Fertilising Products Regulation

02019R1009-20220716 → 02019R1009-20221003

ANNEX I Product Function Categories (PFCs) of EU fertilising products PART I DESIGNATION OF PFCS 1. Fertiliser A. Organic fertiliser I. Solid organic fertiliser II. Liquid organic fertiliser B. Organo-mineral fertiliser I. Solid organo-mineral fertiliser II. Liquid organo-mineral fertiliser C. Inorganic fertiliser I. Inorganic macronutrient fertiliser (a) Solid inorganic macronutrient fertiliser (i) Straight solid … 1,957 unchanged words … inorganic fertiliser which contains more than 1 % by mass of organic carbon (Corg), other than organic carbon (Corg) from: chelating or complexing agents referred to in point 3 of component material category (CMC) 1 in Part II of Annex II, nitrification inhibitors, nitrification, denitrification inhibitors or urease inhibitors inhibiting compounds referred to in point 4 of CMC 1 in Part II of Annex II, coating agents referred to in point 1(a) of CMC 9 in Part II of Annex II, urea (CH4N2O), or calcium cyanamide (CaCN2) shall meet the requirement that pathogens in an … 4,069 unchanged words … the nature of each component EU fertilising product and shall not have an adverse effect on human, animal or plant health, on safety, or on the environment, under reasonably foreseeable conditions of storage or use of the fertilising product blend. 2a. An inhibiting compound in a blend shall be present in a concentration, which is within the range of concentrations that ensures the achievement of the reduction rates in the conditions referred to in PFC 5 in Part II of this Annex and, respectively, in point 4 of CMC 1 in Part II of Annex II, at the level of the blend. 3. The manufacturer of the blend shall assess the conformity of the blend with the requirements set out in points 1 1, 2 and 2 2a of this PFC, ensure the blend’s compliance with the labelling requirements laid down in Annex III, and assume responsibility pursuant to Article 16(4) of this Regulation for the compliance of the blend with the requirements of this Regulation by: (a) drawing up an EU declaration of conformity for the fertilising product blend in accordance with Article 6(2) of this Regulation, and (b) being in possession of the EU declaration of conformity of each of the component EU fertilising products. 4. Economic operators making fertilising product blends available on the market shall respect the following provisions of this Regulation with regard to the EU declaration of conformity of each component EU fertilising product as well as of the blend: (a) Article 6(3) (manufacturers’ obligation to keep the EU declaration of conformity); (b) point (a) of Article 7(2) (authorised representatives’ obligation to keep the EU declaration of conformity); (c) Article 8(8) (importers’ obligation to keep a copy of the EU declaration of conformity at the disposal of the market surveillance authorities).

02019R1009-20220716 → 02019R1009-20221003

ANNEX II Component Material Categories (CMCs) An EU fertilising product shall consist solely of component materials complying with the requirements for one or more of the CMCs listed in this Annex. The component materials, and the input materials used to produce them, shall … 440 unchanged words … phosphate salts, elemental sulphur, calcium carbonate or calcium oxide, which are recovered from waste within the meaning of Article 3, point 1, of Directive 2008/98/EC. 2. All substances incorporated into the EU fertilising product, on their own or in a mixture, except polymers, shall have been registered pursuant to Regulation (EC) No 1907/2006 In the case of a substance recovered in the European Union, this condition is fulfilled if the substance is the same, within the meaning of point (d)(i) of Article 2(7) of Regulation (EC) No 1907/2006, as a substance registered with a dossier containing the information here indicated, and if information is available to the fertilising product manufacturer within the meaning of point (d)(ii) of Article 2(7) of Regulation (EC) No 1907/2006., with a dossier containing: (a) the information provided for by Annexes VI, VII and VIII to Regulation (EC) No 1907/2006, and 1907/2006; (b) a chemical safety report pursuant to Article 14 of Regulation (EC) No 1907/2006 covering the use as a fertilising product, unless explicitly covered by one of the registration obligation exemptions provided for by Annex IV to Regulation (EC) No 1907/2006 or by points 6, 7, 8, 9 or 9 10 (only for magnesia) of Annex V to that Regulation. 3. Where the substance or one of the substances in the mixture is intended to enhance the long term availability to plants of micronutrients in the EU fertilising product, that substance shall be either a chelating agent or a complexing agent, and the following rules shall apply: (a) The chelating agent shall be an organic substance consisting in a molecule which: (i) has two or more sites that donate electron pairs to a central transition metal cation (zinc (Zn), copper (Cu), iron (Fe), manganese (Mn), magnesium (Mg), calcium (Ca) or cobalt (Co)), and (ii) is large enough to form a five- or six- membered cyclic structure. The EU fertilising product shall remain stable for at least 3 days in a solution having any pH within the range declared as guaranteeing acceptable stability. (b) The complexing agent shall be an organic substance forming a flat or steric structure with one di- or tri- valent transition metal cation (zinc (Zn), copper (Cu), iron (Fe), manganese (Mn) or cobalt (Co)). The EU fertilising product shall remain stable in water solution at pH 6 and 7 for at least 1 day. 