HTML PUBLIC "-//W3C//DTD HTML 4.01 Transitional//EN"L 207/4
EN
Official Journal of the European Union
2.8.2012
DECISION OF THE EEA JOINT COMMITTEE
No 37/2012
of 30 March 2012
amending Annex I (Veterinary and phytosanitary matters) to the EEA Agreement
THE EEA JOINT COMMITTEE,
(6) Commission
Regulation
(EU)
No
221/2011
of
4
March
2011 concerning the authorisation of 6-phytase (EC
3.1.3.26) produced by Aspergillus oryzae DSM 14223 as
Having regard to the Agreement on the European Economic
a feed additive for salmonids (holder of authorisation
Area, as amended by the Protocol adjusting the Agreement
DSM Nutritional Products Ltd represented by DSM Nutri
on the European Economic Area, hereinafter referred to as
tional products Sp. Z o.o) ( 6 ) is to be incorporated into
‘the Agreement’, and in particular Article 98 thereof,
the Agreement.
Whereas:
(7) Commission
Regulation
(EU)
No
335/2011
of
7
April
2011 amending Regulation (EC) No 1091/2009 as
(1) Annex
I
to
the
Agreement
was
amended
by
Decision
of
regards the minimum content of the enzyme preparation
the EEA Joint Committee No 5/2012 of 10 February
of endo-1,4-beta-xylanase produced by Trichoderma reesei
2012 ( 1 ).
(MUCL 49755) and endo-1,3(4)-beta-glucanase produced
by Trichoderma reesei (MUCL 49754) as a feed additive in
feed for chickens for fattening ( 7 ) is to be incorporated
into the Agreement.
(2) Commission Regulation (EU) No 170/2011 of
23 February 2011 concerning the authorisation of
Saccharomyces cerevisiae MUCL 39885 as a feed additive
for piglets (weaned) and amending Regulation (EC) No
1200/2005 (holder of authorisation Prosol SpA) ( 2 ) is to
be incorporated into the Agreement.
(8) Commission
Regulation
(EU)
No
336/2011
of
7
April
2011 amending Regulation (EC) No 1292/2008 as
regards the use of the feed additive Bacillus amylolique
faciens CECT 5940 in feed containing diclazuril,
(3) Commission Regulation (EU) No 171/2011 of
monensin sodium and nicarbazin ( 8 ) is to be incor
23 February 2011 concerning the authorisation of 6-
porated into the Agreement.
phytase (EC 3.1.3.26) produced by Aspergillus oryzae
DSM 14223 as a feed additive for poultry and for
porcine species and amending Regulation (EC) No
255/2005 (holder of authorisation DSM Nutritional
Products Ltd represented by DSM Nutritional products
Sp. z o.o) (
(9) Commission
Regulation
(EU)
No
337/2011
of
7
April

3 ) is to be incorporated into the Agreement.
2011 concerning the authorisation of an enzyme prep
aration of endo-1,4-beta-xylanase and endo-1,3(4)-beta-
glucanase as feed additive for poultry, weaned piglets and
(4) Commission Regulation (EU) No 184/2011 of
pigs for fattening (holder of the authorisation Danisco
25 February 2011 concerning the authorisation of
Animal Nutrition) ( 9 ) is to be incorporated into the
Bacillus subtilis C-3102 (DSM 15544) as a feed additive
Agreement.
for chickens reared for laying, turkeys, minor avian
species and other ornamental and game birds (holder
of authorisation Calpis Co. Ltd Japan, represented by
Calpis Co. Ltd Europe Representative Office) ( 4 ) is to be
incorporated into the Agreement.
(10) Commission Implementing Regulation (EU) No
361/2011 of 13 April 2011 concerning the authori
sation of Enterococcus faecium NCIMB 10415 as a feed
(5) Commission
Regulation
(EU)
No
212/2011
of
3
March
additive for chickens for fattening (holder of authori
2011 concerning the authorisation of Pediococcus acidil
sation DSM Nutritional products Ltd represented by
actici CNCM MA 18/5M as a feed additive for laying hens
DSM Nutritional Products Sp. z o.o) and amending Regu
(holder of authorisation Lallemand SAS) ( 5 ) is to be incor
lation (EC) No 943/2005 ( 10 ) is to be incorporated into
porated into the Agreement.
the Agreement.
