2007R0333 — EN — 01.09.2012 — 001.

001 — 1

This document is meant purely as a documentation tool and the institutions do not assume any liability for its contents

►B ►M1 COMMISSION REGULATION (EC) No 333/2007

of 28 March 2007
laying down the methods of sampling and analysis for the official control of the levels of lead,
cadmium, mercury, inorganic tin, 3-MCPD and polycyclic aromatic hydrocarbons in foodstuffs ◄
(Text with EEA relevance)
(OJ L 88, 29.3.2007, p. 29)

Amended by:

Official Journal

No page date
►M1 Commission Regulation (EU) No 836/2011 of 19 August 2011 L 215 9 20.8.2011
 2007R0333 — EN — 01.09.2012 — 001.001 — 2

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▼M1
COMMISSION REGULATION (EC) No 333/2007
of 28 March 2007
laying down the methods of sampling and analysis for the official
control of the levels of lead, cadmium, mercury, inorganic tin, 3-
MCPD and polycyclic aromatic hydrocarbons in foodstuffs
▼B
(Text with EEA relevance)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European Community,

Having regard to Regulation (EC) No 882/2004 of the European

Parliament and of the Council of 29 April 2004 on official controls
performed to ensure the verification of compliance with feed and food
law, animal health and animal welfare rules (1), in particular
Article 11(4) thereof,

Whereas:

(1) Council Regulation (EEC) No 315/93 of 8 February 1993 laying

down Community procedures for contaminants in food (2)
provides that maximum levels must be set for certain
contaminants in foodstuffs in order to protect public health.

(2) Commission Regulation (EC) No 1881/2006 of 19 December

2006 setting maximum levels for certain contaminants in food­
stuffs (3) establishes maximum levels for lead, cadmium, mercury,
inorganic tin, 3-MCPD and benzo(a)pyrene in certain foodstuffs.

(3) Regulation (EC) No 882/2004 lays down general principles for

the official control of foodstuffs. However, in certain cases more
specific provisions are necessary to ensure that official controls
are performed in a harmonised manner in the Community.

(4) The methods of sampling and analysis to be used for the official
control of levels of lead, cadmium, mercury, 3-MCPD, inorganic
tin and benzo(a)pyrene in certain foodstuffs are established in
Commission Directive 2001/22/EC of 8 March 2001 laying
down the sampling methods and the methods of analysis for
the official control of the levels of lead, cadmium, mercury and
3-MCPD in foodstuffs (4), Commission Directive 2004/16/EC

(1) OJ L 165, 30.4.2004, p. 1, corrected by OJ L 191, 28.5.2004, p. 1. Regu­

lation as amended by Commission Regulation (EC) No 1791/2006 (OJ L 363,
20.12.2006, p. 1).
(2) OJ L 37, 13.2.1993, p. 1. Regulation as amended by Regulation (EC) No
1882/2003 of the European Parliament and of the Council (OJ L 284,
31.10.2003, p. 1).
(3) OJ L 364, 20.12.2006, p. 5.
( ) OJ L 77, 16.3.2001, p. 14. Directive as last amended by Directive 2005/4/EC
4

(OJ L 19, 21.1.2005, p. 50).

 2007R0333 — EN — 01.09.2012 — 001.001 — 3

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of 12 February 2004 laying down the sampling methods and the
methods of analysis for the official control of the levels of tin in
canned foods (1) and Commission Directive 2005/10/EC of
4 February 2005 laying down the sampling methods and the
methods of analysis for the official control of the levels of
benzo(a)pyrene in foodstuffs (2), respectively.
(5) Numerous provisions on sampling and analysis for the official
control of the levels of lead, cadmium, mercury, inorganic tin, 3-
MCPD and benzo(a)pyrene in foodstuffs are similar. Therefore,
in the interest of clarity of legislation, it is appropriate to merge
those provisions in one single legislative act.
(6) Directives 2001/22/EC, 2004/16/EC and 2005/10/EC should
therefore be repealed and replaced by a new Regulation.
(7) The measures provided for in this Regulation are in accordance
with the opinion of the Standing Committee for the Food Chain
and Animal Health,
HAS ADOPTED THIS REGULATION:

