WORLD TRADE  
ORGANIZATION  G/TBT/W/307 
17 March 2009 
 (09-1337) 
Committee on Technical Barriers to Trade Original:   English 
  
 
SUBMISSION BY THE AFRICAN, CARIBBEAN AND PACIFIC GROUP  
OF STATES (ACP) TO THE TBT COMMITTEE ON  
NOTIFICATION G/TBT/N/EEC/212 ON NICKEL CLASSIFICATIONS IN THE  
31
ST ATP TO DANGEROUS SUBSTANCES DIRECTIVE 
18-19 MARCH 2009 
 
Communication from Mauritius on behalf of the ACP Group  
   The following communication, dated 16 March 2009, is being circulated at the request of the 
delegation of Mauritius
. 
 
_______________ 
 
A. INTRODUCTION  
1. The ACP Group would like to thank the EC for its Reply to comments from the ACP Group 
and other WTO countries regarding the EC's deci sion to classify as hazardous over 100 nickel 
compounds in the 31st ATP directive.1  However, the issues raised in our comments were not 
satisfactorily addressed by the EC Reply.  
2. The ACP Group is extremely disappointed by the EC's decision to push ahead and adopt the 
31st ATP in January, despite the unprecedented leve l of concern raised at the TBT Meeting in 
November. The ACP Group remains concerned that the decision to classify the nickel substances in 
the 31st ATP will have significant market impacts, and was taken without the re quisite and appropriate 
levels of transparency and scientific rigor. 
3. This document summarises the central issues th at have not been satisfactorily addressed by 
the EC Reply.  It is not necessary to repeat here  the detailed technical comments that we and other 
WTO Members, as well as industry stakeholders, have  provided the EC and which we incorporate by 
reference.  We continue to a dvance and support those comments. 
4. At the outset, we note that the EC Reply states that, upon adoption, the 31st ATP will have 
immediate legal effect across a wide range of exis ting EU laws, including requirements relating to 
cosmetics (Directive 76/768/EEC), biocidal produc ts (Directive 98/8/EC) and plant protection 
products (91/414/EEC).  This contradicts previo us EC representations to WTO Members who 
expressed concerns about the impact of the 31st ATP, in which the EC stated that the 31st ATP only 
                                                      
1  Commission Directive 2009/2/EC of 15 January 2009 amending, for the purpose of its adaptation to 
technical progress, for the 31st time, Council Directive 67/548/EEC on the approximation of the laws, 
regulations and administrative provisions relating to the classification, packaging and labelling of dangerous 
substances, OJ [2009] L11/6. G/TBT/W/307 
Page 2  
 
  related to 'labelling' and would no t result in bans or restrictions on the use of these substances in 
consumer products.
2   
5. The EC also concedes that its actions will have an impact on the market for nickel 
compounds, noting that one of its goals was to classi fy as many nickel compounds as possible in order 
to reduce 'market distortions'.  The reference to 'm arket distortion' confirms the serious trade impact 
that these classifications will have.  Further, the avoi dance of market distortions clearly is not a reason 
to classify without the necessary evidence on the properties of the substances.   
6. The ACP Group believes that the severe classi fication of nickel substances will have a 
significant negative economic and commercial im pact on all nickel producing and exporting 
countries. These adverse effects would be particul arly severe for developing countries which, given 
their low levels of development and industrialisa tion, tend to rely on a few basic exports for 
employment and revenue. For example: 
7. Botswana, Cuba and the Dominican Republic are small and vulnerable economies that are 
highly dependent on mineral exports. In 2007, in each of these countries, nickel contributed to about 
50 per cent of its total exports of goods;   
8. The nickel market is worth about US$ 4 billion per annum to South Afri ca. South Africa fears 
that the implementation of the 31st ATP would seriously affect the future investment by the industry 
itself and impact negatively on trade and growth. 
9. The classification of the nickel compounds in the 31st ATP also takes place in the context of a 
global financial crisis that is se verely affecting developing countri es, and which has led to a global 
contraction of credit, investment and demand.  The 31st ATP is likely to further aggravate conditions 
in this industry, and cause increased produc tion, transport and insurance costs.   
10. The 31st ATP is of concern not only for nickel producers but also for those countries that 
manufacture goods using nickel compounds in diverse industrial chemical processes. The nickel compounds listed in the 31st ATP are used in a br oad range of industries and processes, including in 
important 'green' technologies, such as nickel-hydride batteries. 
11. The EC market accounts for about 40 per cent of total world nickel usage. The classification 
of such a wide and diverse range of nickel compoun ds on such an important world market will affect 
access not merely to that market, but also potentia lly to other major markets. The ACP Group fears 
that it will not be long before a domino effect will be seen in other major ma rkets, as has been the 
case previously with other standards and classifications . We also remain concerned that a read-across 
method based solely on water solubility could be used as a precedent for taking regulatory decisions 
about other substances (be it about organic or inor ganic chemicals) and concentrates produced in the 
ACP or in other jurisdictions, par ticularly given the EC's recent implementation of REACH and of the 
UN's globally harmonised system (GHS) of classification and labelling.  
12. Given the significant commercial implications, it is essential that any classification of nickel 
compounds takes into account the special developmen t, financial and trade needs of developing 
countries, as is required by WTO provisions.  
                                                     
