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Regulation (EU) 2019/1009 of the European Parliament and of the Council of 5 June 2019 laying down rules on the making available on the market of EU fertilising products and amending Regulations (EC) No 1069/2009 and (EC) No 1107/2009 and repealing Regulation (EC) No 2003/2003 (Text with EEA relevance)

Type Regulation

Publication 2019-06-05

Last updated 2025-12-30

State In force

Department Council of the European Union, European Parliament

Source EUR-Lex

articles 54

Reform history JSON API

An EU fertilising product may contain plants, plant parts or plant extracts having undergone no processing other than cutting, grinding, milling, sieving, sifting, centrifugation, pressing, drying, frost treatment, freeze-drying, extraction with water, supercritical CO2 extraction, or fiberisation at a temperature not higher than 100 °C and without any additives except water.

For the purpose of this point, plants include mushrooms and algae and exclude blue-green algae (cyanobacteria).

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;

(c) living or dead organisms or parts thereof, which are unprocessed or processed only by manual, mechanical or gravitational means, by dissolution in water, by flotation, by extraction with water, by steam distillation or by heating solely to remove water, or which are extracted from air by any means, except: (i) materials originating from mixed municipal waste,’; (ii) sewage sludge, industrial sludge or dredging sludge, and (iii) animal by-products or derived products within the scope of Regulation (EC) No 1069/2009.

(d) composting additives which are necessary to improve the process performance or the environmental performance of the composting process provided that: (i) the additive complies with the requirement set out in point 2 in CMC 1 and (ii) the total concentration of all additives does not exceed 5 % of the total input material weight; or

(e) any material listed in points (a) or (c) or in point 1a which: (i) has previously been composted or digested, and (ii) contains no more than 6 mg/kg dry matter of PAH16 (⁶).

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 points 1 and 1a are clearly separated from production lines for the processing of input materials other than those referred to in points 1 and 1a, and

(b) where physical contacts between input and output materials are avoided, including during storage.

3.The 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 as a result of biologically produced heat. All parts of each batch shall be either regularly and thoroughly moved and turned or subject to forced ventilation in order to ensure the correct sanitation and homogeneity of the material. During the composting process, all parts of each batch shall have one of the following temperature-time profiles:

— 70 °C or more for at least 3 days,

— 65 °C or more for at least 5 days,

— 60 °C or more for at least 7 days, or

— 55 °C or more for at least 14 days.

4.The compost shall contain:

(a) no more than 6 mg/kg dry matter of PAH16 (⁷);

(b) no more than 3 g/kg dry matter of macroscopic impurities above 2 mm in any of the following forms: glass, metal or plastics; and

From 16 July 2026, the presence of plastics above 2 mm within the maximum limit value referred to in point (b) shall be no more than 2,5 g/kg dry matter. By 16 July 2029 the limit-value of 2,5 g/kg dry matter for plastics above 2 mm shall be re-assessed in order to take into account the progress made with regards to separate collection of bio-waste.

5.The compost shall meet at least one of the following stability criteria:

(a) Oxygen uptake rate: — Definition: an indicator of the extent to which biodegradable organic matter is being broken down within a specified time period. The method is not suitable for material with a content of particle sizes > 10 mm that exceeds 20 %, — Criterion: maximum 25 mmol O2/kg organic matter/h; or

(b) Self heating factor: — Definition: the maximum temperature reached by a compost in standardised conditions as an indicator of the state of its aerobic biological activity, — Criterion: minimum Rottegrad III.

6.Where compliance with the requirement in point 4(a) follows certainly and uncontestably from the nature or the recovery process of the compost or the manufacturing process of the EU fertilising product, that compliance may be presumed in the conformity assessment procedure without verification (such as testing), under the responsibility of the manufacturer.

1.An EU fertilising product may contain digestate obtained through anaerobic digestion of exclusively one or more of the following input materials:

(a) plants or plant parts grown for the production of biogas. For the purpose of this point, plants include algae and exclude blue-green algae (cyanobacteria);

(b) digestion additives which are needed to improve the process performance or the environmental performance of the digestion process provided that: (i) the additive complies with the requirement set out in point 2 in CMC 1 and (ii) the total concentration of all additives does not exceed 5 % of the total input material weight; or

2.The anaerobic digestion shall take place in a plant:

(a) in which production lines for the processing of input materials referred to in point 1 are clearly separated from production lines for the processing of input materials other than those referred to in point 1, and

(b) where physical contacts between input and output materials are avoided, including during storage.

3.The anaerobic digestion shall consist of controlled decomposition of biodegradable materials, which is predominantly anaerobic and at temperatures suitable for mesophilic or thermophilic bacteria. All parts of each batch shall be regularly and thoroughly moved and turned in order to ensure the correct sanitation and homogeneity of the material. During the digestion process, all parts of each batch shall have one of the following temperature-time profiles:

(a) thermophilic anaerobic digestion at 55 °C for at least 24 hours followed by a hydraulic retention time of at least 20 days;

(b) thermophilic anaerobic digestion at 55 °C with a treatment process including pasteurisation as described in point 1 of Section 1 of Chapter I of Annex V to Commission Regulation (EU) No 142/2011 (⁸);

(c) thermophilic anaerobic digestion at 55 °C followed by composting in: — 70 °C or more for at least 3 days, — 65 °C or more for at least 5 days, — 60 °C or more for at least 7 days, or — 55 °C or more for at least 14 days;

(d) mesophilic anaerobic digestion at 37-40 °C with a treatment process including pasteurisation as described in point 1 of Section 1 of Chapter I of Annex V to Regulation (EU) No 142/2011; or

(e) mesophilic anaerobic digestion at 37-40 °C followed by composting in: — 70 °C or more for at least 3 days, — 65 °C or more for at least 5 days, — 60 °C or more for at least 7 days, or — 55 °C or more for at least 14 days.