Article 1

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1. Sampling and analysis for the official control of the levels of lead,
cadmium, mercury, inorganic tin, 3-MCPD and polycyclic aromatic
hydrocarbons (‘PAH’) listed in Sections 3, 4 and 6 of the Annex to
Regulation (EC) No 1881/2006 shall be carried out in accordance with
the Annex to this Regulation.
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2. Paragraph 1 shall apply without prejudice to the provisions of
Regulation (EC) No 882/2004.

Article 2

Directives 2001/22/EC, 2004/16/EC and 2005/10/EC are hereby

repealed.
References to the repealed Directives shall be construed as references to
this Regulation.

Article 3

This Regulation shall enter into force on the 20th day following its
publication in the Official Journal of the European Union.
It shall apply from 1 June 2007.
This Regulation shall be binding in its entirety and directly applicable in
all Member States.

(1) OJ L 42, 13.2.2004, p. 16.

(2) OJ L 34, 8.2.2005, p. 15.
 2007R0333 — EN — 01.09.2012 — 001.001 — 4

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ANNEX

PART A

DEFINITIONS

For the purposes of this Annex, the following definitions shall apply:

‘lot’: an identifiable quantity of food delivered at one time

and determined by the official to have common char­
acteristics, (such as origin, variety, type of packing,
packer, consignor or markings). In the case of fish,
also the size of fish shall be comparable;

‘sublot’: designated part of a large lot in order to apply the

sampling method on that designated part. Each sublot
must be physically separated and identifiable;

‘incremental sample’: a quantity of material taken from a single place in the

lot or sublot;

‘aggregate sample’: the combined total of all the incremental samples taken
from the lot or sublot; aggregate samples shall be
considered as representative of the lots or sublots
from which they are taken;

‘laboratory sample’: a sample intended for the laboratory.

PART B

SAMPLING METHODS

B.1. GENERAL PROVISIONS

B.1.1. Personnel
Sampling shall be performed by an authorised person as designated by
the Member State.

B.1.2. Material to be sampled

Each lot or sublot which is to be examined shall be sampled separately.

B.1.3. Precautions to be taken

In the course of sampling, precautions shall be taken to avoid any
changes which would affect the levels of contaminants, adversely
affect the analytical determination or make the aggregate samples
unrepresentative.

B.1.4. Incremental samples

As far as possible, incremental samples shall be taken at various places
distributed throughout the lot or sublot. Departure from such procedure
shall be recorded in the record provided for under point B.1.8. of this
Annex.

B.1.5. Preparation of the aggregate sample

The aggregate sample shall be made up by combining the incremental
samples.
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B.1.6. Samples for enforcement, defence and referee purposes
The samples for enforcement, defence and referee purposes shall be
taken from the homogenised aggregate sample unless this conflicts
with the rules of the Member States as regards the rights of the food
business operator.

B.1.7. Packaging and transmission of samples

Each sample shall be placed in a clean, inert container offering
adequate protection from contamination, from loss of analytes by
adsorption to the internal wall of the container and against damage in
transit. All necessary precautions shall be taken to avoid any change in
composition of the sample which might arise during transportation or
storage.

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In case of sampling for PAH analysis plastic containers shall be
avoided if possible as they could alter the PAH content of the
sample. Inert, PAH-free glass containers, adequately protecting the
sample from light, shall be used wherever possible. Where this is prac­
tically impossible, at least direct contact of the sample with plastics
shall be avoided, e.g. in case of solid samples by wrapping the
sample in aluminium foil before placing it in the sampling container.

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B.1.8. Sealing and labelling of samples
Each sample taken for official use shall be sealed at the place of
sampling and identified following the rules of the Member States.

A record shall be kept of each sampling, permitting each lot or sublot to

be identified unambiguously (reference to the lot number shall be
given) and giving the date and place of sampling together with any
additional information likely to be of assistance to the analyst.

