Brazil's tobacco control measures
Restrictions on Additives
In November 2010, Brazil's national health regulator, ANVISA, issued a draft regulation (No. 112) that would limit the tar and nicotine levels in cigarettes, as well as banning certain additives.
In December 2010, it notified the WTO TBT committee.
In November 2011, TBT Committee Secretariat reported that the resolution was again raised in committee. "Objecting to the measure as an unjustifiable restriction on trade were: the EU, Mexico, Nigeria, the Philippines, Indonesia, Turkey, Colombia, Honduras, Zimbabwe, Chile, Zambia and Russia (an observer)."
In March 2012, the issue was again raised at TBT Committee, with concerns expressed by the European Union, Mexico, Honduras, Guatemala, Dominican Republic, Indonesia, Nigeria, Zimbabwe, Colombia, Zambia, and Turkey. Australia and Norway spoke in favour, and Chile asked questions.
In the June 2012 TBT meeting, the issue was raised, with concerns expressed by Mexico, Guatemala, Dominican Republic, Columbia, Chile, Turkey. Australia spoke on behalf of he measure.
Extracts from TBT Minutes:
G/TBT/M/53 . Meeting of 24-25 March 2011
. Meeting of 24-25 March 2011
A. Specific trade concerns
1. The representative of Turkey raised concern over Brazil's draft resolution which would define permitted levels of tar, nicotine and carbon monoxide in cigarette smoke and prohibit the use of a comprehensive list of additives (listed in the annex to the resolution) in all tobacco-related products manufactured and sold in Brazil. Turkey did not question the legitimate objective of Brazil's regulation, namely, the protection of human health and prevention of deceptive practices, but was concerned with the procedures that Brazil had chosen to achieve it. The representative of Turkey explained that the additives prohibited included any substance or compound other than tobacco and water, whether used to process, manufacture or pack tobacco-based products including flavourings, aromas and ameliorants.
2. He explained that some of the banned additives were essential components of Burley and Oriental tobacco, used in blended cigarettes and that as a result, the regulation would effectively ban blended tobacco products from the market. Prohibiting blended tobacco products would unintentionally favour non-blended tobacco products and go against the stated objectives of the regulation. Turkey was of the view that the regulation was more trade restrictive than necessary and would violate Article 2.2 of the TBT Agreement.
3. Moreover, the representative of Turkey questioned the choice of additives included in the annex to the draft resolution. He explained that some additives were essential components for blended cigarettes and did not give any characterizing flavours to the product, leaving blended and non-blended products with the same taste. Turkey was of the view that Brazil had based its decision on the ingredients exclusively, without considering the effects of such ingredients on the final product. By grouping the additives used during the blending process and those lending strong characterizing flavours into the same category, the regulation would violate Article 2.8 of the TBT Agreement. He asked whether less trade restrictive measures, such as only limiting additives with characterizing flavours, had been considering.
4. Furthermore, he noted that Brazil had not cited any studies, as required in the TBT Agreement. He claimed that there was no scientific evidence to demonstrate that additives used in blended tobacco made those products either more attractive for consumers, more harmful to health or more addictive. He requested Brazil to provide evidence that the additives used for blending tobacco, as included in the draft resolution, posed increased risk for human health. He also asked for comparative data on the attractiveness of blended versus non-blended cigarettes, and data on the human health risks of additives used for blending versus additives that gave characterizing flavours. He concluded by noting that Turkey produced 80,000 pounds of Oriental tobacco annually, and stated that Brazil's regulation would affect Turkish social, economic and export interests.
5. The representative of Malawi noted that, in banning additives in tobacco products and prohibiting the manufacture and sale of cigarettes containing any ingredients other than tobacco and water, Brazil's regulation would effectively ban the manufacture and sale of traditional blended cigarettes produced using Burley tobacco. Malawi was of the view that Brazil's draft resolution was even more restrictive than legislation adopted by Canada in 2009 – Bill C-32. He noted however that while traditional blended cigarettes held a very small market share in Canada, they made up almost 100 per cent of the cigarettes currently sold in Brazil. Malawi did not object to Brazil's public health objective of reducing the incentives for young people to smoke, but believed that the proposed legislation was not an appropriate international model for the regulation of ingredients, since it had not been based upon any meaningful scientific assessment or evaluation of ingredients. He noted that Malawi's concerns over Brazil's regulation were the same as its concerns over Canada's Bill C-32.
6. The representative of Malawi claimed that there was no reliable evidence to suggest that the use of flavours caused minors to begin smoking. Instead, he claimed that evidence, and research that existed on the subject, indicated that ingredients were an irrelevant predictor for smoking. Societal influences including peer pressure, parental or family influence and the desire to be perceived as fashionable, independent and more "grown up" were widely acknowledged as the primary explanations for smoking uptake by young people. Moreover, research had demonstrated that there was no significant difference in smoking prevalence between American blend and Virginia style dominated markets. As such, Malawi was of the view that the legislation proposed by Brazil would pose an unnecessary obstacle to international trade, violating Articles 2.2 and 2.8 of the TBT Agreement.
7. The representative of Malawi also expressed concern that Brazil's legislative model could be adopted on a wider basis. Should this occur, he explained that many consumers worldwide who traditionally preferred American blend cigarettes would no longer have legitimate access to their preferred product. Such a situation could incentivise illicit trade in counterfeit and contraband cigarette products. Additionally, the ability of tobacco manufacturers to develop new products would become compromised. In particular, he said that the legislation would disproportionately harm producers of Burley tobacco, including the approximately 700,000 farmers who cultivated tobacco in Malawi. He explained that Malawi was the world's largest exporter of Burley tobacco, accounting for approximately 25 per cent of world production, with an approximate annual crop volume of 208,682 metric tonnes. The tobacco industry in Malawi contributed approximately 13 per cent of the country's GDP and 60 per cent of its foreign exchange earnings. Given that tobacco was Malawi's most important cash crop, that the tobacco industry was the main driver of growth for the economy, and that all of Malawi's Burley tobacco was bought by cigarette manufacturers to be used in the international production of traditional blended cigarettes, the consequences of Brazil’s proposed legislation being adopted on a wider basis would be unthinkable.
8. Malawi recognized the health risks associated with the use of tobacco products, and was of the view that the development of an appropriate and proportionate international framework to regulate the industry, based on sound scientific evidence, was both necessary and right. However, Malawi considered that the legislation being proposed by Brazil was not an appropriate international model for the regulation of ingredients, given the scientific evidence available and the likely consequences of adopting this legislation more widely.
