G/TBT/W/376
6 November 2013
(13-6166)  Page: 1/3
Committee on Technical Barriers to Trade  Original: English
 
 EUROPEAN UNION – TOBACCO PRODUCTS, NICOTINE  CONTAINING PRODUCTS AND 
HERBAL PRODUCTS FOR SMOKING. PACKAGING FOR RETAIL SALE OF ANY OF THE 
AFOREMENTIONED PRODUCTS  
STATEMENT BY MALAWI TO THE COMMITTEE ON  TECHNICAL BARRIERS TO TRADE AT ITS 
MEETING OF 30-31 OCTOBER 2013 
The following communication, dated 5 November 2013, is being circulated at the request of 
the delegation of Malawi. 
 
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1  INTRODUCTION 
 At the outset please allow me to thank the EU for responding, on 30 July 2013 to the 
concerns that Malawi had raised with the EUs TBT enquiry point in relation to the WTO 
compatibility of the TPD. Mr. Chairman, as Members are aware that, since the last meeting of this 
Committee, the European Parliament adopted on October 8 certain amendments to the proposed 
Tobacco Products Directive (TPD). While some of these changes were useful, others have made 
the draft law even more WTO-inconsistent than the initial version tabled by the Commission late 
last year. This should be of strong concern to all WTO Members that seek to uphold a rules-based system for technical regulations, particularly least-developed countries that are dependent on tobacco exports.  
 Mr. Chairman, before turning to the specifics of the revised TPD, we wish to make one point 
clear. We do not presume to tell the EU how to le gislate in the area of public health. This is a 
decision for the EU. However, we have the right and the duty to point out how the revised 
proposal would violate the binding commitments that the EU has made to all WTO Members, 
including Malawi. The WTO Appellate Body has ruled that when Members legislate to protect health, they must do so in a WTO-consistent manner. Unfortunately, Mr. Chairman, the revised 
TPD falls short of this standard.  We note that, while some of the recently adopted amendments 
may represent a step in the right direction, they ar e part of a legislative process which will remain 
open for some time, and the outcome of which is still highly uncertain. 
 Malawi would like to focus its intervention on three particularly problematic parts of the 
revised TPD, concerning (i) the regulation of additives; (ii) enlarged health warnings; and (iii) 
traceability requirements. These sets of provisions, if adopted in their current form, will breach the TBT Agreement and impair access to the EU market  for Malawi. These are examples of Malawi's 
concerns and should not be regarded as an exhaustive list. 
2  REGULATION OF ADDITIVES  I begin with additives. The revised TPD contai ns a new, and highly prescriptive, "positive 
list" approach to the regulation of additives. No additive can be used in tobacco products in the EU 
unless it has been approved and included in an Annex to the TPD. The amendments also prescribe the additives – or rather types of additives – that may not be approved.  
 Manufacturers and importers must make an application to the Commission in order to obtain 
approval for an additive. Yet there are no scientifi c criteria indicated to determine which additives 
can or cannot be accepted on the list. G/TBT/W/376 
 
