EN    EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, 17.3.2016  
COM(2016) 157 final  
ANNEXES 1 to 5  
  
Circular economy package  
ANNEXES  
to the  
Proposal for a regulation of the European Parliament and of the Council  
laying down rules on the making available on the market of CE marked fertilising 
products and amending Regulations (EC) No 1069/2009 and (EC) No 1107/2009  
{SWD(2016) 64 final}  
{SWD(2016) 65 final}    
EN 2   EN ANNEXES  
to the  
Proposal for a regulation of the European Parliament and of the Council  
laying down rules on the making available on the market of CE marked fertilising 
products and amending Regulations (EC) No 1069/2009 and (EC) No 1107/2009   
EN 3   EN ANNEX I  
Produc t Function Categories ('PFC') of CE  marked fertilising products  
PART I 
DESIGNATION OF PRODUCT FUNCTION CATEGORIES  
1. Fertiliser  
A. Organic fertiliser  
I. Solid organic fertiliser  
II. Liquid organic fertiliser  
B. Organo -mineral fertiliser  
I. Solid organo -mineral fertiliser  
II. Liquid organo -mineral fertiliser  
C. Inorganic fertiliser  
I. Inorganic macronutrient fertiliser  
a) Solid inorganic macronutrient fertiliser  
i) Straight solid inorganic macronutrient fertiliser  
A) Straight solid inorganic macron utrient ammonium 
nitrate fertiliser of high nitrogen content  
ii) Compound solid inorganic macronutrient fertiliser  
A) Compound solid inorganic macronutrient 
ammonium nitrate fertiliser of high nitrogen 
content  
b) Liquid inorganic macronutrient fertiliser  
i) Straight liquid inorganic macronutrient fertiliser  
ii) Compound liquid inorganic macronutrient fertiliser  
II. Inorganic micronutrient fertiliser  
a) Straight inorganic micronutrient fertiliser  
b) Compound inorganic micronutrient fertiliser  
2. Liming material  
3. Soil improver  
A. Organic soil improver  
B. Inorganic soil improver  
4. Growing medium  
5. Agronomic additive  
A. Inhibitor  
I. Nitrification inhibitor  
II. Urease inhibitor  
B. Chelating agent  
C. Complexing agent  
6. Plant biostimulant  
A. Microbial plant biostimulant  
B. Non-microbial plant biostimulant  
I. Organic non -microbial plant biostimulant  
II. Inorganic non -microbial plant biostimulant  
7. Fertilising product blend   
EN 4   EN PART II 
REQUIREMENTS RELATED TO PRODUCT FUNCTION CATE GORIES  
1. This Part sets out the requirements related to the Product Function Categories ('PFC') 
to which CE  marked fertilising products shall belong.  
2. The requirements laid down in this Annex for a given PFC apply to CE  marked 
fertilising products in all subc ategories of that PFC.  
3. Where compliance with a given requirement (such as absence of a given 
contaminant) follows certainly and uncontestably from the nature or manufacturing 
process of a CE  marked fertilising product, that compliance can be presumed in th e 
conformity assessment without verification (such as testing), at the responsibility of 
the manufacturer.  
4. Where the CE  marked fertilising product contains a substance for which maximum 
residue limits for food and feed have been established in accordance w ith  
(a) Council Regulation  (EEC) No  315/931,  
(b) Regulation  (EC) No  396/2005 of the European Parliament and of the Council2,  
(c) Regulation (EC) No 470/2009 of the European Parliament and of the Council3 
or  
(d) Directive 2002/32/EC of the European Parliament and of the Council4,  
the use of the CE  marked fertilising product as specified in the use instructions must 
not lead to the exceedance of those limits in food or feed.  
PFC  1: FERTILISER  
A fertiliser shall be a CE marked fertilising product aimed at providing nut rients to 
plants.  
PFC 1(A): Organic fertiliser  
1. An organic fertiliser shall contain  
 carbon (C) and  
 nutrients  
of solely biological origin, excluding material which is fossilized or embedded in 
geological formations.  
                                                 
1 Council Regulation (EEC) No 315/93 of 8 February 1993 laying down Community procedures for 
contaminants in food (OJ L 37, 13.2.1993, p. 1).  
2 Regulation (EC) No 396/2005 of the European Parliament and of the Council of 23 February 2005 on 
maximum residue levels of  pesticides in or on food and feed of plant and animal origin and amending 
Council Directive 91/414/EEC (OJ L 70, 16.3.2005, p. 1).  
3 Regulation (EC) No 470/2009 of the European Parliament and of the Council of 6 May 2009 laying 
down Community procedures f or the establishment of residue limits of pharmacologically active 
substances in foodstuffs of animal origin, repealing Council Regulation (EEC) No 2377/90 and 
amending Directive 2001/82/EC of the European Parliament and of the Council and Regulation (EC) 
No 726/2004 of the European Parliament and of the Council (OJ L 152, 16.6.2009, p. 11).  
4 Directive 2002/32/EC of the European Parliament and of the Council of 7 May 2002 on undesirable 
substances in animal feed (OJ L 140, 30.5.2002, p. 10).   
EN 5   EN 2. Contaminants must not be present in the  CE marked fertilising product by more than 
the following quantities:  
 Cadmium (Cd)  1,5 mg/kg dry matter,  
 Hexavalent chromium (Cr VI)  2 mg/kg dry matter,  
 Mercury (Hg)  1 mg/kg dry matter,  
 Nickel (Ni)  50 mg/kg dry matter,  
 Lead (Pb)  120 mg/kg dry matter, and  
 Biuret (C 2H5N3O2) 12 g/kg dry matter.  
3. Salmonella spp . shall be absent in a 25 g sample of the CE marked fertilising 
product.  
4. None of the two following types of bacteria shall be present in the CE marked 
fertilising product in a concentration of more than 1 000 CFU/g fresh mass:  
(a) Escherichia coli , or 
(b) Enterococcaceae.  
This shall be demonstrated by measuring the presence of at least one of those two 
types of bacteria.  
PFC 1(A)(I): Solid organic fertiliser  
1. A solid organic fertiliser shall contain 40% or more dry matter by mass.  
2. The CE marked fertilising product shall contain at least one of the following declared 
nutrients in the minimum quantities stated : 
 2,5% by mass of total nitrogen (N),  
 2% by mass of total phosphorus pentoxide (P 2O5), or 
 2% by mass of total p otassium oxide (K 2O). 
3. Organic carbon (C) shall be present in the CE marked fertilising product by at least 
15% by mass.  
PFC 1(A)(II): Liquid organic fertiliser  
1. A liquid organic fertiliser shall contain less than 40% dry matter.  
2. The CE marked fertilising pr oduct shall contain at least one of the following declared 
nutrients in the minimum quantities stated : 
 2% by mass of total nitrogen (N),  
 1% by mass of total phosphorus pentoxide (P 2O5), or 
 2% by mass of total potassium oxide (K 2O). 
3. Organic carbon (C) shall  be present in the CE marked fertilising product by at least 
5% by mass.  
PFC 1(B): Organo -mineral fertiliser  
1. An organo -mineral fertiliser shall be a co -formulation of  
 one or more inorganic fertilisers, as specified in PFC 1(C) below, and   
EN 6   EN  a material conta ining  
– organic carbon (C) and  
– nutrients  
of solely biological origin, excluding material which is fossilized or embedded 
in geological formations.  
2. Where one or more of the inorganic fertilisers in the co -formulation is a straight or 
compound solid inorganic macronutrient ammonium nitrate fertiliser of high nitrogen 
content, as specified in PFC  1(C)(I)(a)(i -ii)(A), the CE  marked fertilising product 
shall not contain 15,75  % or more by mass of nitrogen (N) as a result of ammonium 
nitrate (NH 4NO 3). 
3. Contaminants must not be present in the CE marked fertilising product by more than 
the following quantities:  
(a) Cadmium (Cd)  
(1) Where the CE marked fertilising product has a total phosphorus (P) 
content of less than 5  % phosphorus pentoxide (P 2O5)-equivalent by 
mass: 3 mg/kg dry matter, or  
(2) Where the CE marked fertilising product has a total phosphorus (P) 
content of 5  % phosphorus pentoxide (P 2O5)-equivalent or more by mass 
('phosphate fertiliser'):  
 As of [Publications office, please insert the date of application of 
this Regulation]: 60 mg/kg phosphorus pentoxide (P 2O5), 
 As of [Publications office, please insert the date occurring three 
years after the date of application of this Regulation]: 40 mg/kg 
phosphorus pentoxide (P 2O5), and  
 As of [Publications office, ple ase insert the date occurring twelve 
years after the date of application of this Regulation]: 20 mg/kg 
phosphorus pentoxide (P 2O5), 
(b) Hexavalent chromium (Cr VI)  2 mg/kg dry matter,  
(c) Mercury (Hg)  1 mg/kg dry matter,  
(d) Nickel (Ni)  50 mg/kg dry matter, and  
(e) Lead ( Pb) 120 mg/kg dry matter.  
4. Salmonella spp . shall be absent in a 25 g sample of the CE marked fertilising 
product.  
5. None of the two following types of bacteria shall be present in the CE marked 
fertilising product in a concentration of more than 1000 CFU/g fresh mass:  
(a) Escherichia coli , or 
(b) Enterococcaceae.  
This shall be demonstrated by measuring the presence of at least one of those two 
types of bacteria.  
PFC 1(B)(I): Solid organo -mineral fertiliser  
1. A solid organo -mineral fertiliser shall contain 60% or more dry matter by mass.   
EN 7   EN 2. The CE marked fertilising product shall contain at least one of the following declared 
nutrients in the minimum quantities stated : 
 2,5 % by mass of total nitrogen (N), out of which 1  % by mass of the 
CE marked fertilising product shall be organic nitrogen (N), or  
 2 % by mass of total phosphorus pentoxide (P 2O5), or 
 2 % by mass of total potassium oxide (K 2O). 
3. Organic carbon (C) shall be present in the CE marked fertilising product by at least 
7.5 % by mass.  
4. In the CE marked fertilising pr oduct, each unit shall contain the organic matter and 
the nutrients in their declared content.  
PFC 1(B)(II): Liquid organo -mineral fertiliser  
1. A liquid organo -mineral fertiliser shall contain less than 60  % dry matter by mass.  
2. The CE marked fertilising prod uct shall contain at least one of the following declared 
nutrients in the minimum quantities stated : 
 2 % by mass of total nitrogen (N), out of which 0,5  % by mass of the 
CE marked fertilising product shall be organic nitrogen (N), or  
 2 % by mass of total p hosphorus pentoxide (P 2O5), or 
 2 % by mass of total potassium oxide (K 2O). 
3. Organic carbon (C) shall be present in the CE marked fertilising product by at least 
3 % by mass.  
PFC 1(C): Inorganic fertiliser  
An inorganic fertiliser shall be a fertiliser other than an organic or organo -mineral 
fertiliser.  
PFC 1(C)(I): Inorganic macronutrient fertiliser  
1. An inorganic macronutrient fertiliser shall be aimed at providing plants with one or 
more of the following macronutrients: nitrogen (N), phosphorus (P), potassium  (K), 
magnesium (Mg), calcium (Ca), sulphur (S) or sodium (Na).  
2. Contaminants must not be present in the CE marked fertilising product by more than 
the following quantities:  
(a) Cadmium (Cd)  
(1) Where the CE marked fertilising product has a total phosphorus (P) 
content of less than 5  % phosphorus pentoxide (P 2O5)-equivalent by 
mass: 3 mg/kg dry matter, or  
(2) Where the CE marked fertilising product has a total phosphorus (P) 
content of 5  % phosphorus pentoxide (P 2O5)-equivalent or more by mass 
('phosphate fertiliser'):  
 As of [Publications office, please insert the date of application of 
this Regulation]: 60 mg/kg phosphorus pentoxide (P 2O5),  
EN 8   EN  As of [Publications office, please insert the date occurring three 
years after the date of application of this Regulation]: 40 mg/kg 
phosphorus pentoxide (P 2O5), and  
 As of [Publications office, please insert the date occurring twelve 
years after the date of application of this Regulation]: 20 mg/kg 
phosphorus pentoxide (P 2O5), 
(b) Hexavalent chromium (Cr VI)  2 mg/kg dry matter,  
(c) Mercur y (Hg)  2 mg/kg dry matter,  
(d) Nickel (Ni)  120 mg/kg dry matter,  
(e) Lead (Pb)  150 mg/kg dry matter,  
(f) Arsenic (As)  60 mg/kg dry matter,  
(g) Biuret (C 2H5N3O2) 12 g/kg dry matter, and  
(h) Perchlorate (ClO 4-) 50 mg/kg dry matter.  
PFC 1(C)(I)(a): Solid inorganic macronutrient fertiliser  
A solid inorganic fertiliser shall be an inorganic macronutrient fertiliser, which is 
neither in suspension nor in solution within the meaning of PFC 1(C)(I)(b) in this 
Annex.  
PFC 1(C)(I)(a)(i): Straight solid inorganic macronutrient fertiliser  
1. A straight solid inorganic macronutrient fertiliser shall have a declared content of not 
more than one nutrient.  
2. The CE marked fertilising product shall contain one of the following declared 
nutrients in the minimum quantity stated : 
 10% by mass of total ni trogen (N),  
 12% by mass of total phosphorus pentoxide (P 2O5), 
 6% by mass of total potassium oxide (K 2O), 
 5% by mass of total magnesium oxide (MgO),  
 12% by mass of total calcium oxide (CaO),  
 10% by mass of total sulphur trioxide (SO 3), or 
 1% by mass of tota l sodium oxide (Na 2O). 
PFC 1(C)(I)(a)(ii): Compound solid inorganic macronutrient fertiliser  
1. A compound solid inorganic macronutrient fertiliser shall have a declared content of 
more than one nutrient.  
2. The CE marked fertilising product shall contain more than one of the following 
declared nutrients in the minimum quantities stated : 
 3% by mass of total nitrogen (N),  
 3% by mass of total phosphorus pentoxide (P 2O5), 
 3% by mass of total potassium oxide (K 2O), 
 1,5% by mass of total magnesium oxide (MgO),   
EN 9   EN  1,5% by mass of total calcium oxide (CaO),  
 1,5% by mass of total sulphur trioxide (SO 3), or 
 1% by mass of total sodium oxide (Na 2O). 
PFC 1(C)(I)(a)(i -ii)(A): Straight or compound solid inorganic macronutrient ammonium 
nitrate fertiliser of high nitrogen con tent 
1. A straight or compound solid inorganic macronutrient ammonium nitrate fertiliser of 
high nitrogen content shall be ammonium nitrate (NH 4NO 3)-based and contain 28 % 
or more by mass of nitrogen (N) as a result of ammonium nitrate (NH 4NO 3).  
2. Any matter o ther than ammonium nitrate (NH 4NO 3) shall be inert towards 
ammonium nitrate (NH 4NO 3). 
3. The CE marked fertilising product shall be made available to the end -user only in 
packaged form. The package shall be closed in such a way or by such a device that, 
when it is opened, the fastening, the fastening seal or the package itself is irreparably 
damaged. Valve sacks may be used.  
4. The oil retention of the CE marked fertilising product, following two thermal cycles 
as described under Heading  4.1 in Module A1 in Annex  IV, must not exceed 4  % by 
mass.  
5. The detonation resistance of the CE marked fertilising product shall be such, that  
 following five thermal cycles as described under Heading  4.2 in Module A1 in 
Annex IV,  
 in two detonation resistance tests as described und er Heading  4.3 in module A1 
in Annex IV,  
one or more of the supporting lead cylinders is crushed by less than 5  %. 
6. The percentage by mass of combustible material measured as carbon (C) must not 
exceed  
 0,2 % for CE marked fertilising products having a nit rogen (N) content of at 
least 31,5  % by mass, and  
 0,4 % for CE marked fertilising products having a nitrogen (N) content of at 
least 28  % but less than 31,5  % by mass.  
7. A solution of 10  g of the CE marked fertilising product in 100  ml of water must have 
a pH of at least 4,5.  
8. Not more than 5  % by mass of the CE marked fertilising product shall pass through a 
1 mm mesh sieve, and not more than 3  % by mass shall pass through a 0,5  mm mesh 
sieve.  
9. The copper (Cu) content shall not be higher than 10  mg/kg, and th e chlorine (Cl) 
content shall not be higher than 200  mg/kg.  
PFC 1(C)(I)(b): Liquid inorganic macronutrient fertiliser  
A liquid inorganic macronutrient fertiliser shall be an inorganic macronutrient 
fertiliser in suspension or in solution, where  
 a suspension means a two -phase dispersion in which solid particles are 
maintained in suspension in the liquid phase, and   
EN 10   EN  a solution means a liquid that is free of solid particles.  
PFC 1(C)(I)(b)(i): Straight liquid inorganic macronutrient fertiliser  
1. A straig ht liquid inorganic macronutrient fertiliser shall have a declared content of 
not more than one nutrient.  
2. The CE marked fertilising product shall contain one of the following declared 
nutrients in the minimum quantity stated : 
 5% by mass of total nitrogen ( N), 
 5% by mass of total phosphorus pentoxide (P 2O5), 
 3% by mass of total potassium oxide (K 2O), 
 2% by mass of total magnesium oxide (MgO),  
 6% by mass of total calcium oxide (CaO),  
 5% by mass of total sulphur trioxide (SO 3), or 
 1% by mass of total sodium oxide (Na 2O). 
PFC 1(C)(I)(b)(ii): Compound liquid inorganic macronutrient fertiliser  
1. A compound liquid inorganic macronutrient fertiliser shall have a declared content of 
more than one nutrient.  
2. The CE marked fertilising product shall contain more than one  of the following 
declared nutrients in the minimum quantities stated : 
 1,5% by mass of total nitrogen (N),  
 1,5% by mass of total phosphorus pentoxide (P 2O5), 
 1,5% by mass of total potassium oxide (K 2O), 
 0,75% by mass of total magnesium oxide (MgO),  
 0,75% b y mass of total calcium oxide (CaO),  
 0,75% by mass of total sulphur trioxide (SO 3), or 
 0,5% by mass of total sodium oxide (Na 2O). 
PFC 1(C)(II): Inorganic micronutrient fertiliser  
1. An inorganic micronutrient fertiliser shall be an inorganic fertiliser other than a 
macronutrient fertiliser aimed at providing one or more of the following nutrients: 
boron (B), cobalt (Co), copper (Cu), iron (Fe), manganese (Mn), molybdenum (Mo) 
or zinc (Zn).  
2. Micronutrient fertilisers shall be made available to the end -user only in packaged 
form.   
EN 11   EN 3. Contaminants must not be present in the CE marked fertilising product by more than 
the following quantities:  
Contaminant  Maximum concentration by mass, in relation to the 
total micronutrient content  
(mg/kg of total boron (B), cobalt (Co), copper (Cu), 
iron (Fe), manganese (Mn), molybdenum (Mo), and 
zinc (Zn))  
Arsenic (As)  1000  
Cadmium (Cd)  200 
Lead (Pb)  600 
Mercury (Hg)  100 
Nickel (Ni)  2000  
PFC 1(C)(II)(a): Straight inorganic micronutrient fertiliser  
1. A straight inorganic micronutrient fertiliser shall have a declared content of not more 
than one nutrient.  
2. The CE marked fertilising product shall comply with the one of the typologies, 
descriptions and corresponding minimum nutrient content requirements in the table 
below:  
Typology  Description  Minimum nutrient 
content  
Micronutrient salt fertiliser  A chemically obtained solid 
micronutrient fertiliser 
containing a mineral ion salt, 
oxide or hydroxide as its 
essential ingredient  10% by mass of the 
CE marked fertilising 
product shall consist of 
water -soluble micronutrient  
Micronutrient -based 
fertiliser  A micronutrient fertiliser 
combining a micronutrient salt 
fertiliser with one or more other 
micronutrient salt fertilisers 
and/or with a single 
micronutrient chelate  5% by mass of  the 
CE marked fertilising 
product shall consist of 
micronutrient  
Micronutrient solution 
fertiliser  An aqueous solution of different 
forms of a micronutrient 
fertiliser  2% by mass of the 
CE marked fertilising 
product shall consist of 
water -soluble micronu trient  
Micronutrient suspension 
fertiliser  A product obtained by 
suspending different forms of a 
micronutrient fertiliser  2% by mass of the CE 
marked fertilising product 
shall consist of 
micronutrient   
EN 12   EN Micronutrient chelate 
fertiliser  A water -soluble product in 
which the declared micronutrient 
is chemically combined with 
chelating agent(s) fulfilling the 
requirements of PFC 5(B)   5% by mass of the CE 
marked fertilising 
product shall consist of 
water -soluble 
micronutrient, and  
 at least 80% of the 
water -soluble 
micronutrient shall be 
chelated by a chelating 
agent fulfilling the 
requirements of PFC 
5(B) 
Micronutrient complex 
fertiliser  A water -soluble product in 
which the declared micronutrient 
is chemically combined with 
complexing agent(s) fulfilling 
the requirements of PFC 5(C)   5% by mass of the CE 
marked fertilising 
product shall consist of 
water -soluble 
micronutrient, and  
 at least 80% of the 
water -soluble 
micronutrient shall be 
complexed by a 
complexing agent 
fulfilling the 
requirements of 
PFC 5(C) 
PFC 1(C)(II)(b): Compound inorganic micronutrient fertiliser  
1. A compound inorganic micronutrient fertiliser shall have a declared content of more 
than one micronutrient.  
2. The CE marked fertilising product shall contain declared nutrients in at least one of 
the following quantities:  
 2% by mass for fertilisers in suspension or solution ('liquid compound 
inorganic micronutrient fertilisers'), where  
 a suspension means a two -phase dispersion in which solid particles are 
maintained in suspension in the liquid phas e, and  
 a solution means a liquid that is free of solid particles, and  
 5% by mass for other fertilisers ('solid compound inorganic micronutrient 
fertilisers').  
PFC  2: LIMING MATERIAL  
1. A liming material shall be a CE marked fertilising product aimed at corre cting soil 
acidity, and containing oxides, hydroxides, carbonates or silicates of the nutrients 
calcium (Ca) or magnesium (Mg).   
EN 13   EN 2. Contaminants must not be present in the CE marked fertilising product by more than 
the following quantities:  
 Cadmium (Cd)  3 mg/k g dry matter,  
 Hexavalent chromium (Cr VI)  2 mg/kg dry matter,  
 Mercury (Hg)  2 mg/kg dry matter,  
 Nickel (Ni)  90 mg/kg dry matter,  
 Lead (Pb)  200 mg/kg dry matter, and  
 Arsenic (As)  120 mg/kg dry matter.  
3. The following parameters determined on dry matter shall b e met:  
 Minimum neutralising value: 15 (equivalent CaO) or 9 (equivalent HO-), and  
 Minimum reactivity:  10% or 50% after 6 months (incubation test).  
PFC  3: SOIL IMPROVER  
A soil improver shall be a CE marked fertilising product aimed at being added to the 
soil for the purpose of maintaining, improving or protecting the physical or chemical 
properties, the structure or the biological activity of soil.  
PFC 3(A): Organic soil improver  
1. An organic soil improver shall consist exclusively of material of solely biological 
origin, excluding material which is fossilized or embedded in geological formations.  
2. Contaminants must not be present in the CE marked fertilising product by more than 
the following quantities:  
 Cadmium (Cd)  3 mg/kg dry matter,  
 Hexavalent chromiu m (Cr VI)  2 mg/kg dry matter,  
 Mercury (Hg)  1 mg/kg dry matter,  
 Nickel (Ni)  50 mg/kg dry matter, and  
 Lead (Pb)  120 mg/kg dry matter.  
3. When the CE marked fertilising product contains an animal by -product as defined in 
Regulation  (EC) No 1069/2009   
(a) Salmonella spp. shall be absent in a 25 g sample of the CE marked fertilising 
product.  
(b) None of the two following types of bacteria shall be present in the CE marked 
fertilising product in a concentration of more than 1000 CFU/g fresh mass:  
 Escherichia coli , or 
 Entero coccaceae.  
This shall be demonstrated by measuring the presence of at least one of those 
two types of bacteria.  
4. The CE marked fertilising product shall contain 40% or more dry matter.   
EN 14   EN 5. Organic carbon (C) shall be present in the CE marked fertilising product  by at least 
7.5% by mass.  
PFC 3(B): Inorganic soil improver  
1. An inorganic soil improver shall be a soil improver other than an organic soil 
improver.  
2. Contaminants must not be present in the CE marked fertilising product by more than 
the following quantitie s: 
 Cadmium (Cd)  1,5 mg/kg dry matter,  
 Hexavalent chromium (Cr VI)  2 mg/kg dry matter,  
 Mercury (Hg)  1 mg/kg dry matter,  
 Nickel (Ni)  100 mg/kg dry matter, and  
 Lead (Pb)  150 mg/kg dry matter.  
PFC  4: GROWING MEDIUM  
1. A growing medium shall be a material other than soil intended for use as a substrate 
for root development.  
2. Contaminants must not be present in the CE marked fertilising product by more than 
the following quantities:  
 Cadmium (Cd)  3 mg/kg dry matter,  
 Hexavalent chromium (Cr VI)  2 mg/kg dry matter,  
 Mercury (Hg)  1 mg/kg dry matter,  
 Nickel (Ni)  100 mg/kg dry matter, and  
 Lead (Pb)  150 mg/kg dry matter.  
3. Salmonella spp . shall be absent in a 25 g sample of the CE marked fertilising 
product.  
4. None of the two following types of bacteria shall be present in the CE marked 
fertilising product in a concentration of more than 1000 CFU/g fresh mass:  
(a) Escherichia coli , or 
(b) Enterococcaceae.  
This shall be demonstrated by measuring the presence of at least one of those two 
types of bacteria.  
PFC  5: AGRONOMIC ADDITIVE  
An agr onomic additive shall be a CE marked fertilising product intended to be added 
to a product providing plants with nutrient, with the intention to improve that 
product's nutrient release patterns.  
PFC 5(A): Inhibitor  
1. An inhibitor shall be a substance or a mi xture which delays or stops the activity of 
specific groups of micro -organisms or enzymes.   
EN 15   EN 2. Each substance shall have been registered pursuant to Regulation  (EC) 
No 1907/2006,5 in a dossier containing  
(a) the information provided for by Annex VI, VII and VIII o f Regulation (EC) 
No 1907/2006, and  
(b) a chemical safety report pursuant to Article  14 of Regulation (EC) 
No 1907/2006 covering the use as fertilising product,  
unless explicitly covered by one of the registration obligation exemptions provided 
for by Annex IV  to that Regulation or by points 6, 7, 8, or 9 of Annex V to that 
Regulation.  
PFC 5(A)(I): Nitrification inhibitor  
1. A nitrification inhibitor shall inhibit the biological oxidation of ammoniacal nitrogen 
(NH 3-N) to nitrite nitrogen (NO 2-), thus slowing the formation of nitrate nitrogen 
(NO 3-). 
2. A soil -incubation test measuring the ammoniacal nitrogen (NH 3-N) oxidation rate by  
 ammoniacal nitrogen (NH 3-N) disappearance, or  
 the sum of nitrite nitrogen (NO 2-) and nitrate nitrogen (NO 3-) production with 
respect to time  
in a soil sample where the nitrification inhibitor has been added shall show a 
statistical difference in ammoniacal nitrogen (NH 3-N) oxidation rate when compared 
to a control sample where the nitrification inhibitor has not been added.  
PFC 5(A)(II) : Urease inhibitor  
1. An urease inhibitor shall inhibit hydrolytic action on urea (CH 4N2O) by the urease 
enzyme,primarily targeted to reduce ammonia volatilisation.  
2. An in -vitro measuring of the rate of hydrolysis of urea (CH 4N2O) with respect to 
time in a soil sample where the urease inhibitor has been added shall show a 
statistical difference in hydrolysis rate when compared to a control sample where the 
urease inhibitor has not been added.  
PFC 5(B): Chelating agent  
1. A chelating agent shall be an organic su bstance intended to enhance nutrients' 
long-term availability to plants 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 which  
 is large enough to form a five - or six - membered ring structure.  
                                                 
