Fertilising Products Regulation

32019R1009 → 02019R1009-20220716

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 inorganic macronutrient fertiliser (A) Straight solid inorganic macronutrient ammonium nitrate fertiliser of high nitrogen content (ii) Compound solid inorganic macronutrient fertiliser (A) Compound solid inorganic macronutrient ammonium nitrate fertiliser of high nitrogen content (b) Liquid inorganic macronutrient fertiliser (i) Straight liquid inorganic macronutrient fertiliser (ii) Compound liquid inorganic macronutrient fertiliser II. Inorganic micronutrient fertiliser (a) Straight inorganic micronutrient fertiliser (b) Compound inorganic micronutrient fertiliser 2. Liming material 3. Soil improver A. Organic soil improver B. Inorganic soil improver 4. Growing medium 5. Inhibitor A. Nitrification inhibitor B. Denitrification inhibitor C. Urease inhibitor 6. Plant biostimulant A. Microbial plant biostimulant B. Non-microbial plant biostimulant 7. Fertilising product blend PART II REQUIREMENTS RELATED TO PFCS 1. This Part sets out the requirements related to the PFCs to which EU fertilising products belong by virtue of their claimed function. 2. The requirements laid down in this Annex for a given PFC apply to EU fertilising products in all subcategories of that PFC. 3. The claim that an EU fertilising product complies with the function set out in this Annex for the relevant PFC shall be supported by the product’s mode of action, the relative content of its various components, or any other relevant parameter. 4. Where compliance with a given requirement (such as absence of a given contaminant) follows certainly and uncontestably from the nature or manufacturing process of an EU fertilising product, that compliance can be presumed in the conformity assessment procedure without verification (such as testing), at the responsibility of the manufacturer. 5. Where Residues of a pharmacologically active substance within the EU fertilising product contains a substance for which maximum residue limit values for food and feed have been established in accordance with: (a) Council Regulation (EEC) No 315/93 Council Regulation (EEC) No 315/93 meaning of 8 February 1993 laying down Community procedures for contaminants in food (OJ L 37, 13.2.1993, p. 1)., (b) Regulation (EC) No 396/2005 of the European Parliament and of the Council Regulation (EC) No 396/2005 of the European Parliament and of the Council of 23 February 2005 on maximum residue levels of pesticides in or on food and feed of plant and animal origin and amending Council Directive 91/414/EEC (OJ L 70, 16.3.2005, p. 1)., (c) Regulation (EC) No 470/2009 of the European Parliament and of the Council Regulation (EC) No 470/2009 of the European Parliament and of the Council of 6 May 2009 laying down Community procedures for the establishment of residue limits of pharmacologically active substances in foodstuffs of animal origin, repealing Council Regulation (EEC) No 2377/90 and amending Directive 2001/82/EC of the European Parliament and of the Council and Regulation (EC) No 726/2004 of the European Parliament and of the Council (OJ L 152, 16.6.2009, p. 11)., or (d) Directive 2002/32/EC 11). may be present in an EU fertilising product only if that substance is either: included in Table 1 of the European Parliament Annex to Commission Regulation (EU) No 37/2010 Commission Regulation (EU) No 37/2010 of 22 December 2009 on pharmacologically active substances and their classification regarding maximum residue limits in foodstuffs of the Council Directive 2002/32/EC of the European Parliament and of the Council animal origin (OJ L 15, 20.1.2010, p. 1)., or has had a reference point for action established in accordance with Commission Regulation (EU) 2019/1871 Commission Regulation (EU) 2019/1871 of 7 May 2002 November 2019 on undesirable reference points for action for non-allowed pharmacologically active substances present in food of animal feed origin and repealing Decision 2005/34/EC (OJ L 140, 30.5.2002, 289, 8.11.2019, p. 10). 41)., and the use of substance or its residues are present in the EU fertilising product as specified in at a level below that reference point. 5a. An EU fertilising product may contain an active substance within the use instructions must meaning of Article 2(2) of Regulation (EC) No 1107/2009 only if that EU fertilising product does not lead to have a plant protection function within the exceedance meaning of those limit values in food or feed. Article 2(1) of that Regulation. 6. Phosphonates shall not be intentionally added to any EU fertilising product. Unintentional presence of phosphonates shall not exceed 0,5 % by mass. 7. The requirements in this Annex are expressed in oxidised form for certain nutrients. Where compliance is assessed … 3,406 unchanged words … reaction products or biological materials. Typology Description Minimum micronutrient content Micronutrient salt fertiliser A chemically obtained straight solid inorganic micronutrient fertiliser containing a mineral ion salt as its essential ingredient 10 % by mass of micronutrient salt fertiliser shall consist of a water-soluble micronutrient Micronutrient oxide or hydroxide fertiliser A chemically obtained straight solid inorganic micronutrient fertiliser containing oxide or hydroxide as its essential ingredient 10 % by mass of a micronutrient oxide or hydroxide fertiliser shall consist of a micronutrient Micronutrient-based fertiliser A straight inorganic micronutrient fertiliser combining a micronutrient salt fertiliser with one or more other micronutrient salt fertilisers and/or with a single micronutrient chelate 5 % by mass of a micronutrient-based fertiliser shall consist of a micronutrient Micronutrient solution fertiliser An aqueous solution of different forms of a straight inorganic micronutrient fertiliser 2 % by mass of a micronutrient solution fertiliser shall consist of a water-soluble micronutrient Micronutrient suspension fertiliser A suspension of different forms of a straight inorganic micronutrient fertiliser 2 % by mass of a micronutrient suspension fertiliser shall consist of a micronutrient Micronutrient chelate chelated fertiliser A water-soluble straight inorganic micronutrient fertiliser in which the declared micronutrient is chemically combined with chelating agent(s) fulfilling the requirements of CMC 1 in Part II of Annex II 5 % by mass of a micronutrient chelate chelated fertiliser shall consist of a water-soluble micronutrient, and at least 80 % of the water-soluble micronutrient shall be chelated by a chelating agent fulfilling the requirements of CMC 1 in Part II of Annex II UVCB iron micronutrient chelates A water-soluble straight inorganic micronutrient fertiliser in which the declared iron micronutrient is chemically combined with chelating agent(s) fulfilling the requirements of CMC 1 in Part II of Annex II 5 % by mass of UVCB iron micronutrient chelates shall consist of water-soluble iron, micronutrient, and at least 80 % of the water-soluble iron micronutrient shall be chelated (chelated fraction) and at least 50 % of the water soluble iron micronutrient shall be chelated by a specific chelating agent agents fulfilling the requirements of CMC 1 in Part II of Annex II Micronutrient complex complexed fertiliser A water-soluble straight inorganic micronutrient fertiliser in which the declared micronutrient is chemically combined with complexing agent(s) fulfilling the requirements of CMC 1 in Part II of Annex II 5 % by mass of a micronutrient complex complexed fertiliser shall consist of a water-soluble micronutrient, and at least 80 % of the water-soluble micronutrient shall be complexed by a complexing agent fulfilling the requirements of CMC 1 in Part II of Annex II PFC 1(C)(II)(b): COMPOUND INORGANIC MICRONUTRIENT FERTILISER 1. A compound inorganic micronutrient fertiliser shall have a declared content of more than one micronutrient. 2. The sum of all declared micronutrient contents in a compound inorganic micronutrient fertiliser shall be at least: (a) 2 % by mass for fertilisers in liquid form; (b) 5 % by mass for fertilisers in solid form. PFC 2: LIMING MATERIAL 1. A liming material shall be an EU fertilising product the function of which is to correct soil acidity. A liming material shall contain oxides, hydroxides, carbonates or silicates of the nutrients calcium (Ca) or magnesium (Mg). 2. Contaminants in a liming material must not exceed the following limit values: (a) cadmium (Cd) 2 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) 90 mg/kg dry matter, (e) lead (Pb) 120 mg/kg dry matter, (f) arsenic (As) 40 mg/kg dry matter. 3. The copper (Cu) content in a liming material must not exceed 300 mg/kg dry matter, and the zinc (Zn) content in a liming material must not exceed 800 mg/kg dry matter. 4. The following parameters determined on the basis of the mass of a liming material shall be met: (a) minimum neutralising value: 15 (equivalent CaO) or 9 (equivalent HO-), (b) minimum reactivity: 10 % (hydrochloric acid test) or 50 % after 6 months (incubation test), and (c) minimum grain size: at least 70 % < 1 mm, except for burnt limes, granulated liming material and chalk (at least 70 % of the liming material shall pass through a 1 mm sieve). PFC 3: SOIL IMPROVER A soil improver shall be an EU fertilising product the function of which is to maintain, improve or protect the physical or chemical properties, the structure or the biological activity of the soil to which it is added. PFC 3(A): ORGANIC SOIL IMPROVER 1. An organic soil improver shall consist of material 95 % of which is of solely biological origin. An organic soil improver may contain peat, leonardite and lignite, but no other material which is fossilized or embedded in geological formations. 2. Contaminants in an organic soil improver must not exceed the following limit values: (a) cadmium (Cd) 2 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) (Ni): 50 mg/kg dry matter, (e) lead (Pb) 120 mg/kg dry matter, and (f) inorganic arsenic (As) 40 mg/kg dry matter. 3. The copper (Cu) content in an organic soil improver must not exceed 300 mg/kg dry matter, and the zinc (Zn) content in an organic soil improver must not exceed 800 mg/kg dry 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 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 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 … 1,098 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).

