WORLD TRADE  
ORGANIZATION  G/TBT/W/301 
11 November 2008 
 
 (08-5485) 
Committee on Technical Barriers to Trade Original:   Spanish 
  
 
SPECIFIC TRADE CONCERNS OF CUBA RELATING TO THE 31
ST ADAPTATION 
TO TECHNICAL PROGRESS OF DIRECTIVE 67/548/EEC OF THE EUROPEAN 
COMMUNITIES ON THE CONTROL OF DANGEROUS CHEMICAL 
SUBSTANCES (G/TBT/N/EEC/212), ESTABLISHING THE 
CLASSIFICATION OF NICKEL SUBSTANCES 
 
Communication from Cuba  
   The following communication, dated 10 November 2008, is being circulated at the request of 
the delegation of Cuba
. 
 
_______________ 
 
 1. Cuba thanks the European Community for its  notification of 18 Se ptember 2008 in document 
G/TBT/N/EEC/212 of the "Draft Commission Directive amending, for the purpose of its adaptation to 
technical progress, for the 31
st time, Council Directive 67/548/EEC on the approximation of the laws, 
regulations and administrative pr ovisions relating to the classifica tion, packaging and labelling of 
dangerous substances". 
2. Cuba is deeply concerned that  the European Communities (EC) has decided to proceed with 
the 31st Adaptation to Technical Progress (31st ATP) of Directive 67/548/EEC on the control of 
dangerous chemical substances, in spite of the considerable criticism directed at its predecessor - the 
30th ATP - on account of the "read-across" approach, which is once again being used as the basis for 
classifying more than 100 nickel compounds.  The concerns, objections and doubts regarding these 
classifications were set forth in communications sent to various European Commission authorities in 
Brussels by the ACP Group and by a group of de veloping countries in conjunction with other 
developed countries in February and March 2008, respec tively, as well as in a further letter sent by the 
ACP Group at the end of October. 
3. On 4 November 2008, the EC organized a technical  consultation, considered by Cuba to be a 
somewhat tardy endeavour, when 45 days had gone by since the submission of its notification and 
only 15 days remained before the end of the 60-da y comment period.  Given the complexity of this 
issue, this consultation should have taken place earli er and indeed several such consultations should 
have been held.  The EC's responses at that consu ltation were not convincing.  Not a single scientific 
publication was mentioned or distributed, nor was th ere mention of any research centre or researcher 
in a position to back up the EC's theories regardi ng the classification of more than 100 nickel 
compounds, in spite of the fact that Article 2.2 of  the WTO Agreement on Technical Barriers to Trade 
provides that "In assessing such risks, relevant elements of consideration are, inter alia:   available 
scientific and technical information, related pro cessing technology or intended end-uses of products". 
4. Even more disturbing is the fact that, at the above-mentioned consultation, the EC stated that 
it had received many communications and letters in relation to this Directive and asked the Members 
present about the implications for and impact upon their countries and industries, whereas, in G/TBT/W/301 
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  compliance with the provisions of the TBT Agreem ent, these are precisely key factors which the EC 
should have ascertained and assessed when developing this Directive. 
5. In this respect, Article 2.2 of the TBT Agre ement also provides that "Members shall ensure 
that technical regulations are not prepared, adopted or  applied with a view to or with the effect of 
creating unnecessary obstacles to international trade.  For this purpose, technical regulations shall not 
be more trade-restrictive than necessary to fulfil a legitimate objective, taking account of the risks 
non-fulfilment would create. (…)". 
6. The EC will also have to take into consid eration the requirement of Article 12.3 that 
"Members shall, in the preparation and application of technical regulations, standards and conformity 
assessment procedures, take account of the special  development, financial and trade needs of 
developing country Members, with a view to ensuri ng that such technical regulations, standards and 
conformity assessment procedures do not create unn ecessary obstacles to exports from developing 
country Members". 
7. The adverse effects of the new classifications on the nickel industry are incalculable and will 
have repercussions on other industries which use ni ckel and nickel compounds, such as steel, stainless 
steel, surface treatment, batteries, nanotechnologi es, the automotive, aviation and electronics 
industries, etc. even of the EC itself, which ranks  third worldwide in terms of consumption of this 
product.  The impact of these classifications will also be felt by other industries which use nickel 
substances for other industrial or chemical pro cesses as catalysts in oil refining, food processing, 
hydrocracking, etc. 
8. As EC officials themselves pointed out at  the consultation of 4 November 2008, the 
reclassification of these substances will have conse quences for their labelling, packaging, transport 
and handling.  Given that the EC states that it h as a legal obligation to act swiftly, these compounds, 
once reclassified, will have their use regulated and re stricted sooner rather than later and, if it proves 
feasible, will be substituted. 
