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Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 implementing Regulation (EC) No 1107/2009 of the European Parliament and of the Council as regards the list of approved active substances Text with EEA relevance
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· 2011-05-25
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Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 impl
Changes on 2024-05-01
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| 130 | Cyprodinil CAS No 121522-61-2 CIPAC No 511 | (4-cyclopropyl-6-methyl-pyrimidin-2-yl)-phenyl-amine | ≥ 980 g/kg | 1 May 2007 | 15 March 2025 | PART A Only uses as fungicide may be authorised. PART B For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on cyprodinil, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 4 April 2006 shall be taken into account. In this overall assessment Member States: — must pay particular attention to the safety of operators and ensure that conditions of use prescribe the application of adequate personal protective equipment, — must pay particular attention to the protection of birds, mammals and aquatic organisms. Conditions of authorisation should include risk mitigation measures, such as buffer zones. The concerned Member States shall request the submission of further studies to confirm the risk assessment for birds and mammals and for possible presence of residues of metabolite CGA 304075 in food of animal origin. They shall ensure that the notifiers at whose request cyprodinil has been included in this Annex provide such studies to the Commission within two years from the approval. |
| 131 | Fosetyl CAS No 15845-66-6 CIPAC No 384 | Ethyl hydrogen phosphonate | ≥ 960 g/kg (expressed as fosetyl-Al) | 1 May 2007 | 15 March 2025 | PART A Only uses as fungicide may be authorised. PART B For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on fosetyl, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 4 April 2006 shall be taken into account. In this overall assessment Member States: — must pay particular attention to the protection of birds, mammals, aquatic organisms and non-target arthropods. Conditions of authorisation should include risk mitigation measures, where appropriate, such as buffer zones. The concerned Member States shall request the submission of further studies to confirm the risk assessment for non-target arthropods, in particular with regard to in-field recovery, and for herbivorous mammals. They shall ensure that the notifier at whose request fosetyl has been included in this Annex provide such studies to the Commission within two years from the approval. |
| 132 | Trinexapac CAS No 104273-73-6 CIPAC No 732 | 4-(cyclopropyl-hydroxymethylene)-3,5-dioxo- cyclohexanecarboxylic acid | ≥ 940 g/kg (expressed as trinexapac-ethyl) | 1 May 2007 | 15 December 2024 | PART A Only uses as plant growth regulator may be authorised. PART B For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on trinexapac, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 4 April 2006 shall be taken into account. In this overall assessment Member States: — must pay particular attention to the protection of birds and mammals. Conditions of authorisation should include risk mitigation measures, where appropriate. |
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| 133 | Dichlorprop-P CAS No 15165-67-0 CIPAC No 476 | (R)-2-(2,4-dichlorophenoxy) propanoic acid | ≥ 900 g/kg | 1 June 2007 | 15 March 2025 | PART A Only uses as herbicide may be authorised. As regards cereals, only application in spring may be authorised, at rates not exceeding 800 g active substance per hectare per application. Use on grassland shall not be authorised. PART B For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on dichlorprop-P, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 23 May 2006 shall be taken into account. In this overall assessment Member States shall pay particular attention to the protection of birds, mammals, aquatic organisms and non-target plants. Conditions of authorisation shall include risk mitigation measures, where appropriate. |
