EFSA Journal 2011;9(4):2110
SCIENTIFIC OPINION
Scientific Opinion on Safety and efficacy of Sel-Plex® (organic form of
selenium produced by Saccharomyces cerevisiae CNCM I-3060) for all
species1
EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) 2,3
European Food Safety Authority (EFSA), Parma, Italy
This scientific output, published on 26 May 2014, replaces the earlier version published on 5 April 2011.4
ABSTRACT
The selenised yeast produced by Saccharomyces cerevisiae CNCM I-3060 is authorized in the EU as a
nutritional additive for all species. The current assessment was focused on the zootechnical consequences of the
use of the additive claimed by the applicant. Concerning selenium deposition in animal tissues and products, the
FEEDAP Panel concluded that (i) a certain increase of the selenium content of edible tissues and products is a
characteristic consequence of Se supplementation to the diet principally independent from the source of dietary
Se, (ii) Sel-Plex® is more effective than sodium selenite, and (iii) the higher relative potency of Sel-Plex®
increases with higher Sel-Plex® levels. The better availability of Se in Sel-Plex® compared to other inorganic Se
sources is based on the specific nutritional property of selenomethionine - effects typical of nutritional additives.
The FEEDAP Panel concluded further that (i) there was no evidence that dietary supplementation with Sel-Plex®
would further reduce lipid oxidation in meat or improve colour of animal products in comparison with inorganic
Se, and (ii) the supplementation of feed with Se, regardless of the Se source, had no effect on the water binding
capacity of meat. Consumer exposure was calculated for adults and children (age 1-3 years), based on P95
consumption values of consumers only from the Comprehensive European Food Consumption Database and
adding background intake. Exposure of adults was below the UL (300 µg/day) for all Se supplementation levels
and both Se sources. For children the likely total exposure after consuming milk, meat and eggs from animals
treated with 0.2-0.26 and 0.3-0.35 mg Se/kg feed from Sel-Plex® was 66 and 75 µg/day (UL: 60 µg/day),
respectively. The FEEDAP Panel concluded that a maximum supplementation level of 0.2 mg Se/kg feed from
Sel-Plex® is unlikely to result in a health risk for consumers.
© European Food Safety Authority, 2011
KEY WORDS
zootechnical additive, nutritional additive, Sel-Plex®, selenium enriched yeast, selenomethionine, efficacy,
consumer safety
1
2
3
4
On request from the European Commission, Question No EFSA-Q-2009-00752, adopted on 15 March 2011.
Panel members: Gabriele Aquilina, Georges Bories, Andrew Chesson, Pier Sandro Cocconcelli, Joop de Knecht, Noël
Albert Dierick, Mikolaj Antoni Gralak, Jürgen Gropp, Ingrid Halle, Reinhard Kroker, Lubomir Leng, Anne-Katrine
Lundebye Haldorsen, Alberto Mantovani, Miklós Mézes, Derek Renshaw and Maria Saarela.
Acknowledgement: The Panel wishes to thank the members of the Working Group on Trace Elements, including Francesc
Guardiola, for the preparatory work on this scientific opinion.
Revision 1: minor editorial changes. The following sections have been amended: Tables 8, 13 and 14. The changes do not
affect the overall conclusions of the scientific output.
Suggested citation: EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP); Scientific
Opinion on Safety and efficacy of Sel-Plex® (organic form of selenium produced by Saccharomyces cerevisiae CNCM I3060) for all species. EFSA Journal 2011;9(4):2110. [52 pp.] doi:10.2903/j.efsa.2011.2110. Available online:
www.efsa.europa.eu/efsajournal
© European Food Safety Authority, 2011
Sel-Plex® as zootechnical additive for all species
SUMMARY
Following a request from the European Commission, the Panel on Additives and Products or
Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the safety for
the target animals, consumer, user and the environment and the efficacy of the product Sel-Plex®
(organic form of selenium produced by Saccharomyces cerevisiae CNCM I-3060), to be used as a feed
additive for all species.
The selenised yeast produced by Saccharomyces cerevisiae CNCM I-3060 is authorized in the EU as a
nutritional additive for all species. The applicant has now requested authorization of the additive (SelPlex®) as zootechnical additive for all animal species without modifying the conditions of use
approved for the nutritional purpose. The FEEDAP Panel noted that there are at present no new data
which would modify its former position concerning the characterisation of the product, the safety for
the target animals, the user and the environment.
The FEEDAP Panel concluded from the data set submitted and considered on selenium deposition in
edible tissues (a total of eight studies with chicken and turkey for fattening, pheasants, cattle for
fattening, lambs and kids) and in animal products (two studies with laying hens, seven studies on milk
of dairy dairy cows, sheep and goats) that (i) an increase of the selenium content of edible tissues and
products is a characteristic consequence of selenium supplementation to the diet principally
independent from the source of dietary selenium, (ii) Sel-Plex® is more effective than sodium selenite
in increasing the selenium concentration of edible tissues and products, and (iii) the degree of the
higher relative potency of Sel-Plex® depends on the level of selenium supplementation (increase with
higher Sel-Plex® levels). The FEEDAP Panel concluded that the increase in selenium of food of
animal origin observed after supplementation of feed with selenium is considered as a direct
consequence of the nutritional property of selenium-containing additives and not unique to Sel-Plex® effects typical of a nutritional additive.
Differences in thiobarbituric acid reactive substances (TBARS) values between dietary treatments
with different levels of selenium supplementation could be observed in two out of eight studies
considered. Three other studies showed some negative correlations between selenium in meat and
TBARS in meat, but not unique for selenium from Sel-Plex®. Three other studies were without any
effect. Three out of eight studies showed a significant effect of selenium supplementation on better
intensity or maintenance of meat colour without quantitative differences between organic and
inorganic selenium in two studies. The remaining five studies could not demonstrate any effect of
selenium supplementation on these parameters. The FEEDAP Panel concluded that there was no
evidence that dietary supplementation with Sel-Plex® would further reduce lipid oxidation in meat or
improve colour of animal products in comparison with inorganic selenium.
Among the 11 studies considered for an effect of selenium from Sel-Plex® on water binding capacity
of meat, only three showed some inconsistent but significant effects. The FEEDAP Panel concluded
that the supplementation of feed with selenium, regardless of the selenium source (Sel-Plex® or
sodium selenite), had no effect on the water binding capacity of meat.
Consumer exposure was calculated for adults and children of 1-3 years (toddlers), based on P95
consumption values of consumers only (meat, liver, kidney, milk, and eggs for adults; meat, milk and
eggs for children) from the Comprehensive European Food Consumption Database. Exposure of
adults was below the UL (300 µg/day) for all selenium supplementation levels and both selenium
sources. For children the likely exposure after consuming milk, meat and eggs from animals treated
with 0.2-0.26 and 0.3-0.35 mg Se/kg feed from Sel-Plex® and adding background intake from food of
non-animal origin of 10 µg/day was 66 and 75 µg/day (UL: 60 µg/day), respectively. The FEEDAP
Panel concluded that (i) consumer safety, in the particular case of the safety of children of 1-3 years of
age (toddlers), is not given at a dietary supplementation level of ≥ 0.3 mg Se/kg from Sel-Plex®, and
(ii) a maximum supplementation level of 0.2 mg Se/kg feed from Sel-Plex® would be unlikely to result
in a health risk for consumers including children.
EFSA Journal 2011;9(4):2110
2
Sel-Plex® as zootechnical additive for all species
The FEEDAP Panel noted that selenium deposition from the use of other selenised yeasts as feed
additives would likely result in similar selenium tissue and product concentrations. The FEEDAP
Panel also identified a need for analytical methods to detect those organic compounds in feed,
independent from the trace element background.
EFSA Journal 2011;9(4):2110
3
Sel-Plex® as zootechnical additive for all species
TABLE OF CONTENTS
Abstract ....................................................................................................................................................1
Summary ..................................................................................................................................................2
Table of contents ......................................................................................................................................4
Background ..............................................................................................................................................5
Terms of reference....................................................................................................................................5
1. Introduction ......................................................................................................................................8
2. Efficacy ............................................................................................................................................9
2.1.
Impact on the nutritional value of animal products ................................................................9
2.1.1.
Selenium deposition in animal edible tissue.....................................................................9
2.1.2.
Selenium deposition in eggs from laying hens ...............................................................13
2.1.3.
Selenium deposition in milk and dairy products ............................................................14
2.1.4.
Conclusions on the impact on the nutritional values of animal products .......................17
2.2.
Impact on the quality of animal products..............................................................................18
2.2.1.
TBARS and colour of meat and eggs .............................................................................18
2.2.2.
Conclusions on TBARS and colour of meat and eggs ...................................................23
2.2.3.
Water binding capacity of meat ......................................................................................25
2.2.4.
Conclusions on water binding capacity of meat .............................................................27
3. Consumer safety .............................................................................................................................27
3.1.
Methodology .........................................................................................................................27
3.2.
Assessment............................................................................................................................28
4. Post-Market Monitoring .................................................................................................................29
Documentation provided to EFSA .........................................................................................................30
References ..............................................................................................................................................30
Appendices .............................................................................................................................................32
Appendix A. Executive Summary of the Evaluation Report of the European Union Reference
Laboratory for Feed Additives on the Method(s) of Analysis for Sel-Plex® .........................................32
Appendix B. Safety for target species. Tolerance study in lambs ..........................................................34
Appendix C. Description of the efficacy studies submitted in the dossier .............................................35
Appendix D. Safety for the consumer. Consumer exposure tabulated data ...........................................48
EFSA Journal 2011;9(4):2110
4
Sel-Plex® as zootechnical additive for all species
BACKGROUND
Regulation (EC) No 1831/20035 establishes the rules governing the EU authorisation of additives for
use in animal nutrition. In particular, Article 4(1) of that Regulation lays down that any person seeking
authorisation for a feed additive or for a new use of a feed additive shall submit an application in
accordance with Article 7.
The European Commission received a request from the company ALLTECH6 for authorisation of the
product Sel-Plex® (organic form of selenium produced by Saccharomyces cerevisiae CNCM I-3060),
to be used as a feed additive for all species (category: zootechnical additive; functional group: other
zootechnical additives) under the conditions mentioned in Table 1.
According to Article 7(1) of Regulation (EC) No 1831/2003, the Commission forwarded the
application to the European Food Safety Authority (EFSA) as an application under Article 4(1)
(authorisation of a feed additive or new use of a feed additive). EFSA received directly from the
applicant the technical dossier in support of this application.7 According to Article 8 of that
Regulation, EFSA, after verifying the particulars and documents submitted by the applicant, shall
undertake an assessment in order to determine whether the feed additive complies with the conditions
laid down in Article 5. The particulars and documents in support of the application were considered
valid by EFSA as of 21 April 2010.
The organic form of Selenium produced by Saccharomyces cerevisiae CNCM I-3060 is authorised in
the EU under Regulation (EC) No 1831/2003 as a nutritional additive (compounds of trace elements).8
This authorisation was granted following corresponding EFSA opinion (EFSA, 2006).
TERMS OF REFERENCE
According to Article 8 of Regulation (EC) No 1831/2003, EFSA shall determine whether the feed
additive complies with the conditions laid down in Article 5. EFSA shall deliver an opinion on the
safety for the target animals, consumer, user and the environment and the efficacy of the product SelPlex® (organic form of selenium produced by Saccharomyces cerevisiae CNCM I-3060), to be used as
a feed additive for all species, when used under the conditions described in Table 1.
5
OJ L 268, 18.10.2003, p.29.
ALLTECH. 14 place Marie-Jeanne Bassot. 92300 Levallois-Perret. France.
7
EFSA Dossier reference: FAD-2009-0029.
8
OJ L 330, 28.11.2006, p.9.
6
EFSA Journal 2011;9(4):2110
5
Sel-Plex® as zootechnical additive for all species
Table 1:
Description and conditions of use of the additive as proposed by the applicant
Additive
Organic form of selenium produced by Saccharomyces cerevisiae
CNCM I-3060 (Selenised yeast inactivated)
Registration number/EC
No/No (if appropriate)
Not appropriate
Category(-ies) of additive
Zootechnical additive
Functional group(s) of additive
Improve the quality and nutritional value of animal products
Description
Composition,
description
Chemical formula
Organic
form
of
selenium produced by
Saccharomyces
cerevisiae CNCM I3060 (Selenised yeast
inactivated)
Organic selenium mainly
selenomethionine (63 %)
and low molecular weight
selenocomponents (34-36
%) content of 2000-2400
mg Se/kg (97-99 % of
organic selenium)
Purity criteria
(if appropriate)
not applicable
Method of analysis
(if appropriate)
- Zeeman graphite furnace
Atomic Absorption
Spectrometry (AAS) of
Hydrid AAS
- ICP-MS method
(Inductively Coupled
Plasma Mass Spectrometry)
®
Trade name (if appropriate)
Sel-Plex
Name of the holder of
authorisation (if appropriate)
ALLTECH
Conditions of use
Species or
category of
animal
Maximum
Age
All species /
category
-
Minimum content
Maximum content
mg/kg of complete feedingstuffs
-
0.50 (total)
Withdrawal
period
(if appropriate)
not appropriate
Other provisions and additional requirements for the labelling
Specific conditions or restrictions for
use (if appropriate)
Specific conditions or restrictions for
handling (if appropriate)
Post-market monitoring
(if appropriate)
EFSA Journal 2011;9(4):2110
Can only be used through a premixture
For user safety: breathing protection during handling and safety
glasses and gloves
not appropriate
No risks associated with the use of Sel-Plex feed additive are
pointed out; there is no need for specific requirements for a postmarket monitoring plan.
Such requirement is not applicable to the Sel-Plex feed additive
which is composed of a selenised yeast of Saccharomyces
cerevisiae.
If we take into account the safety for animals and consumers, the
data clearly point out that Sel-Plex has no toxic effect (DL50 >2500
ppm). For human, selenised yeast has been authorised (by
derogation) in food for particular nutritional uses (Commission
Directive 2004/6/EC).
Consequently the applicant considers that Sel-Plex is safe for
animals and consumers and post market monitoring should not be
necessary.
6
Sel-Plex® as zootechnical additive for all species
Specific conditions for use in
complementary feedingstuffs
(if appropriate)
The additive shall be incorporated in compound feedingstuffs in
form of a premixture
Maximum Residue Limit (MRL) (if appropriate)
Marker residue
Species or category of
animal
Target tissue(s) or
food products
Maximum content in
tissues
not appropriate
not appropriate
not appropriate
not appropriate
EFSA Journal 2011;9(4):2110
7
Sel-Plex® as zootechnical additive for all species
ASSESSMENT
1.
Introduction
The selenised yeast produced by Saccharomyces cerevisiae CNCM I-3060 is authorized in the EU as a
nutritional additive for all species. The applicant has now requested authorization of the additive (SelPlex®) as zootechnical additive for all animal species and proposed a new functional group
(improvement of quality and nutritional value of animal products), without modifying the conditions
of use as approved for the nutritional purpose.
The product contains 2000-2400 mg Se/kg (97-99 % of organic selenium). Organic selenium consists
mainly of selenomethionine (63 %) and low molecular weight selenocomponents (34-36 %).
The FEEDAP Panel has already assessed an application for the use of this product as nutritional and
zootechnical additive (EFSA, 2006). The Panel concluded (i) that Sel-Plex® is safe for the target
animals, the consumer, the user and the environment, (ii) that the product is efficacious for all animal
species as nutritional additive, but (iii) that the zootechnical effects claimed in the dossier were not all
satisfactorily demonstrated. The increased selenium concentration in tissues and products observed
after Sel-Plex® administration was considered a consequence of the nutritional property of the
additive.
Selenium (as sodium selenate, sodium hydrogen selenite or sodium selenite) is authorised for addition
to foods (Regulation (EC) No 1925/2006)9 and for use in food supplements (Directive 2002/46/EC).10
The Panel on Dietetic Products, Nutrition and Allergies (NDA) concluded that a cause and effect
relationship has been established between the dietary intake of selenium and protection of DNA,
proteins and lipids from oxidative damage, normal function of the immune system, normal thyroid
function and normal spermatogenesis (EFSA, 2009).
The Panel on Food Additives, Flavourings, Processing Aids and Materials in Contact with Food
(AFC) delivered an opinion on the safety and bioavailability of selenium-enriched yeast as a source
for selenium when added for nutritional purposes in foods for particular nutritional uses and foods
(including food supplements) for the general population. The Panel concluded that in general there
were no safety concerns (EFSA, 2008).
Since the selenium-enriched yeast (Sel-Plex®) was authorised in 2006,11 based on a full assessment by
the FEEDAP Panel, the present evaluation considers only whether selenium, and particularly selenium
from Sel-Plex®, influences the nutritional value (composition) and quality of animal products. The
Panel also reconsiders consumer safety, since new data became available on the selenium content of
food of animal origin in the current application and on total selenium exposure of children by literature
(EFSA, 2010). The Panel notes that at present there are no new data which would modify its former
position concerning the characterisation of the product and the safety for the target animals (a new
tolerance study on lambs is referred to in Appendix B), the user and the environment.
The FEEDAP Panel does not comment on the potential classification of Sel-Plex® as “zootechnical
additive” as requested by the applicant. A decision of the European Commission can be derived from
the demonstrated effects as described in the current opinion and the given physiological background of
such effects.
EFSA has verified the European Union Reference Laboratory (EURL) report as it relates to the
methods used for the control of the additive by detection of the main active substance
selenomethionine. The executive summary of the EURL report can be found in the Appendix A.
9
OJ L 404, 30.12.2006, p.26.
OJ L 183, 12.7.2002, p.51.
11
OJ L 330, 28.11.2006, p.9.
10
EFSA Journal 2011;9(4):2110
8
Sel-Plex® as zootechnical additive for all species
2.
Efficacy
The applicant provided a total of 33 studies to demonstrate the efficacy of Sel-Plex® as a zootechnical
additive in improving the nutritional value and the quality of animal products.
The description of the studies is detailed in Appendix C, except for those which are not considered
further (description in the text below). Only the main results are summarised below, separately for the
claims applied. Table 2 gives an overview of the studies submitted in the dossier which were further
considered in the assessment and the claim supported in each of them.
Table 2:
Review of the studies submitted (1) in the dossier
Species/Category
Chickens for fattening
Laying hens
Turkeys for fattening
Pheasants for fattening
Dairy cows
Cattle for fattening
Lambs
Kids
Sheep
Goat
Study (2)
1
2
3
7
8
9
11
12
13
17
18
19
20
22
25
26
27
29
30
31
32
Claim
Improve nutritional
value of animal
products



















Improve quality of
animal products












(1): Only studies that were considered in the Assessment are reported here.
(2): For reference see Appendix C
2.1.
Impact on the nutritional value of animal products
In this section is summarised the effect of Sel-Plex® supplementation to feed compared to sodium
selenite (Na-selenite) on the selenium content of edible tissues (different poultry species and
categories, large and small ruminants), of eggs (from laying hens) and of different dairy products
(milk and cheese from dairy cows and small dairy ruminants). The endpoints measured in some
studies considered also selenium methionine (SeMet), selenium cysteine (SeCys), and tetravalent
selenium (SeIV) in tissues and products.
2.1.1. Selenium deposition in animal edible tissue
2.1.1.1. Poultry species and categories
In a study on chickens for fattening, selenium content of breast muscle increased in a dose dependent
manner (P≤ 0.05); at the same selenium supplementation level (0.3 mg/kg) it was significantly higher
in the Sel-Plex® group than in the Na-selenite (Na2SeO3) group (Table 3).
EFSA Journal 2011;9(4):2110
9
Sel-Plex® as zootechnical additive for all species
Table 3:
Selenium deposition in muscles/edible tissues of chickens for fattening (Study 1, 42 days)
Source of Se
Se supplemented (mg/kg feed)
Control
None
Na2SeO3
0.3
Sel-Plex
0.2
Se content in breast (mg/kg DM)
0.03
0.08
0.18
®
Sel-Plex
0.3
®
Sel-Plex
0.4
0.23
®
0.27
In a study on turkeys for fattening (Table 4), Sel-Plex® supplementation resulted at the same total
dietary selenium (intended 0.30 mg/kg) in higher selenium muscle tissue concentrations (three muscle
samples from breast and thigh) than selenite. The ratios of selenium from SeMet in muscle to total
selenium were 0.59 in the unsupplemented group, 0.49 in the selenite group, 0.48 in the Sel-Plex®
group with the same supplementation level as the selenite group, and 0.47 in the high Sel-Plex® group
in the thigh muscle and 0.52, 0.49, 0.67 and 0.61 in the breast muscle, respectively.