3a.An EU fertilising product may contain a solid or liquid fraction, obtained by mechanical separation of a digestate compliant with points 1 to 3.

3b.An EU fertilising product may contain a digestate compliant with points 1 to 3, or a fraction compliant with point 3a, from which all or part of the soluble ammonium and/or of the phosphate has been removed to recover nitrogen and/or phosphorus, without the intention to otherwise modify the digestate or the fraction.

3c.An EU fertilising product may contain a digestate compliant with points 1 to 3 or point 3b, as well as a fraction compliant with point 3a, which have undergone only physical processing to remove water without the intention to otherwise modify the digestate or the fraction.

3d.Additives needed in the post processing of a digestate or a fraction in accordance with points 3a, 3b and 3c may be used provided that:

(a) the additive complies with the requirement set out in point 2 in CMC 1;

(b) the concentration of the additives needed in each of the processes does not exceed 5 % of the weight of the digestate or fraction used as input in the respective process.

The digestate or a fraction referred to in points 3a, 3b and 3c shall meet at least one of the following stability criteria:

(a) Oxygen uptake rate: — Definition: an indicator of the extent to which biodegradable organic matter is being broken down within a specified time period. The method is not suitable for material with a content of particle sizes > 10 mm that exceeds 20 %; — Criterion: maximum 25 mmol O2/kg organic matter/h; or

(b) Residual biogas potential: — Definition: an indicator of the gas released from a digestate in a 28 day period and measured against the volatile solids contained within the sample. The test is run in triplicate, and the average result is used to demonstrate compliance with the criterion. The volatile solids are those solids in a sample of material that are lost on ignition of the dry solids at 550 °C; — Criterion: maximum 0,25 l biogas/g volatile solids.

1.An EU fertilising product may contain digestate obtained through anaerobic digestion of exclusively one or more of the following input materials:

(a) bio-waste within the meaning of Directive 2008/98/EC resulting from separate bio-waste collection at source;

(d) digestion additives which are necessary to improve the process performance or the environmental performance of the digestion process provided that: (i) the additive complies with the requirement set out in point 2 in CMC 1 and (ii) the total concentration of all additives does not exceed 5 % of the total input material weight; or

(e) any material listed in points (a) or (c) or in point 1a which: (i) has previously been composted or digested, and (ii) contains no more than 6 mg/kg dry matter of PAH16 (⁹).

1a.Notwithstanding point 1, an EU fertilising product may contain digestate obtained through anaerobic digestion of Category 2 or Category 3 materials or derived products thereof, in accordance with the conditions set out in Article 32(1) and (2) and in the measures referred to in Article 32(3) of Regulation (EC) No 1069/2009, alone or mixed with input materials referred to in point 1, provided that:

(a) the end point in the manufacturing chain has been determined in accordance with the third subparagraph of Article 5(2) of Regulation (EC) No 1069/2009, and

(b) the conditions in points 2 and 3 are met.

2.The anaerobic digestion shall take place in a plant:

(b) where physical contacts between input and output materials are avoided, including during storage.

(a) thermophilic anaerobic digestion at 55 °C for at least 24 hours followed by a hydraulic retention time of at least 20 days;

(b) thermophilic anaerobic digestion at 55 °C with a treatment process including pasteurisation as described in point 1 of Section 1 of Chapter I of Annex V to Regulation (EU) No 142/2011;

(d) mesophilic anaerobic digestion at 37-40 °C with a treatment process including pasteurisation as described in point 1 of Section 1 of Chapter I of Annex V to Regulation (EU) No 142/2011; or

3a.An EU fertilising product may contain a solid or liquid fraction obtained by mechanical separation of a digestate compliant with points 1 to 3.

3d.Additives needed in the post processing of a digestate or a fraction in accordance with points 3a, 3b and 3c may be used provided that:

(a) the additive complies with the requirement set out in point 2 in CMC 1;

(b) the concentration of the additives needed in each of the processes does not exceed 5 % of the weight of the digestate or fraction used as input in the respective process.

4.The digestate or the fraction referred to in points 3a, 3b and 3c shall not contain more than 6 mg/kg dry matter of PAH16 (¹⁰).

The digestate or the fraction referred to in points 3a, 3b and 3c shall contain:

(a) no more than 3 g/kg dry matter of macroscopic impurities above 2 mm in any of the following forms: glass, metal or plastics; and

(b) no more than 5 g/kg dry matter of the sum of the macroscopic impurities referred to in point (a).

From 16 July 2026, the presence of plastics above 2 mm within the maximum limit value referred to in point (a) shall be no more than 2,5 g/kg dry matter. By 16 July 2029 the limit-value of 2,5 g/kg dry matter for plastics above 2 mm shall be re-assessed in order to take into account the progress made with regards to separate collection of bio-waste.