9. The representative of Malawi called on Brazil to refrain from implementing the proposed regulations and to consider less restrictive measures that would comply with WTO obligations while safeguarding the economic well-being of Malawi. Furthermore, Malawi called on Canada to overturn Bill C-32, and also called on other Members to refrain from adopting similar legislation in the future. Finally, he noted that Brazil had ratified the World Health Organization's Framework Convention on Tobacco Control (FCTC) and asked Brazil whether it's current proposal contradicted or implicitly undermined the purpose and spirit of the interpretive declaration it had made. He noted that Malawi, and the Executive Council of the African Union, had endorsed the Declaration of the African Ministers of Trade on the Framework Convention on Tobacco Control.
10. The representative of Zambia explained that while his delegation did not question the objective of Brazil's measure, namely of protecting human health and preventing deceptive practices, Brazil's regulation could have major trade implications, and could violate Article 2.2 of the TBT Agreement. He informed the Committee that the Brazilian measure had been extensively discussed during the WHO FCTC Fourth Conference of the Parties held in 2010. Furthermore, Zambia was of the view that the submissions by the Working Group on Article 9 of the FCTC had not been fully adopted and as a result, the mandate of the Working Group had been extended to the Fifth Conference of the Parties, scheduled for October 2012. In particular, the Working Group on Article 9 would undertake further work on issues relating to the definition and measurability of attractiveness and palatability of ingredients necessary in the production of traditionally blended cigarettes. He noted that Brazil had fully participated in past deliberations.
11. Because of the potential implications of the Brazilian and other similar measure on traditionally blended cigarettes, and the tobacco varieties specific to blended cigarettes, the representative of Zambia posed a number of questions: What scientific evidence and experience from other countries had Brazil considered in preparing this regulation? On the basis of that evidence, how would banning the production and sale of tobacco-based products containing additives protect human health and deceptive practices in Brazil? What scientific evidence had been used to measure the effect of ingredients on the palatability of tobacco products?
12. He also questioned why Brazil had gone forward with its regulation, which it had stated was based on the WHO FCTC, when the relevant FCTC Working Group had not finished its work. He reiterated his understanding that the guidelines being prepared by the Working Group would not be completed until October 2012. Because the outcome of the Working Group on Article 9 would serve as useful guidance for countries contemplating possible measures, Zambia saw Brazil's measure as premature.
13. Moreover, the representative of Zambia said that the Brazilian measure posed systematic concerns for traditionally blended tobacco products. In this regard, he noted that the Fourth Conference of the Parties to the FCTC had recognized the difficulties that could be associated with blanket measures such as a total ban, and that general discussions had favoured restriction over prohibition. He noted that Zambia was ready to engage with Brazil on this matter, either bilaterally or through other channels.
14. Finally, he commented that tobacco-related trade concerns had been on the agenda of the TBT Committee for some time, and were likely to continue to be discussed as Members adopted such measures to meet their national policy objectives and fulfil regional or multilateral obligations. In order to facilitate coordination at the national level, and to ensure the supportiveness of obligations undertaken by Members is various multilateral fora, the representative of Zambia proposed that the TBT Committee organize a joint meeting with the WTO and FCTC. Zambia was of the view that it was important to find a lasting solution and that this approach would be the most effective way of addressing Members' tobacco concerns in a holistic manner. He highlighted that this discussion closely mirrored similar discussions on specific trade obligations set out in multilateral environmental agreements in relation to WTO rules.
15. The representative of Mexico stated that his delegation shared Brazil's objective of protecting human health. However, he was worried that the Brazilian measure not only followed the same path as the Canadian Bill C-32, but was in fact more restrictive since it also banned menthol. He noted that while Mexico’s exports of tobacco products to Brazil were currently limited as compared to other Members, the proposed regulation would impose a barrier to future growth potential.
16. The representative of Mexico elaborated four specific concerns with the Brazilian measure. First, relating to Article 2.9 of the TBT Agreement, it was Mexico's understanding that after the deadline of 31 March 2011 for presenting public comments on the draft resolution, Brazil could potentially implement the measure immediately, without Congress examining it. He asked for clarification on whether Brazil intended to implement the measure immediately following the deadline of public consultation.
17. Second, it was the view of Mexico that the measure was inconsistent with Article 2.2 of the TBT Agreement as it was more trade restrictive than necessary to achieve the legitimate objective of protecting public health. He explained that other countries had successfully used less restrictive measures, such as limits on additive levels, without banning their use, to reach their human health objectives. He also echoed previous interventions to the effect that, to date, no study or scientific evidence supported regulation of the type proposed by Brazil's draft resolution.
18. Third, he noted that technical regulations should be based on the use of products rather than design or descriptive characteristics. As such, by regulating ingredients per se instead of only tobacco products that presented certain characteristic additives, he believed that Brazil's regulation was contrary to Article 2.8 of the TBT Agreement.
19. Fourth, he stated that the fact that Brazil’s draft regulation was purportedly based on the WHO FCTC had no relevance as to whether the measure was in line with WTO Agreements, as would be the case with any convention in another international organization directing the actions of Members, since the WTO Law System was in general self-contained. Moreover, he claimed that Brazil's proposed measure did not even fall within the mandate of the FCTC. At the FCTC's fourth Conference of the Parties (COP 4) in November 2010, Parties had partially adopted the guidelines of implementation of Articles 9 and 10 of the FCTC. He elaborated that section 3.1.2 of these guidelines had established that measures considered necessary to regulate ingredients of tobacco products would have to be based on conclusive scientific evidence and on the experience of other countries.
20. In spite of the fact that these guidelines allowed for restrictions on the use of ingredients, he explained that Parties at COP 4 had deemed it necessary to have additional scientific evidence to establish links between the banning of ingredients and the addictiveness or toxicity of tobacco products. Indeed, this point was to be further discussed at COP 5 in 2012. As such, Mexico was of the view that Brazil's proposed measure was premature. Moreover, Mexico was concerned that a tobacco producer such as Brazil was following a precedent that could lead to confusion for other Members as to how they should regulate tobacco products. He echoed Zambia's proposal to organize a joint meeting with the WHO Secretariat of the FCTC so as to increase awareness of TBT issues and coherence with other international organizations.
21. The representative of Indonesia requested clarification on a number of issues related to Brazil's draft regulation. First, regarding the definition of tobacco products, he asked whether these definitions extended to crafted cigarettes. Second, he asked what international laws Brazil had referred to in establishing maximum levels of permissible tar, nicotine and carbon monoxide. Also had sought further explanation as to the rationale for the inclusion of each additive, and whether the prohibition applied to both smoke and smokeless products.
22. Third, he explained to the Committee that Article 4 of the draft resolution prohibited the use of any description on tobacco product packaging or advertising materials that could give consumers misleading information. Referring to words such as class, ultra-low content, low content, soft, light, mild, moderate, and high-content, he asked Brazil to clarify which words were prohibited and provide examples of words still permitted. In this regard, he asked whether Brazil planned to initiate a process to pre-approve packaging and whether the use of brand names which contained prohibited words would also be banned.
