Fertilising Products Regulation

02019R1009-20241117 → 02019R1009-20241120

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 … 737 unchanged words … dry matter. 4. Pathogens in an organic fertiliser must not exceed the limits set out in the following table: Micro-organisms to be tested Sampling plans Limit n c m M Salmonella spp. 5 0 0 Absence in 25 g or 25 ml Escherichia coli or Enterococcaceae enterococci 5 5 0 1000 in 1 g or 1 ml Where: n number of samples to be tested, c number of samples where the number of bacteria expressed in colony forming units (CFU) is between m and M, m threshold value for the number of bacteria expressed … 601 unchanged words … Annex III. 5. Pathogens in an organo-mineral fertiliser must not exceed the limits set out in the following table: Micro-organisms to be tested Sampling plans Limit n c m M Salmonella spp. 5 0 0 Absence in 25 g or 25 ml Escherichia coli or Enterococcaceae enterococci 5 5 0 1000 in 1 g or 1 ml Where: n number of samples to be tested, c number of samples where the number of bacteria expressed in CFU is between m and M, m threshold value for the number of bacteria expressed in CFU that … 537 unchanged words … requirement that pathogens in an inorganic fertiliser must not exceed the limits set out in the following table: Micro-organisms to be tested Sampling plans Limit n c m M Salmonella spp. 5 0 0 Absence in 25 g or 25 ml Escherichia coli or Enterococcaceae enterococci 5 5 0 1000 in 1 g or 1 ml Where: n number of samples to be tested, c number of samples where the number of bacteria expressed in CFU is between m and M, m threshold value for the number of bacteria expressed in CFU that … 2,605 unchanged words … matter. 4. Pathogens in an organic soil improver must not exceed the limits set out in the following table: Micro-organisms to be tested Sampling plans Limit n c m M Salmonella spp. 5 0 0 Absence in 25 g or 25 ml Escherichia coli or Enterococcaceae enterococci 5 5 0 1000 in 1 g or 1 ml Where: n number of samples to be tested, c number of samples where the number of bacteria expressed in CFU is between m and M, m threshold value for the number of bacteria expressed in CFU that is considered satisfactory, M maximum value of the number of bacteria expressed in CFU. 5. An organic soil improver shall contain 20 % or more dry matter. 6. Organic carbon (Corg) content in an organic soil improver shall be at least 7,5 % by mass. PFC 3(B): INORGANIC SOIL IMPROVER 1. An inorganic soil improver shall be a soil improver other than an organic soil improver. 2. Contaminants in an inorganic soil improver must not exceed the following limit values: (a) cadmium (Cd) 1,5 mg/kg dry matter, (b) hexavalent chromium (Cr VI) 2 mg/kg dry matter, (c) mercury (Hg) 1 mg/kg dry matter, (d) nickel (Ni) 100 mg/kg dry matter, (e) lead (Pb) 120 mg/kg dry matter, (f) inorganic arsenic (As) 40 mg/kg dry matter. 3. The copper (Cu) content in an inorganic soil improver must not exceed 300 mg/kg dry matter, and the zinc (Zn) content in an inorganic soil improver must not exceed 800 mg/kg dry matter. 4. Pathogens in an inorganic soil improver that contains more than 1 % by mass of organic carbon (Corg) must not exceed the limits set out in the following table: Micro-organisms to be tested Sampling plans Limit n c m M Salmonella spp. 5 0 0 Absence in 25 g or 25 ml Escherichia coli or Enterococcaceae enterococci 5 5 0 1000 in 1 g or 1 ml Where: n number of samples to be tested, c number of samples where the number of bacteria expressed in CFU is between m and M, m threshold value for the number of bacteria expressed in CFU that is considered satisfactory, M maximum value of the number of bacteria expressed in CFU. PFC 4: GROWING MEDIUM 1. A growing medium shall be an EU fertilising product other than soil in situ, the function of which is for plants or mushrooms to grow in. For the purpose of this point, plants include algae. 2. Contaminants in a growing medium must not exceed the following limit values: (a) cadmium (Cd) 1,5 mg/kg dry matter, (b) hexavalent chromium (Cr VI) 2 mg/kg dry matter, (c) mercury (Hg) 1 mg/kg dry matter, (d) nickel (Ni) 50 mg/kg dry matter, (e) lead (Pb) 120 mg/kg dry matter, and (f) inorganic arsenic (As) 40 mg/kg dry matter. 2a. By derogation from point 2(d), the limit value for nickel (Ni) in a growing medium totally composed by mineral constituents and offered for professional use in horticulture, green roofs or green walls, shall apply to the bioavailable content of the contaminant. 3. The copper (Cu) content in a growing medium must not exceed 200 mg/kg dry matter, and the zinc (Zn) content in a growing medium must not exceed 500 mg/kg dry matter. 