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25.6.2011 Official
Journal
of
the
European
Union L
166/9
COMMISSION REGULATION (EU) No 619/2011
of 24 June 2011
laying down the methods of sampling and analysis for the official control of feed as regards
presence of genetically modified material for which an authorisation procedure is pending or the
authorisation of which has expired
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
Parties, Parties to the Protocol have to inform the other
Parties through the Biosafety Clearing House (BCH) on
any final decision regarding domestic use, including
placing on the market, of a GMO that may be subject
to transboundary movement for direct use as food or
Having regard to the Treaty on the Functioning of the European
feed or for processing. This information shall contain,
Union,
inter alia, a risk assessment report. Countries which are
not Parties to the Protocol may also provide such
information on a voluntary basis. International
information exchange mechanisms regarding the authori
Having regard to Regulation (EC) No 882/2004 of the European
sation of GMOs and their safety assessments are also
Parliament and of the Council of 29 April 2004 on official
provided by FAO and OECD.
controls performed to ensure the verification of compliance
with feed and food law, animal health and animal welfare
rules ( 1 ), and in particular Article 11(4) thereof,
(3) The
EU
imports
significant
quantities
of
commodities
produced in third countries where GMO cultivation is
Whereas:
widespread. While these imported commodities are
used both in the production of food and feed, the
majority of the commodities likely to contain GMOs
are destined for the feed sector thereby entailing a
higher risk of trade disruption for that sector in cases
(1) Commission Regulation (EC) No 152/2009 of
where Member States apply different rules for official
27 January 2009 laying down the methods of
controls. It appears therefore appropriate to limit the
sampling and analysis for the official control of feed ( 2 )
scope of this Regulation to the feed sector which, in
does not provide for special rules for the control of
comparison with other sectors related to the production
material which contains, consists of or is produced
of foodstuffs, has a higher likelihood for GM presence.
from GMOs (GM material) for which an EU authorisation
procedure is pending or GM material the authorisation of
which has expired. Experience has shown that in the
absence of such rules, the official laboratories and the
competent authorities apply different methods of
sampling and different rules for the interpretation of
(4) Regulation
(EC)
No
1829/2003
provides
that
the
placing
the results of the analytical tests. This may lead to
on the market of genetically modified feed is subject to
different conclusions as regards the compliance of a
an authorisation procedure. The authorisation procedure
product with Regulation (EC) No 1829/2003 of the
includes the publication of an EFSA opinion of which the
European Parliament and of the Council of
main component is a safety assessment. In giving its
22 September 2003 on genetically modified food and
opinion, EFSA consults Member States upon receipt of
feed ( 3 ). As a result of the lack of harmonised rules,
a valid application and Member States have 3 months to
economic operators are faced with legal uncertainty
make their opinions known. The opinion of EFSA has
and there is a risk that the functioning of the internal
also to include a method for detection validated by the
market will be affected.
European Union Reference Laboratory (EU-RL).
(2) Different
international
information
exchange
mechanisms
providing information on the safety assessments
(5) In practice, the validation by the European Union
performed by countries authorising the commercial
Reference Laboratory (EU-RL) is carried out inde
isation of GMOs are in place. In accordance with the
pendently of the other elements provided for in the auth
Cartagena Protocol on Biosafety to the Convention on
orisation procedure. Generally the method is validated
Biological Diversity of which all Member States are
and published before all of the other elements are
fulfilled for completing the EFSA opinion. These
methods are published on the website of the EU-RL
( 1 ) OJ L 165, 30.4.2004, p. 1.
( 2 ) OJ L 54, 26.2.2009, p. 1.
and are available to the competent authorities as well
( 3 ) OJ L 268, 18.10.2003, p. 1.
as to any interested parties.

