Report from the Commission to the Council and the European Parliament on the implementation of Regulation (EC) No 1830/2003 concerning the traceability and labelling of genetically modified organisms and the traceability of food and feed products produced from genetically modified organisms and amending Directive 2001/18/EC
Date: 2008-09-17
Institutions: European Commission
Subjects: EC Regulation, animal nutrition, application of EU law, genetically modified organism, human nutrition, labelling, new product, report, traceability

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COMMISSION OF THE EUROPEAN COMMUNITIES 

Brussels, 17.9.2008 
COM(2008) 560 final 

REPORT FROM THE COMMISSION TO THE COUNCIL AND THE EUROPEAN 
PARLIAMENT 

on the implementation of Regulation (EC) No 1830/2003 concerning the traceability and 
labelling of genetically modified organisms and the traceability of food and feed 
products produced from genetically modified organisms and amending Directive 
2001/18/EC  

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REPORT FROM THE COMMISSION TO THE COUNCIL AND THE EUROPEAN 
PARLIAMENT 

on the implementation of Regulation (EC) No 1830/2003 concerning the traceability and 
labelling of genetically modified organisms and the traceability of food and feed 
products produced from genetically modified organisms and amending Directive 
2001/18/EC  

Regulation (EC) No 1830/20031 (hereinafter "the Regulation") was adopted on 22 September 
2003 and, following the publication of Commission Regulation (EC) No 65/2004 establishing 
a  system  for  the  development  and  assignment  of  unique  identifiers  for  genetically  modified 
organisms, became fully applicable on 16 April 2004. 

On  10  May  2006,  and  in  accordance  with  Article  12  of  the  Regulation,  the  Commission 
forwarded to the European Parliament and to the Council a report on the implementation of 
the  Regulation.  However,  since  only  a  limited  amount  of  information  and  experience  was 
available to underpin Member States' input (2005), the Commission has drawn up the current 
report  to  give  a  more  complete  picture  of  its  implementation.  23  Member  States  submitted 
their input, as well as two industry associations (Annex). Other stakeholders were consulted 
as well, but did not submit their input. 

Information  from  Member  States  was  gathered  by  means  of  a  10-part  questionnaire: 
interpretation of traceability rules, implementation and effect of traceability rules, traceability 
of mixtures of GMOs, interpretation of labelling rules, implementation and effect of labelling 
rules,  exceptions  for  traceability  and  labelling  requirements  below  the  thresholds,  unique 
identifiers,  inspection  and  control  measures,  decision  on  documentation  requirements  under 
the Cartagena Protocol and other issues.  

1. 

THE MARKETING OF GMOS IN THE EUROPEAN UNION 

No  new  patterns  have  emerged  after  the  publication  of  the  first  report.  While  the  European 
food  and  retailing  industries  remain  resistant  to  marketing  GM  food  and  food  products,  the 
majority  of  GM  products  placed  on  the  European  market  are  destined  for  animal  feed  and 
originate  from  imported  commodities,  largely  soybean  and  maize.  Many  Member  States 
reported  that  no  living  GMOs  are  imported  for  cultivation.  In  2006  MON810  remained  the 
only  GMO  cultivated  in  six  Member  States,  with  a  total  area  of  approximately  60 000  ha 
(mainly in Spain, but also in France, Germany, Czech Republic, Slovakia and Portugal). This 
area increased in 2007 to some 110 000 ha.. 

With  regard  to  the  traceability  and  labelling  of  GMOs,  many  Member  States  still  report 
limited  or  no  experience  and  as  a  result  submitted  no  new  information.  The  Commission 
(Eurostat) is examining the possibility of obtaining official statistics on extra-EU imports and 
feed market penetration of GM based products. 

1 

OJ  L  268,  18.10.2003,  p.  24.  A  report  from  the  Commission  to  the  Council  and  the  European 
Parliament  on  the  implementation  of  this  Regulation  was  published  on  25.10.2006,  COM(2006)626 
final. 

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2. 