4. Pathogens in a growing medium must not exceed the limits set out in the following table: Micro-organisms to be tested Sampling plans Limit n c m M Salmonella spp. 5 0 0 Absence in 25 g or 25 ml Escherichia coli or Enterococcaceae enterococci 5 5 0 1000 in 1 g or 1 ml Where: n number of samples to be tested, c number of samples where the number of bacteria expressed in CFU is between m and M, m threshold value for the number of bacteria expressed in CFU that … 547 unchanged words … monocytogenes 5 0 Absence in 25 g or 25 ml Vibrio spp. 5 0 Absence in 25 g or 25 ml Shigella spp. 5 0 Absence in 25 g or 25 ml Staphylococcus aureus 5 0 Absence in 25 g or 25 ml Enterococcaceae Enterococci 5 2 10 CFU/g Anaerobic plate count unless the microbial plant biostimulant is an aerobic bacterium 5 2 105 CFU/g or ml Yeast and mould count unless the microbial plant biostimulant is a fungus 5 2 1000 CFU/g or ml Where: n number of units comprising the sample, c number of sample units giving values over the defined limit. 3. When the microbial plant biostimulant is in liquid form, the plant biostimulant shall have a pH optimal for contained micro-organisms and for plants. PFC 6(B): NON-MICROBIAL PLANT BIOSTIMULANT 1. A non-microbial plant biostimulant shall be a plant biostimulant other than a microbial plant biostimulant. 2. Pathogens in a non-microbial plant biostimulant must not exceed the limits set out in the following table: Micro-organisms to be tested Sampling plans Limit n c m M Salmonella spp. 5 0 0 Absence in 25 g or 25 ml Escherichia coli or Enterococcaceae enterococci 5 5 0 1000 in 1 g or 1 ml Where: n number of samples to be tested, c number of samples where the number of bacteria expressed in CFU is between m and M, m threshold value for the number of bacteria expressed in CFU that … 328 unchanged words … 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).

02019R1009-20241117 → 02019R1009-20241120

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 … 2,075 unchanged words … 10 mm that exceeds 20 %, Criterion: maximum 25 mmol O2/kg organic matter/h; or (b) Self heating factor: Definition: the maximum temperature reached by a compost in standardised conditions as an indicator of the state of its aerobic biological activity, Criterion: minimum Rottegrad III. 6. Where compliance with the requirement in point 4(a) follows certainly and uncontestably from the nature or the recovery process of the compost or the manufacturing process of the EU fertilising product, that compliance may be presumed in the conformity assessment procedure without verification (such as testing), under the responsibility of the manufacturer. CMC 4: 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) plants or plant parts grown for the production of biogas. For the purpose of … 1,889 unchanged words … 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. 7. Where compliance with the requirement in point 4 follows certainly and uncontestably from the nature or the recovery process of the digestate, or the fraction thereof, or the manufacturing process of the EU fertilising product, that compliance may be presumed in the conformity assessment procedure without verification (such as testing), under the responsibility of the manufacturer. 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 comply with the requirement set out in point 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 listed in the following table: Azotobacter spp. Mycorrhizal fungi Rhizobium spp. Azospirillum spp. CMC 8: NUTRIENT POLYMERS 1. An EU fertilising product may contain polymers exclusively made up of monomer substances complying with the criteria set out in points 1 and 2 of CMC 1, where the purpose of the polymerisation is to control the release of nutrients from one or more of the monomer substances. 2. At least 60 % of the polymers shall be soluble in a phosphate buffer solution with a pH of 7,5 at 100 °C. 3. The final degradation products shall be only ammonia (NH3), water and carbon dioxide (CO2). 4. The polymers shall not contain more than 600 ppm of free formaldehyde. CMC 9: POLYMERS OTHER THAN NUTRIENT POLYMERS 1. An EU fertilising product may contain polymers other than nutrient polymers only in cases where the purpose of the polymer is: (a) to control the water penetration into nutrient particles and thus the release of nutrients (in which case the polymer is commonly referred to as a coating agent), (b) to increase the water retention capacity or wettability of the EU fertilising product, or (c) to bind material in an EU fertilising product belonging to PFC 4. 1a. An EU fertilising product belonging to PFC 3 may contain a polymer in the form of a mulch film. 2. From 16 July 2026, the polymers referred to in point 1(a) and (b) shall comply with the biodegradability criteria established by delegated acts referred to in Article 42(6). In the absence of such criteria, an EU fertilising product placed on the market after that date shall not contain such polymers. 