EUROPEAN COMMISSION

Brussels, 17.3.2016

COM(2016) 157 final

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}

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

ANNEX I
Product 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 macronutrient 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

Part II
Requirements related to Product Function Categories

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 subcategories 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 the 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 with

(a)Council Regulation (EEC) No 315/93 1 ,

(b)Regulation (EC) No 396/2005 of the European Parliament and of the Council 2 ,

(c)Regulation (EC) No 470/2009 of the European Parliament and of the Council 3 or

(d)Directive 2002/32/EC of the European Parliament and of the Council 4 ,

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 nutrients 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.

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 (C2H5N3O2)    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 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(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 (P2O5), or

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

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 product 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 (P2O5), or

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

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

a material containing

–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)(iii)(A), the CE marked fertilising product shall not contain 15,75 % or more by mass of nitrogen (N) as a result of ammonium nitrate (NH4NO3).

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 (P2O5)-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 (P2O5)-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 (P2O5),

As of [Publications office, please insert the date occurring three years after the date of application of this Regulation]: 40 mg/kg phosphorus pentoxide (P2O5), 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 (P2O5),

(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.

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 (P2O5), or

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

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 product, 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 product 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 phosphorus pentoxide (P2O5), or

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

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 (P2O5)-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 (P2O5)-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 (P2O5),

As of [Publications office, please insert the date occurring three years after the date of application of this Regulation]: 40 mg/kg phosphorus pentoxide (P2O5), 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 (P2O5),

(b)Hexavalent chromium (Cr VI)    2 mg/kg dry matter,

(c)Mercury (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 (C2H5N3O2)    12 g/kg dry matter, and

(h)Perchlorate (ClO4-)    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 nitrogen (N),

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

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

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

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

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

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

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 (P2O5),

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

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

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

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

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

PFC 1(C)(I)(a)(iii)(A): Straight or compound solid inorganic macronutrient ammonium nitrate fertiliser of high nitrogen content

1.A straight or compound solid inorganic macronutrient ammonium nitrate fertiliser of high nitrogen content shall be ammonium nitrate (NH4NO3)-based and contain 28 % or more by mass of nitrogen (N) as a result of ammonium nitrate (NH4NO3).

2.Any matter other than ammonium nitrate (NH4NO3) shall be inert towards ammonium nitrate (NH4NO3).

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 under 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 nitrogen (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 the 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

a solution means a liquid that is free of solid particles.

PFC 1(C)(I)(b)(i): Straight liquid inorganic macronutrient fertiliser

1.A straight 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 (P2O5),

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

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

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

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

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

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 (P2O5),

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

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

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

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

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

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.

3.Contaminants must not be present in the CE marked fertilising product by more than the following quantities:

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:

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 phase, 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 correcting soil acidity, and containing oxides, hydroxides, carbonates or silicates of the nutrients calcium (Ca) or magnesium (Mg).

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)    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 be 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 chromium (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

Enterococcaceae.

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.

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 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)    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 agronomic 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 mixture which delays or stops the activity of specific groups of micro-organisms or enzymes.

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 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.

PFC 5(A)(I): Nitrification inhibitor

1.A nitrification inhibitor shall inhibit the biological oxidation of ammoniacal nitrogen (NH3-N) to nitrite nitrogen (NO2-), thus slowing the formation of nitrate nitrogen (NO3-).

2.A soil-incubation test measuring the ammoniacal nitrogen (NH3-N) oxidation rate by

ammoniacal nitrogen (NH3-N) disappearance, or

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

in a soil sample where the nitrification inhibitor has been added shall show a statistical difference in ammoniacal nitrogen (NH3-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 (CH4N2O) by the urease enzyme,primarily targeted to reduce ammonia volatilisation.

2.An in-vitro measuring of the rate of hydrolysis of urea (CH4N2O) 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 substance intended to enhance nutrients' longterm 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.

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' longterm 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 characteristics of the plant:

(a)nutrient use efficiency,

(b)tolerance to abiotic stress, or

(c)crop quality traits.

