WORLD TRADE  
ORGANIZATION  G/RO/W/117 
15 April 2008 
 
 (08-1741) 
Committee on Rules of Origin Original:   English 
  
 
DRAFT CONSOLIDATED TEXT OF NON-PREFERENTIAL RULES OF ORIGIN 
 
Harmonization Work Programme
 
 
Communication from Switzerland 
 
 
 The following communication, dated 11 April 2008,  is being circulated at the request of the 
Delegation of Switzerland.  
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 A. T
ECHNICAL ISSUES  
 HS Position Chapter 21 
 Subheading 2106.90 others  
This item covers also preparations, often re ferred to as food supplements, based on extracts 
from plants, fruit concentrates, fru ctose, etc. and containing specific chemical/pharmaceutical 
elements/ingredients such as added vitamins, minutes quantities of iron compounds, etc. These 
preparations are often put up in packaging with indica tions/claims that they maintain general health or 
well-being. These preparations are mainly produ ced by companies working in the pharmaceutical/ 
nutritional sector. 
Due to the fact that the said preparations are containing specific chemical/pharmaceutical 
elements, Switzerland would like to pro pose the following rule for Chapter 21: 
ex 2106  Preparations, often referred to as food supplements: 
 
2106.90 - Other As specified for split subheading 
 
 Change in particle size  
 
[The deliberate and controlled modification in par ticle size of a good, other than by merely 
crushing or pressing, resulting in a good having a defined particle size, defined particle size 
distribution or defined surface area, which are rele vant to the purposes of the resulting good and have 
different physical or chemical characteristics from the input materials is considered to be origin 
conferring.] G/RO/W/117 
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  B. S
TRUCTURAL ISSUES  
Chapter 30 
The Swiss delegation would like to draw the a ttention of the CRO on a question concerning 
the non-applicability of the origin rule related to ga lenic forms of medicaments (ampoules, vials, etc.). 
In our view, HS-position 30.02 is a special ca se since both active substances and proportioned 
medicine forms are incorporated here.  Both, the active substance has HS 30.02 as well as the 
proportioned medicine form. 
The galenic form is the proportioned medicine fo rm (put up in measured doses).  It allows a 
patient to take a medicament in the correct dosage. 
Thus, the current formulation of the origin rule for proportioned medicine forms is not 
appropriate (details below). 
1. Active substances 
 Active substance are classified accordi ng to the WCO under HS-position 30.02. 
  Active substances can be biotechnologi cally processed (Chapter 30, note 9). 
 
 The rule of origin "change to the goods of this heading by biological or biotechnological 
processes" can be used here. 
 
2. Galenic form, proportioned medicine form (ampoules, vials, etc.) 
(a) Change to this heading from any other heading (CTH
) 
 Active substances are classified by the WCO under HS 30.02 (including sub-headings).  The 
same goes for galenic forms which are also classi fied under HS 30.02 (inclu ding sub-headings). 
  In HS 30.04 CTH is not applicable for activ e substances of HS 30.02 which are processed in 
proportioned medicine forms ("excluding goods of heading no 30.02, 30.05 or 30.06...."). 
 
 Example: monoclonal anti-body, HS 3002.10,  ampoule with active substance monoclonal 
anti-body 3002.10.   Thus it is not at possible that CTH takes place here.  The same goes for the rule CTSH. 
 
(b) Biotechnological processes
 
 An ampoule is not biotechnologically manufactured.  
  The active substance is mixed with other aux iliary materials (excipients) and then filled 
together into the ampoules. 
 
 The empty glass ampoule is filled in a germ-poor  environment with special racking plants.  
Staff is normally equipped with special protective clothing for germ-poor work.   Filling is thus to be considered as a technical process.   G/RO/W/117 
 Page 3 
 
 
   Since the packing process is not origin conferring, the production of the ampoule is to be 
considered as the last substantial processi ng operation (last substantial transformation). 
  Thus it is not possible that a biotechnological  process takes place.  The rule biotechnological 
process is not applicable for proportioned medicine forms. 
 
(c) Rule for Chapter 3002 – Swiss proposal
 
 Establishing an uniform rule of origin in  Chapter 30 for proportioned medicine: from a 
systematic point of view medicine with HS code 30.02 in the proportioned form (put up in measured 
doses or packed for retail sale) should not have an other approach for establishing origin compared to 
medicine in proportioned form (put up in meas ured doses or packed for retail sale) with 
HS code 30.04.   In the entire Chapter 30 the production of a proportioned medicine form (excluding mere pressing of tablets or by mere encapsulation) should be origin conferring. 
 
 Therefore, the rule of origin for 30.02 for the proportioned medicine should read "production 
of the measured doses or in forms or packing for re tail sale except by mere pressing of tablets or by 
mere encapsulation".  (d) Residual rule
 
 No residual rule was proposed for 30.02. 
  The proposed residual rule for goods of headings 30.03 and 30.04 produced by mixing or otherwise combining materials of different origins,  indicates that these goods originate in the country 
that produced the therapeutic or prophylactic mate rials (disregarding solvents and other non-active 
additives) that predominate by weight or volum e, as appropriate, over those of each other single 
country.   This would mean in practice that a medicament originating in Switzerland and filled there in a 
glass ampoule would have the origin of the glass ampoule.  This, only because glass is heavier than the medicament itself. Such Residual rule contradict s in our mind the concept of the last substantial 
processing step (substantial transformation). 
 (e) Residual rule - Swiss proposal
 
 We propose, to amend point 1 of Chapter 30 residual rule as follows: 
 
1. Goods of headings 30.03 and 30.04 produced by  mixing or otherwise combining materials of 
different origins, originate in the country th at produced the therapeutic or prophylactic 
materials (disregarding solvents and other non- active additives) that predominate by total 
value of materials and related processing activity, over those of each other single country. 
2. We propose the same residual rule for goods of 30.02. 
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