Component Material Categories (CMCs)
An EU fertilising product shall consist solely of component materials complying with the requirements for one or more of the CMCs listed in this Annex.
The component materials, and the input materials used to produce them, shall not contain any of the substances for which maximum limit values are indicated in Annex I in such quantities as to jeopardise the EU fertilising product’s compliance with the applicable requirements of that Annex.
PART I
DESIGNATION OF CMCS
CMC 1: Virgin material substances and mixtures
CMC 2: Plants, plant parts or plant extracts
CMC 3: Compost
CMC 4: Fresh crop digestate
CMC 5: Digestate other than fresh crop digestate
CMC 6: Food industry by-products
CMC 7: Micro-organisms
CMC 8: Nutrient polymers
CMC 9: Polymers other than nutrient polymers
CMC 10: Derived products within the meaning of Regulation (EC) No 1069/2009
CMC 11: By-products within the meaning of Directive 2008/98/EC
CMC 12: Precipitated phosphate salts and derivates
CMC 13: Thermal oxidation materials and derivates
CMC 14: Pyrolysis and gasification materials
CMC 15: Recovered high purity materials
PART II
REQUIREMENTS RELATED TO CMCS
This Part defines the component materials of which EU fertilising products shall solely consist.
CMC 1: VIRGIN MATERIAL SUBSTANCES AND MIXTURES
1. An EU fertilising product may contain substances and mixtures, except (4):
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, 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 20 0 C
pH 7
loading: 10 g/1 000 mL
test time: 24h,
compost, —————
digestate,
precipitated phosphate salts or derivates, which are recovered from waste or are by-products within the meaning of Directive 2008/98/EC,
thermal oxidation materials or derivates which are recovered from waste or are by-products within the meaning of Directive 2008/98/EC, —————
pyrolysis and gasification materials, which are recovered from waste or are by-products within the meaning of Directive 2008/98/EC, or
ammonium salts, sulphate salts, phosphate salts, elemental sulphur, calcium carbonate or calcium oxide, which are recovered from waste within the meaning of Article 3, point 1, of Directive 2008/98/EC.
2. All substances incorporated into the EU fertilising product, on their own or in a mixture, shall have been registered pursuant to Regulation (EC) No 1907/2006 (5), 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 points 6, 7, 8, or 9 of Annex V to that Regulation.
3. Where the substance or one of the substances in the mixture is intended to enhance the long term availability to plants of micronutrients in the EU fertilising product, that substance shall be either a chelating agent or a complexing agent, and the following rules shall apply:
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 for at least 3 days in a solution having any pH within the range declared as guaranteeing acceptable stability.
The complexing agent shall be an organic substance forming a flat or steric structure with one di- or tri- valent transition metal cation (zinc (Zn), copper (Cu), iron (Fe), manganese (Mn) or cobalt (Co)).
The EU fertilising product shall remain stable in water solution at pH 6 and 7 for at least 1 day.
4. Where the substance or one of the substances in the mixture is intended to improve the EU fertilising product’s nutrient release patterns by delaying or stopping the activity of specific groups of micro-organisms or enzymes, that substance shall be an a nitrification inhibitor, a denitrification inhibitor or a urease inhibitor, and the following rules shall apply:
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).
CMC 2: PLANTS, PLANT PARTS OR PLANT EXTRACTS
An EU fertilising product may contain plants, plant parts or plant extracts having undergone no processing other than cutting, grinding, milling, sieving, sifting, centrifugation, pressing, drying, frost treatment, freeze-drying, extraction with water, supercritical CO2 extraction, or fiberisation at a temperature not higher than 100 °C and without any additives except water.
For the purpose of this point, plants include mushrooms and algae and exclude blue-green algae (cyanobacteria).
CMC 3: COMPOST
1. An EU fertilising product may contain compost obtained through aerobic composting of exclusively one or more of the following input materials:
bio-waste within the meaning of Directive 2008/98/EC resulting from separate bio-waste collection at source;
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:
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.