Table 4:
Selenium deposition in muscles/edible tissues of turkeys for fattening (Study 11, 91 days)
Source of Se
Intended total Se (mg/kg complete feed DM)
Se in tissues (mg/kg DM)
Liver
Kidney
Breast M. pectoralis major
Thigh M. gastrocnemius
M. peroneus longus
Control
0.22
Na2SeO3
0.30
Sel-Plex
0.30
1.2
2.5
0.6
0.7
0.7
1.5
3.2
0.8
0.7
1.0
1.9
4.0
1.4
1.4
1.8
®
Sel-Plex
0.45
®
3.0
5.0
2.0
2.0
2.5
In a second study (study 12) with turkeys for fattening (duration 112 days for females and 140 days
for males), there was a tendency to an increase of selenium concentrations in skeletal muscles and
organs with increasing dietary Sel-Plex®, but statistical evaluation was not performed. Therefore the
data are not taken into further consideration.
In a study with pheasants (Table 5), skeletal muscle from breast and thigh as well as heart and liver
showed a significantly higher selenium concentration, when feed was supplemented with Sel-Plex® at
the same supplementation level (0.08 mg Se/kg) compared to selenite .
Table 5:
Selenium deposition in muscles/edible tissues of pheasants (Study 13, 91 days)
Source of Se
Se supplemented (mg/kg feed)
Se in tissues (mg/kg DM)
Liver
Kidney
Breast M. pectoralis major
Thigh M. gastrocnemius
M. peroneus longus
a,b,c
Control
None
Na2SeO3
0.08
Sel-Plex
0.08
2.3a
3.7a
0.6a
0.7a
0.7a
2.4a
3.8ab
0.6a
0.7a
0.7a
2.6b
3.9ab
0.9b
1.0b
0.9b
®
Sel-Plex
0.23
®
2.7b
4.3b
1.0c
1.2c
1.1b
Different letter superscripts in the same line indicate significant differences (P<0.05)
2.1.1.2. Ruminants
In an experiment on cattle for fattening (Table 6) a significant treatment effect (P<0.001) and linear
dose responses (P<0.001) on the concentrations of total selenium in kidney, cardiac tissue, muscle and
hepatic tissue to the graded addition of Sel-Plex® to the diet was found. At the same supplementation
level (0.15 mg Se/kg feed DM) higher concentrations of selenium in kidney, liver and two different
skeletal muscles were found compared to Na-selenite, but only the differences in heart, kidney and M.
longissimus dorsi reached significance.
EFSA Journal 2011;9(4):2110
10
Sel-Plex® as zootechnical additive for all species
Irrespective of treatment, SeMet was the predominant selenised amino acid, it accounted for 54 to 60
% of total selenium in the kidney. In cardiac tissue SeCys accounted for approximately 72% of total
selenium in the group without selenium supplementation. As selenium was added to the diet the
proportion of SeMet in total selenium increased, reaching highest values in the animals that had
received Sel-Plex® (49%) compared to the selenite group (43%).
In the liver, SeCys was the predominant selenised amino acid in the unsupplemented control and for
the groups treated with 0.15 mg supplemental Se/kg feed DM from selenite or Sel-Plex®, accounting
for 55-65 % of total selenium. In the high Sel-Plex® group, SeMet was the predominant selenised
amino acid accounting for 55% of total selenium. Both the M. psoas major and M. longissimus dorsi
showed a pattern similar to that described for liver.
Table 6:
Selenium deposition in muscles/edible tissues of cattle for fattening (Study 22, 91 days)
Source of Se
Se supplemented (mg/kg complete feed DM)
Control
None
Na2SeO3
0.15
Sel-Plex
0.15
0.6a
0.9a
4.5a
0.2a
0.3a
0.7b
1.6ab
5.0a
0.3ab
0.3a
0.9c
2.0b
6.0b
0.4b
0.5b
Se in tissues (mg/kg DM)
Heart
Liver
Kidney
Muscle M. psoas major
M. longissimus dorsi
a,b,c,d
®
Sel-Plex
0.35
®
1.3d
3.0c
6.4b
0.6c
0.7c
Different letter superscripts in the same line indicate significant differences (P<0.05)
In a second study on cattle for fattening (Study 23, 130 days), the effect of 0.3 mg supplemental
selenium from Sel-Plex®/kg Total Mixed Ration (TMR) on zootechnical parameters and muscle and
liver selenium was analysed. Because of the absence of a selenite group, the data will not be
considered further.
In lambs (Table 7), only the supplementation of 0.5 mg Se/kg feed from Sel-Plex® increased liver
selenium significantly (p≤0.01). However, the numerical values at 0.3 mg supplemental Se/kg feed
from selenite or Sel-Plex® were similar (1.7 vs 1.6 mg Se/kg liver DM). Kidney selenium was not
influenced by either selenium dose or source. Total selenium contents of the skeletal muscles psoas
major and longissimus dorsi were similar between muscle types, with values ranging between 0.4 and
0.8 mg Se/kg muscle DM. There were both significant treatment effects (P≤ 0.01) on both muscle
types and a linear dose response (P≤0.001) to the graded addition of Sel-Plex® to the diet.
Table 7:
Selenium deposition in muscles/edible tissues of lambs (Study 25, 112 days)
Source of Se
Intended total Se (mg/kg complete feed DM)
Se in tissues (mg/kg DM)
Liver
Kidney
Muscle M. psoas major
M. longissimus dorsi
a,b,c
Control
0.19
Na2SeO3
0.30
Sel-Plex
0.30
1.3a
5.7
0.4a
0.4a
1.7ab
5.7
0.5a
0.5a
1.6a
5.9
0.6b
0.6a
®
Sel-Plex
0.40
1.8ab
5.6
0.7bc
0.7b
®
Sel-Plex
0.50
®
2.2b
6.5
0.8c
0.8b
Different letter superscripts in the same line indicate significant differences (P<0.05)
In another lamb study (Table 8), selenium supplementation resulted in significant increases of liver,
kidney and muscle selenium. However, at equal selenium doses (0.3 mg/kg feed) tissue content
(except kidney) of selenium was significantly higher after Sel-Plex® supplementation. Furthermore,
the higher selenium dose from Sel-Plex® (0.45 mg Se/kg feed) resulted in significantly higher
selenium contents in liver and muscle compared to 0.3 mg Se/kg from both sources.
EFSA Journal 2011;9(4):2110
11
Sel-Plex® as zootechnical additive for all species
Table 8:
Selenium deposition in muscles/edible tissues of lambs (Study 26, 63 days)
Source of Se
Intended total Se (mg/kg TMR DM)
Se in tissues (mg/kg DM)
Liver
Kidney
Muscle M. longissimus dorsi
a,b,c,
Control
0.10
Na2SeO3
0.30
Sel-Plex
0.30
1.2a
5.1a
0.4a
2.0b
5.8b
0.4b
2.4c
6.0b
0.7c
®
Sel-Plex
0.45
®
3.2d
6.2b
0.8d
Different letter superscripts in the same line indicate significant differences (P<0.05)
In a third lamb study (Table 9), selenium content in kidney tissue was lowest in the control group,
while the only significant difference observed was between the control group and 0.45 mg Se/kg feed
supplemented with Sel-Plex®. The same trend was apparent in hepatic tissue, total selenium contents
were the lowest in the unsupplemented group and the highest in those animals that had received the
highest dose of Sel-Plex®. Furthermore, no significant differences were seen between values of
selenium in liver in the two groups fed a total of 0.3 mg Se/kg feed by either selenite or Sel-Plex®, and
both values were significantly higher than in liver from the unsupplemented control group. The effects
of dietary treatment and selenium source were even more marked in skeletal tissue. The addition of
both selenium sources resulted in a significant increase of muscle selenium. No differences appeared
between the two selenium doses when selenite was added, but dose differences became significant for
Sel-Plex® which were both significantly higher than in muscle tissues of lambs receiving selenite.
SeMet or SeCys in skeletal muscles (L. dorsi) and kidney were measured, but a statistical evaluation
was not performed. In general, SeCys was the predominant selenised amino acid irrespective of the
treatment. In animals without supplementary selenium, SeCys was found to be the predominant
selenised amino acid in kidney tissue, accounting to approximately 55% of total selenium. However,
in the animals which had received selenium supplementation SeCys and SeMet were found in almost
equal proportions of total selenium. Similar trends were seen in muscle tissues.
Table 9:
Selenium deposition in muscles/edible tissues of lambs (Study 27, 133 days)
Source of Se
Intended total Se (mg/kg TMR DM)
Se in tissues (mg/kg DM)
Liver
Kidney
Muscle M. psoas major
M. longissimus dorsi
a,b,c,d
Control
0.20
Na2SeO3
0.30
Na2SeO3
0.45
Sel-Plex
0.30
1.2a
6.1a
0.4a
0.3a
1.8b
6.4ab
0.5b
0.5b
2.1cd
6.6ab
0.5b
0.5b
2.0bc
6.5ab
0.7c
0.6c
®
Sel-Plex
0.45
®
2.3d
7.2b
0.9d
0.8d
Different letter superscripts in the same line indicate significant differences (P<0.05)
In a study with kids (Table 10), selenium content in muscle was significantly increased by selenium
supplementation from both selenium sources. At the same selenium concentration in feed, selenium
deposition in muscle was significantly more marked after Sel-Plex® supplementation compared to
selenite. Furthermore, it showed a significant dose dependent increase in the Sel-Plex® groups with
increasing selenium supplementation of feed. For selenium in liver and kidney, there were no
significant differences between equal dietary selenium doses from sodium selenite or Sel-Plex®.
In the control and the selenite groups, selenium from SeMet in muscle tissue, liver, kidney and heart
was higher than selenium from SeCys and averaged to 64, 59, 68 and 84 % of total selenium. It
increased in muscle tissue with increasing Sel-Plex® supplementation to 78 and 71 % in the low and
intermediate Sel-Plex® groups, whereas SeCys decreased to 27, 24 and 18 % of total selenium (in the
three Sel-Plex® groups) compared to the average of control and selenite groups (38 %).
EFSA Journal 2011;9(4):2110
12
Sel-Plex® as zootechnical additive for all species
Table 10: Selenium deposition in muscles/edible tissues of kids (Study 29, 112 days)
Source of Se
Intended total Se (mg/kg complete feed DM)
Se in tissues (mg/kg DM)
Liver
Kidney
Muscle M. longissimus dorsi
a,b,c,d,e
Control
0.10
Na2SeO3
0.30
Sel-Plex
0.30
0.6a
4.7a
0.2a
1.3b
5.0ab
0.3b
1.5b
5.6bc
0.5c
®
Sel-Plex
0.40
®
2.0c
5.9c
0.7d
Sel-Plex
0.50
®
2.2d
5.5bc
0.8e
Different letter superscripts in the same line indicate significant differences (P<0.05)
2.1.1.3. Pigs for fattening
Three studies with pigs for fattening have been submitted (Study 14,12 1513 and 1614). These studies
were also provided in an earlier submission and used for the assessment of Sel-Plex® as nutritional
additive (EFSA, 2006). In the current assessment, data from these studies could not be considered due
to insufficient experimental design. In its former opinion on pig tissue deposition of selenium, the
FEEDAP Panel did also not use the individual data and its assessment on selenium tissue deposition in
pigs was based on a meta-analysis carried out with this data by the applicant.
2.1.2. Selenium deposition in eggs from laying hens
In the first study on laying hens (Table 11), selenite and Sel-Plex® were compared at only one level of
supplemental selenium in two different basal diets (no unsupplemented control group). In both diets,
0.3 mg supplemental Se/kg feed from Sel-Plex® resulted in significantly higher (P≤0.01) selenium
concentrations in the egg than from selenite.
Table 11: Selenium deposition in eggs from laying hens (Study 7, 35 days)
Source of Se
Se supplemented (mg/kg feed)
Na2SeO3
0.3
Main origin of dietary protein
Sel-Plex
0.3
®
animal
vegetable
animal
vegetable
0.04
0.19
0.15
0.06
0.19
0.18
0.06
0.32
0.30
0.05
0.31
0.27
Se in egg (mg/kg fresh matter)
Day 0
Day 14
Day 28
In a second study (Table 12), egg yolk showed higher selenium concentrations in all groups than the
albumen. There was significant difference (P≤ 0.01) in selenium content in yolk, albumen and whole
egg between control group and supplemented groups and between selenium forms.
Table 12: Selenium deposition in eggs from laying hens (Study 8, 42 days, egg collection after 33
days)
Source of Se
Se supplemented (mg/kg feed)
Control
None
Na2SeO3
0.1
Na2SeO3
0.2
Na2SeO3
0.3
Sel-Plex®
0.1
Sel-Plex®
0.2
Sel-Plex®
0.3
Se in egg (mg/kg fresh matter)
Albumen
Yolk
Whole egg
0.04
0.10
0.06
0.07
0.33
0.14
0.07
0.37
0.16
0.07
0.38
0.16
0.08
0.32
0.15
0.13
0.42
0.22
0.15
0.48
0.25
12
Technical Dossier, Section IV, Vol. 3, Annex 4-5-1
Technical Dossier, Section IV, Vol. 3, Annex 4-5-2
14
Technical Dossier, Section IV, Vol. 3, Annex 4-5-3
13
EFSA Journal 2011;9(4):2110
13
Sel-Plex® as zootechnical additive for all species
In a third study on laying hens (Table 13), selenium concentrations in yolk and albumen were given in
mg/kg DM and were converted to mg/kg fresh matter for an easier comparison. Statistical evaluation
was only performed to examine the effect of Sel-Plex®, which significantly (P< 0.05) increased the
selenium content of albumen and yolk. Supplementation with sodium selenite increased selenium
concentration in albumen and yolk.
Table 13: Selenium deposition in eggs from laying hens (Study 9, 350 days, second phase)*
Source of Se
Intended total Se level in feed (mg/kg)
Se in egg (mg/kg fresh matter)
Albumen
Yolk
Whole egg (calculated)**
Control
0.10
Na2SeO3
0.35
Sel-Plex®
0.23
Sel-Plex®
0.32
Sel-Plex®
0.39
Sel-Plex®
0.46
0.06a
0.15a
0.09
0.10
0.50
0.23
0.17b
0.43b
0.25
0.25c
0.57c
0.35
0.32d
0.67d
0.43
0.36d
0.85e
0.50
*Original egg data (mg Se/kg DM) transformed to mg Se/kg fresh matter. Figures used for transformation: 13 % DM in
albumen, 50 % DM in egg yolk.
**Figures used for calculation: whole egg: 38.8 g albumen, 17.2 g yolk.
a,b,c,d,e
Different letter superscripts in the same line indicate significant differences (P<0.05), Na-selenite treatment not
assessed
A numerical comparison of selenium concentrations in albumen and yolk of the unsupplemented
control group and the selenite group (studies 8 and 9) allows to conclude that also Na-selenite affected
selenium deposition in both compartments.
2.1.3. Selenium deposition in milk and dairy products
The first three studies in dairy cows followed the same design with a duration of 140 days.
Feedingstuffs were supplemented with selenite or Sel-Plex® to give diets with 0.3 and 0.45 mg total
Se/kg feed DM. These four diets were compared with an unsupplemented control feed.
The selenium content of milk from dairy cows (Table 14) increased along with selenium
supplementation of the diet over the entire length of the study (140 days). At various intervals during
the treatment period, the selenium source had a significant effect on milk selenium with higher values
recorded in the Sel-Plex® groups compared with cows receiving sodium selenite. These results are
reflected well in the casein data, which shows a very similar pattern.
A range of dairy products were produced from milk of the control group and the higher
supplementation rates from Na-selenite and Sel-Plex®. Elevated levels of selenium in the milk gave
rise to elevated levels of selenium in dairy products, in an approximate proportion to the protein level.
In all dairy products examined, Sel-Plex® supplementation resulted in higher selenium concentrations
than that of selenite. But also selenite increased the selenium concentration in dairy products
compared to the unsupplemented control group.
SeMet was the predominant selenised amino acid present in milk with lowest values recorded in the
control group. When comparing equal dietary selenium levels from both sources, the results showed
that the selenium source had a marked effect with higher values noted for the Sel-Plex® groups. By the
end of the study the SeMet content of milk derived from cows receiving Sel-Plex® was approximately
two times higher from cows receiving Na2SeO3 (221 vs. 101 and 246 vs. 106 ng Se/g fresh matter at
0.3 and 0.45 mg Se/kg feed DM, respectively). SeCys varied only little in milk. The ratios between
SeMet:SeMet+SeCys+other Se species were 0.518, 0.529, 0.497, 0.565 and 0.569 for the control,
selenite (0.30 mg total Se/kg feed DM), selenite (0.45 mg total Se/kg), Sel-Plex® (0.30 mg total Se/kg)
and Sel-Plex® (0.45 mg total Se/kg feed DM), respectively. The presence of SeIV was detected in milk
whereas it was undetected in either blood or plasma. The level of SeIV was higher in milk from SelPlex® supplemented cows than from the selenite treatments.
EFSA Journal 2011;9(4):2110
14
Sel-Plex® as zootechnical additive for all species
Table 14: Selenium deposition in milk and dairy products from dairy cows (Study 17, 140 days)
Source of Se
Intended total Se (mg/kg feed DM)
Se in milk (µg/kg fresh matter)
Day 28
Day 56
Day 140
Se in casein (µg/kg)
Day 28
Day 56
Day 140
Se in dairy products (µg/kg)
Skimmed milk (n=9)
Cream (n=65)
Yogurt (n=12)
Buttermilk (n=10)
Butter (n=85)
Final hard cheese (n=70)
Final soft cheese (n=20)
®
Control
0.19
Na2SeO3
0.30
Na2SeO3
0.45
Sel-Plex
0.30
19
20
18
21
21
22
24
27
26
28
33
33
44
56
53
253
177
283
467
449
297
676
564
462
729
495
902
970
297
1284
171
22
61
152
4.2
299
282
-
311
60
373
75
8.8
359
307
-
53
719
646
114
11.2
793
766
Sel-Plex
0.45
®
In a second study in dairy cows (Table 15), a strong and significant effect of selenium
supplementation levels on selenium concentrations of whey and curd was observed in the
supplemented groups. This increase was significantly higher in the two Sel-Plex® groups (0.30 and
0.45 mg total Se/kg feed DM) than in the corresponding selenite groups. Selenium concentrations in
milk could not be considered because of the lack of dimensions for the figures given.
Table 15: Selenium deposition in milk and dairy products from dairy cows (Study 18, 140 days)
Source of Se
Intended total Se (mg/kg feed DM)
Control
<0.10
Na2SeO3
0.30
Na2SeO3
0.45
Sel-Plex
0.30
Se in whey (µg/kg DM)
Se in curd (µg/kg DM)
< LOQ
83d
54c
134c
95b
177c
175a
371b
a,b,c,d
®
Sel-Plex
0.45
®
160a
523a
Different letter superscripts in the same line indicate significant differences (P<0.05)
In the third study on dairy cows (Table 16), selenium in milk (and in cheese) showed approximately
the same pattern as in the first study (Table 14).
At the end of the trial, selenium from SeMet was only significantly increased in the two Sel-Plex®
groups. Selenium from SeCys was rather unaffected by selenium dietary levels and sources.
Table 16: Selenium deposition in milk and dairy products from dairy cows (Study 19, 140 days)
Source of Se
Intended total Se (mg/kg feed DM)
Se in milk (µg/L)
Day 28
Day 140
SeMet in milk (µg Se/kg DM), day 140
SeCys in milk (µg Se/kg DM), day 140
Se in cheese (µg/kg DM), day 30/32
a,b,c,d
Control
0.10
Na2SeO3
0.30
Na2SeO3
0.45
Sel-Plex
0.30
17a
17a
93a
40ab
225
27b
22b
96a
32a
315
28b
25b
113a
36a
365
52c
43c
234b
44ab
409
®
Sel-Plex
0.45
®
65d
62d
366c
52b
733
Different letter superscripts in the same line indicate significant differences (P<0.05)
EFSA Journal 2011;9(4):2110
15
Sel-Plex® as zootechnical additive for all species
In a fourth study on dairy cows (Table 17), total selenium in milk (and in cheese) was not influenced
by selenite, but by dietary selenium from Sel-Plex® (significant regression selenium in feed and in
milk). As seen in study 19 (Table 16), SeCys in milk was apparently not influenced by dietary
selenium levels and source, whereas SeMet showed an increase with increasing dietary selenium from
Sel-Plex®.