 
2  See, e.g., Minutes of the Meeting of 1 – 2 July, 2008 , Committee on Technical Barriers to Trade, 
G/TBT/M/45, 9 September 2008.    G/TBT/W/307 
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  B. SERIOUS CONCERNS ABOUT SCIENTIFIC BASIS FOR NICKEL CLASSIFICATIONS  
13. The ACP Group naturally recognises the importance of ensuring a high standard of protection 
for human health and environment and supports the development of re gulatory strategies to achieve 
such protection. However, we maintain that the EC has not proved that the nickel classifications in the 
31st ATP are based on a sound or transparent scientific  method. The EC's Reply has not answered our 
concerns and either others presented by other WTO Members in the last TBT Committee.  
14. We continue to disagree that the EC's 'groupi ng' and 'read-across' methodology used in the 
31st ATP for nickel compounds conformed to the cr iteria established by the OECD or the U.S. EPA 
guidance referred to by the EC.  The EC skippe d 3 of the 8 essential steps set forth in OECD's 
guidance, steps that are critical to verifying, with  objective data, the assumptions made in the read-
across.  The EC has not presented a scientific basis for omitting those essential steps, other than, in its 
judgment and without justification, these steps simply were not necessary.   
15. Further, the EC's continued reliance on a singl e data point, water solubility, as the initial and 
primary basis for categorising nickel compounds is not  supported by the facts and is contrary to the 
OECD and U.S. EPA guidance on which the EC claims  to rely.  At the outset, the EC's claimed 
reliance on water solubility is not supported by the facts, since it did not obtain water solubility data 
for most of the nickel compounds classified.  Most of the water solubility information relied on by the EC was based on estimates contained in an unpublishe d draft document that was not peer reviewed.    
16. Both OECD and U.S. EPA guidelines are clear that establishing categories of chemicals for 
purposes of read-across is a complex process that involves reviewing a number of inputs to determine if a group or category of chemicals whose physicoc hemical (e.g., molecular weight, water solubility, 
particle size and structure, partition coefficient a nd vapour pressure), toxicokinetic and human health 
and/or environmental properties are likely to be similar or follow a regular pattern as a result of 
structural similarity.  The EC did not do this, fa iling to take into account the full range of inputs 
described by the OECD and U.S. EPA.    
17. Perhaps most importantly, the EC has yet to a ffirmatively demonstrate the scientific basis for 
its assertion that water solubility is an 'approximatio n' of the 'systemic bioavailability of the nickel 
ion'.  The few studies referred to by the EC do not support its claim that "the division into groups 
across the spectrum of water solubility follows the approach already widely used for nickel 
compounds"   The EC simply asserts, without scientif ic evidence, that "nic kel substances having 
similar water solubility will induce similar bioavailab ilty" and that "water solubility is thereby an 
acceptable measure of similarity between nickel com pounds" (EC Reply at p. 4).  Such groupings of 
convenience do not scientifically establish a causal re lationship between water solubility and toxicity, 
and ignore the data in the EC's possession that  positively demonstrates the opposite: that water 
solubility is not a good indicator of the bioavailability of the nickel ion.  
18. The EC has essentially been promoting an unpr oven theory, postulating a causal relationship 
between water solubility and toxicity to support an important regulatory decision with significant 
economic consequences, and then claiming that it must be proven wrong: "Industry has had the 
opportunity to put forward data disproving this classification" (EC Reply at p. 7).  However, the EC did not make a request to Industry to provide th ese data within a reasonable time and the EC has 
failed to meet its responsibility to de monstrate the validity of this clas sification in the first instance.  
In any event, when industry submitted data, in th e narrow timeline conceded , on specific substances 
that called into question the EC's hypothesis, the EC's typical response was to simply exclude those 
substances from the classification.
3  Inconsistent with the scientific method and good public policy, 
                                                      