| 134 | Metconazole CAS No 125116-23-6 (unstated stereo-chemistry) CIPAC No 706 | (1RS,5RS:1RS,5SR)-5-(4-chlorobenzyl)-2,2-dimethyl-1-(1H-1,2,4-triazol-1-ylmethyl) cyclopentanol | ≥ 940 g/kg (sum of cis-and trans-isomers) | 1 June 2007 | 15 March 2025 | PART A Only uses as fungicide and plant growth regulator may be authorised. PART B For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on metconazole, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 23 May 2006 shall be taken into account. In this overall assessment: — Member States must pay particular attention to the protection of aquatic organisms, birds and mammals. Conditions of authorisation should include risk mitigation measures, where appropriate, — Member States must pay particular attention to the operator safety. Conditions of authorisation should include protective measures, where appropriate. |
| 135 | Pyrimethanil CAS No 53112-28-0 CIPAC No not allocated | N-(4,6-dimethylpyrimidin-2-yl) aniline | ≥ 975 g/kg (the manufacturing impurity cyanamide is considered to be of toxicological concern and must not exceed 0,5 g/kg in the technical material) | 1 June 2007 | 15 March 2025 | PART A Only uses as fungicide may be authorised. PART B For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on pyrimethanil, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 23 May 2006 shall be taken into account. In this overall assessment Member States: — must pay particular attention to the protection of aquatic organisms. Conditions of authorisation should include risk mitigation measures, where appropriate, such as buffer zones, — must pay particular attention to the operator safety and ensure that conditions of use prescribe the application of adequate personal protective equipment. The Member States concerned shall request the submission of further studies to confirm the risk assessment to fish. They shall ensure that the notifiers at whose request pyrimethanil has been included in this Annex provide such studies to the Commission within two years from the approval. |
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| 232 | Gibberellic acid CAS No 77-06-5 CIPAC No 307 | (3S,3aS,4S,4aS,7S,9aR,9bR,12S)-7,12-dihydroxy-3-methyl-6-methylene-2-oxoperhydro-4a,7-methano-9b,3-propenol(1,2-b)furan-4-carboxylic acid Alt: (3S,3aR,4S,4aS,6S,8aR,8bR,11S)-6,11-dihydroxy-3-methyl-12-methylene-2-oxo-4a,6-methano-3,8b-prop-lenoperhydroindenol (1,2-b) furan-4-carboxylic acid | ≥ 850 g/kg | 1 September 2009 | 15 July 2025 | PART A Only uses as plant growth regulator may be authorised. PART B For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on gibberellic acid (SANCO/2613/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account. Conditions of use shall include, where appropriate, risk mitigation measures. |
| 233 | Gibberellins CAS No GA4: 468-44-0 GA7: 510-75-8 GA4A7 mixture: 8030-53-3 CIPAC No not allocated | GA4: (3S,3aR,4S,4aR,7R,9aR,9bR,12S)-12-hydroxy-3-methyl-6-methylene-2-oxoperhydro-4a,7-methano-3,9b-propanoazuleno[1,2-b]furan-4-carboxylic acid GA7: (3S,3aR,4S,4aR,7R,9aR,9bR,12S)-12-hydroxy-3-methyl-6-methylene-2-oxoperhydro-4a,7-methano-9b,3-propenoazuleno[1,2-b]furan-4-carboxylic acid | Review report (SANCO/2614/2008). | 1 September 2009 | 15 July 2025 | PART A Only uses as plant growth regulator may be authorised. PART B For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on gibberellins (SANCO/2614/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account. Conditions of use shall include, where appropriate, risk mitigation measures. |
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| 234 | Hydrolysed proteins CAS No not allocated CIPAC No 901 | Not available | Review report (SANCO/2615/2008) | 1 September 2009 | 15 April 2025 | PART A Only uses as attractant may be authorised. Hydrolysed proteins of animal origin must be in compliance with Regulation (EC) No 1069/2009 (<sup>17</sup>) and Commission Regulation (EU) No 142/2011 (<sup>18</sup>). PART B For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on hydrolysed proteins (SANCO/2615/08) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 1 June 2012 shall be taken into account. In this overall assessment Member States shall pay particular attention to the operator and worker safety; conditions of use shall include the application of adequate personal protective equipment, where appropriate. Conditions of use shall include, where appropriate, risk mitigation measures. The Member States concerned shall ensure that the applicant submits to the Commission confirmatory information as regards: (a) the specifications of the technical material, as commercially manufactured, supported by appropriate analytical data; (b) the risk to aquatic organisms. The Member States concerned shall ensure that the applicant submits to the Commission the information set out in point (a) by 1 May 2013, the information set out in point (b) by 1 November 2013. |