Table 17: Selenium deposition in milk and dairy products from dairy cows (Study 20, 112 days)
Control
0.16
Na2SeO3
0.30
Sel-Plex®
0.30
Sel-Plex®
0.45
Se in milk (µg/kg fresh matter), day 112
24
38
57
72
Se in bulk milk samples, day 112
From SeMet (µg Se/kg DM)
From SeCys (µg Se/kg DM)
46
52
36
20
111
58
157
75
Se in cheese (µg/kg DM)
Total Se (µg/kg DM)
From SeMet (µg Se/kg DM)
From SeCys (µg Se/kg DM)
190
52
46
180
57
52
340
153
92
-
Source of Se
Intended total Se (mg/kg complete feed DM)
In a study on dairy sheep (Table 18), milk selenium content after 56 days of selenium supplementation
showed an increase from both sources, selenite and Sel-Plex®, but a dose relation was not apparent.
Both SeMet and SeCys increased in milk with dietary inclusion of both selenium sources. However,
this increase appeared to be more marked in the Sel-Plex® groups, particularly at the highest selenium
supplementation (0.5 mg total Se/kg feed DM).
Table 18: Selenium deposition in milk and dairy products from dairy sheeps (Study 30, 112 days)
Source of Se
Intended total Se (mg/kg feed DM)
Se in milk (µg/kg DM)
Day 28 Total
From SeMet
From SeCys
Day 56 Total
From SeMet
From SeCys
Control
0.1
Na2SeO3
0.30
Sel-Plex®
0.30
Sel-Plex®
0.40
Sel-Plex®
0.50
103
28
53
153
48
85
195
74
89
299
104
127
203
105
120
311
132
155
216
106
114
337
179
160
269
149
142
355
203
179
The first study on dairy goats (Table 19) showed a significant increase in milk selenium as a
consequence of supplementing feed with selenium from selenite or Sel-Plex®. At the same
supplementation level (0.3 mg total Se/kg feed DM), there was no difference between the groups with
selenite and Sel-Plex®. Higher dietary selenium from Sel-Plex® resulted in a further increase in milk
selenium. Differences in the selenium content of curd and whey followed approximatively the same
differences observed in milk.
SeCys concentration in milk was elevated by dietary selenium supplementation from both sources
with small, if any, differences between selenite and Sel-Plex® at the same supplementation level (0.3
mg total Se/kg feed DM). An increase of SeMet in milk was less marked and evident only for the
highest selenium incorporation level (0.4 mg total Se/kg feed DM) from Sel-Plex®, (selenite not
tested). The ratios of SeMet:SeMet+SeCys+other Se species in milk were 0.154, 0.173, 0.217 and
0.219 for the control, the selenite group, the groups with 0.3 and 0.4 mg total Se/kg from Sel-Plex®,
respectively.
EFSA Journal 2011;9(4):2110
16
Sel-Plex® as zootechnical additive for all species
Table 19: Selenium deposition in milk and dairy products from dairy goats (Study 31, 112 days)
Control
Na2SeO3
0.30
Sel-Plex®
0.30
Sel-Plex®
0.40
16a
27b
27b
61c
6
2
4
15
4
11
15
6
11
40
12
23
Se in curd (µg/kg)
Se speciation in curd
Total Se (µg/kg curd)
SeMet (µg Se/kg curd)
SeCys (µg Se/kg curd)
Se in whey (µg/kg)
18a
41b
42c
134c
25
7
22
5a
46
9
33
15b
51
13
43
18c
142
40
91
27d
Se in cheese (µg/kg)
Se speciation in cheese
Total Se (µg/kg cheese)
SeMet (µg Se/kg cheese)
SeCys (µg Se/kg cheese)
61a
100b
160c
368d
71
23
50
110
43
56
163
62
111
358
127
213
Source of Se
Intended total Se (mg/kg complete feed DM)
Se in milk (µg/kg)
Se speciation in milk
Total Se (µg/kg milk)
SeMet (µg Se/kg milk)
SeCys (µg Se/kg milk)
a,b,c,d
Different letter superscripts in the same line indicate significant differences (P<0.05)
In a second study on dairy goats (Table 20) selenite and Sel-Plex® were compared at the same
supplementation level (0.3 mg total Se/kg feed DM) with an unsupplemented control group. Feeding
Sel-Plex® resulted in higher selenium concentrations in milk and cheese than the control feed and the
selenite containing diet. However, also sodium selenite lead to an increase of selenium in milk and
cheese. Se-cyst in milk was only elevated by Sel-Plex®, SeMet did not respond to additional dietary
selenium.
Table 20:
Selenium deposition in milk and dairy products from dairy goat (Study 32, 112 days)
Source of Se
Intended Se level in feed (mg/kg DM)
Control
0.19
Na2SeO3
0.30
Sel-Plex®
0.30
Se in milk (µg/kg DM), day 112
SeMet in milk (µg Se/kg DM), day 112
SeCys in milk (µg Se/kg DM), day 112
159
44
151
196
34
149
225
43
201
Se in cheese (µg/kg DM)
SeMet in cheese (µg Se/kg DM)
SeCys in cheese (µg Se/kg DM)
290
99
142
325
107
179
401
117
273
2.1.4. Conclusions on the impact on the nutritional values of animal products
The mean selenium concentration in muscle tissues (seven studies) amounted in the control groups
(marginal or low dietary selenium) to 0.40 mg/kg DM (0.35 mg with the eighth study (chicken study),
in which the values were only about one tenth of the other animal species/categories, probably
reflecting fresh meat concentrations). Supplementation of the diet by selenium, either from sodium
selenite or from Sel-Plex®, resulted in an increase of muscle selenium. Adding 0.1 or 0.2 mg Se/kg
diet from sodium selenite led to an increase of muscle selenium by about 1.3 (data set without the
chicken) and appeared not to be dose dependent. Dietary supplementation of about 0.1, 0.2 and 0.35
mg selenium from Sel-Plex® resulted in a dose dependent increase of muscle selenium by about 1.8,
2.2 and 2.6 (all factors without the chicken experiment), respectively. At a supplementary level of 0.1
mg Se/kg diet, Sel-Plex® was about 1.4 times (four comparisons) more effective than sodium selenite
concerning selenium deposition in muscle tissues, at a supplementary level of 0.2 mg Se/kg diet about
1.6 times (five comparisons). A direct comparison of the tissue levels resulting from the different
EFSA Journal 2011;9(4):2110
17
Sel-Plex® as zootechnical additive for all species
selenium doses from the two selenium sources is difficult because of the uneven distribution of
groups.
Selenium concentration in liver of the control groups averaged 1.2 mg/kg DM (seven studies). Dietary
selenium supplementation (0.1-0.2 mg/kg) from sodium selenite resulted in an increase to 1.8-1.9 mg
selenium, from Sel-Plex® to 2.2 mg/kg liver DM. A further increase to 2.6 mg Se/kg could be seen for
0.35 mg Se/kg diet from Sel-Plex®. Kidneys showed higher values, the mean selenium concentration
in kidney of the controls was 4.6 mg/kg DM. The addition of 0.1-0.2 mg Se/kg diet amounted to
concentrations of 4.8-5.6 mg/kg kidney DM for the sodium selenite groups and of 5.1-5.7 for the
corresponding Sel-Plex® groups. In kidney, a difference between selenium doses and sources was not
evident.
Selenium concentration in eggs (control: 0.06 mg/kg whole egg in study 8, 0.09 mg/kg in study 9)
responded also to supplementary selenium from both sources, by a factor of 2.6 for the
supplementation of 0.2 or 0.3 mg selenium from sodium selenite, and by the factor of 3.8 (4.6) for
selenium from Sel-Plex® at 0.2-0.26 (0.3-0.35) mg supplementary Se/kg diet. At this level, Sel-Plex®
was about 1.5 times more effective than sodium selenite.
Selenium content in milk responded also, and again in a dose dependent manner only for Sel-Plex®
addition, to dietary selenium supplementation of selenium from both sources. Selenium concentration
in milk of the control animals was about 19 µg/L. It increased by dietary supplementation of 0.1 - 0.35
mg Se/kg from sodium selenite by about 1.45. Supplementation of 0.1, 0.2-0.26 and 0.3-0.35 mg
selenium from Sel-Plex® resulted in increases by factors of 2.1, 2.4 and 2.7, respectively. The increase
by Sel-Plex® compared to sodium selenite was 1.4 to 1.8 times higher. Casein (including curd)
behaved similar to whole milk.
The FEEDAP Panel concludes from the data set submitted that (i) a certain increase of the selenium
content of edible tissues and products is a characteristic consequence of selenium supplementation to
the diet principally independent from the source of dietary selenium, (ii) Sel-Plex® is more effective
than sodium selenite in increasing the selenium concentration of edible tissues and products, and (iii)
the degree of the higher relative potency of Sel-Plex® depends on the level of selenium
supplementation (increase with higher Sel-Plex® levels). Consequently, the FEEDAP Panel confirms
its earlier conclusion (EFSA, 2006) that “such effects are based on the bioavailable selenium in SelPlex®. The likely better availability of selenium in Sel-Plex® compared to other inorganic selenium
sources is based on the specific nutritional property of selenomethionine”.
2.2.
Impact on the quality of animal products
The results in this section summarise the effect of Sel-Plex® supplementation compared to sodium
selenite on oxidative stability of animal products (meat from different poultry species and large and
small ruminants and eggs), and on water binding capacity of meat (different poultry species and large
and small ruminants).
Endpoints considered by the applicant to measure lipid oxidation were (Thiobarbituric Acid Reactive
Substances) TBARS values and product colour. Altough product colour is an important quality
parameter which affects consumer acceptance, it is not strictly considered a lipid oxidation parameter
since it is affected by several reactions.
2.2.1. TBARS and colour of meat and eggs
The malondialdehyde (MDA) is a major carbonyl oxidation product derived mainly from
polyunsaturated fatty acids with more than two conjugated double bonds. Most of the methods to
determine MDA are based on its reaction with 2-thiobarbituric acid (TBA) yielding a red chromogen
with a maximum absorbance at 530-537 nm, which is measured by spectrophotometry. As usually
other compounds than MDA react with TBA and contribute to the absorbance, the results of these
EFSA Journal 2011;9(4):2110
18
Sel-Plex® as zootechnical additive for all species
methods are normally reported as TBARS values. The TBARS values are widely used to assess the
degree of lipid oxidation in some foods (specially meat and meat products) and biological samples.
The applicant provided nine studies reporting TBARS values in meat from different species and ten
studies with results on colour of meat. In both cases, only eight studies were considered (studies 1, 11,
13, 22, 25, 26, 27 and 29) because the rest had an inappropiate experimental design (see appendix C).
An additional study (study 7) reporting results on colour of eggs was also provided.
The studies in meat measured the colour by reflectance colourimetry using the CIELAB (L*
(lightness), a* (redness) and b* (yellowness)) colour space (CIE, 2004). Several of these studies used
chroma (C*) and/or hue angle (h) to assess colour (L*C*h colour space). Chroma is the root of the
sum of the squares of a* and b* and it is used to express color saturation. Hue angle is the cotangent of
the quotient of b*/a* and it is used to express colour hue (h= 0, true red; h= 90, true yellow). The
study on eggs (study 7) measured the yolk colour by comparison with the Roche yolk colour fan
(RYCF).15
2.2.1.1. Chickens for fattening
In study 1, TBARS values in the unsupplemented and the selenite groups were similar in meat samples
chilled for one and seven days (Table 21). After one day chilling, only the highest Sel-Plex® dose (0.4
mg Se/kg feed) resulted in a significant decrease of TBARS values compared to the control and the
selenite groups. After seven days chilling, all three Sel-Plex® groups showed significantly lower
TBARS values than the other groups. No significant effect was found in colour of meat after one day
chilling.
Table 21:
TBARS values and colour of meat of chickens for fattening (Study 1, 42 days)
Control
None
Na2SeO3
0.3
Sel-Plex®
0.2
Sel-Plex®
0.3
Sel-Plex®
0.4
TBARS in breast (mg MDA/kg)
after chilling for 1 day
after chilling for 7 days
5.96a
7.42a
5.28a
7.78a
4.01ab
6.06b
3.93ab
5.22b
2.81b
5.85b
Colour in breast after chilling for 1 day
L*
a*
b*
47.6
3.66
0.25
48.0
4.14
0.15
48.4
4.10
0.40
48.8
3.51
0.18
49.1
3.93
0.41
Source of Se
Se supplemented (mg/kg feed)
a,b
Different letter superscripts in the same line indicate significant differences (P<0.05)
TBARS: thiobarbituric acid reactive substances; MDA: malondialdehyde; L*: lightness; a*: redness/greenness; b*:
yellowness/blueness
2.2.1.2. Turkeys for fattening
In study 11, the dietary treatments did not affect breast and thigh TBARS values (Table 22). However,
when values from the inorganic selenium treatment were excluded from the statistical evaluation, the
breast tissue TBARS values showed an inverse linear dose response (P= 0.05) to the graded
supplementation of organic selenium to diets, which indicates that selenium supplementation may
prevent lipid oxidation. However, as TBARS values were lower in breast samples from selenite
treatment than from Sel-Plex® treatment (0.30 mg Se/kg feed), this protective effect can not be
attributed exclusively to organic selenium supplementation. In general compared to studies in which
more selective methods are used, the TBARS values reported in this study are very high for raw meat.
Differences between treatments in colour saturation and hue of thigh samples were not statistically
significant. However, the increase in colour hue after seven days at simulated retail display conditions
was positively related to TBARS values (r2= 0.668).
15
Roche yolk colour fan (RYCF), nowadays called DSM-yolk colour fan (DSM-YCF)
EFSA Journal 2011;9(4):2110
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Sel-Plex® as zootechnical additive for all species
Table 22:
Thiobarbituric Acid Reactive Substances (TBARS) values and colour of meat of turkeys
for fattening (Study 11, 91 days)
Control
0.22
Na2SeO3
0.30
Sel-Plex®
0.30
Sel-Plex®
0.45
TBARS after 5 days at display conditions (mg MDA/kg)
in breast
in thigh
4.4
15.3
3.5
13.1
3.8
12.8
2.6
12.3
Colour saturation (chroma) in thigh
after 0 days at display conditions
after 7 days at display conditions
11.12
5.69
11.45
7.09
12.33
6.68
11.77
6.86
Color hue (hue angle) in thigh
after 0 days at display conditions
after 7 days at display conditions
17.86
66.27
18.52
42.63
19.29
57.17
19.08
50.57
Source of Se
Intended total Se (mg/kg complete feed DM)
TBARS: thiobarbituric acid reactive substances; MDA: malondialdehyde; chroma: root of sum of squares of a* and b*
values; hue angle: cotangent of the quotient of b*/a*
2.2.1.3. Pheasants for fattening
In study 13, TBARS values in breast muscle after five days at simulated retail display conditions were
not affected by the dietary treatments (Table 23). However, a weak inverse relationship (r2= 0.239)
was observed between breast tissue total selenium content and TBARS values. No significant
differences between the treatments were observed in colour saturation and hue angle of breast muscle
just after slaughter. After seven days at display conditions, only the colour hue was significantly
affected by the dietary supplementation with selenium, being lower in breast steaks from birds which
had received the highest dietary dose of Sel-Plex®.
Table 23: Thiobarbituric Acid Reactive Substances (TBARS) values and colour of meat of
pheasants for fattening (Study 13, 91 days)
Control
None
Na2SeO3
0.08
Sel-Plex®
0.08
Sel-Plex®
0.23
1.23
1.04
1.18
0.96
Colour saturation (chroma) in breast
after 0 days at display conditions
after 7 days at display conditions
6.44
5.59
6.28
5.51
6.68
5.96
6.11
5.40
Colour hue (hue angle) in breast
after 0 days at display conditions
after 7 days at display conditions(1)
38.13
53.35
38.87
52.47
39.30
54.61
37.14
49.80
Source of Se
Se supplemented (mg/kg feed)
TBARS in breast after 5 days at display conditions (mg
MDA/kg)
(1)
Significant effect of the dietary treatments on this response (P= 0.022). Results of contrasts between means are not
reported.
TBARS: thiobarbituric acid reactive substances; MDA: malondialdehyde; chroma: root of sum of squares of a* and b*
values; hue angle: cotangent of the quotient of b*/a*
2.2.1.4. Cattle for fattening
In study 22, TBARS values and colour parameters of meat were not affected by dietary treatments
(Table 24). However, an inverse relationship between colour saturation reduction during storage (at
simulated retail display conditions for 21 days) and selenium content of beef meat from all treatments
was observed (r2= 0.204), indicating that the rate of decline of colour saturation during storage slightly
decreased with the ascending total selenium content in meat.
EFSA Journal 2011;9(4):2110
20
Sel-Plex® as zootechnical additive for all species
Table 24: Thiobarbituric Acid Reactive Substances (TBARS) values and colour of meat of cattle for
fattening (Study 22, 91 days)
Source of Se
Se supplemented (mg/kg complete feed DM)
TBARS in meat after 7 days at display conditions (mg
MDA/kg)
Colour saturation (chroma) in meat
after 0 days at display conditions
colour saturation reduction after 21 days at display
conditions
Control
None
Na2SeO3
0.15
Sel-Plex®
0.15
Sel-Plex®
0.35
0.41
0.57
0.60
0.39
21.24
21.58
21.44
21.68
12.77
12.45
12.30
11.58
TBARS: thiobarbituric acid reactive substances; MDA: malondialdehyde; chroma: root of sum of squares of a* and b* values
2.2.1.5. Lambs
In study 25, even though the selenite group showed by far the lower TBARS values in meat after
seven days at simulated retail display conditions, the effect of dietary selenium supplementation was
not significant (Table 25). However, when values from the selenite group were excluded from the
statistical evaluation, the TBARS values showed an inverse relationship (r2 = 0.302) with the selenium
content of meats coming from the treatments supplemented with Sel-Plex®. Colour saturation just after
slaughter tended to be better in meat from animals that had received supplementary selenium, although
meat from the intermediate Sel-Plex® group was the exception to this tendency. In addition, an inverse
relationship between the reduction of colour saturation during storage (at display conditions for 14
days) and selenium content of meat from all treatments was observed (r2 = 0.270).
Table 25: Thiobarbituric Acid Reactive Substances (TBARS) values and colour of meat of lambs
(Study 25, 112 days)
Source of Se
Intended total Se (mg/kg complete feed
DM)
TBARS in meat after 7 days at display
conditions (mg MDA/kg)
Colour saturation (chroma) in meat
after 0 days at display conditions
colour saturation reduction after 14
days at display conditions
Control
Na2SeO3
Sel-Plex®
Sel-Plex®
Sel-Plex®
0.19
0.30
0.30
0.40
0.50
1.47
0.42
1.31
0.80
0.64
18.33ab
18.55ac
18.65ac
18.07b
18.80c
5.98
4.30
4.86
3.30
3.79
a,b,c
Different letter superscripts in the same line indicate significant differences (P<0.05)
TBARS; thiobarbituric acid reactive substances; MDA: malondialdehyde; chroma: root of sum of squares of a* and b* values
In study 26, TBARS, colour saturation and hue of meat samples stored for up to nine days at simulated
retail display conditions were not affected by the dietary treatments (Table 26).
EFSA Journal 2011;9(4):2110
21
Sel-Plex® as zootechnical additive for all species
Table 26:
Thiobarbituric Acid Reactive Substances (TBARS) values and colour of meat of
lambs (Study 26, 63 days)
Control
Na2SeO3
0.30
Sel-Plex®
0.30
Sel-Plex®
0.45
TBARS in meat (mg MDA/kg)
after 0 days at display conditions
after 3 days at display conditions
after 6 days at display conditions
after 9 days at display conditions
0.16
0.46
1.13
1.67
0.20
0.46
1.07
1.43
0.13
0.53
1.15
1.69
0.13
0.39
0.92
1.35
Colour saturation (chroma) in meat
after 0 days at display conditions
after 3 days at display conditions
after 6 days at display conditions
after 9 days at display conditions
16.92
16.80
17.11
16.65
16.94
17.17
16.56
16.95
16.36
16.79
17.18
16.31
17.27
17.17
17.13
18.02
Colour hue (hue angle) in meat
after 0 days at display conditions
after 3 days at display conditions
after 6 days at display conditions
after 9 days at display conditions
24.22
34.14
41.33
48.68
23.74
32.98
40.16
47.54
23.73
34.04
40.69
46.53
22.57
33.65
38.75
42.52
Source of Se
Intended total Se level in TMR (mg/kg DM)
TMR: total mixed ration; TBARS; thiobarbituric acid reactive substances; MDA: malondialdehyde; chroma: root of sum of
squares of a* and b* values; hue angle: cotangent of the quotient of b*/a*
In study 27, TBARS values in meat after 10 days at simulated retail display conditions, and colour
saturation and hue after 0 and 14 days at these conditions did not show differences between the dietary
treatments (Table 27). However, changes in colour (colour saturation and hue) after 14 days at
simulated retail display conditions were positively related with TBARS values (r2 = 0.372 and r2 =
0.640, respectively).
