UK P&I CLUB

Carefully to Carry APRIL 2010

Advice on the importation of

genetically modified
material into Europe “The carrier
shall properly
and carefully
load, handle,
Given in accordance with the current legal frameworks stow, carry,
keep, care for
and discharge
the goods
carried.”

Hague Rules,
Articles iii, Rule 2

Carefully to Carry
Advisory Committee
This report was produced by the Carefully
to Carry Committee – the UK P&I Club’s
advisory committee on cargo matters.
The aim of the Carefully to Carry
Committee is to reduce claims through
contemporaneous advice to the Club’s
Members through the most efficient
means available.

The committee was established in 1961

and has produced many articles on
cargoes that cause claims and other
cargo related issues such as hold
washing, cargo securing, and ventilation.

The quality of advice given has

established Carefully to Carry as a key
This article is a more detailed adjunct to the basic guidelines ‘The carriage
source of guidance for shipowners and
of genetically modified crops into Europe’. It has been prepared to inform ships’ officers. In addition, the articles
UK Club Members on certain current issues pertaining to the importation of have frequently been the source of
GM material, and non-GM material which may be affected by the presence expertise in negotiations over the
settlement of claims and have also been
of low level GM material. The information that follows is not intended as relied on in court hearings.
legal advice or opinion. Some useful sources of further information are
available at the end of the article. In 2002 all articles were revised and
published in book form as well as on disk.
All articles are also available to Members
Genetically modified organisms (GMO) on the Club website. Visit the Carefully to
Carry section in the Loss Prevention area
The process of genetic modification involves the identification, isolation of the Club website www.ukpandi.com for
and transfer of a specific gene from one organism to another. Therefore, more information, or contact the Loss
Prevention Department.
genetically modified organisms (GMO) are organisms whose genetic
makeup has been altered using genetic engineering.
Genetically modified (GM) crops
The process of genetic modification, compared to
conventional breeding methods, results in a faster and
more precise development of crop varieties with
desired characteristics. Genetically modified crop
varieties have been developed to meet different
breeding aims including:
● Herbicide resistance; crops that show minimum
damage following herbicide spraying regimes which
are designed to eliminate weeds.
● Disease; crops that are less prone to be damaged by
fungal, bacterial or viral diseases.
● Pest resistance; crops that are less attractive to
natural predators such as insects.
● Stress resistance; crops that are more tolerant to
various environmental stresses such as drought,
salinity and extreme temperatures.
● Varieties with altered composition; crops that show
improved nutritional values, e.g. ‘Golden Rice’ with
an increased level of vitamin A.
● Elimination of pollutants to be used in
bioremediation; crops that have the ability to
decontaminate land by assimilating hazardous
pollutants and toxic compounds. These plants can
be then harvested and forwarded for industrial use or
incinerated.
●
Pharming (biopharming/molecular farming for the
production of pharmaceuticals, enzymes etc.); crops
that produce increased yields of desirable
compounds industrial and pharmaceutical use,
e.g. starch, fuel, antibodies, hormones, etc.
The first GM seeds were planted for commercial use in
the USA in 1996. By 2006, the total acreage increased
to 102 million hectares, and today it is estimated that
125 million hectares are being cultivated with GM
crops (2008 figures). The USA is leading in the
cultivation of GM crops with approximately half of the
world acreage (60 million hectares in 2008) followed by
Argentina, Brazil and Canada. China and India are
rapidly expanding their cultivation of GM crops. Today,
a total of 25 countries use genetic engineering
commercially. Soybean, maize, oilseed rape (canola)
and cotton account for almost all commercial GMO
production. Other GM crops under cultivation are
sugar beet, potato, rice and carnations.
The legal framework of GMOs
The European Regulations
Two laws govern the authorisation and release of
genetically modified organisms in the EU:
Directive 1829/2003 in effect since 19 April 2004
(Replaces directive 258/97)
The directive defines the use of food and feed that has
been produced from or contains GM plants. The
directive is set out in 49 Articles which give the
detailed requirements for a GMO food or feed that
need to be demonstrated in order for authorisation to
be granted. It specifies the application for authorisation
and the authorisation process, including modifications,
revocations, suspensions and renewals of these.
Directive 2001/18EEC in effect since 17 April 2001
(Replaces directive 90/220EC)
The directive contains 38 Articles which define the
commercial use of genetically modified microorganisms
and their deliberate release into the environment.
These have been compiled with the objective to protect
human health and the environment by controlling the
risk of the deliberate release of GMOs. It clarifies the
obligations, including the notification procedure,
consultation with the public, and exchange of
information prior to the release, as well as the
monitoring and handling of any modifications following
the release.
In addition to these two main directives, there is a
further regulation concerning the traceability and
labelling of GMOs, and a recommendation that
encourages the inclusion of GM crops in European
farming:
Regulation 1830/2003
The regulation (13 Articles) determines the stages
involved in the traceability and labelling of genetically
modified organisms and the traceability of food and
feed products produced from GMOs prior to be placed
on the market. It covers the labelling provisions of all
GM food or feed which consists of /contain/or is
produced from GMOs. For any products comprising of
mixtures of GMOs, a list of the unique identifiers of all
GMO components should be made available. Labelling
of pre packed and non-pre packed products consisting
of, or containing GMOs should include the following
statement on the label:

“This product contains genetically modified organisms”

or “This product contains genetically modified [name
of organism(s)].”

Recommendation 2003/556/EC
This recommendation states that no form of agriculture
should be excluded in the EU and includes guidelines
to be used by the Member States for the development
of measures for the coexistence of GMO crops and
crops developed through conventional breeding. Any
decision should not only be made on the basis of
scientific evidence but it should also assess the
environmental and health aspects in addition to the
economic aspects. The recommendation puts
emphasis on the monitoring and evaluation of
coexistence and encourages the improvement of the
existing segregation measures.
The Cartagena Biosafety Protocol (CBP) and
GMO trade to the EU
Further to the EU legal framework, there are
regulations that have been agreed in the context of the
2006 Cartagena Biosafety Protocol (CBP). The CBP
was designed to promote transparency and control in
the international GMO trade, and up the end of 2009 it
has been signed by 157 countries, excluding the four
main GMO producers, USA, Argentina, Brazil and
Canada.
It is an international regulatory framework put in place
to reconcile the safety of the biodiversity with the use
of products of modern biotechnology. A major
component of the CBP was the establishment of the
Biosafety Clearing-House (BCH) which has been set
up to “to facilitate the exchange of information on
Living Modified Organisms (LMOs) and assist the
Parties to better comply with their obligations under
the Protocol.”
The intentional and unintentional movements of
products of modern biotechnology and their handling
are described in Articles, 11, 17 and 18. Please note
that the CBP refers to living modified organisms
(LMO); the term GMO includes LMOs which are in
effect genetically modified crops and other genetically
modified organisms
Under the protocol exporters are obliged to provide
more information on GMO products before the
shipment, it is then up to the receiving country to
decide whether to accept the shipment or not.
Member States may reject such imports without
quantitative justification or scientific evidence. They
can simply produce the following reasons for rejection:
● Danger to traditional crops
● Undermine local culture
● Undermine the value of biodiversity.
CBP – Article 11
Procedure for living modified organisms intended for
use as food of feed, or for processing (LMO-FFPs)
Article 11 of the CBP describes the procedures
required for living modified organisms (LMO) that are
intended for direct use as food or feed or for
processing (FFP).
CBP – Article 17
Unintentional transboundary movements and
emergency measures
Under the CBP, the presence of GM material found in
non-GM cargos is covered in Article 17, ‘The
unintentional transboundary movements and
emergency measures’. According to this Article, the
duties of parties involved in such movements are:
● To notify of the affected states, the BCH and
international organisations where relevant
● To provide the name, identity and details of the
characteristics/traits of the LMO
● Provide information on the estimated quantities
involved, the date of release, the use of GMO at
origin and any other relevant circumstances
● Inform on the possible adverse effects of the LMO
on local biodiversity, including humans, and provide
possible risk management measures
● Provide a point of contact for further information
and clarifications.
CBP – Article 18
Handling, transport, packaging and identification
Article 18 describes the requirements for handling,
transport, packaging and identification of intentional
transboundary movements of LMOs for direct use as
FFP (Article 18.2a), for contained use (Article 18.2b),
and for intentional introduction into the environment
(Article 18.2c).
Central to the requirements of Article 18.2a is that the
documentation that accompanies cargos of LMO-FFPs
clearly states that it ‘may contain’ LMOs. To this
effect, the International Grain Trade Coalition (IGTC)
recommends that the commercial invoice contains the
following or of a similar meaning declaration:
“Cartagena Protocol Provision: This shipment ‘may
contain’ living modified organisms intended for direct
use as food or feed, or for processing, that are not
intended for intentional introduction into the
environment.”
The European Union has gone beyond the Cartagena
provisions and has introduced tough rules on the
importation of GMOs, based on demanding but clearly
set out principles (see page 2; The legal framework of
GMOs – The European Regulations). Following the
cessation of the de facto moratorium on GMO imports
in 2004, Directive 1829/2003 came into force
specifying the labelling provisions to all food and feed
produced from GMOs (as described above).
Furthermore and in line with the World Trade
Organisation, EFSA authorises GMOs for which there
is no scientific evidence for it to be banned.
Release of GMOs in the EU
Authorisation
Prior to a GMO’s or a GMO-derived product’s release
into the EU market, its safety for humans, animals and