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B.2. SAMPLING PLANS
B.2.1. Division of lots into sublots
Large lots shall be divided into sublots on condition that the sublot may
be separated physically. For products traded in bulk consignments (e.g.
cereals) Table 1 shall apply. For other products Table 2 shall apply.
Taking into account that the weight of the lot is not always an exact
multiple of the weight of the sublots, the weight of the sublot may
exceed the mentioned weight by a maximum of 20 %.

B.2.2. Number of incremental samples

The aggregate sample shall be at least 1 kg or 1 litre except where it is
not possible, e.g. when the sample consists of 1 package or unit.

The minimum number of incremental samples to be taken from the lot

or sublot shall be as given in Table 3.

In the case of bulk liquid products the lot or sublot shall be thoroughly
mixed in so far as possible and in so far it does not affect the quality of
the product, by either manual or mechanical means immediately prior to
sampling. In this case, a homogeneous distribution of contaminants is
assumed within a given lot or sublot. It is therefore sufficient to take
three incremental samples from a lot or sublot to form the aggregate
sample.
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The incremental samples shall be of similar weight/volume. The weight/
volume of an incremental sample shall be at least 100 grams or 100
millilitres, resulting in an aggregate sample of at least about 1 kg or 1
litre. Departure from this method shall be recorded in the record
provided for under point B.1.8 of this Annex.

Table 1
Subdivision of lots into sublots for products traded in bulk
consignments

Lot weight (ton) Weight or number of sublots

≥ 1 500 500 tonnes

> 300 and < 1 500 3 sublots

≥ 100 and ≤ 300 100 tonnes

< 100 —

Table 2
Subdivision of lots into sublots for other products

Lot weight (ton) Weight or number of sublots

≥ 15 15-30 tonnes

< 15 —

Table 3
Minimum number of incremental samples to be taken from the lot
or sublot

Weight or volume of lot/sublot (in kg Minimum number of incremental

or litre) samples to be taken

< 50 3

≥ 50 and ≤ 500 5

> 500 10

If the lot or sublot consists of individual packages or units, then the

number of packages or units which shall be taken to form the aggregate
sample is given in Table 4.

Table 4
Number of packages or units (incremental samples) which shall be
taken to form the aggregate sample if the lot or sublot consists of
individual packages or units

Number of packages or units in the lot/ Number of packages or units to be

sublot taken

≤ 25 at least 1 package or unit

26-100 about 5 %, at least 2 packages or

units

> 100 about 5 %, at maximum 10

packages or units
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The maximum levels for inorganic tin apply to the contents of each can,
but for practical reasons it is necessary to use an aggregate sampling
approach. If the result of the test for an aggregate sample of cans is less
than but close to the maximum level of inorganic tin and if it is
suspected that individual cans might exceed the maximum level, then
it might be necessary to conduct further investigations.

Where it is not possible to carry out the method of sampling set out in
this chapter because of the unacceptable commercial consequences (e.g.
because of packaging forms, damage to the lot, etc.) or where it is
practically impossible to apply the abovementioned method of
sampling, an alternative method of sampling may be applied provided
that it is sufficiently representative for the sampled lot or sublot and is
fully documented.

B.2.3. Specific provisions for the sampling of large fish arriving in large
lots
In case the lot or sublot to be sampled contains large fishes (individual
fishes weighing more than about 1 kg) and the lot or sublot weighs
more than 500 kg, the incremental sample shall consist of the middle
part of the fish. Each incremental sample shall weigh at least 100 g.

B.3. SAMPLING AT RETAIL STAGE

Sampling of foodstuffs at retail stage shall be done where possible in
accordance with the sampling provisions set out in point B.2.2 of this
Annex.

Where it is not possible to carry out the method of sampling set out in
point B.2.2 because of the unacceptable commercial consequences (e.g.
because of packaging forms, damage to the lot, etc.) or where it is
practically impossible to apply the abovementioned method of
sampling, an alternative method of sampling may be applied provided
that it is sufficiently representative for the sampled lot or sublot and is
fully documented.

