressing that a company wishing to sell a medical device in Latin America must obtain marketing authorisation for its product in each country, in compliance with local procedures and documentation. The procedures and documentation for regulating medical devices vary from one country to another. This means that a company wishing to sell medical devices in Latin America should be fully familiar with local laws in order to bring the authorisation procedures for its product to a successful conclusion within a reasonable length of time.
Familiarity with local culture is another important tool for understanding the regulations in a given country. Frequently, gaps in this understanding result in delays in gaining regulatory approval for medical devices in the Latin American countries. This is why special care is urged for companies interested in this region in terms of complying with the laws of each country as well as noting political and cultural aspects. Ideally, the company should build up a regulatory team with local representatives able to respond efficiently to the demand for each country, particularly in terms of dossier preparation.
Experience has shown that many of the problems occurring during the authorisation of medical devices in the Latin American countries are due to a lack of familiarity with local laws. It is not uncommon to see companies submitting their products for registration based on the documentation stipulated by regulatory agencies in other countries such as the US Food and Drug Administration (FDA), almost completely ignoring local requirements established through specific laws.
Product classification criteria are other crucial factors to consider when authorising medical equipment. For instance, one Latin American country may exempt a medical device from registration and consequently not require the presentation of much technical information on the product in order to authorise it. However, another country in the region may handle the same product quite differently as it may lack the same scientific experience or understanding, and may consequently require the product to be registered, backed up by a series of scientific documents on the technology used, in order to ensure its quality, safety and effectiveness. Consequently, a product may be classified differently among the various countries in the region.
Nevertheless, it is noted that even today, many companies are still exporting medical devices to the Latin American countries before gaining authorisation from the local authorities, and are quite unaware of local regulations and specific authorisation requirements. Familiarity with the laws of each country in the region should consequently be rated as a crucial factor for successful sales of medical devices and should in fact form an integral part of corporate business plans, in order to avoid the risk of losses while ensuring success with the business as a whole.

Harmonisation Process
Many of the countries in Latin America have signed the Agreement on the Application of Sanitary and Phytosanitary Measures resulting from the General Agreement on Tariffs and Trade, and prompting massive efforts to harmonise local legislation with that of the other members of the World Trade Organisation (WTO). However, the participation of many of these countries in discussion forums such as the Global Harmonisation Task Force have not resulted in any specific document being signed by the Latin American countries to ensure uniform understanding and reciprocal actions, particularly with regard to a specific single format for the dossier filed to register medical devices in the many different countries in this region.
Accordingly, the process of harmonising regulations and construing procedures has been followed in a far more individual manner by each country in Latin America rather than as a regional bloc, meaning that the results have shown that as international discussions progress in this sector, the trend is for each country to fine-tune its legislation individually, adapting it to understandings that are internationally accepted although without such understandings being reciprocal and uniform with the decisions taken by the countries in the region.
Under the Mercosur [Argentina, Brazil, Uruguay and Paraguay] Southern Cone Market Treaty, some significant technical regulations have been established in the medical devices sector through the following Resolutions:

· GMC No 40/00 (Registration of Medical Products);
· No 04/95 (Good Fabrication Practices for Medical Products);
· No 131/96 (Good Fabrication Practices for Medical Products);
· No 21/02 (Inspection System for the Manufacturers or Importers of Medical Products);
· No 21/98 (Operating Licence for a Company Manufacturing and/or Importing Medical Products);
· No 72/98 (Essential Safety, Security and Efficacy Requirements for Medical Products);
· No 79/96 (Diagnostic Products for In Vitro Use);
· No 65/96 (Good Fabrication and Control Practices for In Vitro Diagnostic Reactive Agents); and
· No 38/98 (Scope of Application for the Mercosur Technical Regulations).