INTERPRETATION, IMPLEMENTATION AND EFFECT OF TRACEABILITY RULES 

Despite  some  concerns  about  the  complexity  of  legislation  and  overlapping  requirements 
between the Regulation and Regulation (EC) No 1829/20032, the majority of Member States 
reported  no  problems  with  interpreting  the  traceability  rules.  They  noted  that  overall  the 
system  is  progressing.  As  a  standard  business  practice,  operators  ask  suppliers  for  the 
necessary documentation, and more and more business operators declare GM modifications in 
the  accompanying  documents.  However,  significant  experience  suggests  that  this  refers 
mainly to the feed industry3.  

The majority of Member States have found that the effect of traceability rules on labelling and 
informed choice is positive, because they facilitate official controls, risk management and the 
functioning  of  the  entire  system.  The  effect  on  imports  is  also  reckoned  to  depend  on  the 
product  and  is  particularly  important  where  exporters  from  third  countries  submit  little 
information  about  the  presence  of  GMOs.  However  it  should  be  noted  that  the  traceability 
rules  of  the  Regulation  make  no  distinction  between  EU  products  and  imports  from  third 
countries. So the challenges concerning the availability of documentation remain the same for 
EU and third countries operators4.  

Traceability rules have an overall positive influence on public opinion on food safety, and a 
favourable  impact  on  the  marketing  of  non-GM  products  due  to  the  persisting  negative 
perception of GM products by consumers5. One Member State also reported that these rules 
had  a  positive  effect  on  small  enterprises  thanks  to  the  improved  control  framework,  thus 
resulting  in  less  economic  damage.  Another  Member  State  reported  that  small  enterprises 
avoid buying GM ingredients because of the administrative and financial burdens associated 
with the EU traceability rules6.  

Several  other  problems  have  been  indicated.  One  Member  State  reported  that  only  large 
enterprises have systems for requesting assurances and certificates, and verification systems, 
such  as  demanding  analytical  reports  or  taking  samples  (though  it  should  be  noted  that 
analytical reports and/or sampling are not required under the Regulation). Under Article 4(1) 
of the Regulation, operators are solely responsible for the written transmission of the unique 
identifier and of information to the effect that the product contains or consists of GMOs. 

Another Member State reported that operators are not always aware of their obligation to keep 
the respective documentation for  five years and that only  in a  few  cases is this  done. Some 
Member States mentioned practical problems in applying the traceability rules, such as when 
the origin of  GMOs cannot be proved or  when the products are not labelled properly  at the 
beginning of the production chain.  

2 
3 

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to 

the 

make 

reference 

OJ L 268, 18.10.2003, p.1 
It  should  be  noted  that  Member  States  have  already  gained  experience  with  the  implementation  of 
Article 18 of Regulation (EC) No 178/2002 on traceability. The Commission has published guidelines 
which 
GMOs. 
(http://ec.europa.eu/food/food/foodlaw/traceability/factsheet_trace_2007_en.pdf). 
Moreover  there  is  no  legal  basis  requiring  third  countries  or  exporters  to  supply  information  under 
Article 5 of the Regulation. However importers' responsibilities are defined in Article 11 of Regulation 
(EC)  No  178/2002  which  make  importers  in  Member  States  ultimately  responsible  for  ensuring  that 
imports  meet  EU  requirements  at  the  point  of  entry  relating  to  more  specific  EU  legislation,  e.g.  on 
traceability and labelling. 
Eurobarometer 64.3, Europeans and Biotechnology in 2005: Patterns and Trends 
On this point it should be noted that operators are required to implement traceability rules under Article 
18 of Regulation (EC) No 178/2002, irrespective of whether or not their products contain GMOs. 

requirements 

traceability 

for 

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It  is  generally  agreed  that  the  EU  food  industry  remains  reluctant  to  use  GM  products.  In 
some Member States, the majority of food and feed operators initially refused GM products to 
avoid compulsory labelling, which in their view would entail additional costs. However feed 
operators  later  compromised  against  the  background  that  almost  all  marketed  soybean  meal 
imported into the EU was genetically modified. One overseas association expressed concern 
at the fact that EU food processors and retailers had stopped using soybean oil from the US, 
because the resulting food and feed products would be labelled as GM even if no DNA from 
the modification appears in the oil, and deplored the fact that such products required labelling. 