23. Fourth, he noted that Annex I to the Brazilian draft resolution outlined a number of exceptions to the ban on the use of additives, for instance, additives that were required to manufacture tobacco products had been excluded. He asked Brazil to explain how and why certain types of additives could be excluded from the ban. Fifth, he observed that in Article 3 of the draft resolution, limits for tar, nicotine and carbon monoxide in the cigarettes sold in Brazil had been determined by quantitative laboratory analysis. He asked which standard Brazil had used to determine quantitative analysis and the kinds of laboratories that were recognized to perform the analysis.
24. Finally, in relation to Article 2.9.2 of the TBT Agreement, he noted that Article 4 of Brazil's draft resolution stated that the measure would take effect immediately. He asked for clarification on this matter, and in particular, if and how long a transition period for compliance would be permitted for manufacturers and importers of cigarettes. If the measure was to apply immediately, he asked if this meant that Brazil regarded the problem as urgent, as described in Article 10 of the TBT Agreement.
25. The representative of Tanzania noted that Tanzania was one of Africa's major tobacco growing countries, and that Brazil's proposed law would disrupt his country's tobacco leaf exports and imports. He explained that the Brazilian market was predominantly a traditional-style blended cigarette market. Traditional blended products used different grades of Burley, Virginia and Oriental tobacco and required blending with certain ingredients, which the Brazilian law sought to prohibit. As such, tobacco manufacturers in Brazil would no longer to able to manufacture traditional blended cigarettes for the Brazilian market, or for export, which would have a negative impact on imports of tobacco into Brazil, including tobacco from Tanzania.
26. The representative of Tanzania further explained that the Brazilian draft resolution would introduce significant changes in tobacco blends, which would in turn impact demand for different leaf grades of Burley, Virginia and Oriental tobacco. Tanzania was of the view that the draft resolution was more trade restrictive than necessary to meet the legitimate objective of protecting public health. In particular, the draft resolution would have a devastating impact on Tanzania's tobacco leaf exports and Tanzania's long-term tobacco crop development prospects. Tanzania produced an annual crop of approximately 12,000 metric tonnes, the majority of it being Virginia tobacco. Moreover, approximately 100,000 families were involved in growing tobacco, with over 95 per cent of the crop being exported to manufacturers worldwide, including Brazil. This generated annual revenue of USD231 million in export earnings. He noted that any measure that restricted blended cigarettes would therefore have devastating implications on Tanzania's earnings. Other cash crops had been struggling in global markets in terms of price, and tobacco had become the leading cash crop in Tanzania.
27. He stated that the Brazilian draft resolution could easily be implemented in a less trade restrictive manner, while still meeting its objective. He reminded the Committee that Article 2.2 of the TBT Agreement prohibited WTO Members from adopting technical regulations that had the effect of creating unnecessary obstacles to trade meaning that technical regulations shall not be more trade restrictive than necessary to fulfil a legitimate objective, taking into account the risks that non-fulfilment will create. He asked Brazil to explain how its draft resolution was consistent with these requirements.
28. The representative of Tanzania also noted that only partial guidelines on Articles 9 and 10 of the WHO FCTC had been adopted during its Conference of the Parties in November 2010. In particular, section 3.1.2 of the guidelines had placed emphasis on the need for scientific foundation of measures. Tanzania was also of the view that Brazil had not demonstrated that traditional blended cigarettes exhibited discernable flavours.
29. Finally, he explained that Article 12.3 of the TBT Agreement required Members to ensure that their technical regulations did not create unnecessary obstacles to exports from developing country Members. According to Tanzania's information, Brazil imported over USD6 million of tobacco from least-developed countries, Tanzania included, and over USD60 million from other developing countries. As such, Brazil's resolution would negatively impact developing countries, particularly LDCs, whose development Brazil had always supported. He urged Brazil to adopt a regulation that would take these concerns and obligations into account.
30. The representative of Zimbabwe also supported the health objective behind Brazil's regulation, but cautioned that this topic needed to be addressed in a scientific manner, which did not contradict the TBT Agreement. He explained that Zimbabwe was one of the major producers of Burley and Virginia tobaccos; that the industry generated employment for many Zimbabwean families; and that tobacco was the country's largest foreign currency earner. If implemented, the measure would have a devastating effect on employment, foreign currency earning and on the general state of the Zimbabwean economy. He urged Brazil to wait until after COP 5 of the FCTC to proceed with its legislation on this topic. He noted that basing regulations on scientific evidence and the TBT Agreement would facilitate trade rather than obstruct it.
31. The representative of the Dominican Republic shared the concerns of others and explained that by prohibiting additives, Brazil's regulation constituted a de facto prohibition on the manufacture and sale of traditional blended cigarettes, and the additives used therein. As a result, this would give rise to a prohibition on the use of Burley and Oriental tobacco in Brazil. Conversely, Brazil's regulation would allow the continuous production of cigarettes free of additives, using only cured tobacco, of which Brazil was the world's largest producer.
32. The Dominican Republic was of the view that Brazil's measure did not comply with Articles 2.2 and 2.8 of the TBT Agreement. He elaborated that in order to determine whether a measure was excessively trade restrictive, Members had to consider scientific and technical information. In particular, he expressed concern that the measure was more trade restrictive than necessary. His delegation believed that the measure sought to prohibit traditionally blended cigarettes, notwithstanding the lack of scientific evidence showing that they provided tastes and flavours different from the characteristic ones of tobacco. Furthermore, the measure was incompatible with Article 2.8 of the TBT Agreement, since it was based on design or descriptive characteristics. As an alternative, the representative suggested that Brazil prohibit tobacco products that presented fruity or sweet flavours, different from tobacco.
33. He asked whether Brazil's proposed measure had been based on scientific evidence. Specifically, he asked whether scientific evidence existed showing that flavours that do not provide distinctive flavours such as fruit or sweets could give rise to an increase in smoking. Furthermore, he inquired if there exited evidence showing that traditional cigarettes were particularly attractive to youths as compared to cured tobacco, or that additive-free tobacco products were less harmful or addictive than tobacco products containing additives. If such evidence existed, he requested that it be shared with the Committee. He also asked if other legislative solutions had been examined and how effective these alternatives were in terms of reducing the incidence of smoking as compared to the proposed measure. Finally, he inquired whether Brazil had carried out an evaluation of the potential impact of the draft resolution on the production and trade in cigarettes.
34. The representative of Mozambique noted that while his delegation did not object to the objective of protecting human health, behind Brazil's proposed regulation, Mozambique, as a tobacco growing country, was concerned about the possible implications for tobacco leaf exporters. He claimed that by banning additives, the measure would effectively ban traditional blended cigarettes and ban the use of Burley and Oriental tobacco in Brazil. He expressed concern that the measure would negatively affect Mozambique's export revenue and economic and development prospects.
