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.)
Modified by
  • Commission Implementing Regulation (EU) 2022/1459of 2 September 2022amending Implementing Regulation (EU) 2019/804 as regards the terms of authorisation of the organic form of selenium produced by Saccharomyces cerevisiae CNCM I-3060 as feed additive for all animal species(Text with EEA relevance), 32022R1459, September 5, 2022
Commission Implementing Regulation (EU) 2019/804of 17 May 2019concerning 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)
Article 1The 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.
Article 21.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 3Regulations (EC) No 1750/2006 and (EC) No 634/2007 are repealed.
Article 4This 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.ANNEX
Details of the analytical methods are available at the following address of the European Union Reference Laboratory: https://joint-research-centre.ec.europa.eu/eurl-fa-eurl-feed-additives/eurl-fa-authorisation/eurl-fa-evaluation-reports_enCategory of nutritional additives. Functional group: compounds of trace elements
Identification number of the additiveName of the holder of authorisationAdditiveComposition, chemical formula, description, analytical method.Species or category of animalMaximum ageMinimum contentMaximum contentOther provisionsEnd of period of authorisation
Selenium in mg/kg of complete feed with a moisture content of 12 %
3b810—Selenised yeast Saccharomyces cerevisiae CNCM I-3060, inactivatedAdditive compositionPreparation of organic selenium:Content of selenium: 2000 to 2400 mg Se/kgOrganic selenium > 97 to 99 % of total seleniumSelenomethionine > 63 % of total seleniumAll species—0,50 (total)1.The additive shall be incorporated into feed in the form of a premixture.2.The directions for use of the additive and premixtures shall indicate the storage and stability conditions.3.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.4.Maximum supplementation with organic selenium:0,2 mg Se/kg of complete feed with a moisture content of 12 %.9 June 2029
Characterisation of the active substanceSelenomethionine produced by Saccharomyces cerevisiae CNCM I-3060Chemical formula: C5H11NO2Se
Analytical method:For the determination of selenomethionine in the feed additive:reversed phase high performance liquid chromatography with UV detection (RP-HPLC-UV) orhigh 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) orinductively 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).
3b810i—Selenised yeast Saccharomyces cerevisiae CNCM I-3060, inactivatedAdditive compositionPreparation of organic selenium:Content of selenium 3000-3500 mg Se/kgOrganic selenium > 97 to 99 % of total seleniumSelenomethionine > 63 % of total seleniumAll species—0,50 (total)1.The additive shall be incorporated into feed in the form of a premixture.2.The directions for use of the additive and premixtures shall indicate the storage and stability conditions.3.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.4.Maximum supplementation with organic selenium:0,2 mg Se/kg of complete feed with a moisture content of 12 %.5.The dusting potential of the additive shall ensure a maximal Se exposure of 0,2 mg Se/m39 June 2029
Characterisation of the active substanceSelenomethionine produced by Saccharomyces cerevisiae CNCM I-3060Chemical formula: C5H11NO2Se
Analytical methodFor the determination of selenomethionine in the feed additive:reversed phase high performance liquid chromatography with UV detection (RP-HPLC-UV) orhigh 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) orinductively 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).
3b811—Selenised yeast Saccharomyces cerevisiae NCYC R397, inactivatedAdditive compositionPreparation of organic selenium:Content of selenium: 2000 to 3500 mg Se/kgOrganic selenium > 98 % of total seleniumSelenomethionine > 63 % of total seleniumCharacterisation of the active substanceSelenomethionine produced by Saccharomyces cerevisiae NCYC R397Chemical formula: C5H11NO2SeAnalytical methodFor the determination of selenomethionine in the feed additive:reversed phase high performance liquid chromatography with UV detection (RP-HPLC-UV) orhigh 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) orinductively 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
Article 1The 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.
Article 21.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 3Regulations (EC) No 1750/2006 and (EC) No 634/2007 are repealed.
Article 4This 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.ANNEX
Details of the analytical methods are available at the following address of the European Union Reference Laboratory: https://joint-research-centre.ec.europa.eu/eurl-fa-eurl-feed-additives/eurl-fa-authorisation/eurl-fa-evaluation-reports_enCategory of nutritional additives. Functional group: compounds of trace elements
Identification number of the additiveName of the holder of authorisationAdditiveComposition, chemical formula, description, analytical method.Species or category of animalMaximum ageMinimum contentMaximum contentOther provisionsEnd of period of authorisation
Selenium in mg/kg of complete feed with a moisture content of 12 %
3b810—Selenised yeast Saccharomyces cerevisiae CNCM I-3060, inactivatedAdditive compositionPreparation of organic selenium:Content of selenium: 2000 to 2400 mg Se/kgOrganic selenium > 97 to 99 % of total seleniumSelenomethionine > 63 % of total seleniumAll species—0,50 (total)1.The additive shall be incorporated into feed in the form of a premixture.2.The directions for use of the additive and premixtures shall indicate the storage and stability conditions.3.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.4.Maximum supplementation with organic selenium:0,2 mg Se/kg of complete feed with a moisture content of 12 %.9 June 2029
Characterisation of the active substanceSelenomethionine produced by Saccharomyces cerevisiae CNCM I-3060Chemical formula: C5H11NO2Se
Analytical method:For the determination of selenomethionine in the feed additive:reversed phase high performance liquid chromatography with UV detection (RP-HPLC-UV) orhigh 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) orinductively 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).
3b810i—Selenised yeast Saccharomyces cerevisiae CNCM I-3060, inactivatedAdditive compositionPreparation of organic selenium:Content of selenium 3000-3500 mg Se/kgOrganic selenium > 97 to 99 % of total seleniumSelenomethionine > 63 % of total seleniumAll species—0,50 (total)1.The additive shall be incorporated into feed in the form of a premixture.2.The directions for use of the additive and premixtures shall indicate the storage and stability conditions.3.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.4.Maximum supplementation with organic selenium:0,2 mg Se/kg of complete feed with a moisture content of 12 %.5.The dusting potential of the additive shall ensure a maximal Se exposure of 0,2 mg Se/m39 June 2029
Characterisation of the active substanceSelenomethionine produced by Saccharomyces cerevisiae CNCM I-3060Chemical formula: C5H11NO2Se
Analytical methodFor the determination of selenomethionine in the feed additive:reversed phase high performance liquid chromatography with UV detection (RP-HPLC-UV) orhigh 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) orinductively 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).
3b811—Selenised yeast Saccharomyces cerevisiae NCYC R397, inactivatedAdditive compositionPreparation of organic selenium:Content of selenium: 2000 to 3500 mg Se/kgOrganic selenium > 98 % of total seleniumSelenomethionine > 63 % of total seleniumCharacterisation of the active substanceSelenomethionine produced by Saccharomyces cerevisiae NCYC R397Chemical formula: C5H11NO2SeAnalytical methodFor the determination of selenomethionine in the feed additive:reversed phase high performance liquid chromatography with UV detection (RP-HPLC-UV) orhigh 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) orinductively 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