5 In the case of an additive recovered in the European Union, this condition is fulfilled if the additive is 
the same, within the meaning of Article  2(7)(d)(i) of Regulation (EC) No 1907/2006, as a substance 
registered in a dossier containing the information here indica ted, and if information is available to the 
fertilising product manufacturer within the meaning of Article  2(7)(d)(ii) of Regulation (EC) 
No 1907/2006.   
EN 16   EN 2. The substance shall have been registered pursuant to Regulation  (EC) 
No 1907/2006,6 in a dossier containing  
(a) the information provided for by Annex VI, VII and VIII of Regulation (EC) 
No 1907/2006, and  
(b) a chemical safety report pursuant to Article  14 of Regulation (EC) 
No 1907/2006 covering the use as fertilising product,  
unless explicitly covered by one of the registration obligation exemptions provided 
for by Annex IV to that Regulation or by points 6, 7, 8, or 9 of Annex V to that 
Regulation.  
3. After 3 days in standard Hoagland solution at pH 7 and 8, the CE marked fertilising 
product shall remain stable.  
PFC 5(C): Complexing agent  
1. A complexing agent shall  be an organic substance intended to enhance nutrients' 
long-term availability to plants, which can form a flat or steric structure with one di 
or three valent transition metal cation.  
2. The substance shall have been registered pursuant to Regulation  (EC) 
No 1907/2006,7 in a dossier containing  
(a) the information provided for by Annex VI, VII and VIII of Regulation (EC) 
No 1907/2006, and  
(b) a chemical safety report pursuant to Article  14 of Regulation (EC) 
No 1907/2006 covering the use as fertilising product,  
unless  explicitly covered by one of the registration obligation exemptions provided 
for by Annex IV to that Regulation or by points 6, 7, 8, or 9 of Annex V to that 
Regulation.  
3. After 1 day in water solution at pH 6 and 7, the CE marked fertilising product shall 
remain stable.  
PFC  6: PLANT BIOSTIMULANT  
1. A plant biostimulant shall be a CE marked fertilising product stimulating plant 
nutrition processes independently of the product's nutrient content with the sole aim 
of improving one or more of the following charact eristics of the plant:  
(a) nutrient use efficiency,  
(b) tolerance to abiotic stress, or  
(c) crop quality traits.  
                                                 
6 In the case of an additive recovered in the European Union, this condition is fulfilled if the additiv e is 
the same, within the meaning of Article  2(7)(d)(i) of Regulation (EC) No 1907/2006, as a substance 
registered in a dossier containing the information here indicated, and if information is available to the 
fertilising product manufacturer within the me aning of Article  2(7)(d)(ii) of Regulation (EC) 
No 1907/2006.  
7 In the case of an additive recovered in the European Union, this condition is fulfilled if the additive is 
the same, within the meaning of Article  2(7)(d)(i) of Regulation (EC) No 1907/2006, a s a substance 
registered in a dossier containing the information here indicated, and if information is available to the 
fertilising product manufacturer within the meaning of Article  2(7)(d)(ii) of Regulation (EC) 
No 1907/2006.   
EN 17   EN 2. Contaminants must not be present in the CE marked fertilising product by more than 
the following quantities:  
 Cadmium (Cd)  3 mg/kg dry matter,  
 Hexavalent chromium (Cr VI)  2 mg/kg dry matter, and  
 Lead (Pb)  120 mg/kg dry matter.  
3. The plant biostimulant shall have the effects that are claimed on the label for the 
crops specified thereon.  
PFC 6(A): Microbial plant biostimulant  
1. A microbial plant biostimulant shall consist solely of a micro -organism or a 
consortium of micro -organisms referred to in Component Material Category  7 of 
Annex  II. 
2. Contaminants must not be present in the CE marked fertilising product by more than 
the following quantities:  
 Mercury (Hg)  1 mg/kg dry matter, and  
 Nickel (Ni)  50 mg/kg dry matter.  
3. Salmonella spp . shall be absent in a 25 g or 25 ml sample of the CE marked 
fertilising product.  
4. Escherichia coli  shall be absent in a 1 g or 1 ml sample of the CE marked fertilising 
product.  
5. Enterococcaceae must not be present in the CE marked fertilising product by more 
than 10  CFU/g fresh mass.  
6. Listeria monocytogene s shall be absent in a 25 g or 25 ml sample of the CE marked 
fertilising product.  
7. Vibrio spp shall be absent in a 25 g or 25 ml sample of the CE marked fertilising 
product.  
8. Shigella spp shall be absent in a 25 g or 25 ml sample of the CE marked fertilising 
product.  
9. Staphylococcus aureus shall be absent in a 1 g or 1 ml sample of the CE marked 
fertilising product.  
10. Aerobic plate coun t shall not exceed 105 CFU/g or ml sample of the CE marked 
fertilising product, unless the microbial biostimulant is an aerobic bacterium.  
11. Yeast and mould count shall not exceed 1000 CFU/g or ml sample of the CE marked 
fertilising product, unless the micro bial biostimulant is a fungus.  
12. When the microbial plant biostimulant consists of a suspension or a solution, where  
 a suspension means a two -phase dispersion in which solid particles are 
maintained in suspension in the liquid phase, and  
 a solution means a l iquid that is free of solid particles,  
the plant biostimulant shall have a pH superior or equal to 4.  
13. The shelf -life of the microbial plant biostimulant shall be at least 6 months under the 
storage conditions specified on the label.   
EN 18   EN PFC 6(B): Non -microbial  plant biostimulant  
A non -microbial plant biostimulant shall be a plant biostimulant other than a 
microbial plant biostimulant.  
PFC 6(B)(I): Organic non -microbial plant biostimulant  
1. An organic non -microbial plant biostimulant shall consist of a substance o r a mixture 
containing carbon (C) of solely animal or plant origin.  
2. Contaminants must not be present in the CE marked fertilising product by more than 
the following quantities:  
 Mercury (Hg)  1 mg/kg dry matter, and  
 Nickel (Ni)  50 mg/kg dry matter.  
3. Salmonella spp . shall be absent in a 25 g sample of the CE marked fertilising 
product.  
4. None of the two following types of bacteria shall be present in the CE marked 
fertilising product by more than 1000 CFU/g fresh mass:  
(a) Escherichia coli , or 
(b) Enterococcacea e. 
This shall be demonstrated by measuring the presence of at least one of those two 
types of bacteria.  
PFC 6(B)(II): Inorganic non -microbial plant biostimulant  
1. An inorganic non -microbial plant biostimulant shall be a non -microbial plant 
biostimulant other  than an organic non -microbial plant biostimulant.  
2. Contaminants must not be present in the CE marked fertilising product by more than 
the following quantities:  
 Mercury (Hg)  2 mg/kg dry matter,  
 Nickel (Ni)  120 mg/kg dry matter, and  
 Arsenic (As)  60 mg/kg dry  matter.  
PFC  7: FERTILISING PRODUCT B LEND  
1. A fertilising product blend shall be a CE marked fertilising product composed of two 
or more CE marked fertilising products of category 1 -6. 
2. The compliance with the requirements of this Regulation of each component  
fertilising product in the blend shall have been demonstrated in accordance with the 
conformity assessment procedure applicable to that component fertilising product.  
3. The blending shall not change the nature of each component fertilising product  
 in a man ner having an adverse effect on human, animal or plant health, on 
safety, or on the environment, under reasonably foreseeable conditions of 
storage or use of the CE marked fertilising product blend, or  
 in any other significant manner.  
4. The manufacturer of the blend shall assess the conformity of the blend with the 
requirements set out in paragraphs  1-3 above, ensure the blend's compliance with the  
EN 19   EN labelling requirements laid down in Annex  III, and assume responsibility pursuant to 
Article  15(4) of this Regu lation for the compliance of the blend with the 
requirements of this Regulation by  
 drawing up an EU declaration of conformity for the CE marked 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 fertilising products.  
5. Economic operators making CE marked fertilising product blends available on the 
market shall respect the following provisions of this Regulation with regard to the 
EU declaration of conformity of each component fertilising product as well as of the 
blend:  
 Article  6(3) (manufacturers' obligation to keep the EU declaration of 
conformity);  
 Article  7(2)(a) (authorised representatives' obligation to keep the EU 
declaration of conformity);  
 Article  8(2) (importers' obligation to ensure that the CE marked fertilising 
product is accompanied by 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 s urveillance authorities); and  
 Article  9(2) (distributors' obligation to verify that the CE marked fertilising 
product is accompanied by the EU declaration of conformity).  
  