Despite the technical standards established under the aegis of Mercosur, companies must still authorise their medical devices in each member country in compliance with local laws and local documentation requirements.
There is no specific control entity covering the medical devices sold in the Mercosur member countries. This means that, at the Mercosur level, the public health entities controlling medical devices in each country are jointly responsible. In Brazil this is the National Sanitary Surveillance Agency (ANVISA, Agência Nacional de Vigilância Sanitária), in Argentina this is the National Medications, Foods and Medical Technology Administration (ANMAT, Administración Nacional de Medicamentos, Alimentos y Tecnología Médica), in Paraguay, the Ministry of Public Health and Social Wellbeing (Ministerio de Salud Pública y Bienestar Social) and in Uruguay, the Ministry of Public Health (Ministerio de Salud Pública).
Under the aegis of the North American Free Trade Association (NAFTA) pact, no specific document has yet been drawn up for the public health sector, far less for medical devices. It is expected that the NAFTA meetings in this sector will progress as the time draws near for this trade agreement to enter into effect.

Definitions
The successful completion of the authorisation process for medical devices in the Latin American countries tends to be proportional to a solid understanding of some important legal and regulatory concepts for this sector. This understanding consists mainly of correctly identifying the documents required by the local authorities. As a result, in-depth familiarity with the regulatory concepts in a specific country will result in more effective technical and scientific talks and negotiations with local professionals, particularly the authorities in charge of authorising the products.
The first and most fundamental concept that should be borne in mind for authorising medical devices in Latin America is the ‘risk to human health’.
According to Articles 3 and 5 of the Agreement on the Application of Sanitary and Phytosanitary Measures, the WTO member countries will ensure that their measures do not constitute arbitrary or unjustified discrimination, and that they are applied in a manner that does not impose clandestine constraints on international trade. Consequently, all public health measures will be based on a proper assessment of the circumstances and the risks to human, animal or plant health or life, taking into consideration the risk assessment techniques drawn up by international entities, with the members taking the available scientific evidence into consideration when assessing risks.
This means that the concept of public health risk is crucial for the progress of discussions with the sanitary control authorities, particularly in the Latin American countries where outdated laws are very common and have not kept up with modern technological trends.

Brazil
According to Brazilian Law, a ‘healthcare product’ is defined as an equipment, device, material, article or system for medical, dental or laboratory use or application, intended for the purposes of prevention, diagnosis, treatment, rehabilitation or birth control and that does not make use of any pharmacological, immunological or metabolic means to perform its main function in human beings, although it could do so.
Resolution RDC No 185, dated 22 October 2001, lists the current procedures for registration, alteration, revalidation and exemptions of medical products registration. This Resolution is applicable to all medical products defined in item 13 of Annex I to the Technical Regulations and ancillary rules defined in item 01 of Annex I, including parts of these products. A ‘part of a medical product’ is taken as meaning a component manufactured solely for the purpose of integration with the product, without which this product does not function, and that may be separated and handled by the user or operator as indicated in the product’s instructions for use.
This Resolution is also applicable to other products defined as ‘correlated’ by Law No 6, 360/76 and Decree No 79, 094/77, including equipment, devices, materials, articles, systems for use or application in physical education, beauty care or aesthetic correction, but excluding reagents for in vitro diagnosis (reagents for clinical analysis laboratories).

Risk rating
For the purposes of applying the registration procedures stipulated in Resolution RDC No 185/01, in item 3.3 of the Form in Annex III.A of the Technical Regulations, the company should state the classification of its product as low risk (Class I), medium risk (Class II), high risk (Class III) or maximum risk (Class IV), applying the classification rules listed in Annex II to the Technical Regulations.

Documentation
The essential basic documents required from the local agent of the foreign company for the registration of products in Brazil are:

a) Application form obtained from the Brazilian Ministry of Health.
b) Original copy of the machine stamped bank slip, which serves as proof of the registration fee payment.
c) Trade Permit (Alvará de Funcionamento) issued by the State authority to the manufacturer’s distributor.
d) Same type of document (Autorização de Funcionamento), issued by the Federal authority to the manufacturer’s distributor.
e) Document showing the technical responsibility of the distributor/manufacturer, issued by the certification entity.
f) Technical Report on the product providing information on the components of, for example, the design/formulation, instructions, directions and cautions.
g) Label sample, brochures and pertinent information about the products, all translated into Portuguese.
h) For products not clearly specified in Brazilian law, it is mandatory to provide information about their utilisation in order to demonstrate efficacy and safety.
i) Copy of the registration granted to the product in the country of origin (or copy of the Certificate of Free Sale).
j) Copy of legal document by which the manufacturer authorises its distributor to trade and distribute the products.
k) A declaration of Good Manufacturing Practices.
l) In the case of a medical equipment, all documents showing product safety, country of origin, comprehensive details of the equipment’s component parts, and the user manual have to be presented for registration.

