. /.   WORLD TRADE  
ORGANIZATION  G/SPS/GEN/628 
25 January 2006 
 (06-0349) 
Committee on Sanitary a nd Phytosanitary Measures Original:   English 
  
 
SUBMISSION BY THE INTERNATIONAL ORGANIZATION FOR STANDARDIZATION 
(ISO) TO THE SPS COMMITTEE MEETING – 1-2 FEBRUARY 2006 
 
 
 The following communication, received on 24 January 2006, is being circulated at the request 
of ISO. 
 
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1. The International Organization for Standardizati on (ISO) has prepared this information paper 
following on-going communications between the IS O Central Secretariat and the Committee on 
Sanitary and Phytosanitary Measures (SPS) of the WTO.  It provides a summary of current work 
undertaken by ISO that may be of interest to the SPS Committee. 
2. ISO is an observer at the Codex Alimentarius Commission.  It is also an observer at the WTO 
Committee on Trade and Environment (CTE) and the Committee on Technical Barriers to Trade 
(TBT).  In the area of technical assistance, ISO cooperates regularly with WTO, as well as with ITC 
and UNIDO, in the framework of a Memora ndum of Understanding in the latter case. 
3. There is a long history of collaboration betw een the Codex Alimentarius and ISO, in 
particular through ISO Technical Committee TC 34, Food products .  Codex and ISO activities are 
complementary.  Codex, as an intergovernmental organization, prepares consensus-based documents 
to assist governments in their statutory and regulatory work to protect their citizens from health 
hazards related to food consumption.  ISO, as a non-governmental organization, prepares standards on 
test methods, nomenclature and specifications, main ly for areas where Codex has no ongoing work 
(spices, tea and coffee), to assist stakeholders along the  food chain to meet the existing statutory and 
regulatory requirements, as well as the requirements of consumers of these products.  The number of 
ISO methods recommended by Codex is almost 100.  
4. In September 2005, ISO published ISO 22000, Food safety management systems — 
Requirements for any organization in the food chain.  It is based on a management systems approach, 
as in ISO 9001:2000, and on the Codex hazard analysis and critical control point (HACCP) system.  The need for a new International Standard arose fr om the fact that a variety of national standards 
(Australian, Danish, Dutch, Irish, etc.) had been  developed and several retailer organizations had 
prepared documents (BRC, EFSIS, IFS, etc.) fo r the establishment and auditing of food safety 
systems, possibly including HACCP requirements.   ISO 22000 should help clarify and harmonize the 
present situation.  
5. A Technical Specification explaining the pro cess approach used in ISO 22000 has also 
recently been published: ISO/TS 22004, Food safety management systems — Guidance on the 
application of ISO 22000:2005 .  For an organization to operate effectively and efficiently, it has to 
identify and manage numerous linke d activities.  An activity using resources and managed to enable 
the transformation of inputs into outputs, is c onsidered as a process.  Often the output from one G/SPS/GEN/628 
Page 2  
 
  process directly forms the input to the next.  Technical Specification ISO/TS 22004 gives generic 
guidance to small and large enterprises on the implementation of ISO 22000. 
6. ISO, through its Technical Committee 34, Food products, and its Committee on Conformity 
Assessment, CASCO, is currently working on Technical Specification ISO/TS 22003, Food safety 
management systems — Requirements for bodies provid ing audit and certification of food safety 
management systems .  It is based on the generic standard that covers the area of certification and 
auditing of management systems, namely ISO/IEC 17021, Conformity assessment — Requirements 
for bodies providing audit and certification of management systems , and includes specific guidance 
on certification to ISO 22000.  It is still at a draft stage but it is hoped it will be published in the second half of 2006. 
7. Work is being undertaken in ISO/TC 34 on a new International Standard, ISO 22005, 
Traceability in the feed and fo od chain — General principles a nd basic requirements for system 
design and implementation .  It is now out for vote as a Draft Inte rnational Standard.  It will assist feed 
and food organizations to document the history, ap plication and location of a product or components.  
It is intended to complement the Codex work on traceability as it explains the design of a suitable 
system to enable organizations to comp ly with the regulations set by Codex. 
8. With regard to analytical and test methods  in the field of milk and milk products, 
ISO/TC 34/SC 5 and the International Dairy Federa tion (IDF) work together to prepare analytical 
methods that are published jointly.  Important new work is Technical Specification TS 22964, Milk 
and milk products — Detection of Enterobacter sakazakii , published in January 2006.  The bacterium 
is thermotolerant and can remain after sterilization.   It has been found to exist in some infant 
formulations.  
9. ISO/TC 34/SC 9, Microbiology , develops horizontal methods for the enumeration of such 
contaminants as Salmonella , Escherichia  coli, Bacillus cereus,  thermotolerant Campylobacter  and 
pathogenic Vibrio , and the use of polymerase chain reaction (PCR) for the detection of food-borne 
pathogens.  Other important international stan dards specify methods for the detection and 
quantification of genetically modified organisms in  foodstuffs.  These standards, developed in close 
cooperation with the European Committee for Standardization (CEN), are as follows: 
ISO 21571:2005, Foodstuffs — Methods of analysis for the detection of genetically modified 
organisms and derived products — Nucleic acid extraction 
ISO 21569:2005, Foodstuffs — Methods of analysis for the detection of genetically modified 
organisms and derived products — Qual itative nucleic acid based methods 
ISO/TS 21098:2005, Foodstuffs — Nucleic acid based methods of analysis of genetically 
modified organisms and derived products — Inform ation to be supplied and procedure for the 
addition of methods to ISO 21569, ISO 21570 or ISO 21571 
ISO 21570:2005, Foodstuffs — Methods of analysis for the detection of genetically modified 
organisms and derived products — Quan titative nucleic acid based methods   
ISO 24276:2006, Foodstuffs  —Methods of analysis for the detection of genetically modified 
organisms and derived products — Ge neral requirements and definitions
 
 
10. ISO considers that using its international standards will assist regulatory authorities in 
achieving their aims in public health and safety at less cost to manufacturers, consumers and the 
taxpayer, whilst at the same time diss eminating new technologies and good practices. 
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