( 1 ) OJ L 161, 21.6.2012, p. 8.
( 6 ) OJ L 60, 5.3.2011, p. 3.
( 2 ) OJ L 49, 24.2.2011, p. 8.
( 7 ) OJ L 94, 8.4.2011, p. 14.
( 3 ) OJ L 49, 24.2.2011, p. 11.
( 8 ) OJ L 94, 8.4.2011, p. 17.
( 4 ) OJ L 53, 26.2.2011, p. 33.
( 9 ) OJ L 94, 8.4.2011, p. 19.
( 5 ) OJ L 59, 4.3.2011, p. 1.
( 10 ) OJ L 100, 14.4.2011, p. 22.

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EN
2.8.2012 Official
Journal
of
the
European
Union L
207/5
(11) Commission Implementing Regulation (EU) No
(17) Commission Implementing Regulation (EU) No
371/2011 of 15 April 2011 concerning the authori
496/2011 of 20 May 2011 concerning the authorisation
sation of dimethylglycine sodium salt as feed additive
of sodium benzoate as a feed additive for weaned piglets
for chickens for fattening (holder of the authorisation
(holder of the authorisation Kemira Oyj) ( 7 ) is to be
Taminco N.V.)
( 1 ) is to be incorporated into the
incorporated into the Agreement.
Agreement.
(18) Commission Implementing Regulation (EU) No
(12) Commission Implementing Regulation (EU) No
515/2011 of 25 May 2011 concerning the authorisation
373/2011 of 15 April 2011 concerning the authori
of vitamin B 6 as a feed additive for all animal species ( 8 )
sation of the preparation of Clostridium butyricum FERM-
is to be incorporated into the Agreement.
BP 2789 as a feed additive for minor avian species except
laying birds, weaned piglets and minor porcine species
(weaned) and amending Regulation (EC) No 903/2009
(holder of authorisation Miyarisan Pharmaceutical Co.
Ltd, represented by Miyarisan Pharmaceutical Europe
S.L.U.) (
(19) Commission Implementing Regulation (EU) No

2 ) is to be incorporated into the Agreement.
516/2011 of 25 May 2011 amending Regulation (EC)
No 600/2005 as regards the use of the preparation of
Bacillus licheniformis DSM 5749 and Bacillus subtilis DSM
5750 in feed containing formic acid ( 9 ) is to be incor
porated into the Agreement.
(13) Commission Implementing Regulation (EU) No
388/2011 of 19 April 2011 concerning the authori
sation of maduramicin ammonium alpha as a feed
additive for chickens for fattening (holder of authori
sation Alpharma (Belgium) BVBA) and amending Regu
lation (EC) No 2430/1999 ( 3 ) is to be incorporated into
(20) Commission Implementing Regulation (EU) No
the Agreement.
527/2011 of 30 May 2011 concerning the authorisation
of a preparation of endo-1,4-β-xylanase produced by
Trichoderma reesei (MUCL 49755), endo-1,3(4)-β-
glucanase produced by Trichoderma reesei (MUCL 49754)
and polygalacturonase produced by Aspergillus aculeatus
(14) Commission Implementing Regulation (EU) No
(CBS 589.94) as feed additive for weaned piglets
389/2011 of 19 April 2011 concerning the authori
(holder of the authorisation Aveve NV) ( 10 ) is to be incor
sation of an enzyme preparation of endo-1,4-beta-
porated into the Agreement.
xylanase, subtilisin and alpha-amylase as feed additive
for laying hens (holder of authorisation Danisco
Animal Nutrition) ( 4 ) is to be incorporated into the
Agreement.
(21) Commission Implementing Regulation (EU) No
528/2011 of 30 May 2011 concerning the authorisation
of endo-1,4-β-xylanase produced by Trichoderma reesei
(ATCC PTA 5588) as a feed additive for weaned piglets
(15) Commission Implementing Regulation (EU) No
and pigs for fattening (holder of authorisation Danisco
406/2011 of 27 April 2011 amending Regulation (EC)
Animal Nutrition) ( 11 ) is to be incorporated into the
No 2380/2001 as regards the composition of the feed
Agreement.
additive maduramicin ammonium alpha ( 5 ) is to be incor
porated into the Agreement.
