Commission Implementing Regulation (EU) No 451/2012
of 29 May 2012
on the withdrawal from the market of certain feed additives belonging to the functional group of silage additives
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Regulation (EC) No 1831/2003 of the European Parliament and of the Council of 22 September 2003 on additives for use in animal nutrition , and in particular Article 10(5) thereof,
Whereas:
(1)
Regulation (EC) No 1831/2003 provides for the authorisation of additives for use in animal nutrition and for the grounds and procedures for granting such authorisation. Article 10(7) of Regulation (EC) No 1831/2003 in conjunction with Article 10(1) to (4) thereof sets out specific provisions for the evaluation of products used in the Union as silage additives at the date that Regulation became applicable.
(2)
The feed additives set out in the Annex were entered in the Community Register of Feed Additives as existing products, in accordance with Article 10(1) of Regulation (EC) No 1831/2003.
(3)
As regards the use of those feed additives as silage additives, no application for authorisation in accordance with Article 10(7) in conjunction with Article 10(2) of Regulation (EC) No 1831/2003 was submitted before the deadline provided for in Article 10(7). As regards the additive hexamethylene tetramine for certain species of animals, no application for authorisation was submitted before that deadline.
(4)
For transparency purpose, the additives for which no application for authorisation was submitted within the period specified in Article 10(7) of Regulation (EC) No 1831/2003 were listed in a separated part of the Community Register of Feed Additives.
(5)
Those feed additives should therefore be withdrawn from the market as far as their use as silage additives is concerned, except for species for which applications for authorisation have been submitted. This measure does not interfere with the use of some of the abovementioned additives according to other categories or functional groups for which they may be allowed.
(6)
Since the withdrawal of the silage additives concerned are not related to safety reasons, it is appropriate to allow a transitional period within which existing stocks of those additives as well as premixtures and silage which have been produced with those additives may be used up.
(7)
The withdrawal of the feed additives listed in the Annex should be considered as without prejudice to a possible future granting of an authorisation concerning them or to the adoption of a measure on their status on the grounds and under the procedures set out in Regulation (EC) No 1831/2003.
(8)
The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health,
HAS ADOPTED THIS REGULATION:

Withdrawal
Article 1
The feed additives specified in Part A of the Annex, belonging to the functional group ‘silage additives’ within the category ‘technological additives’, shall be withdrawn from the market.
The feed additive specified in Part B of the Annex, belonging to the functional group ‘silage additives’ within the category ‘technological additives’, shall be withdrawn from the market in respect of the species of animals mentioned in that Part of the Annex.

Transitional measures
Article 2
1
Existing stocks of the feed additives set out in Part A of the Annex may continue to be placed on the market and used as feed additives belonging to the functional group ‘silage additives’ within the category ‘technological additives’ until 19 June 2013.
2
Premixtures produced with the additives referred to in paragraph 1 may continue to be placed on the market and used until 19 June 2013.
3
Silage produced with the additives referred to in paragraph 1 or with the premixtures referred to in paragraph 2 may continue to be placed on the market and used until 19 June 2014.
4
As regards the feed additive set out in Part B of the Annex, paragraphs 1, 2 and 3 shall apply in respect of the species of animals mentioned in that Part of the Annex.

Entry into force
Article 3
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 29 May 2012.