Among the above requirements, special attention should be paid to the technical report, which must contain the following information:

a) A complete description of the product’s design/formulation, with all the components specified by their chemical designation, and the quantities of each one of them expressed in the metric system.
b) Information on the function of each component, and its function as an integral part of the healthcare product.
c) Name of the components stated in accordance with Pharmacopoeial Standards, Brazilian and International Compendia, or attached bibliography discussing the component and pertinent literature, including safety rules and efficacy. This information must be translated into Portuguese.

Argentina
According to Argentinian Law, a ‘healthcare product’ is an equipment, device, material, article or system for medical, dental or laboratory use or application intended for prevention, diagnosis, treatment, rehabilitation or birth control and that does not make use of any pharmacological, immunological or metabolic means to perform its main function in human beings, although it may be assisted in its functions through such means.
Pursuant to Provision 1285/2004, medical products are classified into Classes I, II, III or IV by the intrinsic risk that they offer to the health of the consumer, the patient, the operator or third parties involved.
The registration of all medical products is mandatory, except for the following:

· Medical products intended for clinical research, complying with the legal provisions established by the Competent Public Health Authority for these activities, with their sale and/or use for other purposes being forbidden.
· New presentations consisting of a set of registered medical products whose label and/or instructions for use should contain information on the medical products in question.
· An accessory produced by a manufacturer solely for integration with another medical product that is already registered where the technical registration report for this medical product contains information on this accessory. New accessories may be attached to the original registration on provision of detailed descriptions of their functions, actions and content.

In order to apply for registration of medical products classified under Classes I, II, III and IV, manufacturers or importers should present the following documents to the Competent Public Health Authority:

a) Documentary proof of payment of the corresponding fee.
b) Information for identifying the manufacturer or importer and the medical product, declared and signed by the duly accredited legal representative and the technical expert in charge.
c) A copy of the intra- or extra-zone authorisation of the manufacturer or exporter, allowing the importer to sell its medical product in the country receiving the product. When authorised by the exporter, the importer should demonstrate the commercial relationship between the exporter and the manufacturer.
d) For imported medical products, documentary proof of registration or Certificate of Free Sale or equivalent document granted by the Competent Authority in the country where the medical product is manufactured and/or sold.
e) Documentary proof of compliance with the legal provisions stipulated by the technical regulations, pursuant to the law regulating this matter.

Manufacturers or importers requesting the registration of medical products classified into Class I should present the documents listed in items (a), (b) and (e) to the Competent Public Health Authority.
The Public Health Authorities will have a period of no more than 180 days to assess the documentation and respond to the applicant. The registration of medical products will be valid for five years and may be revalidated successively for a similar period. An application should be supported by the following documentation:

Class I products
a) Documentary proof of payment of tax.
b) Information identifying the manufacturer or importer and the medical product described in Annexes III.A, III.B and III.C of Provision 2319/02, declared and signed by the duly accredited legal representative and the technical expert in charge.
c) Documentation proving compliance with the technical standards specific to the product, if any (for example, technical regulations for hypodermic syringes or condoms), in the original or notarised copy.
d) For imported medical products, documentary proof of registration or Certificate of Free Sale or equivalent document granted by the Competent Authority in the country where the medical product is manufactured and/or sold (only for the USA, Canada, Japan, EU and Australia). For products originating in Brazil, a Good Manufacturing Practices (BPF) Certificate issued by the public health authorities (ANVISA) and an electrical safety certificate issued by a laboratory acknowledged by ANMAT, where applicable, are required. For products originating in other countries, the establishment must have a Good Manufacturing Practices (BPF) Certificate issued by ANMAT.