EN 20   EN ANNEX II  
Component Material Categories  
A CE marked fertilising produ ct shall consist solely of component materials complying with 
the requirements for one or more of the Component Material Categories ('CMC') listed below.  
The component materials, or the input materials used to produce them, shall not contain one 
of the sub stances for which maximum limit values are indicated in Annex  I of this Regulation 
in such quantities as to jeopardise the CE marked fertilising product's compliance with one of 
the applicable requirements of that Annex.  
PART I 
OVERVIEW OF COMPONENT MATERI AL CATEGORIES  
CMC 1: Virgin material substances and mixtures  
CMC 2: Non -processed or mechanically processed plants, plant parts or plant extracts  
CMC 3: Compost  
CMC 4: Energy crop digestate  
CMC 5: Other digestate than energy crop digestate  
CMC 6: Food ind ustry by -products  
CMC 7: Micro -organisms  
CMC 8: Agronomic additives  
CMC 9: Nutrient polymers  
CMC 10: Other polymers than nutrient polymers  
CMC 11: Certain animal by -products  
PART II 
REQUIREMENTS RELATED TO COMPONENT MATERIAL CATEGORIES  
This Part defines th e component materials of which CE marked fertilising products 
shall solely consist.  
CMC  1: VIRGIN MATERIAL SUBST ANCES AND MIXTURES  
1. A CE marked fertilising product may contain substances and mixtures, other than8  
(a) waste within the meaning of Directive  2008/98/EC,  
(b) by-products within the meaning of Directive  2008/98/EC,  
(c) materials formerly having constituted one of the materials mentioned in one of 
points a -b,  
(d) animal by -products within the meaning of Regulation (EC) No 1069/2009,  
(e) polymers, or  
                                                 
8 The exclusion of a materia l from CMC 1 does not prevent it from being an eligible component material 
by virtue of another CMC stipulating different requirements. See, for instance, CMC 11 on animal 
by-products, CMCs 9 and 10 on polymers, and CMC 8 on agronomic additives.   
EN 21   EN (f) substances or mixtures intended to improve the nutrient release patterns of the 
CE marked fertilising product into which they are incorporated.  
2. All the substances incorporated into the CE marked fertilising product, in their own 
or in a mixture, shall have  been registered pursuant to Regulation  (EC) 
No 1907/2006, in a dossier containing  
(a) the information provided for by Annex VI, VII and VIII of Regulation (EC) 
No 1907/2006, and  
(b) a chemical safety report pursuant to Article  14 of Regulation (EC) 
No 1907/2006 c overing the use as fertilising product,  
unless explicitly covered by one of the registration obligation exemptions provided 
for by Annex IV to that Regulation or by points 6, 7, 8, or 9 of Annex V to that 
Regulation.  
CMC  2: NON-PROCESSED OR MECHANI CALLY PR OCESSED PLANTS , PLANT PARTS OR PLANT  
EXTRACTS  
1. A CE marked fertilising product may contain plants, plant parts or plant extracts 
having undergone no other processing than cutting, grinding, centrifugation, 
pressing, drying, freeze -drying or extraction with water.  
2. For the purpose of paragraph  1, plants are understood to include algae and exclude 
blue-green algae.  
CMC  3: COMPOST  
1. A CE marked fertilising product may contain compost obtained through aerobic 
composting of exclusively one or more of the following i nput materials:  
(a) Bio-waste within the meaning of Directive 2008/98/EC resulting from separate 
bio-waste collection at source;  
(b) Animal by -products of categories 2 and 3 according to Regulation (EC) 
No 1069/2009;  
(c) Living or dead organisms or parts thereof, which are unprocessed or processed 
only by manual, mechanical or gravitational means, by dissolution in water, by 
flotation, by extraction with water, by steam distillation or by heating solely to 
remove water, or which are extracted from air by any means,  except  
 the organic fraction of mixed municipal household waste separated 
through mechanical, physicochemical, biological and/or manual 
treatment,  
 sewage sludge, industrial sludge or dredging sludge, and  
 animal by -products of category  1 according to Regul ation (EC) 
No 1069/2009;   
EN 22   EN (d) 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  1907/2006,9 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 fertilising product,  
unless explicitly covered by o ne of the registration obligation exemptions 
provided for by Annex IV to that Regulation or by points 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  
(e) Any m aterial listed in points (a) -(d) which  
 has previously been composted or digested, and  
 contains no more than 6 mg/kg dry matter of PAH 1610. 
2. The composting shall take place in a plant  
 which only processes input materials referred to in paragraph  1 above, an d 
 where physical contacts between input and output materials shall be avoided, 
including during storage.  
3. The aerobic composting shall consist in controlled decomposition of biodegradable 
materials, which is predominantly aerobic and which allows the develo pment of 
temperatures suitable for thermophilic bacteria as a result of biologically produced 
heat. All parts of each batch shall be regularly and thoroughly moved in order to 
ensure the correct sanitation and homogeneity of the material. During the compos ting 
process, all parts of each batch shall have one of the following temperature -time 
profiles:  
 65°C or more for at least 5 days,  
 60°C or more for at least 7 days, or  
 55°C or more for at least 14 days.  
4. The compost shall contain  
(a) no more than 6 mg/kg dry m atter of PAH 1611, and  
                                                 
9 In the c ase of an additive recovered in the European Union, this condition is fulfilled if the additive is 
the same, within the meaning of Article  2(7)(d)(i) of Regulation (EC) No 1907/2006, as a substance 
registered in a dossier containing the information here in dicated, and if information is available to the 
fertilising product manufacturer within the meaning of Article  2(7)(d)(ii) of Regulation (EC) 
No 1907/2006.  
10 Sum of naphthalene, acenaphthylene, acenaphthene, fluorene, phenanthrene, anthracene, fluoranthene , 
pyrene, benzo[a]anthracene, chrysene, benzo[b]fluoranthene, benzo[k]fluoranthene, benzo[a]pyrene, 
indeno[1,2,3 -cd]pyrene, dibenzo[a,h]anthracene and benzo[ghi]perylene  
11 Sum of naphthalene, acenaphthylene, acenaphthene, fluorene, phenanthrene, anthracene , fluoranthene, 
pyrene, benzo[a]anthracene, chrysene, benzo[b]fluoranthene, benzo[k]fluoranthene, benzo[a]pyrene, 
indeno[1,2,3 -cd]pyrene, dibenzo[a,h]anthracene and benzo[ghi]perylene   
EN 23   EN (b) no more than 5 g/kg dry matter of macroscopic impurities in the form of glass, 
metal and plastics above 2 mm.  
5. As of [Publications office: Please insert the date occurring 5 years after the date of 
application of this Regulation], the compost shall contain no more than 2,5 g/kg dry 
matter of macroscopic impurities in the form of plastics above 2 mm. By 
[Publications office: Please insert the date occurring 8 years after the date of 
application of this Regulation] the limit -value of 2,5 g/kg dry matter shall be re -
assessed in order to take into account the progress made with regards to separate 
collection of bio -waste.  
6. The compost shall meet at least one of the following stability criteria:  
(a) Oxygen uptake rate:  
 Definition: an indicator of the extent to which biodegradable organic 
matter is being broken down within a specified time period. The method 
is not suitable for material with a content of particle sizes > 10 mm 
exceeding 20 %,  
 Criterion: maximum 25 mmol O 2/kg organic matter/h; or  
(b) Self heating factor:  
 Definition: the maximum temperature reached by a compost in 
standardised conditions as an indicator of the state of its aerobic 
biological activity,  
 Criterion: minimum Rottegrad III.  
CMC  4: ENERGY CROP DIGESTATE  
1. A CE marked fertilisin g product may contain digestate obtained through anaerobic 
digestion of exclusively one or more of the following input materials:  
(a) Plants that have not been used for any other purpose. For the purpose of this 
paragraph, plants are understood to include alga e and exclude blue -green algae;  
(b) 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  1907/2006,12 in 
a doss ier 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 fertilising product,  
unless explicitly covered b y one of the registration obligation exemptions 
provided for by Annex IV to that Regulation or by points 6, 7, 8, or 9 of 
Annex V to that Regulation, and  
                                                 
12 In the case of an additive recovered in the European Union, this condi tion is fulfilled if the additive is 
the same, within the meaning of Article  2(7)(d)(i) of Regulation (EC) No 1907/2006, as a substance 
registered in a dossier containing the information here indicated, and if information is available to the 
fertilising pr oduct manufacturer within the meaning of Article  2(7)(d)(ii) of Regulation (EC) 
No 1907/2006.   
EN 24   EN  the total concentration of all additives does not exceed 5 % of the total 
input material weight; or  
(c) Any material referred to in points (a) -(b) that has previously been digested.  
2. The anaerobic digestion shall take place in a plant  
 which only processes input materials referred to in paragraph  1 above, and  
 where physical contacts between input and output materials shall be avoided, 
including during storage.  
3. The anaerobic digestion shall consist in controlled decomposition of biodegradable 
materials, which is predominantly anaerobic and at temperatures suitable for 
mesophilic or thermophilic bacteria. All p arts of each batch shall be regularly and 
thoroughly moved in order to ensure the correct sanitation and homogeneity of the 
material. During the digestion process, all parts of each batch shall have one of the 
following temperature -time profiles:  
(a) Thermophi lic anaerobic digestion at 55°C during at least 24h and a hydraulic 
retention time of at least 20 days;  
(b) Thermophilic anaerobic digestion at 55°C with a treatment process including a 
pasteurisation step (70°C – 1h); 
(c) Thermophilic anaerobic digestion at 55°C followed by composting in  
 65°C or more for at least 5 days,  
 60°C or more for at least 7 days, or  
 55°C or more for at least 14 days;  
(d) Mesophilic anaerobic digestion at 37 -40°C with a treatment process including a 
pasteurisation step (70°C – 1h); or  
(e) Mesophili c anaerobic digestion at 37 -40°C followed by composting in  
 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 
followin g stability criteria:  
(a) Oxygen uptake rate:  
 Definition: an indicator of the extent to which biodegradable organic 
matter is being broken down within a specified time period. The method 
is not suitable for material with a content of particle sizes > 10 mm 
exceeding 20 %.  
 Criterion: maximum 50 mmol O 2/kg organic matter/h; or  
(b) Residual biogas potential:  
 Definition: an indicator of the gas released from a digestate in a 28 day 
period and measured against the volatile solids contained within the 
sample. The test i s run in triplicate, and the average result is used to 
demonstrate compliance with the requirement. The volatile solids are  
EN 25   EN those solids in a sample of material that are lost on ignition of the dry 
solids at 550°C.  
 Criterion: maximum 0,45 l biogas /g volat ile solids.  
CMC  5: OTHER DIGESTATE THAN ENERGY CROP DIGESTAT E 
1. A CE marked fertilising product may contain digestate obtained through anaerobic 
digestion of exclusively one or more of the following input materials:  
(a) Bio-waste within the meaning of Directive 2008/98/EC resulting from separate 
bio-waste collection at source;  
(b) Animal by -products of categories 2 and 3 according to Regulation (EC) 
No 1069/2009;  
(c) Living or dead organisms or parts thereof which are unprocessed or processed 
only by manual, mechanical o r gravitational means, by dissolution in water, by 
flotation, by extraction with water, by steam distillation or by heating solely to 
remove water, or which are extracted from air by any means, except  
 the organic fraction of mixed municipal household waste separated 
through mechanical, physicochemical, biological and/or manual 
treatment,  
 sewage sludge, industrial sludge or dredging sludge,  
 animal by -products of category  1 according to Regulation (EC) 
No 1069/2009;  
(d) 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, 13 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 fertilising product,  
unless it is covered by the registration obl igation exemption provided for 
by Annex IV to that Regulation or by points 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  
(e) Any material listed in points (a )-(d) that  
 has previously been composted or digested, and  
 contains no more than 6 mg/kg dry matter of PAH 1614. 
                                                 
13 In the case of an additive recovered in the European Union, this condition is fulfilled if the additive is 
the same, within the meaning of Article  2(7)(d)(i) of  Regulation (EC) No 1907/2006, as a substance 
registered in a dossier containing the information here indicated, and if information is available to the 
fertilising product manufacturer within the meaning of Article  2(7)(d)(ii) of Regulation (EC) 
No 1907/20 06.  
EN 26   EN 2. The anaerobic digestion shall take place in a plant  
 which only processes input materials referred to in paragraph  1 above, and  
 where physical co ntacts between input and output materials shall be avoided, 
including during storage.  
3. The anaerobic digestion shall constitute of controlled decomposition of 
biodegradable materials, which is predominantly anaerobic and at temperatures 
suitable for mesophi lic or thermophilic bacteria. All parts of each batch shall be 
regularly and thoroughly moved 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 t emperature -time profiles:  
(a) Thermophilic anaerobic digestion at 55°C during at least 24h and a hydraulic 
retention time of at least 20 days;  
(b) Thermophilic anaerobic digestion at 55°C with a treatment process including a 
pasteurisation step (70°C – 1h); 
(c) Thermo philic anaerobic digestion at 55°C followed by composting in  
 65°C or more for at least 5 days,  
 60°C or more for at least 7 days, or  
 55°C or more for at least 14 days;  
(d) Mesophilic anaerobic digestion at 37 -40°C with a treatment process including a 
pasteurisation step (70°C – 1h); or  
(e) Mesophilic anaerobic digestion at 37 -40°C followed by composting in  
 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 PAH 1615.  
5. The digestate shall contain no more than 5 g/kg dry matter of macroscopic impurities 
in the form of glass, metal and plastics above 2 mm.  
6. As of [Publications office: Please insert the date oc curring 5 years after the date of 
application of this Regulation], the digestate shall contain no more than 2,5 g/kg dry 
matter of macroscopic impurities in the form of plastics above 2 mm. By 
[Publications office: Please insert the date occurring 8 years after the date of 
application of this Regulation] the limit -value of 2,5 g/kg dry matter shall be re -
assessed in order to take into account the progress made with regards to separate 
collection of bio -waste.  
                                                                                                                                                         
14 Sum of naphthalene, acenaphthylene, acenaphthene, fluorene, phenanthrene, anthracene, fluoranthene, 
pyrene, benzo[a]anthracene, chrysene, benzo[b]fluoranthene, benzo[k]fluoranthene, benzo[a]pyrene, 
indeno[1,2,3 -cd]pyrene, dibenzo[a,h]anthracene and b enzo[ghi]perylene  
15 Sum of naphthalene, acenaphthylene, acenaphthene, fluorene, phenanthrene, anthracene, fluoranthene, 
pyrene, benzo[a]anthracene, chrysene, benzo[b]fluoranthene, benzo[k]fluoranthene, benzo[a]pyrene, 
indeno[1,2,3 -cd]pyrene, dibenzo[a,h]an thracene and benzo[ghi]perylene   
EN 27   EN 7. Both the solid and the liquid part of the digest ate shall meet at least one of the 
following stability criteria:  
(a) Oxygen uptake rate:  
 Definition: an indicator of the extent to which biodegradable organic 
matter is being broken down within a specified time period. The method 
is not suitable for material w ith a content of particle sizes > 10 mm 
exceeding 20 %.  
 Criterion: maximum 50 mmol O 2/kg organic matter/h; or  
(b) Residual biogas potential:  
 Definition: an indicator of the gas released from a digestate in a 28 day 
period and measured against the volatile sol ids contained within the 
sample. The test is run in triplicate, and the average result is used to 
demonstrate compliance with the requirement. 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 0,45 l biogas /g volatile solids.  
CMC  6: FOOD INDUSTRY BY -PRODUCTS  
1. A CE marked fertilising product may contain component material consisting of one 
of the following substances:  
(a) food industry factory lime, i.e. a material from the food processing industry 
obtained by carbonation of organic matter, using exclusively burnt lime from 
natural sources;  
(b) molasses, i.e. a viscous by -product of the refining of sugarcane or sugar beets 
into sugar; or  
(c) vinasse, i.e. a visco us by -product of the fermentation process of molasses into 
ethanol, ascorbic acid or other products.  
2. The substance shall have been registered pursuant to Regulation  (EC) 
No 1907/2006,16 in a dossier containing  
(a) the information provided for by Annex VI, VII and VIII of Regulation (EC) 
No 1907/2006, and  
(b) a chemical safety report pursuant to Article  14 of Regulation (EC) 
No 1907/2006 covering the use as fertilising product,  
unless explicitly covered by one of the registration obligation exemptions provided 
for b y Annex IV to that Regulation or by points 6, 7, 8, or 9 of Annex V to that 
Regulation.  
                                                 
