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
Commission Implementing Regulation (EU) No 451/2012of 29 May 2012on 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 nutritionOJ L 268, 18.10.2003, p. 29., 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were listed in a separated part of the Community Register of Feed Additives.(5)Those feed additives should therefore be withdrawn from the market as far as their use as silage additives is concerned, except for species for which applications for authorisation have been submitted.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:
Article 1WithdrawalThe 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.
Article 2Transitional measures1.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.
Article 3Entry into forceThis 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 CommissionThe PresidentJosé Manuel BarrosoANNEXFeed additives belonging to the functional group of silage additives withdrawn from the market, as provided for in Article 1
PART AFeed additives belonging to the functional group of silage additives withdrawn for all species and categories of animalsCategory of technological additives. Functional group: silage additives
Identification NumberAdditiveSpecies or category of animals
Alpha-amylase EC 3.2.1.1 from Bacillus subtilis var amyloliquefaciensAll species
Amylase EC 3.2.1.1 from Aspergillus oryzaeAll species
Amylase EC 3.2.1.1 from maltAll species
Beta-1,4 Glucanase cellulase EC 3.2.1.4 from Aspergillus nigerAll species
Beta-1,4 Xylanase EC 3.2.1.37 from Trichoderma reeseiAll species
Beta-glucanase EC 3.2.1.6 from Trichoderma virideAll species
Cellulase EC 3.2.1.4 from Penicillium funiculosumAll species
Cellulase EC 3.2.1.4 from Trichoderma reeseiAll species
Cellulase EC 3.2.1.4 from Trichoderma virideAll species
Cellulase-hemicellulase complex EC 3.2.1.4 from Trichoderma reeseiAll species
Cellulase-xylanase complex EC 3.2.1.4 from Trichoderma reeseiAll species
Endo-1,3-beta-glucanase EC 3.2.1.6 from Bacillus amyloliquefaciensAll species
Endo-1,4-beta-D-mannanase EC 3.2.1.78 from Bacillus lentusAll species
Endo-1,4-beta-glucanase EC 3.2.1.4 from Trichoderma longibrachiatumAll species
Endo-1,4-beta-glucanase EC 3.2.1.6 from Bacillus amyloliquefaciensAll species
Endo-1,4-beta-xylanase EC 3.2.1.8. from Aspergillus oryzaeAll species
Glucoamylase EC 3.2.1.3. from Aspergillus nigerAll species
Glucose oxidase EC 1.1.3.4 from Aspergillus nigerAll species
Hemicellulase EC 3.2.1.8 from Aspergillus nigerAll species
Mannanase EC 3.2.1.77 from Aspergillus nigerAll species
Pectinase EC 3.2.1.15 from Aspergillus nigerAll species
Xylanase EC 3.2.1.8 from Aspergillus nigerAll species
Xylanase EC 3.2.1.8 from Penicillium funiculosumAll species
Xylanase EC 3.2.1.8 from Trichoderma reeseiAll species
Aspergillus oryzae AK 7001 DSM 1862All species
Bacillus coagulans CECT 7001All species
Bacillus lentus 302All species
Bacillus licheniformis DSM 5749All species
Bacillus licheniformis MBS-BL-01All species
Bacillus licheniformis Micron Bio-Systems culture collectionAll species
Bacillus pumilus BP288 ATCC 53682All species
Bacillus pumilus CNCM I-3240/NRRL B4064All species
Bacillus pumilus MBS-BP-01All species
Bacillus pumilus Micron Bio-Systems culture collectionAll species
Bacillus subtilis AK 6012 DSM 8563All species
Bacillus subtilis BS1All species
Bacillus subtilis CNCM I-3239/ATCC 6633All species
Bacillus subtilis DSM 5750All species
Bacillus subtilis Micron Bio-Systems culture collectionAll species
Bacillus subtilis NCIMB 40286All species
Bifidobacterium animalis ssp. Lactis CHCC5445/DSM15954All species
Bifidobacterium longum CNCM I-3241/ATCC 15707All species
Candida glabrata 35120All species