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L 166/10
EN
Official Journal of the European Union
25.6.2011
(6) A
method
may
only
be
validated
if
it
complies
with
the
or produced from SYN-EV176-9 and MON-21-
detailed rules for the fitness of the method set out in
9xMON-81-6 maize and ACS-BN4-7xACS-
Commission Regulation (EC) No 641/2004 of 6 April
BN1-4, ACS-BN4-7xACS-BN2-5 and ACS-
2004 on detailed rules for the implementation of Regu
BN7-1 oilseed rape for which a quantitative method
lation (EC) No 1829/2003 of the European Parliament
has been validated by the European Union Reference
and of the Council as regards the application for the
Laboratory provided that the certified reference material
authorisation of new genetically modified food and
is available. These GM materials were placed on the
feed, the notification of existing products and
market before the application of Regulation (EC) No
adventitious or technically unavoidable presence of
1829/2003 and were notified as existing products
genetically modified material which has benefited from
under Article 20 of that Regulation. As the seeds were
a favourable risk evaluation ( 1 ). In addition, as required
no more commercialised at global scale, the respective
by that Regulation, common criteria for minimum
notifiers informed the Commission that they had no
performance requirements for analytical methods for
intention to submit an application for the renewal of
GMO testing have been set ( 2 ).
the authorisation of the products concerned. As a conse
quence, the Commission adopted Decisions
2007/304/EC ( 3 ), 2007/305/EC
( 4 ), 2007/306/EC
( 5 ),
2007/307/EC ( 6 ) and 2007/308/EC ( 7 ) on the withdrawal
(7)
The methods of analysis validated by the EU-RL in the
from the market of the products concerned (obsolete
context of the authorisation procedure and for the
products). These Decisions provide a tolerance for the
placing on the market, use and processing of existing
presence in products of material which contain, consist
products within the meaning of Article 20 of Regulation
of or are produced from SYN-EV176-9 and MON-
(EC) No 1829/2003 are event-specific quantitative
21-9xMON-81-6 maize and ACS-BN4-
methods. They are validated through a collaborative
7xACS-BN1-4, ACS-BN4-7xACS-BN2-5 and
trial in accordance with the principles of ISO 5725 Inter
ACS-BN7-1 oilseed rape provided that this presence
national standard and/or the International Union of Pure
is adventitious or technically unavoidable and in a
and Applied Chemistry (IUPAC) protocol. As a matter of
proportion no higher than 0,9 % for a limited period
fact, the EU-RL is currently the sole laboratory in the
which expires on 25 April 2012. It is appropriate to
world validating quantitative event-specific methods in
ensure that at the time of the expiry of the tolerance
accordance with the above mentioned standards in the
period set out in Decisions 2007/304/EC, 2007/305/EC,
context of pre-marketing authorisation procedures. These
2007/306/EC, 2007/307/EC and 2007/308/EC this
quantitative methods are considered to be more appro
Regulation applies also to the detection of these
priate than qualitative methods for the purpose of
obsolete products in feed. It should also apply to any
ensuring the harmonisation of the official controls.
other GM material the authorisation of which is not
Indeed testing procedures using qualitative methods
renewed at the expiry of the authorisation due to the
require other sampling schemes as they are otherwise
phasing out of the product.
associated with higher risks to provide diverging results
regarding the presence or absence of genetically modified
material. It is therefore appropriate to use the methods of
analysis validated by the EU-RL in the context of the
authorisation procedure to prevent diverging analytical
(11) Harmonisation of the official controls of feed for the
results amongst Member States.
detection of GM material falling under the scope of
this Regulation should also be ensured through the
adoption of common methods of sampling.
(8) Certified
reference
material
should
also
be
available
to
enable control laboratories to perform their analysis.
(12) These methods should be based on recognised scientific
(9) Accordingly,
the
scope
of
this
Regulation
should
cover
and statistical protocols and, when available, on inter
the detection in feed of GM material authorised for
national standards and should cover the different steps
commercialisation in a third country and for which an
of sampling, including the rules applicable to the
authorisation procedure is pending for more than 3
sampling of the material, the precautions to be taken
months under Regulation (EC) No 1829/2003 where
in the course of sampling and preparation of samples,
the event-specific quantitative methods of analysis
the conditions to be applied for taking incremental
submitted by the applicant have been validated by the
samples and replicate laboratory samples, the handling
EU-RL and provided that the certified reference material
of laboratory samples and the sealing and labelling of
is available.
samples. To ensure adequate representativeness of the
samples taken for official control purposes, specific
conditions adapted to the fact that the lot of feed is
presented in bulk agricultural commodities, pre-
(10) The
scope
of
this
Regulation
should
also
cover
GM
packaging or retail should also be adopted.
material the authorisation of which has expired. It
should therefore apply to feed containing, consisting of
( 3 ) OJ L 117, 5.5.2007, p. 14.