For the Commission
The President
José Manuel Barroso
ANNEX

Feed additives belonging to the functional group of silage additives withdrawn from the market, as provided for in Article 1
PART A
Feed additives belonging to the functional group of silage additives withdrawn for all species and categories of animals
Identification Number | Additive | Species or category of animals
Category of technological additives. Functional group: silage additives
| Alpha-amylase EC 3.2.1.1 from Bacillus subtilis var amyloliquefaciens | All species
| Amylase EC 3.2.1.1 from Aspergillus oryzae | All species
| Amylase EC 3.2.1.1 from malt | All species
| Beta-1,4 Glucanase cellulase EC 3.2.1.4 from Aspergillus niger | All species
| Beta-1,4 Xylanase EC 3.2.1.37 from Trichoderma reesei | All species
| Beta-glucanase EC 3.2.1.6 from Trichoderma viride | All species
| Cellulase EC 3.2.1.4 from Penicillium funiculosum | All species
| Cellulase EC 3.2.1.4 from Trichoderma reesei | All species
| Cellulase EC 3.2.1.4 from Trichoderma viride | All species
| Cellulase-hemicellulase complex EC 3.2.1.4 from Trichoderma reesei | All species
| Cellulase-xylanase complex EC 3.2.1.4 from Trichoderma reesei | All species
| Endo-1,3-beta-glucanase EC 3.2.1.6 from Bacillus amyloliquefaciens | All species
| Endo-1,4-beta-D-mannanase EC 3.2.1.78 from Bacillus lentus | All species
| Endo-1,4-beta-glucanase EC 3.2.1.4 from Trichoderma longibrachiatum | All species
| Endo-1,4-beta-glucanase EC 3.2.1.6 from Bacillus amyloliquefaciens | All species
| Endo-1,4-beta-xylanase EC 3.2.1.8. from Aspergillus oryzae | All species
| Glucoamylase EC 3.2.1.3. from Aspergillus niger | All species
| Glucose oxidase EC 1.1.3.4 from Aspergillus niger | All species
| Hemicellulase EC 3.2.1.8 from Aspergillus niger | All species
| Mannanase EC 3.2.1.77 from Aspergillus niger | All species
| Pectinase EC 3.2.1.15 from Aspergillus niger | All species
| Xylanase EC 3.2.1.8 from Aspergillus niger | All species
| Xylanase EC 3.2.1.8 from Penicillium funiculosum | All species
| Xylanase EC 3.2.1.8 from Trichoderma reesei | All species
| Aspergillus oryzae AK 7001 DSM 1862 | All species
| Bacillus coagulans CECT 7001 | All species
| Bacillus lentus 302 | All species
| Bacillus licheniformis DSM 5749 | All species
| Bacillus licheniformis MBS-BL-01 | All species
| Bacillus licheniformis Micron Bio-Systems culture collection | All species
| Bacillus pumilus BP288 ATCC 53682 | All species
| Bacillus pumilus CNCM I-3240/NRRL B4064 | All species
| Bacillus pumilus MBS-BP-01 | All species
| Bacillus pumilus Micron Bio-Systems culture collection | All species
| Bacillus subtilis AK 6012 DSM 8563 | All species
| Bacillus subtilis BS1 | All species
| Bacillus subtilis CNCM I-3239/ATCC 6633 | All species
| Bacillus subtilis DSM 5750 | All species
| Bacillus subtilis Micron Bio-Systems culture collection | All species
| Bacillus subtilis NCIMB 40286 | All species
| Bifidobacterium animalis ssp. Lactis CHCC5445/DSM15954 | All species
| Bifidobacterium longum CNCM I-3241/ATCC 15707 | All species
| Candida glabrata 35120 | All species
| Clostridium sporogenes phage NCIMB 30008 | All species
| Clostridium tyrobutyricum phage NCIMB 30008 | All species
| Enterococcus faecium AP34 | All species
| Enterococcus faecium CECT 7002 | All species
| Enterococcus faecium CNCM DASF I-1248 | All species
| Enterococcus faecium CNCM I-819 | All species
| Enterococcus faecium DSM 15958 | All species
| Enterococcus faecium DSM 16567 | All species
| Enterococcus faecium DSM 16573 | All species
| Enterococcus faecium DSM 5464 | All species
| Enterococcus faecium M74 CCM 6226 | All species
| Enterococcus faecium NCAIM | All species
| Enterococcus faecium NCIMB 30006 | All species
| Enterococcus faecium NCIMB 30098 | All species
| Enterococcus faecium NCIMB 30122 | All species