Clostridium sporogenes phage NCIMB 30008All species
Clostridium tyrobutyricum phage NCIMB 30008All species
Enterococcus faecium AP34All species
Enterococcus faecium CECT 7002All species
Enterococcus faecium CNCM DASF I-1248All species
Enterococcus faecium CNCM I-819All species
Enterococcus faecium DSM 15958All species
Enterococcus faecium DSM 16567All species
Enterococcus faecium DSM 16573All species
Enterococcus faecium DSM 5464All species
Enterococcus faecium M74 CCM 6226All species
Enterococcus faecium NCAIMAll species
Enterococcus faecium NCIMB 30006All species
Enterococcus faecium NCIMB 30098All species
Enterococcus faecium NCIMB 30122All species
Enterococcus mundtii 82760All species
Lactobacillus acidophilus 36587All species
Lactobacillus acidophilus CHCC3777/DSM13241All species
Lactobacillus acidophilus CNCM DALA I-1246All species
Lactobacillus acidophilus NCIMB 30067All species
Lactobacillus acidophilus NCAIMAll species
Lactobacillus amylolyticus CBS 116420All species
Lactobacillus amylovorans DSM 16251All species
Lactobacillus brevis DSM 16570All species
Lactobacillus brevis KKP. 839All species
Lactobacillus brevis NCIMB 8038All species
Lactobacillus buchneri 71044All species
Lactobacillus buchneri 71065All species
Lactobacillus buchneri BIO 73All species
Lactobacillus buchneri NCIMB 30137All species
Lactobacillus buchneri NCIMB 30138All species
Lactobacillus buchneri NCIMB 8007All species
Lactobacillus bulgaricus MA 547/3MAll species
Lactobacillus casei CCM 3775All species
Lactobacillus casei CHCC2115All species
Lactobacillus casei CNCM DA LC I-1247All species
Lactobacillus casei MA 67/4UAll species
Lactobacillus casei NCIMB 11970All species
Lactobacillus casei NCIMB 30007All species
Lactobacillus casei rhamnosus LC 705 DSM 7061All species
Lactobacillus farciminis MA27/6BAll species
Lactobacillus fermentum DSM 16250All species
Lactobacillus helveticus CNCM DALH I-1251All species
Lactobacillus mucosae DSM 16246All species
Lactobacillus paracasei DSM 16572All species
Lactobacillus paracasei ssp. Paracasei DSM 11394All species
Lactobacillus paracasei ssp. Paracasei DSM 11395All species
Lactobacillus paracasei ssp. Paracasei CNCM I-3292/P4126All species
Lactobacillus plantarum 24001All species
Lactobacillus plantarum 252All species
Lactobacillus plantarum 50050All species
Lactobacillus plantarum 88All species
Lactobacillus plantarum AMY LMG-P22548All species
Lactobacillus plantarum C KKP/783/pAll species
Lactobacillus plantarum CCM 3769All species
Lactobacillus plantarum CNCM DALP. I-1250All species
Lactobacillus plantarum CNCM I-820All species
Lactobacillus plantarum CNCM MA 27/5MAll species
Lactobacillus plantarum DSM 12187All species
Lactobacillus plantarum DSM 13367All species
Lactobacillus plantarum DSM 13543All species
Lactobacillus plantarum DSM 13544All species
Lactobacillus plantarum DSM 13545All species
Lactobacillus plantarum DSM 13546All species
Lactobacillus plantarum DSM 13547All species
Lactobacillus plantarum DSM 13548All species
Lactobacillus plantarum DSM 16247All species
Lactobacillus plantarum DSM 16571All species
Lactobacillus plantarum DSM 16682All species
Lactobacillus plantarum DSM 4784All species
Lactobacillus plantarum DSM 4904All species
Lactobacillus plantarum DSM 8427All species
Lactobacillus plantarum DSM 8428All species
Lactobacillus plantarum DSM 8862All species
Lactobacillus plantarum DSM 8866All species
Lactobacillus plantarum DSMZ 15683All species
Lactobacillus plantarum DSMZ 16627All species
Lactobacillus plantarum EU/EEC 1/24476All species
Lactobacillus plantarum KKP/788/pAll species
Lactobacillus plantarum L43 NCIMB 30146All species
Lactobacillus plantarum L44 NCIMB 30147All species
Lactobacillus plantarum L58All species
Lactobacillus plantarum MA 541/2EAll species