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   To the contrary, the revised TPD enumerates pr ohibited categories of additives in vague, 
arbitrary and highly subjective terms. For exampl e, the text indicates that approval cannot be 
granted for additives that "create the impression" that a tobacco product "has a health benefit or presents reduced health hazards". Prohibited additives also include those supposedly "associated 
with energy and vitality" or additives "which, wh en used, may impart a characterizing flavor".  
 Members will recall that these highly ambiguous criteria were included in the original version 
of the 2012 TPD proposal, as additives that were to  be prohibited by the Member states. Such ill-
defined standards have survived in the new version,  as additives that cannot be included on the 
positive list. 
 When EU regulators consider applications to a pprove additives, they will be operating within 
a legal framework that is entirely subjective. How will manufacturers and importers know which 
additives will or will not be approved? The revised TPD mandates that an application for the 
approval of an additive must be accompanied by "clear evidence supported by scientific data that 
the additive does not fall under any of the exclusion criteria"[.] Yet what "clear evidence supported 
by scientific data" can be provided to demonstrate, for example, that additives do not "create 
impressions" of health benefits? The EU law re quires manufacturers and importers to prove a 
negative. Additives do not "create impressions", and no evidence or data exists to demonstrate 
otherwise.  
 Such an approach to regulation will create "unnecessary obstacles to international trade" as 
it will be "more trade-restrictive than necessary" to fulfil the EU's health objectives, contrary to the 
EU's obligations under TBT Article 2.2. Blocking addi tives on such an arbitrary basis will inevitably 
impair market access for tobacco exporting countries such as Malawi.  
3  HEALTH WARNINGS  I now turn to health warnings. The European Parliament recognized that the Commission's 
proposal for combined health warnings that cover 75% of the package was extreme and 
unwarranted. The amendments have reduced this to 65%. 
 While the amendment was a step in the right direction, Malawi is convinced that a 65% 
health warning on the front and back of packages nonetheless remains excessive, and will be 
ineffective. It is more trade-restrictive than ne cessary to fulfill the EU's health objectives, and 
therefore breaches TBT Article 2.2. 
 Mr. Chairman, as we have indicated earlier, enlarged warnings are based on two 
fundamentally flawed assumptions: that consumers currently lack information on the risks 
associated with smoking, and that larger warnin gs will discourage smoking, particularly at the 
stage of smoking initiation. Such assumptions are demonstrably incorrect. The revised text of the 
TPD continues to ignore the real factors that contribute to smoking initiation, particularly social 
interaction within peer groups. This is particularly important for young people, the target of the Directive. 
 The EU has not provided any reliable evidence that larger health warnings will reduce 
smoking. For this reason, the 65% combined warnings still violate Article 2.2. 
4  TRACEABILITY REQUIREMENTS  Finally, I would like to address the issue of tr aceability requirements. Article 14 of the TPD 
contains new requirements in the area of traceability that would conflict with the EU's WTO 
obligations under Article 2.2 of the TBT Agreemen t, which requires not to introduce regulations 
which are more trade restrictive than necessary. 
 Mr. Chairman, there is already a current voluntary system for tracing and tracking, 
introduced by four manufacturers, which covers 95% of EU cigarettes sales. No scientific support has been provided to establish that the proposed TPD measures would better contribute to the 
EU's policy objective of reducing illicit trade. We believe that the current proposal would result in 
the implementation of an untested and redundan t track and trace system.  On the opposite, G/TBT/W/376 
 
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  obliging all manufacturers of cigarettes sold on the European market to comply with the current 
track and trace system would allow the EU to optimize its fight against illicit trade.  
 Overall, Mr. Chairman, the continued implem entation of the current system would be 
sufficient to fulfill the EU's public health objectives. The proposal for additional legislation requiring 
implementation of the proposed Article 14 of the TPD would create a market barrier for foreign 
exports to the EU, which would amount to a technical barrier to trade, in which would violate the EU's WTO commitments under the TBT Agreement. 
5  CONCLUSIONS 
 Mr. Chairman, we would offer two final observations. First, we should be clear that the EU's 
binding WTO obligations remain unaffected by other agreements. The European Parliament revised Recital 7 of the TPD to refer to the "landmark"  WHO Framework Convention on Tobacco Control, 
and to state that the EU and its Member states "are bound under international law by its 
provisions". Other references to FCTC obligations appear in the TPD.  
 Malawi would make two important comments here. First, not all provisions of the FCTC are 
binding. Second, even for those FCTC provisions that do have legal force, the EU nevertheless 
remains bound by its commitments under the TBT Agreement. Nothing in the FCTC can alter the TBT Agreement. The TPD must be WTO-consistent. 
 Second, the damage to Malawi's tobacco exports to Europe, which will be caused by the EU 
TPD, is a matter of critical importance. In our written statement to the EU earlier this year, we noted that the adoption of this legislation would have disastrous consequences for Malawi's national economy, as 12% of the population is engaged in the value chain for tobacco. We also 
noted that out of the 15 million people in Malawi, 1.5 million are tobacco farmers, and tobacco is 
the backbone of their economic activities. The is sues we are discussing today are thus of grave 
concern to Malawi and, indeed, other least-developed tobacco exporters.  
 We therefore renew our call on the EU to ensure that the TPD is in full compliance with its 
WTO obligations, including the TBT Agreement. 
 
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