animal by-products or derived products which are subject to the requirements of Regulation (EC) No 1069/2009 when made available on the market;

plant protection products covered by the scope of Regulation (EC) No 1107/2009.

‘fertilising product’ means a substance, mixture, micro- organism or any other material, applied or intended to be applied on plants or their rhizosphere or on mushrooms or their mycosphere, or intended to constitute the rhizosphere or mycosphere, either on its own or mixed with another material, for the purpose of providing the plants or mushrooms with nutrient or improving their nutrition efficiency;

‘EU fertilising product’ means a fertilising product which is CE marked when made available on the market;

‘substance’ means a substance as defined in point 1 of Article 3 of Regulation (EC) No 1907/2006;

‘mixture’ means a mixture as defined in point 2 of Article 3 of Regulation (EC) No 1907/2006;

‘micro-organism’ means a micro-organism as defined in point 15 of Article 3 of Regulation (EC) No 1107/2009;

‘liquid form’ means a suspension or a solution, where a suspension is a two-phase dispersion in which solid particles are maintained in suspension in the liquid phase, and a solution is a liquid that is free of solid particles, or a gel and includes pastes;

‘solid form’ means form characterised by structural rigidity and resistance to changes of shape or volume and in which the atoms are tightly bound to each other, either in a regular geometric lattice (crystalline solids) or in an irregular manner (an amorphous solid);

‘% by mass’ means a percentage of the mass of the entire EU fertilising product in the form in which it is made available on the market;

‘making available on the market’ means any supply of an EU fertilising product for distribution or use on the Union market in the course of a commercial activity, whether in return for payment or free of charge;

‘placing on the market’ means the first making available of an EU fertilising product on the Union market;

‘manufacturer’ means any natural or legal person who manufactures an EU fertilising product or has an EU fertilising product designed or manufactured, and markets that EU fertilising product under his or her name or trademark;

‘authorised representative’ means any natural or legal person established within the Union who has received a written mandate from a manufacturer to act on his or her behalf in relation to specified tasks;

‘importer’ means any natural or legal person established within the Union who places an EU fertilising product from a third country on the Union market;

‘distributor’ means any natural or legal person in the supply chain, other than the manufacturer or the importer, who makes an EU fertilising product available on the market;

‘economic operators’ means the manufacturer, the authorised representative, the importer and the distributor;

‘technical specification’ means a document that prescribes technical requirements to be fulfilled by an EU fertilising product, by its production process or by the methods for its sampling and analysis;

‘harmonised standard’ means harmonised standard as defined in point 1(c) of Article 2 of Regulation (EU) No 1025/2012;

‘accreditation’ means accreditation as defined in point 10 of Article 2 of Regulation (EC) No 765/2008;

‘national accreditation body’ means national accreditation body as defined in point 11 of Article 2 of Regulation (EC) No 765/2008;

‘conformity assessment’ means the process demonstrating whether the requirements of this Regulation relating to an EU fertilising product have been fulfilled;

‘conformity assessment body’ means a body that performs conformity assessment activities including testing, certification and inspection;

‘recall’ means any measure aimed at achieving the return of an EU fertilising product that has already been made available to the end-user;

‘withdrawal’ means any measure aimed at preventing an EU fertilising product in the supply chain from being made available on the market;

‘Union harmonisation legislation’ means any Union legislation harmonising the conditions for the marketing of products;

‘CE marking’ means a marking by which the manufacturer indicates that the EU fertilising product is in conformity with the applicable requirements set out in Union harmonisation legislation providing for its affixing.

ensure that the packaging bears his or her name, registered trade name or registered trade mark and postal address preceded by the words ‘packaged by’ or ‘repackaged by’; and

keep a specimen of the original information referred to in Article 6(7) or Article 8(4) at the disposal of the market surveillance authorities for 5 years after having made the EU fertilising product available on the market.

personnel with technical knowledge and sufficient and appropriate experience to perform the conformity assessment tasks;

descriptions of procedures in accordance with which conformity assessment is carried out, ensuring the transparency and the ability of reproduction of those procedures. It shall have appropriate policies and procedures in place that distinguish between tasks it carries out as a notified body and other activities;

procedures for the performance of activities which take due account of the size of an undertaking, the sector in which it operates, its structure, the degree of complexity of the product technology in question and the mass or serial nature of the production process.

the polymer is capable of undergoing physical and biological decomposition in natural soil conditions and aquatic environments across the Union, so that it ultimately decomposes only into carbon dioxide, biomass and water;

the polymer has at least 90 % of the organic carbon converted into carbon dioxide in a maximum period of 48 months after the end of the claimed functionality period of the EU fertilising product indicated on the label, and as compared to an appropriate standard in the biodegradation test; and

the use of polymers does not lead to accumulation of plastics in the environment.

in Article 5, paragraphs 2 and 3 are replaced by the following:

Those derived products may subsequently be placed on the market without restrictions under this Regulation and shall no longer be subject to official controls in accordance with this Regulation.