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 monocytogenes 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 count 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 microbial 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 liquid 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.

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 or 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)Enterococcaceae.

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 blend

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 manner 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 labelling requirements laid down in Annex III, and assume responsibility pursuant to Article 15(4) of this Regulation 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 surveillance authorities); and

Article 9(2) (distributors' obligation to verify that the CE marked fertilising product is accompanied by the EU declaration of conformity).

ANNEX II
Component Material Categories

A CE marked fertilising product 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 substances 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 Material 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 industry 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 the component materials of which CE marked fertilising products shall solely consist.

CMC 1: Virgin material substances and mixtures

1.A CE marked fertilising product may contain substances and mixtures, other than 8  

(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

(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 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.

CMC 2: Non-processed or mechanically processed 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 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 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 Regulation (EC) No 1069/2009;

(d)Composting additives which are necessary to improve the process performance or the environmental performance of the composting process provided that

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 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

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) which

has previously been composted or digested, and

contains no more than 6 mg/kg dry matter of PAH16 10 .

2.The composting 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 aerobic composting shall consist in controlled decomposition of biodegradable materials, which is predominantly aerobic and which allows the development of temperatures suitable for thermophilic bacteria as a result of biologically produced heat. All parts of each batch shall be regularly and thoroughly moved in order to ensure the correct sanitation and homogeneity of the material. During the composting process, all parts of each batch shall have one of the following temperature-time profiles:

65°C or more for at least 5 days,

60°C or more for at least 7 days, or

55°C or more for at least 14 days.

4.The compost shall contain

(a)no more than 6 mg/kg dry matter of PAH16 11 , and

(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 O2/kg organic matter/h; or

(b)Self heating factor:

Definition: the maximum temperature reached by a compost in standardised conditions as an indicator of the state of its aerobic biological activity,

Criterion: minimum Rottegrad III.

CMC 4: Energy crop digestate

1.A CE marked fertilising 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 algae 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 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 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

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 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 temperature-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)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)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.Both the solid and the liquid part of the digestate 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 50 mmol O2/kg organic matter/h; or

(b)Residual biogas potential:

Definition: an indicator of the gas released from a digestate in a 28 day period and measured against the volatile solids contained within the sample. The test is run in triplicate, and the average result is used to demonstrate compliance with the 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 5: Other digestate than energy crop digestate

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 or gravitational means, by dissolution in water, by flotation, by extraction with water, by steam distillation or by heating solely to remove water, or which are extracted from air by any means, except

the organic fraction of mixed municipal household waste separated through mechanical, physicochemical, biological and/or manual treatment,

sewage sludge, industrial sludge or dredging sludge,

animal by-products 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 obligation 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 PAH16 14 .

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

(a)Thermophilic anaerobic digestion at 55°C 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)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 PAH16 15 .

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 occurring 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.

7.Both the solid and the liquid part of the digestate 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 50 mmol O2/kg organic matter/h; or

(b)Residual biogas potential:

Definition: an indicator of the gas released from a digestate in a 28 day period and measured against the volatile solids contained within the sample. The test is run in triplicate, and the average result is used to demonstrate compliance with the 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 viscous 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 by Annex IV to that Regulation or by points 6, 7, 8, or 9 of Annex V to that Regulation.

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 the media on which they were produced, which

have undergone no other processing than drying or freeze-drying and

are listed in the table below:

CMC 8: Agronomic additives

1.A CE marked fertilising 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 marked 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 (NH4+) and urea (CH4N2O).

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 (CH4N2O).

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 declaration of conformity);

(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 conformity);

(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 nutrient polymers

1.A CE marked fertilising product 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 shall be complied with: The polymer shall be capable of undergoing physical, biological decomposition, such that most of it ultimately decomposes into carbon dioxide (CO2), biomass and water. It shall have at least 90 % of the organic carbon converted into CO2 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 materials 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 growth acute toxicity test, an earthworm acute toxicity test and a nitrification inhibition test with soil micro-organisms as follows:

(a)In the plant growth acute toxicity test, the germination rate and the plant biomass of the tested plant species grown on the soil exposed to the test material shall be more than 90 % of the germination rate and the plant biomass of the same plant species grown on corresponding blank soil not exposed to the test material.