( 4 ) OJ L 117, 5.5.2007, p. 17.
( 1 ) OJ L 102, 7.4.2004, p. 14.
( 5 ) OJ L 117, 5.5.2007, p. 20.
( 2 ) http://gmo-crl.jrc.ec.europa.eu/doc/Min_Perf_Requirements_
( 6 ) OJ L 117, 5.5.2007, p. 23.
Analytical_methods.pdf
( 7 ) OJ L 117, 5.5.2007, p. 25.

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EN
25.6.2011 Official
Journal
of
the
European
Union L
166/11
(13) It
is
also
appropriate
to
harmonise
the
rules
for
the
(19) These
implementing rules should be adapted if this
interpretation of the results of the analysis, to ensure
becomes necessary to take account of new developments
that throughout the European Union the same
in particular as regards their impact on the internal
conclusion is drawn from the same analytical results. In
market and on food and feed operators.
this context, it is also necessary to take into account the
technical constraints associated with any method of
analysis, in particular at trace levels since analytical
(20) The
measures
provided
for
in
this
Regulation
are
in
uncertainty increases with decreasing levels of GM
accordance with the opinion of the Standing
material.
Committee for the Food Chain and Animal Health and
neither the European Parliament nor the Council has
opposed them,
(14) To take these constraints into account, as well as the
need to ensure that controls are both feasible, robust
and proportionate, as set out in Regulation (EC) No
HAS ADOPTED THIS REGULATION:
178/2002 of the European Parliament and of the
Council of 28 January 2002 laying down the general
principles and requirements of food law, establishing
Article 1
the European Food Safety Authority and laying down
Definitions
procedures in matters of food safety ( 1 ), it is appropriate
to set as a Minimum Required Performance Limit (MRPL)
1. For the purposes of this Regulation, the following defi
the lowest level of GM material which is considered by
nitions apply:
the EU-RL for the validation of quantitative methods.
This level corresponds to 0,1 % related to mass fraction
of GM material in feed and is the lowest level where
(1) ‘Precision — Relative Repeatability Standard Deviation
results are satisfactorily reproducible between official
(RSDr)’: The relative standard deviation of test results
laboratories when appropriate sampling protocols and
obtained under repeatability conditions. Repeatability
methods of analysis for measuring feed samples are
conditions are conditions where test results are obtained
applied.
with the same method, on identical test items, in the
same laboratory, by the same operator, using the same
equipment within short intervals of time;
(15) The
methods
validated
by
the
EU-RL
are
specific
to
each
transformation event irrespective of the fact that the
transformation event is present in one or several GMOs
(2) ‘Minimum Required Performance Limit (MRPL)’: the lowest
containing one or several transformation events. The
amount or concentration of analyte in a sample that has to
MRPL should thus apply to the whole GM material
be reliably detected and confirmed by official laboratories;
containing the measured transformation event.
(3) ‘GM material’: material which contains, consists of or is
produced from GMOs.
(16) Measurement
uncertainty
should
be
determined
by
each
official laboratory and confirmed as described in the
guidance document on Measurement Uncertainty for
2. The
definitions
set
out
in
Article
2
of
Regulation
(EC)
No
GMO testing laboratories ( 2 ) developed by the Joint
1829/2003 and in Annex I to Regulation (EC) No 152/2009
Research Centre of the Commission (JRC).
apply.
Article 2
(17) A decision of non-compliance of the feed should
therefore only be taken when GM material falling
Scope
under the scope of this Regulation is present at levels
This Regulation shall apply to the official control of feed with
equal or above the MRPL, measurement uncertainty
respect to the presence of the following material:
being taken into account.
