TBT Committee March 2012

Last week we had the latest TBT Committee regular meeting. In it, the bulk of time was dedicated to Specific Trade Concerns, which had the highest number of concerns raised to date with 68, with some time devoted to the Sixth Triennial Review as well.

Out of the new concerns raised it is important to highlight the following:

European Union – Directive 2011/62/EU of the European Parliament and of the Council amending Directive 2001/83/EC on the Community code relating to medicinal products for human use, as regards the prevention of the entry into the legal supply chain of falsified medicinal products

The concern was raised by Brazil and China. In its statement, Brazil stated that Directive requires imported active substances to comply with good manufacturing practices equivalent to the EU and a written declaration from the Country of Origin’s authority as to the equivalence (some Countries are exempted from this requirement). Brazil considered this to be an unnecessary barrier and asked for further clarification on the requirements to be included in the exemption list and also asked for reasons as to why Brazil is not included in this exempted Country list. China stated that the EU failed to provide evidence of counterfeit product coming from China and suggested that a more efficient and less restrictive method of fighting falsified medicinal products was to target these falsified products directly instead of adding barriers to imported products.

The EU replied saying that this regulation applies to both imported and domestic products and stated that it is currently working on accepting a WHO certificate as a substitute for the Country of Origin declaration.

United States – Test procedures for high density discharge lamps

The concern was raised by China. China stated that it had concerns relating to the scientific conclusions basis for this regulation, as well as concerns on the procedures for certification of laboratories that tend to favor laboratories in developed countries. The US responded by saying that so far there have been several laboratories accredited in China, and the regulation has been interpreted to accept ILAC MRA accredited laboratories results.

China – Measures for the Administration of Certification Bodies

This concern was raised by the EU. The EU, supported by the US, asked China to clearly explain the objectives behind this regulation as well as China’s view on how these objectives can be in line with art. 5 of the TBT Agreement (adoption of conformity assessment procedures). Although no specific issues were raised, it seems that the EU and US seek to get a better understanding of the measure as a pre-emptive and informative reaction to it. China stated that it had held several bilateral meetings with the US and EU on this matter and will continue to do so in order to address their concerns.

On the previously raised concerns there were no new developments, as many of the statements from previous meetings were reiterated without the addition of new developments. A few of the notable concerns raised under this section were:


The concern was raised by India and Argentina. India restated its concern with the definition and classification of SME’s, given the labor intensive industries in developing countries like India. Argentina requested proper guidelines to the REACH regulation since it has undergone many modifications, which are not clear to the industry. The EU replied that many of these questions have already been answered in the past, and that it has held several bilaterals trying to clarify these issues. It went on to say that if Members still require further clarifications it would be happy to answer to any other questions in bilateral meetings. The EU also stated that it does not believe the requirements to be burdensome to SME’s, and it referred to its continuous efforts to assist companies, especially ahead of the next registration deadline in 2013. It concluded by stating that information on the upcoming training seminars and activities would be available on its website.

Australia – Tobacco Plain Packaging Bill

The concern was raised by Mexico and Dominican Republic. In this one, the statements echoed statements made in previous committee meetings. Mexico, Dominican Republic, Cuba, Ecuador, Colombia, Chile and Honduras, to name a few reiterated their concerns with the bill and insisted that it is against Australia’s WTO obligations under the TBT. Norway and New Zealand on the other hand applauded Australia’s initiative and stated that they will continue to monitor closely any developments in light of similar provisions being discussed in their respective countries. Australia replied that the bill was passed by the Parliament last December and it will become obligatory for domestic produced tobacco from October 2012 and for internationally produced tobacco from December 2012. The delegate of Australia also indicated that this is just part of the agenda to fight tobacco consumption, which is being complemented by regulations in advertisement, nicotine replacement and taxes, just to name a few. It is important to note that the Ukraine formally filed a dispute against Australia’s Cigarette Packaging Law last week, under case number DS434.

Under the item related to the Committee’s Sixth Triennial Review, it is important to note that the deadline for submittal of papers is June 2013, however, an informal meeting aimed to discuss further some of the already received proposals as well as any other the Secretariat might receive in the coming days will be held in May.

Finally, on the election of the Chairperson of the Committee, since consultations are still ongoing, the election was suspended until next meeting.