32019R1009 → 02019R1009-20220716

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 not contain any of the substances for which maximum limit values are indicated in Annex I in such quantities as to jeopardise the EU fertilising product’s compliance with the applicable requirements of that Annex. PART I DESIGNATION OF CMCS CMC 1: Virgin material substances and mixtures CMC 2: Plants, plant parts or plant extracts CMC 3: Compost CMC 4: Fresh crop digestate CMC 5: Digestate other than fresh crop digestate CMC 6: Food industry by-products CMC 7: Micro-organisms CMC 8: Nutrient polymers CMC 9: Polymers other than nutrient polymers CMC 10: Derived products within the meaning of Regulation (EC) No 1069/2009 CMC 11: By-products within the meaning of Directive 2008/98/EC CMC 12: Precipitated phosphate salts and derivates CMC 13: Thermal oxidation materials and derivates CMC 14: Pyrolysis and gasification materials CMC 15: Recovered high purity materials PART II REQUIREMENTS RELATED TO CMCS This Part defines the component materials of which EU fertilising products shall solely consist. CMC 1: VIRGIN MATERIAL SUBSTANCES AND MIXTURES 1. An EU fertilising product may contain substances and mixtures, except The exclusion of a material from CMC 1 does not prevent it from being an eligible component material by virtue of another CMC stipulating different requirements. See, for instance, CMC 3 on compost, CMCs 4 and 5 on digestate, CMCs 8 and 9 on polymers, CMC 10 on derived products within the meaning of Regulation (EC) No 1069/2009 or CMC 11 on by-products within the meaning of Directive 2008/98/EC.: (a) waste within the meaning of Directive 2008/98/EC, (b) substances or mixtures which have ceased to be waste in one or more Member States by virtue of the national measures transposing Article 6 of Directive 2008/98/EC, (c) substances formed from precursors which have ceased to be waste in one or more Member States by virtue of the national measures transposing Article 6 of Directive 2008/98/EC, or mixtures containing such substances, (d) by-products within the meaning of Directive 2008/98/EC, (e) animal by-products or derived products within the meaning of Regulation (EC) No 1069/2009, (f) polymers, other than: polymers that are the result of a polymerisation process that has taken place in nature, independently of the extraction process with which they have been extracted and that have not been chemically modified within the meaning of Article 3(40) of Regulation (EC) No 1907/2006, biodegradable polymers, or polymers with a water-solubility higher than 2 g/L in the following conditions: temperature 200 C pH 7 loading: 10 g/1000 mL test time: 24h, (g) compost, or (h) digestate. digestate, (i) precipitated phosphate salts or derivates, which are recovered from waste or are by-products within the meaning of Directive 2008/98/EC, (j) thermal oxidation materials or derivates which are recovered from waste or are by-products within the meaning of Directive 2008/98/EC, or (k) pyrolysis and gasification materials, which are recovered from waste or are by-products within the meaning of Directive 2008/98/EC , or (l) 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. 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 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 (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. 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 in standard Hoagland solution at pH 7 and 8 for at least 3 days. 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 … 357 unchanged words … 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 processing than cutting, grinding, milling, sieving, sifting, centrifugation, pressing, drying, frost treatment, freeze-drying or freeze-drying, extraction with water or water, supercritical CO2 extraction. 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: the organic fraction of (i) materials originating from mixed municipal household waste separated through mechanical, physicochemical, biological and/or manual treatment, waste,’; (ii) sewage sludge, industrial sludge or dredging sludge, and (iii) animal by-products or derived products falling within the scope of Regulation (EC) No 1069/2009 for which no end point in the manufacturing chain has been determined in accordance with the third subparagraph of Article 5(2) of that Regulation; 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 the case of an additive recovered 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, 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), (b) (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 obtained through aerobic composting 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 composting shall take place in a plant: (a) in which production lines for the processing of input materials referred to in point points 1 and 1a are clearly separated from production lines for the processing of input materials other than those referred to in point 1, points 1 and 1a, and (b) where physical contacts between input and output materials are avoided, including during storage. 3. The aerobic composting shall consist of controlled decomposition of biodegradable materials, which is predominantly aerobic and which allows the development of temperatures suitable for thermophilic bacteria … 1,112 unchanged words … 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 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) the organic fraction of materials originating from mixed municipal household waste separated through mechanical, physicochemical, biological and/or manual treatment, waste,’; (ii) sewage sludge, industrial sludge or dredging sludge, and (iii) animal by-products or derived products falling within the scope of Regulation (EC) No 1069/2009 for which no end point in the manufacturing chain has been determined in accordance with the third subparagraph of Article 5(2) of that Regulation; 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 the case of an additive recovered 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, 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), (b) (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 obtained through aerobic composting 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 point points 1 and 1a are clearly separated from production lines for the processing of input materials other than those referred to in point 1, 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 … 1,578 unchanged words … CMCs 4 and 5 on digestate, CMCs 8 and 9 on polymers or CMC 10 on derived products within the meaning of Regulation (EC) No 1069/2009.: (a) animal by-products or derived products within the meaning of Regulation (EC) No 1069/2009, (b) polymers, other than: polymers that are the result of a polymerisation process that has taken place in nature, independently of the extraction process with which they have been extracted and that have not been chemically modified within the meaning of Article 3(40) of Regulation (EC) No 1907/2006, biodegradable polymers, or polymers with a water-solubility higher than 2 g/L in the following conditions: temperature 200 C pH 7 loading: 10 g/1000 mL test time: 24h, (c) compost, or (d) digestate. digestate, (e) precipitated phosphate salts or derivates, which are recovered from waste or are by-products within the meaning of Directive 2008/98/EC, (f) thermal oxidation materials or derivates, which are recovered from waste or are by-products within the meaning of Directive 2008/98/EC, or (g) pyrolysis and gasification materials, which are recovered from waste or are 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, 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. 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 which do not comply with such criteria.CMC 12: PRECIPITATED PHOSPHATE SALTS AND DERIVATES 1. An EU fertilising product may contain precipitated phosphate salts obtained through precipitation exclusively from one or more of the following input materials: (a) wastewaters and sewage sludge from municipal wastewater treatment plants, other than animal by-products or derived products within the scope of Regulation (EC) No 1069/2009; (b) wastewaters and sludge from processing of foods, beverages, pet foods, animal feeds, or dairy products, other than animal by-products or derived products within the scope of Regulation (EC) No 1069/2009, unless processing steps involved contact with biocidal products within the meaning of Article 3(1), point (a), of Regulation (EU) No 528/2012 of the European Parliament and of the Council Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products (OJ L 167, 27.6.2012, p. 1). other than those defined as product-type 4 of main group 1 of Annex V to that Regulation; (c) bio-waste within the meaning of Article 3, point 4, of Directive 2008/98/EC resulting from separate bio-waste collection at source, other than animal by-products or derived products within the scope of Regulation (EC) No 1069/2009; (d) processing residues within the meaning of Article 2, point (t), of Directive 2009/28/EC of the European Parliament and of the Council Directive 2009/28/EC of the European Parliament and of the Council of 23 April 2009 on the promotion of the use of energy from renewable sources and amending and subsequently repealing Directives 2001/77/EC and 2003/30/EC (OJ L 140 5.6.2009, p. 16). from the production of bioethanol and biodiesel derived from materials referred to in this point, sub-points (b), (c) and (e); (e) living or dead organisms or parts thereof, which are unprocessed or processed only by manual, mechanical or gravitational means, dissolution in water, flotation, extraction with water, steam distillation or heating solely to remove water, or which are extracted from air by any means, except The exclusion of an input material from a sub-point does not prevent it from being an eligible input material by virtue of another sub-point.: materials originating from mixed municipal waste, sewage sludge, industrial sludge or dredging sludge, animal by-products or derived products within the scope of Regulation (EC) No 1069/2009; (f) substances and mixtures, other than : those referred to in sub-points (a) to (e), waste within the meaning of Article 3,point 1, of Directive 2008/98/EC, substances or mixtures which have ceased to be waste in one or more Member States by virtue of the national measures transposing Article 6 of Directive 2008/98/EC, substances formed from precursors which have ceased to be waste in one or more Member States by virtue of the national measures transposing Article 6 of Directive 2008/98/EC, or mixtures containing such substances, non-biodegradable polymers, animal by-products or derived products within the scope of Regulation (EC) No 1069/2009. In addition, precipitated phosphate salts shall be obtained through precipitation from any input material referred to in sub-points (a) to (f), or a combination thereof, processed by manual, mechanical or gravitational means, solid-liquid fractionation using biodegradable polymers, dissolution in water, flotation, extraction with water, steam distillation or heating solely to remove water, thermal hydrolysis, anaerobic digestion or composting. The temperature under such processes shall not be raised above 275 °C. 2. The precipitation process shall take place under controlled conditions in a reactor. In addition, only input materials, which are not contaminated with other material streams, or input materials, other than animal by-products or derived products within the scope of Regulation (EC) No 1069/2009, which have been unintentionally contaminated with other material streams in a one-off incident resulting only in trace levels of exogenous compounds shall be used. In the plant where the precipitation takes place, physical contacts between input and output materials shall be avoided after the precipitation process, including during storage. 