16 In the case of a substance recovered in the European Union, this condition is fulfilled if the substance is 
the same, within the meaning of Article  2(7)(d)(i) of Regulation (EC) No 1907/2006, as a substance 
registered in a  dossier containing the information here indicated, and if information is available to the 
fertilising product manufacturer within the meaning of Article  2(7)(d)(ii) of Regulation (EC) 
No 1907/2006.   
EN 28   EN CMC  7: MICRO -ORGANISMS  
A CE marked fertilising product may contain micro -organisms, including dead or 
empty -cell micro -organisms and non -harmful residual elements of th e media on 
which they were produced, which  
 have undergone no other processing than drying or freeze -drying and  
 are listed in the table below:  
Azotobacter spp.  
Mycorrhizal fungi  
Rhizobium spp.  
Azospirillum spp.  
CMC  8: AGRONOMIC ADDITIVES  
1. A CE marked fe rtilising product may contain a substance or a mixture intended to 
improve the fertilising product's nutrient release patterns, only if that substance's or 
mixture's compliance with the requirements of this Regulation for a product in PFC  5 
of Annex  I has been demonstrated in accordance with the conformity assessment 
procedure applicable to such an agronomic additive.  
2. The quantity of the compliant agronomic additive in the CE marked fertilising 
product shall be such as  
(a) to produce the effect claimed in the information provided to the user of the 
CE marked fertilising products, and  
(b) not to cause an overall adverse effect on human, animal or plant health, on 
safety, or on the environment, under reasonably foreseeable conditions of 
storage or use of the CE marke d fertilising product.  
3. A CE marked fertilising product may contain a compliant nitrification inhibitor, as 
referred to in PFC  5(A)(I) of Annex  I, only if at least 50% of the total nitrogen (N) 
content of the fertilising product consists of the nitrogen (N)  forms ammonium 
(NH 4+) and urea (CH 4N2O). 
4. A CE marked fertilising product may contain a compliant urease inhibitor, as 
referred to in PFC  5(A)(II) of Annex  I, only if at least 50% of the total nitrogen (N) 
content of the fertilising product consists of the  nitrogen (N) form urea (CH 4N2O). 
5. The manufacturer of the CE marked fertilising product shall be in possession of the 
EU declaration of conformity of the compliant agronomic additive.  
6. Economic operators making the CE marked fertilising product available on  the 
market shall respect the following provisions of this Regulation with regard to the 
EU declarations of conformity of both the CE  marked fertilising product and the 
compliant agronomic additive:  
(a) Article 6(3) (manufacturers' obligation to keep the EU de claration of 
conformity);   
EN 29   EN (b) Article 7(2)(a) (authorised representatives' obligation to keep the EU 
declaration of conformity);  
(c) Article 8(2) (importers' obligation to ensure that the CE marked fertilising 
product is accompanied by the EU declaration of confor mity);  
(d) Article 8(8) (importers' obligation to keep a copy of the EU declaration of 
conformity at the disposal of the market surveillance authorities); and  
(e) Article 9(2) (distributors' obligation to verify that the CE marked fertilising 
product is accompanied by the EU declaration of conformity).  
CMC  9: NUTRIENT POLYMERS  
1. A CE marked fertilising product may contain polymers exclusively made up of 
monomer substances complying with the description in 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 3/5 of the polymers shall be soluble in hot water.  
3. The polymers shall not contain formaldehyde.  
CMC  10: OTHER POLYMERS THAN N UTRIENT POLYMERS  
1. A CE marked fertilising pro duct may contain other polymers than nutrient polymers 
only in cases where the purpose of the polymer is that of  
(a) controlling 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' ), or 
(b) increasing the water retention capacity of the CE marked fertilising product.  
2. As of [Publications office, please insert the date occurring three years after the date 
of application of this Regulation], the following criterion sha ll be complied with: The 
polymer shall be capable of undergoing physical, biological decomposition, such that 
most of it ultimately decomposes into carbon dioxide (CO 2), biomass and water. It 
shall have at least 90  % of the organic carbon converted into CO 2 in maximum 24 
months, in a biodegradability test as specified points  (a)-(c) below.  
(a) The test shall be conducted at 25°C ± 2°C.  
(b) The test shall be conducted in accordance with a method for determining the 
ultimate aerobic biodegradability of plastic materi als in soils by measuring 
oxygen demand or the amount of carbon dioxide evolved.  
(c) A micro -crystalline cellulose powder with the same dimension as the test 
material shall be used as a reference material in the test.  
(d) Prior to the test, the test material shall  not be subject to conditions or 
procedures designed to accelerate the degradation of the film, such as exposure 
to heat or light.  
3. 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 CE marked fertilising product. The polymer shall pass a plant  
EN 30   EN growth acute toxicity test, an earthworm acute toxicity test and a nitrification 
inhibition test with soil micro -organisms  as follows:  
(a) In the plant growth acute toxicity test, the germination rate and the plant 
biomass of the tested plant species grown on the soil exposed to the test 
material shall be more than 90  % of the germination rate and the plant biomass 
of the same pla nt species grown on corresponding blank soil not exposed to the 
test material.  
(b) The results shall be considered valid only if in the controls ( i.e. blank soil):  
 the seedling emergence is at least 70  %; 
 the seedlings do not exhibit visible phytotoxic effect s (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 stu dy; 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.  
(c) 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 o bserved in the control ( i.e. blank soil) is <  10 %, 
and 
 the average loss of biomass (mean weight) of the worms in the blank soil 
does not exceed 20  %. 
(d) 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 tha n ± 20 %.  
CMC  11: CERTAIN ANIMAL BY -PRODUCTS  
A CE marked fertilising product may contain animal by -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 Reg ulation, which are listed in the table 
below and as specified therein:  
 