The digestate or the fraction referred to in points 3a, 3b and 3c shall meet at least one of the following stability criteria:

(a) Oxygen uptake rate: — Definition: an indicator of the extent to which biodegradable organic matter is being broken down within a specified time period. The method is not suitable for material with a content of particle sizes > 10 mm that exceeds 20 %. — Criterion: maximum 25 mmol O2/kg organic matter/h; or

(b) Residual biogas potential: — Definition: an indicator of the gas released from a digestate in a 28 day period and measured against the volatile solids contained within the sample. The test is run in triplicate, and the average result is used to demonstrate compliance with the criterion. The volatile solids are those solids in a sample of material that are lost on ignition of the dry solids at 550 °C. — Criterion: maximum 0,25 l biogas/g volatile solids.

7.Where compliance with the requirement in point 4 follows certainly and uncontestably from the nature or the recovery process of the digestate, or the fraction thereof, or the manufacturing process of the EU fertilising product, that compliance may be presumed in the conformity assessment procedure without verification (such as testing), under the responsibility of the manufacturer.

1.An EU fertilising product may contain component material consisting of one of the following substances:

(a) food industry factory lime, i.e. a material from the food processing industry obtained by carbonation of organic matter, using exclusively burnt lime from natural sources;

(b) molasses, i.e. a viscous by-product of the refining of sugarcane or sugar beets into sugar;

(c) vinasse, i.e. a viscous by-product of the fermentation process of molasses into ethanol, ascorbic acid or other products;

(d) distillers grains, i.e. by-products resulting from the production of alcoholic beverages;

(e) plants, plant parts or plant extracts having undergone only heat treatment or heat treatment in addition to processing methods referred to in CMC 2; or

(f) lime from drinking water production, i.e. residue which is released by production of drinking water from groundwater or surface water and consists, mainly, of calcium carbonate.

2.All substances incorporated into the EU fertilising product, on their own or in a mixture, shall comply with the requirement set out in point 2 in CMC 1.

An EU fertilising product belonging to PFC 6(A) may contain micro-organisms, including dead or empty-cell micro-organisms and non-harmful residual elements of the media on which they were produced, which:

— have undergone no other processing than drying or freeze-drying; and

— are listed in the following table: Azotobacter spp. Mycorrhizal fungi Rhizobium spp. Azospirillum spp.

1.An EU fertilising product may contain polymers exclusively made up of monomer substances complying with the criteria set out in points 1 and 2 of CMC 1, where the purpose of the polymerisation is to control the release of nutrients from one or more of the monomer substances.

2.At least 60 % of the polymers shall be soluble in a phosphate buffer solution with a pH of 7,5 at 100 °C.

3.The final degradation products shall be only ammonia (NH3), water and carbon dioxide (CO2).

4.The polymers shall not contain more than 600 ppm of free formaldehyde.

1.An EU fertilising product may contain polymers other than nutrient polymers only in cases where the purpose of the polymer is:

(a) to control the water penetration into nutrient particles and thus the release of nutrients (in which case the polymer is commonly referred to as a ‘coating agent’),

(b) to increase the water retention capacity or wettability of the EU fertilising product, or

1a.An EU fertilising product belonging to PFC 3 may contain a polymer in the form of a mulch film.

2.From 16 July 2026, the polymers referred to in point 1(a) and (b) shall comply with the biodegradability criteria established by delegated acts referred to in Article 42(6). In the absence of such criteria, an EU fertilising product placed on the market after that date shall not contain such polymers.

2a.The polymer in a mulch film referred to in point 1a shall comply with the biodegradability criteria set out in Appendix 2 to this Annex.

For the polymers referred to in point 1(a) and (b) and in point 1a, neither the polymer, nor its degradation by-products, shall show any overall adverse effect on animal or plant health, or on the environment, under reasonably foreseeable conditions of use in the EU fertilising product. The polymers referred to in point 1(a) and (b) and point 1a shall pass a plant growth acute toxicity test, an earthworm acute toxicity test and a nitrification inhibition test with soil micro-organisms as follows:

(a) In the plant growth acute toxicity test, the germination rate and the plant biomass of the tested plant species grown on the soil exposed to the test material shall be more than 90 % of the germination rate and the plant biomass of the same plant species grown on corresponding blank soil not exposed to the test material. The results shall be considered to be valid only if in the controls (i.e. blank soil): — the seedling emergence is at least 70 %; — the seedlings do not exhibit visible phytotoxic effects (e.g. chlorosis, necrosis, wilting, leaf and stem deformations) and the plants exhibit only normal variation in growth and morphology for that particular species; — the mean survival of emerged control seedlings is at least 90 % for the duration of the study; and — environmental conditions for a particular species are identical and growing media contain the same amount of soil matrix, support media, or substrate from the same source.

(b) In the earthworm acute toxicity test, the observed mortality and the biomass of surviving earthworms in a soil exposed to the test material shall not differ by more than 10 % compared to those from the corresponding blank soil not exposed to the test material. The results shall be considered to be valid, if: — the percent mortality observed in the control (i.e. blank soil) is less than 10 %, and — the average loss of biomass (mean weight) of the worms in the blank soil does not exceed 20 %.

(c) In the nitrification inhibition test with soil micro-organisms, the nitrite formation in soil exposed to the test material shall be more than 90 % of those from the corresponding blank soil not exposed to the test material. The results shall be considered to be valid, if the variation between replicate control samples (blank soil) and test samples is less than 20 %.

