WORLD TRADE  
ORGANIZATION  G/TBT/W/302 
26 November 2008 
 (08-5809) 
Committee on Technical Barriers to Trade Original:   English 
  
 
COMMENTS OF THE DOMINICAN REPUBLIC ON PROPOSED  
EC CLASSIFICATION OF NICKEL SUBSTANCES IN THE 31
ST ATP 
 
Communication from the Dominican Republic  
 
 
 The following communication, dated 18 November 2008, is being circulated at the request of 
the delegation of the Dominican Republic . 
_______________ 
  
I. INTRODUCTION 
1. The Dominican Republic takes note of the EC's notification to the TBT Committee of the 
proposed 31
st Adaptation to Technical Progress (ATP) to the Dangerous Substances Directive, on  
18 September 2008. The draft ATP includes a proposed classification of 117 nickel substances.  The Dominican Republic has serious concerns about the timing for adoption of the proposal and the basis 
for the nickel classifications. For reasons which we shall explain in the following sections of this 
document, we request that the EC rem ove the nickel substances from the ATP. 
 
II. PROBLEMS WITH EC’S APPLICATIO N OF READ-ACROSS METHODOLOGY 
2. The proposed classifications are the result of the EC's decision to "read-across" toxicological 
effects associated with certain specific compounds to a broade r group of nickel substances.  The 
Dominican Republic does not take a contrary position to the use of read-across generally, but strongly 
objects to the manner in which the EC applied the methodology in this case. 
(a) Read-across is based on an assumption that groups of chemicals with certain common 
characteristics (e.g., structural similarities) cause similar toxicological effects.  In 
order to apply the methodology properly, it is necessary to identify the relevant 
defining characteristics and then to verify that those characteristics in fact produce 
similar toxicological effects. 
(b) Without such verification, the assumptions underlying the substances groupings are 
merely unproven hypotheses.  They provide no basis for imposing regulatory restrictions on the substances in the group. 
3. The nickel industry has made clear that the EC  made several fundamental errors in reading-
across toxicological properties to the 117 nickel substances covered by the proposed ATP. 
4. First, read-across is a complex, multi-step process.  The Danish Environmental Protection 
Agency (DEPA), which proposed the classifications, cl aimed that it applied the eight-step read-across 
methodology  described in an OECD Guidance docum ent on the subject.  In fact, the EC misapplied G/TBT/W/302 
Page 2  
 
  the first step and disregarded the key final three st eps.  As a result, the EC failed to verify the 
accuracy of the assumptions underlying the proposed classifications.  
5. Second, the EC chose water solubility as the primary characteristic for defining groups of 
similar nickel substances.  It assumed that nickel substances with similar water solubility would cause 
similar toxicological effects.  However, there is no scientific basis for this assumption, and the EC 
failed to provide any evidence or data to support it. 
6. In identifying water solubility as a critical charac teristic, the EC relied in large part on two 
reports prepared for DEPA in 2001.  However, t hose reports were not finalized, peer reviewed or 
published, and  in fact, concluded that water solubility cannot be the sole criteria for extrapolating all 
biological activity.  Importantly, the reports did not  even contain substance-specific water solubility 
data. 
(a) The OECD guidance is clear that, in groupi ng substances, a range of characteristics 
should be considered such as chemical st ructure and trends in properties and/or 
activities that collectively generate an asso ciation among different substances.  It is 
not appropriate to group subs tances based on a single characteristic, particularly when 
there is no evidence that such characteristic bears any relationship of the toxicity of 
the substance. 
(b) Water solubility is not a predictor of the solubility of nickel compounds in biological 
fluids such as gastric or respiratory fluids.  In fact, (i) nickel compounds with similar water solubility vary widely with respect to solubility in biological fluids and  (ii) solubility varies with respect to different biological fluids.  
7. Third, even if water solubility were otherwise a useful predictor of the toxicological effects of 
the various substances, there is not even data on th e water solubility for most of the nickel compounds 
that are the subject of the classification.  Without th at data, the EC’s analysis fails even under its own 
terms. 
8. Fourth, the EC was provided by the nickel industry with voluminous substance-specific 
information that water solubility was not a useful pr edictor of toxicological effects.  However, when 
presented with this evidence, the EC simply removed those identified substances from the 
classification rather than revisiting the underlyi ng assumption that water solubility was useful 
predictor of toxicity. 
9. Classifications under the Dangerous Substances Di rective must be based on valid scientific 
evidence.  In this respect, we would like to present the following technical questions to the EC, 
regarding the reliance on water solubility and the u se of the read-across method to classify nickel 
compounds in the 31
st ATP.  
(a) Read Across 
(i) Could the EC provide detailed docum entation on how each step of the 
guidance established by the OECD for the read across method was satisfied 
when nickel compounds were categorised and grouped for purposes of the 
31st ATP (taking into account that the technical work on classifying the nickel 
compounds was completed before 2007)? 
(ii) To the extent that any of the read acro ss steps set forth by the OECD was not 
fully implemented, could the EC, for each  such step (particularly steps 1 and  G/TBT/W/302 
 Page 3 
 