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 (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 listed in points (a) or (c) or in point 1a which:
has previously been composted or digested, and
contains no more than 6 mg/kg dry matter of PAH16 (7).
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:
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
the conditions in points 2 and 3 are met.
2. The composting shall take place in a plant:
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
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:
no more than 6 mg/kg dry matter of PAH16 (8);
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.
5. The compost shall meet at least one of the following stability criteria:
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 O 2 /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.
CMC 4: FRESH CROP DIGESTATE
1. An EU fertilising product may contain digestate obtained through anaerobic digestion of exclusively one or more of the following input materials:
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 (9), 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.
2. The anaerobic digestion shall take place in a plant:
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.
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:
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 (10);
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.
4. Both the solid and the liquid part of the digestate shall meet at least one of the following stability criteria:
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 O 2 /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.
CMC 5: DIGESTATE OTHER THAN FRESH CROP DIGESTATE
1. An EU fertilising product may contain digestate obtained through anaerobic digestion of exclusively one or more of the following input materials:
bio-waste within the meaning of Directive 2008/98/EC resulting from separate bio-waste collection at source;
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:
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.
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 (11), 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) or (c) or in point 1a which:
has previously been composted or digested, and
contains no more than 6 mg/kg dry matter of PAH16 (12).
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:
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
the conditions in points 2 and 3 are met.
2. The anaerobic digestion shall take place in a plant:
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
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:
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.
4. Neither the solid nor the liquid part of the digestate shall contain more than 6 mg/kg dry matter of PAH16 (13).
5. The digestate shall contain:
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.
6. Both the solid and the liquid part of the digestate shall meet at least one of the following stability criteria:
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 O 2 /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.
CMC 6: FOOD INDUSTRY BY-PRODUCTS
1. An EU fertilising product may contain component material consisting of one of the following substances:
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.
2. All substances incorporated into the EU fertilising product, on their own or in a mixture, shall have been registered pursuant to Regulation (EC) No 1907/2006 (14), 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.
CMC 7: MICRO-ORGANISMS
An EU fertilising product belonging to PFC 6(A) may contain micro-organisms, including dead or empty-cell micro-organisms and non-harmful residual elements of the media on which they were produced, which:
have undergone no other processing than drying or freeze-drying; and
are listed in the following table:
Azotobacterspp.Mycorrhizal fungiRhizobiumspp.Azospirillumspp.
CMC 8: NUTRIENT POLYMERS
1. An EU fertilising product may contain polymers exclusively made up of monomer substances complying with the criteria set out in points 1 and 2 of CMC 1, where the purpose of the polymerisation is to control the release of nutrients from one or more of the monomer substances.
2. At least 60 % of the polymers shall be soluble in a phosphate buffer solution with a pH of 7,5 at 100 °C.
3. The final degradation products shall be only ammonia (NH3), water and carbon dioxide (CO2).
4. The polymers shall not contain more than 600 ppm of free formaldehyde.
CMC 9: POLYMERS OTHER THAN NUTRIENT POLYMERS
1. An EU fertilising product may contain polymers other than nutrient polymers only in cases where the purpose of the polymer is:
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.
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.
3. For the polymers referred to in point 1(a) and (b), neither the polymer, nor its degradation by-products, shall show any overall adverse effect on animal or plant health, or on the environment, under reasonably foreseeable conditions of use in the EU fertilising product. The polymer shall pass a plant growth acute toxicity test, an earthworm acute toxicity test and a nitrification inhibition test with soil micro-organisms as follows:
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 %.