4.The polymer referred to in point 1a shall pass an earthworm chronic toxicity test so that:

(a) after an incubation period of 28 days, the observed mortality and the biomass of surviving adult earthworms in a soil exposed to the test material shall not differ by more than 10 % compared to those from the corresponding blank soil not exposed to the test material;

(b) after an incubation period of 56 days, the observed number of offspring in a soil exposed to the test material shall not differ by more than 10 % compared to those from the corresponding blank soil not exposed to the test material.

The results shall be considered to be valid only if in the controls (i.e. blank soil):

(a) after an incubation period of 28 days, the observed adult mortality is no more than 10 %;

(b) after an incubation period of 56 days each replicate (containing 10 adults) produces at least 30 offspring; and

1.The biodegradability of polymers in mulch films referred to in section CMC 9, point 1a, shall be demonstrated in the following two environmental compartments:

(a) compartment 1: soil;

(b) compartment 2: fresh, estuarine or marine water, or water sediment interface.

2.The polymer shall achieve:

(a) in compartment 1: (1) ultimate degradation of at least 90 % relative to the degradation of the reference material within 24 months plus the functionality period of the product as indicated on the label; or (2) mineralisation of at least 90 %, measured as evolved CO2, over a maximum of 24 months plus the functionality period of the product as indicated on the label:

(b) in compartment 2: (1) ultimate degradation of at least 30 % relative to the degradation of the reference material in 12 months; or (2) ultimate degradation of at least 90 % relative to the degradation of the reference material in 24 months plus the functionality period of the product as indicated on the label.

3.To demonstrate the biodegradability criteria in point 2(a), one of the following test methods shall be used:

(a) EN ISO 17556:2019. Plastics – Determination of the ultimate aerobic biodegradability of plastic materials in soil by measuring the oxygen demand in a respirometer or the amount of carbon dioxide evolved;

(b) ISO/CD 23517:2021. Plastics – Soil biodegradable materials for mulch films for use in agriculture and horticulture;

4.When there is no phase transition (glass transition or melting transition) between 25 °C and 37 °C, the temperature during testing in accordance with points 3(a), (b) and (c) may be adjusted at 37 ^oC.

In such a case, the relevant criterion in point 2(a) shall be considered as being demonstrated if the polymer achieves:

(a) at least 45 % ultimate degradation or mineralisation as referred to in point 2(a) in a separate test at 25 °C in 10 months, whereby degradation or mineralisation shall be progressing, and the plateau phase shall not have been reached, unless the degradation or mineralisation is at least 90 %; and

(b) one of the following criteria: (i) ultimate degradation of at least 90 % relative to degradation of the reference material within 10 months plus the functionality period of the product as indicated on the label; or (ii) mineralisation of at least 90 %, measured as evolved CO2, over a maximum of 10 months plus the functionality period of the product as indicated on the label.

5.To demonstrate the biodegradability criteria in point 2(b), one of the following test methods shall be used:

(a) EN/ISO 14851:2019 Determination of the ultimate aerobic biodegradability of plastic materials in an aqueous medium. Method by measuring the oxygen demand in a closed respirometer;

(b) EN/ISO 14852:2021 Determination of the ultimate aerobic biodegradability of plastic materials in an aqueous medium. Method by analysis of evolved carbon dioxide;

(c) ASTM D6691:2018 Standard Test Method for Determining Aerobic Biodegradation of Plastic Materials in the Marine Environment by a Defined Microbial Consortium or Natural Sea Water Inoculum;

(d) EN/ISO 19679:2020 Plastics – Determination of aerobic biodegradation of non-floating plastic materials in a seawater/sediment interface – Method by analysis of evolved carbon dioxide;

(e) EN/ISO 18830:2017 Plastics – Determination of aerobic biodegradation of non-floating plastic materials in a seawater/sandy sediment interface – Method by measuring the oxygen demand in closed respirometer.

6.Polymers may be tested in any of the following forms:

(a) in the form of the film placed on the market;

(b) in a powder form of the milled film.

7.The following materials may be used as reference materials:

(a) positive controls: biodegradable materials such as micro-crystalline cellulose powder, ashless cellulose filters or poly-β-hydroxybutyrate;

(b) negative controls: non-biodegradable polymers such as polyethylene or polystyrene.

1.An EU fertilising product may contain derived products within the meaning of Regulation (EC) No 1069/2009 having reached the end point in the manufacturing chain as determined in accordance with that Regulation, and which are listed in the following table and as specified therein:

No	The component material	Additional requirements
	Processed manure fulfilling the conditions in Article 3(d) of Delegated Regulation (EU) 2023/1605 (¹)	1.1. An EU fertilising product may contain processed manure only if it was treated to reach an end point according to Regulation (EC) No 1069/2009 at the latest 36 months before signing the EU declaration of conformity for the respective product and the material underwent additional processing so that at least one of the following conditions is met: (a) at least 90 % by dry mass of the material can pass through a sieve with a mesh of 0,25 mm; (b) the material has been granulated under pressure, pelletised, dried at temperatures higher than 100 °C or has undergone any equivalent process that ensures that the content of viable weed seeds and plant propagules in the processed manure is no more than 3 units/l; or (c) the material fulfills at least one of the stability criteria set out in point 5 of CMC 3. 1.2. The material referred to in point 1.1 may undergo one or more of the following additional processes: (a) the processing methods referred to in CMC 2; (b) biological treatment involving nitrification and denitrification; (c) mechanical separation of the solid and liquid fractions; (d) processes to recover nutrients and/or organic carbon, without the intention to otherwise modify the material; (e) chemical processing to modify the pH without the intention to otherwise modify the material; (f) physical processing to remove water and to transform the material into powder, granules or pellets, without the intention to otherwise modify the material. 1.3. Additives needed in the processing referred to in points 1.1 and 1.2 may be used provided that: (a) the additive complies with the requirement set out in point 2 of CMC 1; (b) the concentration of the additives needed in each of the processes does not exceed 5 % of the weight of the processed manure or fraction used as input in the respective process. 1.4. The processed manure shall contain no more than 6 mg/kg dry matter of PAH16 (²). 1.5. The processed manure to be used as component material in an EU fertilising product shall be stored in a way that protects it against precipitation and direct sunlight.
(¹) Commission Delegated Regulation (EU) 2023/1605 of 22 May 2023 supplementing Regulation (EC) No 1069/2009 of the European Parliament and of the Council as regards the determination of end points in the manufacturing chain of certain organic fertilisers and soil improvers (OJ L 198, 8.8.2023, p. 1). (²) 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.

2.Where compliance with the requirement set out in point 1.4 follows certainly and uncontestably from the nature or the processing of the component material or the manufacturing process of the EU fertilising product, such compliance may be presumed in the conformity assessment procedure without verification (such as testing), under the responsibility of the manufacturer.

1.An EU fertilising product may contain by-products within the meaning of Directive 2008/98/EC, except (¹¹):

(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/1 000 mL — test time: 24h,

(d) 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, —————

(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 comply with the requirement set out in point 2 in CMC 1.

3.From 16 July 2022, the by-products shall comply with the criteria established by delegated act referred to in Article 42(7). An EU fertilising product placed on the market after that date shall not contain by-products referred to in point 1 which do not comply with such criteria.

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 (¹²) 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 (¹³) 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 (¹⁴): — 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 (14) : — 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 enterococci in Annex I, those pathogens shall not exceed the limits set out in the following table:

Micro-organisms to be tested	Sampling plans	Limit
n	c	m	M
Salmonella spp.	5	0	0	Absence in 25 g or 25 ml
Escherichia coli or enterococci	5	5	0	1 000 in 1 g or 1 ml

Where:

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:

10.The requirements set out in points (8) and (9), as well as the requirements for Salmonella spp., Escherichia coli or enterococci set in the corresponding PFC of an EU fertilising product consisting only of precipitated phosphate salts or derivates or both shall not apply when those precipitated phosphate salts or all of the biogenic input materials used in the precipitation process have undergone one of the following processes:

(a) pressure sterilisation through the heating to a core temperature of more than 133 °C for at least 20 minutes at an absolute pressure of at least 3 bars, whereby the pressure must be produced by the evacuation of all air in the sterilisation chamber and the replacement of the air by steam (‘saturated steam’);

(b) processing in a pasteurisation or hygienisation unit that reaches a temperature of 70 °C for at least one hour.

11.Precipitated phosphate salts obtained from materials referred to in sub-point 1(a) and derivates obtained from such precipitated phosphate salts shall have no more than 6 mg/kg dry matter of PAH16 (¹⁵)

12.The sum of aluminium (Al) and iron (Fe) in precipitated phosphate salts or derivates shall not exceed 10 % of the dry matter of the precipitated phosphate salts or the derivates.

13.The precipitated phosphate salts or derivates shall comply with the requirement set out in point 2 in CMC 1.

14.For the purposes of points 3, 11 and 12, the dry matter of precipitated phosphate salts and derivates shall be measured using vacuum drying at 40 °C until constant weight to avoid the loss of crystal-bound water.

15.Where compliance with one of the requirements in points 11 and 12 follows certainly and uncontestably from the nature or the recovery process of the precipitated phosphate salt or the derivate, or the manufacturing process of the EU fertilising product, that compliance may be presumed in the conformity assessment procedure without verification (such as testing), under the responsibility of the manufacturer.

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 (¹⁶): — 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 (¹⁷) 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 (16) 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 (16) 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 (¹⁸),

(b) 20 ng WHO toxicity equivalents (¹⁹) of PCDD/F (²⁰)/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 comply with the requirement set out in point 2 in CMC 1.

9.Where compliance with one of the requirements in points 5 and 7 follows certainly and uncontestably from the nature or the recovery process of the thermal oxidation material or the derivate, or the manufacturing process of the EU fertilising product, that compliance may be presumed in the conformity assessment procedure without verification (such as testing), under the responsibility of the manufacturer.

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 (²¹): — 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 (21) 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 (²²),

(b) 20 ng WHO toxicity equivalents (²³) of PCDD/F (²⁴)/kg dry matter,

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 comply with the requirement set out in point 2 in CMC 1.

8.Where compliance with one of the requirements in points 3 and 6 follows certainly and uncontestably from the nature or the recovery process of the pyrolysis or gasification material, or the manufacturing process of the EU fertilising product, that compliance may be presumed in the conformity assessment procedure without verification (such as testing), under the responsibility of the manufacturer.