The Commission is empowered to adopt delegated acts in accordance with Article 51a supplementing this Regulation by determining an end point in the manufacturing chain, beyond which derived products referred to in this paragraph are no longer subject to the requirements of this Regulation.

the following Article is inserted:

‘Article 51a

Exercise of the delegation

in Article 2(1), point (b) is replaced by the following:

in Article 3, the following point is added:

in Article 80, the following paragraph is added:

an assessment of the functioning of the internal market for fertilising products, including conformity assessment and market surveillance effectiveness and an analysis of the effects of optional harmonisation on production, market shares and trade flows of EU fertilising products and fertilising products placed on the market under national rules;

a review of the limit values for cadmium content in phosphate fertilisers, with a view to assessing the feasibility of reducing these limit values to a lower appropriate level on the basis of available technologies and scientific evidence on cadmium exposure and accumulation in the environment, taking into account environmental factors, in particular in the context of soil and climatic conditions, health factors, as well as socio-economic factors, including considerations of security of supply;

an assessment of the application of restrictions on levels of contaminants set out in Annex I and an assessment of any new relevant scientific information as regards the toxicity and carcinogenicity of contaminants that becomes available, including the risks from uranium contamination in fertilising products.

Articles 4(3), 14, 42, 43, 44, 45, 46 and 47 shall apply from 15 July 2019; and

Articles 20 to 36 shall apply from 16 April 2020.

Solid inorganic macronutrient fertiliser

Liquid inorganic macronutrient fertiliser

Straight inorganic micronutrient fertiliser

Compound inorganic micronutrient fertiliser

2,5 % by mass of total nitrogen (N),

2 % by mass of total phosphorus pentoxide (P2O5), or

2 % by mass of total potassium oxide (K2O).

1 % by mass of total nitrogen (N),

1 % by mass of total phosphorus pentoxide (P2O5), or

1 % by mass of total potassium oxide (K2O).

2 % by mass of total nitrogen (N),

1 % by mass of total phosphorus pentoxide (P2O5), or

2 % by mass of total potassium oxide (K2O).

1 % by mass of total nitrogen (N),

1 % by mass of total phosphorus pentoxide (P2O5), or

1 % by mass of total potassium oxide (K2O).

one or more inorganic fertilisers, as specified in PFC 1(C), and

one or more materials containing:

of solely biological origin.

2,5 % by mass of total nitrogen (N), out of which 1 % by mass shall be organic nitrogen (Norg),

2 % by mass of total phosphorus pentoxide (P2O5), or

2 % by mass of total potassium oxide (K2O).

2 % by mass of total nitrogen (N), out of which 0,5 % by mass shall be organic nitrogen (Norg),

2 % by mass of total phosphorus pentoxide (P2O5), or

2 % by mass of total potassium oxide (K2O).

2 % by mass of total nitrogen (N), out of which 0,5 % by mass shall be organic nitrogen (Norg),

2 % by mass of total phosphorus pentoxide (P2O5), or

2 % by mass of total potassium oxide (K2O).

2 % by mass of total nitrogen (N), out of which 0,5 % by mass shall be organic nitrogen (Norg),

2 % by mass of total phosphorus pentoxide (P2O5), or

2 % by mass of total potassium oxide (K2O).

primary macronutrients: nitrogen (N), phosphorus (P) or potassium (K),

secondary macronutrients: calcium (Ca), magnesium (Mg), sodium (Na) or sulphur (S).

only one macronutrient (nitrogen (N), phosphorus (P), potassium (K), calcium (Ca), magnesium (Mg), sodium (Na), sulphur (S)), or

only one primary macronutrient (nitrogen (N), phosphorus (P), potassium (K)) and one or more secondary macronutrients (calcium (Ca), magnesium (Mg), sodium (Na), sulphur (S)).

10 % by mass of total nitrogen (N),

12 % by mass of total phosphorus pentoxide (P2O5),

6 % by mass of total potassium oxide (K2O),

5 % by mass of total magnesium oxide (MgO),

12 % by mass of total calcium oxide (CaO),

10 % by mass of total sulphur trioxide (SO3), or

1 % by mass of total sodium oxide (Na2O).

that primary macronutrient content shall be at least the following:

that or those secondary macronutrient contents shall be at least the following:

However, the total sodium oxide (Na2O) content shall not exceed 40 % by mass.

more than one primary macronutrient (nitrogen (N), phosphorus (P), potassium (K)), or

more than one secondary macronutrient (calcium (Ca), magnesium (Mg), sodium (Na), sulphur (S)) and no primary macronutrient (nitrogen (N), phosphorus (P), potassium (K)).