(22) Commission Implementing Regulation (EU) No
532/2011 of 31 May 2011 concerning the authorisation
(16) Commission Implementing Regulation (EU) No
of robenidine hydrochloride as a feed additive for rabbits
495/2011 of 20 May 2011 amending Regulation (EC)
for breeding and rabbits for fattening (holder of auth
No 109/2007 as regards the composition of the feed
orisation Alpharma Belgium BVBA) and amending Regu
additive monensin sodium ( 6 ) is to be incorporated into
lations (EC) No 2430/1999 and (EC) No 1800/2004 ( 12 )
the Agreement.
is to be incorporated into the Agreement.
( 1 ) OJ L 102, 16.4.2011, p. 6.
( 7 ) OJ L 134, 21.5.2011, p. 9.
( 2 ) OJ L 102, 16.4.2011, p. 10.
( 8 ) OJ L 138, 26.5.2011, p. 40.
( 3 ) OJ L 104, 20.4.2011, p. 3.
( 9 ) OJ L 138, 26.5.2011, p. 43.
( 4 ) OJ L 104, 20.4.2011, p. 7.
( 10 ) OJ L 143, 31.5.2011, p. 6.
( 5 ) OJ L 108, 28.4.2011, p. 11.
( 11 ) OJ L 143, 31.5.2011, p. 10.
( 6 ) OJ L 134, 21.5.2011, p. 6.
( 12 ) OJ L 146, 1.6.2011, p. 7.

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L 207/6
EN
Official Journal of the European Union
2.8.2012
(23) Commission
Regulation
(EU)
No
574/2011
of
16
June
— 32011 R 0532: Commission Implementing Regu
2011 amending Annex I to Directive 2002/32/EC of the
lation (EU) No 532/2011 of 31 May 2011 (OJ
European Parliament and of the Council as regards
L 146, 1.6.2011, p. 7).’;
maximum levels for nitrite, melamine, Ambrosia spp.
and carry-over of certain coccidiostats and histo
monostats and consolidating Annexes I and II thereto ( 1 )
(2) the following indent shall be added in point 1y (Com
is to be incorporated into the Agreement.
mission Regulation (EC) No 2380/2001):
(24) Commission
Regulation
(EU)
No
575/2011
of
16
June
‘— 32011 R 0406: Commission Implementing Regu
2011 on the Catalogue of feed materials ( 2 ) is to be
lation (EU) No 406/2011 of 27 April 2011 (OJ
incorporated into the Agreement.
L 108, 28.4.2011, p. 11).’;
(25) Commission Implementing Regulation (EU) No
(3) the following indent shall be added in point 1zzd (Com
868/2011 of 31 August 2011 concerning the authori
mission Regulation (EC) No 1800/2004):
sation of a preparation of Lactobacillus plantarum (DSM
21762) and of a preparation of Lactobacillus buchneri
(DSM 22963) as feed additives for all animal species ( 3 )
is to be incorporated into the Agreement.
‘— 32011 R 0532: Commission Implementing Regu
lation (EU) No 532/2011 of 31 May 2011 (OJ
L 146, 1.6.2011, p. 7).’;
(26) Regulation
(EU)
No
171/2011
repeals
Commission
Regu
lation (EC) No 1500/2007 ( 4 ) which is incorporated in
the Agreement and is therefore to be repealed under the
(4) the following shall be added in point 1zzf (Commission
Agreement.
Regulation (EC) No 255/2005):
(27) Regulation
(EU)
No
575/2011
repeals
Commission
Regu
‘, as amended by:
lation (EU) No 242/2010 ( 5 ) which is incorporated in the
Agreement and is therefore to be repealed under the
Agreement.
— 32011 R 0171: Commission Regulation (EU) No
171/2011 of 23 February 2011 (OJ L 49, 24.2.2011,
p. 11).’;
(28) This
Decision
concerns
legislation
regarding
feedingstuffs.