the environment is thoroughly assessed through an
approval system. The approval system is run by the
national authority of the Member State in which the
application is made and then forwarded to the
European Food Safety Authority (EFSA) for
assessment. They in turn pass the application to a
GMO panel.
The GMO Panel is an expert committee of the EFSA
that comprises independent scientist who carry out a
rigorous safety assessment of the GMO under
application. Their decisions are not regulated by
prescribed directives from the EU or the EFSA, and the
expert advice they provide forms the basis of the
opinions submitted by EFSA to the European
Commission.
The European Commission then decides on the
authorisation of the GMO based on the scientific
evidence provided by EFSA and within the regulatory
framework of 1829/2003 and 2001/18EEC. There are
three types of authorisation, food and feed, import and
processing, and cultivation. Authorisation can be
approved under one or more of these categories. The
authorisation is granted for ten years which can be
renewed if application is made within nine years of the
original date of authorisation.
The Member States, however, have the right to uphold
national bans on GMOs despite a clean bill of health
from the EFSA and the EC. A number of Member
States have invoked a so-called ‘safeguard clause’
(Art. 23 Dir. 2001/18/EC). According to this clause,
Member States may provisionally restrict or prohibit the
use and/or sale on its territory of a specific GMO that
has previously been accepted. However, such action
only takes place after new or additional scientific
evidence has been made available that indicates that
the GMO in question poses a risk to human health or
the environment. Six Member States currently apply
safeguard clauses on GMO events: Austria, France,
Greece, Hungary, Germany and Luxembourg.
The Rules on GMOs in the EU are currently under
evaluation by an external contractor and the results are
expected to be released during the summer of 2010.
Detection methods
From April 2007, the threshold of the presence of
unauthorised GMOs in the EU has been 0% (zero
tolerance). Such a threshold is scientifically
unrealistic.
The flaw in the zero-tolerance policy on non-GM
cargoes comes from the very fact that bulk cargoes are
the product of aggregation of many small
consignments, the compliance of which cannot be
guaranteed by the identity preserved (IP) systems. The
European farmers and agri-cooperatives (COPA-
COGECA) recognise that it is unlikely that any GM or
non-GM bulk cargo will be free of adventitious/chance
contaminants and they have requested the lifting of the
zero-tolerance policy that results from LLP. This view
has been shared by the North American Export Grain
Association (NAEGA) which has called for practical
and achievable standards of LLP and the International
Grain Trade Coalition (IGTC) which has recommended
a low level marketing threshold of 5%.
Currently the risks and responsibilities of LLP are
passed along the supply chain from one party to the
next as there is no clear and definitive regulatory
framework that covers these. It has been
recommended that the EU devises new thresholds that
are in line with the current technical detection limits.
Until this happens, the only realistic mitigation
approach is to reduce the risk at destination by carrying
out testing at the port of loading that complies with the
official requirements of the destination port.
It is crucial to identify the potential sources of LLP as
these have serious implications to international trade
when cargoes are rejected. Rejections of imports are
often due to low level presence (LLP) of GM material
which can result from:
1 Asynchronous approval (AA) of GM crops, whereby
the approval of a GM crop at the port of origin
precedes that at the port of destination.
2 An isolated foreign approval (IFP) where there is
contamination of a cargo with GM material that has
been approved and commercialised in specific world
regions.
Confidence in the detection methods is paramount
especially when dealing with traces of GMO. The
presence of GMO in a sample, both qualitatively and
quantitatively, can be determined by using DNA
Figure 1. Cargo testing for the low level presence of GM material
Cargo screened for LLP presence of chance GMOs
Positive
Identification
Is the GMO authorised
Yes No
> 0.9% < 0.9%
Labelling Labelling
REQUIRED NOT REQUIRED
sequencing techniques which allow the search for
specific and unknown GMOs. The Community
Reference Laboratory for GM Food and Feed is the
body responsible for the scientific assessment and
validation of detection methods for GM food and feed
in the European Union.
Additionally, the Institute of Health and Consumer
Protection (IHCP) has developed a database which
contains an array of analytical methods for the
detection, identification and quantification of
genetically modified organisms. This is an online
database, which has been designed to allow direct and
user-friendly access for information. Figure 1 is an
illustration of the process of cargo screening for the