Table 27: Thiobarbituric Acid Reactive Substances (TBARS) values and colour of meat of lambs
(Study 27, 133 days)
0.45
Sel-Plex®
0.30
Sel-Plex®
0.45
2.55
2.27
2.72
2.41
17.27
13.06
16.20
13.45
17.21
13.30
17.26
12.94
16.92
13.62
25.00
42.25
23.91
39.64
24.65
40.54
24.65
40.62
24.14
41.13
Control
0.20
Na2SeO3
0.30
Na2SeO3
2.49
Colour saturation (chroma) in meat
after 0 days at display conditions
after 14 days at display conditions
Colour hue (hue angle) in meat
after 0 days at display conditions
after 14 days at display conditions
Source of Se
Intended total Se level in TMR (mg/kg DM)
TBARS in meat after 10 days at display
conditions (mg MDA/kg)
TBARS; thiobarbituric acid reactive substances; MDA: malondialdehyde; chroma: root of sum of squares of a* and b*
values; hue angle: cotangent of the quotient of b*/a*
2.2.1.6. Kids
In study 29, TBARS values in meat one day after the slaughter were not affected by the dietary
treatments (Table 28). Ten days after slaughter, TBARS values in meat were significantly reduced in
the low and intermediate Sel-Plex® groups compared to the control, while the high Sel-Plex® group
did not show a significant reduction compared to the control. No significant differences in muscle
TBARS values were found between the sodium selenite group and the three Sel-Plex® groups. The
dietary treatments affected meat colour, being redness (a* values) significantly higher in the
intermediate and the high Sel-Plex® groups compared to the unsupplemented control and the low Sel-
EFSA Journal 2011;9(4):2110
22
Sel-Plex® as zootechnical additive for all species
Plex® groups at 1 and 10 days after slaughter (Table 28). But again, there was no difference between
equal dietary selenium doses from sodium selenite and Sel-Plex®.
Table 28: Thiobarbituric Acid Reactive Substances (TBARS) values and colour of meat of kids
(Study 29, 112 days)
Source of Se
Intended total Se (mg/kg complete feed DM)
Control
0.10
Na2SeO3
0.30
Sel-Plex®
0.30
Sel-Plex®
0.40
Sel-Plex®
0.50
TBARS in meat (absorbance/mg lipid fraction)
1 day after slaughter
10 days after slaughter
0.124
0.130b
0.142
0.112ab
0.091
0.089a
0.090
0.080a
0.091
0.096ab
39.4
11.4a
3.07a
41.6b
11.4a
7.6b
39.3
12.1ab
3.15ab
42.5b
11.5a
7.5b
39.7
11.6a
2.93a
41.8b
12.0a
7.9b
38.4
13.1c
3.79b
39.5a
13.6b
4.1a
38.1
12.8bc
3.53b
40.1a
13.3b
4.1a
Colour in meat
1 day after slaughter
10 days after slaughter
L*
a*
b*
L*
a*
b*
a,b,c
Different letter superscripts in the same line indicate significant differences (P<0.05)
TBARS: thiobarbituric acid reactive substances; L*: lightness; a*: redness/greenness; b*: yellowness/blueness
2.2.1.7. Laying hens
The colour of eggs yolk from laying hens fed for 35 days two different diets both supplemented at
equal levels with sodium selenite or Sel-Plex® was measured using the Roche Yolk Colour Fan (study
7). At start all mean values were slightly above 9, they did not change during the experiment,
differences between the diets and the selenium sources were not observed.
2.2.2. Conclusions on TBARS and colour of meat and eggs
2.2.2.1. TBARS of meat
From the eight considered studies, only two (studies 1 and 29) reported differences in TBARS values
between dietary treatments with different levels of selenium supplementation (Tables 21 and 28). In
study 1, TBARS values showed that supplementation with Sel-Plex® improved the oxidative stability
of chicken breast compared to sodium selenite supplementation (and to the non-supplemented
control). In study 29, TBARS values in kid muscle one day after the slaughter were not affected by
dietary treatments. Ten days after slaughter, TBARS values were significantly reduced in muscle
tissue by the low and intermediate supplementation with Sel-Plex® (0.3 and 0.4 mg intended total
Se/kg feed) compared to the non-supplemented control (0.1 mg intended total Se/kg feed). The highest
Sel-Plex® supplementation (0.5 mg intended total Se/kg feed) did not show a significant reduction of
TBARS values compared to the control. No significant differences in muscle TBARS values were
found between equal dietary selenium doses from sodium selenite and Sel-Plex® (0.3 mg intended
total Se/kg feed). Thus, this protective effect against oxidation could not be attributed exclusively to
Sel-Plex® supplementation.
For three of the six studies without significant effect of the dietary treatments on TBARS values, the
applicant reported an inverse relationship between TBARS values and the levels of selenium in meat.
In study 13, a weak inverse relationship (r2 = 0.239) was observed between total selenium content and
TBARS values in breast tissue. However, in the two other studies (11 and 25) this relationship was
established without taking into account data from the groups supplemented with sodium selenite. In
addition, it should be noted that in these three studies supplementation with inorganic selenium
resulted in lower or similar meat TBARS values than that with Sel-Plex®. Thus, even if these negative
correlations would be considered indicative of a protective effect of meat selenium content against
lipid oxidation, the effect could not be attributed exclusively to Sel-Plex®.
EFSA Journal 2011;9(4):2110
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Sel-Plex® as zootechnical additive for all species
Taking all studies together, it is clear that the results are inconsistent and there is not enough evidence
that the supplementation with Sel-Plex® would further reduce lipid oxidation in meat compared with
inorganic selenium supplementation.
2.2.2.2. Colour of meat and eggs
From the eight considered studies on meat colour, only three (13, 25 and 29) showed a significant
effect of selenium supplementation (Tables 23, 25 and 28). In study 25, colour saturation tended to
increase in meat from lambs that had received increasing doses of supplementary selenium, although
the intermediate Sel-Plex® treatment (0.4 mg intended total Se/kg feed) appeared to be the exception
to this rule. In study 29, the treatments seemed to affect muscle colouration, with meat redness (a*
values) significantly higher in the intermediate and the high Sel-Plex® groups (0.3 and 0.4 mg intended
total Se/kg feed) compared to the control (0.1 mg intended total Se/kg feed). However, the authors of
study 29 attributed these differences in colour to differences between trial runs. In addition, as in both
studies (25 and 29) there was no difference in colour between equal doses of selenium from sodium
selenite and Sel-Plex® (0.3 mg intended total Se/kg feed), the effect of selenium on colour can not be
attributed exclusively to organic selenium. In study 13, colour hue and saturation of pheasant breast
steaks were measured just after slaughter and after 7 days at simulated retail display conditions.
Colour hue was significantly affected only on day 7, being lower in breast steaks from birds which had
received the highest dietary dose of Sel-Plex® (0.23 mg Se supplementation/kg feed).
In addition, in study 25, a significant inverse relationship between colour saturation reduction during
storage (at display conditions for 14 days) and selenium content of lamb meat from all treatments was
observed (r2= 0.270). Similar results indicating that the rate of decline of colour saturation during
storage decreased with the ascending total selenium content in meat were obtained in study 22. In this
study, also an inverse relationship between colour saturation reduction during storage (at display
conditions for 21 days) and selenium content of beef meat from all treatments was observed (r 2=
0.204). However, in this study, in contrast to study 25, there was no significant effect of selenium
supplementation on colour saturation of meat.
The remaining five studies considered in this opinion with results on meat (1, 11, 26 and 27) and hen
eggs (7) colour did not show any effect of selenium supplementation.
Therefore, from all these studies, the FEEDAP Panel concludes that the results are controversial and
there is not enough evidence supporting that the supplementation with Sel-Plex® further improves
colour of animal products compared to sodium selenite supplementation.
2.2.2.3. Methodological considerations
Some of the controversial results for TBARS might have been explained by the analysis of fatty acid
composition and tocols content of meats, which have not been measured in any of these studies. It is
well known that TBARS values are highly dependent of fatty acid composition and tocopherol content
(Raharjo and Sofos, 1993). In addition, most of the methods used in these studies to determine
TBARS values are among those methods considered to show high variability and low selectivity for
MDA. Most of the studies (11, 13, 22, 25, 26 and 27) used distillation methods to measure TBARS in
meat, which have been widely reported to artefactually produce MDA and other TBA reactive
substances because of the heating of sample during distillation (Raharjo and Sofos, 1993). This fact
might explain the very high TBARS values found in the study 11, in comparison to the values reported
for raw poultry meat during the last decade. In study 29, the TBARS values are determined in the lipid
fraction extracted from meat using a method recommended for fats and oils, which is not common for
TBARS determination in meat. In fact, introducing the lipid extraction step will increase the
variability of the determination and the artefactual formation of lipid oxidation products during the
analysis (Fernández et al., 1997). As lipid oxidation is a very complex process, the determination of at
least one primary oxidation parameter (e.g. hydroperoxide determination) in addition to TBARS
values, which is a secondary oxidation parameter, would have helped to interpret these controversial
results for raw meats (Gray and Monahan, 1992).
EFSA Journal 2011;9(4):2110
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Sel-Plex® as zootechnical additive for all species
Even though there are several studies in the literature reporting correlations between colour and lipid
oxidation parameters in meats, the colour is not strictly considered a lipid oxidation parameter since it
is affected by several meat reactions and particularly by myoglobin changes. In addition, it is widely
known that the maintenance of colour in meat is usually related with their tocopherol content. Thus,
colour determination must be considered only a complementary measure to study lipid oxidation in
meat.
The experimental weaknesses described above and the absence of additional endpoints necessary for a
better understanding of lipid oxidation might have prevented a clear recognition of the selenium
effects on this deteriorative process.
2.2.3. Water binding capacity of meat
The applicant provided 14 studies reporting results for various parameters related to the water binding
capacity of meat (carcass drip loss, meat drip loss, expressible moisture, and cooking loss), from
which only 11 (studies 1, 2, 3, 11, 12, 13, 22, 25, 26, 27 and 29) were further considered and evaluated
in this opinion because the rest had an inappropiate experimental design (see appendix C).
2.2.3.1. Chickens for fattening
The drip loss of breast muscle of chickens for fattening was determined after chilling the fillets for one
and two days (study 1), and after 18 h at 4 ºC (studies 2 and 3).
In study 1, drip loss of breast after chilling for one day was not affected by dietary selenium
supplementation and was in the range of 0.8 to 0.9 % for all groups (unsupplemented control; 0.3 mg
Se/kg feed from selenite; and 0.2, 0.3 and 0.4 mg Se/kg feed from Sel-Plex®) (Table 29). The drip loss
after chilling for two days was somewhat higher and varied between 1.0 and 1.4 % (no significant
differences were found). The cooking loss of breast meat chilled for one and seven days did not show
differences between treatments; only in samples which were frozen for seven days the cooking loss
was significantly reduced in the intermediate and the high Sel-Plex® groups compared to the selenite
group.
Table 29:
Water binding capacity of meat of chickens for fattening (Study 1, 42 days)
Source of Se
Se supplemented (mg/kg feed)
Drip loss in breast (%)
After chilling for 1 day at 1-5 ºC
After chilling for 2 days at 1-5 ºC
Cooking loss in breast (%)
Chilled for 1 day at 4 ºC
Chilled for 7 days at 4 ºC
Frozen for 7 days at -20 ºC
a,b,c
Control
0
Na2SeO3
0.3
Sel-Plex®
0.2
Sel-Plex®
0.3
Sel-Plex®
0.4
0.9
1.4
0.9
1.1
0.8
1.0
0.8
1.0
0.8
1.1
21.9
21.4
23.4ab
21.1
21.9
23.9a
18.2
20.0
23.5ab
18.6
20.3
22.1bc
19.4
19.8
21.8c
Different letter superscripts in the same line indicate significant differences (P<0.05)
In studies 2 and 3, the same dietary treatments supplemented with selenium were tested
(unsupplemented control; 0.3 mg Se/kg feed from selenite; and 0.3 mg Se/kg feed from Sel-Plex®)
(Table 30). In study 2, selenium supplementation had no effect on the drip loss of carcass, water
binding capacity and expressible moisture of breast fillets. However, drip loss of breast fillets from the
unsupplemented control was significantly lower than in breasts from the sodium selenite group and
similar to breasts from the Sel-Plex® group (Table 30). In study 3, among the parameters measured in
relation to water binding capacity of breast fillets (moisture, water holding capacity, expressible
moisture, drip loss and cooking losses), selenium supplementation only affected expressible moisture,
EFSA Journal 2011;9(4):2110
25
Sel-Plex® as zootechnical additive for all species
which was significantly higher in the Sel-Plex® group compared to the unsupplemented and the
sodium selenite groups (Table 30).
Table 30:
Water binding capacity of meat of chickens for fattening (Studies 2 and 3, 49 days)
Control
0
Na2SeO3
0.3
Sel-Plex®
0.3
0.67
0.55
0.61
Breast fillet
Drip loss after 18 h at 4 ºC (%)
Moisture (%)
Water holding capacity (mL/g)
Expressible moisture (%)
0.48a
71.30
0.384
29.39
1.01b
71.41
0.366
30.30
0.54ab
71.16
0.324
30.86
Study 3
Breast fillet
Drip loss after 18 h at 4ºC (%)
Cooking loss (%)
Moisture (%)
Water holding capacity (mL/g)
Expressible moisture (%)
1.2
28.0
73.3
0.27
30.4a
1.2
26.8
73.1
0.26
30.7a
1.1
27.3
73.3
0.29
34.0b
Source of Se
Se supplemented (mg/kg feed)
Study 2
Carcass drip loss after 18 h at 4 ºC (%)
a,b
Different letter superscripts in the same line indicate significant differences (P<0.05)
2.2.3.2. Turkeys
In two studies on turkeys for fattening, selenium supplementation from sodium selenite (0.30 mg
intended total Se/kg feed) was compared to an equivalent selenium dose from Sel-Plex® and to an
unsupplemented control group as well as to higher supplemented Sel-Plex® groups (0.45 (study 11), or
0.40 and 0.50 mg intended total Se/kg feed (study 12)).
In study 11, drip loss of breast muscle was not different among the treatments (range: 2.4 to 2.5 %). In
study 12, selenium supplementation had no significant effect on the drip loss of the carcass (range: 0.6
to 0.7 %), breast (range: 5.1 to 6.2 %) and leg muscle (range: 2.1 to 4.8 %).
2.2.3.3. Pheasants
In a study on pheasants (study 13), supplementation of selenium from Sel-Plex® (0.08 and 0.23 mg
Se/kg feed) and from sodium selenite (0.08 mg Se/kg feed) were compared to a control group.
Selenium supplementation had no significant effect on carcass drip loss (range: 7.28 to 8.94
g/carcass).
2.2.3.4. Cattle for fattening
In a study on cattle for fattening (study 22), supplementation of selenium from Sel-Plex® (0.15 and
0.35 mg Se/kg feed) and from sodium selenite (0.15 mg Se/kg feed) was compared to a control group.
Selenium supplementation had no significant effect on drip loss of carcass (range: 1.52 to 2.70 %) and
meat (range: 1.50 to 1.69 %).
2.2.3.5. Lambs
In two studies on lambs, selenium supplementation from sodium selenite (0.30 mg intended total Se
kg/feed) was compared to an equivalent selenium dose from Sel-Plex® and to an unsupplemented
control group as well as to higher supplemented Sel-Plex® groups (0.40 and 0.50 (study 25), or 0.45
mg intended total Se/kg feed (study 26)).
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Sel-Plex® as zootechnical additive for all species
In study 25, the dietary treatments supplemented with selenium had no significant effect on carcass
(range: 2.49 to 3.30 %) and meat (range: 1.26 to 1.70 %) drip loss. In study 26, neither drip loss of
carcass (range: 2.26 to 2.82 %) and meat (range: 1.81 to 2.29 %) nor cooking losses (range: 20.51 to
23.03 %) were significantly affected by dietary selenium supplementation.
In another study on lambs (study 27), supplementation of selenium from Sel-Plex® (0.30 and 0.45 mg
intended total Se/kg feed) and from sodium selenite (0.30 and 0.45 mg intended total Se/kg feed) were
compared to an unsupplemented control group (0.20 mg intended total Se/kg feed). In this study,
carcass drip loss was also not significantly affected by the dietary selenium supplementation and
ranged from 2.68 to 4.28 %.
2.2.3.6. Kids
In a study on kids (study 29), supplementation of selenium from Sel-Plex® (0.30, 0.40 and 0.50 mg
intended total Se/kg feed) and from sodium selenite (0.30 mg intended total Se/kg feed) were
compared to an unsupplemented control group (0.10 mg intended total Se/kg feed). Carcass drip loss
was not influenced by the dietary treatments and ranged from 0.6 to 1.1 %.
2.2.4. Conclusions on water binding capacity of meat
Among the eleven studies considered, only three (1, 2 and 3) in chicken breast fillets showed some
significant effect of dietary supplementation with selenium on the water binding capacity of meat
(Tables 29 and 30). In study 1, neither drip loss (after chilling meat for 1 or 2 days) nor cooking losses
(in meat chilled for one or seven days) were affected by the dietary selenium supplementation.
However, the cooking losses measured in meat frozen for seven days were significantly influenced by
selenium supplementation, resulting in lower cooking losses in breast meat from the intermediate and
the high Sel-Plex® groups (0.3 and 0.4 mg Se supplementation/kg feed) compared to the selenite group
(0.3 Se supplementation/kg feed). Studies 2 and 3 were carried out by the same authors. In study 2, the
authors found that selenium supplementation had no effect on the drip loss of the carcass and on
moisture, water holding capacity and expressible moisture of breast fillets; however, drip loss in
breasts from the unsupplemented treatment was lower than in breasts from the inorganic selenium
treatment (0.3 mg Se supplementation/kg feed) and similar to breasts from the organic selenium
treatment (0.3 mg Se supplementation/kg feed). In the study 3, concerning meat water binding
parameters measured in breast tissue (moisture, water holding capacity, expressible moisture, drip loss
and cooking losses), selenium supplementation only affected expressible moisture, which was higher
in the treatments supplemented with selenium from Sel-Plex®. Thus, the results from studies 2 and 3
show that selenium supplementation, regardless the source, does not improve the water binding
capacity of breast; in addition inconsistencies with respect to significant effects of selenium from
selenite or Sel-Plex® were observed.
The FEEDAP Panel concludes that the supplementation with selenium, regardless of the selenium
source (Sel-Plex® or sodium selenite), had no positive effect on the water binding capacity of meat.
3.
Consumer safety
The safety of selenium from Sel-Plex® for the consumer was assessed by the FEEDAP Panel in 2006.
Since (i) with the present application a comprehensive data set on selenium deposition in edible tissues
and products from Sel-Plex® administered to animals is available, and (ii) a recent report on long-term
dietary exposure to selenium in young children living in different European countries (EXPOCHI)
(EFSA, 2010) indicates a selenium intake which may be near or above the UL, a re-assessment of the
consequences for the consumer from feeding Sel-Plex® to animals is considered necessary.
3.1.
Methodology
As a basis to estimate the selenium intake, the data described in section 2.1 (Impact on the nutritional
value of animal products) are used. Several scenarios have been developed for calculations of
consumer exposure. Scenario I is based on the standard food basket given in Regulation (EC) No
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Sel-Plex® as zootechnical additive for all species
429/2008 for adults. Scenarios II and III use consumption data from the Comprehensive European
Food Consumption Database (EFSA, 2011). The data is derived from consumers only and refer to the
95 percentile. Scenario II considers adults and scenario III children aged 1-3 years (toddlers). In all
scenarios, the selenium intake from edible tissues and products is based on values from the control
groups with marginal or deficient selenium supply. In a second step, the consumer exposure is
calculated for products and tissues from animals with about 0.2 mg Se/kg diet from sodium selenite.