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| 235 | *Iron sulphate*: Iron(II)sulfate anhydrous: CAS No 7720-78-7 Iron(II)sulfate monohydrate: CAS No 17375-41-6 Iron(II)sulfate heptahydrate: CAS No 7782-63-0 CIPAC No 837 | Iron(II)sulphate or iron(2+) sulfate | Iron(II)sulfate anhydrous: ≥ 350 g/kg total iron. Relevant impurities: arsenic, 18 mg/kg cadmium, 1,8 mg/kg chromium, 90 mg/kg lead, 36 mg/kg mercury, 1,8 mg/kg expressed on the basis of the anhydrous variant | 1 September 2009 | 30 November 2026 | PART A Only uses as herbicide may be authorised. PART B For the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the amended review report on iron sulphate (SANCO/2616/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 1 June 2012 shall be taken into account. In this overall assessment Member States shall pay particular attention to: — the risk for operator; — the risk to children/residents playing on treated turf; — the risk to surface waters and to aquatic organisms. Conditions of use shall include, where appropriate, risk mitigation measures and the application of adequate personal protective equipment. The notifier shall submit to the Member States, the Commission and the Authority, confirmatory information as regards the equivalence between the specifications of the technical material, as commercially manufactured, and those of the test material used in the toxicity dossiers. The Member States concerned shall ensure that the notifier submits to the Commission such information by 1 May 2013. |
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| 257 | Urea CAS No 57-13-6 CIPAC No 913 | Urea | ≥ 98 % w/w | 1 September 2009 | 30 November 2026 | PART A Only uses as attractant and fungicide may be authorised. PART B For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on urea (SANCO/2637/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 1 June 2012 shall be taken into account. Conditions of use shall include, where appropriate, risk mitigation measures. The notifier shall submit confirmatory information as regards: (a) the analysis method for urea and for the impurity biuret; (b) the risk for operators, workers and bystanders. The information set out in point (a) and in point (b) shall be submitted to the Member States, the Commission and the Authority respectively by 1 May 2013 and 1 January 2016. |
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| 167 | Aluminium ammonium sulfate (dodecahydrate) *CAS No:* 7784-26-1 CIPAC No: 840 | Aluminium ammonium sulfate | — 975 g/kg — Anhydrous - Not less than 510 g/kg — No relevant impurities | 1.2.2024 | 31.1.2039 | For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on Aluminium ammonium sulfate, and in particular Appendices I and II thereto, shall be taken into account. In this overall assessment Member States shall pay particular attention to: — the protection of operators and workers where relevant, ensuring that conditions of use include the application of adequate personal protective equipment; — the protection of aquatic organisms when the substance is applied in regions with acidic or basic soil conditions; — the protection of bees from spray applications during the flowering period of adjacent fields or when flowering weeds are present in the treated field; — the protection of groundwater, when the substance is applied in regions with vulnerable soil and/or climatic conditions (i.e. situations when soil pH is lower than 5,5, e.g. grassland in upland areas, areas of coniferous forestry and areas of ericaceous ornamental plant growing); — the authorisation, for use on row and combinable crops, as a barrier treatment only on field edges. Conditions of use shall include risk mitigation measures where relevant. |
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| 168 | Ethephon CAS No: 16672-87-0 CIPAC No: 373 | 2-chloroethylphosphonic acid | ≥ 692 g/kg (TK) ≥ 910 g/kg (TC, theoretical) The following impurities are of toxicological concern and shall not exceed the following levels in the technical material: TK: 1,2-dichloroethane < 0,3 g/kg 2-chloroethanol < 0,3 g/kg TC (theoretical): 1,2-dichloroethane < 0,5 g/kg 2-chloroethanol < 0,3 g/kg | 1 February 2024 | 31 January 2039 | For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on ethephon, and in particular Appendices I and II thereto, shall be taken into account. In this overall assessment Member States shall pay particular attention to: — the protection of operators and workers, ensuring that conditions of use include the application of adequate personal protective equipment; — the protection of bystanders and residents, ensuring that conditions of use include the use of drift reduction equipment during application. Conditions of use shall include risk mitigation measures, where appropriate. |