Legislation regarding feedingstuffs shall not apply to
Liechtenstein as long as the application of the
(5) the following indent shall be added in point 1zzi (Com
Agreement between the European Community and the
mission Regulation (EC) No 521/2005):
Swiss Confederation on trade in agricultural products is
extended to Liechtenstein, as specified in the sectoral
adaptations to Annex I to the Agreement. This
Decision is therefore not to apply to Liechtenstein,
‘— 32011 R 0221: Commission Regulation (EU) No

221/2011 of 4 March 2011 (OJ L 60, 5.3.2011,
p. 3).’;
HAS ADOPTED THIS DECISION:
(6) the following indent shall be added in point 1zzj (Com
Article 1
mission Regulation (EC) No 600/2005):
Chapter II of Annex I to the Agreement shall be amended as
follows:
‘— 32011 R 0516: Commission Implementing Regu
lation (EU) No 516/2011 of 25 May 2011 (OJ
L 138, 26.5.2011, p. 43).’;
(1) the following indents shall be added in point 1k (Com
mission Regulation (EC) No 2430/1999):
(7) the following indent shall be added in point 1zzl (Com
mission Regulation (EC) No 943/2005):
‘— 32011 R 0388: Commission Implementing Regu
lation (EU) No 388/2011 of 19 April 2011 (OJ
L 104, 20.4.2011, p. 3),
‘, as amended by:
( 1 ) OJ L 159, 17.6.2011, p. 7.
( 2 ) OJ L 159, 17.6.2011, p. 25.
— 32011 R 0361: Commission Implementing Regulation
( 3 ) OJ L 226, 1.9.2011, p. 2.
( 4 ) OJ L 333, 19.12.2007, p. 54.
(EU) No 361/2011 of 13 April 2011 (OJ L 100,
( 5 ) OJ L 77, 24.3.2010, p. 17.
14.4.2011, p. 22).’;

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EN
2.8.2012 Official
Journal
of
the
European
Union L
207/7
(8) the following indent shall be added in point 1zzm (Com
feed additive for piglets (weaned) and amending
mission Regulation (EC) No 1200/2005):
Regulation (EC) No 1200/2005 (holder of authori
sation Prosol SpA) (OJ L 49, 24.2.2011, p. 8).
‘— 32011 R 0170: Commission Regulation (EU) No
170/2011 of 23 February 2011 (OJ L 49, 24.2.2011,
p. 8).’;
2u. 32011
R 0171: Commission Regulation (EU) No
171/2011 of 23 February 2011 concerning the auth
orisation of 6-phytase (EC 3.1.3.26) produced by
(9) the following indent shall be added in point 1zzzg (Com
Aspergillus oryzae DSM 14223 as a feed additive for
mission Regulation (EC) No 109/2007):
poultry and for porcine species and amending Regu
lation (EC) No 255/2005 (holder of authorisation
DSM Nutritional Products Ltd represented by DSM
‘— 32011 R 0495: Commission Implementing Regu
Nutritional products Sp. z o.o) (OJ L 49, 24.2.2011,
lation (EU) No 495/2011 of 20 May 2011 (OJ
p. 11).
L 134, 21.5.2011, p. 6).’;
(10) the text of point 1zzzzf (Commission Regulation (EC) No
2v. 32011
R 0184: Commission Regulation (EU) No
1500/2007) shall be deleted;
184/2011 of 25 February 2011 concerning the auth
orisation of Bacillus subtilis C-3102 (DSM 15544) as
a feed additive for chickens reared for laying, turkeys,
(11) the following shall be added in point 1zzzzze (Com
minor avian species and other ornamental and game
mission Regulation (EC) No 1292/2008):
birds (holder of authorisation Calpis Co. Ltd Japan,
represented by Calpis Co. Ltd Europe Representative
Office) (OJ L 53, 26.2.2011, p. 33).
‘, as amended by:
— 32011 R 0336: Commission Regulation (EU) No
2w. 32011 R 0212: Commission Regulation (EU) No
336/2011 of 7 April 2011 (OJ L 94, 8.4.2011,
212/2011 of 3 March 2011 concerning the auth
p. 17).’;
orisation of Pediococcus acidilactici CNCM MA 18/5M
as a feed additive for laying hens (holder of auth
orisation Lallemand SAS) (OJ L 59, 4.3.2011, p. 1).