4. Where the substance or one of the substances in the mixture is intended to improve the EU fertilising product’s nutrient release patterns by delaying or stopping the activity of specific groups of micro-organisms or enzymes, that substance shall be an a nitrification inhibitor, nitrification, a denitrification inhibitor or a urease inhibitor, inhibiting compound, and the following rules shall apply: (a) The nitrification inhibitor inhibiting compound shall inhibit the biological oxidation of ammoniacal nitrogen (NH3-N) contained in the EU fertilising product to nitrite nitrogen (NO2-), thus slowing the formation of nitrate nitrogen (NO3-). The ammoniacal nitrogen (NH3-N) oxidation rate shall be measured by either by: of the following: (i) ammoniacal nitrogen (NH3-N) disappearance, or disappearance; (ii) the sum of nitrite nitrogen (NO2-) and nitrate nitrogen (NO3-) production with respect to time. Compared to a control sample where the nitrification inhibitor inhibiting compound has not been added, a soil sample containing the nitrification inhibitor inhibiting compound shall show a 20 % reduction in ammoniacal nitrogen (NH3-N) oxidation rate based on an analysis carried out 14 days after application at the 95 % confidence level. The nitrification inhibiting compound shall be present in the EU fertilising product in a concentration, which is within the range of concentrations that ensures the achievement of such a reduction. At least 50 % of the total nitrogen (N) content of the EU fertilising product shall consist of the nitrogen (N) forms ammonium (NH4+) (NH4 +) and urea (CH4N2O). (b) The denitrification inhibitor inhibiting compound shall inhibit the formation of nitrous oxide (N2O) contained in the EU fertilising product by slowing down or blocking the conversion of nitrate (NO3-) to dinitrogen (N2) without influencing the nitrification process as described in PFC 5(A). Compared to a control sample where the denitrification inhibitor inhibiting compound has not been added, an in vitro test containing the denitrification inhibitor inhibiting compound shall show a 20 % reduction in rate of the release of nitrous oxide (N2O) based on an analysis carried out 14 days after application at the 95 % confidence level. The denitrification inhibiting compound shall be present in the EU fertilising product in a concentration, which is within the range of concentrations that ensures the achievement of such a reduction. (c) The urease inhibitor inhibiting compound shall inhibit hydrolytic action on urea (CH4N2O) contained in the EU fertilising product by the urease enzyme, primarily targeted to reduce ammonia volatilisation. Compared to a control sample where the urease inhibitor inhibiting compound has not been added, an in vitro test containing the urease inhibitor inhibiting compound shall show a 20 % reduction in the rate of hydrolysis of urea (CH4N2O) based on an analysis carried out 14 days after application at the 95 % confidence level. The urease inhibiting compound shall be present in the EU fertilising product in a concentration, which is within the range of concentrations that ensures the achievement of such a reduction. At least 50 % of the total nitrogen (N) content of the EU fertilising product shall consist of the nitrogen (N) form urea (CH4N2O). CMC 2: PLANTS, PLANT PARTS OR PLANT EXTRACTS An EU fertilising product may contain plants, plant parts or plant extracts having undergone no processing other than cutting, grinding, milling, sieving, sifting, centrifugation, pressing, drying, frost treatment, freeze-drying, extraction with water, supercritical CO2 extraction, or fiberisation at a temperature not higher than 100 °C and without any additives except water. For the purpose of this point, plants include mushrooms and algae and exclude blue-green algae (cyanobacteria). CMC 3: COMPOST 1. An EU fertilising product may contain compost obtained through aerobic composting of exclusively one or more of the following input materials: (a) bio-waste within the meaning of Directive 2008/98/EC resulting from separate bio-waste collection at source; (b) derived products referred to in Article 32 of Regulation (EC) No 1069/2009 for which the end point in the manufacturing chain has been determined in accordance with the third subparagraph of Article 5(2) of that Regulation; (c) living or dead organisms or parts thereof, which are unprocessed or processed only by manual, mechanical or gravitational means, by dissolution in water, by flotation, by extraction with water, by steam distillation or by heating solely to remove water, or which are extracted from air by any means, except: (i) materials originating from mixed municipal waste,’; (ii) sewage sludge, industrial sludge or dredging sludge, and (iii) animal by-products or derived products within the scope of Regulation (EC) No 1069/2009. (d) composting additives which are necessary to improve the process performance or the environmental performance of the composting process provided that: (i) the additive is registered pursuant to Regulation (EC) No 1907/2006 In complies with the case of an additive recovered requirement set out in the European Union, this condition is fulfilled if the additive is the same, within the meaning of point (d)(i) of Article 2(7) of Regulation (EC) No 1907/2006, as a substance registered with a dossier containing the information here indicated, and if information is available to the fertilising product manufacturer within the meaning of point (d)(ii) of Article 2(7) of Regulation (EC) No 1907/2006., with a dossier containing: the information provided