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| 169 | Trinexapac-ethyl CAS No 95266-40-3 CIPAC No 732.202 | ethyl (1*RS*,4*EZ*)-4-cyclopropyl(hydroxy)methylene-3,5-dioxocyclohexanecarboxylate | ≥ 950 g/kg The following impurities shall not exceed the following levels in the technical material: — toluene: 3 g/kg — ethyl (1*RS*)-3-hydroxy-5-oxocyclohex-3-ene-1-carboxylate (CGA158377): 6 g/kg | 1 May 2024 | 30 April 2039 | For the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the renewal report on trinexapac-ethyl, and in particular Appendices I and II thereof, shall be taken into account. In their overall assessment Member States shall pay particular attention to: — the specification of technical material used in plant protection products, in particular when carrying out assessments of equivalence in accordance with Article 38 of Regulation (EC) No 1107/2009; — the assessment of consumer intake from the diet taking into account the residues of the metabolites of trinexapac-ethyl and the impact of processing; — the levels of residues of the metabolites of trinexapac-ethyl, when straw is used as animal feeding stuff. Conditions of use shall include restrictions for feeding of straw to animals and risk mitigation measures, where appropriate. The applicant shall submit to the Commission, Member States and the Authority confirmatory information as regards the effect of water treatment processes on the nature of residues of trinexapac-ethyl and its metabolites present in surface water, when surface water is abstracted for drinking water, by 1 April 2026. |
| (<sup>1</sup>) Further details on identity and specification of active substance are provided in the review report. (<sup>2</sup>) 2-hydroxy-4,6-dimethoxypyrimidine. (<sup>3</sup>) 2,4-dihydroxy-6-methoxypyrimidine. (<sup>4</sup>) sodium 2-hydroxy-6-(4-hydroxy-6-methoxypyrimidin-2-yl)oxybenzoate. (<sup>5</sup>) 5-(trifluoromethyl)-2(1H)-pyridinone. (<sup>6</sup>) 4-{[5-(trifluoromethyl)-2-pyridinyl]oxy}phenol. (<sup>7</sup>) M03: [(8-tert-butyl-1,4-dioxaspiro[4.5]dec-2-yl)methyl]ethyl(propyl)amine oxide. (<sup>8</sup>) 5-[2-chloro-4-(trifluoromethyl)phenoxy]-2-[(methoxymethyl)amino]phenol. (<sup>9</sup>) 3-chloro-4-[3-(ethenyloxy)-4-hydroxyphenoxy]benzoic acid. (<sup>10</sup>) 2-chloro-1-(3-methoxy-4-nitrophenoxy)-4-(trifluoromethyl)benzene. (<sup>11</sup>) 4-(3-ethoxy-4-hydroxyphenoxy)benzoic acid. (<sup>12</sup>) 3-phenoxybenzaldehyde. (<sup>13</sup>) Dioxins (sum of polychlorinated dibenzo-para-dioxins (PCDDs) and polychlorinated dibenzofurans (PCDFs), expressed as World Health Organisation (WHO) toxic equivalent (TEQ) using the WHO-toxic equivalency factors (WHO-TEFs)). (<sup>14</sup>) 7-amino-5-ethyl[1,2,4]triazolo[1,5-a]pyrimidine-6-carboxylic acid. (<sup>15</sup>) 3-chloro-5-[(4,6-dimethoxy-2-pyrimidinyl)amino]-1-methyl-1*H*-pyrazole-4-carboxylic acid. (<sup>16</sup>) 3-chloro-1-methyl-5-sulfamoyl-1*H*-pyrazole-4-carboxylic acid. (<sup>17</sup>) *p*-methyl-phenethylamine. (<sup>18</sup>) OJ L 353, 31.12.2008, p. 1. (<sup>19</sup>) Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006 (OJ L 353, 31.12.2008, p. 1). (<sup>20</sup>) Commission Regulation (EU) 2018/605 of 19 April 2018 amending Annex II to Regulation (EC) No 1107/2009 by setting out scientific criteria for the determination of endocrine disrupting properties. (OJ L 101, 20.4.2018, p. 33). (<sup>21</sup>) https://ec.europa.eu/food/sites/food/files/plant/docs/pesticides_ppp_app-proc_guide_phys-chem-ana_microbial-contaminant-limits.pdf (<sup>22</sup>) Guidance for the identification of endocrine disruptors in the context of Regulations (EU) No 528/2012 and (EC) No 1107/2009. EFSA Journal 2018;16(6):5311; ECHA-18-G-01-EN. (<sup>23</sup>) Guidance for the identification of endocrine disruptors in the context of Regulations (EU) No 528/2012 and (EC) No 1107/2009 https://efsa.onlinelibrarv.wilev.eom/doi/epdt710.2903/i.efsa.2018.5311 (<sup>24</sup>) https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32018R0605&from=EN (<sup>25</sup>) Commission Regulation (EU) 2022/1439 of 31 August 2022 amending Regulation (EU) No 283/2013 as regards the information to be submitted for active substances and the specific data requirements for micro-organisms (OJ L 227, 1.9.2022, p. 8). (<sup>26</sup>) Guidance on the risk assessment of metabolites produced by microorganisms used as plant