3. 

INTERPRETATION, IMPLEMENTATION AND EFFECT OF LABELLING RULES 

Most Member States reported no problems with way labelling rules were being interpreted by 
officials. A few Member States noted a lack of clarity about the precise differences between 
the  scope  of  the  Regulation  and  Regulation  (EC)  No  1829/2003  for  GM  food  and  feed. 
Another  Member  State  was  unclear  about  the  labelling  of  some  types  of  food  and  feed 
produced from GMOs which are used only for industrial purposes (e.g. oil used for cleaning 
frying  pans)  and  about  the  precise  interpretation  of  the  term  "food  and  feed  produced  from 
GMOs".  A  further  Member  State  reported  a  lack  of  clarity  among  industry  representatives 
concerning the need for labelling of particular products (e.g. fermentation products vis-a-vis 
soya oil)7.  

Member  States  generally  consider  the  labelling  rules  to  be  running  smoothly.  Identified 
problems  concern  mislabelling  (e.g.  labels  indicating  that  a  product  "may"  contain  GMOs), 
negative  labelling  in  breach  of  national  legislation  (e.g.  "non-GM"  or  "GM-free"),  lack  of 
documentation  indicating  GM  presence  in  non  pre-packaged  products,  and  lack  of  labelling 
despite  the  0.9%  threshold  being  exceeded.  One  Member  State  felt  that  the  option  for 
operators  to  indicate  either  that  "This  product  contains  GMOs"  or  "This  product  contains 
genetically  modified  (name  of  organism(s))"  on  a  label  (Art.  4(6)  of  the  Regulation)  might 
prevent the final recipient from knowing precisely how much GMO the product contained.  

Most  Member  States  reported  that  labelling  rules  produced  effects  on  the  market  and 
consumers,  such  as  more  informed  choice,  more  efficient  prevention  of  deceptive  practices 
and an increase in consumer demand for non-GM ingredients in the food chain. However, and 
because  of  the  0.9%  threshold,  some  Member  States  indicated  that  for  GMOs  such  as 
feedingstuffs,  the  unavailability  of  information  about  the  adventitious  or  technically 
unavoidable presence of GMOs below the 0.9% made it impossible to purchase entirely GM-
free products.  

4. 

LABELLING THRESHOLDS AND ADVENTITIOUS PRESENCE OF GMOS 

The  majority  of  Member  States  have  indicated  no  particular  problems  with  the  proper 
application of thresholds (0.9%) for the exemption from labelling of food and feed products. 
Random  samplings  and  laboratory  analyses  are  the  usual  practice,  and  a  few  infringements 
(such  as  mislabelling)  have  been  noted.  Member  States  usually  check  certificates  from 
suppliers, technical data sheets and identity preservation of the product.  

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A new regulation on food enzymes and amending Council Directive 83/417/EEC, Council Regulation 
(EC)  No  1493/1999,  Directive  2000/13/EC  and  Council  Directive  2001/112/EC  which  clearly  define 
GMOs 
Commission 
(http://ec.europa.eu/food/food/chemicalsafety/additives/prop_leg_en.htm). 

proposed 

enzymes 

been 

has 

the 

for 

by 

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However some Member States pointed to the need to resolve the threshold issue in the case of 
stacked events. There are practical difficulties when a mixture of grains, flours or a processed 
product  has  to  be  analysed,  as  they  might  contain  different  ingredients  produced  from  the 
same raw material, e.g. starch and flour from maize. Some Member States and stakeholders 
also  pointed  to  the  need  for  labelling  thresholds  for  the  presence  of  GMOs  in  seeds.  The 
Commission is currently carrying out an impact assessment to examine this issue. 

One professional association notes that the 0.9% threshold constitutes an arbitrary choice and 
should be raised to a more pragmatic level. An overseas organisation considers that as a result 
of  the  labelling  rules  importers  have  stopped  importing  soybean  oil  for  food  use,  forcing 
industries to use high priced conventional rapeseed oil instead. They also note that labelling 
requirements are based on origin rather than detection, i.e. on the availability of the necessary 
certificates and not the possibility of detecting GMOs in the products. In their view this places 
an  unfair  burden  on  operators  in  the  food  and  feed  sector  to  verify  compliance  of  refined 
material8.  