presence of GMO.
Sampling
Correct sampling is crucial and incorrect sampling is
often the main source of error. Good sampling
techniques are designed to minimise error. The
Department of Environment, Food and Rural Affairs
(DEFRA) has sponsored a study entitled ‘Kernel Lot
Distribution Assessment (KeLDA)’ which has been
designed to test the widespread assumption that the
distribution of GM material in large shipments is
random. The results suggested that the randomness of
GM contamination in large shipments cannot be
assumed and that any sampling methods used should
be free of such assumptions.
Currently, there are two testing guidelines which have
been specifically designed to be used when testing for
the presence of GM material and they do not make
assumptions about the distribution of the material to be
tested.
Negative
Cargo release
ILLEGAL
Rejection due to
‘zero tolerance’ policy
The two documents that provide technical guidance on
sampling for the detection of GMOs are the
recommendation 2004/787/EC and the draft European
standard prCEN/TS 21568:2005. Recommendation
2004/787/EC further specifies which ISO method
should be used for the collection of the material as
shown in Table 1. It is worth noting that the
recommendation of 2004/787/EC under the general
principles specifies the following:
● Official controls should be carried out at any stage
of the production, processing, and storage,
distribution of products that contain or may contain
GMOs or food and feed produced from GMOs,
including at the point of import [3].
● Operators whose products are subject to sampling
and analysis should be entitled to appeal for a
second opinion. Official bodies should collect a
sufficient number of counter samples for
enforcement and referee purposes in order to
guarantee operators appeal right and have a second
opinion, as required by national legislation.
● Alternative sampling strategies to those
recommended in this guidance may be applied.
Table 1. ISO methods used for the collection of material for
the detection of GMOs
Commodity to be sampled ISO method to be used
Free flowing commodities 6644/13690
Oilseeds 542
Pre-packaged food
and feed products 2859
Material larger than grains
(e.g. potatoes, fruits, rhizomes) 2859
Material for testing should be collected in intermittent
sampling periods which can be calculated by dividing
the estimated total off-loading time by the total number
of increments. Table 2 shows the recommended number
of increments which varies according to the lot size.
Table 2. Size of bulk samples (kg) and number of
increments to be collected for testing for GMOs in cargoes
Lot size Size of bulk Number of
in tonnes sample in kg increments
< 50 5 10
100 10 20
250 25 50
> 500 50 100
Labelling
According to EU regulation 1829/2003, labelling of
GMOs has been introduced to help consumers to make
an informed decision on their choice between
conventional products and GMO/GMO-containing
products. The following table (Table 3) includes details
of which products require, and do not require,
labelling.
Table 3. Labelling requirements of GMO-related products
PRODUCTS THAT REQUIRE LABELLING
Food which is a genetically modified organism (GMO)
or which consists of GMOs
(e.g. canned sweetcorn, approved but not available in the EU)
Food Ingredients or additives, which are produced
from GMOs
(e.g. oil from GM rapeseed or soy beans, starch from GM
maize and sugar from GM sugar beet)
Food ingredients and additives which contain
genetically modified organisms
(e.g. beer with GM yeast, blue cheese with GM moulds,
yoghurt with GM lactobacilli)
NOTE: No GM yeast/bacteria/fungi have been approved for
use in food in the EU.
PRODUCTS THAT DO NOT REQUIRE LABELLING
Food containing GMOs up to a threshold of 0.9%
● The producer/importer of a product needs to supply
evidence that the presence of such material is either
adventitious or technically unavoidable and that every
possible step to minimise the presence of such material has
been taken
● The GMO in question has already been classified as safe
and has received an EU authorisation
NOTE: From April 2007, the threshold of unauthorised
GMOs is 0% (zero tolerance)
Food which is produced with the aid of genetically
modified organisms
(e.g. meat, eggs or dairy products produced from animals fed
on GM feed, also additives, flavours and vitamins produced
with the help of GM microorganisms such as artificial
sweeteners, flavour enhancers and thickening agents)
Substances that not required to be declared on the
list of ingredients
● Enzymes used in food processing (e.g. chymosin used in
cheese production and pectinases used to degrade cell
membranes in juice or wine)
● Substrates (growth media) for microorganisms (e.g. bakers’
yeast cultured on a medium containing GM corn and
vitamin C, produced by microorganisms raised using
glucose derived from GM corn starch)
● Carrier substances; substances used to prolong shelf life,
facilitate transportation etc (e.g. starch/glucose/dextrin-
derived)
Honey containing pollen or nectar from genetically
modified plants
Cultivation of GMOs in the
European Union