3. The precipitated phosphate salts shall contain: (a) a minimum phosphorus pentoxide (P2O5) content of 16 % of the dry matter content; (b) a maximum organic carbon (Corg) content of 3 % of the dry matter content; (c) no more than 3 g/kg dry matter of macroscopic impurities above 2 mm in any of the following forms: organic matter, glass, stones, metal and plastics; (d) no more than 5 g/kg dry matter of the sum of the macroscopic impurities referred to in sub-point (c). 4. An EU fertilising product may contain derivates from precipitated phosphate salts produced through one or more chemical manufacturing steps that react the precipitated phosphate salts with materials referred to in sub-point 1(f) that are consumed in or used for chemical processing. The derivate manufacturing process shall be executed so as to intentionally modify the chemical composition of the precipitated phosphate salts. 5. The precipitated phosphate salts used for the derivates shall comply with points 1, 2 and 3. 6. Notwithstanding point 1, an EU fertilising product may contain precipitated phosphate salts obtained through precipitation from Category 2 or Category 3 materials or derived products thereof, in accordance with the conditions set out in Article 32(1) and (2) of Regulation (EC) No 1069/2009 and in the measures referred to in Article 32(3) of that Regulation, alone or mixed with input materials referred to in point 1, provided that both of the following conditions are fulfilled: (a) the end point in the manufacturing chain has been determined in accordance with Article 5(2), third subparagraph, of Regulation (EC) No 1069/2009; (b) the conditions in points 2 and 3 are met. An EU fertilising product may also contain derivates from such precipitated phosphate salts, obtained in accordance with the conditions set out in point 4. 7. In the plant where the precipitation takes place, the production lines for the processing of input materials allowed for the precipitated phosphate salts and derivates referred to in points 1, 4 and 6 shall be clearly separated 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 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 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 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. Precipitated phosphate salts or derivates shall have been registered pursuant to Regulation (EC) No 1907/2006 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. 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 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, 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 The exclusion of an input material from a sub-point does not prevent it from being an eligible input material by virtue of another sub-point.: materials originating from mixed municipal waste, sewage sludge, industrial sludge or dredging sludge, and animal by-products or derived products within the scope of Regulation (EC) No 1069/2009; (b) vegetable waste from the food processing industry and fibrous vegetable waste from virgin pulp production and from production of paper from virgin pulp, if not chemically modified; (c) bio-waste fraction resulting from subsequent treatment operations of bio-waste separately collected for recycling within the meaning of Directive 2008/98/EC, for which incineration delivers the best environmental outcome in accordance with Article 4 of that Directive other than animal by-products or derived products within the scope of Regulation (EC) No 1069/2009; (d) materials resulting from a controlled microbial or thermochemical conversion process using exclusively the input materials referred to in sub-points (a), (b), and (c); (e) sewage sludge from municipal wastewater treatment plants, other than animal by-products or derived products within the scope of Regulation (EC) No 1069/2009; (f) materials from the independently operated treatment of waste water not covered by Council Directive 91/271/EEC Council Directive 91/271/EEC of 21 May 1991 concerning urban waste-water treatment (OJ L 135, 30.5.1991, p. 40). from food processing, pet food, feed, milk and drink industries, other than animal by-products or derived products within the scope of Regulation (EC) No 1069/2009; (g) waste within the meaning of Directive 2008/98/EC with the exception of: input materials referred to in sub-points (a) to (f), hazardous waste within the meaning of Article 3, point 2 of Directive 2008/98/EC, materials originating from mixed municipal waste, bio-waste within the meaning of Article 3, point 4 of Directive 2008/98/EC resulting from separate bio-waste collection at source, and animal by-products or derived products within the scope of Regulation (EC) No 1069/2009; (h) auxiliary fuels (natural gas, liquefied gas, natural gas condensate, process gases and components thereof, crude-oil, coal, coke as well as their derived materials), when used to process input materials referred to in sub-points (a) to (g); (i) substances which are used in production processes of the iron and steel industry; or (j) substances and mixtures, with the exception of: input materials referred to in sub-points (a) to (i), waste within the meaning of Article 3, point 1 of Directive 2008/98/EC, substances or mixtures which have ceased to be waste in one or more Member States by virtue of the national measures transposing Article 6 of Directive 2008/98/EC, substances formed from precursors which have ceased to be waste in one or more Member States by virtue of the national measures transposing Article 6 of Directive 2008/98/EC, or mixtures containing such substances, and animal by-products or derived products within the scope of Regulation (EC) No 1069/2009. 2. Notwithstanding point 1, an EU fertilising product may contain thermal oxidation materials obtained through thermochemical conversion under non-oxygen-limiting conditions from Category 2 or Category 3 materials or derived products thereof, in accordance with the conditions set out in Article 32(1) and (2) of Regulation (EC) No 1069/2009 and in the measures referred to in Article 32(3) of that Regulation, alone or mixed with input materials referred to in point 1, provided that both of the following conditions are fulfilled: (a) the end point in the manufacturing chain has been determined in accordance with Article 5(2), third subparagraph of Regulation (EC) No 1069/2009; (b) the conditions in points 3, 4, and 5 are met. 3. The thermal oxidation shall take place under non-oxygen limiting conditions in such a way that the gas resulting from the thermochemical conversion process is raised, after the last injection of combustion air, in a controlled and homogeneous fashion and even under the most unfavourable conditions to a temperature of at least 850 °C for at least 2 seconds. These conditions shall apply to all input materials, with the exemption of: (a) the input materials referred to in points 1(a), (b) and (h), or resulting from a controlled microbial or thermochemical conversion process using exclusively those materials, and (b) input materials referred to in point 2, for which a temperature of at least 450 °C for at least 0,2 seconds shall apply; 4. The thermal oxidation shall take place in an incineration or combustion chamber. The chamber may only process input materials, which are not contaminated with other material streams, or input materials, other than animal by-products or derived products within the scope of Regulation (EC) No 1069/2009, which have been contaminated with other material streams unintentionally in a one-off incident resulting only in trace levels of exogenous compounds. All of the following conditions shall be met in the plant, where the thermal oxidation takes place: (a) the production lines for the processing of input materials referred to in points 1 and 2 shall be clearly separated from production lines for the processing of other input materials, (b) the input material shall be oxidised in such a way that the total organic carbon (Corg) content of the resulting slags and bottom ashes is less than 3 % by dry matter of the material, (c) physical contact between input and output materials shall be avoided after the thermochemical conversion process, including during storage. 5. The thermal oxidation materials shall be ashes or slags, and have no more than: (a) 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., (b) 20 ng WHO toxicity equivalents van den Berg M., L.S. Birnbaum, M. Denison, M. De Vito, W. Farland, et al. (2006) The 2005 World Health Organization Re-evaluation of Human and Mammalian Toxic Equivalency Factors for Dioxins and Dioxin-like Compounds. Toxicological sciences: an official journal of the Society of Toxicology 93:223-241. doi:10.1093/toxsci/kfl055. of PCDD/F Polychlorinated dibenzo-p-dioxins and dibenzofurans./kg dry matter. 6. An EU fertilising product may contain derivates from thermal oxidation materials that have been produced from the input materials referred to in points 1 and 2 that meet the conditions of point 5 and that have been manufactured by a thermochemical conversion process in accordance with points 3 and 4. The derivate manufacturing process shall be executed so as to intentionally modify the chemical composition of the thermal oxidation material. The derivate manufacturing process shall be of the following nature: (a) chemical manufacturing: derivates are produced through one or more chemical manufacturing steps that react thermal oxidation materials with input materials referred to in sub-point 1(j) that are consumed in or used for chemical processing whereas non-biodegradable polymers shall not be used; (b) thermochemical manufacturing: derivates are produced through one or more manufacturing steps that thermochemically react thermal oxidation materials with reactants referred to in points 1 and 2 that are consumed in or used for chemical processing. Thermal oxidation materials that display one or more of the hazardous properties listed in Annex III to Directive 2008/98/EC shall not be mixed or reacted, either with waste, substances or materials with the intention of reducing hazardous substances to levels below the limit values for the hazardous property as laid down in Annex III to that Directive. Using a mass balance approach, manufacturers that use thermal oxidation materials with hazardous properties must demonstrate the removal or transformation of the contaminants to levels below the limit values laid down in Annex III to Directive 2008/98/EC. 7. Contaminants in an EU fertilising product containing or consisting of thermal oxidation materials or derivates must not exceed the following limit values: (a) total chromium (Cr): 400 mg/kg dry matter, if the thermal oxidation materials or derivates are from input materials referred to in sub-points 1(e), (g) or (i); (b) thallium (Tl): 2 mg/kg dry matter, if the thermal oxidation materials or derivates are from input materials referred to in sub-points 1(e), (g), (h) or (i); The chlorine (Cl-) content shall not be higher than 30 g/kg of dry matter. However, this limit value shall not apply to EU fertilising products produced through a manufacturing process where a Cl- containing compound has been added with the intention of producing alkali metal salts or alkaline earth metal salts, and is declared in accordance 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, 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. 