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PART C

SAMPLE PREPARATION AND ANALYSIS

C.1. LABORATORY QUALITY STANDARDS

Laboratories shall comply with the provisions of Article 12 of Regu­
lation (EC) No 882/2004 ►M1
__________ ◄.

Laboratories shall participate in appropriate proficiency testing schemes

which comply with the ‘International Harmonised Protocol for the
Proficiency Testing of (Chemical) Analytical Laboratories’ (1)
developed under the auspices of IUPAC/ISO/AOAC.

Laboratories shall be able to demonstrate that they have internal quality

control procedures in place. Examples of these are the ‘ISO/
AOAC/IUPAC Guidelines on Internal Quality Control in Analytical
Chemistry Laboratories’ (2).

Wherever possible the trueness of analysis shall be estimated by

including suitable certified reference materials in the analysis.

(1) ‘The international harmonized protocol for the proficiency testing of analytical chemistry
laboratories’ by M. Thompson, S.L.R. Ellison and R. Wood, Pure Appl. Chem., 2006,
78, 145-96.
(2) Edited by M. Thompson and R. Wood, Pure Appl. Chem., 1995, 67, 649-666.
 2007R0333 — EN — 01.09.2012 — 001.001 — 8

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C.2. SAMPLE PREPARATION
C.2.1. Precautions and general considerations
The basic requirement is to obtain a representative and homogeneous
laboratory sample without introducing secondary contamination.

All of the sample material received by the laboratory shall be used for
the preparation of the laboratory sample.

Compliance with maximum levels laid down in Regulation (EC) No

1881/2006 shall be established on the basis of the levels determined in
the laboratory samples.

C.2.2. Specific sample preparation procedures

C.2.2.1. S p e c i f i c p r o c e d u r e s f o r l e a d , c a d m i u m , m e r c u r y
and inorganic tin
The analyst shall ensure that samples do not become contaminated
during sample preparation. Wherever possible, apparatus and
equipment coming into contact with the sample shall not contain
those metals to be determined and be made of inert materials e.g.
plastics such as polypropylene, polytetrafluoroethylene (PTFE) etc.
These should be acid cleaned to minimise the risk of contamination.
High quality stainless steel may be used for cutting edges.

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There are many satisfactory specific sample preparation procedures
which may be used for the products under consideration. For those
aspects not specifically covered by this Regulation, the CEN Standard
‘Foodstuffs - Determination of trace elements – Performance criteria,
general considerations and sample preparation’ (1) has been found to be
satisfactory but other sample preparation methods may be equally valid.

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In the case of inorganic tin, care shall be taken to ensure that all the
material is taken into solution as losses are known to occur readily,
particularly because of hydrolysis to insoluble hydrated Sn(IV) oxide
species.

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C.2.2.2. S p e c i f i c procedures for polycyclic aromatic
hydrocarbons
The analyst shall ensure that samples do not become contaminated
during sample preparation. Containers shall be rinsed with high purity
acetone or hexane before use to minimise the risk of contamination.
Wherever possible, apparatus and equipment coming into contact with
the sample shall be made of inert materials such as aluminium, glass or
polished stainless steel. Plastics such as polypropylene or PTFE shall be
avoided because the analytes can adsorb onto these materials.

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C.2.3. Treatment of the sample as received in the laboratory
The complete aggregate sample shall be finely ground (where relevant)
and thoroughly mixed using a process that has been demonstrated to
achieve complete homogenisation.

(1) Standard EN 13804:2002, ‘Foodstuffs — Determination of trace elements —

Performance criteria, general considerations and sample preparation’, CEN, Rue de
Stassart 36, B-1050 Brussels.
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C.2.4. Samples for enforcement, defence and referee purposes
The samples for enforcement, defence and referee purposes shall be
taken from the homogenised material unless this conflicts with the
rules of the Member States on sampling as regards the rights of the
food business operator.