3 % by mass of total nitrogen (N),

3 % by mass of total phosphorus pentoxide (P2O5),

3 % by mass of total potassium oxide (K2O),

1,5 % by mass of total magnesium oxide (MgO),

1,5 % by mass of total calcium oxide (CaO),

1,5 % by mass of total sulphur trioxide (SO3), or

1 % by mass of total sodium oxide (Na2O).

only one macronutrient (nitrogen (N), phosphorus (P), potassium (K), calcium (Ca), magnesium (Mg), sodium (Na), sulphur (S)), or

only one primary macronutrient (nitrogen (N), phosphorus (P), potassium (K)) and one or more secondary macronutrients (calcium (Ca), magnesium (Mg), sodium (Na), sulphur (S)).

5 % by mass of total nitrogen (N),

5 % by mass of total phosphorus pentoxide (P2O5),

3 % by mass of total potassium oxide (K2O),

2 % by mass of total magnesium oxide (MgO),

6 % by mass of total calcium oxide (CaO),

5 % by mass of total sulphur trioxide (SO3), or

1 % by mass of total sodium oxide (Na2O).

that primary macronutrient content shall be at least the following:

that or those secondary macronutrient contents shall be at least the following:

However, the total sodium oxide (Na2O) content shall not exceed 20 % by mass.

more than one primary macronutrient (nitrogen (N), phosphorus (P), potassium (K)), or

more than one secondary macronutrient (calcium (Ca), magnesium (Mg), sodium (Na), sulphur (S)), and no primary macronutrient (nitrogen (N), phosphorus (P), potassium (K)).

1,5 % by mass of total nitrogen (N),

1,5 % by mass of total phosphorus pentoxide (P2O5),

1,5 % by mass of total potassium oxide (K2O),

0,75 % by mass of total magnesium oxide (MgO),

0,75 % by mass of total calcium oxide (CaO),

0,75 % by mass of total sulphur trioxide (SO3), or

0,5 % by mass of total sodium oxide (Na2O).

2 % by mass for fertilisers in liquid form;

5 % by mass for fertilisers in solid form.

minimum neutralising value: 15 (equivalent CaO) or 9 (equivalent HO-),

minimum reactivity: 10 % (hydrochloric acid test) or 50 % after 6 months (incubation test), and

minimum grain size: at least 70 % < 1 mm, except for burnt limes, granulated liming material and chalk (at least 70 % of the liming material shall pass through a 1 mm sieve).

ammoniacal nitrogen (NH3-N) disappearance, or

the sum of nitrite nitrogen (NO2-) and nitrate nitrogen (NO3-) production with respect to time.

nutrient use efficiency,

tolerance to abiotic stress,

quality traits, or

availability of confined nutrients in the soil or rhizosphere.

drawing up an EU declaration of conformity for the fertilising product blend in accordance with Article 6(2) of this Regulation, and

being in possession of the EU declaration of conformity of each of the component EU fertilising products.

Article 6(3) (manufacturers’ obligation to keep the EU declaration of conformity);

point (a) of Article 7(2) (authorised representatives’ obligation to keep the EU declaration of conformity);

Article 8(8) (importers’ obligation to keep a copy of the EU declaration of conformity at the disposal of the market surveillance authorities).

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:

compost, ►M2  ————— ◄

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, ►M5  ————— ◄

pyrolysis and gasification materials, which are recovered from waste or are by-products within the meaning of Directive 2008/98/EC ►M5  , 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.

the information provided for by Annexes VI, VII and VIII to Regulation (EC) No 1907/2006;

a chemical safety report pursuant to Article 14 of Regulation (EC) No 1907/2006 covering the use as a fertilising product,

The chelating agent shall be an organic substance consisting in a molecule which:

▼M1

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.

▼B

The complexing agent shall be an organic substance forming a flat or steric structure with one di- or tri- valent transition metal cation (zinc (Zn), copper (Cu), iron (Fe), manganese (Mn) or cobalt (Co)).

The EU fertilising product shall remain stable in water solution at pH 6 and 7 for at least 1 day.

The nitrification inhibiting compound shall inhibit the biological oxidation of ammoniacal nitrogen (NH3-N) contained in the EU fertilising product to nitrite nitrogen (NO2 -), thus slowing the formation of nitrate nitrogen (NO3 -).

The ammoniacal nitrogen (NH3-N) oxidation rate shall be measured by either of the following:

Compared to a control sample where the nitrification inhibiting compound has not been added, a soil sample containing the nitrification inhibiting compound 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.

The nitrification inhibiting compound shall be present in the EU fertilising product in a concentration, which is within the range of concentrations that ensures the achievement of such a reduction.

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 inhibiting compound shall inhibit the formation of nitrous oxide (N2O) contained in the EU fertilising product 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 inhibiting compound has not been added, an in vitro test containing the denitrification inhibiting compound 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 denitrification inhibiting compound shall be present in the EU fertilising product in a concentration, which is within the range of concentrations that ensures the achievement of such a reduction.