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 thereof, which are unprocessed or processed only by manual, mechanical or gravitational means, by dissolution in water, by flotation, extraction with water, by steam distillation or by heating solely to remove water, or which are extracted from air by any means, except The exclusion of an input material from a sub-point does not prevent it from being an eligible input material by virtue of another sub-point.: materials originating from mixed municipal waste, sewage sludge, industrial sludge or dredging sludge, and animal by-products or derived products within the scope of Regulation (EC) No 1069/2009; (b) vegetable waste from the food processing industry and fibrous vegetable waste from virgin pulp production and from production of paper from virgin pulp, if not chemically modified; (c) processing residues within the meaning of Article 2, point (t) of Directive 2009/28/EC from the production of bioethanol and biodiesel, derived from materials referred to in sub-points (a), (b) and (d); (d) bio-waste within the meaning of Article 3, point 4 of Directive 2008/98/EC resulting from separate bio-waste collection at source, other than animal by-products or derived products within the scope of Regulation (EC) No 1069/2009 or (e) pyrolysis or gasification additives which are necessary to improve the process performance or the environmental performance of the pyrolysis or gasification process, provided that those additives are consumed in chemical processing or used for such processing and that total concentration of all additives do not exceed 25 % of the fresh matter of the total input material, with the exception of: input materials referred to in sub-points (a) to (d), waste within the meaning of Article 3, point 1 of Directive 2008/98/EC, substances or mixtures which have ceased to be waste in one or more Member States by virtue of the national measures transposing Article 6 of Directive 2008/98/EC, substances formed from precursors which have ceased to be waste in one or more Member States by virtue of the national measures transposing Article 6 of Directive 2008/98/EC, or mixtures containing such substances, non-biodegradable polymers, and animal by-products or derived products within the scope of Regulation (EC) No 1069/2009. An EU fertilising product may contain pyrolysis or gasification materials obtained through thermochemical conversion under oxygen-limiting conditions of any input material referred to in sub-points (a) to (e), or combination thereof, processed by manual, mechanical or gravitational means, by solid-liquid fractionation using biodegradable polymers, by dissolution in water, by flotation, by extraction with water, by steam distillation or by heating solely to remove water, by composting or by anaerobic digestion. 2. The thermochemical conversion process shall take place under oxygen-limiting conditions in such a way that a temperature of at least 180 °C for at least two seconds is reached in the reactor. The pyrolysis or gasification reactor may only process input materials, which are not contaminated with other material streams, or input materials, other than animal by-products or derived products within the scope of Regulation (EC) No 1069/2009, which have been contaminated with other material streams unintentionally in a one-off incident resulting only in trace levels of exogenous compounds. In the plant where the pyrolysis or gasification takes place, physical contacts between input and output materials shall be avoided after the thermochemical process, including during storage. 3. The pyrolysis and gasification materials shall have a molar ratio of hydrogen (H) to organic carbon (H/Corg) of less than 0,7, with testing to be performed in the dry and ash-free fraction for materials that have an organic carbon (Corg) content of less than 50 %. They shall have no more than: (a) 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., (b) 20 ng WHO toxicity equivalents van den Berg M., L.S. Birnbaum, M. Denison, M. De Vito, W. Farland, et al. (2006) The 2005 World Health Organization Re-evaluation of Human and Mammalian Toxic Equivalency Factors for Dioxins and Dioxin-like Compounds. Toxicological sciences: an official journal of the Society of Toxicology 93:223-241. doi:10.1093/toxsci/kfl055. of PCDD/F Polychlorinated dibenzo-p-dioxins and dibenzofurans./kg dry matter, (c) 0,8 mg/kg dry matter of ndl-PCB Sum of congeners PCB 28, 52, 101, 138, 153, 180., 4. Notwithstanding point 1, an EU fertilising product may contain pyrolysis or gasification materials obtained through the thermochemical conversion under oxygen-limiting conditions of Category 2 or Category 3 materials or derived products thereof, in accordance with the conditions set out in Article 32(1) and (2) of Regulation (EC) No 1069/2009 and in the measures referred to in Article 32(3) of that Regulation, alone or mixed with input materials referred to in point 1, provided that both of the following conditions are fulfilled: (a) the end point in the manufacturing chain has been determined in accordance with Article 5(2), third subparagraph of Regulation (EC) No 1069/2009; (b) the conditions in points 2 and 3 are met. 5. In the plant where the pyrolysis or gasification takes place, the production lines for the processing of input materials referred to in points 1 and 4 shall be clearly separated from production lines for the processing of other input materials. 6. In an EU fertilising product containing or consisting of pyrolysis and gasification materials: (a) the chlorine (Cl-) content shall not be higher than 30 g/kg dry matter and (b) the thallium (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, 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. 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 least 95 % dry matter of the material. (2) The high purity material shall be recovered from waste generated from: (a) a production process that uses as input materials substances and mixtures other than animal by-products or derived products within the scope of Regulation (EC) No 1069/2009 Regulation (EC) No 1069/2009 of the European Parliament and of the Council of 21 October 2009 laying down health rules as regards animal by-products and derived products not intended for human consumption and repealing Regulation (EC) No 1774/2002 (Animal by-products Regulation) (OJ L 300, 14.11.2009, p. 1)., or (b) a gas purification or emission control process designed to remove nutrients from off-gases derived from one or more of the following input materials and facilities: (i) substances and mixtures, other than waste within the meaning of Article 3, point 1, of Directive 2008/98/EC; (ii) plants or plant parts; (iii) bio-waste within the meaning of Article 3, point 4, of Directive 2008/98/EC, resulting from separate bio-waste collection at source; (iv) urban and domestic waste waters within the meaning of Article 2, points 1 and 2, respectively, of Directive 91/271/EEC Council Directive 91/271/EEC of 21 May 1991 concerning urban waste-water treatment (OJ L 135, 30.5.1991, p. 40).; (v) sludge within the meaning of Article 2, point (a), of Directive 86/278/EEC Council Directive 86/278/EEC of 12 June 1986 on the protection of the environment, and in particular of the soil, when sewage sludge is used in agriculture (OJ L 181, 4.7.1986, p. 6)., which displays no hazardous properties listed in Annex III to Directive 2008/98/EC; (vi) waste within the meaning of Article 3, point 1, of Directive 2008/98/EC, and fuels input to a waste co-incineration plant as defined in Directive 2010/75/EU of the European Parliament and of the Council Directive 2010/75/EU of the European Parliament and of the Council of 24 November 2010 on industrial emissions (integrated pollution prevention and control) (OJ L 334, 17.12.2010, p. 17). and operated according to the conditions of that Directive, on condition that these inputs display no hazardous properties listed in Annex III to Directive 2008/98/EC; (vii) 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, provided that the off-gases are derived from a composting or digestion process in accordance with CMCs 3 and 5, respectively, in Annex II to this Regulation; (viii) manure within the meaning of Article 3, point 20, of Regulation (EC) No 1069/2009 or derived products thereof; or (ix) livestock housing facilities. The input materials referred to in points (i) to (vi) shall not contain animal by-products or derived products within the scope of Regulation (EC) No 1069/2009. (3) The high purity material shall have an organic carbon (Corg) content of no more than 0,5 % dry matter of the material. (4) The high purity material shall contain no more than: (a) 6 mg/kg dry matter of polycyclic aromatic hydrocarbons (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.; (b) 20 ng WHO toxicity equivalents van den Berg M., L.S. Birnbaum, M. Denison, M. De Vito, W. Farland, et al. (2006) The 2005 World Health Organization Re-evaluation of Human and Mammalian Toxic Equivalency Factors for Dioxins and Dioxin-like Compounds. Toxicological sciences: an official journal of the Society of Toxicology 93:223-241. doi:10.1093/toxsci/kfl055./kg dry matter of the polychlorinated dibenzo-para-dioxins and dibenzofurans (PCDD/PCDF) Sum of 2,3,7,8-TCDD, 1,2,3,7,8-PeCDD; 1,2,3,4,7,8-HxCDD; 1,2,3,6,7,8-HxCDD; 1,2,3,7,8,9-HxCDD; 1,2,3,4,6,7,8-HpCDD; OCDD; 2,3,7,8-TCDF; 1,2,3,7,8-PeCDF; 2,3,4,7,8-PeCDF; 1,2,3,4,7,8-HxCDF; 1,2,3,6,7,8-HxCDF; 1,2,3,7,8,9-HxCDF; 2,3,4,6,7,8-HxCDF; 1,2,3,4,6,7,8-HpCDF; 1,2,3,4,7,8,9-HpCDF; and OCDF.. (5) An EU fertilising product containing or consisting of high purity materials shall contain no more than: (a) 400 mg/kg dry matter of total chromium (Cr); and (b) 2 mg/kg dry matter of thallium (Tl). (6) Where compliance with a given requirement laid down in points 4 and 5 (such as absence of a given contaminant) follows certainly and uncontestably from the nature or the recovery process of the high purity 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. (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 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 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 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 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 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 have been registered pursuant to 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 points 6, 7, 8, or 9 of Annex V to that Regulation.