2a. The polymer in a mulch film referred to in point 1a shall comply with the biodegradability criteria set out in Appendix 2 to this Annex. 3. For the polymers referred to in point 1(a) and (b), (b) and in point 1a, neither the polymer, nor its degradation by-products, shall show any overall adverse effect on animal or plant health, or on the environment, under reasonably foreseeable conditions of use in the EU fertilising product. The polymer polymers referred to in point 1(a) and (b) and point 1a shall pass a plant growth acute toxicity test, an earthworm acute toxicity test and a nitrification inhibition test with soil micro-organisms as follows: (a) In the plant growth acute toxicity test, the germination rate and the plant biomass of the tested plant species grown on the soil exposed to the test material shall be more than 90 % of the germination rate and the plant biomass of the same plant species grown on corresponding blank soil not exposed to the test material. The results shall be considered to be valid only if in the controls (i.e. blank soil): the seedling emergence is at least 70 %; the seedlings do not exhibit visible phytotoxic effects (e.g. chlorosis, necrosis, wilting, leaf and stem deformations) and the plants exhibit only normal variation in growth and morphology for that particular species; the mean survival of emerged control seedlings is at least 90 % for the duration of the study; and environmental conditions for a particular species are identical and growing media contain the same amount of soil matrix, support media, or substrate from the same source. (b) In the earthworm acute toxicity test, the observed mortality and the biomass of surviving earthworms in a soil exposed to the test material shall not differ by more than 10 % compared to those from the corresponding blank soil not exposed to the test material. The results shall be considered to be valid, if: the percent mortality observed in the control (i.e. blank soil) is less than 10 %, and the average loss of biomass (mean weight) of the worms in the blank soil does not exceed 20 %. (c) In the nitrification inhibition test with soil micro-organisms, the nitrite formation in soil exposed to the test material shall be more than 90 % of those from the corresponding blank soil not exposed to the test material. The results shall be considered to be valid, if the variation between replicate control samples (blank soil) and test samples is less than 20 %. 4. The polymer referred to in point 1a shall pass an earthworm chronic toxicity test so that: (a) after an incubation period of 28 days, the observed mortality and the biomass of surviving adult earthworms in a soil exposed to the test material shall not differ by more than 10 % compared to those from the corresponding blank soil not exposed to the test material; (b) after an incubation period of 56 days, the observed number of offspring in a soil exposed to the test material shall not differ by more than 10 % compared to those from the corresponding blank soil not exposed to the test material. The results shall be considered to be valid only if in the controls (i.e. blank soil): (a) after an incubation period of 28 days, the observed adult mortality is no more than 10 %; (b) after an incubation period of 56 days each replicate (containing 10 adults) produces at least 30 offspring; and (c) the coefficient of variation of reproduction is no more than 30 %. Appendix 2 Biodegradability criteria of polymers for mulch films referred to in section CMC 9, point 1a 1. The biodegradability of polymers in mulch films referred to in section CMC 9, point 1a, shall be demonstrated in the following two environmental compartments: (a) compartment 1: soil; (b) compartment 2: fresh, estuarine or marine water, or water sediment interface. 2. The polymer shall achieve: (a) in compartment 1: (1) ultimate degradation of at least 90 % relative to the degradation of the reference material within 24 months plus the functionality period of the product as indicated on the label; or (2) mineralisation of at least 90 %, measured as evolved CO2, over a maximum of 24 months plus the functionality period of the product as indicated on the label: (b) in compartment 2: (1) ultimate degradation of at least 30 % relative to the degradation of the reference material in 12 months; or (2) ultimate degradation of at least 90 % relative to the degradation of the reference material in 24 months plus the functionality period of the product as indicated on the label. 