Steps three, four and five consider tissues and products from animals fed diets supplemented with 0.1,
0.2-0.26 and 0.3-0.35 mg Se/kg from Sel-Plex®. The selenium concentration of food from animals
with selenium supply is derived from the factors giving the relative potency of selenium sources and
doses (see 2.1.4). The outcome is compared with the UL for selenium set by the Scientific Committee
on Food (EC, 2000) (adults: 300 µg/day, children of the age group 1-3 years: 60 µg/day).
The selenium concentrations in meat, liver, and kidney provided in the studies are expressed in terms
of dry matter concentration. To adjust these data to the requirements of food baskets, they have been
converted to fresh matter concentrations. Fresh matter data were taken from foodstuff tables published
by Souci et al. (2008); the DM percentages are for meat from cattle 35, from poultry and lambs 26,
from kids (calf value) 24, for liver 30, for kidney 23, for egg albumen and egg yolk 13 and 50,
respectively (see also Table 13). In all scenarios, fat is not considered because of lack of data for its
selenium content. However, the selenium content of body lipids is considered low and therefore it is
expected to make a negligible contribution to the estimate of consumer safety assessment. In Scenario
III (toddlers), the consumption of liver and kidney is also not considered because of negligible
quantities consumed.
The FEEDAP Panel considers that the figures provided by the applicant for selenium in milk of
control animals (without additional selenium supplementation to the feed) appear high (0.019 mg/L)
compared to European values. Based on data of a meta-analysis (15 EU-based experiments and two
trials from non-EU countries with a similar low selenium background in feeds) from Ceballos et al.
(2009) a representative figure of 0.010 mg Se/L milk from cows fed diets without selenium
supplementation under EU farming conditions was derived. The FEEDAP Panel modified therefore
Scenarios II and III to Scenarios IIa and IIIa using the European data while maintaining the relative
potency factors for sources of selenium.
For background exposure of adults, the value already used in a previous opinion (EFSA, 2006) was
used (60 µg per day). The EXPOCHI (EFSA, 2010) contains - among others - estimates of the
selenium exposure of children of 1, 2 and 3 years of age from 10 studies giving a total of 24 values for
the age group 1 to 3 years. The P50 exposure calculated as a mean from lower bound values (the upper
bound values may include consumption data of food of animals administered organic selenium in
feedingstuffs) amounts to 2.8 µg/kg bw, the P95 value to 5 µg/kg bw. Another calculation in the same
report identified three food groups, which contribute most to total selenium exposure. Data from 15
studies for the intake of cereals and vegetables considered representative for the background intake
from non-animal origin sum up to 30% of selenium exposure from these two food groups. The
background intake is calculated following the above assumptions with 10 (P50) and 18 (P95) µg/day.
Since consumption data of scenarios II and III are not fully additive (they consider consumers only)
and already give a conservative estimate, data resulting from the P50 exposure (10 µg/day) are taken
as background exposure of children of 1 to 3 years of age.
3.2.
Assessment
The tabulated data of the different scenarios on selenium exposure can be found in Appendix D.
Scenario I (standard food basket) showed a selenium intake of 221 µg/person (74 % of the UL) for
food from sodium selenite fed animals. Increasing supplementation levels of 0.1, 0.2-0.26 and 0.3-0.35
mg Se from Sel-Plex® /kg diet resulted in an exposure of 253, 301 and 355 µg per adult person,
corresponding to 84, 100 and 118 % of the UL, respectively. However, the standard food basket is not
considered sufficiently accurate to reflect a risk arising from the intake of a nutrient or micronutrient.
EFSA Journal 2011;9(4):2110
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Sel-Plex® as zootechnical additive for all species
Scenario II resulted in a selenium intake of 149 µg/person (50 % of the UL for adults) for food from
sodium selenite application to animals. The corresponding values for the three selenium levels from
Sel-Plex® were 180, 216 and 257 µg/person (60, 72, and 86 % of the UL), respectively. Considering
also the background selenium exposure, the cumulated selenium intake after administration of 0.30.35 mg Se from Sel-Plex® /kg diet (317 µg/day) is marginally above (by 6 %) the UL for adults (300
µg/day). However, the modified Scenario IIa with lower selenium concentration in milk of
unsupplemented dairies showed for consumers of food from the highest selenium supplementation
from Sel-Plex® a selenium intake of 221 µg/day, which is together with the background intake below
the UL (281 µg = 94 % of the UL).
Scenario III estimated the selenium intake of children (1-3 years of age) after administration of 0.2 mg
Se/kg feed from sodium selenite with 48 µg (80 % of the UL). The corresponding figures for 0.1, 0.20.26 and 0.3-0.35 mg Se/kg diet from Sel-Plex® are 66, 78 and 90 µg/child, respectively, milk being
the main contributor. The intermediate and the high seleniumn supplementation level of Sel-Plex®
resulted in intake figure for toddlers that are above the UL (130 and 150 % of the UL, respectively).
The modified Scenario IIIa identified selenium exposure levels of toddlers after the use of 0.2 to 0.26
and of 0.3 to 0.35 mg Se/kg feedingstuffs from Sel-Plex® with 56 µg and 65 µg per day, respectively.
The intermediate selenium supplementation from Sel-Plex® resulted in an intake below the UL (93 %),
the high supplementation level to an intake above the UL (108 %). However, Scenario IIIa (as
scenario III) did not take into account selenium intake from sources (e.g. cereals, vegetables) other
than food of animal origin.
Total exposure of children according to scenario IIIa after the use of 0.1, 0.2 to 0.26 and 0.3 to 0.35
mg Se/kg feedingstuffs from Sel-Plex® was 56, 66 and 75 µg Se/day, respectively. These figures (i)
identify 0.1 mg supplemental selenium per kg diet from Sel-Plex® as safe for children and (ii) would
preclude the further use of Sel-Plex® at the supplementation level of 0.3 (and more) mg Se/kg
feedingstuffs (daily selenium intake 125 % of the UL).
For the intermediate dose range (0.2 to 0.26 mg Se/kg feed from Sel-Plex®), the calculated intake is
also numerically above the UL (110 %). However, considering (i) the above dose range (a 30%
difference occurs between 0.20 and 0.26 mg), (ii) the absolute dimension of the estimated excess (6 µg
more than 60 µg), and (iii) the inherent conservativeness of the overall estimate, the FEEDAP Panel
concludes that a maximum supplementation level of 0.2 mg Se/kg feed from Sel-Plex® would be
unlikely to result in a health risk for children of the age group 1-3 years (toddlers).
4.
Post-Market Monitoring
No risks associated with the use of the product are foreseen. It is considered that there is no need for
specific requirements for a post-market monitoring plan other than those established in the Feed
Hygiene Regulation16 and Good Manufacturing Practice.
CONCLUSIONS
Concerning the impact on nutritional composition, the FEEDAP Panel concludes that the increase in
selenium of food of animal origin observed after supplementation of feed with selenium is considered
as a direct consequence of the nutritional property of selenium-containing additives and not unique to
Sel-Plex® - effects typical of a nutritional additive.
Concerning the impact on product quality, the FEEDAP Panel concludes that (i) results do not provide
evidence that dietary supplementation with Sel-Plex® would further reduce lipid oxidation in meat or
improve colour of animal products in comparison with inorganic selenium and (ii) the
supplementation of feed with selenium, regardless of the selenium source (Sel-Plex® or sodium
selenite), has no effect on the water binding capacity of meat.
16
OJ L 35, 8.2.2005, p. 1.
EFSA Journal 2011;9(4):2110
29
Sel-Plex® as zootechnical additive for all species
Exposure of adults was below the UL (300 µg/day) for all selenium supplementation levels and both
selenium sources. For children the likely exposure after consuming milk, meat and eggs from animals
treated with 0.2-0.26 and 0.3-0.35 mg Se/kg feed from Sel-Plex® was 56 and 65 µg/day (UL: 60
µg/day), respectively. Adding the background exposure from food of non-animal origin of 10 µg/day,
the corresponding values were slightly above the UL (110 %) and considerably above the UL (125 %),
respectively.
The FEEDAP Panel concludes that a maximum supplementation level of 0.2 mg Se/kg feed from SelPlex® would be unlikely to result in a health risk for consumers including children of 1-3 years of age,
considering (i) selenium dose range, (ii) dimension of the estimated excess and (iii) the
conservativeness of the consumption model.
GENERAL REMARKS
The FEEDAP Panel notes that there are likely no principal differences in the metabolic behavior of
selenium from different selenised yeasts (mainly SeMet) when fed to animals. Selenium deposition
from the use of these selenised yeasts as feed additives would therefore result in similar selenium
tissue and product concentrations.
The FEEDAP Panel considered different options to ensure a selenium supply to consumers which
would not exceed the ULs. The Panel dismissed (i) a reduction of the current maximum content for
total selenium in feed as well as (ii) the introduction of MRLs. Both measures imply that the selenium
background content of feed materials and its availability after ingestion is so accurately known that
calculations on the amount of a supplementation to cover the requirement and to avoid an excess of
the MRLs could be done. This is in practice not the case. The only effective measure would be a
limitation of the selenium supplementation from selenised yeasts. However, the FEEDAP Panel notes
also that at present no method suitable for official control exists to verify occurence or origin of a
potential selenium supplementation.
The FEEDAP Panel repeats a remark, which is since 2007 an element of all opinions of the Panel
related to organic forms of trace elements: the FEEDAP Panel stresses the need for analytical methods
to detect those organic compounds in feed, independent from the trace element background.
As an interim solution, the FEEDAP Panel could envisage the addition of a tracer to selenised yeasts
which would in turn allow quantification of a feed supplementation from these sources.
DOCUMENTATION PROVIDED TO EFSA
1.
Sel-Plex® Application for authorisation as zootechnical feed additive. September 2008.
Submitted by ALLTECH.
2.
Evaluation report of the European Union Reference Laboratory for Feed Additives on the
methods(s) of analysis for Sel-Plex®.
3.
Comments from Member States received through the ScienceNet.
REFERENCES
Ceballos A, Sánchez J, Stryhn H, Montgomery JB, Barkema HW, Wichtel JJ, 2009. Meta-analysis of
the effect of oral selenium supplementation on milk selenium concentration in cattle. Journal of
Dairy Science, 92, 324-342
CIE Technical Report, 2004. Colorimetry, 3rd edition. Publication 15:2004, CIE Central Bureau,
Vienna
EFSA Journal 2011;9(4):2110
30
Sel-Plex® as zootechnical additive for all species
EC (European Commission), 2000. Opinion of the Scientific Committee on Food on the Tolerable
Upper Intake Level of Selenium. Available from: http://ec.europa.eu/food/fs/sc/scf/out80g_en.pdf
EFSA (European Food Safety Authority). 2006. Opinion of the Scientific Panel on Additives and
Products or Substances used in Animal Feed on the safety and efficacy of the product SelPlex®2000 as a feed additive according to Regulation (EC) No 1831/2003. The EFSA Journal, 348,
1-40.
EFSA (European Food Safety Authority), 2008. Selenium-enriched yeast as source for selenium added
for nutritional purposes in foods for particular nutritional uses and foods (including food
supplements) for the general population. The EFSA Journal, 766, 1-42.
EFSA (European Food Safety Authority), 2009. Scientific Opinion on the substantiation of health
claims related to selenium and protection of DNA, proteins and lipids from oxidative damage (ID
277, 283, 286, 1289, 1290, 1291, 1293, 1751), function of the immune system (ID 278), thyroid
function (ID 279, 282, 286, 1289, 1290, 1291, 1293), function of the heart and blood vessels (ID
280), prostate function (ID 284), cognitive function (ID 285) and spermatogenesis (ID 396)
pursuant to Article 13(1) of Regulation (EC) No 1924/2006. EFSA Journal, 7(9): 1220.
EFSA (European Food Safety Authority), 2010. Long-term dietary exposure to selenium in young
children living in different European countries (EXPOCHI). Available from:
http://www.efsa.europa.eu/en/scdocs/scdoc/56e.htm
EFSA (European Food Safety Authority), 2011, online. The EFSA Comprehensive European Food
Consumption Database . Available from: http://www.efsa.europa.eu/en/datex/datexfooddb.htm
Fernández J, Pérez-Álvarez, JA and Fernández-López JA, 1997. Thiobarbituric acid test for
monitoring lipid oxidation in meat. Food Chemistry, 59, 345-353.
Gray JI and Monahan FJ, 1992. Measurement of lipid oxidation in meat and meat products. Trends in
Food Science and Technology, 3, 315-319.
Raharjo S and Sofos JN, 1993. Methodology for measuring malonaldehyde as a product of lipid
peroxidation in muscle tissues: a review. Meat Science, 35, 145-169.
Souci SW, Fachmann W, Kraut H, 2008. Food Composition and Nutrition Tables. Seventh edition.
EFSA Journal 2011;9(4):2110
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Sel-Plex® as zootechnical additive for all species
APPENDICES
APPENDIX A. EXECUTIVE SUMMARY OF THE EVALUATION REPORT OF THE EUROPEAN
UNION REFERENCE LABORATORY FOR FEED ADDITIVES ON THE METHOD(S) OF ANALYSIS
®17
FOR SEL-PLEX
In the current applications authorisation is sought for Sel-Plex 2000 (FAD-2009-29) and
selenomethionine (FAD-2010-44) under Article 4(1),
- under the category of 'zootechnical' functional group 4(d) 'other zootechnical additives' (for
FAD-2009-0029); and
- under 'nutritional additives' functional group 3(b), 'compounds of trace elements' (for FAD2010-0044),
according to Annex I of Regulation (EC) No 1831/2003. Specifically, authorisation is sought for the
use of selenomethionine for all animal species and categories.
The product with the trade name Sel-Plex 2000 (FAD-2009-29) is a selenium enriched inactivated
yeast (Saccharomyces cerevisiae CNCM I-3060) containing 2000 to 2400 mg total selenium / kg with
a maximum of 3% of residual inorganic selenium. At least 63% of the total organic selenium in SelPlex 2000 is selenomethionine. The product related to application FAD-2010-44 and with the trade
name Selemax 1000 and 2000 is a selenium enriched inactivated yeast (Saccharomyces cerevisiae
YSC 11111-R646) containing a minimum of 1000 and 2000 mg total selenium / kg, respectively, with
a maximum of 2% of residual inorganic selenium. At least 70% of the total organic selenium in
Selemax is selenomethionine.
Both products are intended to be incorporated in the form of premixtures to obtain a maximum dosage
of 0.5 mg total selenium /kg in complete feedingstuffs, to comply with legal requirements. None of the
Applicants proposed minimum doses.
Both Applicants submitted a single laboratory validated and further verified methods developed by the
same laboratory, internationally reputed in the field of selenium speciation.
For the determination of selenomethionine in the feed additives the Applicants proposed a triple
proteolytic digestion/extraction followed by anion-exchange high performance chromatography
coupled to ICPMS (HPLC-ICPMS). The following performance characteristics were presented:
- a recovery rate (Rrec) ranging from 94 to 103%;
- a relative standard deviation for repeatability (RSDr) ranging from 1 to 4%; and
- a relative standard deviation for intermediate precision (RSDip) ranging from 5 to 8%.
Based on the performance characteristics presented, the EURL recommends for official control the
single laboratory validated and further verified HPLC-ICPMS method, submitted by the Applicants, to
determine selenomethionine in the feed additives.
For the determination of total selenium in the feed additive, premixtures and feedingstuffs the
Applicants proposed a microwave digestion using nitric acid and hydrogen peroxide (HNO3/H2O2)
followed by inductively coupled plasma mass spectrometry (ICPMS). The following performance
17
The EURL produced a combined report for the additives Sel-Plex 2000 and Selemax 1000/2000
EFSA Journal 2011;9(4):2110
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Sel-Plex® as zootechnical additive for all species
characteristics were reported for the feed additives: Rrec ranging from 94 to 95%; and RSDip ranging
from 2 to 7%.
Based on the performance characteristics presented, the EURL recommends for official control the
single laboratory validated and further verified ICPMS method, submitted by the Applicants, to
determine total selenium in the feed additives.
However, for the determination of total selenium in feedingstuffs, the EURL investigated the former
ring trial validated VDLUFA method, recently adopted as CEN standard prEN 16159:2010, based on
by hydride generation atomic absorption spectrometry (HGAAS). The following performance
characteristics are reported:
- a relative standard deviation for repeatability (RSDr) ranging from 3.4 to 10%;
- a relative standard deviation for reproducibility (RSDR) ranging from 15 to 23%; and
- a limit of quantification of 0.125 mg/kg, clearly below the legal limit of 0.5 mg Se /kg feed.
For the determination of total selenium in premixtures, the EURL suggests diluting the premixtures
samples with ground cereal feed and applying the abovementioned HGAAS method.
Based on the performance characteristics presented, the EURL recommends for official control, the
ring trial validated CEN method (prEN 16159:2010) for the determination of total selenium in
premixtures and feedingstuffs.
Further testing or validation of the methods to be performed through the consortium of National
Reference Laboratories as specified by Article 10 (Commission Regulation (EC) No 378/2005) is not
considered necessary.
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Sel-Plex® as zootechnical additive for all species
APPENDIX B. SAFETY FOR TARGET SPECIES. TOLERANCE STUDY IN LAMBS
A tolerance study conducted in United Kingdom (2005) was performed with 32 lambs (Texel x
Suffolk) of 4 kg body weight and ca. 7 days of age, for 91 days.18 The animals were allotted to two
groups with 16 individuals each: a control group without selenium supplementation to milk replacer
and pelleted complete diet (0.13/0.14 mg Se/kg DM, milk replacer/pelleted diet) and a treated group
with 5 mg selenium supplementation from Sel-Plex®/kg milk replacer and pelleted complete diet
(5.94/6.63 mg Se/kg DM, milk replacer/pelleted diet). During a pre-experimental period, from birth to
the start of the experiment, the treated group was fed feed with increasing selenium levels up to the
intended selenium concentration at the start of the experiment.
Animal performance (feed intake, body weight, feed to ratio ratio (FCR)), routine biochemistry in
blood (ALT, AST, alkaline phosphatase (ALP), creatine phosphokinase (CPK), glutamate
dehydrogenase (GLDH), lactate dehydrogenase (LDH), GSH-Px, albumin. globulin, total protein,
glucose, urea, phosphate and total selenium and SeMet), haematology (Hb, RBC, PCV, Ht, MCV,
MCH, platelets, WBS, white blood cell differentials) and tissue selenium concentration (in heart, liver,
kidney, muscle, perirenal fat and wool) were measured. Statistical differences were determined by
analysis of variance (ANOVA). Two animals, one from the control group and one from the treated
group, suffered from acute urolithiasis and were subsequently sacrificed on veterinary advice; one
animal of the control group died because of bloat.
Animal performance parameters did not show any significant difference (control ADG: 416 g, FCR:
2.3 kg DMI/kg gain). Whole blood selenium was higher in the treated animals (P< 0.001) as well as
serum creatine phosphokinase (p < 0.1). Lower platelet counts were observed in the treated group (P=
0.020). Selenium concentrations in all tissues, organs and products examined showed significantly (P<
0.001) higher levels in the treated group compared to control group.
The FEEDAP Panel concludes that no adverse effects of feeding selenium overdose from Sel-Plex®,
equivalent to a 10-fold selenium overdose compared to the authorised maximum total selenium
content for 13 weeks to lambs became evident. The findings are not in line with earlier observations
on poultry, pigs and bovines, which responded to such an overdose by depression of performance
parameters, indicating a narrow margin of safety for the maximum content of dietary selenium.
However, 0.5 mg selenium from Sel-Plex®/kg diet is considered safe for all animal species.
18
Technical Dossier, Section III, Annex III 3-1-8
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Sel-Plex® as zootechnical additive for all species
APPENDIX C. DESCRIPTION OF THE EFFICACY STUDIES SUBMITTED IN THE DOSSIER
1
Chickens for fattening
The study was conducted with 900 day-old male chickens for fattening Ross 308, during 42 days.19
The birds were randomly assigned to five groups (9 pens, 20 birds/pen in each group) according to
dietary treatments. Treatments consisted of a control unsupplemented diet, a diet supplemented with
selenium dose of 0.3 mg/kg from sodium selenite, and three diets supplemented with selenium 0.2, 0.3
and 0.4 mg/kg from Sel-Plex®. Supplementation of dietary selenium was analytically confirmed.