32019R1009 → 02019R1009-20220716

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); (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 of products in liquid form by dry weight, in descending order of magnitude by dry weight, magnitude, including the designations of the relevant CMCs as referred to in Part I of Annex II to this Regulation; where Regulation. Where the ingredient is a substance or a mixture, it shall be identified as specified in accordance with Article 18 of Regulation (EC) No 1272/2008. Naturally occurring substances may be identified by their mineral names. 2. Where the EU fertilising product has functions described in two or more of the PFCs laid down in Annex I, only those functions for which the EU fertilising product has been subject to a successful conformity assessment in accordance with this Regulation may be claimed by using the corresponding PFC designations as indicated in Part I of Annex I. 3. Where the EU fertilising product contains a substance for which component material which, if placed on the market as food or feed, would have been subject to maximum residue limits for food and feed have been established in accordance with Regulation (EEC) No 315/93, Regulation (EC) No 396/2005, pursuant to Regulation (EC) No 470/2009 or Regulation (EU) No 1831/2003 of the European Parliament and of the Council Regulation (EC) No 1831/2003 of the European Parliament and of the Council of 22 September 2003 on additives for use in animal nutrition (OJ L 268, 18.10.2003, p. 29)., maximum residue levels set in accordance with Regulation (EC) No 396/2005 of the European Parliament and of the Council Regulation (EC) No 396/2005 of the European Parliament and of the Council of 23 February 2005 on maximum residue levels of pesticides in or on food and feed of plant and animal origin and amending Council Directive 2002/32/EC, 91/414/EEC (OJ L 70, 16.3.2005, p. 1)., or maximum levels established pursuant to Council Regulation (EEC) No 315/93 Council Regulation (EEC) No 315/93 of 8 February 1993 laying down Community procedures for contaminants in food (OJ L 37, 13.2.1993, p. 1). or Directive 2002/32/EC of the instructions referred to European Parliament and of the Council Directive 2002/32/EC of the European Parliament and of the Council of 7 May 2002 on undesirable substances in point 1(d) shall ensure animal feed (OJ L 140, 30.5.2002, p. 10)., and that component material contains a substance in exceedance of (one of) the intended use corresponding limit value(s), the maximum concentration of that substance in the EU fertilising product does shall be indicated, together with a warning that the EU fertilising product must not lead be used in such a manner as to risk leading to the exceedance of those limits that limit in food or feed. 4. Where the EU fertilising product contains derived products within the meaning of Regulation (EC) No 1069/2009 other than manure, the following instruction shall be provided on the label: Farmed animals shall not be fed, either directly or by grazing, with herbage from land to which the product has been applied unless the cutting or grazing takes place after the expiry of a waiting period of at least 21 days.. 5. Where the EU fertilising product contains ricin, the following instruction shall be provided on the label: Hazardous to animals in case of ingestion. 6. Where the EU fertilising product contains unprocessed or processed cocoa shells, the following instruction shall be provided on the label: Toxic to dogs and cats. 7. Where the EU fertilising product is a growing medium as referred to in point 2a of PFC 4 in Part II of Annex I, or contains a polymer with the purpose of binding material in the product, product as referred to in point 1(c) of CMC 9 in Part II of Annex II, the user shall be instructed not to use the product in contact with soil, and in collaboration with the manufacturer, to make sure of a sound disposal of the products product after end of use. 7a. Where the EU fertilising product contains or consists of thermal oxidation materials and derivates as referred to in CMC 13 in Part II in Annex II or pyrolysis or gasification materials as referred to in CMC 14 in Part II of that Annex and has a manganese (Mn) content above 3,5 % by mass, the manganese content shall be declared. 7b. Where the EU fertilising product contains or consists of high purity materials referred to in Part II, CMC 15, of Annex II and: (a) has a selenium (Se) content exceeding 10 mg/kg dry matter, the selenium content shall be indicated; (b) has a chloride (Cl-) content exceeding 30 g/kg dry matter, the chloride content shall be indicated, unless the EU fertilising product is produced through a manufacturing process where chloride containing substances or mixtures have been used with the intention of producing or including alkali metal salts or alkaline earth metal salts, and information on these salts is provided in accordance with Annex III. When the content of selenium or chloride is indicated in accordance with point (a) and (b), it shall be clearly separated from nutrient declaration and it may be expressed as a range of values Where the fact that such an EU fertilising product contains selenium or chloride below the limit values in points (a) and (b) follows certainly and uncontestably from the nature or recovery operation of the high purity material or the production process of the EU fertilising product containing such a material, as applicable, the label may contain no information on these parameters, without verification (such as testing), at the responsibility of the manufacturer. 8. Information other than the information required under points 1 to 6: (a) shall not mislead the user, for example by attributing to the product properties that it does not possess, or by suggesting that the product possesses unique characteristics which … 357 unchanged words … 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 contain 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, denitrification inhibitors or urease inhibitors … 895 unchanged words … shall be provided: (a) indication of the names and chemical symbols of the declared micronutrients, listed in the following order: boron (B), cobalt (Co), copper (Cu), iron (Fe), manganese (Mn), molybdenum (Mo) and zinc (Zn), followed by the names of their counter-ions; counter-ions when the declared micronutrients are intentionally added; (b) the total micronutrient content expressed as % by mass: where those micronutrients are totally soluble in water, only as the content soluble in water; where the soluble content of those micronutrients is at least a quarter of the total content of those micronutrients, as the total content and as the content soluble in water; in other cases, as the total content; (c) where the declared micronutrients are chelated by chelating agents, gent(s) or complexed by complexing agent(s): the following qualifier as applicable, after the name and the chemical identifier of the micronutrient: chelated by … (name [name of the chelating agent agent(s) or its(their) abbreviation]/complexed by [name of the complexing agent(s) or its(their) abbreviation]/chelated by [name of the chelating agent(s) or its(their) abbreviation] and complexed by [name of the complexing agent(s) or its abbreviation), and (their) abbreviation]; the amount of chelated micronutrient chelated/complexed micronutrient(s) as % by mass; (ca) where the declared micronutrients are chelated by chelating agent(s), the pH range guaranteeing acceptable stability; (d) where the organo-mineral fertiliser contains micronutrients complexed by complexing agents the following qualifier after the name and the chemical identifier of the micronutrient: complexed by … (name of the complexing agent or its abbreviation), and the amount of complexed micronutrient … 411 unchanged words … their declared content. 2. The granulometry of a solid inorganic macronutrient fertiliser shall be indicated, expressed as % by mass of the product passing through a determined sieve. 3. The form of the physical unit of the product shall be indicated with one one, or a combination of two or more, of the following mentions: (a) granules, (b) pellets, (c) powder, where at least 90 % by mass of the product can pass through a sieve with a mesh of 1 mm, or (d) prills. prills, 4. For coated solid inorganic macronutrient fertilisers, the name of the coating agents and the percentage of fertiliser coated by each coating agent shall be indicated and followed by: (a) for polymer coated solid inorganic macronutrient fertilisers, the following marking: The rate of nutrient releases can vary according to the temperature of the substrate. An adjustment of fertilisation may be necessary; and (b) for sulphur (S) coated solid inorganic macronutrient fertilisers and sulphur (S)/polymer coated solid inorganic macronutrient fertilisers, the following marking: The rate of nutrient release can vary according to the temperature of the substrate and the biological activity. An adjustment of fertilisation may be necessary. 5. Where one or more of the micronutrients boron (B), cobalt (Co), iron (Fe), manganese (Mn) and molybdenum (Mo) are present in the minimum content indicated in the following table as % by mass, they: shall be declared if they are intentionally added to the solid inorganic macronutrient fertiliser, and may be declared in other cases: Micronutrient Content of micronutrients (% by mass) Intended for use on crops or grassland Intended for horticultural use Boron (B) 0,01 0,01 Cobalt (Co) 0,002 n.a. Iron (Fe) 0,5 0,02 Manganese (Mn) 0,1 0,01 Molybdenum (Mo) 0,001 0,001 6. Where one or both of the micronutrients copper (Cu) and zinc (Zn) are present, without being intentionally added, in the minimum content indicated as % by mass in the following table, they may be declared: Micronutrient Content of micronutrients (% by mass) Intended for use on crops or grassland Intended for horticultural use Copper (Cu) 0,01 0,002 Zinc (Zn) 0,01 0,002 7. Where copper (Cu) or zinc (Zn) is intentionally added to the solid inorganic macronutrient fertiliser the total content of copper (Cu) or zinc (Zn) shall be declared. 