for by Annexes VI, VII and VIII to Regulation (EC) No 1907/2006, and a chemical safety report pursuant to Article 14 of Regulation (EC) No 1907/2006 covering the use as a fertilising product, unless explicitly covered by one of the registration obligation exemptions provided for by Annex IV to Regulation (EC) No 1907/2006 or by point 6, 7, 8 or 9 of Annex V to that Regulation, 2 in CMC 1 and (ii) the total concentration of all additives does not exceed 5 % of the total input material weight; or (e) any material listed in points (a) or (c) or in point 1a which: (i) has previously been composted or digested, and (ii) contains … 557 unchanged words … the production of biogas. For the purpose of this point, plants include algae and exclude blue-green algae (cyanobacteria); (b) digestion additives which are needed to improve the process performance or the environmental performance of the digestion process provided that: (i) the additive is registered pursuant to Regulation (EC) No 1907/2006 In complies with the case of an additive recovered requirement set out in the European Union, this condition is fulfilled if the additive is the same, within the meaning of point (d)(i) of Article 2(7) of Regulation (EC) No 1907/2006, as a substance registered with a dossier containing the information here indicated, and if information is available to the fertilising product manufacturer within the meaning of point (d)(ii) of Article 2(7) of Regulation (EC) No 1907/2006., with a dossier containing: the information provided for by Annexes VI, VII and VIII to Regulation (EC) No 1907/2006, and a chemical safety report pursuant to Article 14 of Regulation (EC) No 1907/2006 covering the use as a fertilising product, unless explicitly covered by one of the registration obligation exemptions provided for by Annex IV to Regulation (EC) No 1907/2006 or by point 6, 7, 8 or 9 of Annex V to that Regulation, 2 in CMC 1 and (ii) the total concentration of all additives does not exceed 5 % of the total input material weight; or (c) any material referred to in point (a) that has previously been digested. 2. The anaerobic digestion shall take place in a plant: (a) in which production lines for the processing of input materials referred to in point 1 are clearly separated from production lines for the processing of input materials other than those referred to in point 1, and (b) where physical contacts between input and output materials are avoided, including during storage. 3. The anaerobic digestion shall consist of controlled decomposition of biodegradable materials, which is predominantly anaerobic and at temperatures suitable for mesophilic or thermophilic bacteria. All parts of each batch shall be regularly and thoroughly moved and turned in order to ensure the correct sanitation and homogeneity of the material. During the digestion process, all parts of each batch shall have one of the following temperature-time profiles: (a) thermophilic anaerobic digestion at 55 °C for at least 24 hours followed by a hydraulic retention time of at least 20 days; (b) thermophilic anaerobic digestion at 55 °C with a treatment process including pasteurisation as described in point 1 of Section 1 of Chapter I of Annex V to Commission Regulation (EU) No 142/2011 Commission Regulation (EU) No 142/2011 of 25 February 2011 implementing Regulation (EC) No 1069/2009 of the European Parliament and of the Council laying down health rules as regards animal by-products and derived products not intended for human consumption and implementing Council Directive 97/78/EC as regards certain samples and items exempt from veterinary checks at the border under that Directive (OJ L 54, 26.2.2011, p. 1).; (c) thermophilic anaerobic digestion at 55 °C followed by composting in: 70 °C or more for at least 3 days, 65 °C or more for at least 5 days, 60 °C or more for at least 7 days, or 55 °C or more for at least 14 days; (d) mesophilic anaerobic digestion at 37-40 °C with a treatment process including pasteurisation as described in point 1 of Section 1 of Chapter I of Annex V to Regulation (EU) No 142/2011; or (e) mesophilic anaerobic digestion at 37-40 °C followed by composting in: 70 °C or more for at least 3 days, 65 °C or more for at least 5 days, 60 °C or more for at least 7 days, or 55 °C or more for at least 14 days. 4. Both the 3a. An EU fertilising product may contain a solid and the or liquid fraction, obtained by mechanical separation of a digestate compliant with points 1 to 3. 3b. An EU fertilising product may contain a digestate compliant with points 1 to 3, or a fraction compliant with point 3a, from which all or part of the soluble ammonium and/or of the phosphate has been removed to recover nitrogen and/or phosphorus, without the intention to otherwise modify the digestate or the fraction. 3c. An EU fertilising product may contain a digestate compliant with points 1 to 3 or point 3b, as well as a fraction compliant with point 3a, which have undergone only physical processing to remove water without the intention to otherwise modify the digestate or the fraction. 3d. Additives needed in the post processing of a digestate or a fraction in accordance with points 3a, 3b and 3c may be used provided that: (a) the additive complies with the requirement set out in point 2 in CMC 1; (b) the concentration of the additives needed in each of the processes does not exceed 5 % of the weight of the digestate or fraction used as input in the respective process. 