protection active substances (SANCO/2020/12258): https://food.ec.europa.eu/system/files/2020-11/pesticides_ppp_app-proc_guide_180653_microorganism-metabolites-concern_202011.pdf. (<sup>27</sup>) Guidance on the approval and low-risk criteria linked to ‘antimicrobial resistance’ applicable to microorganisms used for plant protection (SANTE/2020/12260): https://food.ec.europa.eu/system/files/2020-11/pesticides_ppp_app-proc_guide_180652_microorganism-amr_202011.pdf. (<sup>28</sup>) pesticides_ppp_app-proc_guide_phys-chem-ana_microbial-contaminant-limits.pdf (europa.eu). (<sup>29</sup>) Commission Implementing Regulation (EU) 2023/574 of 13 March 2023 setting out detailed rules for the identification of unacceptable coformulants in plant protection products in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council (OJ L 75, 14.3.2023, p. 7). (<sup>30</sup>) Directive 2000/60/EC of the European Parliament and of the Council of 23 October 2000 establishing a framework for Community action in the field of water policy (OJ L 327, 22.12.2000, p. 1). | | | | | | |
### PART C
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| 23 | *Allium cepa* L. bulb extract CAS No: not allocated CIPAC No: not allocated | Not applicable | The onion bulbs used to prepare the extracts shall be of food grade quality meeting the requirements of WHO monographs on selected medicinal plants (Volume 1, Geneva, 1999) on Bulbus *Allii Cepae* | 17.2.2021 | *Allium cepa* L. bulb extract shall be used in accordance with the specific conditions included in the conclusions of the review report on *Allium cepa* L. bulb extract (SANTE/10842/2020 Rev2) and in particular Appendices I and II thereof. |
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| 24 | Chitosan CAS No: 9012-76-4 EC No: 618-480-0 | Chemical name (not IUPAC): poly[4-O-(2-acetamido-2-deoxy-β-D-glucopyranosyl)-2-amino-2-deoxy-β-D-glucopyranose] | ≥ 85 % chitosan heavy metals: max. 20 mg/kg Food grade, meeting the specifications for ‘chitosan extract from fungi’ as set out in Commission Implementing Regulation (EU) 2017/2470 (<sup>5</sup>) | 11 April 2022 | Chitosan shall be used in accordance with the specific conditions included in the conclusions of the review report on chitosan (SANTE/10594/2021) and in particular Appendices I and II thereto. |
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| 25 | magnesium hydroxide E528 CAS No: 1309-42-8 CIPAC No: Not available | magnesium dihydroxide | 95 % Relevant impurities: Lead < 2 mg/kg Arsenic < mg/kg | 2 April 2024 | Magnesium hydroxide shall be used in accordance with the specific conditions included in the conclusions of the review report on magnesium hydroxide (PLAN/2023/2331 RR Rev2) and in particular Appendices I and II thereof. |
| (<sup>1</sup>) Further details on identity, specification and manner of use of basic substance are provided in the review report. (<sup>2</sup>) Available online: http://www.fao.org/fao-who-codexalimentarius/standards/list-of-standards/en/ (<sup>3</sup>) Commission Regulation (EU) No 231/2012 of 9 March 2012 laying down specifications for food additives listed in Annexes II and III to Regulation (EC) No 1333/2008 of the European Parliament and of the Council (OJ L 83, 22.3.2012, p. 1). (<sup>4</sup>) Commission Implementing Regulation (EU) No 1060/2013 of 29 October 2013 concerning the authorisation of bentonite as a feed additive for all animal species (OJ L 289, 31.10.2013, p. 33). (<sup>5</sup>) Commission Implementing Regulation (EU) 2017/2470 of 20 December 2017 establishing the Union list of novel foods in accordance with Regulation (EU) 2015/2283 of the European Parliament and of the Council on novel foods (OJ L 351, 30.12.2017, p. 72). | | | | | |
### PART D
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| 45 | Fat distillation residues CAS No not available 915 (CIPAC No) | Not available | ≥ 400 g/kg of cleaved fatty acids (free/ester bonded) palmitic acid min 19 % of cleaved fatty acids stearic acid min 18 % of cleaved fatty acids oleic acid min 37 % of cleaved fatty acids acid value min 70 mg KOH/g The following impurity is of toxicological concern and shall not exceed the following levels in the technical material: nickel max 0,1 g/kg | 1 November 2023 | 31 October 2038 | For the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the renewal report on fat distillation residues, and in particular Appendices I and II thereof, shall be taken into account. Conditions of use shall include risk mitigation measures, where appropriate. |
