- Y Diweddaraf sydd Ar Gael (Diwygiedig)
- Gwreiddiol (Fel y’i mabwysiadwyd gan yr UE)
Commission Implementing Regulation (EU) 2020/2118 of 16 December 2020 concerning the renewal of the authorisation of Pediococcus pentosaceus DSM 16244 as a feed additive for all animal species and repealing Regulation (EU) No 514/2010 (Text with EEA relevance)
When the UK left the EU, legislation.gov.uk published EU legislation that had been published by the EU up to IP completion day (31 December 2020 11.00 p.m.). On legislation.gov.uk, these items of legislation are kept up-to-date with any amendments made by the UK since then.
Mae unrhyw newidiadau sydd wedi cael eu gwneud yn barod gan y tîm yn ymddangos yn y cynnwys a chyfeirir atynt gydag anodiadau.Ar ôl y diwrnod ymadael bydd tair fersiwn o’r ddeddfwriaeth yma i’w gwirio at ddibenion gwahanol. Y fersiwn legislation.gov.uk yw’r fersiwn sy’n weithredol yn y Deyrnas Unedig. Y Fersiwn UE sydd ar EUR-lex ar hyn o bryd yw’r fersiwn sy’n weithredol yn yr UE h.y. efallai y bydd arnoch angen y fersiwn hon os byddwch yn gweithredu busnes yn yr UE. EUR-Lex Y fersiwn yn yr archif ar y we yw’r fersiwn swyddogol o’r ddeddfwriaeth fel yr oedd ar y diwrnod ymadael cyn cael ei chyhoeddi ar legislation.gov.uk ac unrhyw newidiadau ac effeithiau a weithredwyd yn y Deyrnas Unedig wedyn. Mae’r archif ar y we hefyd yn cynnwys cyfraith achos a ffurfiau mewn ieithoedd eraill o EUR-Lex. The EU Exit Web Archive legislation_originated_from_EU_p3
EU_status_warning_original_version
This legislation may since have been updated - see the latest available (revised) version
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(1), and in particular Article 9(2) 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 and renewing such authorisation.
(2) Pediococcus pentosaceus DSM 16244 was authorised for 10 years as a feed additive for all animal species by Commission Regulation (EU) No 514/2010(2).
(3) In accordance with Article 14 of Regulation (EC) No 1831/2003, an application was submitted for the renewal of the authorisation of Pediococcus pentosaceus DSM 16244 as a feed additive for all animal species, requesting the additive to be classified in the additive category ‘technological additives’. That application was accompanied by the particulars and documents required under Article 14(2) of that Regulation.
(4) The European Food Safety Authority (‘the Authority’) concluded in its opinion of 25 May 2020(3) that the applicant has provided evidence that the additive complies with the existing conditions of authorisation. The Authority concluded that Pediococcus pentosaceus DSM 16244 does not have an adverse effect on animal health, consumer safety or the environment. It also concluded that is not irritant to skin and eyes but considered a skin and respiratory sensitiser. Therefore, the Commission considers that appropriate protective measures should be taken to prevent adverse effects on human health, in particular as regards to users of the additive.
(5) The assessment of Pediococcus pentosaceus DSM 16244 shows that the conditions for authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied. Accordingly, the authorisation of that additive should be renewed as specified in the Annex to this Regulation.
(6) As a consequence of the renewal of the authorisation of Pediococcus pentosaceus DSM 16244 as a feed additive under the conditions laid down in the Annex to this Regulation, Regulation (EU) No 514/2010 should be repealed.
(7) The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,
HAS ADOPTED THIS REGULATION:
The authorisation of the additive specified in the Annex, belonging to the additive category ‘technological additives’ and to the functional group ‘silage additives’, is renewed subject to the conditions laid down in that Annex.
Regulation (EU) No 514/2010 is repealed.
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, 16 December 2020.
For the Commission
The President
Ursula von der Leyen
a Details of the analytical methods are available at the following address of the Reference Laboratory:https://ec.europa.eu/jrc/en/eurl/feed-additives/evaluation-reports | ||||||||
Identification number of the additive | Additive | Composition, chemical formula, description, analytical method | Species or category of animal | Maximum age | Minimum content | Maximum content | Other provisions | End of period of authorisation |
---|---|---|---|---|---|---|---|---|
CFU/kg of fresh material | ||||||||
Category of technological additives. Functional group: silage additives | ||||||||
1k2101 | Pediococcus pentosaceus DSM 16244 | Additive composition Preparation of Pediococcus pentosaceus DSM 16244 containing a minimum of 4 × 1011 CFU/g additive. | All animal species | - | - | - | 1. In the directions for use of the additive and premixtures, the storage conditions shall be indicated. 2. Minimum content of the additive when used without combination with other micro-organisms as silage additives: 1×108 CFU/kg fresh material. 3. For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks resulting from its use. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including gloves and breathing protection. | 6.1.2031 |
Characterisation of the active substance Pediococcus pentosaceus DSM 16244. | ||||||||
Analytical method a
|
Commission Regulation (EU) No 514/2010 of 15 June 2010 concerning the authorisation of Pediococcus pentosaceus (DSM 16244) as a feed additive for all animal species (OJ L 150, 16.6.2010, p. 42).
EFSA Journal 2020;18(6):6166.
Y Diweddaraf sydd Ar Gael (diwygiedig):Y fersiwn ddiweddaraf sydd ar gael o’r ddeddfwriaeth yn cynnwys newidiadau a wnaed gan ddeddfwriaeth ddilynol ac wedi eu gweithredu gan ein tîm golygyddol. Gellir gweld y newidiadau nad ydym wedi eu gweithredu i’r testun eto yn yr ardal ‘Newidiadau i Ddeddfwriaeth’.
Gwreiddiol (Fel y’i mabwysiadwyd gan yr UE): Mae'r wreiddiol version of the legislation as it stood when it was first adopted in the EU. No changes have been applied to the text.
Gallwch wneud defnydd o ddogfennau atodol hanfodol a gwybodaeth ar gyfer yr eitem ddeddfwriaeth o’r tab hwn. Yn ddibynnol ar yr eitem ddeddfwriaeth sydd i’w gweld, gallai hyn gynnwys:
Defnyddiwch y ddewislen hon i agor dogfennau hanfodol sy’n cyd-fynd â’r ddeddfwriaeth a gwybodaeth am yr eitem hon o ddeddfwriaeth. Gan ddibynnu ar yr eitem o ddeddfwriaeth sy’n cael ei gweld gall hyn gynnwys:
liciwch ‘Gweld Mwy’ neu ddewis ‘Rhagor o Adnoddau’ am wybodaeth ychwanegol gan gynnwys