(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 (²⁵), 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 (²⁶); (v) sludge within the meaning of Article 2, point (a), of Directive 86/278/EEC (²⁷), 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 (²⁸) 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) (²⁹);

(b) 20 ng WHO toxicity equivalents (³⁰)/kg dry matter of the polychlorinated dibenzo-para-dioxins and dibenzofurans (PCDD/PCDF) (³¹).

(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 Enterococci have been laid down in Annex I, those pathogens in the EU fertilising product shall not exceed the limits set out in the following table:

Micro-organisms to be tested	Sampling plans	Limit
n	c	m	M
Salmonella spp.	5	0	0	Absence in 25 g or 25 ml
Escherichia coli or enterococci	5	5	0	1 000 in 1 g or 1 ml

Where:

(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 enterococci set out in Annex I for the corresponding PFC of the EU fertilising product shall be verified via testing, in accordance with point 5.1.3.1 in Module D1 – quality assurance of the production process in Part II of Annex IV.

The requirements in point (7) and the requirements for Salmonella spp., Escherichia coli or enterococci set out in Annex I for the corresponding PFC of an EU fertilising product consisting only of high purity materials referred to in point 2(b) shall not apply, when the high purity materials or all of the biogenic input materials used have undergone one of the following processes:

(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 enterococci set out in Annex I for the corresponding PFC of an EU fertilising product consisting only of high purity materials referred to in point 2(b) shall not apply, where the off-gases derive from an incineration process as defined in Directive 2010/75/EU.

(9)High purity materials that are stored in a way that does not protect them against precipitation and direct sunlight may be added to an EU fertilising product only if they have been manufactured maximum 36 months before signing the EU declaration of conformity for the respective EU fertilising product.

(10)The high purity material shall comply with the requirement set out in point 2 in CMC 1.

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;

(d) instructions for intended use, including application rates, timing and frequency, and target plants or mushrooms;

(e) recommended storage conditions;

(f) for products containing a polymer belonging to CMC 9 in Part II of Annex II, the time period following use during which the nutrient release is being controlled or the water retention capacity is being increased (the ‘functionality period’), which shall not be longer than the period between two applications in accordance with the use instructions referred to in point (d);

(fa) for products belonging to PFC 3 containing a polymer referred to in Part II, section CMC 9, point 1a, of Annex II: (a) the time period following use during which the soil improver will fulfil its function (the ‘functionality period’), which shall not be longer than the period between two applications in accordance with the use instructions referred to in point (d) of this point; (b) an instruction to apply the product in compliance with the buffer zones required for fertilising products in accordance with the relevant national rules or, in the absence of such rules, to apply the product at least 3 m from any surface water body; (c) an instruction to follow the national measures on handling mulch films after their functionality period or, in the absence of such measures, to incorporate in soil the product after its functionality period and maintain it buried;

(g) any relevant information on measures recommended to manage risks to human, animal or plant health, to safety or to the environment; and

(h) a list of all ingredients above 5 % by product weight or volume, or in the case of products in liquid form by dry weight, in descending order of magnitude, including the designations of the relevant CMCs as referred to in Part I of Annex II to this Regulation. Where the ingredient is a substance or a mixture, it shall be identified 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 component material which, if placed on the market as food or feed, would have been subject to maximum residue limits established pursuant to Regulation (EC) No 470/2009 or Regulation (EU) No 1831/2003 of the European Parliament and of the Council (³²), maximum residue levels set in accordance with Regulation (EC) No 396/2005 of the European Parliament and of the Council (³³), or maximum levels established pursuant to Council Regulation (EEC) No 315/93 (³⁴) or Directive 2002/32/EC of the European Parliament and of the Council (³⁵), and that component material contains a substance in exceedance of (one of) the corresponding limit value(s), the maximum concentration of that substance in the EU fertilising product shall be indicated, together with a warning that the EU fertilising product must not be used in such a manner as to risk leading to the exceedance of 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.The end-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 product after end of use where the EU fertilising product:

(a) is a growing medium as referred to in Part II, section PFC 4, point 2a, of Annex I; or

(b) contains a polymer with the purpose of binding material in the product as referred to in Part II, section CMC 9, point 1(c) of Annex II, which does not meet any of the requirements in Part II, section CMC 1, point 1(f)(i), (ii), (iii) or (iv) of that Annex.

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.

7c.Where an EU fertilising product contains processed manure as referred to in Part II, CMC 10, of Annex II, information about the possible air quality impacts of the release of ammonia from the product’s use and an invitation to users to apply appropriate remediation measures shall be included on the label.

Where an EU fertilising product contains processed manure as referred to in Part II, CMC 10, of Annex II, the following warning shall be included on the label ‘This product may contain aminopyralid or clopyralid and must not be used for the production of plants susceptible to these substances, such as beans, clover, lentils, peas, salat, sunflowers and tomatoes. This product must be used in such a manner as to avoid leading to the exceedance of the maximum residue levels for food or feed set in accordance with Regulation (EC) 396/2005’, or a similar warning. Such a warning is not needed for EU fertilising products containing processed manure with no more than 50 μg aminopyralid or clopyralid/kg dry matter.

7d.Where an EU fertilising product contains a component material out of manure, the total content of nitrogen originated out of manure shall be indicated.