9. At the same time, the reclassification of nickel on one of the largest and most important world 
nickel markets will affect the access of nickel and nickel products not merely to that market, but also 
to other major markets, given that  it will not be long before a domino effect sees other major markets 
adopting this classification, as has been the case previously with other standards and classifications. 
10. These consequences will result in hundreds or thou sands of millions of dollars in costs for a 
large group of developing countries, including a number of least developed and African countries 
which are amongst the poorest in the world, as well  as Latin American and Asian countries.  They 
will be required - perhaps without it being truly necessary - to set up special and costly storage and 
handling facilities, to improve worker protection and safety and to pay higher wages at both the 
production, storage and transport stages and in the end-use industries - all as a result of purported risks which have not been scientifically proven. 
11. This reclassification of nickel substances is taking place in the context of the international 
financial crisis which is also a ffecting developing countries and which, logically, has led to a global 
contraction of the credit and investment which we badl y need for our development.  It also comes at a 
time characterized by the adverse effects of the high  prices of staple foods and of oil, of which the 
nickel industry is a major consumer, prices which, despite having fallen somewhat in recent weeks, 
still remain high. 
12. This classification of nickel substances as cate gory I carcinogens will trigger a contraction in 
demand and investment in this industry and an increase in production, transport, insurance, etc. costs.  
At the same time, the international price of nick el, which climbed to more than US$50,000 per tonne  G/TBT/W/301 
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  not long ago, barely struggled above  US$8,500 per tonne in the last few days, that is to say, less than 
20 per cent or a fifth of the peak reached some months ago.  Moreover, the above does not take into account the possible replacement of nickel, should this  prove feasible, in many branches of production 
and processes, which would bring about the downfall of  this industry in several developing countries 
which lack the large sums required to convert an industry. 
13. Nickel prices began to plummet prior to the out break of the current financial crisis, the onset, 
this summer, of a slight decline in agriculture commodity prices and the current economic downturn.  
Given the speculative nature of the markets for co mmodities such as nickel and their sensitivity to 
factors such as new standards, it cannot be ruled out that the process related to the 31
st ATP is one of 
the factors that brought about the fall in nickel prices. 
14. These adverse effects will be particularly sever e for developing countries which, given their 
low levels of development and i ndustrialization, are reliant as key sources of employment and revenue 
upon a few export products, notably nickel, the inte rnational prices of which are very volatile, in 
particular nickel ore. 
15. The Cuban economy will be significantly affected by this measure, given that it possesses one 
of the world's largest reserves of nickel and that nickel constitutes the country's main export product. 
16. Cuba considers that the 31st ATP represents an unnecessary obstacle to trade which is 
inconsistent with Article 2.2 of the TBT Agreement, given that it is more trade-restrictive than 
necessary. 
17. Furthermore, attention should be drawn to the fact that the "read-across" method consists of 
predicting the adverse effects on the environment and on health of chemical substances for which no 
toxicity data exist, by comparing them with ot her substances with similar structures or properties 
about which information does exist.  Thus, an atte mpt is now being made to  establish a similarity 
between 100 nickel compounds and nickel carbonate on the basis of a comparison of their water 
solubility.  Let us recall that the substance now being used as a reference was already incorrectly 
reclassified as dangerous using the same method without any scientific underpinning. 
18. A number of specialized bodies, such as the Ni ckel Institute, state that the comparison 
methodology used by the EC does not follow either  the guidelines established by the OECD or the 
criteria of the US Environmental Protection Ag ency (US EPA), on the basis of which this 
methodology was developed.  This is due to the f act that the EC disregar ded three of the eight 
essential verification steps established by the OECD guidelines, without providing any explanation as 
to why those steps were omitted. 
19. The EC asserts that this procedure is justified by "expert criteria".  What is curious in this case 
is that, contrary to the OECD guidelines, US EPA practice and even European Community legislation 
itself, the EC has not furnished the data on which th e "expert criteria" was based, nor indicated either 
the scientific criteria or processes used in the applicat ion of the expert criteria or the qualifications of 
the expert(s) who defined the criteria. 
20. Moreover, for both the OECD and the US EPA, establishing categories or groups of 