Lactobacillus plantarum Micron Bio-Systems culture collectionAll species
Lactobacillus plantarum NCIMB 12422All species
Lactobacillus plantarum NCIMB 30004All species
Lactobacillus plantarum NCIMB 30114All species
Lactobacillus plantarum NCIMB 30115All species
Lactobacillus plantarum NCIMB 30170All species
Lactobacillus plantarum PL3/CSLAll species
Lactobacillus plantarum PL6/CSLAll species
Lactobacillus plantarum PLA/CSLAll species
Lactobacillus reuteri CNCM MA28/6E-gAll species
Lactobacillus reuteri CNCM MA28/6U-gAll species
Lactobacillus reuteri DSM 16248All species
Lactobacillus reuteri DSM 16249All species
Lactobacillus rhamnosus MA27/6RAll species
Lactobacillus sakei DSM 16564All species
Lactobacillus sakei ssp. Sakei AK 5115 DSM 20017All species
Lactococcus lactis CNCM I-3291/ATCC 7962All species
Lactococcus Lactis NCIMB 30149All species
Lactococcus lactis ssp. Lactis biovar diacetylactis CHCC2237All species
Lactococcus lactis subsp. Lactis CHCC2871All species
Leuconostoc mesenteroides DSM 8865All species
Leuconostoc oeno LO1All species
Leuconostoc pseudomesenteroides CHCC2114All species
Pediococcus acidilactici AK 5201 DSM 20284All species
Pediococcus acidilactici CNCM MA 151/5RAll species
Pediococcus acidilactici DSM 10313All species
Pediococcus acidilactici DSM 13946All species
Pediococcus acidilactici ET 6All species
Pediococcus acidilactici NCIMB 30005All species
Pediococcus pentosaceus 69221All species
Pediococcus pentosaceus AP35All species
Pediococcus pentosaceus CCM 3770All species
Pediococcus pentosaceus CNCM MA 25/4JAll species
Pediococcus pentosaceus DSM 16566All species
Pediococcus pentosaceus DSM 16569All species
Pediococcus pentosaceus HTS LMG P-22549All species
Pediococcus pentosaceus Micron Bio-Systems culture collectionAll species
Pediococcus pentosaeceus EU/EEC 2124476All species
Propionibacterium freudenreichii shermanii JS DSM 7067All species
Propionibacterium freudenreichii ssp. Shermanii AK 5502 DSM 4902All species
Propionibacterium globosum CNCM DAPB I-1249All species
Propionibacterium shermanii ATCC 9614All species
Propionibacterium shermanii MBS-PS-01All species
Propionibacterium sp. DSM 9576All species
Propionibacterium sp. DSM 9577All species
Rhodopseudomonas palustris ATTC 17001All species
Saccharomyces cerevisiae 37584All species
Saccharomyces cerevisiae 80566All species
Serratia rubidaea NCIMB 40285All species
Streptococcus cremoris CNCM DASC I-1244All species
Streptococcus faecium 36 KKP. 880All species
Streptococcus thermophilus CHCC3021All species
Streptococcus thermophilus CNCM DAST I-1245All species
Ammonium acetateAll species
Ammonium acetate tetrahydrateAll species
Ammonium benzoateAll species
Ammonium bisulphiteAll species
Ammonium dipropionateAll species
Attapulgite (clay) CAS No 12174-11-7All species
E 210Benzoic acidAll species
Ethyl benzoateAll species
E 507Hydrochloric acidAll species
Hydrogen peroxideAll species
Isobutyric acidAll species
MethenamineAll species
E 285Methylpropionic acidAll species
Potassium bisulphiteAll species
Potassium formateAll species
Potassium sulphateAll species
Silicon dioxideAll species
E 222Sodium bisulphiteAll species
E 223Sodium metabisulphiteAll species
Sodium sulphiteAll species
Sodium thiosulphateAll species
E 513Sulphuric acidAll species
Tannin extract from sweet chestnut wood (Castanea sativa Mill, CAS No 1401-55-4)All species
PART BFeed additive belonging to the functional group of silage additives withdrawn for certain species or categories of animalsCategory of technological additives. Functional group: silage additives
Identification NumberAdditiveSpecies or category of animals
Hexamethylene tetramineAll species with the exception of Bovines; Ovines; Pigs; Poultry; Rabbits; Horses; Goats