(12) the following shall be added in point 1zzzzzn (Com
mission Regulation (EC) No 903/2009):
2x. 32011
R 0221: Commission Regulation (EU) No
‘, as amended by:
221/2011 of 4 March 2011 concerning the auth
orisation of 6-phytase (EC 3.1.3.26) produced by
Aspergillus oryzae DSM 14223 as a feed additive for
— 32011 R 0373: Commission Regulation (EU) No
salmonids (holder of authorisation DSM Nutritional
373/2011 of 15 April 2011 (OJ L 102, 16.4.2011,
Products Ltd represented by DSM Nutritional
p. 10).’;
products Sp. Z o.o) (OJ L 60, 5.3.2011, p. 3).
(13) the following shall be added in point 1zzzzzt (Com
mission Regulation (EC) No 1091/2009):
2y. 32011
R 0337: Commission Regulation (EU) No
337/2011 of 7 April 2011 concerning the authori
sation of an enzyme preparation of endo-1,4-beta-
‘, as amended by:
xylanase and endo-1,3(4)-beta-glucanase as feed
additive for poultry, weaned piglets and pigs for
fattening (holder of the authorisation Danisco
— 32011 R 0335: Commission Regulation (EU) No
Animal Nutrition) (OJ L 94, 8.4.2011, p. 19).
335/2011 of 7 April 2011 (OJ L 94, 8.4.2011,
p. 14).’;
2z. 32011
R 0361: Commission Implementing Regu
(14) the following points shall be inserted after point 2s (Com
lation (EU) No 361/2011 of 13 April 2011
mission Regulation (EU) No 1120/2010):
concerning the authorisation of Enterococcus faecium
NCIMB 10415 as a feed additive for chickens for
fattening (holder of authorisation DSM Nutritional
‘2t. 32011
R 0170: Commission Regulation (EU) No
products Ltd represented by DSM Nutritional
170/2011 of 23 February 2011 concerning the auth
Products Sp. z o.o) and amending Regulation (EC)
orisation of Saccharomyces cerevisiae MUCL 39885 as a
No 943/2005 (OJ L 100, 14.4.2011, p. 22).

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L 207/8
EN
Official Journal of the European Union
2.8.2012
2za. 32011 R 0371: Commission Implementing Regu
produced by Trichoderma reesei (ATCC PTA 5588)
lation (EU) No 371/2011 of 15 April 2011
as a feed additive for weaned piglets and pigs for
concerning the authorisation of dimethylglycine
fattening (holder of authorisation Danisco Animal
sodium salt as feed additive for chickens for
Nutrition) (OJ L 143, 31.5.2011, p. 10).
fattening (holder of the authorisation Taminco
N.V.) (OJ L 102, 16.4.2011, p. 6).
2zi. 32011 R 0532: Commission Implementing Regu
2zb. 32011 R 0373: Commission Implementing Regu
lation (EU) No 532/2011 of 31 May 2011
lation (EU) No 373/2011 of 15 April 2011
concerning the authorisation of robenidine hydro
concerning the authorisation of the preparation of
chloride as a feed additive for rabbits for breeding
Clostridium butyricum FERM-BP 2789 as a feed
and rabbits for fattening (holder of authorisation
additive for minor avian species except laying birds,
Alpharma Belgium BVBA) and amending Regulations
weaned piglets and minor porcine species (weaned)
(EC) No 2430/1999 and (EC) No 1800/2004 (OJ
and amending Regulation (EC) No 903/2009 (holder
L 146, 1.6.2011, p. 7).
of authorisation Miyarisan Pharmaceutical Co. Ltd,
represented by Miyarisan Pharmaceutical Europe
S.L.U.) (OJ L 102, 16.4.2011, p. 10).