The urease inhibiting compound shall inhibit hydrolytic action on urea (CH4N2O) contained in the EU fertilising product by the urease enzyme, primarily targeted to reduce ammonia volatilisation.

Compared to a control sample where the urease inhibiting compound has not been added, an in vitro test containing the urease inhibiting compound 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.

The urease inhibiting compound shall be present in the EU fertilising product in a concentration, which is within the range of concentrations that ensures the achievement of such a reduction.

At least 50 % of the total nitrogen (N) content of the EU fertilising product shall consist of the nitrogen (N) form urea (CH4N2O).

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:

composting additives which are necessary to improve the process performance or the environmental performance of the composting process provided that:

▼M6

▼B

▼M1

any material listed in points (a) or (c) or in point 1a which:

▼B

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.

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.

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

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).

Oxygen uptake rate:

Self heating factor:

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:

▼M6

▼B

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 ( 8 );

thermophilic anaerobic digestion at 55 °C followed by composting in:

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:

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

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.

Oxygen uptake rate:

Residual biogas potential:

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:

digestion additives which are necessary to improve the process performance or the environmental performance of the digestion process provided that:

▼M6

▼B

▼M1

any material listed in points (a) or (c) or in point 1a which:

▼B

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.

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.

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:

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:

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

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.

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).

Oxygen uptake rate:

Residual biogas potential:

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.

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):

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:

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 %.

animal by-products or derived products within the meaning of Regulation (EC) No 1069/2009,

polymers, other than:

compost, ►M2  ————— ◄

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, ►M5  ————— ◄

pyrolysis and gasification materials, which are recovered from waste or are by-products within the meaning of Directive 2008/98/EC, ►M5  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.

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 ( 13 ) 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 ( 14 ) 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 ( 15 ):

substances and mixtures, other than (15) :

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).

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.

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.

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 ( 17 ):

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 ( 18 ) 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 (17)  of:

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 (17)  of:

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.

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,

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.

6 mg/kg dry matter of PAH16 ( 19 ),

20 ng WHO toxicity equivalents ( 20 ) of PCDD/F ( 21 )/kg dry matter.

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.

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);

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 ( 22 ):

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 (22)  of:

6 mg/kg dry matter of PAH16 ( 23 ),

20 ng WHO toxicity equivalents ( 24 ) of PCDD/F ( 25 )/kg dry matter,

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.

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.

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 ( 26 ), 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:

6 mg/kg dry matter of polycyclic aromatic hydrocarbons (PAH16) ( 30 );

20 ng WHO toxicity equivalents ( 31 )/kg dry matter of the polychlorinated dibenzo-para-dioxins and dibenzofurans (PCDD/PCDF) ( 32 ).

400 mg/kg dry matter of total chromium (Cr); and

2 mg/kg dry matter of thallium (Tl).

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.

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;

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;

the quantity of the EU fertilising product, indicated by mass or volume;

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

recommended storage conditions;

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);

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

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.

has a selenium (Se) content exceeding 10 mg/kg dry matter, the selenium content shall be indicated;

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.

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;

shall relate to verifiable factors;

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

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.

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

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);

the denitrification inhibiting compound content shall be expressed as a % by mass of the nitrate (NO3 -) present;

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

the mineral fertiliser must not cñontain more than 1 % by mass of organic carbon (Corg), other than organic carbon from:

▼M6

▼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:

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

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

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);

the content of the following declared nutrients and other parameters, in the following order and as % by mass:

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

production date;

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

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

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;

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);

the content of the following declared nutrients and other parameters, in the following order and as % by mass:

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.

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;

the total micronutrient content expressed as % by mass:

where the declared micronutrients are chelated by chelating gent(s) or complexed by complexing agent(s):

‘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]’;

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

where micronutrients are intentionally added, the following statement: ‘To be used only where there is a recognised need. Do not exceed the application rate’.

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

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;

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);

the content of the following declared nutrients, in the following order and as % by mass:

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.

granules,

pellets,

powder, where at least 90 % by mass of the product can pass through a sieve with a mesh of 1 mm, or

prills,

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

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’.

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;

the total micronutrient content expressed as % by mass:

where the declared micronutrients are chelated by chelating agent(s) or complexed by complexing agent(s):

‘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]’;

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

where micronutrients are intentionally added, the following statement: ‘To be used only where there is a recognised need. Do not exceed the application rate’.

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;

the total micronutrient content expressed as % by mass or volume:

where the declared micronutrients are chelated by chelating agent(s) or complexed by complexing agent(s):

‘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]’;

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

where micronutrients are intentionally added, the following statement: ‘To be used only where there is a recognised need. Do not exceed the application rate’.