4. The digestate or a fraction referred to in points 3a, 3b and 3c shall meet at least one of the following stability criteria: (a) Oxygen uptake rate: Definition: an indicator of the extent to which biodegradable organic matter is being broken down within a specified time period. The method is not suitable for material with a content of particle sizes > 10 mm that exceeds 20 %; Criterion: maximum 25 mmol O2/kg organic matter/h; or (b) Residual biogas potential: Definition: an indicator of the gas released from a digestate in a 28 day period and measured against the volatile solids contained within the sample. The test is run in triplicate, and the average result is used to demonstrate compliance with the criterion. The volatile solids are those solids in a sample of material that are lost on ignition of the dry solids at 550 °C; Criterion: maximum 0,25 l biogas/g volatile solids. CMC 5: DIGESTATE OTHER THAN FRESH CROP DIGESTATE 1. An EU fertilising product may contain digestate obtained through anaerobic digestion of exclusively one or more of the following input materials: (a) bio-waste within the meaning of Directive 2008/98/EC resulting from separate bio-waste collection at source; (b) derived products referred to in Article 32 of Regulation (EC) No 1069/2009 for which the end point in the manufacturing chain has been determined in accordance with the third subparagraph of Article 5(2) of that Regulation; (c) living or dead organisms or parts thereof, which are unprocessed or processed only by manual, mechanical or gravitational means, by dissolution in water, by flotation, by extraction with water, by steam distillation or by heating solely to remove water, or which are extracted from air by any means, except: (i) materials originating from mixed municipal waste,’; (ii) sewage sludge, industrial sludge or dredging sludge, and (iii) animal by-products or derived products within the scope of Regulation (EC) No 1069/2009. (d) digestion additives which are necessary to improve the process performance or the environmental performance of the digestion process provided that: (i) the additive is registered pursuant to Regulation (EC) No 1907/2006 In complies with the case of an additive recovered requirement set out in the European Union, this condition is fulfilled if the additive is the same, within the meaning of point (d)(i) of Article 2(7) of Regulation (EC) No 1907/2006, as a substance registered with a dossier containing the information here indicated, and if information is available to the fertilising product manufacturer within the meaning of point (d)(ii) of Article 2(7) of Regulation (EC) No 1907/2006., with a dossier containing: the information provided for by Annexes VI, VII and VIII to Regulation (EC) No 1907/2006, and a chemical safety report pursuant to Article 14 of Regulation (EC) No 1907/2006 covering the use as a fertilising product, unless explicitly covered by one of the registration obligation exemptions provided for by Annex IV to Regulation (EC) No 1907/2006 or by point 6, 7, 8 or 9 of Annex V to that Regulation, 2 in CMC 1 and (ii) the total concentration of all additives does not exceed 5 % of the total input material weight; or (e) any material listed in points (a) or (c) or in point 1a which: (i) has previously been composted or digested, and (ii) contains no more than 6 mg/kg dry matter of PAH16 Sum of naphthalene, acenaphthylene, acenaphthene, fluorene, phenanthrene, anthracene, fluoranthene, pyrene, benzo[a]anthracene, chrysene, benzo[b]fluoranthene, benzo[k]fluoranthene, benzo[a]pyrene, indeno[1,2,3-cd]pyrene, dibenzo[a,h]anthracene and benzo[ghi]perylene.. 1a. Notwithstanding point 1, an EU fertilising product may contain compost digestate obtained through aerobic composting anaerobic digestion of Category 2 or Category 3 materials or derived products thereof, in accordance with the conditions set out in Article 32(1) and (2) and in the measures referred to in Article 32(3) of Regulation (EC) No 1069/2009, alone or mixed with input materials referred to in point 1, provided that: (a) the end point in the manufacturing chain has been determined in accordance with the third subparagraph of Article 5(2) of Regulation (EC) No 1069/2009, and (b) the conditions in points 2 and 3 are met. 2. The anaerobic digestion shall take place in a plant: (a) in which production lines for the processing of input materials referred to in points 1 and 1a are clearly separated from production lines for the processing of input materials other than those referred to in points 1 and 1a, and (b) where physical contacts between input and output materials are avoided, including during storage. 3. The anaerobic digestion shall consist of controlled decomposition of biodegradable materials, which is predominantly anaerobic and at temperatures suitable for mesophilic or thermophilic bacteria. All parts of each batch shall be regularly and thoroughly moved and turned in order to ensure the correct sanitation and homogeneity of the material. During the digestion process, all parts of each batch shall have one of the following temperature-time profiles: (a) thermophilic anaerobic digestion at 55 °C for at least 24 hours followed by a hydraulic retention time of at least 20 days; (b) thermophilic anaerobic digestion at 55 °C with a treatment process including pasteurisation as described in point 1 of Section 1 of Chapter I of Annex V to Regulation (EU) No 142/2011; (c) thermophilic anaerobic digestion at 55 °C followed by composting in: 70 °C or more for at least 3 days, 65 °C or more for at least 5 days, 60 °C or more for at least 7 days, or 55 °C or more for at least 14 days; (d) mesophilic anaerobic digestion at 37-40 °C with a treatment process including pasteurisation as described in point 1 of Section 1 of Chapter I of Annex V to Regulation (EU) No 142/2011; or (e) mesophilic anaerobic digestion at 37-40 °C followed by composting in: 70 °C or more for at least 3 days, 65 °C or more for at least 5 days, 60 °C or more for at least 7 days, or 55 °C or more for at least 14 days. 4. Neither the 3a. An EU fertilising product may contain a solid nor the or liquid fraction obtained by mechanical separation of a digestate compliant with points 1 to 3. 