Class II, III and IV products
a) Documentary proof of payment of tax.
b) A copy of the intra- or extra-zone authorisation of the manufacturer or the exporter allowing the importer to sell its medical product in the country receiving the product. When authorised by the exporter, the importer should demonstrate the commercial relationship between the exporter and the manufacturer (original or notarised copy, with the corresponding notarization and translation by a sworn translator, when required).
c) Documentation proving compliance with the technical standards specific to the product, if any (for example, technical regulations for hypodermic syringes or condoms), in the original or notarised copy.
d) For imported medical products, documentary proof of registration or Certificate of Free Sale or equivalent document granted by the Competent Authority in the country where the medical product is manufactured and/or sold (only for the USA, Canada, Japan, EU and Australia). For products originating in Brazil, a Good Manufacturing Practices (BPF) Certificate issued by the public health authorities (ANVISA) and an electrical safety certificate issued by a laboratory acknowledged by ANMAT, where applicable, are required. For products originating in other countries, the establishment must have a Good Manufacturing Practices (BPF) Certificate issued by ANMAT.

Venezuela
All equipment or material used in human medicine should be subject to registration or control by the public authorities in the country of origin, in order to ensure that such equipment or material is ‘safe, secure and effective’.
In Venezuela, the registration and control of medical equipment and materials is regulated by Resolution No DM-001 0-99, dated 21 September 1999 (Government Gazette No 36, 843, dated 3 December 1999).
Article 1 of this Resolution stipulates that ‘[a]ll corporate legal entities legally established in Venezuela and wishing to manufacture, import, sell or render maintenance services for materials and equipment used at the various levels in the healthcare area should be registered in advance on the National Sanitary Register, kept by the Healthcare Professions, Establishments, Equipment and Materials Control Regulation Administration, under the General Sector Administration of the Sanitary Control Bureau’.
In turn, Article 4 stipulates that ‘[t]he materials and equipment used in the human healthcare area should be registered with the corresponding Administration of this Ministry as stipulated in Article 1 of this Resolution’.
Among the items required to obtain such registration, the applicant should present a Quality Certificate issued by an accredited institution (Article 6, f).
In order to comply with this legal requirement, the Venezuelan State has approved certain institutions with specialised staff and infrastructure to handle the procedures that lead to the issue of the required certificate, based on the above-mentioned principle of ‘safety, security and effectiveness’. These institutions include the Simón Bolívar University. The safety and security of medical materials or equipment are subject to the criteria used by the specialist analyst, and where effectiveness may depend on complying with the functions for which they were designed and built, pursuant to the technical specifications issued by the manufacturer (meaning that the equipment functions as intended). These two elements are sufficient to provide new grounds for issuing the Quality Certificate.

Documentation
a) Company registration with the public health authorities.
b) Certificate of Free Sale for the product to be registered, issued by the authorities in the country of origin.
c) Power to import, manufacture or register the product in Venezuela, granted by its proprietor to the company applying for registration with the public health authorities.
d) Certificate of compliance with Good Manufacturing Practices issued by the Competent Authorities in the country of origin.
e) Certificate of analytical trials and/or clinical surveys proving the quality and efficacy of the described characteristics of the product, performed in the country of origin, appending protocols certifying to its quality, stability and/or activity, ensuring the confirmation of the product, as applicable.
f) Quality Certificate and protocol for the analysis, providing satisfactory documentary evidence of the product characteristics, issued by one of the institutions accredited by the Ministry of Health and Social Development.

Mexico
According to Mexican Law, ‘health products’ are devices, accessories and instruments for specific purposes, intended to provide medical care, surgery, exploratory diagnostic treatment and rehabilitation procedures in patients, as well as those intended for biomedical research purposes.
The general purpose of the authorisation process is to grant public health registration to medical devices whose therapeutic efficacy and safety have been proven through scientific methodology acceptable to the international community, and which comply with the requirements stipulated in the General Healthcare Act and other applicable provisions for the benefit of the Mexican people.
Materials are classified by risk for public health registration purposes into Class I, Class II and Class III, pursuant to Article 82 of the Healthcare Input Materials Regulations.
Taking into account the provisions in Article 194 of the General Healthcare Act, it is important to note that the documentation should be submitted prior to forwarding the application for preliminary review and guidance, in order to ensure that the application moves ahead smoothly.
Specific documents and data that should be included or appended to the application are:

a) Scientific and technical information demonstrating that the item is safe, secure and effective.
b) The draft label, written in Spanish, pursuant to the corresponding standard.
c) Instructions for use, if any, or operating manual, written in Spanish.
d) A description of the manufacturing process.
e) A description of the structure, materials, parts and functions of any medical equipment.
f) A declaration of Good Manufacturing Practices.
g) Laboratory evidence to ascertain the specifications of the item.
h) Bibliographical references.
i) Other documentation stipulated by the Bureau in the corresponding standards.

In order to obtain public health registration for items manufactured abroad, in addition to complying with the requirements listed above, an application should be submitted in the official format, attaching the following documentation:

a) Certificate of Free Sale or equivalent issued by the public health authority in the country of origin.
b) A letter of representation issued by the manufacturer if the product is not manufactured by the head offices, plant or laboratory applying for registration in Mexico.
c) Certificate of Good Manufacturing Practices issued by the public health authority in the country of origin.
d) Original analysis certificate issued by the company preparing the product, with its company stamp, signed by the chemist in charge of the foreign company.

Chile
There are no legal registration requirements for medical devices as there are for pharmaceutical products, meaning that they may be sold freely with no authorisation issued by the Public Health Institute, pursuant to Law No 19, 497 and Regulation 825/98.
Companies wishing to assess the details of their products may do so at the Diagnostic Reactive and Medical Devices Sub-Department, on a free and voluntary basis, in order to carry out a conformity check which consists of ascertaining, for example, the composition, planned use, manufacturer quality certificates, FDA certificates or those issued by some other agency showing that the product is a medical device. Finally, the Sub-Department issues the certificate and an annex summarising all the technical information on the device.

by Eliana Silva de Moraes is an attorney specialising in food and drug law for the Latin American region.

GM Foods Debate Hits Latin America

A forum on Latin America and biotechnology did little to paint a clear picture of the future for genetically modified crops in the nations south of the United States. 'But it did clearly illustrate that the real debate over agricultural biotechnology rests between the European Union and the United States.

Today's "Latin America Biotechnology Forum," hosted by the U.S. Chamber of Commerce, detailed how Mexico, Brazil and Argentina are all at very different points on the path to acceptance of genetically modified (GM) foods. The agricultural industries in all three countries all seem keen to deploy biotechnology in their fields, but their governments and public citizens are not so sure.

And none of these countries can escape the shadow of the U.S./EU debate, which is threatening to boil over into a major trade dispute.

Genetically modified corn (Photo courtesy Monsanto)
The United States produces some two-thirds of the world's genetically modified crops and is embroiled in a bitter dispute with the European Union over its four year moratorium on the approval of new GM crops.

The U.S. agricultural industry claims it has lost hundreds of millions, including $200 million in corn sales, because of the moratorium. In late November, the European Union proposed stricter labeling and traceability of all food and animal feed containing more than 0.9 percent genetically modified ingredients. EU officials say they are simply responding to the European public's demand for tight controls.

These new regulations could affect more than $4 billion in U.S. agricultural trade. It is not surprising U.S. officials are warning of possible action through the World Trade Organization (WTO).

"The EU moratorium on approvals is a blatant violation of the WTO treaty," said David Hegwood, counsel to the Secretary of Agriculture, U.S. Department of Agriculture. "If we can get the moratorium lifted without taking a case, then it saves us a whole lot of time and trouble. But that's our ultimate objective, to get the moratorium lifted."

Hegwood, the luncheon speaker at today's forum, focused not on Latin America, but on the need to pressure Europe to change its ways. The ripple effect of EU policies, he said, is having a devastating impact on African nations who have refused U.S. food aid for fear of genetically modified crops.

"The fear of Europe is keeping food out of the mouths of hungry people in Africa," Hegwood said, adding that African governments are needlessly concerned that the food aid will end up in crops or beef tagged for export to Europe. These exports then could be rejected by the EU because of its moratorium, he explained.