35. He explained that Mozambique exported USD2 million per year in terms of tobacco to Brazil. This amount was significant for Mozambique who hoped to see increased tobacco export volume to Brazil. He requested that Brazil adopt a measure that did not create technical barriers to trade for tobacco originating from developing countries, for which tobacco was often a main export product. He supported Zambia's proposal to organize a joint discussion between the WHO and WTO on this matter.
36. The representative of Ecuador noted that his country was an exporter of tobacco and tobacco blends to Brazil. He his delegation recognized the legitimacy of the objective of protecting human health. However, he reminded the Committee of Members' obligations to not adopt regulations that could create unnecessary barriers to trade, in line with Articles 2.2 and 2.8 of the TBT Agreement. He elaborated that for measures to be in compliance with the TBT Agreement, they needed to be backed by technical analysis and sufficient scientific evidence to justify their adoption or promulgation. Ecuador was of the view that Brazil had alternative political options, which could be effective in reaching their legitimate objective without prohibiting in a de jure or de facto way, the trade of tobacco in the Brazilian market. Finally, he supported Zambia's earlier proposal, noting that this would help clarify the necessary measures for the control of tobacco consumption and the obligations that Members have under the multilateral trading system.
37. The representative of Jordan noted that his delegation supported the Brazilian measure's objective of protecting human health. However, he suggested that when dealing with human health, scientific evidence needed to exist. Hence, he questioned whether scientific evidence existed in this regard and whether the Brazilian measure was in line with Brazil's obligations under Article 2.2 of the TBT Agreement. Jordan was of the view that the Brazilian measure was far more restrictive than necessary.
38. The representative of Kenya informed the Committee that his delegation would submit written questions to Brazil later that day.
39. The representative of the Former Yugoslav Republic of Macedonia expressed concern with the direct effect of the implementation of Brazil's proposed regulation on trade in Oriental tobacco, of which Macedonia was the second largest exporter to Brazil in 2010. Moreover, he cautioned that such a regulation would jeopardize the vulnerable economies of countries in transition and least developed countries, especially in a period when Members were not progressing on the Doha Development Agenda, and were feeling the negative effects of the global economic crisis.
40. The representative of Chile was concerned that this type of measure could act as an unnecessary barrier to trade. For this reason, he called on Brazil to provide the scientific evidence upon which they had based their measure. He reiterated that the WHO FCTC guidelines detailed the necessity of scientific evidence before taking regulatory decisions. While Chile supported the legitimate objective of reducing the consumption of tobacco products in order to protect public health, they considered this measure more trade restrictive than necessary.
41. The representative of Nicaragua considered that Brazil's regulation would restrict trade in tobacco products more than necessary. More specifically, the measure would form an obstacle to trade, violating Article 2.2 of the TBT Agreement. She explained that while the objective behind the measure that Brazil had set forth in its notification to the WTO was recognized under Article 2.2 of the TBT Agreement, Nicaragua was not aware of any scientific evidence upon which the measure had been based, notably pertaining to the use of additives and human health. She requested that Brazil provide information on the scientific evidence upon which they had based the development of this measure.
42. The representative of Honduras joined others in voicing concern over the impact that Brazil's regulation would have on its exports. She noted that Honduras recognized the protection of public health as a legitimate objective, but was of the view that the Brazilian measure was excessive and would generate unnecessary barriers to trade. She explained that the measure would prohibit virtually all additives (including menthol) instead of only prohibiting pertinent additives, as was the case in other jurisdictions. As such, this could represent a de facto prohibition to the trade of certain tobacco products.
43. She noted that the Brazilian measure would prohibit the use of Burley tobacco in Brazil, which Honduras produced. This would cause Honduras' exports to fall, lead to job loss, and dampen the country's economic prospects, especially given the scarcity of alternatives for Honduras. Moreover, she claimed that the measure had not been based on scientific evidence proving that a specific flavour or certain additive would give rise to a certain pattern of consumption or make tobacco products more attractive.
44. She recalled Articles 2.2 and 2.8 of the TBT Agreement, and suggested that other types of measures could be put in place that would not have an impact on the final elaboration of the product. Moreover, regarding Article 12.3 of the TBT Agreement, she noted that Brazil's measure would create an unnecessary obstacle to the income of developing countries. She asked Brazil to explain how they would take into account the special circumstances of developing countries.
45. The representative of Cuba echoed the concerns expressed by others regarding Brazil's draft regulation. His delegation was of the view that no scientific evidence existed which proved a causal relationship between the use or patterns of tobacco smoking and the flavour and additives they contained; or that cigarettes with additives were more harmful or more attractive to youth than those which did not contain additives. As such, Cuba was of the view that this measure was unlikely to contribute to decreased tobacco consumption in Brazil.
46. While Cuba fully supported the objective of reducing the incidence of smoking habits among young people and the population in general, they were of the view that the regulation would unnecessarily restrict trade. Additionally, he explained that his delegation was concerned that the regulation could create a precedent, leading other Members to establish their own lists of additive restrictions, in turn leading to uncertainty and unnecessary obstacles in terms of trade flows. He suggested that Brazil consider adopting a less restrictive regulation, similar to other countries that had banned tobacco products highly flavoured with aromas. This approach was preferable since the regulation was based on the performance of the product rather than design and descriptive characteristics, as enshrined in Article 2.8 of the TBT Agreement.
47. The representative of Colombia believed that Brazil's regulation violated Article 2.2 of the TBT Agreement. He explained that while Colombia was ready to abide by the commitments it had made under the FCTC, discussions on questions of additives in tobacco products should be dealt with at the WHO.
48. More specifically, he commented that Brazil's broad restrictions on tobacco products and additives would be detrimental to cigarette trade, especially for Burley tobacco, which required additives to process this tobacco into American blend cigarettes. The representative claimed that the WTO was not the forum to discuss whether or not the measure would affect the smoking patterns of youth. Regarding the broader objective of protecting public health, he claimed that no evidence existed showing that tobacco products containing additives were more addictive. He highlighted that Brazil had raised similar concerns over Canada's draft tobacco regulation at previous TBT Committee meetings, causing Colombia to question why Brazil was now going forward with its own similar legislation.
49. His delegation was of the view that local tobacco producers in Brazil had influenced the adoption of this regulation. According to 2008 figures published by the Brazilian farming sector, Virginia tobacco represented 80 per cent of all Brazilian tobacco production, Burley tobacco 14.8 per cent, and others 5.4 per cent. Because the measure would be easier to implement for Virginia tobacco producers, he expressed the view that the measure would discriminate against those Members that produced other varieties of tobacco.
50. The representative of the European Union stated that the proposed Brazilian measure would imply that exports of traditionally blended tobacco products to Brazil would have to be discontinued. Moreover, it would affect exports of additives used in tobacco products from the European Union. She confirmed that the European Union supported the objective of protection of human health, which was in line with the WHO FCTC. She noted that the European Union was itself in the process of revisiting its Tobacco Directive in order to implement the recommendations of the WHO and in this regard had some questions for Brazil.