3b. An EU fertilising product may contain a digestate compliant with points 1 to 3, or a fraction compliant with point 3a, from which all or part of the soluble ammonium and/or of the phosphate has been removed to recover nitrogen and/or phosphorus, without the intention to otherwise modify the digestate or the fraction. 3c. An EU fertilising product may contain a digestate compliant with points 1 to 3 or point 3b, as well as a fraction compliant with point 3a, which have undergone only physical processing to remove water without the intention to otherwise modify the digestate or the fraction. 3d. Additives needed in the post processing of a digestate or a fraction in accordance with points 3a, 3b and 3c may be used provided that: (a) the additive complies with the requirement set out in point 2 in CMC 1; (b) the concentration of the additives needed in each of the processes does not exceed 5 % of the weight of the digestate or fraction used as input in the respective process. 4. The digestate or the fraction referred to in points 3a, 3b and 3c shall not contain more than 6 mg/kg dry matter of PAH16 Sum of naphthalene, acenaphthylene, acenaphthene, fluorene, phenanthrene, anthracene, fluoranthene, pyrene, benzo[a]anthracene, chrysene, benzo[b]fluoranthene, benzo[k]fluoranthene, benzo[a]pyrene, indeno[1,2,3-cd]pyrene, dibenzo[a,h]anthracene and benzo[ghi]perylene. benzo[ghi]perylene.. 5. The digestate or the fraction referred to in points 3a, 3b and 3c shall contain: (a) no more than 3 g/kg dry matter of macroscopic impurities above 2 mm in any of the following forms: glass, metal or plastics; and (b) no more than 5 g/kg dry matter of the sum of the macroscopic impurities referred to in point (a). From 16 July 2026, the presence of plastics above 2 mm within the maximum limit value referred to in point (a) shall be no more than 2,5 g/kg dry matter. By 16 July 2029 the limit-value of 2,5 g/kg dry matter for plastics above 2 mm shall be re-assessed in order to take into account the progress made with regards to separate collection of bio-waste. 6. Both The digestate or the solid fraction referred to in points 3a, 3b and the liquid part of the digestate 3c shall meet at least one of the following stability criteria: (a) Oxygen uptake rate: Definition: an indicator of the extent to which biodegradable organic matter is being broken down within a specified time period. The method is not suitable for material with a content of particle sizes > 10 mm that exceeds 20 %. Criterion: maximum 25 mmol O2/kg organic matter/h; or (b) Residual biogas potential: Definition: an indicator of the gas released from a digestate in a 28 day period and measured against the volatile solids contained within the sample. The test is run in triplicate, and the average result is used to demonstrate compliance with the criterion. The volatile solids are those solids in a sample of material that are lost on ignition of the dry solids at 550 °C. Criterion: maximum 0,25 l biogas/g volatile solids. CMC 6: FOOD INDUSTRY BY-PRODUCTS 1. An EU fertilising product may contain component material consisting of one of the following substances: (a) food industry factory lime, i.e. a material from the food processing industry obtained by carbonation of organic matter, using exclusively burnt lime from natural sources; (b) molasses, i.e. a viscous by-product of the refining of sugarcane or sugar beets into sugar; (c) vinasse, i.e. a viscous by-product of the fermentation process of molasses into ethanol, ascorbic acid or other products; (d) distillers grains, i.e. by-products resulting from the production of alcoholic beverages; (e) plants, plant parts or plant extracts having undergone only heat treatment or heat treatment in addition to processing methods referred to in CMC 2; or (f) lime from drinking water production, i.e. residue which is released by production of drinking water from groundwater or surface water and consists, mainly, of calcium carbonate. 2. All substances incorporated into the EU fertilising product, on their own or in a mixture, shall have been registered pursuant to Regulation (EC) No 1907/2006 In comply with the case of a substance recovered requirement set out in the European Union, this condition is fulfilled if the substance is the same, within the meaning of point (d)(i) of Article 2(7) of Regulation (EC) No 1907/2006, as a substance registered with a dossier containing the information here indicated, and if information is available to the fertilising product manufacturer within the meaning of point (d)(ii) of Article 2(7) of Regulation (EC) No 1907/2006., with a dossier containing: (a) the information provided for by Annexes VI, VII and VIII to Regulation (EC) No 1907/2006, and (b) a chemical safety report pursuant to Article 14 of Regulation (EC) No 1907/2006 covering the use as a fertilising product, unless explicitly covered by one of the registration obligation exemptions provided for by Annex IV to Regulation (EC) No 1907/2006 or by point 6, 7, 8, or 9 of Annex V to that Regulation. 