C.3. METHODS OF ANALYSIS

C.3.1. Definitions

The following definitions shall apply:

‘r’ = Repeatability the value below which the absolute

difference between single test results obtained
under repeatability conditions (i.e., same sample,
same operator, same apparatus, same laboratory,
and short interval of time) may be expected to lie
within a specific probability (typically 95 %) and
hence r = 2,8 × sr.

‘sr’ = Standard deviation calculated from results

generated under repeatability conditions.

‘RSDr’ = Relative standard deviation calculated from results

generated under repeatability conditions [(sr/ )
× 100].

‘R’ = Reproducibility the value below which the absolute

difference between single test results obtained
under reproducibility conditions (i.e., on identical
material obtained by operators in different labora­
tories, using the standardised test method), may be
expected to lie within a certain probability
(typically 95 %); R = 2,8 × sR.

‘sR’ = Standard deviation, calculated from results under

reproducibility conditions.

‘RSDR’ = Relative standard deviation calculated from results

generated under reproducibility conditions [(sR/ )
× 100].

‘LOD’ = Limit of detection, smallest measured content, from

which it is possible to deduce the presence of the
analyte with reasonable statistical certainty. The
limit of detection is numerically equal to three
times the standard deviation of the mean of blank
determinations (n > 20).

‘LOQ’ = Limit of quantification, lowest content of the

analyte which can be measured with reasonable
statistical certainty. If both accuracy and precision
are constant over a concentration range around the
limit of detection, then the limit of quantification is
numerically equal to six or 10 times the standard
deviation of the mean of blank determinations
(n > 20).

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‘’HORRAT (1)r = The observed RSDr divided by the RSDr value
estimated from the (modified) Horwitz equation (2)
(cf. point C.3.3.1 (‘Notes to the performance crite­
ria’)) using the assumption r = 0,66 R.

(1) Horwitz W. and Albert, R., 2006, The Horwitz Ratio (HorRat): A useful Index of
Method Performance with respect to Precision, Journal of AOAC International, Vol.
89, 1095-1109.
(2) M. Thompson, Analyst, 2000, p. 125 and 385-386.
 2007R0333 — EN — 01.09.2012 — 001.001 — 10

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‘HORRAT (1)R’ = The observed RSDR divided by the RSDR value
estimated from the (modified) Horwitz equation (2)
(cf. point C.3.3.1 (‘Notes to the performance crite­
ria’)).

‘u’ = Combined standard measurement uncertainty

obtained using the individual standard measurement
uncertainties associated with the input quantities in
a measurement model (3)

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‘U’ = The expanded measurement uncertainty, using a
coverage factor of 2 which gives a level of
confidence of approximately 95 % (U = 2u).

‘Uf’ = Maximum standard measurement uncertainty.

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C.3.2. General requirements
Methods of analysis used for food control purposes shall comply with
the provisions of Annex III to Regulation (EC) No 882/2004.

Methods for analysis for total tin are appropriate for official control on
inorganic tin levels.

For the analysis of lead in wine, the methods and rules established by
the OIV (4) apply in accordance with Article 31 of Council Regulation
(EC) No 479/2008 (5).

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C.3.3. Specific requirements
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C.3.3.1. P e r f o r m a n c e c r i t e r i a

Where no specific methods for the determination of contaminants in

foodstuffs are prescribed at European Union level, laboratories may
select any validated method of analysis for the respective matrix
provided that the selected method meets the specific performance
criteria set out in Tables 5, 6 and 7.

It is recommended that fully validated methods (i.e. methods validated

by collaborative trial for the respective matrix) are used where appro­
priate and available. Other suitable validated methods (e.g. in-house
validated methods for the respective matrix) may also be used
provided that they fulfil the performance criteria set out in Tables 5,
6 and 7.