(a) GM material authorised for commercialisation in a third
(18) The
rules
established
by
this
Regulation
should
not
affect
country and for which a valid application has been
the possibility for the Commission, or where applicable
submitted under Article 17 of Regulation (EC) No
for a Member State, to adopt emergency measures in
1829/2003 and for which the authorisation procedure has
accordance with Articles 53 and 54 of Regulation (EC)
been pending for more than 3 months provided that:
No 178/2002.
(i) it has not been identified by EFSA as susceptible to
( 1 ) OJ L 31, 1.2.2002, p. 1.
( 2 ) http://www.irmm.jrc.be/html/reference_materials_catalogue/user_
have adverse effects on health or the environment
support/EUR22756EN.pdf
when present under the MRPL;

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L 166/12
EN
Official Journal of the European Union
25.6.2011
(ii) the quantitative method requested under that Article
Article 6
has been validated and published by the European
Union Reference Laboratory; and
Measures in case of detection of GM material referred to in
Article 2
1. Where
results
of
analytical
tests
indicate
the
presence
of
GM material referred to in Article 2 are at or above the MRPL
(iii) that the certified reference material fulfils the conditions
as defined in accordance with the rules of interpretation set out
set out in Article 3;
in Annex II Part B, the feed shall be considered as non-
compliant with Regulation (EC) No 1829/2003. Member
States shall immediately notify this information through the
(b) after 25 April 2012, GM material notified under Article 20
RASFF in accordance with Article 50 of Regulation (EC) No
of Regulation (EC) No 1829/2003 of which the authori
178/2002.
sation has expired and for which a quantitative method
has been validated and published by the European Union
Reference Laboratory provided that certified reference
material fulfils the conditions set out in Article 3; and
2. Where
results
of
analytical
tests
indicate
the
presence
of
GM material referred to in Article 2 is below the MRPL as
defined in accordance with the rules of interpretation set out
(c) GM material for which the authorisation has expired due to
in Annex II Part B, Member States shall record this information
the fact that no application for renewal in accordance with
and notify the Commission and the other Member States by 30
Article 23 of Regulation (EC) No 1829/2003 has been
June of each year. Recurrent findings over a period of time of 3
submitted provided that certified reference material fulfils
months shall be notified without delay.
the conditions set out in Article 3.
Article 3
3. The
Commission
shall
or
a
Member
State
may,
where
Certified reference material
appropriate, adopt emergency measures in accordance with
Articles 53 and 54 of Regulation (EC) No 178/2002.
1. Certified
reference
material
must
be
available
to
Member
States and any third party.
2. Certified
reference
material
shall
be
produced
and
certified
Article 7
in accordance with ISO guides 30 to 35.
List of GM material referred to in Article 2
The Commission shall publish the list of GM material
complying with the conditions set out in Article 2 on its
3. The
information
accompanying
the
certified
reference website. The list shall include information as to the place
material shall include information on the breeding of the
where the certified reference material can be accessed as
plant which has been used for the production of the certified
required by Article 17(3)(j) of Regulation (EC) No 1829/2003
reference material and on the zygosity of the insert(s). The
and, if applicable, information on the measures adopted in
certified value of the GMO content shall be given in mass
accordance with paragraph 3 of Article 6 of this Regulation.
fraction and, where available, in copy number per haploid
genome equivalent.
Article 4
Article 8
Methods of sampling
Review
Samples for the official control of feed as regards the presence
The Commission shall monitor the application of this Regu
of the GM material referred to in Article 2, shall comply with
lation and its impact on the internal market as well as on
the methods of sampling, as set out in Annex I.
feed, livestock and other operators, and, if necessary, bring
forward proposals to review this Regulation.
Article 5
Sample preparation, methods of analysis and interpretation
Article 9
of results
Entry into force
The preparation of laboratory samples, the methods of analysis
and the interpretation of results shall comply with the
This Regulation shall enter into force on the 20th day following
requirements set out in Annex II.
its publication in the Official Journal of the European Union.