  
EN 31   EN ANNEX  III 
Labelling requirements  
This Annex sets out the labelling requirements for CE marked fertilising products. 
The requirements laid down in Part  2 and Part  3 of this Annex for a given Product 
Function Category ('PFC'), as specified in Annex  I, apply to CE marked fertilising 
products in all subcategories of that PFC.  
PART 1 
GENERAL LABELLING REQ UIREMENTS  
1. The information elements required by this Regulation shall b e clearly separated from 
any other information elements.  
2. The following information elements shall be provided:  
(a) The designation of the Product Function Category ('PFC') as indicated in Part  I 
of Annex  I; 
(b) The quantity of the CE marked fertilising product, in dicated by mass or 
volume;  
(c) Instructions for intended use, including intended application rate and intended 
target plants;  
(d) Any relevant information on measures recommended to manage risks to 
human, animal or plant health, safety, or the environment; and  
(e) A description of all components above 5% by product weight in descending 
order of magnitude by dry weight, including an indication of the relevant 
component material categories ('CMC') as referred to in Annex  II. 
3. Where the conformity assessment procedure has  involved a notified body, the 
identification number of the notified body shall be indicated.  
4. Where the CE marked fertilising product contains animal by -products within the 
meaning of Regulation (EC) No 1069/2009 other than manure, it shall carry the 
follo wing user instruction: 'Farmed animals shall not be fed, either directly or by 
grazing, with herbage from land to which the product has been applied unless the 
cutting or grazing takes place after the expiry of a waiting period of at least 21 days.'  
5. Where the CE marked fertilising product contains a substance for which maximum 
residue limits for food and feed have been established in accordance with 
Regulation  (EEC) No  315/93, Regulation  (EC) No  396/2005, Regulation (EC) 
No 470/2009 or Directive 2002/32/EC,  the instructions referred to in paragraph  2(c) 
shall ensure that the intended use of the CE marked fertilising product does not lead 
to the exceedance of those limits in food or feed.  
6. The designation of a product function category ('PFC'), as indicated in  Annex I, must 
not be indicated on a CE marked fertilising product which has not been subject of a 
successful conformity assessment in accordance with this Regulation for that PFC.  
7. Information elements other than those required under paragraphs  2-6 
(a) shall n ot 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;   
EN 32   EN (b) shall relate to verifiable factors; and  
(c) shall not make claims such as 'sustainable' or 'environmentally friendly' 
unless such claims can be objectively verified against widely recognised 
guidance, standards or schemes.  
8. The phrase 'poor in chloride' or similar may only be used if the chloride (Cl-) content 
is below 30  g/kg.  
PART 2 
PRODUCT -SPECIFIC LABELLING R EQUIREMENTS  
PFC  1: FERTILISER  
1. The content of nitrogen (N), phosphorus (P) and potassium (K) shall be declared 
only where those nutrients are present in the CE marked fertilising product in the 
minimum quanti ty specified in Annex I for the relevant product function category 
(PFC).  
2. The following rules apply to fertilisers containing nitrification or urease inhibitors, as 
specified in paragraphs  3 and 4 of component material category ('CMC')  8 in 
Annex  II: 
(a) The label shall state the words “nitrification inhibitor” or "urease inhibitor", as 
relevant, as well as the identification number of the notified body having 
examined the conformity assessment of the nitrification inhibitor or the urease 
inhibitor.  
(b) The nitrif ication inhibitor content shall be expressed as a percentage by mass of 
the total nitrogen (N) present as ammonium nitrogen (NH 4+) and urea nitrogen 
(CH 4N2O). 
(c) The urease inhibitor content shall be expressed as a percentage by mass of the 
total nitrogen (N)  present as urea nitrogen (CH 4N2O). 
(d) Technical information shall be provided enabling the user to determine the 
rates and timing of application in relation to the crop being grown.  
PFC 1(A): Organic fertiliser  
The following information elements shall be pre sent:  
(a) the declared nutrients nitrogen (N), phosphorus (P) or potassium (K), by their 
chemical symbols in the order N -P-K; 
(b) the declared nutrients magnesium (Mg), calcium (Ca), sulphur (S) or sodium 
(Na), by their chemical symbols in the order Mg -Ca-S-Na; 
(c) numbers indicating the total content of the declared nutrients nitrogen (N), 
phosphorus (P) or potassium (K), followed by numbers in brackets indicating 
the total content of magnesium (Mg), calcium (Ca), sulphur (S) or sodium 
(Na),   
EN 33   EN (d) the content of the followi ng declared nutrients and other parameters, in the 
following order and as a percentage of the fertiliser by mass,  
 Total Nitrogen (N)  
– minimum amount of organic nitrogen (N), followed by a 
description of the origin of the organic matter used;  
– Nitrogen (N) i n the form of ammoniacal nitrogen;  
 Total phosphorus pentoxide (P 2O5); 
 Total potassium oxide (K 2O); 
 Magnesium oxide (MgO), calcium oxide (CaO), sulphur trioxide (SO 3) 
and sodium oxide (Na 2O), expressed  
– where those nutrients are totally soluble in water, only as the 
content soluble in water;  
– where the soluble content of those nutrients is at least a quarter of 
the total content of those nutrients, the total content and the content 
soluble in water; and  
– in other cases, as the total content;  
 Total copper (Cu ) and zinc (Zn), if above 200 and 600 mg/kg dry matter 
respectively;  
 Organic carbon (C); and  
 Dry matter.  
PFC 1(B): Organo -mineral fertiliser  
1. The following information elements relating to macronutrients shall be present:  
(a) the declared nutrients nitrogen (N), phosphorus (P) or potassium (K), by their 
chemical symbols in the order N -P-K; 
(b) the declared nutrients magnesium (Mg), calcium (Ca), sulphur (S) or sodium 
(Na), by their chemical symbols in the order Mg -Ca-S-Na; 
(c) numbers indicating the total content of the declared nutrients nitrogen (N), 
phosphorus (P) or potassium (K), followed by numbers in brackets indicating 
the total content of magnesium (Mg), calcium (Ca), sulphur (S) or sodium 
(Na);  
(d) the content of the following declared nutrients, in the followin g order and as a 
percentage of the fertiliser by mass:  
 Total Nitrogen (N)  
– minimum amount of organic nitrogen (N), followed by a 
description of the origin of the organic matter used;  
– Nitrogen (N) in the form of nitric nitrogen;  
– Nitrogen (N) in the form of a mmoniacal nitrogen;  
– Nitrogen (N) in the form of urea nitrogen;   
EN 34   EN  Total phosphorus pentoxide (P 2O5); 
– Water -soluble phosphorus pentoxide (P 2O5); 
– phosphorus pentoxide (P 2O5) soluble in neutral ammonium citrate;  
– where soft ground phosphate is present, phosphorus  pentoxide 
(P2O5) soluble in formic acid;  
 Total potassium oxide (K 2O); 
– Water soluble potassium oxide (K 2O); 
 magnesium oxide (MgO), calcium oxide (CaO), sulphur trioxide (SO 3) 
and sodium oxide (Na 2O), expressed  
– where those nutrients are totally soluble in w ater, only as the 
content soluble in water;  
– where the soluble content of those nutrients is at least a quarter of 
the total content of those nutrients, the total content and the content 
soluble in water;  
– in other cases, as the total content, and  
(e) where urea  (CH 4N2O) is present, information about the possible air quality 
impacts of the release of ammonia from the fertiliser use, and an invitation to 
users to apply appropriate remediation measures.  
2. The following other elements shall be indicated as a percentage by mass of the CE 
marked fertilising product:  
 Organic carbon (C) content; and  
 Dry matter content.  
PFC 1(B)(I): Solid organo -mineral fertiliser  
Where one or more of the micronutrients boron (B), cobalt (Co), copper (Cu), iron 
(Fe), manganese (Mn), molybdenum (Mo) and zinc (Zn), are present in the minimum 
content indicated as a percentage by mass in the table below, they  
 shall be declared if they are intentionally added to the CE marked fertilising 
product, and  
 may be declared in other cases:  
Micronutrient  Intended for use on crops or 
grassland  Intended for horticultural 
use  
Boron (B)  0,01 0,01 
Cobalt (Co)  0,002  n.a. 
Copper (Cu)  0,01 0,002  
Iron (Fe)  0,5 0,02 
Manganese (Mn)  0,1 0,01  
EN 35   EN Molybdenum 
(Mo)  0,001  0,001  
Zinc 0,01 0,002  
They shall  be declared after the information on macronutrients. The following 
information elements shall be present:  
(a) indication of the names and chemical symbols of the declared  micronutrients, 
listed in the following order: boron (B), cobalt (Co), copper (Cu), iron (Fe), 
manganese (Mn), molybdenum (Mo) and zinc (Zn), followed by the name(s) of 
their counter -ion(s);  
(b) The total micronutrient content expressed as a percentage of the  fertiliser by 
mass  
– where those nutrients are totally soluble in water, only as the content 
soluble in water;  
– where the soluble content of those nutrients is at least a quarter of the 
total content of those nutrients, the total content and the content solu ble 
in water; and  
– in other cases, as the total content;  
(c) Where the declared micronutrient(s) are chelated by chelating agent(s), the 
following qualifier after the name and the chemical identifier of the 
micronutrient:  
– ‘chelated by…’ name of the chelating agent or its abbreviation, and the 
amount of chelated micronutrient as a percentage of the CE marked 
fertilising product by mass;  
(d) Where the CE marked fertilising product contains micronutrient(s) complexed 
by complexing agent(s):  
– the following qualifier af ter the name and the chemical identifier of the 
micronutrient: ‘complexed by …', and the amount of complexed 
micronutrient as a percentage of the CE marked fertilising product by 
mass; and  
– the name of the complexing agent or its abbreviation.  
(e) The following  statement: ‘To be used only where there is a recognised need. 
Do not exceed the appropriate rate’.  
PFC 1(B)(II): Liquid organo -mineral fertiliser  
Where one or more of the micronutrients boron (B), cobalt (Co), copper (Cu), iron 
(Fe), manganese (Mn), molyb denum (Mo) and zinc (Zn), are present in the minimum 
content indicated as a percentage by mass in the table below, they  
 shall be declared if they are intentionally added to the CE marked fertilising 
product, and   
EN 36   EN  may be declared in other cases:  
Micronutrie nt Percentage by mass  
Boron (B)  0,01 
Cobalt (Co)  0,002  
Copper (Cu)  0,002  
Iron (Fe)  0,02 
Manganese (Mn)  0,01 
Molybdenum (Mo)  0,001  
Zinc 0,002  
They shall be declared after the information on macronutrients. The following 
information elements shall be  present:  
(a) indication of the names and chemical symbols of the declared  micronutrients, 
listed in the following order: boron (B), cobalt (Co), copper (Cu), iron (Fe), 
manganese (Mn), molybdenum (Mo) and zinc (Zn), followed by the name(s) of 
their counter -ion(s); 
(b) The total micronutrient content expressed as a percentage of the fertiliser by 
mass  
– where those nutrients are totally soluble in water, only as the content 
soluble in water;  
– where the soluble content of those nutrients is at least a quarter of the 
total content of those nutrients, the total content and the content soluble 
in water; and  
– in other cases, as the total content;  
(c) Where the declared micronutrient(s) are chelated by chelating agent(s), the 
following qualifier after the name and the chemical identifier of the 
micronutrient:  
– ‘chelated by…’ name of the chelating agent or its abbreviation, and the 
amount of chelated micronutrient as a percentage of the CE marked 
fertilising product by mass;  
(d) Where the CE marked fertilising product contains micronu trient(s) complexed 
by complexing agent(s):  
– the following qualifier after the name and the chemical identifier of the 
micronutrient: ‘complexed by …', and the amount of complexed 
micronutrient as a percentage of the CE marked fertilising product by 
mass; a nd 
– the name of the complexing agent or its abbreviation.  
(e) The following statement: ‘To be used only where there is a recognised need. 
Do not exceed the appropriate rate’.   
EN 37   EN PFC 1(C): Inorganic fertiliser  
PFC 1(C)(I): Inorganic macronutrient fertiliser  
1. The following information elements relating to macronutrients shall be present:  
(a) the declared nutrients nitrogen (N), phosphorus (P) or potassium (K), by their 
chemical symbols in the order N -P-K; 
(b) the declared nutrients magnesium (Mg), calcium (Ca), sulphur (S)  or sodium 
(Na), by their chemical symbols in the order Mg -Ca-S-Na; 
(c) numbers indicating the total content of the declared nutrients nitrogen (N), 
phosphorus (P) or potassium (K), followed by numbers in brackets indicating 
the total content of magnesium (Mg) , calcium (Ca), sulphur (S) or sodium 
(Na);  
(d) the content of the following declared nutrients, in the following order and as a 
percentage of the fertiliser by mass,  
 Total Nitrogen (N);  
– Nitrogen (N) in the form of nitric nitrogen  
– Nitrogen (N) in the form of ammoniacal nitrogen;  
– Nitrogen (N) in the form of urea nitrogen;  
– Nitrogen (N) from urea formaldehyde, isobutylidenediurea, 
crotonylidenediurea;  
– Nitrogen (N) from cyanamide nitrogen;  
 Total phosphorus pentoxide (P 2O5); 
– Water -soluble phosphorus pentoxide (P 2O5); 
– phosphorus pentoxide (P 2O5) soluble in neutral ammonium citrate;  
– where soft ground phosphate is present, phosphorus pentoxide 
(P2O5) soluble in formic acid;  
 Water soluble potassium oxide (K 2O); 
 magnesium oxide (MgO), calcium oxide (CaO), sulphur trioxid e (SO 3) 
and sodium oxide (Na 2O), expressed  
– where those nutrients are totally soluble in water, only as the 
content soluble in water;  
– where the soluble content of those nutrients is at least a quarter of 
the total content of those nutrients, the total conte nt and the content 
soluble in water; and  
– in other cases, as the total content, and  
(e) where urea (CH 4N2O) 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.   
EN 38   EN PFC 1(C)(I)(a): Solid inorganic macronutrient fertiliser  
1. The fertiliser shall be labelled  
(a) 'complex', where each particle contains all the declared nutrients in their 
declared content, and  
(b) 'mix' in other cases.  
2. The granulometry of the fertiliser shall be indicated, expressed a percentage of 
product passing through a determined sieve.  
3. The particle form of the product shall be indicated with one of the following 
mentions:  
(a) Granule,  
(b) pellet,  
(c) powder, where at least 90% o f the product can pass through a sieve with a 
mesh of 10 mm, or  
(d) prill.  
4. For coated fertilisers, the name of the coating agent(s) and the percentage of 
fertilisers coated by each coating agent(s) shall be indicated and followed by:  
(a) Release time defined in mo nths of the coated fraction(s) followed by the 
percentage of nutrients released during this time for each fraction;  
(b) The name of the medium (solvent or substrate) used in the test performed by 
the manufacturer for determining the release time;  
(c) The temperatu re at which the test was conducted;  
(d) For polymer coated 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  
(e) For sulphur (S) coated f ertilisers and sulphur (S)/polymer coated fertilisers, the 
following marking: ‘The rate of nutrient release can vary according to the 
temperature of the substrate and the biological activity. An adjustment of 
fertilisation may be necessary”.  
5. Where one or m ore of the micronutrients boron (B), cobalt (Co), copper (Cu), iron 
(Fe), manganese (Mn), molybdenum (Mo) and zinc (Zn), are present in the minimum 
content indicated below as a percentage by mass, they  
 shall be declared if they are intentionally added to t he CE marked fertilising 
product, and  
 may be declared in other cases:  
Micronutrient  Intended for use on crops or 
grassland  Intended for horticultural 
use  
Boron (B)  0,01 0,01 
Cobalt (Co)  0,002  n.a.  
EN 39   EN Copper (Cu)  0,01 0,002  
Iron (Fe)  0,5 0,02 
Manganese (Mn)  0,1 0,01 
Molybdenum 
(Mo)  0,001  0,001  
Zinc 0,01 0,002  
They shall be declared after the information on macronutrients. The following 
information elements shall be present:  
(a) indication of the names and chemical symbols of the declared  micronutrients, 
listed in the following order: boron (B), cobalt (Co), copper (Cu), iron (Fe), 
manganese (Mn), molybdenum (Mo) and zinc (Zn), followed by the name(s) of 
their counter -ion(s);  
(b) The total micronutrient content expressed as a percentage of the  fertiliser by 
mass  
– where those nutrients are totally soluble in water, only as the content 
soluble in water;  
– where the soluble content of those nutrients is at least a quarter of the 
total content of those nutrients, the total content and the content solu ble 
in water; and  
– in other cases, as the total content;  
(c) Where the declared micronutrient(s) are chelated by chelating agent(s), the 
following qualifier after the name and the chemical identifier of the 
micronutrient:  
– ‘chelated by…’ name of the chelating ag ent or its abbreviation, and the 
amount of chelated micronutrient as a percentage of the CE marked 
fertilising product by mass;  
(d) Where the CE marked fertilising product contains micronutrient(s) complexed 
by complexing agent(s):  
– the following qualifier afte r the name and the chemical identifier of the 
micronutrient: ‘complexed by …', and the amount of complexed 
micronutrient as a percentage of the CE marked fertilising product by 
mass; and  
– the name of the complexing agent or its abbreviation.  
(e) The following s tatement: ‘To be used only where there is a recognised need. 
Do not exceed the appropriate rate’.  
PFC 1(C)(I)(b): Liquid inorganic macronutrient fertiliser  
1. The label shall indicate whether the fertiliser is in suspension or in solution, where  
 a suspension means a two -phase dispersion in which solid particles are 
maintained in suspension in the liquid phase, and   
EN 40   EN  a solution means a liquid that is free of solid particles.  
2. The nutrient content shall be indicated as a percentage by mass or volume of the CE 
marke d fertilising product.  
3. Where one or more of the micronutrients boron (B), cobalt (Co), copper (Cu), iron 
(Fe), manganese (Mn), molybdenum (Mo) and zinc (Zn), are present in the minimum 
content indicated below as a percentage by mass, they  
 shall be declared  if they are intentionally added to the CE marked fertilising 
product, and  
 may be declared in other cases:  
Micronutrient  Percentage by mass  
Boron (B)  0,01 
Cobalt (Co)  0,002  
Copper (Cu)  0,002  
Iron (Fe)  0,02 
Manganese (Mn)  0,01 
Molybdenum (Mo)  0,001  
Zinc 0,002  
They shall be declared after the information on macronutrients. The following 
information elements shall be present:  
(a) indication of the names and chemical symbols of the declared  micronutrients, 
listed in the following order: boron (B), cobalt (Co), copper (Cu), iron (Fe), 
manganese (Mn), molybdenum (Mo) and zinc (Zn), followed by the name(s) of 
their counter -ion(s);  
(b) The total micronutrient content expressed as a percentage of the  fertiliser by 
mass  
– where those nutrients are totally soluble in water, only as the content 
soluble in water;  
– where the soluble content of those nutrients is at least a quarter of the 
total content of those nutrients, the total content and the content solu ble 
in water; and  
– in other cases, as the total content;  
(c) Where the declared micronutrient(s) are chelated by chelating agent(s), the 
following qualifier after the name and the chemical identifier of the 
micronutrient:  
– ‘chelated by…’ name of the chelating ag ent or its abbreviation, and the 
amount of chelated micronutrient as a percentage of the CE marked 
fertilising product by mass;   
EN 41   EN (d) Where the CE marked fertilising product contains micronutrient(s) complexed 
by complexing agent(s):  
– the following qualifier afte r the name and the chemical identifier of the 
micronutrient: ‘complexed by …', and the amount of complexed 
micronutrient as a percentage of the CE marked fertilising product by 
mass; and  
– the name of the complexing agent or its abbreviation.  
(e) The following s tatement: ‘To be used only where there is a recognised need. 
Do not exceed the appropriate rate’.  
PFC 1(C)(II): Inorganic micronutrient fertiliser  
1. The declared micronutrients in the CE marked fertilising product shall be listed by 
their names and chemical symbols in the following order: boron (B), cobalt (Co), 
copper (Cu), iron (Fe), manganese (Mn), molybdenum (Mo) and zinc (Zn), followed 
by the name(s) of their counter -ion(s),  
2. Where the declared micronutrient(s) are chelated by chelating agent(s), and eac h 
chelating agent can be identified and quantified and chelates at least 1% water -
soluble micronutrient, the following qualifier shall be added after the name and the 
chemical identifier of the micronutrient:  
– ‘chelated by…’ name of the chelating agent or its abbreviation, and the amount 
of chelated micronutrient as a percentage of the CE marked fertilising product 
by mass.  
3. Where the declared micronutrient(s) are complexed by complexing agent(s), the 
following qualifier shall be added after the name and the  chemical identifier of the 
micronutrient:  
– ‘complexed by …', and the amount of complexed micronutrient as a percentage 
of the CE marked fertilising product by mass, and  
– the name of the complexing agent or its abbreviation.  
4. The following statement shall ap pear: ‘To be used only where there is a recognised 
need. Do not exceed the appropriate rate’.  
PFC 1(C)(II)(a): Straight inorganic micronutrient fertiliser  
1. The label shall indicate the relevant typology, as referred to in the table under 
PFC 1(C)(II)(a) in Part II of Annex  I. 
2. The total micronutrient content shall be expressed as a percentage of the fertiliser by 
mass  
– where the micronutrient is totally soluble in water, only as the content soluble 
in water;  
– where the soluble content of the micronutrient is at  least a quarter of the total 
content of that nutrient, the total content and the content soluble in water; and  
– in other cases, as the total content.   
EN 42   EN PFC 1(C)(II)(b): Compound inorganic micronutrient fertiliser  
1. Micronutrients can be declared only if they a re present in the fertiliser in the 
following quantities:  
Micronutrient  Non-chelated, non -complexed  Chelated or complexed  
Boron (B)  0,2 n.a. 
Cobalt (Co)  0,02 0,02 
Copper (Cu)  0,5 0,1 
Iron (Fe)  2 0,3 
Manganese (Mn)  0,5 0,1 
Molybdenum (Mo)  0,02 n.a. 
Zinc 0,5 0,1 
2. If the fertiliser is in suspension or in solution, the label shall indicate "in suspension" 
or "in solution", as relevant.  
3. The total micronutrient content shall be expressed as a percentage of the fertiliser by 
mass  
– where the micronutrients a re totally soluble in water, only as the content 
soluble in water;  
– where the soluble content of the micronutrients is at least half of the total 
content of those nutrients, the total content and the content soluble in water; 
and 
– in other cases, as the total content.  
PFC  2: LIMING MATERIAL  
The following parameters shall be declared in the following order:  
– Neutralising value;  
– Granulometry, expressed a percentage of product passing through a determined 
sieve;  
– Total CaO, expressed as a percentage by mass of  the CE marked fertilising product;  
– Total MgO, expressed as a percentage by mass of the CE marked fertilising product;  
– Reactivity, except for oxide and hydroxide limes; and  
– for slags and carbonates of natural origin: method of determination of reactivity.  
PFC  3: SOIL IMPROVER  
The following parameters shall be declared in the following order, and expressed as a 
percentage of the CE marked fertilising product by mass:  
– Dry matter;   
EN 43   EN – Organic carbon (C) content;  
– Total nitrogen (N) content;  
– Total phosphorus pentoxi de (P 2O5) content;  
– Total potassium oxide (K 2O) content;  
– Total copper (Cu) and zinc (Zn) content, if above 200 and 600 mg/kg dry matter 
respectively; and  
– pH. 
PFC  4: GROWING MEDIUM  
The parameters shall be declared in the following order:  
– Electrical conductiv ity, except for mineral wool;  
– pH; 
– Quantity  
 For mineral wool, expressed as number of pieces and the three dimensions 
length, height, and width,  
 For other pre -shaped growing media, expressed as size in at least two 
dimensions, and  
 For other growing media, expressed as total volume;  
– Except for pre -shaped growing media, quantity expressed as volume of materials 
with a particle size greater than 60 mm;  
– Total nitrogen (N);  
– Total phosphorus pentoxide (P 2O5); and  
– Total potassium oxide (K 2O). 
PFC  5: AGRONOMIC ADDI TIVE  
Only the general labelling requirements apply to this PFC.  
PFC  6: PLANT BIOSTIMULANT  
The following information elements shall be present:  
(a) physical form;  
(b) manufacturing and expiry date;  
(c) storage conditions;  
(d) application method(s);  
(e) dose, timing (plant deve lopment stage) and frequency of application;  
(f) effect claimed for each target plant; and  
(g) any relevant instructions related to the efficacy of the product, including soil 
management practices, chemical fertilisation, incompatibility with plant 
protection prod ucts, recommended spraying nozzles size and sprayer pressure.   
EN 44   EN PFC 6(A): Microbial plant biostimulant  
The label shall contain the following phrase: 'Micro -organisms may have the 
potential to provoke sensitising reactions'.  
PFC  7: FERTILISING PRODUCT B LEND  
All the labelling requirements applicable to all component CE marked fertilising 
products apply to the CE marked fertilising product blend, and shall be expressed in 
relation to the final CE marked fertilising product blend.  
PART 3 
TOLERANCE RULES  
1. The decl ared nutrient content or physico -chemical characteristics of a CE marked 
fertilising product may deviate from the actual value only in accordance with the 
tolerances established in this Part for the relevant product function category. The 
tolerances are in tended to allow for deviations in manufacture, sampling and 
analysis.  
2. The tolerances allowed in respect of the declared parameters indicated in this Part are 
negative and positive values in percentage by mass.  
3. The manufacturer, importer or distributor sha ll not take systematic advantage of the 
tolerances.  
4. By derogation from paragraph  1, the actual content in a CE marked fertilising 
product of a component for which a minimum or a maximum content is specified in 
Annex  I or Annex  II may never be lower than th e minimum content or exceed the 
maximum content.  
PFC  1: FERTILISER  
PFC 1(A): Organic fertiliser  
 Permissible tolerance for the declared nutrient 
content and other declared parameter  
Organic carbon (C) ± 20 % relative deviation of the declared value up to a 
maximum of 2,0 percentage point in absolute terms    
Dry matter content  ± 5,0 percentage point in absolute terms  
Total nitrogen (N)  ± 50 % relative deviation of the declared value up to a 
maximum of  1,0 percentage point in absolute terms  
Organic nitro gen (N)  ± 50 % relative deviation of the declared value up to a 
maximum of  1,0 percentage point in absolute terms  
Total phosphorus pentoxide 
(P2O5) ± 50 % relative deviation of the declared value up to a 
maximum of  1,0 percentage point in absolute terms  
Total potassium oxide (K 2O) ± 50 % relative deviation of the declared value up to a 
maximum of  1,0 percentage point in absolute terms   
EN 45   EN Total and water -soluble 
magnesium oxide, calcium 
oxide, sulphur trioxide or 
sodium oxide  ± 25% of the declared content  of those nutrients up to 
a maximum of 1,5 percentage points in absolute terms.  
Total copper (Cu)  ± 50 % relative deviation of the declared value up  to a 
maximum of 2,5 percentage points in absolute terms  
Total zinc (Zn)  ± 50 % relative deviation of th e declared value up  to a 
maximum of 2,0 percentage points in absolute terms  
Quantity  - 5 % relative deviation of the declared value  
PFC 1(B): Organo -mineral fertiliser  
Permissible tolerance for the declared content of forms of inorganic macronutrient  
N P2O5 K2O MgO  CaO SO 3  Na2O   
± 25% of the declared content 
of the nutrient forms present 
up to a maximum of 2  
percentage point in absolute 
terms  ± 25% of the declared content of 
those nutrients up to a maximum 
of 1,5 percentage points in 
absolute terms.  ± 25% of the 
declared content up 
to a maximum of 
0,9 percentage 
points in absolute 
terms  
 
Micro -nutrient fertilisers  Permissible tolerance for the declared 
content of forms of micronutrient  
Concentration below or equal to 2%   ± 20 % of the declared value  
Concentration of between 2,1% and 
10% ± 0,3 percentage points in absolute terms  
Concentration of more than 10%  ± 1,0 percentage points in absolute terms  
Organic carbon: ± 20 % relative deviation of the declared value up to a maximum of 2,0 
percentage point in absolute terms    
Organic nitrogen: ± 50 % relative deviation of the declared value up to a maximum of  1,0 
percentage point in absolute terms  
Total copper (Cu)  ± 50 % relative deviation of the declared value up  to a maximum of 
2,5 per centage points in absolute terms  
Total zinc (Zn)  ± 50 % relative deviation of the declared value up  to a maximum of 
2,0 percentage points in absolute terms  
Dry matter content: ± 5,0 percentage point in absolute terms  
Quantity: -5% relative deviation of th e declared value   
EN 46   EN PFC 1(C): Inorganic fertiliser  
PFC 1(C)(I): Inorganic macronutrient fertiliser  
Permissible tolerance for the declared content of forms of macronutrient  
N P2O5 K2O MgO  CaO SO 3  Na2O   
± 25% of the declared content 
of the nutrient forms present 
up to a maximum of 2  
percentage point in absolute 
terms  ± 25% of the declared content of 
those nutrients up to a maximum 
of 1,5 percentage points in 
absolute terms.  ± 25% of the 
declared content up 
to a maximum of 
0,9 percentage 
points in absolute  
terms  
Granulometry: ± 10 % relative deviation applicable to the declared percentage of material 
passing a specific sieve  
Quantity:  ± 5  % relative deviation of the declared value  
PFC 1(C)(II): Inorganic micronutrient fertiliser  
Micro -nutrient fertilisers  Permissible tolerance for the declared 
content of forms of micro -nutrient  
Concentration below or equal to 2%   ± 20 % of the declared value  
Concentration of between 2,1% and 
10% ± 0,3 percentage points in absolute terms  
Concentration of more than 10%  ± 1,0 percentage points in absolute terms  
Quantity:  ± 5  % relative deviation of the declared value  
PFC  2: LIMING MATERIAL  
 Permissible tolerances for the declared 
parameter  
Neutralising value  ± 3 
Granulometry  ± 10 % relative deviation applicable to the 
declared percentage of material passing a 
specific sieve.  
Total calcium oxide  ± 3 percentage points in absolute terms  
Total magnesium oxide  
Concentration below 8%  
Concentration between 8 to 16%  
Concentration above or equal to 16%   
± 1,0 percentage points in absolute terms  
± 2,0 percentage points in absolute terms  
± 3,0 percentage points in absolute terms  
Reactivity  ± 15 percentage points in absolute terms   
EN 47   EN Quantity  - 5 % relative deviation applicable to the 
declared value  
PFC  3: SOIL IMPROVER  
Forms of the declared nutrient and 
other declared quality criteria  Permissible tolerances for the declared 
parameter  
pH ± 0,7  at the time of manufacture  
± 1,0 at any time in the distribution chain  
Organic carbon (C) ± 10% relative deviation of the declared value up 
to a maximum of 1,0 percentage points in 
absolute terms  
Total nitrogen (N)  ± 20% relative deviation up to a maximum of 1,0 
percentage point in absolute terms  
Total phosphorus pentoxide (P 2O5) ± 20% relative deviation up to a maximum of 1,0 
percentage point in absolute terms  
Total potassium oxide (K 2O) ± 20% relative deviation up to a maximum of 1,0 
percentage point in absolute terms  
Dry matter  ± 10% relative deviation of the declared value  
Quantity  - 5% relative deviation  of the declared value at 
the time of manufacture  
- 25% relative deviation  of the declared value at 
any time in the distribution chain  
Carbon (C) org /Nitrogen (N) org  ± 20% relative deviation of the declared value up 
to a maximum of 2 ,0 percentage points in 
absolute terms  
Granulometry  ± 10 % relative deviation applicable to the 
declared percentage of material passing a 
specific sieve.  
PFC  4: GROWING MEDIUM  
Forms for the declared nutrient 
and other declared quality criteria  Permissi ble tolerances for the declared 
parameter  
Electric conductivity  ± 50% relative deviation at the time of 
manufacture  
± 75% relative deviation at any time in the 
distribution chain  
pH ± 0,7 at the time of manufacture  
± 1,0 at any time in the distribution chain   
EN 48   EN Quantity by volume (litres or m³)  - 5% relative deviation at the time of 
manufacture  
- 25% relative deviation at any time in the 
distribution chain  
Quantity (volume) determination of 
materials with particle size greater 
than 60 mm  - 5% relative deviation at the time of 
manufacture  
- 25% relative deviation at any time in the 
distribution chain  
Quantity (volume) determination of 
pre-shaped GM  - 5% relative deviation at the time of 
manufacture  
- 25% relative deviation  at any time in the 
distribut ion chain  
Water -soluble nitrogen (N)  ± 50% relative deviation  at the time of 
manufacture  
± 75% relative deviation  at any time in the 
distribution chain  
Water -soluble phosphorus pentoxide 
(P2O5) ± 50% relative deviation  at the time of 
manufacture  
± 75%  relative deviation  at any time in the 
distribution chain  
Water -soluble potassium oxide 
(K2O)  ± 50% relative deviation  at the time of 
manufacture  
± 75% relative deviation  at any time in the 
distribution chain  
PFC  6: PLANT BIOSTIMULANT  
Declared content in g/kg or g/l at 20°C  Permissible tolerance  
Up to 25  ± 15% relative deviation for PFC 6  
± 15% relative deviation when plant 
biostimulants are blended with other CE 
marked fertilising products under PFC 7  
More than 25 up to 100  ± 10% relative deviation  
More than 100 up to 250  ± 6% relative deviation  
More than 250 up to 500  ± 5% relative deviation  
More than 500  ± 25g/kg or ± 25g/l  
  