(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 effects (e.g. chlorosis, necrosis, wilting, leaf and stem deformations) and the plants exhibit only normal variation in growth and morphology for that particular species;

the mean survival of emerged control seedlings is at least 90 % for the duration of the study; and

environmental conditions for a particular species are identical and growing media contain the same amount of soil matrix, support media, or substrate from the same source.

(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 observed 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 than ± 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 Regulation, which are listed in the table below and as specified therein:

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 requirements

1.The information elements required by this Regulation shall be 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, indicated 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 following 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 not mislead the user, for example by attributing to the product properties that it does not possess, or by suggesting that the product possesses unique characteristics which similar products also have;

(b)shall relate to verifiable factors; 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 requirements

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 quantity 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 nitrification inhibitor content shall be expressed as a percentage by mass of the total nitrogen (N) present as ammonium nitrogen (NH4+) and urea nitrogen (CH4N2O).

(c)The urease inhibitor content shall be expressed as a percentage by mass of the total nitrogen (N) present as urea nitrogen (CH4N2O).

(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 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 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) in the form of ammoniacal nitrogen;

Total phosphorus pentoxide (P2O5);

Total potassium oxide (K2O);

Magnesium oxide (MgO), calcium oxide (CaO), sulphur trioxide (SO3) and sodium oxide (Na2O), 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 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) in the form of nitric nitrogen;

–Nitrogen (N) in the form of ammoniacal nitrogen;

–Nitrogen (N) in the form of urea nitrogen;

Total phosphorus pentoxide (P2O5);

–Water-soluble phosphorus pentoxide (P2O5);

–phosphorus pentoxide (P2O5) soluble in neutral ammonium citrate;

–where soft ground phosphate is present, phosphorus pentoxide (P2O5) soluble in formic acid;

Total potassium oxide (K2O);

–Water soluble potassium oxide (K2O);

magnesium oxide (MgO), calcium oxide (CaO), sulphur trioxide (SO3) and sodium oxide (Na2O), 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;

–in other cases, as the total content, and

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

2.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:

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 micronutrient(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; 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), 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:

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 micronutrient(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; 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(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 (P2O5);

–Water-soluble phosphorus pentoxide (P2O5);

–phosphorus pentoxide (P2O5) soluble in neutral ammonium citrate;

–where soft ground phosphate is present, phosphorus pentoxide (P2O5) soluble in formic acid;

Water soluble potassium oxide (K2O);

magnesium oxide (MgO), calcium oxide (CaO), sulphur trioxide (SO3) and sodium oxide (Na2O), 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, and

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

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% of 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 months 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 temperature 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 fertilisers 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 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:

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 micronutrient(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; 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(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

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 marked 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:

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 micronutrient(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; 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(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 each 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 appear: ‘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.

PFC 1(C)(II)(b): Compound inorganic micronutrient fertiliser

1.Micronutrients can be declared only if they are present in the fertiliser in the following quantities:

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 are 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;

–Organic carbon (C) content;

–Total nitrogen (N) content;

–Total phosphorus pentoxide (P2O5) content;

–Total potassium oxide (K2O) 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 conductivity, 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 (P2O5); and

–Total potassium oxide (K2O).

PFC 5: Agronomic additive

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 development 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 products, recommended spraying nozzles size and sprayer pressure.

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 blend

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 declared 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 intended 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 shall 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 the minimum content or exceed the maximum content.

PFC 1: Fertiliser

PFC 1(A): Organic fertiliser

PFC 1(B): Organo-mineral fertiliser

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 percentage 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 the declared value

PFC 1(C): Inorganic fertiliser

PFC 1(C)(I): Inorganic macronutrient fertiliser

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

Quantity: ± 5 % relative deviation of the declared value

PFC 2: Liming material

PFC 3: Soil improver

PFC 4: Growing medium

PFC 6: Plant biostimulant

ANNEX IV
Conformity assessment procedures

Part 1
Applicability of conformity 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 internal production control (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 polymers 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 fertiliser of high nitrogen content, as specified in PFC 1(C)(I)(a)(iii)(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 internal production control 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 specified in PFC 1(C)(I)(a)(iii)(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 internal production control (Module C)

1.Module B in combination 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,

(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)(iii)(A), or a fertilising product blend containing such a product.