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EN
25.6.2011 Official
Journal
of
the
European
Union L
166/13
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 24 June 2011.
For the Commission
The President
José Manuel BARROSO

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L 166/14
EN
Official Journal of the European Union
25.6.2011
ANNEX I
METHODS OF SAMPLING
1. For the purpose of applying Annex I to Regulation (EC) No 152/2009, GM material shall be considered as a substance
likely to be distributed non-uniformly throughout the feed.
2. By derogation from points 5.B.3., 5.B.4 and 6.4 of Annex I to Regulation (EC) No 152/2009, the size of the aggregate
samples for feed materials shall be not less than the weight corresponding to 35 000 grains/seeds and the final sample
shall be not less than the weight corresponding to 10 000 grains/seeds.
The mass equivalent of 10 000 grains/seeds is provided in Table 1 below.
Table 1
Mass equivalent of 10 000 grains/seeds for different plants
Plant Mass,
in
grams,
corresponding
to
10
000
grain/seed
Barley, Millet, Oat, Rice, Rye, Wheat 400
Maize 3
000
Soybean 2
000
Rape seed 40

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EN
25.6.2011 Official
Journal
of
the
European
Union L
166/15
ANNEX II
CRITERIA FOR SAMPLE PREPARATION AND METHODS OF ANALYSIS
In order to detect the presence in feed of the GM material referred to in Article 2, the official laboratories shall use the
methods of analysis and control requirements described in this Annex.
A. PREPARATION OF SAMPLES FOR ANALYSIS
In addition to the requirements of Annex II Part A to Regulation (EC) No 152/2009, the following provisions shall
apply.
1. Treatment of the final samples
Official laboratories shall use the standard EN ISO 24276, ISO 21570, ISO 21569 and ISO 21571 that indicate
strategies for the homogenisation of the final sample (also designated as the ‘laboratory sample’ in the ISO
standards), the reduction of the final sample to the sample for analysis, the preparation of the test sample and
the extraction and the analysis of target analyte.
2. Size of the sample for analysis
The sample for analysis shall be of a size which ensures the quantification of GM material at a presence
corresponding to the MRPL with a statistical degree of confidence of 95 %.
B. APPLICATION OF METHODS OF ANALYSIS AND EXPRESSION OF THE RESULTS
By derogation from Part C of Annex II to Regulation (EC) No 152/2009, the following rules for the application of
methods of analysis and expression of results shall apply.
1. General conditions
Official laboratories shall comply with the requirements of ISO 17025 and use quantitative methods of analysis
that have been validated by the European Union Reference Laboratory in collaboration with the European Network
of GMO Laboratories. They shall ensure that, considering the whole analytical method starting with the treatment
of the laboratory sample of feed, they are in position to carry out the analysis at the level of 0,1 % related to mass
fraction of GM material in feed with an adequate precision (relative repeatability standard deviation less than or
equal to 25 %).
2. Rules for interpretation of results
To ensure a level of confidence of approximately 95 %, the outcome of the analysis shall be reported as x +/– U
whereby x is the analytical result for one measured transformation event and U is the appropriate expanded
measurement uncertainty.
U shall be specified by the official laboratory for the whole analytical method and confirmed as described in the
guidance document on Measurement Uncertainty for GMO testing laboratories ( 1 ) developed by JRC.
A feed material, feed additive or, in the case of compound feed each of the feed material and feed additive of which
it is composed shall be considered as non-compliant with Regulation (EC) No 1829/2003 when the analytical
result (x) for one measured transformation event minus the expanded measurement uncertainty (U) equals or
exceeds the level of 0,1 % related to mass fraction of GM material. When results are primarily expressed as GM-
DNA copy numbers in relation to target taxon specific DNA copy numbers calculated in terms of haploid
genomes, they shall be translated into mass fraction in accordance with the information provided in each validation
report of the EU-RL.
( 1 ) http://www.irmm.jrc.be/html/reference_materials_catalogue/user_support/EUR22756EN.pdf

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