8. The micronutrients referred to in points 5, 6 and 7 shall be declared after the information on macronutrients. The following information shall be provided: (a) indication of the names and chemical symbols of the declared micronutrients, listed in the following order: boron (B), cobalt (Co), copper (Cu), iron (Fe), manganese (Mn), molybdenum (Mo) and zinc (Zn), followed by the names of their counter-ions; counter-ions when the declared micronutrients are intentionally added; (b) the total micronutrient content expressed as % by mass: where those micronutrients are totally soluble in water, only as the content soluble in water; where the soluble content of those micronutrients is at least a quarter of the total content of those micronutrients, as the total content and as the content soluble in water; in other cases, as the total content; (c) where the declared micronutrients are chelated by chelating agents, agent(s) or complexed by complexing agent(s): the following qualifier qualifier, as applicable, after the name and the chemical identifier of the micronutrient: chelated by … (name [name of the chelating agent agent(s) or its(their) abbreviation]/complexed by [name of the complexing agent(s) or its(their) abbreviation]/chelated by [name of the chelating agent(s) or its(their) abbreviation] and complexed by [name of the complexing agent(s) or its abbreviation), and (their) abbreviation]; the amount of chelated micronutrient chelated/complexed micronutrient(s) as % by mass; (ca) where the declared micronutrients are chelated by chelating agent(s), the pH range guaranteeing acceptable stability; (d) where the solid inorganic macronutrient fertiliser contains micronutrients complexed by complexing agents the following qualifier after the name and the chemical identifier of the micronutrient: complexed by … (name of the complexing agent or its abbreviation), and the amount of complexed micronutrient as % by mass; (e) where micronutrients are intentionally added, the following statement: To be used only where there is a recognised need. Do not exceed the application rate. PFC 1(C)(I)(b): LIQUID INORGANIC MACRONUTRIENT FERTILISER 1. The label shall indicate whether the liquid inorganic macronutrient fertiliser is in suspension or in solution. 2. The nutrient content may be indicated as % by mass or volume. 3. Where one or more of the micronutrients boron (B), cobalt (Co), iron (Fe), manganese (Mn) and molybdenum (Mo) are present in the minimum content indicated in the following table as % by mass, they: shall be declared if they are intentionally added to the liquid inorganic macronutrient fertiliser, and may be declared in other cases: Micronutrient Content of micronutrient (% by mass) Boron (B) 0,01 Cobalt (Co) 0,002 Iron (Fe) 0,02 Manganese (Mn) 0,01 Molybdenum (Mo) 0,001 4. Where one or both of the micronutrients copper (Cu) and zinc (Zn) are present, without being intentionally added, by at least 0,002 % by mass, they may be declared. 5. Where copper (Cu) or zinc (Zn) is intentionally added to the liquid inorganic macronutrient fertiliser the total content of copper (Cu) or zinc (Zn) shall be declared. 6. The micronutrients referred to in points 3, 4 and 5 shall be declared after the information on macronutrients. The following information shall be provided: (a) indication of the names and chemical symbols of the declared micronutrients, listed in the following order: boron (B), cobalt (Co), copper (Cu), iron (Fe), manganese (Mn), molybdenum (Mo) and zinc (Zn), followed by the names of their counter-ions; counter-ions when the declared micronutrients are intentionally added; (b) the total micronutrient content expressed as % by mass or volume: where those micronutrients are totally soluble in water, only as the content soluble in water; where the soluble content of those micronutrients is at least a quarter of the total content of those micronutrients, as the total content and as the content soluble in water; in other cases, as the total content; (c) where the declared micronutrients are chelated by chelating agents, agent(s) or complexed by complexing agent(s): the following qualifier qualifier, as applicable, after the name and the chemical identifier of the micronutrient: chelated by … (name [name of the chelating agent agent(s) or its(their) abbreviation]/complexed by [name of the complexing agent(s) or its(their) abbreviation]/chelated by [name of the chelating agent(s) or its(their) abbreviation] and complexed by [name of the complexing agent(s) or its abbreviation), and (their) abbreviation]; the amount of chelated micronutrient chelated/complexed micronutrient(s) as % by mass; (ca) where the declared micronutrients are chelated by chelating agent(s), the pH range guaranteeing acceptable stability; (d) where the liquid inorganic macronutrient fertiliser contains micronutrients complexed by complexing agents the following qualifier after the name and the chemical identifier of the micronutrient: complexed by … (name of the complexing agent or its abbreviation), and the amount of complexed micronutrient as % by mass; (e) where micronutrients are intentionally added, the following statement: To be used only where there is a recognised need. Do not exceed the application rate. PFC 1(C)(II): INORGANIC MICRONUTRIENT FERTILISER 1. The declared micronutrients in the inorganic micronutrient fertiliser shall be listed by their names and chemical symbols of the declared micronutrients, in the following order: boron (B), cobalt (Co), copper (Cu), iron (Fe), manganese (Mn), molybdenum (Mo) and zinc (Zn), followed by the names of their counter-ions. counter-ions when the declared micronutrients are intentionally added. 2. Where the declared micronutrients are chelated by chelating agents, agent(s) and each chelating agent can be identified and quantified and chelates at least 1 % water-soluble micronutrient, or the declared micronutrients are complexed by complexing agent(s), the following qualifier qualifiers shall be added added, as applicable, after the name and the chemical identifier of the micronutrient: chelated by … (name [name of the chelating agent agent(s) or its(their) abbreviation]/complexed by [name of the complexing agent(s) or its(their) abbreviation]/chelated by [name of the chelating agent(s) or its(their) abbreviation] and complexed by [name of the complexing agent(s) or its abbreviation), and (their) abbreviation], the amount of chelated micronutrient chelated/complexed micronutrient(s) as % by mass. 2a. Where the declared micronutrients are chelated by chelating agent(s), the pH range guaranteeing acceptable stability shall be indicated. 3. Where the declared micronutrients are complexed by complexing agents, the following qualifier shall be added after the name and the chemical identifier of the micronutrient: complexed by … (name of the complexing agent or its abbreviation), and the amount of … 1,376 unchanged words … terms Concentration of more than 10 % ± 1,0 percentage point in absolute terms PFC 1(C): INORGANIC FERTILISER Forms of the declared nutrient and other declared parameters Permissible tolerance for the declared macronutrient content and other declared parameters Declared forms of nitrogen (N) ± 20 25 % relative deviation of the declared value up to a maximum of 1,5 2 percentage points in absolute terms Declared forms of phosphorus pentoxide (P2O5) ± 20 25 % relative deviation of the declared value up to a maximum of 1,5 2 percentage points in absolute terms Declared forms of potassium oxide (K2O) ± 20 25 % relative deviation of the declared value up to a maximum of 1,5 2 percentage points in absolute terms Declared forms of nitrogen (N), phosphorus pentoxide (P2O5) or potassium oxide (K2O) in binary fertilisers ± 1,5 percentage points in absolute terms Declared forms of nitrogen (N), phosphorus pentoxide (P2O5) or potassium oxide (K2O) in tertiary fertilisers ± 1,9 percentage points in absolute terms Total and water-soluble magnesium oxide (MgO), calcium oxide (CaO), sulphur trioxide (SO3) ± 25 -50 and +100 % relative deviation of the declared content of those nutrients up to a maximum of 1,0 -2 and + 4 percentage point points in absolute terms Total and water soluble sodium oxide (Na2O) – 25 % of the declared content up to a maximum of 0,9 percentage point in absolute terms + 50 % of the declared content up to a maximum of 1,8 percentage points in absolute terms Granulometry ± 10 20 % relative deviation of the declared percentage of material passing a specific sieve Quantity ± 1 % relative deviation of the declared value Micronutrient Permissible tolerance for the declared content of forms of micronutrient Concentration below or equal to 2 % ± 20 50 % of the declared value Concentration of more than 2 % and below or equal to 10 % ± 20 50 % of the declared value up to a maximum of 1,0 percentage point in absolute terms Concentration of more than 10 % ± 1,0 percentage point in absolute terms Quantity: ± 5 % relative deviation of the declared value PFC 2: LIMING MATERIAL Forms of the declared nutrient and other declared parameters Permissible tolerances for the declared parameter Neutralising value ± 3 Granulometry ± 10 % relative deviation of the declared percentage of material passing a specific sieve. Total calcium oxide (CaO) ± 3,0 percentage points in absolute terms Total magnesium oxide (MgO) Concentration below 8 % ± 1,0 percentage point in absolute terms Concentration between 8 to 16 % ± 2,0 percentage points in absolute terms Concentration above or equal to 16 % ± 3,0 percentage points in absolute terms Reactivities (hydrochloric acid test and incubation test) ± 5,0 percentage points in absolute terms Quantity ± 1 % relative deviation of the declared value PFC 3: SOIL IMPROVER Forms of the declared nutrient and other declared parameters Permissible tolerances for the declared parameter pH ± 1,0 of the declared value Organic carbon (Corg) ± 10 % relative deviation of the declared value up to a maximum of 1,0 3,0 percentage point points in absolute terms Organic nitrogen (Norg) ± 50 % relative deviation of the declared value up to a maximum of 1,0 percentage point in absolute terms Total nitrogen (N) ± 20 % relative deviation up to a maximum of 1,0 percentage point in absolute terms Total phosphorus pentoxide (P2O5) ± 20 % relative deviation up to a maximum of 1,0 percentage point in absolute terms Total potassium oxide (K2O) ± 20 % relative deviation up to a maximum of 1,0 percentage point in absolute terms Dry matter content ± 10 % relative deviation of the declared value Quantity ± 5 % relative deviation of the declared value Electrical conductivity ± 75 % relative deviation of the declared value PFC 4: GROWING MEDIUM Forms for the declared nutrient and other declared parameters Permissible tolerances for the declared parameter Electrical conductivity ± 75 % relative deviation of the declared value pH ± 1,0 of the declared value Quantity by volume (litres or m3) ± 5 % relative deviation of the declared value Quantity (volume) determination of materials with particle size greater than 60 mm ± 5 % relative deviation of the declared value Quantity (volume) determination of pre-shaped growing medium ± 5 % relative deviation of the declared value Nitrogen (N) extractable by CaCl2/DTPA (calcium chloride/ diethylenetriaminepentaacetic acid; CAT-soluble) ± 75 % relative deviation of the declared value Phosphorus pentoxide (P2O5) extractable by CaCl2/DTPA (calcium chloride/ diethylenetriaminepentaacetic acid; CAT-soluble) ± 75 % relative deviation of the declared value Potassium oxide (K2O) extractable by CaCl2/DTPA (calcium chloride/ diethylenetriaminepentaacetic acid; CAT-soluble) ± 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 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 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. 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