51. First, she asked for the background regarding Brazil's approach and reasons motivating the proposed ban on all additives, including sugars. Moreover, she inquired as to the grounds justifying a ban on additives, rather than setting limits. She asked whether Brazil had evaluated other legislative solutions, and whether it had carried out an assessment to determine if these alternative solutions were less effective in decreasing smoking rates than the proposed approach. She recalled that the Partial guidelines for implementation of Article 9 and 10 of the WHO FCTC recommended that Parties consider scientific evidence when determining new measures on ingredients.
52. Second, she enquired as to whether Brazil had assessed the impacts of the measure, including impacts on the consumption of tobacco products. In particular, she asked if Brazil considered whether smokers might shift to other type of cigarettes that did not contain additives, such as Virginia tobacco. If an impact assessment had been carried out, she asked that its conclusions be shared with the Committee.
Finally, she enquired about the timing for the adoption of the
proposal, and whether it would be necessary to issue any
implementing measures before these requirements could be put in
54. The representative of Brazil clarified some points regarding its National Health Surveillance Agency (ANVISA)'s Draft Resolution No. 112. He stressed that the proposed technical regulation had been notified to the TBT Committee. In addition, a period of four months, ending 31 March 2011, had been given to Members to make their comments. He confirmed that all comments received would be duly taken into account before the final technical regulation was published.
He confirmed that the objective of the measure was to protect
public health through the reduction of cigarette attractiveness.
In response to Mexico's claim, he noted that Brazil was an
important producer and consumer of Burley tobacco, and that
there was no reason to suggest any kind of discrimination in
this measure. He clarified that there would be no
requirement for this measure to be approved by the Brazilian
Congress, as it was completely under the scope of ANVISA's
competencies. He also confirmed that the measure had been based
on the WHO FCTC and its implementing guidelines.
With regard to the adequacy and necessity of the proposed
technical regulation, Brazil was of the view that the measure
was adequate. Since the evaluation of the presence of
aromas and flavours is subjective, previous attempts to prohibit
them without prohibiting additives had proven to be ineffective.
He also noted that the Brazilian Government had received
indications that the tobacco industry had mastered the
technology to process Burley tobacco without additives since
1996, thus leaving no grounds for allegations that prohibiting
additives would de facto prohibit Burley tobacco. In
addition, he noted that some countries produced and sold blended
cigarettes using Burley tobacco without the additives that this
measure intended to prohibit.
He informed the Committee that the Brazilian regulatory
authorities had information indicating that additives increased
the effect of nicotine, thus making cigarettes more addictive.
Sugar for example, when burned, became a substance known as
Acetaldehyde, which made cigarettes more addictive.
Additionally, some additives themselves were harmful to human
health since when burnt they released carcinogenic substances.
He noted that he had references to all of these studies and
would be willing to share them with Members. Finally, he
expressed an openness to further discuss this issue bilaterally
with interested delegations.
(xxiii) Brazil - Draft Resolution No. 112, 29 November 2010; maximum levels of tar, nicotine and carbon monoxide permitted on tobacco products and prohibition of additives (G/TBT/N/BRA/407)
253. The representative of the European Union supported the objective of protecting human health, which Brazil had indicated as the rationale behind its draft resolution, but referred to previous comments. Specifically, the proposed measure would imply that EU exports of traditionally-blended tobacco products to Brazil and its exports of additives currently used in tobacco would be discontinued. She highlighted that the European Union was itself in the process of revising Directive 2001/37/EC on the approximation of laws, regulations and administrative provisions of the Member States concerning the manufacture, presentation and sale of tobacco products and had identified the regulation of ingredients as one policy area that could potentially change. She recalled that a number of questions had been raised by the European Union at the previous meeting and, while acknowledging Brazil's helpful responses to several, noted that others remained unanswered. Specifically, she invited Brazil to clarify the grounds justifying a ban on additives over setting limits on use. At the previous meeting, Brazil had indicated that previous attempts to regulate aromas and flavours had been unsuccessful, but had offered no clarifications as to how this justified a complete ban. Furthermore, the European Union was also interested in whether Brazil had conducted an impact assessment, including on the consumption of tobacco products, as well as on growers and employment - particularly if Brazil had considered possible consumption shifts to additive-free cigarettes, such as Virginia tobacco. She requested a copy of any impact assessment, or a summary of its conclusions, if one had been carried out. Additionally, at the previous meeting Brazil had mentioned that its authorities had information indicating that additives enhanced the effect of nicotine, thereby making cigarettes more addictive. She requested more information on those studies, including the references of these studies to enable their evaluation by EU experts. Finally, the representative of the European Union requested an update of the state-of-play and asked Brazil to provide a written reply to its comments on the TBT notification before the adoption of the notified draft.
254. The representative of Mexico endorsed the European Union's concerns and asked for assurance that comments had been taken into account, if a written response to submitted comments would be forthcoming, and details about when Brazil planned to implement the regulation.
255. The representative of Chile requested time to prepare supporting evidence, citing the WHO document on tobacco control which supported governments giving consideration to scientific and any other kind of technical evidence. He supported the aim of reducing consumption to protect the health of young people but argued that these objectives could be achieved through less-restrictive barriers to trade.
256. The representative of Honduras was of the view that the Resolution would prohibit practically all types of additives, including menthol, representing a de facto ban on the marketing and sales of products containing certain types of tobacco, such as Burley and Oriental tobacco. Honduras remained concerned as Burley tobacco represented a significant proportion of its production and the draft Resolution would ban its use in Brazil, decreasing Honduran exports and national production. He argued that even though additives did not necessarily produce a specific flavour, the majority would be banned without supporting scientific or technical evidence; he added that no scientific evidence suggested that specific flavours would create a consumption pattern or make smoking more attractive. Honduras was concerned about the negative impact on its economy in the long-term.
257. The representative of Turkey questioned the definition of additives listed for prohibition in all tobacco-related products, specifically the inclusion of any substance or compound other than tobacco or water used to process, manufacture or pack tobacco-based products, including flavourings. The extensive list of prohibited additives and lack of supporting scientific evidence of any increased risk to human health concerned Turkey as the draft resolution would prohibit Burley and Oriental tobacco used in traditional blended products. Turkey had submitted comments and urged Brazil to consider them and amend the draft resolution to comply with its TBT obligations.
258. The representative of Colombia asked how Brazil would make use of the comments and queries received, suggesting they would prove a useful basis for a resolution more in-line with the TBT Agreement. He asked Brazil to provide updates on progress and reiterated concern that the draft would be set out and implemented as notified under G/TBT/N/BRA/407. He also asked for access to the scientific evidence used to justify the prohibition of the additives in question and any studies demonstrating the ineffectiveness of less-restrictive measures.