2 in CMC 1. CMC 7: MICRO-ORGANISMS An EU fertilising product belonging to PFC 6(A) may contain micro-organisms, including dead or empty-cell micro-organisms and non-harmful residual elements of the media on which they were produced, which: have undergone no other processing than drying or freeze-drying; and are … 888 unchanged words … by-products within the meaning of Directive 2008/98/EC, or (h) ammonium salts, sulphate salts, phosphate salts, elemental sulphur, calcium carbonate or calcium oxide, which are recovered from waste within the meaning of Article 3, point 1, of Directive 2008/98/EC. 2. The by-products shall have been registered pursuant to Regulation (EC) No 1907/2006, comply with a dossier containing: (a) the information provided for by Annexes VI, VII and VIII to Regulation (EC) No 1907/2006, and (b) a chemical safety report pursuant to Article 14 of Regulation (EC) No 1907/2006 covering the use as a fertilising product, unless explicitly covered by one of the registration obligation exemptions provided for by Annex IV to Regulation (EC) No 1907/2006 or by requirement set out in point 6, 7, 8 or 9 of Annex V to that Regulation. 2 in CMC 1. 3. From 16 July 2022, the by-products shall comply with the criteria established by delegated act referred to in Article 42(7). An EU fertilising product placed on the market after that date shall not contain by-products referred to in point … 1,374 unchanged words … benzo[a]anthracene, chrysene, benzo[b]fluoranthene, benzo[k]fluoranthene, benzo[a]pyrene, indeno[1,2,3-cd]pyrene, dibenzo[a,h]anthracene and benzo[ghi]perylene. 12. The sum of aluminium (Al) and iron (Fe) in precipitated phosphate salts or derivates shall not exceed 10 % of the dry matter of the precipitated phosphate salts or the derivates. 13. Precipitated The precipitated phosphate salts or derivates shall have been registered pursuant to Regulation (EC) No 1907/2006 comply with a dossier containing: (a) the information provided for by Annexes VI, VII and VIII of Regulation (EC) No 1907/2006; and; (b) a chemical safety report pursuant to Article 14 of Regulation (EC) No 1907/2006 covering the use as a fertilising product, unless explicitly covered by one of the registration obligation exemptions provided for by Annex IV to Regulation (EC) No 1907/2006 or by points 6, 7, 8, or 9 of Annex V to that Regulation. requirement set out in point 2 in CMC 1. 14. For the purposes of points 3, 11 and 12, the dry matter of precipitated phosphate salts and derivates shall be measured using vacuum drying at 40 °C until constant weight to avoid the loss of crystal-bound water. CMC 13: THERMAL … 1,381 unchanged words … with Annex III; The vanadium (V) content shall not be higher than 600 mg/kg dry matter if the thermal oxidation materials or derivates are from input materials referred to in sub-points 1(g) or (i). 8. The thermal oxidation materials or derivates shall have been registered pursuant to Regulation (EC) No 1907/2006, comply with the requirement set out in a dossier containing: (a) the information provided for by Annexes VI, VII and VIII of Regulation (EC) No 1907/2006, and (b) a chemical safety report pursuant to Article 14 of Regulation (EC) No 1907/2006 covering the use as a fertilising product, unless explicitly covered by one of the registration obligation exemptions provided for by Annex IV to Regulation (EC) No 1907/2006 or by points 6, 7, 8 or 9 of Annex V to that Regulation. point 2 in CMC 1. CMC 14: PYROLYSIS AND GASIFICATION MATERIALS 1. An EU fertilising product may contain pyrolysis or gasification materials obtained through the thermochemical conversion under oxygen-limiting conditions of exclusively one or more of the following input materials: (a) living or dead organisms or parts … 845 unchanged words … (Tl) content shall not be higher than 2 mg/kg dry matter, in case more than 5 % of pyrolysis or gasification additives relative to the fresh weight of total input material have been applied. 7. The pyrolysis and gasification material shall have been registered pursuant to Regulation (EC) No 1907/2006, comply with the requirement set out in a dossier containing: (a) the information provided for by Annex VI, VII and VIII of Regulation (EC) No 1907/2006, and (b) a chemical safety report pursuant to Article 14 of Regulation (EC) No 1907/2006 covering the use as a fertilising product, unless explicitly covered by one of the registration obligation exemptions provided for by Annex IV to Regulation (EC) No 1907/2006 or by points 6, 7, 8 or 9 of Annex V to that Regulation. point 2 in CMC 1. CMC 15: RECOVERED HIGH PURITY MATERIALS (1) An EU fertilising product may contain a recovered high purity material, which is ammonium salt, sulphate salt, phosphate salt, elemental sulphur, calcium carbonate or calcium oxide, or mixtures thereof, of a purity of at … 1,087 unchanged words … against precipitation and direct sunlight may be added to an EU fertilising product only if they have been manufactured maximum 36 months before signing the EU declaration of conformity for the respective EU fertilising product. (10) The high purity material shall have been registered pursuant to Regulation (EC) No 1907/2006, comply with a dossier containing: (a) the information provided for by Annexes VI, VII and VIII to Regulation (EC) No 1907/2006, and (b) a chemical safety report pursuant to Article 14 of Regulation (EC) No 1907/2006 covering the use as a fertilising product, unless explicitly covered by one of the registration obligation exemptions provided for by Annex IV to Regulation (EC) No 1907/2006 or by points 6, 7, 8, or 9 of Annex V to that Regulation. requirement set out in point 2 in CMC 1.