Still, many countries as well as UN Secretary General Kofi Annan have supported the right of African nations to ban genetically modified foods. South Africa and Japan, among others, have said they can help fill the void if U.S. GM corn is not accepted as food aid.

But the villain is clear in Hegwood's eyes, and the implications are grave, he said.

"European consumers aren't sure about biotechnology so hungry people in Africa don't eat," Hegwood said. "If European attitudes are influential enough to take food away from hungry people in Africa, imagine what impact it is having in the rest of the world."

"If it happens to the United States, it will happen to every country that utilizes biotechnology," Hegwood said.

Genetically modified corn (Photo courtesy Monsanto)
According to representatives from Latin America at today's forum, these attitudes are indeed having an impact on their countries. The governments of Argentina, Brazil and Mexico are all concerned about the export market for genetically modified goods and this economic concern has been added to a list of worries over the environmental and social impacts of agricultural biotechnology.

The patents for GM crops are held by only a handful of multinational corporations and this weighs heavy on the minds of many Mexicans, according to Jose Luis Solleiro, member of La Comisi�n Intersecretarial de Bioseguridad y Organismos Gen�ticamente Modificados (CIBIOGEM)'s Biosafety Council and technical director of AgroBIO Mexico.

"There is concern over increasing economic control by the multinationals," Solleiro said. "The idea that biotechnology only benefits big multinational corporations has very deep roots in Mexico."

Mexico allows genetically modified foods to be imported as long as they are labeled, but the planting of GM crops has not been allowed. The fear that genetic modifications could end up affecting the native corn is a paramount concern for Mexicans. Corn has it origins in Mexico and is the staple food for much of the population.

Fears over this biosafety aspect of genetically modified crops has prompted the introduction of six separate Congressional resolutions addressing the issue, said Alvaro Rodriguez Tirado, managing director of Estrategia Total, an agricultural consulting firm.

"Mexican society has increased pressure on Congress to do something," Tirado said, adding that a recent survey indicated 40 percent of Mexicans in support of GM crops, 40 percent opposed and 20 percent undecided.

Brazil has had an import and production ban on genetically modified crops since 1998, much to the distaste of the Brazilian representatives at today's forum. Biotechnology could help the country lower its high costs of production, according to Paulo D'Arrigo Vellinho, executive director of the Brazilian Poultry Industry Union and vice president for the South Region of Brazil.

"All we have in Brazil is a political issue," agreed Luis Antonio Barreto de Castro, head of the Genetic Resources and Biotechnology/Brazilian Agricultural Research Corp. from the Ministry of Agriculture and Supply, known as Cenargem/Embrapa.

"Agriculture is the only sector that is profitable in Brazil," Barreto de Castro said, adding that he hoped economic pressures could help prompt the incoming government to reconsider the policy against GM crops.

There was evidence later today, however, that some change may be afoot. Brazil's new agricultural minister told Globo TV today that Brazil might need to import corn next year from genetically modified crop producers to feed its livestock.

Many Brazilian farmers already grow GM crops in Brazil. Barreto de Castro said government officials estimate some four million hectares of GM soybeans are been grown throughout the country. This accounts for some 25 percent of the Brazil's soybean production.

GM soybeans is a crop Argentina has embraced with gusto, as some 90 percent of its soybean crop is genetically modified, according to Marcelo Regunaga, Argentina's former agricultural secretary. Argentina is the world's number one soybean exporter and has found the GM version of the crop a major boon to its agricultural industry.

"We don't subsidize agricultural production so we need to be competitive through means that can lower our costs of production," Regunaga said. "And these products have a positive impact on the environment."

Less pesticides and higher yields, Regunaga said, have many in Argentina convinced that genetically modified crops are the future. But its experience with GM corn shows that all is not rosy with agricultural biotechnology.

GM corn from biotechnology giant Monsanto was introduced in 1998 but has not been approved in Argentina. Argentina exports some 9.5 million tons of corn a year. Although only some of its corn is exported to European markets, the fear that GM corn would be rejected has led the government to avoid the genetically modified variety.