Several Member States reported their views on how to interpret "adventitious presence". The 
assessment  of  whether  GMOs  are  present  in  the  food  and  feed  chain  by  accident  or  due  to 
operators' negligence is on a case-by-case basis, and Member States seem to follow different 
methods. Operators usually have to provide evidence of their intention to avoid GM presence 
at  all  stages  of  production.  This  evidence  includes  certificates  of  ordering  and  purchase  of 
non-GM material, use of separate storages areas, and production lines free of GMOs. Some 
Member States also check the order of production, the cleaning procedures and all necessary 
measures  to  conclude  that  any  presence  is  adventitious  and  technically  unavoidable.  A  few 
Member States reported that, if the original material in the food and feed chain is labelled as 
GM, then the final product is labelled GM as well, even if the traces are below 0.9%, because 
in that case their presence is not considered to be adventitious. 

5. 

THE USE OF UNIQUE IDENTIFIERS 

Most  Member  States  regard  unique  identifiers  as  useful  tools  for  identifying  and  labelling 
genetically modified products and report no serious problems.  Overall they reported limited 
but positive experience with regard to the implementation of Regulation (EC) No 65/2004 and 
the use of unique identifiers.  

One Member State where GM-maize is cultivated reported that unique identifiers are included 
in the documentation transmitted from the seed suppliers to farmers and the processors. One 
industry  association  also  felt  that  the  requirements  for  transaction  and  labelling  of  GM 
varieties had been implemented as standard business practice where requested, but that these 
requirements  had  increased  existing  administrative  obligations  and  costs.  These  unique 
identifiers, such as MON-04032-6, are readily available at: 

http://ec.europa.eu/food/dyna/gm_register/index_en.cfm. 

A few Member States pointed to the fact that unique identifiers are not always included in the 
documentation  accompanying  the  products  –  in  that  case  traceability  is  not  reliable  and 
business operators endeavour to get these codes by requesting additional information from the 
suppliers. 

8 

It should be noted that in the context of this report, any reference to "origin" should be associated with 
the production and processing methods and not the geographic origin, which is not important in terms 
of the traceability and labelling of GMOs.  

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6. 

ENFORCEMENT  OF  THE  REGULATION  BY  THE  MEMBER  STATES  AND 
IMPLEMENTATION OF RECOMMENDATION 2004/787/EC  

The  majority  of  Member  States  reported  that  overall  controls  and  official  inspections  are 
carried out without serious problems. However it should be noted that some of their practices 
differ  significantly.  In  some  Member  States  the  majority  of  checks  are  documentary,  while 
sampling and analysis are limited due to the cost factor. Other Member States reported that 
control  officers  principally  check  whether  the  operators  perform  "in  house"  controls  in 
accordance with the regulations. 

Several  Member  States  reported  problems  with  the  limited  resources  available,  and  the 
resultant reduction in inspections and controls. In several Member States additional staff are 
needed  on  a  seasonal  basis,  e.g.  on  auditing  seed  installations.  One  Member  State  reported 
lack  of  resources  for  testing  food  in  accordance  with  the  Recommendation  2004/787/EC, 
which requires separate analysis of file incremental samples.  

Several Member States made reference to the benefits of training programmes for inspectors, 
such  as  the  ones  provided  by  the  JRC  and  within  the  framework  of  TAIEX,  and  the 
advantages of having their laboratories involved in the ENGL network. 

National provisions have established sanctions for infringing the respective Community and 
national legislation, including warnings, withdrawal of products, return to country of origin, 
re-labelling,  fines  and  imprisonment.  No  serious  patterns  of  infringement  have  been  noted, 
while  most  of  the  identified  violations  of  the  law  concern  non-labelling  and  insufficient 
operating procedures for traceability of GM products. A professional organisation notes that 
some  penalties  have  been  disproportionate  for  the  adventitious  presence  of  EU-authorised 
events, including mandatory destructions and criminal prosecutions. 