259. The representative of the Philippines was of the view that the draft resolution was arbitrary and unjustified discrimination, which would potentially result in a total ban of traditional blended cigarettes.
260. The representative of Brazil informed the Committee that the draft regulation and the comments received were still under consideration, that responses would be forthcoming and that he was unable to indicate when the final regulation would be published. He stressed that the objective was the legitimate protection of public health, with particular attention given to Article 184.108.40.206 of the partial guidelines to the implementation of Articles 9 and 10 of the WHO's Framework Convention on Tobacco Control. He recalled that the name "partial guidelines" only indicated that some parts of the instrument were pending further discussion while others were already fully approved. Article 220.127.116.11 was one of the provisions that had been unanimously approved by WHO and stated that, from a public health perspective, there is no justification for permitting ingredients such as flavouring agents, which made tobacco products more attractive. He observed that Articles 18.104.22.168 and 22.214.171.124 of these guidelines were similarly unanimously approved, and stated that regulation of ingredients aimed at reducing product attractiveness could contribute to reducing the prevalence of tobacco use and dependence among new and continuing users. Those articles also stated that attractiveness and its impact upon dependence should be considered when designing regulatory measures; and that the harsh and irritating character of tobacco smoke provides a significant barrier to experimentation and initial use. He referred to tobacco industry documents describing significant efforts to mitigate those negative characteristics of tobacco smoke. He cited a survey conducted by the Brazilian National Institute on Cancer (INCA) that had found that 45 per cent of people aged 13-15 consumed flavoured tobacco products.
261. For Brazil the measure was necessary given the failure of previous efforts to prohibit flavoured products rather than additives, due to the subjectivity of assessing flavouring and smells of products. Furthermore, according to information received by the Brazilian Government, the processing of Burley tobacco without additives was technologically feasible since 1996. He explained that evidence existed that some additives (including acetaldehyde, levulinic acid, gammavalerolactone and ammonia) strengthened the effect of nicotine. In addition, some studies indicated that, besides increasing the addictiveness of tobacco products, some additives, when burnt, could augment the carcinogenic properties of cigarettes. He informed Members that Brazil had compiled scientific references related to the properties and effects of additives and offered to share them with interested Parties. Finally, he referred to Brazil's production of Burley tobacco, highlighting that the measure did not differentiate between domestic and foreign producers and was thus nondiscriminatory.
Extract from WTO NEWS
Tobacco: specific trade concerns
Brazil has introduced a new draft regulation establishing the maximum permissible levels of tar, nicotine and carbon monoxide in tobacco products, and prohibiting the use of all additives in these products (G/TBT/N/BRA/407 — notified to the WTO on 29 November 2010).
Producers and exporters of Burley and Oriental varieties of tobacco perceive the ban on additives to be a de facto prohibition on 'blended' tobacco products (conventionally produced by blending these varieties of tobacco with a number of additives) in the Brazilian market. About 15 members said that this regulation was more trade restrictive than necessary to achieve Brazil's objective. This was particularly important for some countries, including African and least-developed countries (Zambia, Tanzania, Dominican Republic, Mozambique, Kenya), which depend on the sale of Burley and Oriental tobacco for national revenue.
Most members argued that Brazil gave insufficient scientific evidence justifying that additives made tobacco products more dangerous to health, or more attractive to consumers, especially young ones.
Brazil is not the only WTO member targeting tobacco products. Other members have taken similar measures to prohibit additives in tobacco products in line with the guidance of the WHO Framework Convention on Tobacco Control. Canada's measure (Bill C-32) was debated in the last Technical Barriers to Trade (TBT) meeting, and some members reverted to this issue. A summary of the discussions can be read here.
(xx) Brazil - Draft Resolution No. 112, November 29th 2010; maximum levels of tar, nicotine and carbon monoxide permitted on tobacco products and prohibition of additives (G/TBT/N/BRA/407)
127. The representative of the European Union referred to comments made at the previous two Committee meetings on this measure. The proposed measure would imply discontinuation of European exports of traditionally blended tobacco products to Brazil, and would also affect European exports of additives that were currently used in tobacco products. The EU supported Brazil's objective of protecting human health, in line with the WHO Framework Convention on Tobacco Control (FCTC). It explained that it was itself in the process of revising its Tobacco Products Directive and had identified regulation of ingredients as one area of possible change. She recalled questions raised by the European Union at previous meetings to help facilitate understanding of the measure; for instance, had Brazil evaluated alternative legislative solutions to a ban on all additives and why had these alternatives not been considered as effective for achieving the legitimate health objective? She requested an update on the status of the proposal, and a reply, prior to adoption of the notified draft, to the EU's written comments.
128. The representative of Mexico requested information on the implementation of Brazil's draft resolution, and a formal response from the Brazilian Government on Mexico's comments regarding the draft resolution presented on 31 March 2011.
129. The representative of Nigeria said his delegation was concerned with this draft resolution because his country had a long tradition of both growing and manufacturing tobacco products, and because the draft resolution came from Brazil, the world's third largest grower of tobacco leaf, behind only China and India in both the number of hectares devoted to tobacco growing and the number of tonnes of tobacco leaf harvested each year. ANVISA, Brazil's National Health Surveillance Agency responsible for the draft resolution, continued to review its content and to gather public input. He asked for an update on the latest developments in the public hearing process.
130. He further asked Brazil to reassess the resolution prior to adoption, so as to ensure coherence between the rights and obligations of Nigeria, along with the other African, Caribbean and Pacific countries (ACP) and African Union (AU) member States in the WHO, WTO and other international fora, particularly with respect to agricultural and rural development objectives. He expressed concern with Brazil's intention to impose a regulation that would create an unnecessary obstacle to trade for an agricultural product of great importance to many developing countries. He encouraged Brazil to modify the proposed resolution to ensure that it was fully WTO compatible.
131. The representative of the Philippines echoed concerns raised. In particular, the resolution to ban the use of various types of additives with no reasonable justification equated to a total ban of traditionally blended tobacco products in the Brazilian market. Philippines shared the objective of protecting young people's health. However, this objective could be achieved through less restrictive measures; her delegation encouraged Brazil to base any final decision on this resolution on scientific and technical evidence.
132. The representative of Indonesia informed that her
delegation had consulted with Brazil on the follow up of its
official letter of 4 April 2011 to the Minister of Development,
Industry and Foreign Trade. She asked Brazil to clarify
the date of the public hearing on the Draft Resolution No. 112.
133. The representative of Turkey said her delegation was closely following this measure.
134. The representative of Colombia supported the concerns raised, and asked Brazil to explain any progress made with respect to this resolution. He was concerned that the draft resolution could be confirmed as notified, and believed it ran counter to Article 2.1 of the TBT Agreement.
135. The representative of Honduras, Zambia and the Dominican Republic reiterated previously raised concerns on the draft resolution and requested an update from Brazil on the measure. The latter asked if Brazil could reassess the resolution in favour of a less trade restrictive alternative?