Although, the cultivation of GM crops is legally

possible in the EU, the lack of public acceptance of
GM crops has resulted in slow authorisation, release
and cultivation of GM crops. In fact, there is a well
organised consumer lobby against the introduction of
GM containing foods, so strong that some EU
governments (including the UK) who might like to
approve their use hesitate to do so. At the moment
there is no regulatory framework which prevents
governments in Europe from rejecting a cargo
containing GM crops due to pressures by the anti-GM
lobby.
Currently only six Member States, Spain, France,
Germany, Portugal, Slovakia and the Czech Republic
commercially cultivate GM plants and that is limited to
only one variety of maize (Bt maize). Table 4, below,
summarises the genetically modified plants that have
been approved or await approval in the EU.
Table 4. Status of GM plants in the EU (up to 03/12/2009)
Crop Total Authorised Authorised Authorisation
number of for import in progess
GM varieties
Recommendations for
shipowners and their
representatives on GMO trading
to the EU
✔ Cargoes of soybean, maize, oilseed rape and
cotton, loaded in USA, Argentina, Brazil and
Canada come with an increased likelihood of
being genetically modified. It is therefore
recommended that analysis of those specific
cargoes, from the above mentioned locations, is
carried out prior to loading. The GM or non-GM
nature of the cargo should be certified based on
the analysis carried out.
✔ The bill of lading should clearly state the species
and the variety which, if the cargo is GM should be
on the list of authorised GMOs:
http://ec.europa.eu/food/dyna/gm_register/
index_en.cfm

