Article 1
The authorisation of the additives specified in the Annex, belonging to the additive category ‘nutritional additives’ and to the functional group ‘compounds of trace elements’, is renewed subject to the conditions laid down in that Annex.
Commission Implementing Regulation (EU) 2019/804 of 17 May 2019 concerning the renewal of the authorisation of organic form of selenium produced by Saccharomyces cerevisiae CNCM I-3060 and of selenomethionine produced by Saccharomyces cerevisiae NCYC R397 as feed additives for all animal species and repealing Regulations (EC) No 1750/2006 and (EC) No 634/2007 (Text with EEA relevance.)
Commission Implementing Regulation (EU) 2019/804 of 17 May 2019 concerning the renewal of the authorisation of organic form of selenium produced by Saccharomyces cerevisiae CNCM I-3060 and of selenomethionine produced by Saccharomyces cerevisiae NCYC R397 as feed additives for all animal species and repealing Regulations (EC) No 1750/2006 and (EC) No 634/2007 (Text with EEA relevance.)
Data as of 2026-07-04 · Compiled from an official source version. Later amendments or repeals may not be reflected; the official text prevails. · Read the official text ↗
Article 2
1. The organic form of selenium produced by Saccharomyces cerevisiae CNCM I-3060, selenomethionine produced by Saccharomyces cerevisiae NCYC R397 and premixtures containing these substances, which are produced and labelled before 9 December 2019 in accordance with the rules applicable before 9 June 2019 may continue to be placed on the market and used until the existing stocks are exhausted. 2. Feed materials and compound feed containing the substances referred to in point 1, which are produced and labelled before 9 June 2020 in accordance with the rules applicable before 9 June 2019 may continue to be placed on the market and used until the existing stocks are exhausted if they are intended for food-producing animals. 3. Feed materials and compound feed containing the substances referred to in point 1, which are produced and labelled before 9 June 2021 in accordance with the rules applicable before 9 June 2019 may continue to be placed on the market and used until the existing stocks are exhausted if they are intended for non-food-producing animals.
Article 3
Regulations (EC) No 1750/2006 and (EC) No 634/2007 are repealed.
Article 4
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union .
Supplementary provisions
ANNEXSupplementary provisions
ANNEX Identification number of the additive Name of the holder of authorisation 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 Selenium in mg/kg of complete feed with a moisture content of 12 % Category of nutritional additives. Functional group: compounds of trace elements 3b810 — Selenised yeast Saccharomyces cerevisiae CNCM I-3060, inactivated Additive composition Preparation of organic selenium: Content of selenium: 2 000 to 2 400 mg Se/kg Organic selenium > 97 to 99 % of total selenium Selenomethionine > 63 % of total selenium Characterisation of the active substance Selenomethionine produced by Saccharomyces cerevisiae CNCM I-3060 Chemical formula: C 5 H 11 NO 2 Se Analytical method ( 1 ) For the determination of selenomethionine in the feed additive: — reversed phase high performance liquid chromatography with UV detection (RP-HPLC-UV) or — high performance liquid chromatography and inductively coupled plasma mass spectrometry (HPLC-ICPMS) after triple proteolytic digestion. For the determination of total selenium in the feed additive: — inductively coupled plasma atomic emission spectrometry (ICP-AES) or — inductively coupled plasma mass spectrometry (ICPMS). For the determination of total selenium in premixtures, compound feed and feed materials: — hydride generation atomic absorption spectrometry (HGAAS) after microwave digestion (EN 16159:2012). All species — 0,50 (total) 1. The additive shall be incorporated into feed in the form of a premixture. 2. For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation. 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 breathing protection. 3. In the directions for use of the additive and premixtures, indicate the storage and stability conditions. 4. Maximum supplementation with organic selenium: 0,20 mg Se/kg of complete feed with a moisture content of 12 %. 9 June 2029 3b811 — Selenised yeast Saccharomyces cerevisiae NCYC R397, inactivated Additive composition Preparation of organic selenium: Content of selenium: 2 000 to 3 500 mg Se/kg Organic selenium > 98 % of total selenium Selenomethionine > 63 % of total selenium Characterisation of the active substance Selenomethionine produced by Saccharomyces cerevisiae NCYC R397 Chemical formula: C 5 H 11 NO 2 Se Analytical method ( 1 ) For the determination of selenomethionine in the feed additive: — reversed phase high performance liquid chromatography with UV detection (RP-HPLC-UV) or — high performance liquid chromatography and inductively coupled plasma mass spectrometry (HPLC-ICPMS) after triple proteolytic digestion. For the determination of total selenium in the feed additive: — inductively coupled plasma atomic emission spectrometry (ICP-AES) or — inductively coupled plasma mass spectrometry (ICPMS). For the determination of total selenium in premixtures, compound feed and feed materials: — hydride generation atomic absorption spectrometry (HGAAS) after microwave digestion (EN 16159:2012). All species — 0,50 (total) 1. The additive shall be incorporated into feed in the form of a premixture. 