EN 49   EN ANNEX IV  
Conformity assessment procedures  
PART 1 
APPLICABILITY OF CONF ORMITY ASSESSMENT PROCEDURES  
This Part sets out the applicability of conformity assessment procedure modules, as 
specified in Part 2 of this Annex, to CE marked fertilising products depending on 
their Component Material Categories as specified in Annex  II ('CMC'), and their  
Product Function Categories as specified in Annex  I ('PFC').  
1. APPLICABILITY OF INTE RNAL PRODUCTION CONT ROL (MODULE A) 
1. Module  A may be used for a CE marked fertilising product composed solely of one 
or more  
(a) virgin material substances or mixtures as specified in CMC  1,  
(b) energy crop digestates as specified in CMC  4, 
(c) food industry by -products as specified in CMC  6,  
(d) micro -organisms as specified in CMC  7, 
(e) agronomic additives as specified in CMC  8, or 
(f) nutrient pol ymers as specified in CMC  9. 
2. Module  A may also be used for a fertilising product blend as specified in PFC  7. 
3. By derogation from paragraphs  1 and 2, Module  A must not be used for  
(a) a straight or compound solid inorganic macronutrient ammonium nitrate 
fertili ser of high nitrogen content, as specified in PFC  1(C)(I)(a)(i -ii)(A), or a 
fertilising product blend containing such a product,  
(b) a nitrification inhibitor as specified in PFC 5(A)(I),  
(c) a urease inhibitor as specified in PFC 5(A)(II), or  
(d) a plant biostimulant  as specified in PFC  6. 
2. APPLICABILITY OF INTE RNAL PRODUCTION CONT ROL PLUS SUPERVISED PRODUCT 
TESTING (MODULE  A1) 
Module  A1 shall be used for a straight or compound solid inorganic macronutrient 
ammonium nitrate fertiliser of high nitrogen content, as sp ecified in 
PFC 1(C)(I)(a)(i -ii)(A), and for a fertilising product blend as specified in PFC  7 
containing such a product.  
3. APPLICABILITY OF EU-TYPE EXAMINATION (MODULE B) AND CONFORMITY TO 
TYPE BASED ON INTERN AL PRODUCTION CONTRO L (MODULE C) 
1. Module  B in c ombination with Module  C may be used for a CE marked fertilising 
product composed solely of one or more  
(a) non-processed or mechanically processed plant, plant parts or plant extracts as 
specified in CMC  2,   
EN 50   EN (b) other polymers than nutrient polymers as specified in CMC  10,  
(c) certain animal by -products as specified in CMC  11, or  
(d) CMCs eligible for Module  A pursuant to paragraph  1 under Heading  1 on 
applicability of that Module.  
2. Module  B and Module  C may also be used for  
(a) a nitrification inhibitor as specified in PFC 5(A)(I),  
(b) a urease inhibitor as specified in PFC 5(A)(II),  
(c) a plant biostimulant as specified in PFC  6, and  
(d) a product eligible for Module  A pursuant to paragraph  2 under Heading  1 on 
applicability of that Module.  
3. By derogation from paragraphs  1 and 2, Module  B and Module  C must not be used 
for a straight or compound solid inorganic macronutrient ammonium nitrate fertiliser 
of high nitrogen content, as specified in PFC  1(C)(I)(a)(i -ii)(A), or a fertilising 
product blend containing such a product.  
4. APPL ICABILITY OF QUALITY  ASSURANCE OF THE PRO DUCTION PROCESS 
(MODULE  D1) 
1. Module  D1 may be used for any CE marked fertilising product.  
2. By derogation from paragraph  1, Module  D1 must not be used for a straight or 
compound solid inorganic macronutrient ammonium n itrate fertiliser of high nitrogen 
content, as specified in PFC  1(C)(I)(a)(i -ii)(A), or a fertilising product blend 
containing such a product.  
PART 2 
DESCRIPTION OF CONFOR MITY ASSESSMENT PROC EDURES  
MODULE A – INTERNAL PRODUCTION C ONTROL  
1. Description of t he module  
1. Internal production control is the conformity assessment procedure whereby the 
manufacturer fulfils the obligations laid down under Headings 2, 3 and 4 below, and 
ensures and declares on his or her sole responsibility that the CE marked fertilising 
products concerned satisfy the requirements of this Regulation that apply to them.  
2. Technical documentation  
2.1 The manufacturer shall establish the technical documentation. The documentation 
shall make it possible to assess the CE marked fer tilising product's conformity to the 
relevant requirements, and shall include an adequate analysis and assessment of the 
risk(s).  
2.2 The technical documentation shall specify the applicable requirements and cover, as 
far as relevant for the assessment, t he design, manufacture and use of the CE marked 
fertilising product. The technical documentation shall contain at least the following 
elements:  
(a) a general description of the CE marked fertilising product,  
(b) conceptual design and manufacturing drawings and sc hemes,   
EN 51   EN (c) descriptions and explanations necessary for the understanding of those 
drawings and schemes and the use of the CE marked fertilising product,  
(d) a list of the harmonised standards applied in full or in part the references of 
which have been published i n the Official Journal of the European Union  and, 
where those harmonised standards have not been applied, descriptions of the 
solutions adopted to meet the essential requirements of this Regulation, 
including a list of common specifications or other releva nt technical 
specifications applied. In the event of partly applied harmonised standards, the 
technical documentation shall specify the parts which have been applied,  
(e) results of design calculations made, examinations carried out, etc., and  
(f) test reports.  
3. Manufacturing  
3. The manufacturer shall take all measures necessary so that the manufacturing process 
and its monitoring ensure compliance of the manufactured CE marked fertilising 
products with the technical documentation referred to under Heading 2 above a nd 
with the requirements of this Regulation that apply to them.  
4. CE marking, EU declaration of conformity  
4.1. The manufacturer shall affix the CE mark to each individual fertilising product that 
satisfies the applicable requirements of this Regulation.  
4.2. The manufacturer shall draw up a written EU declaration of conformity for each CE 
marked fertilising product lot and keep it together with the technical documentation 
at the disposal of the national authorities for 10 years after the CE marked fertili sing 
product has been placed on the market. The EU declaration of conformity shall 
identify the CE marked fertilising product for which it has been drawn up.  
4.3. A copy of the EU declaration of conformity shall accompany every CE marked 
fertilising produc t. 
5. Authorised representative  
5. The manufacturer's obligations set out under Heading 4 above may be fulfilled by his 
or her authorised representative, on his or her behalf and under his or her 
responsibility, provided that they are specified in the mandate . 
MODULE A1 – INTERNAL PRODUCTION C ONTROL PLUS SUPERVIS ED PRODUCT TESTING  
1. Description of the module  
1. Internal production control plus supervised product testing is the conformity 
assessment procedure whereby the manufacturer fulfils the obligations laid down 
under Headings 2, 3, 4, and 5 below, and ensures and declares on his or her sole 
responsibility that the CE marked fertilising products concerned satisfy the 
requirements of this Regulation that apply to them.  
2. Technical documentation  
2.1. The manuf acturer shall establish the technical documentation. The documentation 
shall make it possible to assess the CE marked fertilising product's conformity with 
the relevant requirements, and shall include an adequate analysis and assessment of 
the risk(s).   
EN 52   EN 2.2. The technical documentation shall specify the applicable requirements and cover, as 
far as relevant for the assessment, the design, manufacture and use of the CE marked 
fertilising product. The technical documentation shall contain, wherever applicable, 
at least the following elements:  
(a) a general description of the CE marked fertilising product,  
(b) conceptual design and manufacturing drawings and schemes,  
(c) descriptions and explanations necessary for the understanding of those 
drawings and schemes and the use o f the CE marked fertilising product,  
(d) the names and addresses of the sites, and of the operators of the sites, at which 
the product and its principal components were manufactured,  
(e) a list of the harmonised standards applied in full or in part the references of 
which have been published in the Official Journal of the European Union  and, 
where those harmonised standards have not been applied, descriptions of the 
solutions adopted to meet the essential requirements of this Regulation, 
including a list of common specifications or other relevant technical 
specifications applied. In the event of partly applied harmonised standards, the 
technical documentation shall specify the parts which have been applied,  
(f) results of design calculations made, examinations carried o ut, etc., and  
(g) test reports.  
3. Manufacturing  
3. The manufacturer shall take all measures necessary so that the manufacturing process 
and its monitoring ensure compliance of the manufactured CE marked fertilising 
products with the technical documentation re ferred to under Heading 2 above and 
with the requirements of this Regulation.  
4. Product checks for oil retention and detonation resistance  
4. The cycles and test referred to under Headings  4.1-4.3 below shall be carried out on a 
representative sample of t he product at least every 3 months on behalf of the 
manufacturer, in order to verify conformity with  
(a) the oil retention requirement referred to in paragraph  4 under 
PFC 1(C)(I)(a)(i -ii)(A) in Annex  I to this Regulation, and  
(b) the detonation resistance requi rement referred to in paragraph  5 under 
PFC 1(C)(I)(a)(i -ii)(A) in Annex  I to this Regulation.  
The tests shall be carried out under the responsibility of a notified body chosen by 
the manufacturer.  
4.1. Thermal cycles prior to a test for compliance with the oil retention requirement 
referred to in paragraph  4 under PFC  1(C)(I)(a)(i -ii)(A) in Annex  I 
4.1.1.  Principle and definition  
4.1.1.  In an Erlenmeyer flask, heat the sample from ambient temperature to 50°C and 
maintain at this temperature for a period of two hours (phase at 50°C). Thereupon 
cool the sample until a temperature of 25°C is achieved and maintain at that 
temperature for two hours (phase at  25°C). The combination of the successive phases 
at 50°C and 25°C forms one thermal cycle. After being subjected to two thermal  
EN 53   EN cycles, the test sample is held at a temperature of  20 (±3)°C for the determination of 
the oil retention value.  
4.1.2.  Apparatus  
4.1.2.  Normal laboratory apparatus, in particular:  
(a) water baths thermostated at 25 (  1) and 50 (  1)°C respectively,  
(b) Erlenmeyer flasks with an individual capacity of 150  ml. 
4.1.3.  Procedure  
4.1.3.1.  Put each test sample of 70 (  5) grams into an Erlenmeyer flask which is then sealed 
with a stopper.  
4.1.3. 2. Move each flask every two hours from the 50°C bath to the 25°C bath and vice 
versa.  
4.1.3.3.  Maintain the water in each bath at constant temperature and keep in motion by rapid 
stirring to ensure the water level comes above the level of the sample. Prot ect the 
stopper from condensation by a foam rubber cap.  
4.2. Thermal cycles prior to the detonation resistance test referred to in paragraph 5 
under PFC  1(C)(I)(a)(i -ii)(A)  in Annex I  
4.2.1.  Principle and definition  
4.2.1.  In a watertight box heat the samp le from ambient temperature to 50°C and maintain 
at this temperature for a period of one hour (phase at 50°C). Thereupon cool the 
sample until a temperature of 25°C is achieved and maintain at that temperature for 
one hour (phase at 25°C). The combination of the successive phases at 50°C and 
25°C forms one thermal cycle. After being subjected to the required number of 
thermal cycles, the test sample is held at a temperature of 20 (±3)°C pending the 
execution of the detonability test.  
4.2.2.  Apparatus  
(a) A wate r bath, thermostated in a temperature range of 20 to 51°C with a 
minimum heating and cooling rate of 10°C/h, or two water baths, one 
thermostated at a temperature of 20°C, the other at 51°C. The water in the 
bath(s) is continuously stirred; the volume of t he bath shall be large enough to 
guarantee ample circulation of the water.  
(b) A stainless steel box, watertight all around and provided with a thermocouple 
in the centre. The outside width of the box is 45 (  2) mm and the wall 
thickness is 1,5  mm (see Figure  1). The height and length of the box can be 
chosen to suit the dimensions of the water bath, e.g. length 600  mm, height 
400 mm. 
4.2.3.  Procedure  
4.2.3.  Place a quantity of fertilisers sufficient for a single detonation into the box and close 
the cover.  P lace the box in the water bath. Heat the water to 51°C and measure the 
temperature in the centre of the fertiliser. One hour after the temperature at the centre 
has reached 50°C cool the water. One hour after the temperature at the centre has 
reached 25°C heat the water to start the second cycle. In the case of two water baths, 
transfer the box to the other bath after each heating/cooling period.   
EN 54   EN Figure 1  
 
4.3. Detonation resistance test referred to in paragraph 5 under PFC  1(C)(I)(a)(i -ii)(A)  
in Annex I  
4.3.1.  Description  
4.3.1.1  The test shall be carried out on a representative sample of the CE marked fertilising 
product. Before being tested for resistance to detonation, the whole mass of the 
sample is to be thermally cycled five times complying with the  provisions under 
heading  4.2 above.  
4.3.1.2.  The CE marked fertilising product shall be subjected to the test of resistance to 
detonation in a horizontal steel tube under the following conditions:  
(a) seamless steel tube,  
(b) Tube length: 1  000 mm at least,  
(c) Nomin al external diameter: 114  mm at least,  
(d) Nominal wall thickness: 5  mm at least,  
(e) Booster: the type and mass of the booster chosen shall be such as to maximise 
the detonation pressure applied to the sample in order to determine its 
susceptibility to the transm ission of detonation,  
(f) Test temperature: 15 -25°C,  
(g) Witness lead cylinders for detecting detonation: 50  mm diameter and 100  mm 
high 
(h) placed at 150  mm intervals and supporting the tube horizontally. The test is to 
be carried out twice. The test is deemed conclu sive if in both tests one or more 
of the supporting lead cylinders is crushed by less than 5%.  
 