CMC 10: DERIVED PRODUCTS WITHIN THE MEANING OF REGULATION (EC) NO 1069/2009
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 (15):
CMC 11: BY-PRODUCTS WITHIN THE MEANING OF DIRECTIVE 2008/98/EC
1. An EU fertilising product may contain by-products within the meaning of Directive 2008/98/EC, except (16):
animal by-products or derived products within the meaning of Regulation (EC) No 1069/2009,
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 20 0 C
pH 7
loading: 10 g/1 000 mL
test time: 24h,
compost, —————
digestate,
precipitated phosphate salts or derivates, which are recovered from waste or are by-products within the meaning of Directive 2008/98/EC,
thermal oxidation materials or derivates, which are recovered from waste or are by-products within the meaning of Directive 2008/98/EC, —————
pyrolysis and gasification materials, which are recovered from waste or are by-products within the meaning of Directive 2008/98/EC, or
ammonium salts, sulphate salts, phosphate salts, elemental sulphur, calcium carbonate or calcium oxide, which are recovered from waste within the meaning of Article 3, point 1, of Directive 2008/98/EC.
2. The by-products shall have been registered pursuant to Regulation (EC) No 1907/2006, with a dossier containing:
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.
3. From 16 July 2022, the by-products shall comply with the criteria established by delegated act referred to in Article 42(7). An EU fertilising product placed on the market after that date shall not contain by-products referred to in point 1 which do not comply with such criteria.
CMC 12: PRECIPITATED PHOSPHATE SALTS AND DERIVATES
1. An EU fertilising product may contain precipitated phosphate salts obtained through precipitation exclusively from one or more of the following input materials:
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;
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 (17) other than those defined as product-type 4 of main group 1 of Annex V to that Regulation;
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;
processing residues within the meaning of Article 2, point (t), of Directive 2009/28/EC of the European Parliament and of the Council (18) from the production of bioethanol and biodiesel derived from materials referred to in this point, sub-points (b), (c) and (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 (19):
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;
substances and mixtures, other than (19):
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 minimum phosphorus pentoxide (P2O5) content of 16 % of the dry matter content;
a maximum organic carbon (Corg) content of 3 % of the dry matter content;
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;
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:
the end point in the manufacturing chain has been determined in accordance with Article 5(2), third subparagraph, of Regulation (EC) No 1069/2009;
the conditions in points 2 and 3 are met.
An EU fertilising product may also contain derivates from such precipitated phosphate salts, obtained in accordance with the conditions set out in point 4.
7. In the plant where the precipitation takes place, the production lines for the processing of input materials allowed for the precipitated phosphate salts and derivates referred to in points 1, 4 and 6 shall be clearly separated from production lines for the processing of other input materials.
8. Where for the PFC of an EU fertilising product containing or consisting of precipitated phosphate salts or derivates or both there are no requirements regarding Salmonella spp., Escherichia coli or Enterococcaceae in Annex I, those pathogens shall not exceed the limits set out in the following table:
Micro-organisms to be tested | Sampling plans | Limit | ||
n | c | m | M | |
Salmonella spp. | 5 | 0 | 0 | Absence in 25 g or 25 ml |
Escherichia coli or Enterococcaceae | 5 | 5 | 0 | 1 000 in 1 g or 1 ml |
Where:
n = number of samples to be tested, |
c = number of samples where the number of bacteria expressed in CFU is between m and M, |
m = threshold value for the number of bacteria expressed in CFU that is considered satisfactory, |
M = maximum value of the number of bacteria expressed in CFU. |
9. Pathogens in an EU fertilising product containing or consisting of precipitated phosphate salts obtained from materials referred to in sub-point 1(a) or derivates from such precipitated phosphate salts or both shall not exceed the limits set out in the following table:
Micro-organisms to be tested | Sampling plans | Limit | ||
n | c | m | M | |
Clostridium perfringens | 5 | 5 | 0 | 100 CFU in 1 g or 1 ml |
Ascaris sp. viable eggs | 5 | 0 | 0 | Absence in 25 g or 25 ml |
Where:
n = number of samples to be tested, |
c = number of samples where the number of bacteria expressed in CFU is between m and M, |
m = threshold value for the number of bacteria expressed in CFU that is considered satisfactory, |
M = maximum value of the number of bacteria expressed in CFU. |
10. The requirements set out in points (8) and (9), as well as the requirements for Salmonella spp., Escherichia coli or Enterococcaceae set in the corresponding PFC of an EU fertilising product consisting only of precipitated phosphate salts or derivates or both shall not apply when those precipitated phosphate salts or all of the biogenic input materials used in the precipitation process have undergone one of the following processes:
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’);
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 (20)
12. The sum of aluminium (Al) and iron (Fe) in precipitated phosphate salts or derivates shall not exceed 10 % of the dry matter of the precipitated phosphate salts or the derivates.