3. To demonstrate the biodegradability criteria in point 2(a), one of the following test methods shall be used: (a) EN ISO 17556:2019. Plastics – Determination of the ultimate aerobic biodegradability of plastic materials in soil by measuring the oxygen demand in a respirometer or the amount of carbon dioxide evolved; (b) ISO/CD 23517:2021. Plastics – Soil biodegradable materials for mulch films for use in agriculture and horticulture; (c) ASTM D5988-96:2018. Standard Test Method for Determining Aerobic Biodegradation in Soil of Plastic Materials. 4. When there is no phase transition (glass transition or melting transition) between 25 °C and 37 °C, the temperature during testing in accordance with points 3(a), (b) and (c) may be adjusted at 37 oC. In such a case, the relevant criterion in point 2(a) shall be considered as being demonstrated if the polymer achieves: (a) at least 45 % ultimate degradation or mineralisation as referred to in point 2(a) in a separate test at 25 °C in 10 months, whereby degradation or mineralisation shall be progressing, and the plateau phase shall not have been reached, unless the degradation or mineralisation is at least 90 %; and (b) one of the following criteria: (i) ultimate degradation of at least 90 % relative to degradation of the reference material within 10 months plus the functionality period of the product as indicated on the label; or (ii) mineralisation of at least 90 %, measured as evolved CO2, over a maximum of 10 months plus the functionality period of the product as indicated on the label. 5. To demonstrate the biodegradability criteria in point 2(b), one of the following test methods shall be used: (a) EN/ISO 14851:2019 Determination of the ultimate aerobic biodegradability of plastic materials in an aqueous medium. Method by measuring the oxygen demand in a closed respirometer; (b) EN/ISO 14852:2021 Determination of the ultimate aerobic biodegradability of plastic materials in an aqueous medium. Method by analysis of evolved carbon dioxide; (c) ASTM D6691:2018 Standard Test Method for Determining Aerobic Biodegradation of Plastic Materials in the Marine Environment by a Defined Microbial Consortium or Natural Sea Water Inoculum; (d) EN/ISO 19679:2020 Plastics – Determination of aerobic biodegradation of non-floating plastic materials in a seawater/sediment interface – Method by analysis of evolved carbon dioxide; (e) EN/ISO 18830:2017 Plastics – Determination of aerobic biodegradation of non-floating plastic materials in a seawater/sandy sediment interface – Method by measuring the oxygen demand in closed respirometer. 6. Polymers may be tested in any of the following forms: (a) in the form of the film placed on the market; (b) in a powder form of the milled film. 7. The following materials may be used as reference materials: (a) positive controls: biodegradable materials such as micro-crystalline cellulose powder, ashless cellulose filters or poly-β-hydroxybutyrate; (b) negative controls: non-biodegradable polymers such as polyethylene or polystyrene. CMC 10: DERIVED PRODUCTS WITHIN THE MEANING OF REGULATION (EC) No 1069/2009 1. An EU fertilising product may contain derived products within the meaning of Regulation (EC) No 1069/2009 having reached the end point in the manufacturing chain as determined in … 1,738 unchanged words … from production lines for the processing of other input materials. 8. Where for the PFC of an EU fertilising product containing or consisting of precipitated phosphate salts or derivates or both there are no requirements regarding Salmonella spp., Escherichia coli or Enterococcaceae enterococci in Annex I, those pathogens shall not exceed the limits set out in the following table: Micro-organisms to be tested Sampling plans Limit n c m M Salmonella spp. 5 0 0 Absence in 25 g or 25 ml Escherichia coli or Enterococcaceae enterococci 5 5 0 1000 in 1 g or 1 ml Where: n number of samples to be tested, c number of samples where the number of bacteria expressed in CFU is between m and M, m threshold value for the number of bacteria expressed in CFU that is considered satisfactory, M maximum value of the number of bacteria expressed in CFU. 9. Pathogens in an EU fertilising product containing or consisting of precipitated phosphate salts obtained from materials referred to in sub-point 1(a) or derivates from such precipitated phosphate salts or both shall not exceed the limits set out in the following table: Micro-organisms to be tested Sampling plans Limit n c m M Clostridium perfringens 5 5 0 100 CFU in 1 g or 1 ml Ascaris sp. viable eggs 5 0 0 Absence in 25 g or 25 ml Where: n number of samples to be tested, c number of samples where the number of bacteria expressed in CFU is between m and M, m threshold value for the number of bacteria expressed in