EN 55   EN 4.3.2.  Principle  
4.3.2.  The test sample is confined in a steel tube and subjected to detonation shock from an 
explosive booster charge. Propagation of the detonation is determined from the 
degree of crushing of lead cylinders on which the tube rests horizontally during the 
test. 
4.3.3.  Materials  
(a) Plastic explosive containing 83 to 86% penthrite  
 Density: 1  500 to 1  600 kg/m3  
 Detonation velocity: 7  300 to 7  700 m/s 
 Mass: 500 (  1) gram.  
(b) Seven lengths of flexible detonating cord with non -metallic sleeve  
 Filling mass: 11 to 13  g/m 
 Length of each cord: 400 (  2) mm. 
(c) Compressed pellet of secondary explosive, recessed to receive detonator  
 Explosive: hexogen/wax 95/5  or tetryl or similar secondary explosive, 
with or without added graphite.  
 Density: 1  500 to 1  600 kg/m3 
 Diameter: 19 to 21  mm 
 Height: 19 to 23  mm 
 Central recess to receive detonator: diameter 7 to 7,3  mm, depth 12  mm. 
(d) Seamless steel tube as specified in ISO 65 – 1981 – Heavy Series, with 
nominal dimensions DN 100 (4'')  
 Outside diameter: 113,1 to 115,0  mm 
 Wall thickness: 5,0 to 6,5  mm 
 Length: 1 005 (  2) mm. 
(e) Bottom place  
 Material: steel of good weldable quality  
 Dimensions: 160  160 mm 
 Thickness: 5 to 6  mm. 
(f) Six lead cylinders  
 Diameter: 50 (  1) mm 
 Height: 100 to 101  mm 
 Materials: soft lead, at least 99,5% purity.  
(g) Steel block  
 Length: at least 1  000 mm 
 Width: at least 150  mm  
EN 56   EN  Height: at least 150  mm 
 Mass: at least 300  kg if there is no firm base for the steel block.  
(h) Plastic or cardboard cylinder for booster charge  
 Wall thickness: 1,5 to 2,5  mm 
 Diameter: 92 to 96  mm 
 Height: 64 to 67  mm. 
(i) Detonator (electric or non -electric) with initiation force 8 to 10  
(j) Wooden disc  
 Diameter: 92 to 96  mm.  Diameter to be matched to the internal diameter 
of the plastic or cardboard cylinder (point (h) above)  
 Thickness: 20  mm. 
(k) Wooden rod of same dimensions as detonator (point (i) above)  
(l) Dressmaking pins (maximum length 20  mm)  
4.3.4.  Procedure  
4.3.4.1.  Preparation of booster charge for insertion into steel tube  
4.3.4.1.  Depending on the availability of equipment, the explosive can be initiated in the 
booster charge either  
 by seven -point simultaneous initiation as referred to under Heading  4.3.4.1.1. 
below, or  
 by central initiation b y a compressed pellet as referred to under 
Heading   4.3.4.1.2. below.  
4.3.4.1.1.  Seven -point simultaneous initiation  
4.3.4.1.1.  The booster charge prepared for use is shown in Figure 2 below.  
4.3.4.1.1.1.  Drill holes in the wooden disc (point  (j) under Hea ding 4.3.3. above) parallel to 
the axis of the disc through the centre and through six points symmetrically 
distributed around a concentric circle 55  mm in diameter. The diameter of the holes 
shall be 6 to 7  mm (see Section A -B in Figure 2), depending on t he diameter of the 
detonating cord used (point  (b) under Heading 4.3.3. above).  
4.3.4.1.1.2.  Cut seven lengths of flexible detonating cord (point  (b) under Heading 4.3.3. 
above) each 400  mm long, avoiding any loss of explosive at each end by making a 
clean  cut and immediately sealing the end with adhesive. Push each of the seven 
lengths through each of the seven holes in the wooden disc (point  (j) under Heading 
4.3.3. above) until their ends project a few  centimetres on the other side of the disc. 
Then inse rt a small dressmaking pin (point  (l) under Heading 4.3.3. above) 
transversally into the textile sleeve of each length of cord 5 to 6  mm from the end 
and apply adhesive around the outside of the lengths of cord in a band 2  cm wide 
adjacent to the pin. Fina lly, pull the long piece of each cord to bring the pin into 
contact with the wooden disc.  
4.3.4.1.1.3.  Shape the plastic explosive (point (a) under Heading 4.3.3. above) to form a 
cylinder 92 to 96  mm in diameter, depending on the diameter of the cylinder 
(point  (h) under Heading 4.3.3. above). Stand this cylinder upright on a level surface  
EN 57   EN and insert the shaped explosive. Then insert the wooden disc  17 carrying the seven 
lengths of detonating cord into the top of the cylinder and press it down onto the 
explosive. Adjust the height of the cylinder (64 to 67  mm) so that its top edge does 
not extend beyond the level of the wood. Finally, fix the cylinder to the wooden disc 
for instance with staples or small nails, around its entire circumference.  
4.3.4.1.1.4.  Group the free ends of the seven lengths of detonating cord around the 
circumference of the wooden rod (point (k) under Heading 4.3.3. above) so that their 
ends are all level in a plane perpendicular to the rod. Secure them in a bundle around 
the rod by mea ns of adhesive tape18. 
4.3.4.1.2.  Central initiation by a compressed pellet  
4.3.4.1.2.  The booster charge prepared for use is shown in Figure 3.  
4.3.4.1.2.1.  Preparing a compressed pellet  
4.3.4.1.2.1.  Taking the necessary safety precautions, place 10  grams of a secondary 
explosive  (point (c) under Heading 4.3.3. above) in a mould with an inside diameter 
of 19 to 21  mm and compress to the correct shape and density. (The ratio of 
diameter: height should be roughly 1:1). In the centre of the bottom of the mould  
there is a peg, 12  mm in height and 7,0 to 7,3  mm in diameter (depending on the 
diameter of the detonator used), which forms a cylindrical recess in the compressed 
cartridge for subsequent insertion of the detonator.  
4.3.4.1.2.2.  Preparing the booster cha rge 
4.3.4.1.2.2.  Place the explosive (point (a) under Heading 4.3.3. above) into the cylinder 
(point (h) under Heading 4.3.3. above) standing upright on a level surface, then press 
it down with a wooden die to give the explosive a cylindrical shape with a central 
recess. Insert the compressed pellet into this recess. Cover the cylindrically shaped 
explosive containing the compressed pellet with a wooden disc (point (j) under 
Heading 4.3.3. above) having a central hole 7,0 to 7,3  mm in diameter for insertion  
of a detonator. Fix the wooden disc and the cylinder together with a cross of adhesive 
tape. Ensure that the hole drilled in the disc and the recess in the compressed pellet 
are coaxial by inserting the wooden rod (point (k) under Heading 4.3.3. above).  
4.3.4.2.  Preparing steel tubes for the detonation tests  
4.3.4.2.  At one end of the steel tube (point (d) under Heading 4.3.3. above), drill two 
diametrically opposed holes 4  mm in diameter perpendicularly through the side wall 
at a distance of 4  mm from the  edge. Butt weld the bottom plate (point (e) under 
Heading  4.3.3. above) to the opposite end of the tube, completely filling the right 
angle between the bottom place and the wall of the tube with weld metal around the 
entire circumference of the tube.  
4.3.4.3. Filling and charging the steel tube  
4.3.4.3.  See Figures 2 and 3.  
4.3.4.3.1.  The test sample, the steel tube and the booster charge shall be conditioned to 
temperatures of 20 (  5)°C. 16 to 18  kg of the test sample are needed for two 
detonation tests.  
                                                 
17 The diameter of the disc must always correspond to the inside diameter of the cylinder.  
18 NB: When the six peripheral lengths of cord are taut after assembly, the central cord must remain 
slightly slack.   
EN 58   EN 4.3.4.3.2.1  Place the tube upright with its square bottom place resting on a firm, flat 
surface, preferably concrete. Fill the tube to about one -third of its height with the test 
sample and drop it 10  cm vertically onto the floor five times to compact the  prills or 
granules as densely as possible in the tube. To accelerate compaction, vibrate the 
tube by striking the side wall with a 750 to 1  000-gram hammer between drops for a 
total of 10 times.  
4.3.4.3.2.2.  Repeat this charging method with another portio n of the test sample. Finally, a 
further addition shall be made such that, after compaction by raising and dropping 
the tube 10  times and a total of 20 intermittent hammer blows, the charge fills the 
tube to a distance of 70  mm from its orifice.  
4.3.4.3.2. 3 The filling height of the sample shall be adjusted in the steel tube so that the 
booster charge (referred to above under Heading  4.3.4.1.1. or 4.3.4.1.2.) to be 
inserted later will be in close contact with the sample over its entire surface.  
4.3.4.3.3.  Insert the booster charge into the tube so that it is in contact with the sample; 
the top surface of the wooden disc shall be 6  mm below the end of the tube. Ensure 
essential close contact between explosive and test sample by adding or removing 
small quanti ties of sample. As shown in Figures 2 and 3, split pins should be inserted 
through the holes near the open end of the tube and their legs opened flat against the 
tube.  
4.3.4.4.  Positioning of the steel tube and lead cylinders (see figure 4)  
4.3.4.4.1.  Number the bases of the lead cylinders (point (f) under Heading 4.3.3. above) 
1 to 6.  Make six marks 150  mm apart on the centre line of a steel block (4.3.7) lying 
on a horizontal base, with the first mark at least 75  mm from the edge of the block.  
Place  a lead cylinder upright on each of these marks, with the base of each cylinder 
centred on its mark.  
4.3.4.4.2.  Lay the steel tube prepared according to 4.3.4.3. horizontally on the lead 
cylinders so that the axis of the tube is parallel to the centre line  of the steel block 
and the welded end of the tube extends 50  mm beyond lead cylinder No  6. To 
prevent the tube from rolling, insert small wooden wedges between the tops of the 
lead cylinders and the tube wall (one on each side) or place a cross of wood be tween 
the tube and the steel block.  
Note:  Make sure that the tube is in contact with all six lead cylinders; a slight 
curvature of the tube surface can be compensated for by rotating the tube about its 
longitudinal axis; if any of the lead cylinders is too  tall, tap the cylinder in question 
carefully with a hammer until it is the required height.  
4.3.4.5.  Preparation for detonation  
4.3.4.5.1.  Set up the apparatus as described under Heading  4.3.4.4. in a bunker or 
suitably prepared underground site (e.g. min e or tunnel). Ensure that the temperature 
of the steel tube is kept at  20 ( 5)°C before detonation.  
Note : Should such firing sites not be available, the work can, if necessary, be done in a 
concrete -lined pit covered over with wooden beams. Detonation can  cause steel 
fragments to be projected with high kinetic energy, therefore, firing shall be carried 
out at a suitable distance from dwellings or thoroughfares.  
4.3.4.5.2.  If the booster charge with seven -point initiation is used, ensure that the 
detonation  cords are stretched out as described in the footnote to 
paragraph  4.3.4.1.1.4 above and arranged as horizontally as possible.   
EN 59   EN 4.3.4.5.3.  Finally, remove the wooden rod and replace with the detonator. Do not carry 
out firing until the danger zone has been evacuated and the test personnel have taken 
cover.  
4.3.4.5.4.  Detonate the explosive.  
4.3.4.6.1  Allow sufficient time for the fumes (gaseous and sometimes toxic decomposition 
products such as nitrous gases) to disperse, then collect the lead cylinders and 
measure their heights with a Vernier caliper  
4.3.4.6.2.  Record for each of the marked lead cylinders, the degree of crushing expressed 
as a percentage of the original height of 100  mm. If the cylinders are crushed 
obliquely, record the highest and the lowe st values and calculate the average.  
4.3.4.7.  A probe for continuous measurement of the detonation velocity can be used; the 
probe should be inserted longitudinally to the axis of the tube or along its side wall.  
4.3.4.8.  Two detonation tests per sample ar e to be carried out.  
4.3.5.  Test report  
4.3.5.  Values for the following parameters are to be given in the test report for each of the 
detonation tests:  
 the values actually measures for the outside diameter of the steel tube and for 
the wall thickness,  
 the Brinell hardness of the steel tube,  
 the temperature of the tube and the sample shortly before firing,  
 the packing density (kg/m3) of the sample in the steel tube,  
 the height of each lead cylinder after firing, specifying the corresponding 
cylinder number,  
 method of initiation employed for the booster charge.  
4.3.5.1.  Evaluation of test results  
4.3.5.1.  If, in each firing, the crushing of at least one lead cylinder is less than 5%, the test 
shall be considered conclusive.   
EN 60   EN Figure 2  
 
 
EN 61   EN Figure 3  
 
 
EN 62   EN Figure 4  
 
5. Conformity marking and EU declaration of conformity  
5.1. The manufacturer shall affix the CE mark to each individual fertilising product that 
satisfies the applicable requirements of this Regulation.  
5.2. The manufacturer shall draw up a written EU declara tion of conformity for each CE 
marked fertilising product lot and keep it together with the technical documentation 
at the disposal of the national authorities for 10 years after the CE marked fertilising 
product has been placed on the market. The EU decla ration of conformity shall 
identify such CE marked fertilising product for which it has been drawn up.  
 