136. The representative of Zimbabwe joined other delegations in requesting an update from Brazil on the status of this draft resolution. His delegation had submitted written comments expressing its concerns and awaited Brazil's response.
137. The representative of Chile shared the concerns raised, in particular that the measure was more trade restrictive than necessary. Her delegation did not oppose the legitimate objective of the measure, but believed there were alternative measures to achieve the objective in a less trade restrictive way. She asked for an update on the current status of this measure.
138. The representative of the Russian Federation, speaking as an observer shared Brazil's objective of protecting human health and of reducing the incidence of smoking amongst young people and the general population. Nevertheless, he supported concerns raised, in particular that the measure was more trade-restrictive than necessary and violated Article 2.2 of the TBT Agreement. There was insufficient scientific evidence to demonstrate that additives used in blended tobacco made those products either more attractive to consumers, more harmful to health, or more addictive. Could Brazil provide the evidence upon which the draft resolution was based? His delegation was particularly interested in comparative data on the health impact of blended versus non-blended cigarettes, and on the risk to human health of additives used for blended products versus additives that give characteristic flavours.
139. The representative of Brazil reiterated that the objectives of this measure were to protect public health by reducing the attractiveness of certain tobacco products particularly to children and youth. Tobacco addiction usually began at a young age, when individuals were more vulnerable to tobacco products' appeal; flavourings could increase their appeal. A previously cited study conducted by the National Institute on Cancer in Brazil showed that 45 per cent of smokers in Brazil between 13 and 15 years of age consumed tobacco products with flavour. In addition, the WHO, through its partial guidelines linked to the implementations of Articles 9 and 10 of the FCTC, had recognized that from the perspective of public health there was no justification for permitting the use of ingredients such as flavouring agents which help make tobacco products attractive. With respect to the status of this measure, the draft resolution had not yet been published as a final regulation. His delegation was consolidating comments received on the draft resolution; given the large amount received, additional time had been required but all comments would be answered prior to final adoption. Also, a public hearing on the draft regulation was tentatively scheduled for December 2011.
140. Regarding the scientific basis of the measure, Brazil had compiled the scientific references that served as a basis for this measure. These had been shared with Members that expressed concerns during the last TBT Committee meeting; he would offer it to other interested delegations. On the question of why Brazil had chosen to prohibit additives instead of flavoured products, he reiterated that previous attempts in Brazil to prohibit flavoured products rather than additives proved inefficient, given the subjective nature of the assessment regarding the presence of flavours and smells in a product. Moreover, certain additives, such as acetaldehyde, levulinic acid, gamma-valerolactone, and ammonia, apart from their flavouring properties, could potentiate the addictive effects of nicotine. Finally, studies indicated that in addition to increasing the addictiveness of tobacco products, some additives when burned could augment the carcinogenic properties of cigarettes.
141. Regarding the impact of the draft resolution on traditional blended products, the tobacco industry had possessed the technology to produce blended tobacco products without additives since 1996; for example, processing burley tobacco without sugar. Finally, both domestic and foreign producers were required to comply with the requirements of the draft resolution.
(xx) Brazil – Draft Resolution No. 112, 29 Nov 2010; maximum levels of tar, nicotine and carbon monoxide permitted on tobacco products and prohibition of additives (G/TBT/N/BRA/407)
114. The representative of the European Union asked Brazil for an update on this proposal, as the EU had learned that a text had been adopted and published on 16 March 2012 as ANVISA Resolution 14/2012. The EU also asked Brazil to provide an outline of the changes contained in the adopted Resolution, compared to the notified draft, and a timeline of implementation of the measure. She reiterated her request for Brazil to reply in writing to the EU's written comments.
115. The representative of Mexico associated her delegation with the EU's statement regarding possible breaches to the TBT Agreement in this draft technical resolution. She asked Brazil for a formal response on Mexico's comments on the draft resolution presented on 31 March 2011.
116. The representative of Honduras considered that the Brazilian measure seemed to be incompatible with the TBT Agreement; Article 2.1 of the Agreement required that technical regulations not discriminate against domestic and like imported products. Depending on market conditions, the prohibition on the use of components may be incompatible with this obligation because it would be a de facto prohibition of traditional US-blend cigarettes, whereas Virginia‑type cigarettes would not be similarly affected. Article 2.2 of the TBT Agreement provided that technical regulations not be more trade restrictive than necessary to fulfil a legitimate objective and that they must take into account the risks of non‑fulfilment. This provision also stated that in evaluating these important elements, the following elements should be relevant when assessing such risks: available scientific and technical information; related processing technology; and intended end use of products. Brazil had been unable to explain how its legislation would fulfil such requirements. In particular, it seemed that the Brazilian measure was not based on scientific evidence or any impact assessment.
117. Article 2.8 of the TBT Agreement stated that, wherever appropriate, Members shall specify technical regulations based on product requirements in terms of performance rather than design or descriptive characteristics. Other WTO Members had adopted a standard based on performance that only prohibited those cigarettes that truly had a fruity or sweet characteristic flavour. Brazil was seeking to regulate the design of the product and the components of cigarettes without taking into account how such components affected the performance; in other words the characteristic flavour of the product. The focus based on characteristic flavour was a lot more specific and targeted than an approach prohibiting a list of additives in any amount, regardless of their effect on the end product. Article 12.3 of the TBT Agreement required Members to ensure that their technical regulations would not create unnecessary barriers to exports from developing country Members. By affecting tobacco leaf markets, Brazil's measure may be creating a barrier in violation of this provision.
118. The representative of Guatemala supported previous comments and expressed concern that the measure might have an impact on the trade of US blends cigarettes using burley tobacco. As the Resolution was recently published, Guatemala was still looking at its possible impact on the marketing of tobacco products. Guatemala was concerned that banning certain kinds of additives that were necessary to make the US blend may result in a de facto ban on the marketing of this kind of cigarettes. Because of the way it was cured, burley tobacco had to use certain additives in order for the cigarette to retain moisture and recover the sugars that were lost during the curing process. This measure would therefore have an impact on the growing of burley tobacco and would seriously affect small countries like Guatemala where the production of this type of tobacco accounted for approximately 98per cent of its domestic tobacco production, generating 1,000 direct jobs and some 4,000 related jobs. Guatemala's tobacco exports in 2011 reached $54 million US. While Guatemala recognized Members' right to adopt standards for the protection of human health and safety, in so doing the criteria established in Article 2.2 of the TBT Agreement, in particular the obligation that technical regulations shall not be more trade restrictive than necessary in order to fulfil their legitimate objectives, must be respected. She requested Brazil to explain how it took into account Members' concerns raised in this Committee and to indicate whether Brazil felt that its resolution would allow for production and consumption of American blend tobacco. In particular, how would each of the ingredients of American blend be covered by Article 7 of the Resolution?