Genetically modified cotton (Photo courtesy Monsanto)
Argentina's dilemma is not one farmers in the United States are facing as they embrace genetically modified crops with increasing enthusiasm. Some 34 percent of U.S. corn is genetically modified, as is some 71 percent of U.S. cotton and 75 percent of U.S. soybeans.

"Biotechnology foods do not create an environmental concern, nor are they a threat to consumers or producers," said Tom Sell, majority deputy staff director for the House Committee on Agriculture. "There is wide consumer acceptance in the United States."

"Scientists say these foods are safe - that is the established consensus," added Karil Kokenderfer, director of international trade environmental affairs and coordinator of biotechnology for the Grocery Manufacturers of America. Kokendefer expressed the unanimous view of all the forum's panelists that labeling, especially the regime planned by the European Union, is unnecessary.

"Labeling is not knowledge nor a surrogate for food safety," she said. "It is not an appropriate import control nor is it a reflection of consumer values."

The European approach, added Terry Medley, vice president of global regulatory affairs for DuPont Agriculture and Nutrition, will not enhance public confidence as it is intended.

"It will cause more trouble and distrust," he said.

More than 35 countries, however, have followed Europe's lead and developed some form of labeling requirement for genetically modified foods.

Latin America in the spotlight as dietary supplement regulation evolves

Key decision-makers from government and industry are set to convene in Colombia to address changing dietary supplement regulation throughout theLatin American region and its impact on consumers.

Taking place in Bogota on 4-5 September 2013, the Scientific and Regulatory Trends on Dietary Supplements Workshop comes to Colombia as it is recognised to be a reference for regulation in the Latin American region.

The workshop is being organised by the Latin American Responsible Nutrition Alliance (ALANUR) with the support of the International Alliance of Dietary/Food Supplement Associations (IADSA) for regulators, policy and scientific experts to share ideas and identify new avenues in areas where legislation is not yet complete.

With changes in dietary supplements regulation being felt across more than 70 countries, the workshop will highlight regulatory trends across Latin America and worldwide. It will address the challenges and opportunities emerging in Colombia's regulatory environment, including issues such as substantiating health claims and ensuring the safety of bioactive substances in dietary supplements, as well as the food supplements policy and regulation, current regulatory practices and plans for further development of the regulation in the countries that are invited to participate at the workshop.

ALANUR Vice Chair, Norma Cavazos, said: "We have chosen Colombia for
this workshop because of its dynamic marketplace. It is one of the largest single market for dietary supplements, and in many ways will be a springboard for the rest of Latin America."

The workshop will gather authorities from particularly Andean Community member countries, such as Colombia, Bolivia, Ecuador, Peru, and also from Venezuela, and Paraguay, together with academic experts to address scientific and regulatory trends around dietary supplements. Attendees will also be given an overview of the key regulatory developments and current industry requirements, intermingled with regular interactive ‘question and answer' sessions.

Key discussion points at the workshop includes the classification and definition of food supplements, the safety of food supplement ingredients, the requirements related to the use of claims insupplements and developing effective systems for quality, market access and control of these products.

"The workshop will provide the regulators the opportunity to debate the key regulatory issues in the region and the potential for change in the light of international regulations and practice," said ALANUR Chair, Dr. Tatiana Pires.

In addition, IADSA Regulatory Affairs Director David Pineda Ereño said: "One of the aims of ALANUR and IADSA is to encourage greater communication on the regulation and science behind dietary supplements, and we will continue to encourage further detailed discussions at regional and national level."

ALANUR is the first association of food supplements in Latin America at a regional level. It was founded in 2011 to contribute with the development of the regulatory framework of food supplements and ingredients. IADSA was founded in 1998 and, nowadays, more than 50 associations of manufacturers and providers all over the world are members. ALANUR and IADSA jointly cooperate on the aim of creating forums where authorities, regulators and other experts can share information, experiences and perspectives on the use, regulation and scientific trends of food supplements and ingredients.

Latin America a diverse regulatory pool for functional food says EAS

Strategic advice on nutritional products

Successfully launching functional foods across Latin America requires a clear understanding of the diverse legislations from country to country EAS has said.