2zj. 32011 R 0868: Commission Implementing Regu
2zc. 32011 R 0388: Commission Implementing Regu
lation (EU) No 868/2011 of 31 August 2011
lation (EU) No 388/2011 of 19 April 2011
concerning the authorisation of a preparation of
concerning the authorisation of maduramicin
Lactobacillus plantarum (DSM 21762) and of a prep
ammonium alpha as a feed additive for chickens
aration of Lactobacillus buchneri (DSM 22963) as feed
for fattening (holder of authorisation Alpharma
additives for all animal species (OJ L 226, 1.9.2011,
(Belgium) BVBA) and amending Regulation (EC) No
p. 2).’;
2430/1999 (OJ L 104, 20.4.2011, p. 3).
2zd. 32011 R 0389: Commission Implementing Regu
(15) the following indent shall be added in point 33 (Directive
lation (EU) No 389/2011 of 19 April 2011
2002/32/EC of the European Parliament and of the
concerning the authorisation of an enzyme prep
Council):
aration of endo-1,4-beta-xylanase, subtilisin and
alpha-amylase as feed additive for laying hens
(holder of authorisation Danisco Animal Nutrition)
(OJ L 104, 20.4.2011, p. 7).
‘— 32011 R 0574: Commission Regulation (EU) No
574/2011 of 16 June 2011 (OJ L 159, 17.6.2011,
2ze. 32011 R 0496: Commission Implementing Regu
p. 7).’;
lation (EU) No 496/2011 of 20 May 2011
concerning the authorisation of sodium benzoate as
a feed additive for weaned piglets (holder of the auth
orisation Kemira Oyj) (OJ L 134, 21.5.2011, p. 9).
(16) the text of point 49 (Commission Regulation (EU) No
242/2010) shall be deleted;
2zf. 32011 R 0515: Commission Implementing Regu
lation (EU) No 515/2011 of 25 May 2011
concerning the authorisation of vitamin B 6 as a
feed additive for all animal species (OJ L 138,
(17) the following point shall be inserted after point 50 (Com
26.5.2011, p. 40).
mission Regulation (EU) No 454/2010):
2zg. 32011 R 0527: Commission Implementing Regu
lation (EU) No 527/2011 of 30 May 2011
‘51. 32011 R 0575: Commission Regulation (EU) No
concerning the authorisation of a preparation of
575/2011 of 16 June 2011 on the Catalogue of
endo-1,4-β-xylanase produced by Trichoderma reesei
feed materials (OJ L 159, 17.6.2011, p. 25).’.
(MUCL 49755), endo-1,3(4)-β-glucanase produced
by Trichoderma reesei (MUCL 49754) and polygalactu
ronase produced by Aspergillus aculeatus (CBS 589.94)
as feed additive for weaned piglets (holder of the
authorisation Aveve NV) (OJ L 143, 31.5.2011, p. 6).
Article 2
The texts of Regulations (EU) No 170/2011, (EU) No
171/2011, (EU) No 184/2011, (EU) No 212/2011, (EU) No
2zh. 32011 R 0528: Commission Implementing Regu
221/2011, (EU) No 335/2011, (EU) No 336/2011, (EU) No
lation (EU) No 528/2011 of 30 May 2011
337/2011, Implementing Regulations (EU) No 361/2011, (EU)
concerning the authorisation of endo-1,4-β-xylanase
No 371/2011, (EU) No 373/2011, (EU) No 388/2011, (EU) No

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EN
2.8.2012 Official
Journal
of
the
European
Union L
207/9
389/2011, (EU) No 406/2011, (EU) No 495/2011, (EU) No
Article 4
496/2011, (EU) No 515/2011, (EU) No 516/2011, (EU) No
527/2011, (EU) No 528/2011, (EU) No 532/2011, Regulations
This Decision shall be published in the EEA Section of, and in
(EU) No 574/2011, (EU) No 575/2011 and Implementing
the EEA Supplement to, the Official Journal of the European
Regulation (EU) No 868/2011 in the Icelandic and Norwegian
Union.
languages, to be published in the EEA Supplement to the Official
Journal of the European Union, shall be authentic.
Done at Brussels, 30 March 2012.
Article 3
For the EEA Joint Committee
This Decision shall enter into force on 1 May 2012, provided
that all the notifications under Article 103(1) of the Agreement
The Acting President
have been made to the EEA Joint Committee (*).
Gianluca GRIPPA
(*) No constitutional requirements indicated.

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