| Enterococcus mundtii 82760 | All species
| Lactobacillus acidophilus 36587 | All species
| Lactobacillus acidophilus CHCC3777/DSM13241 | All species
| Lactobacillus acidophilus CNCM DALA I-1246 | All species
| Lactobacillus acidophilus NCIMB 30067 | All species
| Lactobacillus acidophilus NCAIM | All species
| Lactobacillus amylolyticus CBS 116420 | All species
| Lactobacillus amylovorans DSM 16251 | All species
| Lactobacillus brevis DSM 16570 | All species
| Lactobacillus brevis KKP. 839 | All species
| Lactobacillus brevis NCIMB 8038 | All species
| Lactobacillus buchneri 71044 | All species
| Lactobacillus buchneri 71065 | All species
| Lactobacillus buchneri BIO 73 | All species
| Lactobacillus buchneri NCIMB 30137 | All species
| Lactobacillus buchneri NCIMB 30138 | All species
| Lactobacillus buchneri NCIMB 8007 | All species
| Lactobacillus bulgaricus MA 547/3M | All species
| Lactobacillus casei CCM 3775 | All species
| Lactobacillus casei CHCC2115 | All species
| Lactobacillus casei CNCM DA LC I-1247 | All species
| Lactobacillus casei MA 67/4U | All species
| Lactobacillus casei NCIMB 11970 | All species
| Lactobacillus casei NCIMB 30007 | All species
| Lactobacillus casei rhamnosus LC 705 DSM 7061 | All species
| Lactobacillus farciminis MA27/6B | All species
| Lactobacillus fermentum DSM 16250 | All species
| Lactobacillus helveticus CNCM DALH I-1251 | All species
| Lactobacillus mucosae DSM 16246 | All species
| Lactobacillus paracasei DSM 16572 | All species
| Lactobacillus paracasei ssp. Paracasei DSM 11394 | All species
| Lactobacillus paracasei ssp. Paracasei DSM 11395 | All species
| Lactobacillus paracasei ssp. Paracasei CNCM I-3292/P4126 | All species
| Lactobacillus plantarum 24001 | All species
| Lactobacillus plantarum 252 | All species
| Lactobacillus plantarum 50050 | All species
| Lactobacillus plantarum 88 | All species
| Lactobacillus plantarum AMY LMG-P22548 | All species
| Lactobacillus plantarum C KKP/783/p | All species
| Lactobacillus plantarum CCM 3769 | All species
| Lactobacillus plantarum CNCM DALP. I-1250 | All species
| Lactobacillus plantarum CNCM I-820 | All species
| Lactobacillus plantarum CNCM MA 27/5M | All species
| Lactobacillus plantarum DSM 12187 | All species
| Lactobacillus plantarum DSM 13367 | All species
| Lactobacillus plantarum DSM 13543 | All species
| Lactobacillus plantarum DSM 13544 | All species
| Lactobacillus plantarum DSM 13545 | All species
| Lactobacillus plantarum DSM 13546 | All species
| Lactobacillus plantarum DSM 13547 | All species
| Lactobacillus plantarum DSM 13548 | All species
| Lactobacillus plantarum DSM 16247 | All species
| Lactobacillus plantarum DSM 16571 | All species
| Lactobacillus plantarum DSM 16682 | All species
| Lactobacillus plantarum DSM 4784 | All species
| Lactobacillus plantarum DSM 4904 | All species
| Lactobacillus plantarum DSM 8427 | All species
| Lactobacillus plantarum DSM 8428 | All species
| Lactobacillus plantarum DSM 8862 | All species
| Lactobacillus plantarum DSM 8866 | All species
| Lactobacillus plantarum DSMZ 15683 | All species
| Lactobacillus plantarum DSMZ 16627 | All species
| Lactobacillus plantarum EU/EEC 1/24476 | All species
| Lactobacillus plantarum KKP/788/p | All species
| Lactobacillus plantarum L43 NCIMB 30146 | All species
| Lactobacillus plantarum L44 NCIMB 30147 | All species
| Lactobacillus plantarum L58 | All species
| Lactobacillus plantarum MA 541/2E | All species
| Lactobacillus plantarum Micron Bio-Systems culture collection | All species
| Lactobacillus plantarum NCIMB 12422 | All species
| Lactobacillus plantarum NCIMB 30004 | All species
| Lactobacillus plantarum NCIMB 30114 | All species
| Lactobacillus plantarum NCIMB 30115 | All species
| Lactobacillus plantarum NCIMB 30170 | All species