Ainhoa Larrañaga, regulatory affairs manager at EAS’ Latin America office in Buenos Aires, said that legislative differences include issues of classification in terms of whether products are considered food or medicine, different rules on the use of botanicals and varying limits on distribution channels.

Ms Larrañaga also highlighted that while in a number of countries in the region regulations are still limited on the use of ingredients and levels, trends are moving towards the consideration of safety rather than Recommended Daily Allowances (RDAs) for setting maximum levels, and an interest in notification systems rather than registration.

“The regulatory disparities across the region do not facilitate the marketing of products with just one formula and marketing strategy, as permitted ingredients, levels and use of claims vary from country to country,” she said. “Companies should be aware of these regulatory discrepancies when launching their products regionally.”

Ms Larrañaga highlighted that many countries in the region are also actively developing legislation relating to claims and nutrition labelling, with Brazil in the process of making amendments to its nutrition claims regulation, Argentina developing a regulation on health claims, and Mexico and Colombia having introduced new nutrition labelling regulation this year.

“Unlike the European Union and the ASEAN region, there is no harmonisation as yet for the whole Latin America region,” said Ms Larrañaga. “But there are stirrings towards standardised norms. There are standardised rules for food and nutrition labelling within Mercosur, which is made up of Argentina, Brazil, Paraguay and Uruguay. And in Central America nutrition labelling as well as food additive rules have been standardised in Costa Rica, El Salvador, Guatemala, Honduras and Nicaragua.”

For more information on regulatory requirements and developments in the Latin America region contact the EAS Latin America office in Buenos Aires at info@eas-americalatina.com or visit www.eas-americalatina.com

Regulation of Food Supplements Gains Momentum in Latin America

Food Manufacturers Authorities from Bolivia, Colombia, Ecuador, Paraguay and Peru met with scientific experts and experts in regulatory policies on Sep. 4 and 5 in Bogota, Colombia, in order to address the regulatory changes and the scientific trends currently underway on food supplements and its impact on markets. Dr. Diana Liévano opened the event and highlighted the opportunity of sharing information on dietary supplements in the region. Speakers presented and debated about the main regulatory developments on the different countries. Topics on the agenda ranged from food supplements definition, safety on the use of ingredients in supplements and criteria to establish maximum levels of vitamins and minerals, to regulation and substantiation on the use of health and nutrition claims, adequate good manufacturing practices requirements for food supplements and systems for market access and monitoring of supplements on the market. The following regulators participated at the event: Dr. Diana Liévano, Coordinator of Sanitary Registrations of Phyto-therapeutic Products, Homeopathic Medicines and Dietary Supplements, INVIMA, Colombia; Ms. Gabriela Ferreira Silvero, Technical Assessor, Department of Evaluation and Registration, National Agency for Sanitary Surveillance, Paraguay; Eng. Katty Rojas, Head on Food Safety, National Service on Agricultural Health and Food Safety (SENASAG), Ministry of Agriculture, Bolivia; Noemí La Torre Paredes, Specialist on Health Evaluation of Dietetic Products and Sweeteners, General Directorate of Drugs (DIGEMID), Peru; Dr. Veronia Flor Terán, Food Safety Analyst, National Directorate Health Surveillance and Control, Ministry of Public Health, Ecuador; and Jannet Arismendi from the Ministry of Health of Colombia. “This event was a unique platform that brought together authorities, academics and representatives from the supplements sector and during which the basis to continue with the cooperation and organization of scientific technical events with the aim of continuing the work on key issues around food supplements regulations have been set, and where ALANUR and IADSA are positioned as sources of information and guidance on the dietary supplements framework,” said David Pineda Ereño, Regulatory Affairs Director of IADSA. “We are delighted to offer this space for communication and exchange of information on regulatory and scientific issues around food supplements, which promotes the cooperation in the work in the region,” said Dr. Tatiana Pires, Chair of ALANUR. “ALANUR, with the support of IADSA, will continue working on the approximation of criteria to serve as a reference point for food supplement regulations across Latin America,” she added. In this sense, ALANUR and IADSA will continue providing technical support to authorities, and also through the organization of events that permit the flow of information for building responsible practices through the promotion of science, quality and safety in relation to food supplements. -
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