119. The representative of Dominican Republic supported the concerns raised by other Members and reiterated its previously stated concerns.
120. The representative of Indonesia reiterated its request that Brazil reply in writing to the letters from the Indonesian Minister of Trade, sent in March and April 2011, related to this draft resolution.
121. The representative of Nigeria associated herself with the previous speakers and asked for an update on the public health consultation process. Given that the resolution would ban the use of additives with no reasonable justification, Nigeria encouraged Brazil to ensure that any final decision be based on scientific and technical evidence.
122. The representative of Zimbabwe stated that his delegation was still waiting for Brazil's written responses to the written comments it had sent before the November TBT meeting.
123. The representative of Australia welcomed Brazil's decision to implement tobacco control policies and preventive measures aimed at reducing the attractiveness of certain tobacco products, particularly to children and youth. Each Member had the right to implement necessary measures to protect public health. Australia would follow Brazil's implementation of these measures with interest and was prepared to continue to defend the right of members to protect public health while complying with relevant international treaty obligations.
124. The representative of Chile asked about the resolution's status. At the last meeting, Brazil said that it was reviewing all comments received and would respond to these before the resolutions' adoption. Chile sought these responses as the resolution would affect developing countries which export tobacco products.
125. The representative of Colombia reiterated previous concerns that this measure would be contrary to the TBT Agreement and would have an impact on Colombian tobacco products by restricting the American blend marketing based on oriental and burley tobacco. Recently Brazil published a new version of the resolution, similar to the previous one, restricting the import and sale of tobacco products containing ingredients that were indispensable for the American blend. The exclusion of sugar in the most recent version of the resolution would not substantially change the situation for American blend cigarettes. Other banned ingredients were required for this blend, and it was likely that sugar would be banned in the future. Colombia was concerned that the resolution would infringe Article 1.2 of the TBT Agreement, establishing less favourable treatment of international products by banning cured tobacco and sugar, of which Brazil was the main producer. He asked for the date of the new resolution, whether it had been notified, and if not, when it would be.
126. The representative of Zambia asked Brazil to confirm that it had enacted a final resolution on tobacco additives and, if so, whether it intended to notify it to the TBT Committee. Did Brazil intend to take into account the special development, financial and trade needs of developing countries in the application of this technical regulation, as provided for in Article 12.3 of the TBT Agreement? Brazil had not provided peer reviewed scientific evidence that the banning of additives would address its stated health objectives and the imposition of such measures could create trade barriers, more so because the legislation would ban additives on a selective basis. This measure would have far reaching implications for countries like Zambia as its implementation would make it impossible to blend tobacco, especially the type produced in Africa. Zambia considered that there were more balanced approaches to meeting Brazil's policy objectives than the current measure. The regulation of ingredients should not be deemed an effective measure to reduce the threat posed by tobacco. Because it was naturally addictive with or without ingredients. Efforts should focus therefore on measures that had proven effective on the consumers' behaviour.
127. The representative of Turkey supported the concerns expressed. While committed to the protection of human health consistent with the WHO Framework Convention on Tobacco Control and respectful of the measures taken by Members based on that Convention, Turkey was concerned that some Members could use areas of this Convention for commercial interests. The Brazilian regulation containing a list of additives to be prohibited in all tobacco-related products in Brazil, was an issue for Turkey, one of the major Oriental tobacco producers. Some of the prohibited additives were essential components of the blended type of cigarettes, in which both Oriental and Burley tobacco were used. The TBT Agreement prohibited discrimination between "like products". The Brazilian Resolution would ban the production and sales of blended cigarettes, leaving the market to the Virginia type products. He noted that Brazil was one of the main producers of the Virginia type tobacco. Additives did not give any characterizing flavour to tobacco products and this decision was made without considering the effects on final products. Turkey asked Brazil to indicate scientific evidence proving that the prohibited additives would pose increased risk to human health. There was no difference with respect to the "end use" between blended and the Virginia types, and Brazil had not provided a satisfactory explanation for discrimination between these two types. Turkey requested Brazil to respond to its comments and to amend the Resolution in accordance with the TBT Agreement.
128. The representative of Norway informed Members that Norway had implemented measures to combat smoking and would continue to follow the Brazilian tobacco regulation closely. Norway believed that it was within a Member's right to implement necessary measures in order to protect public health and that this was not in contradiction with a Member's trade obligations.
129. The representative of Brazil informed Members that on 16 March 2012, ANVISA, the Brazilian Health Surveillance Agency, published the final regulation on maximum levels of tar, nicotine and carbon monoxide for cigarettes and on the restriction of additives in tobacco products. The measure would be notified to the TBT Committee. A draft regulation had been notified and a four‑month period for comments was provided. Further, ANVISA promoted several rounds of public debate all along the process. In December 2011, Brazil held a public hearing on the issue and in February and March 2012, the board of Directors of ANVISA discussed the draft measure in open meetings, with the participation of industry, governments, civil society, academia, etc. Comments received were carefully examined by the Brazilian authorities who were working on a consolidated answer for all Members. Companies now had 18 months to adapt their products to the new requirements; those that did not comply could be sold for 24 months only. The main difference between the draft and the final measure was that sugar had been removed from the list of prohibited additives in tobacco products. The use of sugar as an additive would only be allowed to restore the sugar lost during the drying process of certain tobacco leaves. Arguments about a possible discrimination against traditional blends produced with burley tobacco did not stand since sugar would be allowed for this process.
130. In Brazil, 200,000 people died every year due to diseases caused by tobacco consumption. The objective of the measure was to protect public health by reducing tobacco products' attractiveness, especially on children and the youth. Studies showed that the risks of tobacco addiction were significantly higher when people start smoking as children or teenagers; the Brazilian regulation was therefore intended to reduce the incentive for first experimentation since flavoured products had evident appeal to the youth. A recent study conducted by the Oswaldo Cruz Institute in Brazil, surveyed more than 17,000 thousand students in several Brazilian cities. It found that more than 50per cent of young smokers preferred flavoured cigarettes. The Brazilian regulation also prohibited the use of additives used to reduce the harshness of tobacco smoke and to potentiate the effect of nicotine which reduced the natural rejection to tobacco products and increased their addictive characteristics. Brazilian authorities had taken into account the FCTC "partial guidelines" to the implementation of Articles 9 and 10 as a basis for the regulation. Brazilian authorities had also taken into account the extensive scientific literature on the properties and effects of additives in tobacco products and had produced a compilation of the scientific references on this subject, which had been shared with several Member. Brazil is willing to continue to share it with other interested Members. Moreover, in defining the flavouring additives covered by the regulation, Brazil had taken into account the work of the Joint FAO/WHO Expert Committee on Food Additives and of the Flavour and Extract Manufacturers Association. Finally, the measure did not differentiate between national or foreign producers.