32019R1009 → 02019R1009-20220716

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, … 387 unchanged words … derived products within the meaning of Regulation (EC) No 1069/2009 as specified in CMC 10 in Part II of Annex II, (e) CMCs referred to in point 1.1 of this Part. 3.2. Module B followed by Module C may also be used for: (a) an inhibitor as specified in PFC 5, (b) a plant biostimulant as specified in PFC 6, and (c) for a fertilising product blend as specified in PFC 7. 3.3. By derogation from points 3.1 and 3.2, Module B followed by Module C must not be used for a straight or compound solid inorganic macronutrient ammonium nitrate fertiliser of high nitrogen … 372 unchanged words … 13, common specifications referred to in Article 14 and/or other relevant technical specifications applied. In the event of partly applied harmonised standards or common specifications, the technical documentation shall specify the parts which have been applied, (g) results of calculations made, including the calculations to demonstrate conformity with point 5 of Part II of Annex I, examinations carried out, etc., (h) test reports, (i) where the EU fertilising product contains or consists of by-products within the meaning of Directive 2008/98/EC, technical and administrative evidence that the by-products comply with the criteria established by delegated act referred to in Article 42(7) of this Regulation, and with the national measures transposing Article 5(1) of Directive 2008/98/EC and, where applicable, implementing acts referred to in Article 5(2) or national measures adopted under Article 5(3) of that Directive, (j) where the EU fertilising product contains total chromium (Cr) above 200 mg/kg, mg/kg dry matter, information about the maximum quantity and exact source of total chromium (Cr). 3. Manufacturing The manufacturer shall take all measures necessary so that the manufacturing process and its monitoring ensure compliance of the manufactured EU fertilising products with the technical documentation referred … 469 unchanged words … 13, common specifications referred to in Article 14 and/or other relevant technical specifications applied. In the event of partly applied harmonised standards or common specifications, the technical documentation shall specify the parts which have been applied, (h) results of calculations made, including the calculations to demonstrate conformity with point 5 of Part II of Annex I, examinations carried out, etc., (i) test reports, including the reports from product checks for oil retention and detonation resistance, referred to in point 4 and (j) where the EU fertilising product contains or consists of by-products within the meaning of Directive 2008/98/EC, … 1,185 unchanged words … per sample are to be carried out. 4.2.6. Test report 4.2.6.1. Expression of the results 4.2.6.1.1. Method of calculation and formula The oil retention, from each determination (point 4.2.5.1) expressed as a % by mass of the sieved test portion, is given by the equation: Oil retention m2 equation:Oil retentionm2 m1m1 100 where: m1 is the mass, in grams, of the sieved test portion (point 4.2.5.2), m2 is the mass, in grams, of the test portion according to points 4.2.5.4 and 4.2.5.5 respectively as the result of the last weighing. 4.2.6.1.2. Take as the … 3,396 unchanged words … 13, common specifications referred to in Article 14 and/or other relevant technical specifications applied. In the event of partly applied harmonised standards or common specifications, the technical documentation shall specify the parts which have been applied, (g) results of calculations made, including the calculations to demonstrate conformity with point 5 of Part II of Annex I, examinations carried out, etc., (h) test reports, (i) where the EU fertilising product contains or consists of derived products within the meaning of Regulation (EC) No 1069/2009, the commercial documents or health certificates required pursuant to that Regulation, and evidence that the derived products have reached the end point in the manufacturing chain within the meaning of that Regulation, (j) where the EU fertilising product contains or consists of by-products within the meaning of Directive 2008/98/EC, technical and administrative evidence that the by-products comply with the criteria established by delegated act referred to in Article 42(7) of this Regulation, and with the national measures transposing Article 5(1) of Directive 2008/98/EC and, where applicable, implementing acts referred to in Article 5(2) or national measures adopted under Article 5(3) of that Directive, and (k) where the EU fertilising product contains total chromium (Cr) above 200 mg/kg, mg/kg dry matter, information about the maximum quantity and exact source of total chromium (Cr). 3. Application for EU-type examination 3.1. The manufacturer shall lodge an application for EU-type examination with a single notified body of his or her choice. 3.2. The application shall include: (a) the … 1,430 unchanged words … manufacturing process, (c) the EU declarations of conformity for the component EU fertilising products of the fertilising product blend, (d) drawings, schemes, descriptions and explanations necessary for the understanding of the manufacturing process of the EU fertilising product, and, in relation to compost materials belonging to CMC 3 CMCs 3, 5, 12, 13, 14 or digestate belonging to CMC 5, 15 as defined in Annex II, a written description and a diagram of the production or recovery process, where each treatment, storage vessel and area is clearly identified, (e) a specimen of the label or the leaflet, or both, referred to in Article 6(7) containing the information required in accordance with Annex III, (f) a list of the harmonised standards referred to in Article 13, common specifications referred to in Article 14 and/or other relevant technical specifications applied. In the event of partly applied harmonised standards or common specifications, the technical documentation shall specify the parts which have been applied, (g) results of calculations made, including examinations carried out, etc., (ga) hazardous waste calculations for EU fertilising products containing or consisting of CMC 13; the calculations testing referred to demonstrate conformity with in point 5 of 6 in CMC 13 in Part II of Annex I, examinations II shall be carried out, etc., out at least every year, or sooner than scheduled in case of any significant change that may affect the safety or quality of the EU fertilising product (for example processing of input material batches of different composition, modification of process conditions). For a representative input material batch that is processed at the plant, the hazardous property identified (in accordance with point 5.1.3.1) and the total mass shall be measured on the different input materials (1, …, n) and on the output material that will be incorporated in the EU fertilising product. The incorporation rate of the hazardous property into the output material shall then be calculated as follows: Where: HPC the concentration of the hazardous property (mg/kg), M the total mass (kg), and i (1-n) the different input materials used in the production process. The removal of the hazardous property during the production process shall be such that the incorporation rate multiplied by the concentration of the hazardous property of each individual input material is below the limit values laid down in Annex III to Directive 2008/98/EC for that hazardous property, (h) test reports, (i) where the EU fertilising product contains or consists of derived products within the meaning of Regulation (EC) No 1069/2009, the commercial documents or health certificates required pursuant to that Regulation, and evidence that the derived products have reached the end point in the manufacturing chain within the meaning of that Regulation, (j) where the EU fertilising product contains or consists of by-products within the meaning of Directive 2008/98/EC, technical and administrative evidence that the by-products comply with the criteria established by delegated act referred to in Article 42(7) of this Regulation, and with the national measures transposing Article 5(1) of Directive 2008/98/EC and, where applicable, implementing acts referred to in Article 5(2) or national measures adopted under Article 5(3) of that Directive, and (k) where the EU fertilising product contains total chromium (Cr) above 200 mg/kg, mg/kg dry matter, information about the maximum quantity and exact source of total chromium (Cr). 3. Availability of technical documentation The manufacturer shall keep the technical documentation at the disposal of the relevant national authorities for 5 years after the EU fertilising product has been placed on the market. 4. Manufacturing The manufacturer shall operate an approved quality system for production, final product inspection and testing of the EU fertilising products concerned as specified in point 5, and shall be subject to surveillance as specified in point 6. 5. Quality system 5.1. The manufacturer shall implement a quality system which shall ensure compliance of the EU fertilising products with the requirements of this Regulation that apply to them. 5.1.1. The quality system shall cover the quality objectives and the organisational structure with responsibilities and powers of the management with regard to product quality. 5.1.1.1. For compost materials belonging to CMC 3 CMCs 3, 5, 12, 13, 14 and digestate belonging to CMC 5, 15, as defined in Annex II, senior management of the manufacturer’s organisation shall: (a) ensure that sufficient resources (people, infrastructure, equipment) are available to create and implement the quality system; (b) appoint a member of the organisation’s management who shall be responsible for: ensuring that quality management processes are established, approved, implemented and maintained; reporting to senior management of the manufacturer on the performance of the quality management and any need for improvement; ensuring the promotion of awareness of customer needs and legal requirements throughout the manufacturer’s organisation, and for making the personnel aware of the relevance and importance of the quality management requirements to meet the legal requirements of this Regulation; ensuring that each person whose duties affect the product quality is sufficiently trained and instructed; and ensuring the classification of the quality management documents mentioned under point 5.1.4; (c) conduct an internal audit every year, or sooner than scheduled if triggered by any significant change that may affect the quality of the EU fertilising product; and (d) ensure that appropriate communication processes are established within and outside the organisation and that communication take place regarding the effectiveness of the quality management. 