 
  6 – 8), explain why and describe the pote ntial effect of this omission on the 
validity of the read across? 
(iii) To the extent that the EC relied on "expert judgment” in the 31st ATP to reach 
its conclusions, could the EC explai n and document when and how such 
expert judgment was exercised and ju dgments reached (i.e., the documented 
process, evidence and criteria used), when and how this information was 
made publicly available, and how the ex ercise of such judgment substantially 
met the goals described in the steps of the OECD guidance on read across? 
(iv) Could the EC explain in detail (using published studies or guidance) each of 
the scientific criteria and the related da ta that should be used to support a 
conclusion that because one substance is  carcinogenic, another (i.e., different) 
substance is also carcinogenic?  Could the EC explain how each of those criteria were applied during the classification of nickel compounds in the 31
st 
ATP? 
(v) Does the EC believe that it is possible to classify the hazards of a substance 
without any scientific data about that substance?  Could the EC explain how, 
as a scientific matter, one can classify substances in the absence of data?  To the extent that the EC believes that th ere is a minimum scientific "data set” 
that is necessary to classify a substa nce, could the EC describe that "data 
set”?  
(vi) Could the EC provide its documented assessment of the risks and exposures 
related to the normal and expected use of the nickel compounds classified by 
the 31
st ATP? 
(vii) Does the EC intend in the future to use in REACH the read across methods 
and processes employed to classify nickel compounds in the 31st ATP? 
(viii) Recognizing that the 31st ATP process was launched before the effective date 
of REACH, could the EC explain, as a technical matter, how the methods and 
processes employed to classify nickel compounds in the 31st ATP meet each 
of the criteria for classifying substances under REACH?    
(b) Water Solubility 
(i) Could the EC provide the scientif ic evidence from published studies 
demonstrating that water solubility is a predictor for the bioavailability of the 
nickel ion in target cells in human organs? 
(ii) Could the EC provide the scientif ic evidence from published studies 
indicating that water solubility might not be a predictor for the bioavailability of the nickel ion in target cells in human organs? 
(iii) Could the EC provide the studies that were performed that validated the 
water solubility-based read across used as a foundation for the 31
st ATP?    
(iv) Existing data indicates that the solubilit y of nickel compounds is not the same 
in water as in bodily fluids.  Can the EC provide data or studies demonstrating a contrary conclusion? G/TBT/W/302 
Page 4  
 