2. For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal, mucosae or eye contact. 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 breathing protection, safety glasses and gloves. 3. In the directions for use of the additive and premixtures, indicate the storage and stability conditions. 4. Maximum supplementation with organic selenium: 0,20 mg Se/kg of complete feed with a moisture content of 12 %. 9 June 2029 ( 1 ) Details of the analytical methods are available at the following address of the European Union Reference Laboratory: http://irmm.jrc.ec.europa.eu/EURLs/EURL_feed_additives/authorisation/evaluation_reports/Pages/index.aspx
Other acts of the same type
Commission Implementing Regulation (EU) 2020/1177 of 7 August 2020 amending Implementing Regulation (EU) 2020/469 as regards postponing dates of application of certain measures in the context of the COVID-19 pandemic (Text with EEA relevance)Commission Regulation (EU) 2020/1181 of 7 August 2020 correcting certain language versions of Directive 2007/46/EC of the European Parliament and of the Council establishing a framework for the approval of motor vehicles and their trailers, and of systems, components and separate technical units intended for such vehicles (Framework Directive), correcting certain language versions of Commission Regulation (EU) No 582/2011 implementing and amending Regulation (EC) No 595/2009 of the European Parliament and of the Council with respect to emissions from heavy duty vehicles (Euro VI) and amending Annexes I and III to Directive 2007/46/EC of the European Parliament and of the Council, and correcting the Danish language version of Commission Regulation (EU) 2017/2400 implementing Regulation (EC) No 595/2009 of the European Parliament and of the Council as regards the determination of the CO2 emissions and fuel consumption of heavy-duty vehicles and amending Directive 2007/46/EC of the European Parliament and of the Council and Commission Regulation (EU) No 582/2011 (Text with EEA relevance)Commission Implementing Regulation (EU) 2020/1187 of 7 August 2020 granting a Union authorisation for the biocidal product family ‘Iodine based products – CID LINES NV’ (Text with EEA relevance)Commission Implementing Regulation (EU) 2020/1198 of 7 August 2020 approving a non-minor amendment to the specification for a name entered in the register of protected designations of origin and protected geographical indications (‘Piave’ (PDO))Commission Implementing Regulation (EU) 2020/1208 of 7 August 2020 on structure, format, submission processes and review of information reported by Member States pursuant to Regulation (EU) 2018/1999 of the European Parliament and of the Council and repealing Commission Implementing Regulation (EU) No 749/2014 (Text with EEA relevance)Commission Implementing Regulation (EU) 2020/1163 of 6 August 2020 authorising the placing on the market of vitamin D2 mushroom powder as a novel food under Regulation (EU) 2015/2283 of the European Parliament and of the Council and amending Commission Implementing Regulation (EU) 2017/2470 (Text with EEA relevance)Commission Delegated Regulation (EU) 2020/1564 of 6 August 2020 amending Delegated Regulation (EU) 2018/985 as regards its transitional provisions in order to address the impact of the COVID-19 crisisCommission Implementing Regulation (EU) 2020/1158 of 5 August 2020 on the conditions governing imports of food and feed originating in third countries following the accident at the Chernobyl nuclear power station (Text with EEA relevance)Commission Implementing Regulation (EU) 2020/1159 of 5 August 2020 amending Regulations (EU) No 1321/2014 and (EU) No 2015/640 as regards the introduction of new additional airworthiness requirementsCommission Implementing Regulation (EU) 2020/1160 of 5 August 2020 amending Implementing Regulation (EU) No 540/2011 as regards the extension of the approval periods of the active substances aluminium ammonium sulphate, aluminium silicate, blood meal, calcium carbonate, carbon dioxide, extract from tea tree, fat distillation residues, fatty acids C7 to C20, garlic extract, gibberellic acid, gibberellins, hydrolysed proteins, iron sulphate, kieselgur (diatomaceous earth), plant oils/rape seed oil, potassium hydrogen carbonate, quartz sand, fish oil, repellents by smell of animal or plant origin/sheep fat, Straight Chain Lepidopteran Pheromones, tebuconazole and urea (Text with EEA relevance)Commission Delegated Regulation (EU) 2020/2012 of 5 August 2020 amending Delegated Regulation (EU) 2018/161 establishing a de minimis exemption to the landing obligation for certain small pelagic fisheries in the Mediterranean Sea, as regards its period of applicationCommission Regulation (EU) 2020/1149 of 3 August 2020 amending Annex XVII to Regulation (EC) No 1907/2006 of the European Parliament and of the Council concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) as regards diisocyanates (Text with EEA relevance)
Source: EUR-Lex (Publications Office of the EU), © European Union, reuse permitted under Commission Decision 2011/833/EU.
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