13. Precipitated phosphate salts or derivates shall have been registered pursuant to Regulation (EC) No 1907/2006 with a dossier containing:
the information provided for by Annexes VI, VII and VIII of 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.
14. For the purposes of points 3, 11 and 12, the dry matter of precipitated phosphate salts and derivates shall be measured using vacuum drying at 40 °C until constant weight to avoid the loss of crystal-bound water.
CMC 13: THERMAL OXIDATION MATERIALS OR DERIVATES
1. An EU fertilising product may contain thermal oxidation materials obtained through thermochemical conversion under non-oxygen-limiting conditions exclusively from one or more of the following input materials:
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 (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;
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;
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;
materials resulting from a controlled microbial or thermochemical conversion process using exclusively the input materials referred to in sub-points (a), (b), and (c);
sewage sludge from municipal wastewater treatment plants, other than animal by-products or derived products within the scope of Regulation (EC) No 1069/2009;
materials from the independently operated treatment of waste water not covered by Council Directive 91/271/EEC (22) 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;
waste within the meaning of Directive 2008/98/EC with the exception (21) 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;
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);
substances which are used in production processes of the iron and steel industry; or
substances and mixtures, with the exception (21) 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:
the end point in the manufacturing chain has been determined in accordance with Article 5(2), third subparagraph of Regulation (EC) No 1069/2009;
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:
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
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:
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,
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,
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:
6 mg/kg dry matter of PAH16 (23),
20 ng WHO toxicity equivalents (24) of PCDD/F (25)/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:
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;
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:
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);
thallium (Tl): 2 mg/kg dry matter, if the thermal oxidation materials or derivates are from input materials referred to in sub-points 1(e), (g), (h) or (i);
The chlorine (Cl-) content shall not be higher than 30 g/kg of dry matter. However, this limit value shall not apply to EU fertilising products produced through a manufacturing process where a Cl- containing compound has been added with the intention of producing alkali metal salts or alkaline earth metal salts, and is declared in accordance with Annex III;
The vanadium (V) content shall not be higher than 600 mg/kg dry matter if the thermal oxidation materials or derivates are from input materials referred to in sub-points 1(g) or (i).
8. The thermal oxidation materials or derivates shall have been registered pursuant to Regulation (EC) No 1907/2006, in a dossier containing:
the information provided for by Annexes VI, VII and VIII of 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.
CMC 14: PYROLYSIS AND GASIFICATION MATERIALS
1. An EU fertilising product may contain pyrolysis or gasification materials obtained through the thermochemical conversion under oxygen-limiting conditions of exclusively one or more of the following input materials:
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 (26):
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;
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;
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);
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
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 (26) 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:
6 mg/kg dry matter of PAH16 (27),
20 ng WHO toxicity equivalents (28) of PCDD/F (29)/kg dry matter,
0,8 mg/kg dry matter of ndl-PCB (30),
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:
the end point in the manufacturing chain has been determined in accordance with Article 5(2), third subparagraph of Regulation (EC) No 1069/2009;
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:
the chlorine (Cl-) content shall not be higher than 30 g/kg dry matter and
the thallium (Tl) content shall not be higher than 2 mg/kg dry matter, in case more than 5 % of pyrolysis or gasification additives relative to the fresh weight of total input material have been applied.
7. The pyrolysis and gasification material shall have been registered pursuant to Regulation (EC) No 1907/2006, in a dossier containing:
the information provided for by Annex VI, VII and VIII of 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.
CMC 15: RECOVERED HIGH PURITY MATERIALS
(1) An EU fertilising product may contain a recovered high purity material, which is ammonium salt, sulphate salt, phosphate salt, elemental sulphur, calcium carbonate or calcium oxide, or mixtures thereof, of a purity of at least 95 % dry matter of the material.