| Lactobacillus plantarum PL3/CSL | All species
| Lactobacillus plantarum PL6/CSL | All species
| Lactobacillus plantarum PLA/CSL | All species
| Lactobacillus reuteri CNCM MA28/6E-g | All species
| Lactobacillus reuteri CNCM MA28/6U-g | All species
| Lactobacillus reuteri DSM 16248 | All species
| Lactobacillus reuteri DSM 16249 | All species
| Lactobacillus rhamnosus MA27/6R | All species
| Lactobacillus sakei DSM 16564 | All species
| Lactobacillus sakei ssp. Sakei AK 5115 DSM 20017 | All species
| Lactococcus lactis CNCM I-3291/ATCC 7962 | All species
| Lactococcus Lactis NCIMB 30149 | All species
| Lactococcus lactis ssp. Lactis biovar diacetylactis CHCC2237 | All species
| Lactococcus lactis subsp. Lactis CHCC2871 | All species
| Leuconostoc mesenteroides DSM 8865 | All species
| Leuconostoc oeno LO1 | All species
| Leuconostoc pseudomesenteroides CHCC2114 | All species
| Pediococcus acidilactici AK 5201 DSM 20284 | All species
| Pediococcus acidilactici CNCM MA 151/5R | All species
| Pediococcus acidilactici DSM 10313 | All species
| Pediococcus acidilactici DSM 13946 | All species
| Pediococcus acidilactici ET 6 | All species
| Pediococcus acidilactici NCIMB 30005 | All species
| Pediococcus pentosaceus 69221 | All species
| Pediococcus pentosaceus AP35 | All species
| Pediococcus pentosaceus CCM 3770 | All species
| Pediococcus pentosaceus CNCM MA 25/4J | All species
| Pediococcus pentosaceus DSM 16566 | All species
| Pediococcus pentosaceus DSM 16569 | All species
| Pediococcus pentosaceus HTS LMG P-22549 | All species
| Pediococcus pentosaceus Micron Bio-Systems culture collection | All species
| Pediococcus pentosaeceus EU/EEC 2124476 | All species
| Propionibacterium freudenreichii shermanii JS DSM 7067 | All species
| Propionibacterium freudenreichii ssp. Shermanii AK 5502 DSM 4902 | All species
| Propionibacterium globosum CNCM DAPB I-1249 | All species
| Propionibacterium shermanii ATCC 9614 | All species
| Propionibacterium shermanii MBS-PS-01 | All species
| Propionibacterium sp. DSM 9576 | All species
| Propionibacterium sp. DSM 9577 | All species
| Rhodopseudomonas palustris ATTC 17001 | All species
| Saccharomyces cerevisiae 37584 | All species
| Saccharomyces cerevisiae 80566 | All species
| Serratia rubidaea NCIMB 40285 | All species
| Streptococcus cremoris CNCM DASC I-1244 | All species
| Streptococcus faecium 36 KKP. 880 | All species
| Streptococcus thermophilus CHCC3021 | All species
| Streptococcus thermophilus CNCM DAST I-1245 | All species
| Ammonium acetate | All species
| Ammonium acetate tetrahydrate | All species
| Ammonium benzoate | All species
| Ammonium bisulphite | All species
| Ammonium dipropionate | All species
| Attapulgite (clay) CAS No 12174-11-7 | All species
E 210 | Benzoic acid | All species
| Ethyl benzoate | All species
E 507 | Hydrochloric acid | All species
| Hydrogen peroxide | All species
| Isobutyric acid | All species
| Methenamine | All species
E 285 | Methylpropionic acid | All species
| Potassium bisulphite | All species
| Potassium formate | All species
| Potassium sulphate | All species
| Silicon dioxide | All species
E 222 | Sodium bisulphite | All species
E 223 | Sodium metabisulphite | All species
| Sodium sulphite | All species
| Sodium thiosulphate | All species
E 513 | Sulphuric acid | All species
| Tannin extract from sweet chestnut wood (Castanea sativa Mill, CAS No 1401-55-4) | All species
PART B
Feed additive belonging to the functional group of silage additives withdrawn for certain species or categories of animals
Identification Number | Additive | Species or category of animals
Category of technological additives. Functional group: silage additives
| Hexamethylene tetramine | All species with the exception of Bovines; Ovines; Pigs; Poultry; Rabbits; Horses; Goats
OJ L 268, 18.10.2003, p. 29.