CFU that is considered satisfactory, M maximum value of the number of bacteria expressed in CFU. 10. The requirements set out in points (8) and (9), as well as the requirements for Salmonella spp., Escherichia coli or Enterococcaceae enterococci set in the corresponding PFC of an EU fertilising product consisting only of precipitated phosphate salts or derivates or both shall not apply when those precipitated phosphate salts or all of the biogenic input materials used in the precipitation process have undergone one of the following processes: (a) pressure sterilisation through the heating to a core temperature of more than 133 °C for at least 20 minutes at an absolute pressure of at least 3 bars, whereby the pressure must be produced by the evacuation of all air in the sterilisation chamber and the replacement of the air by steam (saturated steam); (b) processing in a pasteurisation or hygienisation unit that reaches a temperature of 70 °C for at least one hour. 11. Precipitated phosphate salts obtained from materials referred to in sub-point 1(a) and derivates obtained from such precipitated phosphate salts shall have 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. 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. The precipitated phosphate salts or derivates shall comply with the 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. 15. Where compliance with one of the requirements in points 11 and 12 follows certainly and uncontestably from the nature or the recovery process of the precipitated phosphate salt or the derivate, or the manufacturing process of the EU fertilising product, that compliance may be presumed in the conformity assessment procedure without verification (such as testing), under the responsibility of the manufacturer. CMC 13: THERMAL OXIDATION MATERIALS OR DERIVATES 1. An EU fertilising product may contain thermal oxidation materials obtained through thermochemical conversion under non-oxygen-limiting conditions exclusively from one or more of the following input materials: (a) living or dead organisms or parts thereof, … 1,356 unchanged words … 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 comply with the requirement set out in point 2 in CMC 1. 9. Where compliance with one of the requirements in points 5 and 7 follows certainly and uncontestably from the nature or the recovery process of the thermal oxidation material or the derivate, or the manufacturing process of the EU fertilising product, that compliance may be presumed in the conformity assessment procedure without verification (such as testing), under the responsibility of the manufacturer. 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 … 857 unchanged words … 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 comply with the requirement set out in point 2 in CMC 1. 8. Where compliance with one of the requirements in points 3 and 6 follows certainly and uncontestably from the nature or the recovery process of the pyrolysis or gasification material, or the manufacturing process of the EU fertilising product, that compliance may be presumed in the conformity assessment procedure without verification (such as testing), under the responsibility of the manufacturer. 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 … 666 unchanged words … (such as testing), under the responsibility of the manufacturer. (7) Where for the product function category of an EU fertilising product containing or consisting of high purity materials referred to in point 2(b) no requirements regarding Salmonella spp., Escherichia coli or Enterococcaceae enterococci have been laid down in Annex I, those pathogens in the EU fertilising product shall not exceed the limits set out in the following table: Micro-organisms to be tested Sampling plans Limit n c m M Salmonella spp. 5 0 0 Absence in 25 g or 25 ml Escherichia coli or Enterococcaceae enterococci 5 5 0 1000 in 1 g or 1 ml Where: n number of samples to be tested, c number of samples where the number of bacteria expressed in colony forming units (CFU) is between m and M, m threshold value for the number of bacteria expressed in CFU that is considered satisfactory, M maximum value of the number of bacteria expressed in CFU. (8) The compliance of an EU fertilising product containing or consisting of high purity materials referred to in point 2(b) with requirements in point (7), or with the requirements for Salmonella spp., Escherichia coli or Enterococcaceae enterococci set out in Annex I for the corresponding PFC of the EU fertilising product shall be verified via testing, in accordance with point 5.1.3.1 in Module D1 – quality assurance of the production process in Part II of Annex IV. The requirements in point (7) and the requirements