EN 63   EN 6. Authorised representative  
6. The manufacturer's obligations set out under Heading  5 above may be fulfilled by his 
or her authorised representative, on  his or her behalf and under his or her 
responsibility, provided that they are specified in the mandate.  
MODULE B – EU-TYPE EXAMINATION  
1. EU-type examination is the part of a conformity assessment procedure in which a 
notified body examines the technical design of a CE marked fertilising product and 
verifies and attests that the technical design of the CE marked fertilising product 
meets the requirements of this Regulation.  
2. Assessment of the adequacy of the technical design of the CE marked fertilising 
product may be carried out through examination of the technical documentation and 
supporting evidence referred to in paragraph  3.2 below, plus examination of 
specimens, representative of the production envisaged, of one or more critical 
components of the p roduct (combination of production type and design type).  
3.1. The manufacturer shall lodge an application for EU -type examination with a single 
notified body of his or her choice.  
3.2. The application shall include:  
(a) the name and address of the manufacturer  and, if the application is lodged by 
the authorised representative, his or her name and address as well,  
(b) a written declaration that the same application has not been lodged with any 
other notified body,  
(c) the technical documentation. The technical documenta tion shall make it 
possible to assess the CE marked fertilising product's conformity with the 
applicable requirements of this Regulation and shall include an adequate 
analysis and assessment of the risk(s). The technical documentation shall 
specify the app licable requirements and cover, as far as relevant for the 
assessment, the design, manufacture and use of the CE marked fertilising 
product. The technical documentation shall contain, wherever applicable, at 
least the following elements:  
 a general descript ion of the CE marked fertilising product,  
 conceptual design and manufacturing drawings and schemes  
 descriptions and explanations necessary for the understanding of those 
drawings and schemes and the use of the CE marked fertilising product,  
 a list of the harmonised standards applied in full or in part the references 
of which have been published in the Official Journal of the European 
Union  and, where those harmonised standards have not been applied, 
descriptions of the solutions adopted to me et the essential requirements 
of this Regulation, including a list of common specifications or other 
relevant technical specifications applied. In the event of partly applied 
harmonised standards, the technical documentation shall specify the parts 
which h ave been applied,  
 results of design calculations made, examinations carried out, etc., 
 test reports, and   
EN 64   EN  where the product contains or consists of animal by -products within the 
meaning of Regulation  (EC) No  1069/2009, the commercial documents 
or health cer tificates required pursuant to that Regulation, and evidence 
that the animal by -products have reached the end point in the 
manufacturing chain within the meaning of that Regulation;  
(d) the specimens representative of the production envisaged. The notified bod y 
may request further specimens if needed for carrying out the test programme;  
(e) the supporting evidence for the adequacy of the technical design solution. This 
supporting evidence shall mention any documents that have been used, in 
particular where the rele vant harmonised standards have not been applied in 
full. The supporting evidence shall include, where necessary, the results of tests 
carried out in accordance with other relevant technical specifications by the 
appropriate laboratory of the manufacturer, or by another testing laboratory on 
his or her behalf and under his or her responsibility.  
4. The notified body shall:  
(a) For the CE marked fertilising product:  
(1) examine the technical documentation and supporting evidence to assess 
the adequacy of the technica l design of the CE marked fertilising 
product;  
(b) For the specimen(s):  
(2) verify that the specimen(s) have been manufactured in conformity with 
the technical documentation, and identify the elements which have been 
designed in accordance with the applicable prov isions of the relevant 
harmonised standards and/or technical specifications, as well as the 
elements which have been designed in accordance with other relevant 
technical specifications;  
(3) carry out appropriate examinations and tests, or have them carried out , to 
check whether, where the manufacturer has chosen to apply the solutions 
in the relevant harmonised standards and/or technical specifications, 
these have been applied correctly;  
(4) carry out appropriate examinations and tests, or have them carried out, to  
check whether, where the solutions in the relevant harmonised standards 
and/or technical specifications have not been applied, the solutions 
adopted by the manufacturer meet the corresponding essential 
requirements of this Regulation;  
(5) agree with the manuf acturer on a location where the examinations and 
tests will be carried out.  
5. The notified body shall draw up an evaluation report that records the activities 
undertaken in accordance with point 4 and their outcomes. Without prejudice to its 
obligations vis-à-vis the notifying authorities, the notified body shall release the 
content of that report, in full or in part, only with the agreement of the manufacturer.  
6.1. Where the type meets the requirements of this Regulation that apply to the CE 
marked fertilising product concerned, the notified body shall issue an EU -type 
examination certificate to the manufacturer. The certificate shall contain the name 
and address of the manufacturer, the conclusions of the examination, the conditions  
EN 65   EN (if any) for its validity and the necessary data for identification of the approved type. 
The certificate may have one or more annexes attached.  
6.2. The certificate and its annexes shal l contain all relevant information to allow the 
conformity of manufactured CE marked fertilising products with the examined type 
to be evaluated and to allow for further in -service control.  
6.3. Where the type does not satisfy the requirements of this Regu lation, the notified 
body shall refuse to issue an EU -type examination certificate and shall inform the 
applicant accordingly, giving detailed reasons for its refusal.  
7.1. The notified body shall keep itself apprised of any changes in the generally 
acknow ledged state of the art which indicate that the approved type may no longer 
comply with the requirements of this Regulation and shall determine whether such 
changes require further investigation. If so, the notified body shall inform the 
manufacturer accor dingly.  
7.2. The manufacturer shall inform the notified body that holds the technical 
documentation relating to the EU -type examination certificate of all modifications to 
the approved type that may affect the conformity of the CE marked fertilising 
produc t with the requirements of this Regulation or the conditions for validity of the 
certificate. Such modifications shall require additional approval in the form of an 
addition to the original EU -type examination certificate.  
8.1. Each notified body shall inf orm its notifying authority concerning the EU -type 
examination certificates and/or any additions thereto which it has issued or 
withdrawn, and shall, periodically or upon request, make available to its notifying 
authorities the list of certificates and/or any additions thereto refused, suspended or 
otherwise restricted.  
8.2. Each notified body shall inform the other notified bodies concerning the EU -type 
examination certificates and/or any additions thereto which it has refused, 
withdrawn, suspended or othe rwise restricted, and, upon request, concerning the 
certificates and/or additions thereto which it has issued.  
8.3. The Commission, the Member States and the other notified bodies may, on request, 
obtain a copy of the EU -type examination certificates and/o r additions thereto. On 
request, the Commission and the Member States may obtain a copy of the technical 
documentation and the results of the examinations carried out by the notified body.  
8.4. The notified body shall keep a copy of the EU -type examinatio n certificate, its 
annexes and additions, as well as the technical file including the documentation 
submitted by the manufacturer, until the expiry of the validity of the certificate.  
9. The manufacturer shall keep a copy of the EU -type examination certifi cate, its 
annexes and additions together with the technical documentation at the disposal of 
the national authorities for 10 years after the CE marked fertilising product has been 
placed on the market.  
10. The manufacturer's authorised representative may lodge the application referred to in 
point 3 and fulfil the obligations set out in points 7 and 9, provided that they are 
specified in the mandate.   
EN 66   EN MODULE C – CONFORMITY TO TYPE BA SED ON INTERNAL PROD UCTION CONTROL  
1. Description of the module  
1. Conformity to type based on internal production control is the part of a conformity 
assessment procedure whereby the manufacturer fulfils the obligations laid down in 
points 2 and 3, and ensures and declares that the CE marked fertilising products 
concerne d are in conformity with the type described in the EU -type examination 
certificate and satisfy the requirements of this Regulation that apply to them.  
2. Manufacturing  
2. The manufacturer shall take all measures necessary so that the manufacturing process 
and its monitoring ensure conformity of the manufactured CE marked fertilising 
products with the approved type described in the EU -type examination certificate and 
with the requirements of this Regulation that apply to them.  
3. Conformity marking and EU de claration of conformity  
3.1 The manufacturer shall affix the CE marking to each individual fertilising product 
that is in conformity with the type described in the EU -type examination certificate 
and satisfies the requirements of this Regulation.  
3.2 The m anufacturer shall draw up a written EU declaration of conformity for a CE 
marked fertilising product lot and keep it at the disposal of the national authorities 
for 10 years after the CE marked fertilising product has been placed on the market. 
The EU decl aration of conformity shall identify the CE marked fertilising product lot 
for which it has been drawn up.  
3.3. A copy of the EU declaration of conformity shall be made available to the relevant 
authorities upon request.  
4. Authorised representative  
4. The manufacturer's obligations set out in point 3 may be fulfilled by his or her 
authorised representative, on his or her behalf and under his or her responsibility, 
provided that they are specified in the mandate.  
MODULE D1:  QUALITY ASSURANCE OF THE PRODUCTI ON PROCESS  
1. Description of the module  
1. Quality assurance of the production process is the conformity assessment procedure 
whereby the manufacturer of the CE marked fertilising product fulfils the obligations 
laid down under Headings 2, 4, and 7, and ensur es and declares on his or her sole 
responsibility that the CE marked fertilising products concerned satisfy the 
requirements of this Regulation that apply to them.  
2. Technical documentation  
2. The manufacturer of the CE marked fertilising product shall estab lish the technical 
documentation. The documentation shall make it possible to assess the product's 
conformity with the relevant requirements, and shall include an adequate analysis 
and assessment of the risk(s). The technical documentation shall specify th e 
applicable requirements and cover, as far as relevant for the assessment, the design, 
manufacture and use of the product. The technical documentation shall, wherever 
applicable, contain at least the following elements:  
(a) a general description of the produc t,  
EN 67   EN (b) conceptual design and manufacturing drawings and schemes, including a 
written description and a diagram of the production process, where each 
treatment, storage vessel and area is clearly identified,  
(c) descriptions and explanations necessary for the under standing of those 
drawings and schemes and of the use of the CE marked fertilising product,  
(d) a list of the harmonised standards applied in full or in part the references of 
which have been published in the Official Journal of the European Union  and, 
where t hose harmonised standards have not been applied, descriptions of the 
solutions adopted to meet the essential requirements of this Regulation, 
including a list of common specifications or other relevant technical 
specifications applied. In the event of part ly applied harmonised standards, the 
technical documentation shall specify the parts which have been applied,  
(e) results of design calculations made, examinations carried out, etc., 
(f) test reports, and  
(g) where the product contains or consists of animal by -product s within the 
meaning of Regulation (EC) No 1069/2009, the commercial documents or 
health certificates required pursuant to that Regulation, and evidence that the 
animal by -products have reached the end point in the manufacturing chain 
within the meaning of  that Regulation.  
3. Availability of technical documentation  
3. The manufacturer shall keep the technical documentation at the disposal of the 
relevant national authorities for 10 years after the CE marked fertilising product has 
been placed on the market.  
4. Manufacturing  
4. The manufacturer shall operate an approved quality system for production, final 
product inspection and testing of the products concerned as specified in point 5, and 
shall be subject to surveillance as specified in point 6.  
5. Quality system  
5.1. The manufacturer shall implement a quality system which shall ensure compliance of 
the CE marked fertilising product with the requirements of this Regulation that apply 
to them.  
5.1.1.  The quality system shall include quality objectives and an organisational structure 
with responsibilities and powers of the management with regard to product quality.  
5.1.1.1.  For compost belonging to component material category ('CMC')  3 and digestate 
belonging to CMC  5, as defined in Annex  II, senior management of the 
manufacturer's organisation shall:  
(a) Ensure that sufficient resources (people, infrastructure, equipment) are 
available to create and implement the quality system;  
(b) Appoint a member of the org anisation’s management who shall be responsible 
for: 
 Ensuring that quality management processes are established, approved, 
implemented and maintained;   
EN 68   EN  Reporting to senior management of the manufacturer on the performance 
of the quality management and any n eed for improvement;  
 Ensuring the promotion of awareness of customer needs and legal 
requirements throughout the manufacturer's organisation, and for making 
the personnel aware of the relevance and importance of the quality 
management requirements to meet the legal requirements of this 
Regulation;  
 Ensuring that each person whose duties affect the product quality is 
sufficiently trained and instructed; and  
 Ensuring the classification of the quality management documents 
mentioned under paragraph 5.1.4. below;  
(c) Conduct an internal audit every year, or sooner than scheduled if triggered by 
any significant change that may affect the quality of the CE marked fertilising 
product; and  
(d) Ensure that appropriate communication processes are established within and 
outside the organisation and that communication take place regarding the 
effectiveness of the quality management.  
5.1.2.  The quality system shall be implemented through manufacturing, quality control and 
quality assurance techniques, processes and systematic actio ns. 
5.1.2.1.  For compost belonging to component material category ('CMC') 3 and digestate 
belonging to CMC 5, as defined in Annex II, the system shall ensure compliance 
with the composting and digestion process criteria specified in that Annex.  
5.1.3.  The quality system shall comprise examinations and tests to be carried out before, 
during and after manufacture with a specified frequency.  
5.1.3.1.  For compost belonging to CMC  3 and digestate belonging to CMC  5, as defined in 
Annex  II, the examinations and tests shall comprise the following elements:  
(a) The following information shall be recorded for each lot of input materials:  
(1) Date delivered;  
(2) Amount by weight (or estimation based on the volume and density);  
(3) Identity of the input material supplier;  
(4) Input material type;  
(5) Identification of each lot and delivery location on site. A unique 
identification code shall be assigned throughout the production process 
for quality management purposes; and  
(6) In case of refusal, the reasons for the rejection of the lot and where it was 
sent. 
(b) Qualified staff shall carry out a visual inspection of each consignment of input 
materials and verify compatibility with the specifications of input materials in 
CMC  3 and CMC  5 in Annex II.   
EN 69   EN (c) The manufacturer shall refuse any consignment of any given input material 
where visual inspection raises any suspicion of  
 the presence of hazardous or damageable substances for the composting 
or digestion process or for the quality of the final CE marked fertilising 
product, or of  
 incompatibility wi th the specifications of CMC  3 and CMC  5 in 
Annex  II, in particular by presence of plastics leading to excedence of the 
limit value for macroscopic impurities.  
(d) The staff shall be trained on  
 potential hazardous properties that may be associated with input 
materials, and  
 features that allow hazardous properties and the presence of plastics to be 
recognised.  
(e) Samples shall be taken on output materials, to verify that they comply with the 
component material specifications for compost and digestate laid down in  
CMC  3 and CMC  5 in Annex II, and that the properties of the output material 
does not jeopardise the CE marked fertilising product's compliance with the 
relevant requirements in Annex  I. 
(f) The output material samples shall be taken with at least the followin g 
frequency:  
Annual input  
(tonnes)  Samples / year  
≤ 3000  1 
3001 – 10000  2 
10001 – 20000  3 
20001 – 40000  4 
40001 – 60000  5 
60001 – 80000  6 
80001 – 100000  7 
100001 – 120000  8 
120001 – 140000  9 
140001 – 160000  10 
160001 – 180000  11 
> 180000  12 
(g) If any tested output material sample fails one or more of the applicable limits 
specified in the relevant sections of Annexes I and II to this Regulation, the  
EN 70   EN person responsible for quality management referred to above in point 5.1.1.1(b) 
shall:  
(1) Clearly iden tify the non -conforming products and their storage place,  
(2) Analyse the reasons of the non -conformity and take any necessary action 
to avoid its repetition,  
(3) Record in the quality records referred to in paragraph 5.1.4 if 
reprocessing takes place, or if the p roduct is eliminated.  
5.1.4.  The manufacturer shall maintain the quality records, such as inspection reports and 
test data, calibration data, qualification reports on the personnel concerned, etc.,  
5.1.4.1.  For compost belonging to component material cate gory ('CMC')  3 and digestate 
belonging to CMC  5, as defined in Annex  II, the quality records shall demonstrate 
effective control of input materials, production, storage and compliance of input - and 
output materials with the relevant requirements of this Re gulation. Each document 
shall be legible and available at its relevant place(s) of use, and any obsolete version 
shall be promptly removed from all places where it is used, or at least identified as 
obsolete. The quality management documentation shall at l east contain the following 
information:  
(a) A title,  
(b) A version number,  
(c) A date of issue,  
(d) The name of the person who issued it,  
(e) Records about the effective control of input materials,  
(f) Records about the effective control of the production process,  
(g) Records about the effective control of the output materials,  
(h) Records of non -conformities,  
(i) Reports on all accidents and incidents that occur to the site, their known or 
suspected causes and actions taken,  
(j) Records of the complaints expressed by third parties and how they have been 
addressed,  
(k) A record of the date, type and topic of training followed by the persons 
responsible for the quality of the product,  
(l) Results of internal audit and actions taken, and  
(m) Results of external audit review and actions taken.  
5.1.5  The achieve ment of the required product quality and the effective operation of the 
quality system shall be monitored.  
5.1.5.1.  For compost belonging to component material category ('CMC')  3 and digestate 
belonging to CMC  5, as defined in Annex  II, the manufacturer sh all establish an 
annual internal audit program in order to verify the compliance to the quality system, 
with the following components:  
(1) A procedure that defines the responsibilities and requirements for planning and 
conducting internal audits, establishing  records and reporting results shall be  
EN 71   EN established and documented. A report identifying the non -conformities to the 
quality scheme shall be prepared and all corrective actions shall be reported. 
The records of the internal audit shall be annexed to the qu ality management  
documentation.  
(2) Priority shall be given to non -conformities identified by external audits.  
(3) Each auditor shall not audit his or her own work.  
(4) The management responsible for the area audited shall ensure that the 
necessary corrective actions  are taken without undue delay.  
(5) Internal audit realised in the frame of another quality management system can 
be taken into account provided that it is completed by an audit of the 
requirements to this quality system.  
5.2. The manufacturer shall lodge an application for assessment of his or her quality 
system with the accredited notified body of his or her choice, for the products 
concerned. The application shall include:  
- the name and address of the manufacturer and, if the application is lodged by 
the a uthorised representative, his or her name and address as well,  
- a written declaration that the same application has not been lodged with any 
other notified body,  
- all relevant information for the product category envisaged,  
- the documentation concerning  the quality system,  
- technical documentation of all the quality system elements set out in 
paragraphs  5.1 and subparagraphs.  
5.3. All the elements, requirements and provisions adopted by the manufacturer shall be 
documented in a systematic and orderly m anner in the form of written policies, 
procedures and instructions. The quality system documentation shall permit a 
consistent interpretation of the quality programmes, plans, manuals and records. It 
shall, in particular, contain an adequate description of  all the quality management 
elements mentioned above in paragraph  5.1 and subparagraphs.  
5.4.1.  The notified body shall assess the quality system to determine whether it satisfies the 
requirements referred to in paragraph  5.1 and subparagraphs.  
5.4.2.  It shall presume conformity with those requirements in respect of the elements of the 
quality system that comply with the corresponding specifications of the relevant 
harmonised standard.  
5.4.3.  In addition to experience in quality management systems, the audi ting team shall 
have at least one member with experience of evaluation in the relevant product field 
and product technology concerned, and knowledge of the applicable requirements of 
this Regulation. The audit shall include an assessment visit to the manuf acturer's 
premises. The auditing team shall review the technical documentation referred to in 
point 2 in order to verify the manufacturer's ability to identify the relevant 
requirements of this Regulation and to carry out the necessary examinations with a 
view to ensuring compliance of the CE marked fertilising product with those 
requirements.  
5.4.4.  The decision shall be notified to the manufacturer. The notification shall contain the 
conclusions of the audit and the reasoned assessment decision.   
EN 72   EN 5.5. The manufacturer shall undertake to fulfil the obligations arising out of the quality 
system as approved and to maintain it so that it remains adequate and efficient  
5.6.1.  The manufacturer shall keep the notified body that has approved the quality system 
informed of any intended change to the quality system.  
5.6.2.  The notified body shall evaluate any proposed changes and decide whether the 
modified quality system will continue to satisfy the requirements referred to in point 
5.2 or whether reassessment is ne cessary.  
5.6.3.  It shall notify the manufacturer of its decision. The notification shall contain the 
conclusions of the examination and the reasoned assessment decision.  
6. Surveillance under the responsibility of the notified body  
6.1 The purpose of surve illance is to make sure that the manufacturer duly fulfils the 
obligations arising out of the approved quality system.  
6.2. The manufacturer shall, for assessment purposes, allow the notified body access to 
the manufacture, inspection, testing and storage sites and shall provide it with all 
necessary information, in particular:  
- the quality system documentation,  
- the technical documentation referred to in paragraph 2,  
- the quality records, such as inspection reports and test data, calibration data, 
quali fication reports on the personnel concerned.  
6.3.1  The notified body shall carry out periodic audits to make sure that the manufacturer 
maintains and applies the quality system and shall provide the manufacturer with an 
audit report.  
6.3.2  For compost belonging to component material category ('CMC') 3 and digestate 
belonging to CMC 5, as defined in Annex II, the notified body shall take and analyse 
output material samples during each audit, and the audits shall be carried out with the 
following frequenc y: 
(a) During the notified body's first year of surveillance of the plant in question: 
The same frequency as the sampling frequency indicated in the table included 
in paragraph  5.1.3.1(f); and  
(b) During the following years of surveillance: Half the sampling frequency 
indicated in the table included in paragraph  5.1.3.1(f).  
6.4 In addition, the notified body may pay unexpected visits to the manufacturer. During 
such visits the notified body may, if necessary, carry out product tests, or have them 
carried out, in order to verify that the quality system is functioning correctly. The 
notified body shall provide the manufacturer with a visit report and, if tests have 
been carried out, with a test report.  
7. Conformity marking and EU declaration of conformity  
7.1. The manufacturer shall affix the CE marking and, under the responsibility of the 
notified body referred to in paragraph  5.2, the latter's identification number to each 
individual product that satisfies the applicable requirements of this Regulation.  
7.2.1  The manufacturer shall draw up a written EU declaration of conformity for each CE 
marked fertilising product lot and keep it at the disposal of the national authorities 
for 10  years after the CE marked fertilising product has been placed on the market.  
EN 73   EN The EU declaration of conformity shall identify the product lot for which it has been 
drawn up.  
7.2.2.  A copy of the EU declaration of conformity shall be made available to the relevant 
authorities upon request.  
8. Availability of quality system documentation  
8. The manufacturer shall, for a period ending at least 10 years after the product has 
been placed on the market, keep at the disposal of the national authorities:  
- the documentation referred to in paragraph  5.3, 
- the change referred to in paragraph  5.6 and subparagraphs, as approved,  
- the decisions and reports of the notified body referred to in 
paragraph  5.6.1 -5.6.3, paragraph  6.3 and paragraph  6.4. 
9. Notified bodies' information obligation  
9.1. Each notified body shall inform its notifying authoritie s of quality system approvals 
issued or withdrawn, and shall, periodically or upon request, make available to its 
notifying authorities the list of quality system approvals refused, suspended or 
otherwise restricted.  
9.2. Each notified body shall inform th e other notified bodies of quality system approvals 
which it has refused, suspended or withdrawn, and, upon request, of quality system 
approvals which it has issued.  
10. Authorised representative  
The manufacturer's obligations set out in paragraph  3, parag raph 5.2, 
paragraphs  5.6.1 -5.6.3 , Heading  7 and Heading  8 may be fulfilled by his or her 
authorised representative, on his or her behalf and under his or her responsibility, 
provided that they are specified in the mandate.   
EN 74   EN ANNEX  V 
EU Declar ation of conformity (No XXX)19 
1. CE marked fertilising product (product -, batch -, type - or serial - number):  
2. Name and address of the manufacturer and, where applicable, its authorised 
representative:  
3. This EU declaration of conformity is issued under t he sole responsibility of the 
manufacturer.  
4. Object of the declaration (identification of product allowing traceability; it may, where 
necessary for the identification of the CE marked fertilising product, include an image):  
5. The object of the declarat ion described above is in conformity with the relevant Union 
harmonisation legislation:  
6. References to the relevant harmonised standards used or references to the other 
technical specifications in relation to which conformity is declared:  
7. Where applicable, the notified body ... (name, number) performed … (description of 
intervention) and issued the certificate:  
8.  Additional information:  
Signed for and on behalf of:  
(place and date of issue):  
(name, function) (signature):  
                                                 
19 It is optional for the manufacturer to assign a number to the EU declaration of conformity.