Animal performance (body weight, feed intake, mortality), feather scores, carcass yield and quality
and tissue selenium concentration were measured. Nine breast muscle samples per treatment were
collected and used in analysis of parameters investigated. Selenium was analysed in the breast
samples. TBARS values were analysed in muscle chilled for one and seven days at 4 ºC. Colour (L*,
a*, b*) was measured in muscle chilled for one day at 4 ºC. Drip loss as % weight loss was determined
in muscle after chilling for 24 and 48 h at 1 to 5 ºC. Cooking loss was measured in muscle chilled for
one and seven days and on muscle frozen for seven days by placing the meat packed in polythene bags
in a water bath at 70 oC for 60 min. Chilling and freezing temperatures applied were 4 oC and -20 oC,
respectively. Frozen samples were thawed at 4°C for use about 24 hours prior to cooking.
Overall mortality ( 13 birds per treatment) was not related to treatments. Body weight gain was not
affected by treatments. Whereas feed intake and feed to gain ratio of birds fed diets supplemented with
the selenium dose of 0.3 mg/kg from selenite and 0.2 mg/kg from Sel-Plex® were similar, these values
were higher (P<0.05) than those of birds fed diets enriched with selenium doses of 0.3 and 0.4 mg/kg
from Sel-Plex®. Increasing additions of selenium from resulted in progressive reductions in feed to
gain ratio, with birds receiving 0.4 mg/kg reaching its lowest value (P<0.05).
2
Chickens for fattening
The experiment (Downs et al., 2000) was conducted with 900 chickens for fattening (breed not
specified) of 0 days of age and lasted 49 days.20 The birds were divided into three groups with evenly
distributed sexes (ten pens and 30 birds/pen in each treatment), and fed according to dietary
treatments. Treatments consisted of control unsupplemented diet and diets supplemented with a
selenium dose of 0.3 mg/kg from sodium selenite or Sel-Plex®. Supplementation of dietary selenium
was analytically confirmed. Zootechnical performance (body weight and feed conversion) was
recorded. Chickens were slaughtered at the end of the experiment. After slaughter, breast fillets (M.
pectoralis major) were collected and used to study the effect of selenium supplementation on water
binding capacity of meat. Tissue moisture by drying, water holding capacity (according to Barbut,
1993) and expressible moisture by centrifugation (Earl et al., 1996) were measured in breast fillets.
Drip loss of carcass and breast fillets were determined after 18 h of chilling at 4 oC. The data were
partly statistically analysed.
Mortality (11.6, 9.1 and 14.4 % in the three groups, respectively) was not related to treatments. The
zootechnical performance was not affected by treatments (control bw 2.94 kg and feed to gain ratio
1.92 g/g).
3
Chickens for fattening
This trial has been evaluated by EFSA in the former Sel-Plex® opinion (EFSA, 2006). The experiment
(Downs et al, 2000) used the identical protocol as in study 2.21 It was conducted with 900 chickens for
19
Technical Dossier, Section IV, Vol. 3, Annex 4-4-4
Technical Dossier, Section IV, Vol. 3, Annex 4-4-6
21
Technical Dossier, Section IV, Vol. 3, Annex 4-4-7
20
EFSA Journal 2011;9(4):2110
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Sel-Plex® as zootechnical additive for all species
fattening (breed not specified) of 0 days of age and lasted 49 days. The birds were divided into three
groups with evenly distributed sexes (ten pens and 30 birds/pen in each treatment). Birds were fed
according to the dietary treatments. The treatments consisted of a control unsupplemented diet, and
diets supplemented with a selenium dose of 0.3 mg/kg from sodium selenite or Sel-Plex®.
Supplementation of dietary selenium was analytically confirmed. Zootechnical performance (body
weight and feed conversion) was recorded. Chickens were slaughtered at the end of the experiment.
After slaughter, breast fillets (M. pectoralis major and M. pectoralis minor) were collected and used to
study the effect of selenium supplementation on water binding capacity of meat. Tissue moisture,
water holding capacity, expressible moisture and breast drip loss were determined as described in the
previous study. Cooking losses were determined by cooking the breast fillets at 177 oC (convection
oven) to an internal temperature of 77ºC. Only part of the data were statistically analysed.
Mortality (14.0, 13.3 and 9.7 % in the groups, respectively) was not related to treatments. The
zootechnical performance was not affected by treatments (control bw 2.88 kg and feed to gain ratio
1.87 g/g). Due to lack of statistical analysis, selenium deposition data in muscles could not be
considered.
4
Chickens for fattening
This trial has been evaluated by EFSA in the former Sel-Plex® opinion (EFSA, 2006). Data from this
study could not be considered due to insufficient experimental design (no analytical confirmation of
selenium supplementation).22
5
Chickens for fattening
This trial has been evaluated by EFSA in the former Sel-Plex® opinion (EFSA, 2006). Data from this
study could not be considered due to insufficient experimental design (no analytical confirmation of
selenium supplementation).23
6
Chickens for fattening
This study could not be considered due to inadequate experimental design.24
7
Laying hens
This trial has been evaluated by EFSA in the former Sel-Plex® opinion (EFSA, 2006). The study was
conducted on 96 Single Comb White Leghorns hens (age 45 weeks, initial bw 1.89 kg) which were
pre-treated with an unsupplemented selenium diet (selenium 0.06 mg/kg feed) for six weeks. 25 Then
the hens were assigned to two selenium supplementation treatments (0.3 mg/kg feed) either from
sodium selenite or from Sel-Plex® for five weeks. Two different diets due to different fat source were
applied in each treatment. No negative control was included in trial. Birds (48 per treatment) were
placed in cages/replicates with six hens in each. Supplementation of selenium to diets was analytically
confirmed. Zootechnical performance was recorded. Eggs for selenium analysis were collected weekly
in 2-day collection periods; additionally shell breaking strength and egg composition (cholesterol,
vitamin and fatty acid concentration) were measured.
No health problems appeared. Zootechnical performance was not affected by treatments (mean feed
intake 116.5 g/hen/day, laying rate 85.8 %, egg mass to feed ratio 0.45 g/g).
22
Technical Dossier, Section IV, Vol. 1, Annex 4-4-9
Technical Dossier, Section IV, Vol. 3, Annex 4-4-8
24
Technical Dossier, Section IV, Vol. 3, Annex 4-4-5
25
Technical Dossier, Section IV, Vol. 3, Annex 4-6-2
23
EFSA Journal 2011;9(4):2110
36
Sel-Plex® as zootechnical additive for all species
8
Laying hens
This trial has been evaluated by EFSA in the former Sel-Plex® opinion (EFSA, 2006). The study was
conducted on 126 Single Comb White Leghorns laying hens (34 weeks of age, initial bw 1.54 kg)
which were, after a pre-treatment period with an unsupplemented selenium diet (selenium 0.06 mg/kg
feed, for 16 weeks), allotted to seven groups (3 replicates with 6 hens in each treatment).26 One group
(control) continued on unsupplemented diet and the other six treatments comprised selenium
supplementation to diets at levels 0.1, 0.2 and 0.3 mg/kg complete feed either from sodium selenite or
Sel-Plex®. Supplementation of selenium to diets was analytically confirmed. Zootechnical
performance (feed intake, body weight, egg production) was recorded. Eggs for selenium analysis
were collected during days 33 through 42 of supplementation period.
One hen died during trial. Zootechnical performance was not affected by treatments (control feed
intake 89.7 g/hen/day, laying rate 94.9 %, egg weight 53.1 g).
9
Laying hens
This trial has been evaluated by EFSA in the former Sel-Plex® opinion (EFSA, 2006). The study was
conducted on 270 Isa Brown laying hens (breeding flock, 20 weeks of age, 45 birds per treatment,
with three birds/cage) in two phases.27 The dietary treatments lasted 50 weeks and consisted of
unsupplemented treatment, a diet supplemented with selenium from sodium selenite up to intended
total selenium levels 0.35 mg/kg feed, and four diets supplemented with selenium from Sel-Plex® up
to intended total selenium level 0.23, 0.32, 0.39 and 0.45 mg/kg feed. Only phase 2 (week 50 through
70 of bird age) could be considered due to failed experimental procedure in phase 1. Supplementation
of selenium was analytically confirmed. Zootechnical performance (feed intake, body weight) was
recorded. No data on health status of birds during the supplementation period was submitted. Eggs for
selenium analysis and selenium speciation in yolk and white were collected.
Zootechnical performance was not affected by treatments (final control bw was 1.83 kg, laying rate
during phase 2 was 76.7 %). Feed intake could not be statistically assessed due to low number of
replicates (3).
10
Laying hens
The study was performed on a total 128 H&N laying hens (70 weeks of age) divided in two treatments
and housed in layer cages with 16 replicates (4 hens) per treatment.28 Hens were fed control
unsupplemented basal diet or identical diet supplemented with 0.3 mg selenium per kg from Sel-Plex®
for 4 weeks. Selenium supplementation was analytically confirmed. Zootechnical performance was
recorded. No data on health state of birds during supplementation period was submitted. Eggs for
selenium analysis (fluorometry) were collected after 4-week intake of experimental diets. The study
design did not consider a positive control group (selenite), hence the FEEDAP Panel retains the study
as no relevant for the Sel-Plex® evaluation.
Zootechnical performance was not affected by treatments (mean feed intake 118 g/hen/day, laying rate
81.4 %, egg weight 66.3 g).
11
Turkeys for fattening
The study was conducted with 216 turkey female poults of BUT8 breed, during 91 days. 29 At the age
of seven days, 24 poults were slaughtered for analysis of pre-treatment selenium levels in tissues; the
26
Technical Dossier, Section IV, Vol. 3, Annex 4-6-3
Technical Dossier, Section IV, Vol. 3, Annex 4-6-4
28
Technical Dossier, Section IV, Vol. 3, Annex 4-6-1
29
Technical Dossier, Section IV, Vol. 3, Annex 4-4-2
27
EFSA Journal 2011;9(4):2110
37
Sel-Plex® as zootechnical additive for all species
remaining 192 poults were allotted into four groups (six pens with eight birds/pen in each group). The
study lasted 91 days. Treatments consisted of a control unsupplemented diet, a diet supplemented with
selenium dose of 0.08 mg/kg DM from sodium selenite, and diets supplemented with 0.08 and 0.23
mg selenium per kg DM from Sel-Plex®. The intended total selenium levels in the three supplemented
diets were 0.26, 0.26 and 0.40 mg/kg complete feed, respectively. Supplementation of dietary
selenium was analytically confirmed. Feed intake (recorded daily on group pen basis) animal live
weights (recorded weekly), FCR (calculated on group pen basis) and feather scoring were monitored.
Blood samples for the determination of haematology and biochemistry (including erythrocyte GSH-Px
activity) parameters, selenium content (incl. selenium speciation) and T3/T4 thyroid hormones were
taken postmortem at several days. After 91 days of supplementary period the birds were slaughtered.
After slaughter, selenium was analysed (ICP-MS) in samples of muscles (M. pectoralis major, M.
gastrocnemius and M. peroneus longus), liver, kidney and heart (ICP-MS). Breast (M. pectoralis
major) and thigh (M. gastrocnemius and M. peroneus longus) muscle samples from 12 birds per
treatment were collected, cut into 20 mm steaks and individually packed into modified atmosphere
packs (O2:CO2, 75:25) and subjected to simulated retail display conditions (3 oC, 700 lux for 16
hours/day) for several days. After five days at these conditions, TBARS values and GSH-Px activity
were determined in breast and thigh samples. Colour (L*, a*, b*) was measured daily in thighs during
aging for 7 days at the retail display conditions. From a* and b*, colour saturation (chroma) and hue
angle (colour hue) were calculated. Drip loss was measured only in breast samples as the % weight
loss after 48 hours at 3 ºC.
No mortality occurred during the study. Zootechnical performance was not affected by treatments;
control average DM intake, body weight gain and feed to gain ratio were 157.5 g/day, 62.8 g/day and
2.49 kg DM/kg, respectively.
12
Turkeys for fattening
The trial started with a total of day-old 290 turkey poults of BUT8 breed.30 After week of adaptation
period on low selenium starter diet, 20 birds were slaughtered for analysis of pre-treatment selenium
levels in tissues and blood. The remaining 270 poults were allotted into five groups (three pens with
eight male birds/pen, and three pens with ten female birds/pen). Treatments consisted of an
unsupplemented control diet with selenium background 0.08 mg/kg feed, a control diet supplemented
with selenium dose 0.3 mg/kg from sodium selenite, and groups fed control diets supplemented with
0.3, 0.4 and 0.5 mg selenium from Sel-Plex® per kg. Supplementation of dietary selenium was
analytically confirmed. Pelleted diets were fed in five phases (starter, grower 1 and 2, finisher 1 and 2)
up to age 16 and 20 weeks to females and males, respectively. The study lasted 140 days. Individual
animal weights (at placement, at 4 week intervals and just prior to slaughter) and feed intake were
recorded. Blood selenium content and GSH-Px activity were determined at the ages of 7, 49, 113 (end
of the trial for females) and 140 (end of the trial for males) days. At all ages, tissue samples [heart,
kidney, spleen, liver, gizzard, thigh (M. gastrocnemius and M. peroneus longus), breast (M. pectoralis
major), fat and feather (wing)] were retained for analysis of selenium content. At the end of the trial,
after slaughter, the carcasses were hung at 4 °C for 24 hours to determine drip loss from whole carcass
(hot carcass weight - cold carcass weight, expressed as loss %). In addition, samples of breast (M..
pectoralis major) and thigh (M. gastrocnemius and M. peroneus longus) were collected at the end of
the trial for assessment of meat quality. However, the method to determine drip loss in breast and leg
muscle tissues was not reported. The performance results and blood parameters were statistically
analysed; regression analysis was used to test possible relationship between dietary selenium and bird
performance.
Overall mortality (4.1 %) was not related to treatments. Zootechnical performance was not affected by
treatments. In control females (0-112 days) feed intake, weight gain and feed to gain ratio were 28.5
30
Technical Dossier, Section IV, Vol. 3, Annex 4-4-1
EFSA Journal 2011;9(4):2110
38
Sel-Plex® as zootechnical additive for all species
kg/bird, 11.1 kg/bird and 2.6 g/g, respectively. In control males (0-140 days) feed intake, weight gain
and feed to gain ratio were 53.4 kg/bird, 19.5 kg/bird and 2.74 g/g, respectively.
13
Pheasants
The study was conducted on 216 five week old female Chinese Ringed Necked Pheasants (Phasianus
colchicus torquator) (mean initial body weight of 527 g).31 At enrollment 24 randomly selected birds
were sacrificed for an initial sample collection and remaining 192 birds were allotted to four
treatments with 48 birds in each (6 pens with 8 birds in each/treatment). The dietary treatments lasted
13 weeks and consisted on an unsupplemented selenium diet (control), a diet supplemented with 0.08
mg selenium per kg DM from sodium selenite, and two diets supplemented with 0.08 and 0.23 mg
selenium per kg DM from Sel-Plex®. Supplementation of selenium to diets was analytically
confirmed. Zootechnical performance (feed intake and live weight) was recorded. After animals
slaughtering, samples of muscle (M. pectoralis major, M. gastrocnemius and M. peroneus longus)
were collected for analysis of selenium (ICP-MS). Selenium deposition and speciation (SeMet and
SeCys) were assessed in muscle, liver, kidney, pancreas and gizzard. Breast muscle (M. pectoralis
major) was cut into three 20 mm steaks and individually packed into modified atmosphere packs
(MAP) (O2:CO2, 75:25) and subjected to simulated retail display conditions (3 ºC, 700 lux for 16
hours out of 24 hours). Colour (L*, a*, b*) was measured daily on the surface of two of the steaks
through the lidding film. From a* and b*, colour saturation (chroma) and hue angle (colour hue) were
calculated. TBARS values were measured in meat samples after 5 days at display conditions. Drip loss
was measured in carcass and breast. After slaughter, some carcasses were hung for 24 h at 2-4 °C and
drip loss was determined by the difference in g between hot carcass weight and cold carcass weight.
Drip loss was measured in breast as the % weight loss after 48 hours at 3 ºC. Glutathione peroxidase
was determined in samples of breast tissue (i) taken immediately post-slaughter and (ii) breas steaks
that had undergone five days in MAP. Data were statistically analysed.
Three birds were sacrificed due to cannibalism or breaking a limb. Zootechnical performance was not
affected by treatments (control DM intake 45.5 g/day, bw gain 343 g, and feed to gain ratio 13.30 g
DM/g).
14, 15 and 16 Pigs for fattening
Three studies with pigs for fattening have been submitted (Study 1432, 1533 and 1634). These studies
were also provided in an earlier submission and used for the assessment of Sel-Plex® as nutritional
additive (EFSA, 2005). In the current assessment, data from these studies could not be considered due
to insufficient experimental design and conduct.
In its former opinion on pig tissue deposition of selenium, the FEEDAP Panel did also not use the
individual data and based its assessment on selenium tissue deposition in pigs on a meta-analysis
carried out with this data by the applicant.
17
Dairy cows
The study was carried out on 50 multiparous Holstein-Friesian dairy cows, which received an identical
diet for one week before experimental period.35 After that, the animals were allotted to five groups,
based on average milk yield and parity, with ten cows in each, and fed five diets consisting on a TMR
of maize and grass silages with concentrate; diets differed only in the source or amount of selenium
31
Technical Dossier, Section IV, Vol. 3, Annex 4-4-3
Technical Dossier, Section IV, Vol. 3, Annex 4-5-1
33
Technical Dossier, Section IV, Vol. 3, Annex 4-5-2
34
Technical Dossier, Section IV, Vol. 3, Annex 4-5-3
35
Technical Dossier, Section IV, Vol. 1, Annex 4-1-2
32
EFSA Journal 2011;9(4):2110
39
Sel-Plex® as zootechnical additive for all species
supplemented. The background selenium content of TMR was 0.09 mg/kg DM. Concentrates for three
groups were supplemented with sodium selenite to obtain the intended selenium levels of 0.19, 0.30,
0.45 mg/kg DM of TMR, whereas concentrates for the two Sel-Plex® treatments were enriched with
selenium from Sel-Plex® up to intended total selenium levels 0.30 and 0.45 mg/kg DM of TMR,
respectively. Since selenium analysis was done in all TMR components, the actual selenium levels in
complete feed for each treatment could be estimated based on their inclusion in TMR. Zootechnical
performance (feed intake, live weight and body condition) and production parameters (milk
production and milk composition by weekly taken samples of two consecutive milkings) were
recorded. Nevertheless, production parameters for the two Sel-Plex® groups were reported only for
nine and eight cows, respectively. Biochemistry (incl. GSH-Px activity) and haematological
parameters plus levels of thyroid hormones (T3-triiodothyronine and T4-thyroxine) and selenium
levels were recorded in blood. GSH-Px and T3 in milk were also analysed. Total selenium, SeMet and
SeCys were analysed in whole blood and plasma, milk and dairy products (cheese, yogurt, cream and
butter). Data were statistically analysed.
No health problems were recorded during the study. Zootechnical performance and milk quality were
not affected by treatments; control values for DM intake, milk production, fat and energy corrected
milk yield and milk SCC were 24,0 32.1, 34.3, 34.8 kg/day and 5.2 log10/mL, respectively.
18
Dairy cows
The study was conducted on 40 Prim Holstein dairy cows (30- 86 months old) which, after a 2-week
pre-treatment period, were divided, based on average milk yield and parity, into five groups with eight
animals in each.36 The experimental period with the selenium supplementation lasted 20 weeks.
Animals were fed a TMR consisting of forages and concentrate with mineral and vitamin supplement.
The background selenium level was 0.03 mg/kg DM. Dietary treatments consisted of a control
unsupplemented diet, two treatments with diets supplemented with selenium from sodium selenite up
to intended total selenium levels of 0.30 and 0.45 mg/kg DM, and two treatments with diets
supplemented with selenium from Sel-Plex® up to intended total selenium levels of 0.30 and 0.45
mg/kg DM. Selenium supplementation was done by top-dressing of vitamin and mineral premix on
final TMR. Despite of selenium analysis was done in all TMR components, the actual selenium levels
in complete feed for each treatment could only be estimated based on their inclusion and/or selenium
dose top-dressed to TMR. Zootechnical performance (individual intakes of basal diets, production
concentrate, cow’s weight, milk yields) milk quality (fat, protein, lactose content and SCC) and health
status of animals were recorded. Total selenium was determined in milk, cheese, curd and whey; milk
was also analysed for SeMet and SeCys. Blood haematological and biochemical parameters were
analysed at day 0, 140 and 225; in addition GSH-Px, total Se, SeMet, SeCys and thyroid hormones in
blood/plasma were analysed at day 0, 28, 56, 84, 112, 140, 168. 196 and 225. Data were statistically
analysed.