for Salmonella spp., Escherichia coli or Enterococcaceae enterococci set out in Annex I for the corresponding PFC of an EU fertilising product consisting only of high purity materials referred to in point 2(b) shall not apply, when the high purity materials or all of the biogenic input materials used have undergone one of the following processes: (a) pressure sterilisation through the heating to a core temperature of more than 133 °C for at least 20 minutes at an absolute pressure of at least 3 bars, whereby the pressure must be produced by the evacuation of all air in the sterilisation chamber and the replacement of the air by steam (saturated steam); (b) processing in a pasteurisation or hygienisation unit that reaches a temperature of 70 °C for at least one hour. The requirements in point (7) and the requirements for Salmonella spp., Escherichia coli or Enterococcaceae enterococci set out in Annex I for the corresponding PFC of an EU fertilising product consisting only of high purity materials referred to in point 2(b) shall not apply, where the off-gases derive from an incineration process as defined in Directive 2010/75/EU. (9) High purity materials that are stored in a way that does not protect them 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 comply with the requirement set out in point 2 in CMC 1.

02019R1009-20241117 → 02019R1009-20241120

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 in all subcategories of that PFC. PART I GENERAL LABELLING REQUIREMENTS 1. The following information shall be provided: (a) for EU fertilising products in PFC 1 to PFC 6, the designation as indicated in Part I of Annex I of the PFC corresponding to the product’s claimed function; (b) for EU fertilising products in PFC 7, the designations as indicated in Part I of Annex I of all the PFCs corresponding to the claimed functions of the component EU fertilising products; (c) the quantity of the EU fertilising product, indicated by mass or volume; (d) instructions for intended use, including application rates, timing and frequency, and target plants or mushrooms; (e) recommended storage conditions; (f) for products containing a polymer belonging to CMC 9 in Part II of Annex II, the time period following use during which the nutrient release is being controlled or the water retention capacity is being increased (the functionality period), which shall not be longer than the period between two applications in accordance with the use instructions referred to in point (d); (fa) for products belonging to PFC 3 containing a polymer referred to in Part II, section CMC 9, point 1a, of Annex II: (a) the time period following use during which the soil improver will fulfil its function (the functionality period), which shall not be longer than the period between two applications in accordance with the use instructions referred to in point (d) of this point; (b) an instruction to apply the product in compliance with the buffer zones required for fertilising products in accordance with the relevant national rules or, in the absence of such rules, to apply the product at least 3 m from any surface water body; (c) an instruction to follow the national measures on handling mulch films after their functionality period or, in the absence of such measures, to incorporate in soil the product after its functionality period and maintain it buried; (g) any relevant information on measures recommended to manage risks to human, animal or plant health, to safety or to the environment; and (h) a list of all ingredients above 5 % by product weight or volume, or in the case … 6,254 unchanged words … % of the declared content up to a maximum of 1,8 percentage points in absolute terms Granulometry ± 20 % relative deviation of the declared percentage of material passing a specific sieve Quantity ± 1 % relative deviation of the declared value for products belonging to PFC 1(C)(I) ± 5 % relative deviation of the declared value for products belonging to PFC 1(C)(II) Micronutrient Permissible tolerance for the declared content of forms of micronutrient Concentration below or equal to 2 % ± 50 % of the declared value Concentration of more than 2 % and below or equal to 10 % ± 50 % of … 423 unchanged words … ± 75 % relative deviation of the declared value PFC 5: INHIBITOR Inhibiting compound Permissible tolerance for the declared content of inhibiting compound Concentration below or equal to 2 % ± 20 % of the declared value Concentration of more than 2 % ± 0,3 percentage point 10 % of the declared value up to a maximum of ± 2 % in absolute terms Quantity: ± 5 % relative deviation of the declared value PFC 6: 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 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