(1) Horwitz W. and Albert, R., 2006, The Horwitz Ratio (HorRat): A useful Index of
Method Performance with respect to Precision, Journal of AOAC International, Vol.
89, 1095-1109.
(2) M. Thompson, Analyst, 2000, p. 125 and 385-386.
(3) International vocabulary of metrology – Basic and general concepts and associated terms
(VIM), JCGM 200:2008.
(4) Organisation internationale de la vigne et du vin.
( ) Council Regulation (EC) No 479/2008 of 29 April 2008 on the common organisation of
5

the market in wine amending Regulations (EC) No 1493/1999, (EC) No 1782/2003, (EC)
No 1290/2005, (EC) No 3/2008 and repealing Regulations (EEC) No 2392/86 and (EC)
No 1493/1999 (OJ L 148, 6.6.2008, p. 1).
 2007R0333 — EN — 01.09.2012 — 001.001 — 11

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Where possible, the validation of in-house validated methods shall
include a certified reference material.

(a) Performance criteria for methods of analysis for lead, cadmium,

mercury and inorganic tin:

Table 5

Parameter Criterion

Applicability Foods specified in Regulation (EC) No 1881/2006

Specificity Free from matrix or spectral interferences

Repeatability (RSDr) HORRATr less than 2

Reproducibility HORRATR less than 2

(RSDR)

Recovery The provisions of point D.1.2 apply

Inorganic tin Lead, cadmium, mercury

ML is < 0,100 mg/kg ML is ≥ 0,100 mg/kg

LOD ≤ 5 mg/kg ≤ one fifth of the ≤ one tenth of the

ML ML

LOQ ≤ 10 mg/kg ≤ two fifths of the ≤ one fifth of the

ML ML

(b) Performance criteria for methods of analysis for 3-MCPD:

Table 6

Parameter Criterion

Applicability Foods specified in Regulation (EC)

No 1881/2006

Specificity Free from matrix or spectral interfer­

ences

Field blanks Less than LOD

Repeatability (RSDr) 0,66 times RSDR as derived from

(modified) Horwitz equation

Reproducibility (RSDR) as derived from (modified) Horwitz

equation

Recovery 75-110 %

LOD ≤ 5 μg/kg (on dry matter basis)

LOQ ≤ 10 μg/kg (on dry matter basis)

(c) Performance criteria for methods of analysis for polycyclic aromatic

hydrocarbons:

The four polycyclic aromatic hydrocarbons to which these criteria

apply are benzo(a)pyrene, benz(a)anthracene, benzo(b)fluoranthene
and chrysene.
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Table 7

Parameter Criterion

Applicability Foods specified in Regulation (EC)

No 1881/2006

Specificity Free from matrix or spectral interfer­

ences, verification of positive
detection

Repeatability (RSDr) HORRATr less than 2

Reproducibility (RSDR) HORRATR less than 2

Recovery 50-120 %

LOD ≤ 0,30 μg/kg for each of the four

substances

LOQ ≤ 0,90 μg/kg for each of the four

substances

(d) Notes to the performance criteria:

The Horwitz equation (1) (for concentrations 1,2 × 10–7 ≤ C ≤

0,138) and the modified Horwitz equation (2) (for concentrations
C < 1,2 × 10–7) are generalised precision equations which are
independent of analyte and matrix but solely dependent on concen­
tration for most routine methods of analysis.

Modified Horwitz equation for concentrations C < 1,2 × 10–7:

RSDR = 22 %

where:

— RSDR is the relative standard deviation calculated from results

generated under reproducibility conditions [(sR / ) × 100]

— C is the concentration ratio (i.e. 1 = 100 g/100 g, 0,001 =

1 000 mg/kg). The modified Horwitz equation applies to
concentrations C < 1,2 × 10–7.

Horwitz equation for concentrations 1,2 × 10–7 ≤ C ≤ 0,138:

RSDR = 2C(–0,15)

where:

— RSDR is the relative standard deviation calculated from results

generated under reproducibility conditions [(sR / ) × 100]

— C is the concentration ratio (i.e. 1 = 100 g/100 g, 0,001 =

1 000 mg/kg). The Horwitz equation applies to concentrations
1,2 × 10–7 ≤ C ≤ 0,138.