02019R1009-20220716 → 02019R1009-20221003

ANNEX III Labelling requirements This Annex sets out the labelling requirements for EU fertilising products. The requirements laid down in Part II and Part III of this Annex for a given PFC, as specified in Annex I, apply to EU fertilising products … 1,344 unchanged words … (P) are not declared nutrients, the content of nitrogen (N) or phosphorus pentoxide (P2O5) shall nevertheless be indicated if above 0,5 % by mass. That indication shall be separate from the nutrient declaration. 3. The following rules apply to fertilisers containing inhibitors, inhibiting compounds, as specified in CMC 1 in Part II of Annex II: (a) the label shall state the words nitrification inhibitor, denitrification inhibitor or urease inhibitor, as relevant; (b) the nitrification inhibitor inhibiting compound content shall be expressed as a % by mass of the total nitrogen (N) present as ammonium nitrogen (NH4+) (NH4 +) and urea nitrogen (CH4N2O); (c) the denitrification inhibitor inhibiting compound content shall be expressed as a % by mass of the nitrate (NO3-) present; (d) the urease inhibitor inhibiting compound content shall be expressed as a % by mass of the total nitrogen (N) present as urea nitrogen (CH4N2O). 4. The term mineral fertiliser may be used only if the fertiliser belongs to PFC 1(C) and fulfils the following additional conditions: (a) the mineral fertiliser must not cñontain more than 1 % by mass of organic carbon (Corg), other than organic carbon from: (i) chelating or complexing agents referred to in point 3 of CMC 1 in Part II of Annex II, (ii) nitrification inhibitors, nitrification, denitrification inhibitors or urease inhibitors inhibiting compounds referred to in point 4 of CMC 1 in Part II of Annex II, (iii) coating agents referred to in point 1(a) of CMC 9 in Part II of Annex II, (iv) urea (CH4N2O), or (v) calcium cyanamide (CaCN2); (b) where phosphorus (P) is … 3,273 unchanged words … (calcium chloride/ diethylenetriaminepentaacetic acid; CAT-soluble), if above 150 mg/l; phosphorus pentoxide (P2O5) extractable by CaCl2/DTPA (calcium chloride/ diethylenetriaminepentaacetic acid; CAT-soluble), if above 20 mg/l; potassium oxide (K2O) extractable by CaCl2/DTPA (calcium chloride/ diethylenetriaminepentaacetic acid; CAT-soluble), if above 150 mg/l; production date. PFC 5: INHIBITOR 1. All ingredients shall be declared by product weight or volume in descending order of magnitude. 2. The content of the inhibiting compound(s) as % by mass or volume shall be declared. 3. The use instructions referred to in point 1(d) in Part I of this Annex shall contain information on: (a) the types of EU fertilising products with which the inhibitor may be mixed, in particular: (i) for the nitrification inhibitor referred to in PFC 5(A) in Part II of Annex I, an EU fertilising product in which at least 50 % of the total nitrogen (N) content consists of the nitrogen (N) forms ammonium (NH4 +) and urea (CH4N2O); (ii) for the urease inhibitor referred to in PFC 5(C) in Part II of Annex I, an EU fertilising product in which at least 50 % of the total nitrogen (N) content consists of the nitrogen (N) form urea (CH4N2O); (b) the minimum and maximum recommended concentration of inhibiting compound(s) when mixed with a fertiliser prior to its use: (i) for the nitrification inhibitor referred to in PFC 5(A) in Part II of Annex I, as a % by mass of the total nitrogen (N) present as ammonium nitrogen (NH4 +) and urea nitrogen (CH4N2O); (ii) for the denitrification inhibitor referred to in PFC 5(B) in Part II of Annex I, as a % by mass of the nitrate (NO3-) present; (iii) for the urease inhibitor referred to in PFC 5(C) in Part II of Annex I, as a % by mass of the total nitrogen (N) present as urea nitrogen (CH4N2O). PFC 6: PLANT BIOSTIMULANT The following information shall be provided: (a) physical form; (b) production and expiry date; (c) application method(s); (d) effect claimed for each target plant; and (e) any relevant instructions related to the efficacy of the product, including soil management practices, chemical fertilisation, incompatibility with plant protection products, recommended spraying nozzles size, sprayer pressure and other anti-drift measures. PFC 6(A): MICROBIAL PLANT BIOSTIMULANT All intentionally added micro-organisms shall be indicated. Where the micro-organism has several strains, the intentionally added strains shall be indicated. Their concentration shall be expressed as the number of active units per volume or weight, or in any other manner that is relevant to the micro-organism, e.g. colony forming units per gram (cfu/g). The label shall contain the following phrase: Micro-organisms may have the potential to provoke sensitising reactions. PFC 7: FERTILISING PRODUCT BLEND All the labelling requirements applicable to all component EU fertilising products apply to the fertilising product blend, and shall be expressed in relation to the final fertilising product blend. Where the fertilising product blend contains one or more plant biostimulants belonging to PFC 6, the concentration of each plant biostimulant in the blend shall be indicated in g/kg or g/l at 20 °C. Where the fertilising product blend contains one or more inhibitors belonging to PFC 5, the use instructions referred to in point 3 in PFC 5 in Part II of this Annex shall not be added. PART III TOLERANCE RULES 1. The declared nutrient content or physico-chemical characteristics of an EU fertilising product may deviate from the actual value only in accordance with the tolerances established in this Part for the relevant PFC. The tolerances are intended to allow for deviations in manufacture, in the distribution chain, and during sampling and analysis. 