(2) The high purity material shall be recovered from waste generated from:
a 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 (31), or
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:
substances and mixtures, other than waste within the meaning of Article 3, point 1, of Directive 2008/98/EC;
plants or plant parts;
bio-waste within the meaning of Article 3, point 4, of Directive 2008/98/EC, resulting from separate bio-waste collection at source;
urban and domestic waste waters within the meaning of Article 2, points 1 and 2, respectively, of Directive 91/271/EEC (32);
sludge within the meaning of Article 2, point (a), of Directive 86/278/EEC (33), which displays no hazardous properties listed in Annex III to Directive 2008/98/EC;
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 (34) 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;
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;
manure within the meaning of Article 3, point 20, of Regulation (EC) No 1069/2009 or derived products thereof; or
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:
6 mg/kg dry matter of polycyclic aromatic hydrocarbons (PAH16) (35);
20 ng WHO toxicity equivalents (36)/kg dry matter of the polychlorinated dibenzo-para-dioxins and dibenzofurans (PCDD/PCDF) (37).
(5) An EU fertilising product containing or consisting of high purity materials shall contain no more than:
400 mg/kg dry matter of total chromium (Cr); and
2 mg/kg dry matter of thallium (Tl).
(6) Where compliance with a given requirement laid down in points 4 and 5 (such as absence of a given contaminant) follows certainly and uncontestably from the nature or the recovery process of the high purity material or the manufacturing process of the EU fertilising product, that compliance may be presumed in the conformity assessment procedure without verification (such as testing), under the responsibility of the manufacturer.
(7) Where for the product function category of an EU fertilising product containing or consisting of high purity materials referred to in point 2(b) no requirements regarding Salmonella spp., Escherichia coli or Enterococcaceae have been laid down in Annex I, those pathogens in the EU fertilising product shall not exceed the limits set out in the following table:
Micro-organisms to be tested | Sampling plans | Limit | ||
n | c | m | M | |
Salmonella spp. | 5 | 0 | 0 | Absence in 25 g or 25 ml |
Escherichia coli or Enterococcaceae | 5 | 5 | 0 | 1 000 in 1 g or 1 ml |
Where:
n = number of samples to be tested, |
c = number of samples where the number of bacteria expressed in colony forming units (CFU) is between m and M, |
m = threshold value for the number of bacteria expressed in CFU that is considered satisfactory, |
M = maximum value of the number of bacteria expressed in CFU. |
(8) The compliance of an EU fertilising product containing or consisting of high purity materials referred to in point 2(b) with requirements in point (7), or with the requirements for Salmonella spp., Escherichia coli or Enterococcaceae set out in Annex I for the corresponding PFC of the EU fertilising product shall be verified via testing, in accordance with point 5.1.3.1 in Module D1 – quality assurance of the production process in Part II of Annex IV.
The requirements in point (7) and the requirements for Salmonella spp., Escherichia coli or Enterococcaceae set out in Annex I for the corresponding PFC of an EU fertilising product consisting only of high purity materials referred to in point 2(b) shall not apply, when the high purity materials or all of the biogenic input materials used have undergone one of the following processes:
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’);
processing in a pasteurisation or hygienisation unit that reaches a temperature of 70 °C for at least one hour.
The requirements in point (7) and the requirements for Salmonella spp., Escherichia coli or Enterococcaceae set out in Annex I for the corresponding PFC of an EU fertilising product consisting only of high purity materials referred to in point 2(b) shall not apply, where the off-gases derive from an incineration process as defined in Directive 2010/75/EU.
(9) High purity materials that are stored in a way that does not protect them against precipitation and direct sunlight may be added to an EU fertilising product only if they have been manufactured maximum 36 months before signing the EU declaration of conformity for the respective EU fertilising product.
(10) The high purity material shall have been registered pursuant to Regulation (EC) No 1907/2006, with a dossier containing:
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.