chemicals for the purpose of this methodology is a complex process involving the review of a number 
of elements in order to determine whether the prope rties of a chemical substance allow its similarity 
to be established or it to be stated that substances have similar properties as a result of having similar structures.  One of the many physico-chemical properties to be considered when making the comparison is water solubility.  Far from taking the entire range of factors established in the 
OECD guidelines into consideration, the EC rest ricted itself almost exclusively to the least G/TBT/W/301 
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  appropriate one, if account is taken of the fact that  no data exist on the water solubility of most of the 
nickel compounds that the EC proposes classifying in the 31
st ATP. 
21. Similarly, it has been scientifically demonstrat ed that water solubility is not a property which 
determines whether nickel compounds are soluble in biological fluids, given that solubility varies widely from one fluid to another. 
22. There are thus a great many issues which Cuba would like to address, but we will restrict 
ourselves to five key questions: 
(a) Could the EC explain, on the basis of sci entific evidence, how water solubility was 
used as the key factor for grouping nickel  substances, when there are no available 
data on the water solubility of most of th e nickel compounds which it is proposing to 
classify in the 31
st ATP? 
(b) Data exist which indicate that the solubility of nickel compounds in water (those 
compounds for which data exist) is not the same as solubility in body fluids and that the solubility of nickel substances in human body fluids varies.  Could the EC furnish 
us with data or scientific studies wh ich provide evidence to the contrary? 
(c) Could the EC provide us with scientif ic evidence from published studies which 
proves that water solubility predicts the bioava ilability of the nickel ion in the cells of 
human organs?  If so, we would appr eciate knowing the scientific institute 
responsible and the names of the authors. 
(d) Could the EC provide us with a detailed explanation, on the basis of published 
studies, of the scientific criteria and data  supporting the conclusion that because one 
substance is carcinogenic, another di fferent substance must also be so? 
(e) Could the EC make available to us its evaluation, or documented evidence, of the 
risks and exposure from normal and expected use of the nickel compounds classified 
in the 31
st ATP? 
23. In addition to the lack of scientific consistency of this draft regulation, Cuba wishes to draw 
the attention of this Committee to the timetable established by the EC for the adoption of the 31st ATP. 
24. The 60-day comment period comes to an end on 18 November 2008.  Cuba considers that the 
EC is not allowing enough time for Members to subm it comments and for consultations to be held on 
what are highly technical and complex issues involving a great many chemical substances.  Neither is 
this period sufficient for the EC to review, respond to, discuss and "take into account" these 
comments, as required under Article 2.9.4. of the TBT Agreement.  This deadline also precludes any 
possibility of in-depth discussions being held with in this Committee, as required under Article 2.9. 
25. Cuba is particularly concerned by informa tion according to which the EC could organize a 
vote within the Technical Progress Committee (TPC) on 19 November - barely two weeks after the TBT meeting and one day after the 60-day period comes to an end - after which, in practice, 
amendments to the 31
st ATP will be virtually impossible.  Ho w is the EC going to study and take 
account of comments and, if necess ary, amend this Directive within 24 hours of the end of the 
notification comment period? 
26. We should be grateful if the EC would inform us of the timetable for the next steps in the 
internal process regarding this Directive.  G/TBT/W/301 
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  27. Should the 31st ATP suffer the same fate as the 30th ATP, i.e., if it is approved and 
implemented in spite of the doubts and objections of a great many WTO Members, notably developing countries, the effectiveness and cred ibility of the TBT Agreement and of this very 
Committee would be jeopardized, as would the comm itment undertaken at the Doha Ministerial 
Conference to place development and special and differential treatment at the heart of this 
Organization, its Agreements and its work. 
28. It would appear that the EC is dete rmined to present WTO Members with a fait accompli , in 
violation of the requirements of Article 2.9.2 of the TBT Agreement. 
29. Finally, Cuba requests that the EC take due account of its concerns and comments, as echoed 
by many other developing countries and other Memb ers, and that it amend this draft regulation to 
exclude nickel compounds from the scope of application. 
30. Furthermore, Cuba requests the extension, by at  least 60 days, of the 60-day period to enable 
other WTO Members to submit comments and furthe r bilateral and multilatera l consultations to be 
held, so as to ensure appropriate interaction amo ngst interested parties, including the study of 
comments on the nickel classification proposal s and a full response to these comments. 
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