  (v) Existing data indicates that the solubility of nickel compounds varies across 
different bodily fluids.  Can the EC pr ovide data or studies demonstrating a 
contrary conclusion? 
(vi) Could the EC explain (with scientific  evidence) how water solubility was 
used as a central factor in grouping nickel compounds when water solubility 
data was not available for most of the nickel compounds proposed for 
classification in the 31
st ATP? 
(vii) Existing data indicates that there is not a correlation between LD 50 and the 
water solubility of nickel compounds.  Can the EC provide studies demonstrating that such a correlation does exist?  
(viii) Can the EC demonstrate how, and for which nickel compounds, each of the 
physico-chemical properties other than  water solubility described in the 
OECD guidance were taken into account in grouping nickel compounds?   
(ix) To the extent that physico-chemical properties other than water solubility 
contradicted, for a specific substance,  the postulated relationship between 
water solubility and toxicity, could th e EC demonstrate how it used that 
information to re-evaluate the postulated relationship? 
III. INCONSISTENCIES WITH THE TBT AGREEMENT 
10. The fundamental flaws in the EC’s approach also raise significant questions about the WTO 
consistency of the proposed classifications. 
11. The Dominican Republic agrees with the EC that protection of health, safety and the 
environmental are legitimate objectives when adopting technical regulations.  However, Article 2.2 of 
the TBT Agreement requires that, in formulating technical regulations, WTO Members "take account 
of the risks non fulfillment (of such objectives) w ould create”.  In assessing such risks, Article 2.2 
states that relevant elements of consideration incl ude "available scientific and technical information” 
or "intended end-uses of products”. 
12. The Dominican Republic is concerned that the EC has not, in fact taken into account the 
relevant elements of considerati on identified in Article 2.2.  The EC has not followed internationally 
accepted procedures for conducting read-across and has failed to consider fully the scientific evidence 
(or lack thereof) regarding the use of wate r solubility as a predictor of toxicity. 
13. Article 2.2 also requires that technical regula tions "not be more trade-restrictive than 
necessary to fulfill a legitimate objective”.  The clas sification and labeling requirements that will be 
imposed on the nickel substances if the draft 31
st ATP is adopted (not to mention the other 
downstream regulatory consequences of the classi fication) will have serious adverse commercial 
consequences for nickel producers and users of nickel.  In this regard, it is important to mention that 
in the year 2007, the nickel exports represented more  than 50% of the total exports of the Dominican 
Republic, with a total value of 1,153 millions of US dolla rs.  In addition, we consider that if the draft 
31st ATP is adopted, the EC will fails to comply with article 12.3 of the TBT Agreement that states 
that "Members shall, in the preparation and a pplication of technical regulations, standards and 
conformity assessment procedures, take account of th e special development, financial and trade needs 
of developing country Members, with a view to ensuring that such technical regulations, standards 
and conformity assessment procedures do not create unnecessary obstacles to exports from developing country Members”.  G/TBT/W/302 
 Page 5 
 
 
  14. It is our view, that the read-across analysis the EC has offered fails to assess properly the 
toxicological effects of the nickel substances and provides no basis for imposing any trade restrictive 
measures on them.   
IV. CONCERNS REGARDING THE TIME TABLE INTENDED BY THE EC FOR THE 
ADOPTION OF THE 31ST ATP 
15. The Dominican Republic is concerned that the legislative timetable intended by the EC for 
the adoption of the 31st ATP fails to provide sufficient time for consultation with other WTO 
Members.  The Dominican Republic believes that, unless rectified, the EC’s timetable effectively forecloses the possibility of a meaningful discussion by the TBT  Committee of the 31
st ATP to the 
Directive 67/548/EEC, as is required by Article 2.9 of the TBT Agreement. 
16. The scientific issues related to the proposed classification of over 100 nickel substances in the 
31st. ATP are highly technical.  The 60 days commen t period is not sufficient to allow other WTO 
Members to provide comments to the EC, and for th e EC to review, respond to, discuss and "take into 
account” those comments as required by Article 2.9.4.  Certainly, there is insufficient time to conduct such a dialogue in the few days between the TB T Committee meeting on 5-6 November  2008 and the 
end of the comment period on 18 November 2008. 
17. The Dominican Republic is particularly concer ned by some reports that the EC may organize 
a vote of the Technical Progress Committee (TPC) as early as 19 November 2008 (just one day after the end of the 60 days consultation peri od) following which amendments to the 31
st ATP will in 
practice be virtually impossible.  Could the EC explain why is there such a rush to push this legislation through when there are clearly so many concerns from industry and other countries as to 
the science ? 
18. It appears to the Dominican Republic that the EC is determined to present WTO Members 
with a fait accompli, in violation of the requireme nts of Article 2.9.2 of the TBT Agreement.  The 
Dominican Republic calls on the EC to provide assurances that it will fully engage with WTO Members on the 31
st ATP, including considering and responding fully to comments on the nickel 
classification proposals and reiterate our request that the nickel substances be removed from the 
proposed 31st ATP. 
 
__________