Several  Member  States  have  reported  enforcement  problems  with  products  derived  from 
GMOs which do not contain any detectable and identifiable GMO-material but still have to be 
labelled. The main challenge in this area lies with the fact that the competent authorities can 
carry out only documentary checks on preventive measures, while due to the absence in many 
cases  of  detectable  DNA,  sampling  would  not  necessarily  be  an  option.  Therefore  they 
sometimes face problems where exporters and authorities in third countries are unwilling to 
provide  importers  with  the  necessary  information  to  comply  with  traceability  and  labelling 
legislation.  On  the  other  hand  it  should  be  noted  that  importers  are  obliged  to  demand  this 
information.  Otherwise  they  would  be  in  breach  of  Community  law  by  importing  products 
which fail to comply with the respective provisions. An industry organisation considers that 
the  obligation  of  labelling  these  products  creates  a  competitive  disadvantage  for  European 
industry.  An  overseas  association  claims  that  the  mandatory  traceability  and  labelling  of 
refined soybean oil is open to fraudulent practice, since it  cannot  be verified  by any sort of 
scientific test.  

As  in  the  previous  report,  Member  States  indicated  problems  with  the  implementation  of 
Recommendation  2004/787/EC  on  sampling  and  detection.  The  majority  of  Member  States 
consider its implementation as expensive and time-consuming, especially with regard to big 
shipments. They claim that checking and sampling imported bulk shipments according to the 
technical guidance of the Recommendation places a major burden on control authorities and 
the results are not in proportion with the time spent or the financial burden. They report that 
the required number of incremental samples is too high, especially in ships above 500 tonnes. 
A few Member States reported that they employ methods for sampling feeds based on the old 
feeding sampling Directive 76/371/EEC, establishing the quantitative method of sampling for 
the  official  control  of  feedingstuffs.  A  Member  State  also  reports  that  sampling  of  bulk 
commodities  is  in  accordance  with  the  general  principles  and  methods  described  in  ISO 

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standard 13690 (1999). It is also claimed that the Recommendation is impossible to apply for 
pre-packaged food or for small amounts of an ingredient. 

As  indicated  in  the  first  report,  there  are  still  problems  in  terms  of  the  units  in  which  GM 
content  should  be  expressed.  Recommendation  2004/787/EC  advises  that  "the  results  of 
quantitative  analysis  should  be  expressed  as  the  percentage  of  GM  DNA  copy  numbers  in 
relation to target taxon specific DNA copy numbers calculated in terms of haploid genomes". 
Nevertheless,  some  Member  States  ask  their  laboratories  to  express  measurements  of 
authorised  GM  materials  in  weight-%  rather  than  haploid  genomes-%,  as  the  labelling 
threshold  in  their  view  must  be  with  respect  to  weight  or  number  of  grains  and  not  DNA 
content.  One  Member  State  reported  that  they  use  haploid  genomes-%  only  when  plasmid-
based reference material is available.  

Some  other  Member  States  have  noted  that  method  validation  according  to  ISO  17025,  as 
suggested by the Recommendation, depends on the national accreditation body. Requirements 
differ significantly between Member States. It has been claimed that ISO 17025 accreditation 
is more of a bureaucratic device, which guarantees good traceability and documentation inside 
a  laboratory,  than  a  tool  which  guarantees  scientific  harmonisation.  It  should  be  noted  that 
ISO 17025 is a system for quality assurance in laboratories, not a method for the qualitative 
and quantitative analysis of GMOs. There are CRL methods for all authorised GMOs under 
Regulation  (EC)  No  1829/2003  which  are  then  validated  in  Member  States'  laboratories 
according to the framework quality control rules set out in ISO 17025. 

As  indicated  in  the  previous  report,  a  further  problem  concerns  the  difficulty  in  inspecting 
unauthorised GMOs or stacked gene events without validated detection methods and certified 
reference material. 

7. 

CONCLUSIONS 

Member States and stakeholders have gained additional experience on the implementation of 
the  Regulation  since  the  publication  of  the  last  report.  This  is  particularly  true  of  the  feed 
sector,  and  it  has  been  evident  in  their  input  on  a  series  of  practical  matters.  However,  the 
overall  experience  in  the  food  sector  remains  modest,  mainly  due  to  the  limited  number  of 
GMOs and derived products currently being marketed in the European Union.  