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 similar products also have;

(b) shall relate to verifiable factors;

(c) shall not make claims such as ‘sustainable’ or ‘environmentally friendly’ unless such claims refer to legislation, or clearly identified guidelines, standards or schemes, with which the EU fertilising product complies; and

(d) shall not make claims by means of statements or visual representations that the EU fertilising product prevents or treats plant diseases or protects plants against harmful organisms.

9.The phrase ‘poor in chloride’ or similar may only be used if the chloride (Cl-) content is below 30 g/kg of dry matter.

10.Where the nutrient content information requirements in this Annex are expressed in oxidised form, the nutrient content may be expressed in elemental form instead or in addition to the oxidised form in accordance with the following conversion factors:

phosphorus (P) = phosphorus pentoxide (P2O5) × 0,436;

potassium (K) = potassium oxide (K2O) × 0,830;

calcium (Ca) = calcium oxide (CaO) × 0,715;

magnesium (Mg) = magnesium oxide (MgO) × 0,603;

sodium (Na) = sodium oxide (Na2O) × 0,742;

sulphur (S) = sulphur trioxide (SO3) × 0,400.

11.Where the information requirements in this Annex refer to organic carbon (Corg), the information may refer to organic matter instead of or in addition to organic carbon (Corg), in accordance with the following conversion factor:

PART II

PRODUCT-SPECIFIC LABELLING REQUIREMENTS

1.The content of nutrients may be declared only where they are present in the EU fertilising product in the minimum quantity specified in Annex I for the relevant PFC.

2.If nitrogen (N) or phosphorus (P) are not declared nutrients, the content of nitrogen (N) or phosphorus pentoxide (P2O5) shall nevertheless be indicated if above 0,5 % by mass. That indication shall be separate from the nutrient declaration.

3.The following rules apply to fertilisers containing inhibiting compounds, as specified in CMC 1 in Part II of Annex II:

(a) the label shall state the words ‘nitrification inhibitor’, ‘denitrification inhibitor’ or ‘urease inhibitor’, as relevant;

(b) the nitrification inhibiting compound content shall be expressed as a % by mass of the total nitrogen (N) present as ammonium nitrogen (NH4 ⁺) and urea nitrogen (CH4N2O);

(d) the urease inhibiting compound content shall be expressed as a % by mass of the total nitrogen (N) present as urea nitrogen (CH4N2O).

4.The term ‘mineral fertiliser’ may be used only if the fertiliser belongs to PFC 1(C) and fulfils the following additional conditions:

(a) the mineral fertiliser must not cñontain more than 1 % by mass of organic carbon (Corg), other than organic carbon from: (i) chelating or complexing agents referred to in point 3 of CMC 1 in Part II of Annex II, (ii) nitrification, denitrification or urease inhibiting compounds referred to in point 4 of CMC 1 in Part II of Annex II, (iii) coating agents referred to in point 1(a) of CMC 9 in Part II of Annex II, (iv) urea (CH4N2O), or (v) calcium cyanamide (CaCN2);

(b) where phosphorus (P) is a declared nutrient, the declared phosphorus content shall consist only of phosphorus in the phosphatic form, and the mineral fertiliser shall fulfil at least one of the following solubility criteria: (i) water solubility: minimum level 40 % of total phosphorus (P), (ii) solubility in neutral ammonium citrate: minimum level 75 % of total phosphorus (P), or (iii) solubility in formic acid (only for soft rock phosphate): minimum level 55 % of total phosphorus (P);

(c) where nitrogen (N) is a declared nutrient, the declared nitrogen content shall consist only of the sum of nitric nitrogen, ammoniacal nitrogen, ureic nitrogen, and nitrogen from methylene-urea, from isobutylidenediurea, and from crotonylidenediurea.

The following information shall be provided:

(a) the declared primary nutrients nitrogen (N), phosphorus (P) or potassium (K), by their chemical symbols in the order N-P-K;

(b) the declared secondary nutrients calcium (Ca), magnesium (Mg), sodium (Na), or sulphur (S) by their chemical symbols in the order Ca-Mg-Na-S;

(c) numbers indicating the content of the declared nutrients total nitrogen (N), total phosphorus in the form of phosphorus pentoxide (P2O5) or total potassium in the form of potassium oxide (K2O), followed by numbers in brackets indicating the total content of calcium oxide (CaO), magnesium oxide (MgO), sodium oxide (Na2O) or sulphur trioxide (SO3);

(e) the ratio of organic carbon to total nitrogen (Corg/N);

(f) production date;

(g) the form of the physical unit of the product, such as powder or pellets, if applicable.

1.The following information shall be provided:

(a) the declared primary nutrients nitrogen (N), phosphorus (P) or potassium (K), by their chemical symbols in the order N-P-K;

(b) where applicable, the declared secondary nutrients calcium (Ca), magnesium (Mg), sodium (Na) or sulphur (S) by their chemical symbols in the order Ca-Mg-Na-S;