2. The tolerances allowed in respect of the declared parameters indicated in this Part are negative and positive values. 3. By derogation from point 1, the actual content of a component, in an EU fertilising product, for which a minimum or a maximum content is specified in Annex I or Annex II may never be lower than the minimum content or exceed the maximum content. PFC 1: FERTILISER The following tolerance rules apply to fertilisers containing nitrification inhibitors, nitrification, denitrification inhibitors or urease inhibitors, inhibiting compounds, as specified in CMC 1 in Part II of Annex II: Inhibitors Inhibiting compounds Permissible tolerance for the declared content of inhibitors inhibiting compounds Concentration below or equal to 2 % ± 20 % of the declared value Concentration of more than 2 % ± 0,3 percentage points in absolute terms PFC 1(A): ORGANIC FERTILISER Forms of the declared nutrient and other declared parameters Permissible tolerance for … 1,236 unchanged words … PLANT BIOSTIMULANT The quantity of a plant biostimulant may deviate by ± 5 %.from the declared value. PFC 6(A): MICROBIAL PLANT BIOSTIMULANT The actual concentration(s) of micro-organisms may deviate by no more than 15 % from the declared value(s). PFC 7: FERTILISING PRODUCT BLEND Where the fertilising product blend contains one or more plant biostimulants belonging to PFC 6, the following tolerances shall apply for the declared concentration of each plant biostimulant: Declared parameter Permissible tolerance for the declared parameter Quantity the tolerance is the sum of the relative proportion of each component EU fertilising product multiplied by the tolerance for the PFC for that fertilising product. If the proportion of each EU fertilising product in the fertilising product blend cannot be determined, the tolerance is that of the PFC with the strictest quantity tolerance value. Where the fertilising product blend contains one or more plant biostimulants belonging to PFC 6, the following tolerances shall apply for the declared concentration of each plant biostimulant: Declared concentration in g/kg or g/l at 20 °C Permissible tolerance Up to 25 ± 15 % relative deviation More than 25 up to 100 ± 10 % relative deviation More than 100 up to 250 ± 6 % relative deviation More than 250 up to 500 ± 5 % relative deviation More than 500 ± 25 g/kg or ± 25 g/l

02019R1009-20220716 → 02019R1009-20221003

ANNEX IV Conformity assessment procedures PART I APPLICABILITY OF CONFORMITY ASSESSMENT PROCEDURES This Part sets out the applicability of conformity assessment procedure modules, as specified in Part II of this Annex, to EU fertilising products depending on their CMCs as specified in Annex II, and their PFCs as specified in Annex I. 1. APPLICABILITY OF INTERNAL PRODUCTION CONTROL (MODULE A) 1.1. Module A may be used for an EU fertilising product composed solely of one or more of the following component materials: (a) virgin material substances or mixtures as specified in CMC 1 in Part II of Annex II, except a nitrification inhibitor, nitrification, a denitrification inhibitor or a urease inhibitor, inhibiting compound, (b) fresh crop digestates as specified in CMC 4 in Part II of Annex II, (c) food industry by-products as specified in CMC 6 in Part II of Annex II, (d) micro-organisms as specified in CMC 7 in Part II of Annex II, (e) nutrient polymers as specified in CMC 8 in Part II of Annex II, (f) by-products within the meaning of Directive 2008/98/EC as specified in CMC 11 in Part II of Annex II. 1.2. Module A may also be used for a fertilising product blend as specified in PFC 7. 1.3. By derogation from points 1.1 and 1.2, Module A must not be used for: (a) a straight or compound solid inorganic macronutrient ammonium nitrate fertiliser of high nitrogen content, as specified in PFC 1(C)(I)(a)(i-ii)(A), or a fertilising product blend as specified in PFC 7 containing 28 % or more by mass of nitrogen (N) from an EU fertilising product belonging to PFC 1(C)(I)(a)(i-ii)(A), (b) an inhibitor as specified in PFC 5, or (c) a plant biostimulant as specified in PFC 6. 2. APPLICABILITY OF INTERNAL PRODUCTION CONTROL PLUS SUPERVISED PRODUCT TESTING (MODULE A1) Module A1 shall be used for a straight or compound solid inorganic macronutrient ammonium nitrate fertiliser of high nitrogen content, as specified in PFC 1(C)(I)(a)(i-ii)(A), and for a fertilising product blend as specified in PFC 7 containing 28 % or more by mass of nitrogen (N) from an EU fertilising product belonging to PFC 1(C)(I)(a)(i-ii)(A). 3. APPLICABILITY OF EU-TYPE EXAMINATION (MODULE B) FOLLOWED BY CONFORMITY TO TYPE BASED ON INTERNAL PRODUCTION CONTROL (MODULE C) 3.1. Module B followed by Module C may be used for an EU fertilising product composed solely of one or more of the following component materials: (a) nitrification inhibitor, nitrification, denitrification inhibitor or urease inhibitor inhibiting compound as specified in CMC 1 in Part II of Annex II, (b) plants, plant parts or plant extracts as specified in CMC 2 in Part II of Annex II, (c) polymers other than nutrient polymers as specified in CMC 9 in Part … 10,523 unchanged words … manufacturer’s obligations set out in points 3, 5.2, 5.5.1, 7 and 8 may be fulfilled by his or her authorised representative, on his or her behalf and under his or her responsibility, provided that they are specified in the mandate.