One cow from group supplemented with 0.30 mg/kg DM from sodium selenite was removed due to
repeated problems with lameness. The zootechnical performance and milk quality were not affected by
treatments; control values for DM intake and milk production were 20.3 and 32.2 kg/day, respectively.
Control fat, protein and lactose milk contents were at the end of experiment 37.2, 34.0 and 53.5 g/kg,
respectively. Control milk SCC was of 9.2 x 104/mL.
19
Dairy cows
The study was conducted on 40 Italian Fresian lactating dairy cows.37 The study lasted 196 days, from
which the supplementation period was of 140 days (plus a pre- and post- unsupplemented period).
During the 2-month pre-treatment period the cows were fed an identical basal diet with selenium 0.1
36
37
Technical Dossier, Section IV, Vol. 1, Annex 4-1-3
Technical Dossier, Section IV, Vol. 1, Annex 4-1-4
EFSA Journal 2011;9(4):2110
40
Sel-Plex® as zootechnical additive for all species
mg/kg DM. After that, they were divided into five groups with eight animals in each, based on average
milk yield and parity. Cows were fed TMR consisting of forages and concentrate with mineral and
vitamin supplement. Selenium was supplemented directly into TMR via specific premix and mixed
daily. The trial protocol comprised five dietary treatments: a control group with intended selenium
level 0.10 mg/kg DM, two groups supplemented with selenium from sodium selenite up to intended
respective selenium levels 0.30 and 0.45 mg/kg DM, and two groups supplemented with selenium
from Sel-Plex® up to intended respective selenium levels 0.30 and 0.45 mg/kg DM. The experimental
period with selenium supplementation lasted 20 weeks. Selenium supplementation was analytically
confirmed and values measured were close to those calculated on base of the analysis of all TMR
components. Zootechnical performance (feed intake, body condition score, body weight) and health
status of the animals were recorded. Milk yield and composition (fat, protein, lactose, casein and urea
contents SCC), rennet coagulation properties and GSH-Px levels in milk were analysed. Total
selenium (ICP-MS), SeMet and SeCys were determined in milk and cheese. Blood haematological and
biochemical parameters - including GSH-Px and selenium in whole blood and plasma, plus selenium
speciation in pooled blood - were analysed; parameters of heat stress (reactive oxygen metabolites,
total antioxidants and thiol groups, were also analysed in milk. Data were statistically analysed;
correlation coefficients were calculated between blood, plasma and milk selenium and GSH-Px
contents with all the blood biochemical and milk parameters.
No health problems were reported during the study. In overall, the zootechnical performance was not
affected by treatments; control DM intake was 25.1 kg/day, milk production 33.2 kg/day, milk fat 3.56
%, lactose 5.03%, urea 5.5 mmol/L.
20
Dairy cows
The study was conducted on forty multiparous Holstein-Friesian dairy cows (lactation for ca 54 days,
bw 647 kg and milk production 38.1 kg/day).38 During a 2-week adaptation period cows were fed a
basal unsupplemented diet (selenium 0.16 mg/kg DM). After this, and for the following 16 weeks
cows were allotted into four groups (based on milk production, parity and bw) with ten animals in
each and fed the TMR diet either unsupplemented or supplemented with selenium either from sodium
selenite up to intended total selenium level 0.30 mg/kg DM or from Sel-Plex® up to intended total
selenium levels 0.30 and 0.45 mg/kg DM. Selenium was supplemented into diets via mineral premix
added to different blends of concentrates. Analysed selenium contents of grass and maize as forages in
TMR were 0.06 and 0.04 mg/kg, respectively. Supplemented selenium was analytically confirmed in
concentrates. Total selenium in TMRs were estimated based on diet composition and analysed
selenium content of its each component. Zootechnical performance (feed intake and live weight) and
health status (including body condition score) were recorded. Milk yield, milk composition (fat,
protein , lactose, SCC and titratable acidity) and milk keeping quality (including lactoperoxidase
analysis) were monitored; milk and cheese were further analysed for selenium (ICP-MS), SeMet and
SeCys. Haematology, blood biochemistry (including GSH-Px) and thyroid hormones were analysed;
blood was further analysed for selenium, SeMet and SeCys.
All cows remained healthy throughout the study period. Dry matter intake was not affected by
treatments (control 22.8 kg/day). There were significant (P<0.05) positive linear effects of the level of
Sel-Plex® on milk production and yields of milk fat, protein and lactose. However, the source of
selenium did not significantly affect DM intake, milk production, concentration of milk fat, protein
and lactose or the yields of these milk constituents. Somatic cell count was not affected by treatments.
No statistics were provided for selenium content in milk and cheese. Regression analysis of dietary
selenium content on total selenium content in milk was done.
21
38
Dairy cows
Technical Dossier, Section IV, Vol. 1, Annex 4-1-1
EFSA Journal 2011;9(4):2110
41
Sel-Plex® as zootechnical additive for all species
Outcomes of this study are not relevant for the product quality assessment.39
22
Cattle for fattening
A study was carried out on 32 castrated male Limousin×Holstein-Friesian cattle (average initial bw of
489 kg, age 20 months) during 20 weeks.40 After an adaptation period of 28 days (forage diet without
selenium supplementation), animals were enrolled in weekly blocks of eight animals (two animals per
treatment). The dietary treatments lasted 16 weeks and consisted on a control unsupplemented
selenium diet, a diet supplemented with 0.15 mg selenium per kg DM from sodium selenite, and two
diets supplemented with selenium doses 0.15 and 0.35 mg/kg DM from Sel-Plex®. The background
selenium level in maize silage and concentrate were 0.12 and 0.32 mg/kg DM. Selenium was
supplemented via mineral premixes added to concentrates which were subsequently mixed into TMR.
Supplementation of selenium was analytically confirmed in both concentrates and TMR. However,
due to homogeneity problems with TMR sampling (unexpectedly low analytical values of selenium)
the applicant submitted also the estimated selenium levels based on analysis of TMR components.
Zootechnical performance (feed intake and live weight) and animal health were monitored. Blood
haematology and biochemistry (including GSH-Px levels, selenium in whole blood and plasma,
selenium speciation (SeMet and SeCys) and T3-T4 circulating hormones) were analysed. After
animals were slaughtered, samples of muscle (M. longissimus dorsi and M. psoas major), heart, liver
and kidney were collected for analysis of selenium, SeMet and SeCys, and assessment of meat quality
parameters (muscle only). M. Longissimus dorsi steaks were cut into three 20 mm steaks and
individually packed into modified atmosphere packs (MAP) (O2:CO2, 75:25) and subjected to
simulated retail display conditions (3 ºC, 700 lux for 16 hours out of 24 hours). Colour (L*, a*, b*)
was measured daily on the surface of two of the steaks through the lidding film. From a* and b*,
colour saturation (chroma) was calculated. TBARS values were measured in meat samples after seven
days at display conditions. Drip loss was measured in carcass (after 24 hours at 2 °C, as the difference
between hot carcass weight and cold carcass weight, expressed as loss %) and in M. longissimus dorsi
(as the % weight loss after 48 hours at 3ºC). Glutathione peroxidase was determined in samples of the
M. longissimus dorsi (i) taken immediately post-slaughter and (ii) steaks that had undergone ten days
aging in MAP.
23
Cattle for fattening
Data from this study could not be considered due to inappropriate experimental design (no inclusion of
a selenite group). 41
24
Cattle for fattening
Outcomes of this study are not relevant for product quality assessment.42
25
Lambs
The study was carried out on fifty castrated male North CountryMule×Suffolk lambs (age 4 months,
initial bw 29.5 kg) which were allocated to five groups with ten animals in each.43 Lambs were
individually housed and fed a TMR given ad libitum. The TMR comprised maize silage and
concentrate with background selenium levels 0.13 and 0.34 mg/kg, respectively. Treatments consisted
of an unsupplemented control diet, a diet supplemented with selenium from sodium selenite up to total
39
Technical Dossier, Section IV, Vol. 1, Annex 4-1-5
Technical Dossier, Section IV, Vol. 2, Annex 4-3-8
41
Technical Dossier, Section IV, Vol. 2, Annex 4-3-9
42
Technical Dossier, Section IV, Vol. 2, Annex 4-3-7
43
Technical Dossier, Section IV, Vol. 2, Annex 4-3-1
40
EFSA Journal 2011;9(4):2110
42
Sel-Plex® as zootechnical additive for all species
intended selenium level 0.30 mg/kg TMR, and diets enriched with selenium from Sel-Plex® up to the
total intended selenium levels of 0.30, 0.4 and 0.50 mg/kg TMR. Selenium was supplemented via
minerals into concentrates and subsequently TMR was prepared by mixing of maize silage (750 g/kg
DM of TMR) and respective concentrate (250 g/kg DM of TMR). Supplementation of selenium was
analytically confirmed in both concentrates and TMR. Zootechnical performance (feed intake, live
weight) and animal health were monitored. Blood haematology and biochemistry (including GSH-Px
levels and whole blood selenium) were analysed; thyroid samples were also analysed. One animal had
to be removed from the trial due to pneumonia. After the supplementation period (16 weeks) lambs
were slaughtered and samples of muscles (M. psoas major and M. Longissimus thoracis), liver,
kidney, heart, hoof and wool were collected to analyse selenium, SeMet and SeCys. Longissimus dorsi
steaks were cut into three 20 mm steaks and individually packed into MAP (O2:CO2, 75:25) and
subjected to simulated retail display conditions (3ºC, 700 lux for 16 hours out of 24 hours). Colour
parameters (L*, a*, b*) were measured daily on the surface of two of the steaks through the lidding
film; from a* and b*, colour saturation (chroma) was calculated. TBARS values were measured in
meat samples after seven days at display conditions. Drip loss was measured in carcass and M.
longissimus thoracis. After slaughter, the carcasses were refrigerated for 24 hours at 2 °C and drip loss
was determined by the difference between hot carcass weight and cold carcass weight, expressed as
loss %. Drip loss was measured in M. longissimus dorsi as the % weight loss after 48 hours at 3ºC.
Glutathione peroxidase was analysed in M. longissumus thoracis from (i) samples taken immediately
post slaughter and (ii) samples taken from steaks that had undergone 10 days aging in MAP.
Dry matter intake (control 2.2 kg/day) was not affected by treatments. Although feed to gain ration
was not affected by treatments but in general it was poor due to advanced age of animals (control
13.97 kg DM intake/kg gain). Total body weight gain was significantly higher in selenite given lambs
than in control group.
26
Lambs
The study was conducted on 48 Apennine lambs of both genders (initial age ca. 30 days, bw 12.8 kg)
during 11 weeks.44 The experiment was conducted in block design (one block of animals with four
animals per each treatment was enrolled weekly). Animals were randomly allocated into four groups,
each one with equal numbers of males and females, with four animals/pen and three pens/treatment.
During the supplementation period (63 days), lambs were fed TMRs which were either selenium
unsupplemented (with background selenium level of 0.13 mg/kg DM) or supplemented with selenium
from sodium selenite up to total intended selenium level 0.30 mg/kg DM) or with selenium from SelPlex® up to total intended selenium levels 0.30 and 0.45 mg /kg DM. Selenium was supplemented via
mineral premixes added to concentrates which were subsequently mixed into TMR. Supplemented
selenium was analytically confirmed in TMR. Zootechnical performance (live weight, feed intake) and
animal health were monitored. Blood haematology and biochemistry (including GSH-Px levels,
selenium in whole blood and plasma, and T3-T4 circulating hormone levels) were analysed. In
addition selenium speciation (SeMet and SeCys) was analysed in blood. After slaughter, samples of
muscle (M. longissimus dorsi), and tissues (heart, liver, kidney) were collected for analysis of
selenium (ICP-MS), SeMet and SeCys. Kidney fat and wool were also analysed for total selenium.
The carcasses were stored in a ventilated cold room at 4 °C for 24 hours; subsequently carcass drip
loss (hot carcass weight - cold carcass weight, expressed as loss %) and meat quality parameters in M.
longissimus dorsi (TBARS values, colour, and drip and cooking loss) were determined. Meat drip loss
(%) was calculated after storage for 24 hours at 4 ºC. Cooking loss (%) was calculated after cooking in
bags to an internal temperature of 70°C. Meat was packed and subjected to simulated retail display (16
hours of light/day) at 4°C for nine days; on these samples, TBARS values and colour (L, *a*, b*) were
determined at 0, 3, 6 and 9 days. From a* and b*, colour saturation (chroma) and hue angle (colour
hue) were calculated.
44
Technical Dossier, Section IV, Vol. 2, Annex 4-3-3
EFSA Journal 2011;9(4):2110
43
Sel-Plex® as zootechnical additive for all species
Overall health state of animals was good, only one animal died due to acute nephritis and lung edema.
Growing performance was not influenced by treatment nor were there differences between selenium
levels or sources (mean bw gain 166 g/day). Similarly, feed intake (mean 901 g/day) and feed to gain
ratio (mean 5.6 kg/kg) did not differ between treatments.
27
Lambs
The study was conducted on 60 home bred female North Country Mule cross Suffolk lambs in a
randomised complete block design, during 25 weeks.45 At birth lambs were given 140 ml of
collostrum, removed from dam and fed a milk replacer up to age ca. six weeks (mean bw 19.3 kg)
when were assigned to one group per treatments (12 lambs per treatment, 3 lambs/pen). During the
supplementation period the animals were fed an identical TMR and concentrate. The background
selenium levels in maize, soy bean and ground wheat were 0.03, 0.32 and 0.06 mg/kg DM. Treatments
were: control, diets supplemented with selenium from sodium selenite up to total intended selenium
levels 0.30 and 0.45 mg/kg DM, and diets enriched with selenium from Sel-Plex® up to the total
intended selenium levels 0.30 and 0.45 mg /kg DM. Selenium was supplemented to diets via mineral
premixes added to concentrates which were subsequently mixed into TMR. Supplementation of
selenium was analytically confirmed in both concentrates and TMR. Zootechnical performance (feed
intake and live weight) and animal health were monitored. Blood haematology and biochemistry
(including GSH-Px levels, selenium in whole blood and plasma and T3-T4 circulating hormones) were
analysed. At the end of the trial total antioxidants and d-ROM’s were analysed in blood. At the end of
the trial, animals were slaughtered and samples of muscle (M. longissimus thoracis) were collected for
assessment of meat quality parameters. Selenium was analysed in muscle (M. longissimus dorsi and
M. psoas major), heart, liver and kidney. Selenium speciation was done in muscle and kidney (ICPMS). M. longissimus dorsi steaks were cut into three 20 mm steaks and individually packed into
modified atmosphere packs (O2:CO2, 75:25) and subjected to simulated retail display conditions (3 ºC,
700 lux for 16 hours out of 24 hours). Colour (L*, a*, b*) was measured daily on the surface of two of
the steaks through the lidding film. From a* and b*, colour saturation (chroma) and hue angle (colour
hue) were calculated. TBARS values were measured in meat samples after 10 days at display
conditions. Drip loss was measured in carcass (after 24 hours at 2 °C, as the difference between hot
carcass weight and cold carcass weight, expressed as loss %) and in M. longissimus dorsi (as the %
weight loss after 48 hours at 3ºC); however, the results reported for meat drip loss were erroneous.
Glutathione peroxidase was determined in samples of the M. longissimus dorsi (i) taken immediately
post-slaughter and (ii) steaks that had undergone ten days in MAP.
Five lambs had to be removed due to health problems which were not related to treatments
(inappetance, lameness, spinal tumor and pneumonia). Zootechnical performance was not affected by
treatments (control DM intake 1.04 kg/day, total bw gain 24.6 kg, feed to gain ratio 5.70 kg DM/kg).
28
Lambs
Outcomes of this study are not relevant to a meat/product quality assessment.46
29
Kids
Fifty male kids (Alpine Chamoisée breed; 24 h after birth, 0.23 mg selenium (sodium selenite) were
administered i.m.) of an age of 19 to 32 days (6 to 14 kg bw, average 10 kg) were distributed to five
groups with ten animals per cage (no replicate on a cage basis).47 The treatments consisted of a control
group, a group supplemented with selenium from sodium selenite and three treatment groups with
45
Technical Dossier, Section IV, Vol. 2, Annex 4-3-4
Technical Dossier, Section IV, Vol. 2, Annex 4-3-2
47
Technical Dossier, Section IV, Vol. 2, Annex 4-3-5
46
EFSA Journal 2011;9(4):2110
44
Sel-Plex® as zootechnical additive for all species
increasing selenium supplementation from Sel-Plex®, so that after one week adaptation period diets
with intended total selenium of 0.1, 0.3, 0.3, 0.4 and 0.5 mg Se/kg were fed for a total of 16 weeks.
Diet from week 3 to week 8 of kid’s age consisted on milk replacer (0.12 mg Se/kg with manual
addition of selenium sources according to treatments) and unsupplemented concentrate, the latter one
was consumed at negligible levels. From age of eight weeks kids were fed a control unsupplemented
concentrate or a concentrate diet supplemented with sodium selenite or Sel-Plex® up to the intended
levels plus hay ad libitum (<15 µg Se/kg). Supplementation of selenium to both milk replacer and
concentrate was analytically confirmed. The study was performed in two consecutive runs (first run
with both control groups and the low Sel-Plex® group, second run two weeks later with the two higher
Sel-Plex® groups).
Animal performance parameters (feed intake, live weight and animal health) were recorded. Blood
samples were taken for haematology and routine biochemistry, including selenium in whole blood and
plasma at start of the study, then at 4-week intervals and at 1 day before slaughter. After slaughter (24
to 39 kg bw), samples of muscle tissue from longissimus dorsi and longissimus lumborum from both
sides of carcass were collected 24 hours post mortem. The samples from the left side were
immediately used to analyse TBARS and colour, while the samples from the right side were
individually packed into modified atmosphere packs (O2:CO2, 75:25) and subjected to simulated retail
display conditions (4oC, 600 lux) for nine days. Ten days after slaughter the packs were opened and
meat analysed for TBARS content and colour again. Carcass drip loss was measured by the difference
between hot weight (after slaugther) and cold weight (after 24 at refrigeration at 2 ºC), expressed as
loss %. Total selenium was determined in liver, muscle, heart, kidney and hair (in three pooled
samples/tissue, by ICP-MS); selenium speciation was carried out in heart, liver, kidney and muscle
(one pooled sample/tissue, by HPLC ICP-MS).
No mortality occurred during the trial, one kid in the high Sel-Plex® group did not consume the
concentrate and was excluded from trial evaluation. Diseases (digestive (about two third of all cases),
respiratory diseases) had a frequency of about two to four cases per ten animals and were not
treatment related. Due to weaknesses in conducting the trial and the inconsistencies in reporting data,
the zootechnical parameters were not considered.
30
Dairy sheeps
Fifty 2-3 parity twin-rearing Greyface lactating ewes were fed an identical basal diet (choped hay and
concentrate) without selenium supplementation for two weeks.48 This was followed by a 16-week
supplementation period consisting on a lactation phase (nine weeks) and post lactation phase (seven
weeks); subsequently, a 12-week withdrawal period completed the trial. During the experimental
period animals were allocated to five treatments with ten ewes in each. Treatments were: a control
group, without selenium supplementation, a group supplemented with selenium from sodium selenite
up to the intended total selenium level 0.30 mg/kg feed, and three groups supplemented with selenium
from Sel-Plex® up to the intended total selenium levels 0.30, 0.40 and 0.50 mg/kg feed, respectively.
Selenium supplementation to concentrates was analytically confirmed. Hay intake was recorded but its
selenium content was not analysed. Zootechnical performance (feed intake, live weight) and health
status (including body condition score) of ewes and lambs were monitored. Milk yield (via the
oxytocin test), milk composition (fat, protein, lactose, urea, pH, Bacterial cell count, somatic cell
counts and titratable acidity) and milk keeping quality (including lactoperoxidase analysis) were
monitored; milk was further analysed for selenium (ICP-MS), SeMet and SeCys. Haematology, blood
biochemistry (including GSH-Px) and thyroid hormones were analysed; blood was further analysed
for selenium, SeMet and SeCys. Selenium was also analysed in wool. Data were statistically analysed.