(d) the content of the following declared nutrients and other parameters, in the following order and as % by mass: (i) nitrogen (N): — total nitrogen (N); — minimum amount of organic nitrogen (Norg), followed by a description of the origin of the organic matter used; — nitrogen in the form of nitric nitrogen; — nitrogen in the form of ammoniacal nitrogen; — nitrogen in the form of urea nitrogen; (ii) phosphorus pentoxide (P2O5): — total phosphorus pentoxide (P2O5); — water-soluble phosphorus pentoxide (P2O5); — phosphorus pentoxide (P2O5) soluble in neutral ammonium citrate; — where soft ground phosphate is present, phosphorus pentoxide (P2O5) soluble in formic acid; (iii) potassium oxide (K2O): — total potassium oxide (K2O); — water soluble potassium oxide (K2O); (iv) calcium oxide (CaO), magnesium oxide (MgO), sodium oxide (Na2O) and sulphur trioxide (SO3), expressed: — where those nutrients are totally soluble in water, only as the content soluble in water; — where the soluble content of those nutrients is at least a quarter of the total content of those nutrients, as the total content and as the content soluble in water; — in other cases, as the total content; (v) organic carbon (Corg); (vi) dry matter,

(e) where urea (CH4N2O) is present, information about the possible air quality impacts of the release of ammonia from the fertiliser use, and an invitation to users to apply appropriate remediation measures.

2.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 as % by mass in the following table, they:

— shall be declared if they are intentionally added to an organo-mineral fertiliser, and

— may be declared in other cases:

Micronutrient	Content of micronutrient (% by mass)
Solid organo-mineral fertiliser	Liquid organo-mineral fertiliser
Intended for use on crops or grassland	Intended for horticultural use
Boron (B)	0,01	0,01	0,01
Cobalt (Co)	0,002	n.a.	0,002
Iron (Fe)	0,5	0,02	0,02
Manganese (Mn)	0,1	0,01	0,01
Molybdenum (Mo)	0,001	0,001	0,001

3.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 micronutrient (% by mass)
Solid organo-mineral fertiliser	Liquid organo-mineral fertiliser
Intended for use on crops or grassland	Intended for horticultural use
Copper (Cu)	0,01	0,002	0,002
Zinc (Zn)	0,01	0,002	0,002

4.Where copper (Cu) or zinc (Zn) is intentionally added to the organo-mineral fertiliser, the total content of copper (Cu) or zinc (Zn) shall be declared.

5.The micronutrients referred to in points 2, 3 and 4 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 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 gent(s) or complexed by complexing agent(s): — the following qualifier as applicable, after the name and chemical identifier of the micronutrient: ‘chelated by [name of the chelating 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 (their) abbreviation]’; — the amount of chelated/complexed micronutrient(s) as % by mass;

(ca) where the declared micronutrients are chelated by chelating agent(s), the pH range guaranteeing acceptable stability;

(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’.

6.Where an organo-mineral fertiliser has a cadmium (Cd) content equal to or lower than 20 mg/kg phosphorus pentoxide (P2O5), the statement ‘Low cadmium (Cd) content’ or similar, or a visual representation to that effect, may be added.

1.The following information shall be provided:

(a) where applicable, the declared primary nutrients nitrogen (N), phosphorus (P) or potassium (K), by their chemical symbols in the order N-P-K;

(b) where applicable, the declared secondary nutrients calcium (Ca), magnesium (Mg), sodium (Na) or sulphur (S) by their chemical symbols in the order Ca-Mg-Na-S;

(d) the content of the following declared nutrients, in the following order and as % by mass: (i) nitrogen (N): — total nitrogen (N); — nitrogen in the form of nitric nitrogen; — nitrogen in the form of ammoniacal nitrogen; — nitrogen in the form of urea nitrogen; — nitrogen from urea formaldehyde, isobutylidenediurea, crotonylidenediurea; — nitrogen from cyanamide nitrogen; (ii) phosphorus pentoxide (P2O5): — total phosphorus pentoxide (P2O5); — water-soluble phosphorus pentoxide (P2O5); — phosphorus pentoxide (P2O5) soluble in neutral ammonium citrate; — where soft ground phosphate is present, phosphorus pentoxide (P2O5) soluble in formic acid; (iii) water soluble potassium oxide (K2O); (iv) calcium oxide (CaO), magnesium oxide (MgO), sodium oxide (Na2O) and sulphur trioxide (SO3), expressed: — where those nutrients are totally soluble in water, only as the content soluble in water; — where the soluble content of those nutrients is at least a quarter of the total content of those nutrients, as the total content and as the content soluble in water; — in other cases, as the total content;

2.Where an inorganic macronutrient fertiliser has a cadmium (Cd) content equal to or lower than 20 mg/kg phosphorous pentoxide (P2O5), the statement ‘Low cadmium (Cd) content’ or similar, or a visual representation to that effect, may be added.

1.A solid inorganic macronutrient fertiliser may be labelled ‘complex’ only if each physical unit contains all the declared nutrients in 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, or a combination of two or more, of the following mentions:

(a) granules,

(b) pellets,

(d) 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:

(c) where the declared micronutrients are chelated by chelating agent(s) or complexed by complexing agent(s): — the following qualifier, as applicable, after the name and chemical identifier of the micronutrient: ‘chelated by [name of the chelating 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 (their) abbreviation]’; — the amount of chelated/complexed micronutrient(s) as % by mass;

(ca) where the declared micronutrients are chelated by chelating agent(s), the pH range guaranteeing acceptable stability;

(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’.

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:

(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;

(ca) where the declared micronutrients are chelated by chelating agent(s), the pH range guaranteeing acceptable stability;

(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’.

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 when the declared micronutrients are intentionally added.

2.Where the declared micronutrients are chelated by chelating 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 qualifiers shall be added, as applicable, after the name and chemical identifier of the micronutrient:

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