(1) W. Horwitz, L.R. Kamps, K.W. Boyer, J.Assoc.Off.Analy.Chem.,1980, 63, 1344.

(2) M. Thompson, Analyst, 2000, p. 125 and 385-386.
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C.3.3.2. ‘Fitness-for-purpose’ approach
For in-house validated methods, as an alternative a ‘fitness-for-purpose’
approach (1) may be used to assess their suitability for official control.
Methods suitable for official control must produce results with a
combined standard measurement uncertainty (u) less than the
maximum standard measurement uncertainty calculated using the
formula below:

qffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffi
Uf ¼ ðLOD=2Þ2 þ ðαCÞ2

where:

— Uf is the maximum standard measurement uncertainty (μg/kg).

— LOD is the limit of detection of the method (μg/kg). The LOD must
meet the performance criteria set in point C.3.3.1 for the concen­
tration of interest.

— C is the concentration of interest (μg/kg);

— α is a numeric factor to be used depending on the value of C. The

values to be used are given in Table 8.

Table 8
Numeric values to be used for α as constant in formula set out in
this point, depending on the concentration of interest

C (μg/kg) α

≤ 50 0,2

51-500 0,18

501-1 000 0,15

1 001-10 000 0,12

> 10 000 0,1

The analyst shall note the ‘Report on the relationship between analytical
results, measurement uncertainty, recovery factors and the provisions of
EU food and feed legislation’ (2).

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PART D

REPORTING AND INTERPRETATION OF RESULTS

D.1. REPORTING
D.1.1. Expression of results
The results shall be expressed in the same units and with the same
number of significant figures as the maximum levels laid down in
Regulation (EC) No 1881/2006.

D.1.2. Recovery calculations

If an extraction step is applied in the analytical method, the analytical
result shall be corrected for recovery. In this case the level of recovery
must be reported.

(1) M. Thompson and R. Wood, Accred. Qual. Assur., 2006, p. 10 and 471-478.
(2) http://ec.europa.eu/food/food/chemicalsafety/contaminants/report-sampling_analy­
sis_2004_en.pdf
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In case no extraction step is applied in the analytical method (e.g. in
case of metals), the result may be reported uncorrected for recovery if
evidence is provided by ideally making use of suitable certified
reference material that the certified concentration allowing for the
measurement uncertainty is achieved (i.e. high accuracy of the measure­
ment), and thus that the method is not biased. In case the result is
reported uncorrected for recovery this shall be mentioned.
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D.1.3. Measurement uncertainty
The analytical result shall be reported as x +/– U whereby x is the
analytical result and U is the expanded measurement uncertainty, using
a coverage factor of 2 which gives a level of confidence of approxi­
mately 95 % (U = 2u).
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The analyst shall note the ‘Report on the relationship between analytical
results, measurement uncertainty, recovery factors and the provisions of
EU food and feed legislation’ (1).
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D.2. INTERPRETATION OF RESULTS
D.2.1. Acceptance of a lot/sublot
The lot or sublot is accepted if the analytical result of the laboratory
sample does not exceed the respective maximum level as laid down in
Regulation (EC) No 1881/2006 taking into account the expanded
measurement uncertainty and correction of the result for recovery if
an extraction step has been applied in the analytical method used.
D.2.2. Rejection of a lot/sublot
The lot or sublot is rejected if the analytical result of the laboratory
sample exceeds beyond reasonable doubt the respective maximum level
as laid down in Regulation (EC) No 1881/2006 taking into account the
expanded measurement uncertainty and correction of the result for
recovery if an extraction step has been applied in the analytical
method used.
D.2.3. Applicability
The present interpretation rules shall apply for the analytical result
obtained on the sample for enforcement. In case of analysis for
defence or reference purposes, the national rules shall apply.

(1) http://ec.europa.eu/food/food/chemicalsafety/contaminants/report-sampling_analy­
sis_2004_en.pdf