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- Original (As adopted by EU)
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)
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This Part defines the component materials of which EU fertilising products shall solely consist.
waste within the meaning 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,
by-products within the meaning of Directive 2008/98/EC,
animal by-products or derived products within the meaning of Regulation (EC) No 1069/2009,
polymers,
compost, or
digestate.
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 points 6, 7, 8, or 9 of Annex V to that Regulation.
The chelating agent shall be an organic substance consisting in a molecule which:
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
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.
The complexing agent shall be an organic substance forming a flat or steric structure with one di- or tri- valent transition metal cation (zinc (Zn), copper (Cu), iron (Fe), manganese (Mn) or cobalt (Co)).
The EU fertilising product shall remain stable in water solution at pH 6 and 7 for at least 1 day.
The nitrification inhibitor shall inhibit the biological oxidation of ammoniacal nitrogen (NH3-N) to nitrite nitrogen (NO2-), thus slowing the formation of nitrate nitrogen (NO3-).
The ammoniacal nitrogen (NH3-N) oxidation rate shall be measured either by:
ammoniacal nitrogen (NH3-N) disappearance, or
the sum of nitrite nitrogen (NO2-) and nitrate nitrogen (NO3-) production with respect to time.
Compared to a control sample where the nitrification inhibitor has not been added, a soil sample containing the nitrification inhibitor shall show a 20 % reduction in ammoniacal nitrogen (NH3-N) oxidation rate based on an analysis carried out 14 days after application at the 95 % confidence level.
At least 50 % of the total nitrogen (N) content of the EU fertilising product shall consist of the nitrogen (N) forms ammonium (NH4 +) and urea (CH4N2O).
The denitrification inhibitor shall inhibit the formation of nitrous oxide (N2O) by slowing down or blocking the conversion of nitrate (NO3-) to dinitrogen (N2) without influencing the nitrification process as described in PFC 5(A).
Compared to a control sample where the denitrification inhibitor has not been added, an in vitro test containing the denitrification inhibitor shall show a 20 % reduction in rate of the release of nitrous oxide (N2O) based on an analysis carried out 14 days after application at the 95 % confidence level.
The urease inhibitor shall inhibit hydrolytic action on urea (CH4N2O) by the urease enzyme, primarily targeted to reduce ammonia volatilisation. Compared to a control sample where the urease inhibitor has not been added, an in vitro test containing the urease inhibitor shall show a 20 % reduction in the rate of hydrolysis of urea (CH4N2O) based on an analysis carried out 14 days after application at the 95 % confidence level.
At least 50 % of the total nitrogen (N) content of the EU fertilising product shall consist of the nitrogen (N) form urea (CH4N2O).
An EU fertilising product may contain plants, plant parts or plant extracts having undergone no other processing than cutting, grinding, milling, sieving, sifting, centrifugation, pressing, drying, frost treatment, freeze-drying or extraction with water or supercritical CO2 extraction.
For the purpose of this point, plants include mushrooms and algae and exclude blue-green algae (cyanobacteria).
bio-waste within the meaning of Directive 2008/98/EC resulting from separate bio-waste collection at source;
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;
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 mixed municipal household waste separated through mechanical, physicochemical, biological and/or manual treatment,
sewage sludge, industrial sludge or dredging sludge, and
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;
composting additives which are necessary to improve the process performance or the environmental performance of the composting process provided that:
the additive is registered pursuant to Regulation (EC) No 1907/2006(3), 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
the total concentration of all additives does not exceed 5 % of the total input material weight; or
any material listed in points (a), (b) or (c) which:
has previously been composted or digested, and
contains no more than 6 mg/kg dry matter of PAH16 (4).
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
where physical contacts between input and output materials are avoided, including during storage.
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.
no more than 6 mg/kg dry matter of PAH16 (5);
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
no more than 5 g/kg dry matter of the sum of the macroscopic impurities referred to in point (b).
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.
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
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.
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);
digestion additives which are needed to improve the process performance or the environmental performance of the digestion process provided that:
the additive is registered pursuant to Regulation (EC) No 1907/2006(6), 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
the total concentration of all additives does not exceed 5 % of the total input material weight; or
any material referred to in point (a) that has previously been digested.
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
where physical contacts between input and output materials are avoided, including during storage.
thermophilic anaerobic digestion at 55 °C for at least 24 hours followed by a hydraulic retention time of at least 20 days;
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(7);
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;
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
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.
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
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.
bio-waste within the meaning of Directive 2008/98/EC resulting from separate bio-waste collection at source;
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;
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 mixed municipal household waste separated through mechanical, physicochemical, biological and/or manual treatment,
sewage sludge, industrial sludge or dredging sludge,
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;
digestion additives which are necessary to improve the process performance or the environmental performance of the digestion process provided that:
the additive is registered pursuant to Regulation (EC) No 1907/2006(8), 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
the total concentration of all additives does not exceed 5 % of the total input material weight; or
any material listed in points (a), (b) or (c) which:
has previously been composted or digested, and
contains no more than 6 mg/kg dry matter of PAH16 (9).
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
where physical contacts between input and output materials are avoided, including during storage.
thermophilic anaerobic digestion at 55 °C for at least 24 hours followed by a hydraulic retention time of at least 20 days;
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;
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;
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
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.
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
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.
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
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.
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;
molasses, i.e. a viscous by-product of the refining of sugarcane or sugar beets into sugar;
vinasse, i.e. a viscous by-product of the fermentation process of molasses into ethanol, ascorbic acid or other products;
distillers grains, i.e. by-products resulting from the production of alcoholic beverages;
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
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.
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.
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. |
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’),
to increase the water retention capacity or wettability of the EU fertilising product, or
to bind material in an EU fertilising product belonging to PFC 4.
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.
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 %.
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 %.
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(12):
animal by-products or derived products within the meaning of Regulation (EC) No 1069/2009,
polymers,
compost, or
digestate.
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.
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.
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.
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.
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.
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.
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.
Commission Regulation (EU) No 142/2011 of 25 February 2011 implementing Regulation (EC) No 1069/2009 of the European Parliament and of the Council laying down health rules as regards animal by-products and derived products not intended for human consumption and implementing Council Directive 97/78/EC as regards certain samples and items exempt from veterinary checks at the border under that Directive (OJ L 54, 26.2.2011, p. 1).
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.
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.
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
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.
The table will be established by delegated acts referred to in Article 42(5).
The exclusion of a material from CMC 11 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 or CMC 10 on derived products within the meaning of Regulation (EC) No 1069/2009.
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