As also mentioned in the last report, Member States indicated that the Regulation's provisions 
were  being  properly  interpreted  and  implemented.  They  consider  the  provisions  as  steps 
towards  more  informed  choice,  more  efficient  prevention  of  deceptive  practices  and  better 
official controls. However, several problems concerning the application of business practices 
pose major challenges for GMO policy making and its enforcement in the European Union.  

Industrial  associations  and  exporters  from  third  countries  continue  to  argue  that  the 
Regulation introduces excessive administrative burdens. It restricts the export of GMOs to the 
European  Union,  and  forces  European  operators  to  use  high  priced  conventional  products. 
They consider the labelling thresholds as arbitrary choices and claim that labelling products 
produced  from  GMOs,  where  no  GM  material  can  be  detected,  places  an  unfair  burden  on 
operators in the food and feed sector to verify compliance of refined material.  

As  also  indicated  in  the  first  report,  the  Commission  considers  that  several  factors,  like 
consumer  demand  for  non-GM  products,  higher  prices  in  the  feed  sector  and  asynchronous 
approval for  GMOs between countries,  have  had a far greater effect on the trade in GMOs. 
The  requirement  for  labelling  aims  to  deliver  free  choice  for  operators  and  consumers  and 
should not be considered as an obstacle to the marketing of authorised GM products.  

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The Commission will continue to work with the Competent Authorities of Member States to 
ensure the appropriate implementation of the Regulation. At the same time it will continue to 
examine  with  stakeholders  all  possible  aspects  of  implementing  and  possibly  improving  the 
policy  on  the  traceability  and  labelling  of  GMOs.  The  Commission  (Eurostat)  will  also 
continue  its  efforts  to  obtain  official  statistics  on  GM  based  products,  in  particular  on  the 
volume  of  EU  imports  of  GM  based  products  from  non-EU  countries,  on  feed  market 
penetration and on GMO cultivated surfaces. 

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ANNEX 

Institutions which contributed their input 

Ministry of Health, Family and Youth, Austria 

Federal Public Services Public Health, Food Chain and Environment, Belgium 

FAVV / AFSCA: Federal Agency for the Food Chain Safety, Belgium 

Department of Agriculture, Cyprus 

Ministry of the Environment, Czech Republic 

Danish Plant Directorate 

Ministry of Trade and Industry, Finland 

Ministry of Agriculture and Forestry, Finland 

Finnish Food Safety Authority Evira 

Customs Laboratory, Finland 

Ministry of the Environment, Finland 

Federal Office of consumer Protection and Food Safety, Germany 

Ministry of Rural Development and Food, Greece 

Ministry of Development, Hellenic Food Safety Authority, Greece 

Ministry of Economy and Finance, General Chemical State Laboratory, Greece 

Ministry for Environment and Water, Hungary 

Ministry for the Environment and Territory, Italy 

Food and Veterinary Service, Latvia 

Ministry of Agriculture, Latvia 

Ministry of Environment, Lithuania 

State Food and Veterinary Service, Lithuania 

Ministry of Health, Luxembourg 

Malta Environment and Planning Authority 

Malta Standards Authority 

Ministry of Housing, Spatial Planning and the Environment, Netherlands 

Ministry of the Environment, Department of Nature Conservation, Poland 

GPP, Cabinet of Political Planning, Portugal 

DGADR, General Directorate of Agriculture and Rural Development, Portugal 

National Sanitary Veterinary and Food Safety Authority, Romania 

State Veterinary and Food Administration, Slovakia 

Central Controling and Testing Institute for Agriculture, Slovakia 

Ministry of Agriculture, Forestry and Food, Slovenia 

Ministry of Health, Slovenia 

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Ministry for the Environment and Spatial Planning, Slovenia 

Ministry of Environment, Spain 

National Food Administration, Sweden 

Department for Environment, Food and Rural Affairs, UK 

European Association fro Bio-industries (EuropaBio) 

American Soybean Association (ASA) 

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