3  This approach is reflected in the following statement: "The essential refinement of the approach [i.e., 
classification based on water solubility] was to remove from each group compounds th at would not be expected G/TBT/W/307 
Page 4  
 
  the EC did not use these submissions to critically re view its unproven postulate that water solubility is 
a predictor of toxicity and bioavailability.
4 
19. The EC also incorrectly cl aims nickel carbonate, whic h was classified in the 30th ATP, was 
not used as a reference substance for the category of slightly soluble nickel compounds in the 31st 
ATP.  The original classification proposal by the Da nish EPA was clear that "[f]or sparingly soluble 
nickel (II) compounds the hazards are based on the classification agreed for the nickel carbonates."5  
Further, the EC incorrectly claims that th e classification of nickel carbonate in the 30th ATP was not 
based on a derogation, or deviation,  from the otherwise applicable science and data based criteria.  
The European Chemicals Bureau, part of the Commission, explicitly in formed the Technical 
Committee on Classification and Labelling that "due to the derogation statement" nickel carbonate 
should be classified as a mutagen despite advice to the contrary from the Specialised Experts.6  
C. TBT  NOTIFICATION OF 31ST ATP  WAS SERIOUSLY FLAWED  
20. The scientific and commercial issues raised by the nickel classifications in the 31st ATP are 
highly technical and complex. Yet, the legislative timetable of the 31st ATP failed to provide 
sufficient time for meaningful consultation with othe r WTO Members, as is required by Article 2.9 of 
the TBT Agreement.  
21. The EC notified the 31st ATP to the WTO Committee on Technical Barriers to Trade on 
18 September 2008, announcing a 60-day comm ent period scheduled to conclude on 
18 November 2008.  The EC's Technical Progress Committee (TPC) met and decided to approve the 
31st ATP on 19 November, not even 24 hours after the close of the comment period. Therefore, the 
ACP Group disagrees with the EC that EU Member States had a full opportunity to consider the 
comments that have been made by WTO Members on the 31st ATP.7  Further, the full list of over 600 
substances subject to the 31st ATP was distributed to the EU Member States several weeks in advance 
of the November 19 meeting, with the instruction that Member States could only accept or reject the entire list, and could not object to or revise speci fic proposed classifications, such as those relating to 
nickel compounds.
8  There was obviously insufficient time or meaningful opportunity for full 
consideration of any concerns the TPC Members wished to raise, or for the TPC Members to 
communicate with WTO Member States regarding the comments.9   
                                                                                                                                                                     
to behave similarly to the nickel compound used for comparison" (EC Reply at p. 8).  In other words, the default 
approach was to categorise and classify based on th e hypothesis that there was a causal connection between 
water solubility and toxicity, unless the actual data demonstrated otherwise.  
4  The EC’s dismissal of contrary data was sometimes simply conclusory, a non-scientific approach 
illustrated by this passage: "However, the nickel industry has as yet not submitted any information or 
experimental results on the basis of which members of the TC C&L were ready to change their original opinion on the hazardous properties of the Nickel compounds at stake" (EC Reply at p. 7).  A simple unwillingness to 
‘change opinions’ is not a scientific rebuttal to, for example, the data submitted to the EC demonstrating that the 
solubility of nickel compounds in water was not a predictor of their solubility in biological fluids. 
5  Danish proposal for classification of the nickel compounds in the 31st ATP (ECBI/96/04 Add. 2). 
6  Summary record of the TC C&L meeting of 21-24 September 2004 (ECBI/139/04 Rev. 2). 
7  "[T]he EC confirms that written comments from  WTO Members are fully and properly taken into 
account during the on going legislative process," and the "Committee vote of 19 November 2008 took therefore 
place in full knowledge of the third countr ies’ comments"  (EC Reply at p. 18). 
8  At least one EU Member State was refused permission to vote on the 31st ATP list without the nickel 
compounds. 
9  The EC attempts to gloss over this shortcoming by claiming that the WTO Members’ comments were 
‘carefully examined’ by EC staff, a nd that EC staff summarised the resu lts of TBT meetings for EU Member 
States (EC Reply at p. 18).  Communications with an d among EC staff is not a substitute for timely, full and 
direct communications among WTO Members.  G/TBT/W/307 
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  D. NOTIFICATION OF THE 1ST ATP  TO THE CLP  REGULATION  
22. The ACP Group understands that the EC intends to reintroduce the 30th and 31st ATP nickel 
classifications in the 1st ATP to the EC's new classification legislation, the CLP Regulation,10 and that 
this legislative process has already begun. We trus t that, as is required by Article 2.9 of the TBT 
Agreement, the EC will notify any such proposal to the TBT Committee at an early stage and will 
fully engage with WTO Members to address any concerns that we may have.   
 
 
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10  Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 
2008 on classification, labelling and packaging of substa nces and mixtures, amending and repealing Directives 
67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006. OJ [2008] L353/1.