Animals were in overall good health status except of one ewe from the group receiving 0.50 mg Se/kg
feed from Sel-Plex® successfully treated for mastitis and one ewe from the group receiving 0.40 mg
Se/kg feed from Sel-Plex® which had to be sacrificed due to Jaagsiekte disease. Overall zootechnical
48
Technical Dossier, Section IV, Vol. 1, Annex 4-2-3
EFSA Journal 2011;9(4):2110
45
Sel-Plex® as zootechnical additive for all species
performance was not affected by treatments (control body weight 63.8 kg, hay intake 2.18 kg/day,
milk production 308 ml/4 hours). Control milk protein, fat and lactose were 4.18, 7.79 and 4.89 %,
respectively. Mean litter body weight gain was significantly suppressed in the group given feed with
lowest selenium supplementation level from Sel-Plex®.
31
Dairy goats
Thirty-two Murciano-Granadina dairy goats (7 primiparous and 25 multiparous, mean bw of 45.2
kg).49 The experiment lasted 210 days, including three periods: (1) two weeks of unsupplementation,
(2) 16 weeks of supplementation and (3) 12 weeks of unsuppementation “washing out“. Aproximately
at week 3 of lactation anímals were fed for two weeks an identical diet without selenium supplement.
After that they were allocated into four groups with eight goats in each according to treatments with
selenium supplementation (control, as basal unsupplemented diet, diet supplemented with selenium
from sodium selenite up to total selenium level 0.3 mg/kg complete feed, diets supplemented with
selenium from Sel-Plex® up to total selenium level 0.3 and 0.45 mg/kg complete feed, respectively).
Diet consisted of forage (65% tall fescue hay and 35% pelletized alfalfa hay) and concentrate.
Selenium supplemented via concentrates was analytically confirmed. Background selenium levels in
tall fescue hay, pelletized alfalfa hay and unsupplemented concentrate were of 0.08, 0.09 and 0.04
mg/kg DM, respectively. Forage was available ad libitum and daily concentrate dose was 0.8 kg/goat.
Zootechnical performance (feed intake, body weight) and health status of animals (including the body
condition score) were recorded. Milk yield and milk composition (total solids, fat, protein, casein and
SCC) were analysed. Milk keeping properties (pH, titratable acidity, lactoperoxidase activity, rennet
clotting time) and cheese manufacture ability were also measured. Selenium, SeMet and SeCys were
determined in milk, curd and cheese. Additionally selenium was measurend in blood (whole and
plasma), hair and hooves. Blood haematological and biochemical parameters (including GSH-Px) and
thyroidal hormones were analysed.
One goat from each Sel-Plex® supplemented groups was removed due to mastitis or poor milking
performance. No further health problems appeared. Zootechnical performance could not be considered
due to inadequacies in the experimental design. No effects were observed concerning milk yield (in
control, 1.82 L/day), or milk composition (total solids, fat, protein and casein were in control 13.09,
4.71, 3.64 and 2.82 %, respectively); SCC were significantly increased by both selenite and lower SelPlex® dose.
32
Dairy goats
The study was conducted on 89 lactating Saanen dairy goats (mean age of four years).50 For two
months before the supplementation period the animals were fed an identical basal diet (BD) without
selenium supplementation. After that, animals were allotted into three groups (based on age, milk
yield and lactation period) and fed diets supplemented with selenium for the following 112 days.
Control treatment (30 goats) continued with unsupplemented BD, whereas two groups (29 and 30
goats, respectively) consisted on the identical BD supplemented with selenium 0.26 mg/day either
from sodium selenite or from Sel-Plex®, respectively. All selenium supplements were given daily to
each individual goat by top-dressing to concentrate using calcium carbonate during afternoon milking
(10 g/head/day). Based on selenium analysis of each dietary component the total selenium contents
could be estimated. Zootechnical performance (feed intake) and health status (including body
condition score) were monitored. Goats were milked twice daily. Milk yield, milk quality (fat, protein,
lactose, urea and casein), milk safety and technological parameters (SCC, Total bacteria count, pH),
milk SCN and Lactoperoxidase, and milk shelf life parameters (in individual and bulk milk samples)
were assessed. Total selenium was determined in total and pooled milk and cheese samples; SeMet
and SeCys were determined in pooled milk and cheese samples. Haematology and blood biochemistry
49
50
Technical Dossier, Section IV, Vol. 1, Annex 4-2-1
Technical Dossier, Section IV, Vol. 1, Annex 4-2-2
EFSA Journal 2011;9(4):2110
46
Sel-Plex® as zootechnical additive for all species
(including GSH-Px) and thyroid hormones in plasma were analysed. Selenium was further analysed in
whole blood and plasma and hair. Data were statistically analysed.
No information on health status of animals was submitted. The zootechnical performance could not be
considered completely due to inadequacies in the experimental design. Milk yield (control 720
g/milking) and milk composition (control fat 3.4%, protein 4.1 and lactose 4.4%) were not affected by
treatments after 112 days.
33
Mares
The study in mares provided data on the selenium content in milk for a 60-day period in two groups:
one supplemented with sodium selenite and the other with Sel-Plex®. Since mares milk would not
essentially contribute to human milk consumption the data was not considered further.
REFERENCES
Barbut, S. 1993. Colour measurements for evaluating the pale, soft, exudative (PSE) occurrence in
turkey meat. Food Research International, 26, 39-43.
Downs, KM, Hess, JB and Bilgili, SF. 2000. Selenium source effect on broiler carcass characteristic,
meat quality, and drip loss. Journal of Applied Animal Research, 18, 61-72.
Earl, LA, King, AJ, Fitzpatrick, DP and Cooper, JE. 1996. A modification of a method to determine
expressible moisture in ground, dark poultry meat. Poultry Science, 75, 1433-1436.
EFSA (European Food Safety Authority). 2006. Opinion of the Scientific Panel on Additives and
Products or Substances used in Animal Feed on the safety and efficacy of the product SelPlex®2000 as a feed additive according to Regulation (EC) No 1831/2003. The EFSA Journal,
348, 1-40.
EFSA Journal 2011;9(4):2110
47
Sel-Plex® as zootechnical additive for all species
APPENDIX D. SAFETY FOR THE CONSUMER. CONSUMER EXPOSURE TABULATED DATA
Scenario I:
Selenium exposure of adults (mg/day) Standard Food Basket
Table DI.1: Control (tissues/products from animals fed Se unsupplemented diets)
Food
Meat
Liver
Kidney
Milk
Egg
Total (mg)
Amount consumed
(kg)
0.300
0.100
0.050
1.500
0.100
Food Se content
(mg/kg FM)
0.107
0.340
1.061
0.019
0.074
Se Intake
(mg)
0.032
0.034
0.053
0.029
0.007
0.155
Table DI.2: Sodium selenite (tissues/products from animals fed diets supplemented with 0.2 mg Se/kg)
Food
Meat
Liver
Kidney
Milk
Egg
Total (mg)
Amount consumed
(kg)
0.300
0.100
0.050
1.500
0.100
Factor Se
0.2 mg/kg
1.30
1.78
1.10
1.45
2.60
Se in control
(mg/kg FM)
0.107
0.340
1.061
0.019
0.074
Food Se content
(mg/kg FM)
0.139
0.605
1.167
0.028
0.192
Se Intake
(mg)
0.042
0.061
0.058
0.041
0.019
0.221
Table DI.3: Sel-Plex® (tissues/products from animals fed diets supplemented with 0.1 mg Se/kg)
Food
Meat
Liver
Kidney
Milk
Egg
Total (mg)
Amount consumed
(kg)
0.300
0.100
0.050
1.500
0.100
Factor Se
0.1 mg/kg
1.82
1.53
1.19
2.08
2.70
Se in control
(mg/kg FM)
0.107
0.340
1.061
0.019
0.074
Food Se content
(mg/kg FM)
0.195
0.520
1.263
0.040
0.200
Se Intake
(mg)
0.058
0.052
0.063
0.059
0.020
0.253
Table DI.4: Sel-Plex® (tissues/products from animals fed diets supplemented with 0.2-0.26 mg Se/kg)
Food
Meat
Liver
Kidney
Milk
Egg
Total (mg)
Amount consumed
(kg)
0.300
0.100
0.050
1.500
0.100
Factor Se
0.2 mg/kg
2.20
1.96
1.29
2.36
3.84
Se in control
(mg/kg FM)
0.107
0.340
1.061
0.019
0.074
Food Se content
(mg/kg FM)
0.235
0.666
1.369
0.045
0.284
Se Intake
(mg)
0.071
0.067
0.068
0.067
0.028
0.301
Table DI.5: Sel-Plex® (tissues/products from animals fed diets supplemented with 0.3-0.35 mg Se/kg)
Food
Meat
Liver
Kidney
Milk
Egg
Total (mg)
Amount consumed
(kg)
0.300
0.100
0.050
1.500
0.100
EFSA Journal 2011;9(4):2110
Factor Se
0.3 mg/kg
2.58
2.76
1.29
2.67
4.57
Se in control
(mg/kg FM)
0.107
0.340
1.061
0.019
0.074
Food Se content
(mg/kg FM)
0.276
0.938
1.369
0.051
0.338
Se Intake
(mg)
0.083
0.094
0.068
0.076
0.034
0.355
48
Sel-Plex® as zootechnical additive for all species
Scenario II: Selenium exposure of adults (mg/day)
Comprehensive European Food Consumption Database (EFSA, 2011) - P95 of consumers only
Table DII.1: Control (tissues/products from animals fed Se unsupplemented diets)
Food
Meat
Liver
Kidney
Milk
Egg
Total (mg)
Amount consumed
(kg)
0.290
0.060
0.015
1.500
0.070
Food Se content
(mg/kg FM)
0.107
0.340
1.061
0.019
0.074
Se Intake
(mg)
0.031
0.020
0.016
0.029
0.005
0.101
Table DII.2: Sodium selenite (tissues/products from animals fed diets supplemented with 0.2 mg Se/kg)
Food
Meat
Liver
Kidney
Milk
Egg
Total (mg)
Amount consumed
(kg)
0.290
0.060
0.015
1.500
0.070
Factor Se
0.2
1.30
1.78
1.10
1.45
2.60
Se in control
(mg/kg FM)
0.107
0.340
1.061
0.019
0.074
Food Se content
(mg/kg FM)
0.139
0.605
1.167
0.028
0.192
Se Intake
(mg)
0.040
0.036
0.018
0.041
0.013
0.149
Table DII.3: Sel-Plex® (tissues/products from animals fed diets supplemented with 0.1 mg Se/kg)
Food
Meat
Liver
Kidney
Milk
Egg
Total (mg)
Amount consumed
(kg)
0.290
0.060
0.015
1.500
0.070
Factor Se
0.1
1.82
1.53
1.19
2.08
2.70
Se in control
(mg/kg FM)
0.107
0.340
1.061
0.019
0.074
Food Se content
(mg/kg FM)
0.195
0.520
1.263
0.040
0.200
Se Intake
(mg)
0.056
0.031
0.019
0.059
0.014
0.180
Table DII.4: Sel-Plex® (tissues/products from animals fed diets supplemented with 0.2-0.26 mg Se/kg)
Food
Meat
Liver
Kidney
Milk
Egg
Total (mg)
Amount consumed
(kg)
0.290
0.060
0.015
1.500
0.070
Factor Se
0.2
2.20
1.96
1.29
2.36
3.84
Se in control
(mg/kg FM)
0.107
0.340
1.061
0.019
0.074
Food Se content
(mg/kg FM)
0.235
0.666
1.369
0.045
0.284
Se Intake
(mg)
0.068
0.040
0.021
0.067
0.020
0.216
Table DII.5: Sel-Plex® (tissues/products from animals fed diets supplemented with 0.3-0.35 mg Se/kg)
Food
Meat
Liver
Kidney
Milk
Egg
Total (mg)
Amount consumed
(kg)
0.290
0.060
0.015
1.500
0.070
EFSA Journal 2011;9(4):2110
Factor Se
0.3
2.58
2.76
1.29
2.67
4.57
Se in control
(mg/kg FM)
0.107
0.340
1.061
0.019
0.074
Food Se content
(mg/kg FM)
0.276
0.938
1.369
0.051
0.338
Se Intake
(mg)
0.080
0.056
0.021
0.076
0.024
0.257
49
Sel-Plex® as zootechnical additive for all species
Scenario IIa: Selenium exposure of adults (mg/day)
Comprehensive European Food Consumption Database (EFSA, 2011) - P95 of consumers only
Se in milk of unsupplemented dairy cows’ adjusted (10µg/L) according to literature
Table DIIa.1: Control (tissues/products from animals fed Se unsupplemented diets)
Food
Meat
Liver
Kidney
Milk
Egg
Total (mg)
Amount consumed
(kg)
0.290
0.060
0.015
1.500
0.070
Food Se content
(mg/kg FM)
0.107
0.340
1.061
0.010
0.074
Se Intake
(mg)
0.031
0.020
0.016
0.015
0.005
0.088
Table DIIa.2: Sodium selenite (tissues/products from animals fed diets supplemented with 0.2 mg Se/kg)
Food
Meat
Liver
Kidney
Milk
Egg
Total (mg)
Amount consumed
(kg)
0.290
0.060
0.015
1.500
0.070
Factor Se
0.2
1.30
1.78
1.10
1.45
2.60
Se in control
(mg/kg FM)
0.107
0.340
1.061
0.010
0.074
Food Se content
(mg/kg FM)
0.139
0.605
1.167
0.015
0.192
Se Intake
(mg)
0.040
0.036
0.018
0.022
0.013
0.129
Table DIIa.3: Sel-Plex® (tissues/products from animals fed diets supplemented with 0.1 mg Se/kg)
Food
Meat
Liver
Kidney
Milk
Egg
Total (mg)
Amount consumed
(kg)
0.290
0.060
0.015
1.500
0.070
Factor Se
0.1
1.82
1.53
1.19
2.08
2.70
Se in control
(mg/kg FM)
0.107
0.340
1.061
0.010
0.074
Food Se content
(mg/kg FM)
0.195
0.520
1.263
0.021
0.200
Se Intake
(mg)
0.056
0.031
0.019
0.031
0.014
0.152
Table DIIa.4: Sel-Plex® (tissues/products from animals fed diets supplemented with 0.2-0.26 mg Se/kg)
Food
Meat
Liver
Kidney
Milk
Egg
Total (mg)
Amount consumed
(kg)
0.290
0.060
0.015
1.500
0.070
Factor Se
0.2
2.20
1.96
1.29
2.36
3.84
Se in control
(mg/kg FM)
0.107
0.340
1.061
0.010
0.074
Food Se content
(mg/kg FM)
0.235
0.666
1.369
0.024
0.284
Se Intake
(mg)
0.068
0.040
0.021
0.035
0.020
0.184
Table DIIa.5: Sel-Plex® (tissues/products from animals fed diets supplemented with 0.3-0.35 mg Se/kg)
Food
Meat
Liver
Kidney
Milk
Egg
Total (mg)
Amount consumed
(kg)
0.290
0.060
0.015
1.500
0.070
EFSA Journal 2011;9(4):2110
Factor Se
0.3
2.58
2.76
1.29
2.67
4.57
Se in control
(mg/kg FM)
0.107
0.340
1.061
0.010
0.074
Food Se content
(mg/kg FM)
0.276
0.938
1.369
0.027
0.338
Se Intake
(mg)
0.080
0.056
0.021
0.040
0.024
0.221
50
Sel-Plex® as zootechnical additive for all species
Scenario III: Selenium exposure of children of 1-3 years of age (mg/day)
Comprehensive European Food Consumption Database (EFSA, 2011) - P95 of consumers only
Table DIII.1: Control (tissues/products from animals fed Se unsupplemented diets)
Food
Meat
Milk
Egg
Total (mg)
Amount consumed
(kg)
0.090
1.050
0.035
Food Se content
(mg/kg FM)
0.107
0.019
0.074
Se Intake
(mg)
0.010
0.020
0.003
0.032
Table DIII.2: Sodium selenite (tissues/products from animals fed diets supplemented with 0.2 mg Se/kg)
Food
Meat
Milk
Egg
Total (mg)
Amount consumed
(kg)
0.090
1.050
0.035
Factor Se
0.2
1.30
1.45
2.60
Se in control
(mg/kg FM)
0.107
0.019
0.074
Food Se content
(mg/kg FM)
0.139
0.028
0.192
Se Intake
(mg)
0.013
0.029
0.007
0.048
Table DIII.3: Sel-Plex® (tissues/products from animals fed diets supplemented with 0.1 mg Se/kg)
Food
Meat
Milk
Egg
Total (mg)
Amount consumed
(kg)
0.090
1.050
0.035
Factor Se
0.1
1.82
2.08
2.70
Se in control
(mg/kg FM)
0.107
0.019
0.074
Food Se content
(mg/kg FM)
0.195
0.040
0.200
Se Intake
(mg)
0.018
0.041
0.007
0.066
Table DIII.4: Sel-Plex® (tissues/products from animals fed diets supplemented with 0.2-0.26 mg Se/kg)
Food
Meat
Milk
Egg
Total (mg)
Amount consumed
(kg)
0.090
1.050
0.035
Factor Se
0.2
2.20
2.36
3.84
Se in control
(mg/kg FM)
0.107
0.019
0.074
Food Se content
(mg/kg FM)
0.235
0.045
0.284
Se Intake
(mg)
0.021
0.047
0.010
0.078
Table DIII.5: Sel-Plex® (tissues/products from animals fed diets supplemented with 0.3-0.35 mg Se/kg)
Food
Meat
Milk
Egg
Total (mg)
Amount consumed
(kg)
0.090
1.050
0.035
EFSA Journal 2011;9(4):2110
Factor Se
0.3
2.58
2.67
4.57
Se in control
(mg/kg FM)
0.107
0.019
0.074
Food Se content
(mg/kg FM)
0.276
0.051
0.338
Se Intake
(mg)
0.025
0.053
0.012
0.090
51
Sel-Plex® as zootechnical additive for all species
ScenarioIIIa: Selenium exposure of children of 1-3 years of age (mg/day)
Comprehensive European Food Consumption Database (EFSA, 2011) - P95 of consumers only
Se in milk of unsupplemented dairy cows’ adjusted (10µg/L) according to literature
Table DIIIa.1: Control (tissues/products from animals fed Se unsupplemented diets)
Food
Meat
Milk
Egg
Total (mg)
Amount consumed
(kg)
0.090
1.050
0.035
Food Se content
(mg/kg FM)
0.107
0.010
0.074
Se Intake
(mg)
0.010
0.011
0.003
0.023
Table DIIIa.2: Sodium selenite (tissues/products from animals fed diets supplemented with 0.2 mg Se/kg)
Food
Meat
Milk
Egg
Total (mg)
Amount consumed
(kg)
0.090
1.050
0.035
Factor Se
0.2
1.30
1.45
2.60
Se in control
(mg/kg FM)
0.107
0.010
0.074
Food Se content
(mg/kg FM)
0.139
0.015
0.192
Se Intake
(mg)
0.013
0.015
0.007
0.034
Table DIIIa.3: Sel-Plex® (tissues/products from animals fed diets supplemented with 0.1 mg Se/kg)
Food
Meat
Milk
Egg
Total (mg)
Amount consumed
(kg)
0.090
1.050
0.035
Factor Se
0.1
1.82
2.08
2.70
Se in control
(mg/kg FM)
0.107
0.010
0.074
Food Se content
(mg/kg FM)
0.195
0.021
0.200
Se Intake
(mg)
0.018
0.022
0.007
0.046
Table DIIIa.4: Sel-Plex® (tissues/products from animals fed diets supplemented with 0.2-0.26 mg Se/kg)
Food
Meat
Milk
Egg
Total (mg)
Amount consumed
(kg)
0.090
1.050
0.035
Factor Se
0.2
2.20
2.36
3.84
Se in control
(mg/kg FM)
0.107
0.010
0.074
Food Se content
(mg/kg FM)
0.235
0.024
0.284
Se Intake
(mg)
0.021
0.025
0.010
0.056
Table DIIIa.5: Sel-Plex® (tissues/products from animals fed diets supplemented with 0.3-0.35 mg Se/kg)
Food
Meat
Milk
Egg
Total (mg)
Amount consumed
(kg)
0.090
1.050
0.035
EFSA Journal 2011;9(4):2110
Factor Se
0.3
2.58
2.67
4.57
Se in control
(mg/kg FM)
0.107
0.010
0.074
Food Se content
(mg/kg FM)
0.276
0.027
0.338
Se Intake
(mg)
0.025
0.028
0.012
0.065
52