5.1.2. The quality system shall cover the manufacturing, quality control and quality assurance techniques, processes and systematic actions. 5.1.2.1. For compost materials belonging to CMC 3 CMCs 3, 5, 12, 13, 14 and digestate belonging to CMC 5, 15, as defined in Annex II, the quality system shall ensure compliance with the composting and digestion process criteria requirements specified in that Annex. 5.1.3. The quality system shall cover the examinations and tests to be carried out before, during and after manufacture with a specified frequency. 5.1.3.1. For compost materials belonging to CMC 3 CMCs 3, 5, 12, 13, 14 and digestate belonging to CMC 5, 15, as defined in Annex II, the examinations and tests shall comprise the following elements: (a) The following information shall be recorded for each batch of input materials: (i) date of delivery; (ii) amount by weight (or estimation based on the volume and density); (iii) identity of the input material supplier; (iv) input material type; (v) identification of each batch and delivery location on site. A unique identification code shall be assigned throughout the production process for quality management purposes; and (vi) in case of refusal, the reasons for the rejection of the batch and where it was sent. (b) Qualified staff shall carry out a visual inspection of each consignment of input materials and verify compatibility with the specifications of input materials laid down in CMC 3 CMCs 3, 5, 12, 13, 14 and CMC 5 15 in Annex II. II [OR: as defined in Annex II]. (c) The manufacturer shall refuse any consignment of any given input material where visual inspection raises suspicion of any suspicion of: of the following: the presence of hazardous or damageable damaging substances for the composting or digestion process or for the quality of the final EU fertilising product, or incompatibility with the specifications laid down in CMC 3 CMCs 3, 5, 12, 13, 14 and CMC 5 15 in Annex II, II [OR: as defined in Annex II], in particular by presence of plastics leading to exceedence exceedance of the limit value for macroscopic impurities. (d) The staff shall be trained on: potential hazardous properties that may be associated with input materials, and features that allow hazardous properties and the presence of plastics to be recognised. (e) Samples shall be taken on output materials, to verify that they comply with the component material specifications for compost and digestate laid down in CMC 3 CMCs 3, 5, 12, 13, 14 and CMC 5 15, as defined in Annex II, and that the properties of the output material do not jeopardise the EU fertilising product’s compliance with the relevant requirements laid down in Annex I. (f) The For materials belonging to CMCs 3 and 5, the output material samples shall be taken on a regular basis with at least the following frequency: Annual input (tonnes) Samples / year ≤ 3000 1 3001 – 10000 2 10001 – 20000 3 20001 – 40000 4 40001 – 60000 5 60001 – 80000 6 80001 – 100000 7 100001 – 120000 8 120001 – 140000 9 140001 – 160000 10 160001 – 180000 11 > 180000 12 (fa) For materials belonging to CMCs 12, 13, 14 and 15, the output material samples shall be taken with at least the following default frequency, or sooner than scheduled in the case of any significant change that may affect the quality of the EU fertilising product: Annual output (tonnes) Samples/year ≤ 3000 4 3001 – 10000 8 10001 – 20000 12 20001 – 40000 16 40001 – 60000 20 60001 – 80000 24 80001 – 100000 28 100001 – 120000 32 120001 – 140000 36 140001 – 160000 40 160001 – 180000 44 > 180000 48 Manufacturers may reduce the default frequency of testing for contaminants as indicated above by considering the distribution of historical samples. After a minimum monitoring period of one year and a minimum number of 10 samples showing compliance with the requirements in Annex I and II, the manufacturer may reduce the default sampling frequency for that parameter by a factor 2 in case the greatest contaminant level recorded from the last 10 samples is smaller than half of the limit value for that parameter laid down in Annexes I and II. (fb) For materials belonging to CMCs 12, 13, 14 and 15, each batch or portion of production shall be assigned a unique code for quality management purposes. At least one sample per 3000 tonnes of these materials or one sample per two months, whichever occurs sooner, shall be stored in good condition for a period of at least two years. (g) If any tested output material sample fails one or more of the applicable limits specified in the relevant sections of Annexes I and II, the person responsible for quality management referred to in point 5.1.1.1(b) shall: (i) clearly identify the non-conforming output materials and their storage place, (ii) analyse the reasons of the non-conformity and take any necessary action to avoid its repetition, (iii) record in the quality records referred to in point 5.1.4 if reprocessing takes place, or if the output material is eliminated. eliminated, (iv) for materials belonging to CMCs 12, 13, 14 and 15, measure retainer samples referred to in sub-point (fb) and take the necessary corrective actions to prevent possible further transport and use of that material. 5.1.4. The quality system shall cover the manufacturer’s quality records, such as inspection reports and test data, calibration data, qualification reports on the personnel concerned, etc. 5.1.4.1. For compost materials belonging to CMC 3 CMCs 3, 5, 12, 13, 14 and digestate belonging to CMC 5, 15, as defined in Annex II, the quality records shall demonstrate effective control of input materials, production, storage and compliance of input- and output materials with the relevant requirements of this Regulation. Each document shall be legible and available at its relevant place(s) of use, and any obsolete version shall be promptly removed from all places where it is used, or at least identified as obsolete. The quality management documentation shall at least contain the following information: (a) a title, (b) a version number, (c) a date of issue, (d) the name of the person who issued it, (e) records about the effective control of input materials, (f) records about the effective control of the production process, (g) records about the effective control of the output materials, (h) records of non-conformities, (i) reports on all accidents and incidents that occur to the site, their known or suspected causes and actions taken, (j) records of the complaints expressed by third parties and how they have been addressed, (k) a record of the date, type and topic of training followed by the persons responsible for the quality of the product, (l) results of internal audit and actions taken, and (m) results of external audit review and actions taken. 5.1.5. The quality system shall cover the means of monitoring the achievement of the required product quality and the effective operation of the quality system. 5.1.5.1. For compost materials belonging to CMC 3 CMCs 3, 5, 12, 13, 14 and digestate belonging to CMC 5, 15, as defined in Annex II, the manufacturer shall establish an annual internal audit program in order to verify the compliance of the quality system with the following components: (a) a procedure that defines the responsibilities and requirements for planning and conducting … 629 unchanged words … test data, calibration data, qualification reports on the personnel concerned. 6.3.1. The notified body shall carry out periodic audits to make sure that the manufacturer maintains and applies the quality system and shall provide the manufacturer with an audit report. 6.3.2. For compost materials belonging to CMC 3 CMCs 3, 5, 12, 13, 14 and digestate belonging to CMC 5, 15, as defined in Annex II, the notified body shall take and analyse output material samples during each audit, and the those audits shall be carried out with the following frequency: (a) during the notified body’s first year of surveillance of the plant in question: the same frequency as the sampling frequency indicated in the table tables included in point 5.1.3.1(f); points 5.1.3.1(f) and, respectively, 5.1.3.1(fa); and (b) during the following years of surveillance: half the sampling frequency indicated in the table included in point 5.1.3.1(f). 5.1.3.1(f) and, respectively, 5.1.3.1(fa). 6.4 In addition, the notified body may pay unexpected visits to the manufacturer. During such visits the notified body may, if necessary, carry out product tests, or have them carried out, in order to verify that the quality system is functioning correctly. The notified body shall provide the manufacturer with a visit report and, if tests have been carried out, with a test report. 7. CE marking and EU declaration of conformity 7.1. The manufacturer shall affix the CE marking and, under the responsibility of the notified body referred to in point 5.2, the latter’s identification number to each individual packaging of the EU fertilising product that satisfies the applicable requirements of this Regulation or, where it is supplied without packaging, in a document accompanying the EU fertilising product. 7.2. The manufacturer shall draw up a written EU declaration of conformity for an EU fertilising product or type and keep it, together with the technical documentation at the disposal of the national authorities for 5 years after the EU fertilising product has been placed on the market. The EU declaration of conformity shall identify the EU fertilising product or type for which it has been drawn up. 7.3. A copy of the EU declaration of conformity shall be made available to the relevant authorities upon request. 8. Availability of quality system documentation The manufacturer shall, for 5 years after the EU fertilising product has been placed on the market, keep at the disposal of the national authorities: the documentation referred to in point 5.1.6, the information on the changes referred to in points 5.5.1 and 5.5.2, as approved, the decisions and reports of the notified body referred to in points 5.5.3, 6.3.1 and 6.4. 9. Notified bodies’ information obligation 9.1. Each notified body shall inform its notifying authority of quality system approvals issued or withdrawn, and shall, periodically or upon request, make available to its notifying authority the list of quality system approvals refused, suspended or otherwise restricted. 9.2. Each notified body shall inform the other notified bodies of quality system approvals which it has refused, withdrawn, suspended or otherwise restricted, and, upon request, of quality system approvals which it has issued. 10. Authorised representative The 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.