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| 46 | *Cydia pomonella* granulovirus (CpGV) | Not applicable | *Bacillus cereus*: < 1 × 10<sup>7</sup> CFU/g in the formulated products. | 1 November 2023 | 31 October 2038 | For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on *Cydia pomonella* granulovirus (CpGV), and in particular Appendices I and II thereto, shall be taken into account. In this overall assessment Member States shall pay particular attention to: — the strict maintenance of environmental conditions and quality control analysis during the manufacturing process to be assured by the producer, in order to ensure the fulfilment of the limits on microbiological contamination as referred to in the Working Document SANCO/12116/2012 (<sup>5</sup>), — the protection of operators and workers, taking into account that microorganisms are per se considered as potential sensitizers, ensuring that adequate personal protective equipment is included as a condition of use. Conditions of use shall include risk mitigation measures, where appropriate. |
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| 47 | Hydrolysed proteins CAS No: Not applicable CIPAC No: 901 | Not available | Hydrolysed proteins. *Animal tissues hydrolysate excluding ruminants hides and skins* (no ISO common name): — 708 g/kg on a dry weight basis [range in TK (technical concentrate) 400-434 g/kg]. Hydrolysed proteins. *Urea enriched beet molasses, hydrolysed* (no ISO common name): — 110 g/kg on a dry weight basis [range in TK (technical concentrate) 90-110 g/kg]. Hydrolysed Proteins. *Collagen protein Hydrolysate* (no ISO common name): — 582 g/kg on a dry weight basis [range in TK (technical concentrate) 249-262 g/kg]. Lead, cadmium, arsenic, mercury and biuret in accordance with Regulation (EU) 2019/1009 on fertilising products. Formaldehyde below 1 g/kg. | 1 May 2024 | 30 April 2039 | For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the renewal report on hydrolysed proteins, and in particular Appendices I and II thereto, shall be taken into account. In this overall assessment Member States shall pay particular attention to: — the specification of the technical material for *‘hydrolysed proteins-urea enriched beet molasses, hydrolysed’* as commercially manufactured on the basis of an analysis of at least five representative batches. Conditions of use shall include risk mitigation measures, where appropriate. |
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| 48 | Urea CAS No: 57-13-6 CIPAC No: 913 | Urea | 980 g/kg The following impurities were considered of toxicological concern and a maximum level is established of: Biuret: < 12 g/kg Formaldehyde: < 0,5 g/kg Cadmium: < 1 mg/kg Mercury: < 0,1 mg/kg Lead: < 1 mg/kg Arsenic: < 1 mg/kg | 1 May 2024 | 30 April 2039 | For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the renewal report on urea, and in particular Appendices I and II thereto, shall be taken into account. In this overall assessment Member States shall pay particular attention to: — the specification of the technical material as commercially manufactured on the basis of an analysis of at least five representative batches. Conditions of use shall include risk mitigation measures, where appropriate. |
| (<sup>1</sup>) Further details on identity and specification of active substance are provided in the review report. (<sup>2</sup>) https://ec.europa.eu/food/sites/food/files/plant/docs/pesticides_ppp_app-proc_guide_phys-chem-ana_microbial-contaminant-limits.pdf (<sup>3</sup>) Commission Regulation (EU) No 546/2011 of 10 June 2011 implementing Regulation (EC) No 1107/2009 of the European Parliament and of the Council as regards uniform principles for evaluation and authorisation of plant protection products (OJ L 155, 11.6.2011, p. 127). (<sup>4</sup>) The concerned active substance was initially approved as *Verticillium lecanii*, but later, for scientific reasons, its name was changed to *Lecanicillium muscarium* strain Ve6, which was later changed again to the name under which the approval was renewed, *Akanthomyces muscarius* strain Ve6. (<sup>5</sup>) https://ec.europa.eu/food/system/files/2016-10/pesticides_ppp_app-proc_guide_phys-chem-ana_microbial-contaminant-limits.pdf (<sup>6</sup>) Directive 2002/32/EC of the European Parliament and of the Council of 7 May 2002 on undesirable substances in animal feed (OJ L 140, 30.5.2002, p. 10). (<sup>7</sup>) Expressed in World Health Organisation (WHO) toxic equivalents. | | | | | | |
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original version
Text at this date