Cotton 12 1 1/1 11
✔ It is recommended that any GMO qualitative and
Flowers 2 1 1/1 1 quantitative tests carried out at the port of loading
follow the protocols set out by the National
Maize 33 11 7/11 22 Reference Laboratory of the destination country. In
Potato 1 - - 1 this way, the danger of variable results due to
laboratory discrepancies is minimised. A list of
Rapeseed 6 3 1/3 3 National Reference laboratories which can carry
Rice 1 - - 1
out analyses of GMO material and work under the
auspices of the European Central Reference
Soybean 9 2 2/2 7 Laboratory (CRL) can be found in the following list:
http://ec.europa.eu/food/food/biotechnology/
Sugarbeet 2 1 0/1 1
gmo_reference_lab_en.htm

✔ Establish whether the import country is a party to

the CBP through the BCH (http://bch.biodiv.org)

✔ Establish whether the import country has any

additional regulations on LMO shipments for FFP,
as in the case of the EU Members who accept only
previously authorised GM crops.

✔ The International Grade Trade Coalition

recommends that the commercial invoice contains
the contact information of the last exporter prior to
the transboundary movement and the first importer
after such movement.

✔ Enquire whether the testing laboratory at the port

of origin is accredited to carry out sampling
specifically for GM material.
Selected sources of information

1. Biosafety Clearing-House (BCH)

http://bch.biodiv.org

2. The global pipeline of new GM crops - Implications of asynchronous approval for international trade
ftp://ftp.jrc.es/pub/EURdoc/report_GMOpipeline_online_preprint.pdf

3. Regulation (EC) No 1829/2003 of the European Parliament and of the Council of 22 September 2003 on
genetically modified food and feed (Text with EEA relevance)
http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CELEX:32003R1829:EN:HTML

4. Directive 2001/18/EC of the European Parliament and of the Council of 12 March 2001 on the deliberate
release into the environment of genetically modified organisms and repealing Council Directive 90/220/EEC -
Commission Declaration
http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CELEX:32001L0018:EN:HTML

5. Regulation (EC) No 1830/2003 of the European Parliament and of the Council of 22 September 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
http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CELEX:32003R1830:EN:HTML

6. Commission Recommendation of 23 July 2003 on guidelines for the development of national strategies and
best practices to ensure the coexistence of genetically modified crops with conventional and organic farming
(notified under document number C (2003) 2624)
http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CELEX:32003H0556:EN:HTML

7. MAKING SENSE OF GM - What is the genetic modification of plants and why are scientists doing it?
http://www.senseaboutscience.org.uk/PDF/MakingSenseofGM.pdf

8. GMO Compass
http://www.gmo-compass.org/eng/gmo/db/

9. Provision of updated guidance to enforcement authorities for sampling food and feed to determine the
presence of GMOs: draft guidance for consultation/feedback
http://www.food.gov.uk/multimedia/pdfs/consultationresponse/gmsamplingniresponse.pdf

10. Database of published analytical methods for GMO detection

http://ihcp.jrc.ec.europa.eu/facilities/Database_of_published_analytical_methods_for_GMO_detection.htm

11. Kernel lot distribution assessment (KeLDA): a study on the distribution of GMO in large soybean shipments
http://www.springerlink.com/content/78p12626305n3818/fulltext.pdf

12. 2004/787/EC: Commission Recommendation of 4 October 2004 on technical guidance for sampling and
detection of genetically modified organisms and material produced from genetically modified organisms as or in
products in the context of Regulation (EC) No 1830/2003Text with EEA relevance
http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2004:348:0018:01:EN:HTML

UK P&I CLUB For further information please contact:

IS MANAGED Loss Prevention Department, Thomas Miller P&I Ltd
BY THOMAS Tel: +44 20 7204 2307. Fax +44 20 7283 6517
MILLER Email: lossprevention.ukclub@thomasmiller.com