4.Applicability of quality assurance of the production 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 nitrate fertiliser of high nitrogen content, as specified in PFC 1(C)(I)(a)(iii)(A), or a fertilising product blend containing such a product.

Part 2
Description of conformity assessment procedures

Module A – Internal production control

1.Description of the 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

2.1The manufacturer shall establish the technical documentation. The documentation shall make it possible to assess the CE marked fertilising product's conformity to the relevant requirements, and shall include an adequate analysis and assessment of the risk(s).

2.2The 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 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 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 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,

(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 and 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 fertilising 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 product.

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 control plus supervised 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 manufacturer 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).

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 of 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 out, 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 referred 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 the 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)(iii)(A) in Annex I to this Regulation, and

(b)the detonation resistance requirement referred to in paragraph 5 under PFC 1(C)(I)(a)(iii)(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)(iii)(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 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. Protect 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)(iii)(A) in Annex I

4.2.1.Principle and definition

4.2.1.In a watertight box heat the sample 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 water 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 the 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. Place 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.

Figure 1

4.3.Detonation resistance test referred to in paragraph 5 under PFC 1(C)(I)(a)(iii)(A) in Annex I

4.3.1.Description

4.3.1.1The 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)Nominal 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 transmission of detonation,

(f)Test temperature: 1525°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 conclusive if in both tests one or more of the supporting lead cylinders is crushed by less than 5%.

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 nonmetallic 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

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 nonelectric) 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 sevenpoint simultaneous initiation as referred to under Heading 4.3.4.1.1. below, or

by central initiation by a compressed pellet as referred to under Heading  4.3.4.1.2. below.

4.3.4.1.1.Sevenpoint 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 Heading 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 AB in Figure 2), depending on the 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 insert 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. Finally, 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 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 means of adhesive tape 18 .

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 charge

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.

4.3.4.3.2.1Place the tube upright with its square bottom place resting on a firm, flat surface, preferably concrete. Fill the tube to about onethird 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 000gram hammer between drops for a total of 10 times.

4.3.4.3.2.2.Repeat this charging method with another portion 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.

4.3.4.3.2.3The 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 quantities 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 between 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. mine 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 concretelined 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 sevenpoint 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.

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.

4.3.4.6.1Allow 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 lowest 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 are 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.

Figure 2

Figure 3

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 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 fertilising product has been placed on the market. The EU declaration of conformity shall identify such CE marked fertilising product for which it has been drawn up.

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 product (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 documentation 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 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 general description 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 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,

results of design calculations made, examinations carried out, etc.,

test reports, and

where the product contains or consists of animal by-products 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;

(d)the specimens representative of the production envisaged. The notified body 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 relevant 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 technical 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 provisions 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 manufacturer 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 (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 shall 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 Regulation, 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 acknowledged 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 accordingly.

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 product 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 inform 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 otherwise 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/or 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 examination 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 certificate, 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.

Module C – Conformity to type based on internal production 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 concerned 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 declaration of conformity

3.1The 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.

3.2The manufacturer 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 declaration 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 production 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 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.The manufacturer of the CE marked fertilising product shall establish 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 the 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 product,

(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 understanding 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 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,

(e)results of design calculations made, examinations carried out, etc.,

(f)test reports, and

(g)where the product contains or consists of animal by-products 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 organisation’s management who shall be responsible for:

Ensuring that quality management processes are established, approved, implemented and maintained;

Reporting to senior management of the manufacturer on the performance of the quality management and any need 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 actions.

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.

(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 with 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 following frequency:

(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 person responsible for quality management referred to above in point 5.1.1.1(b) shall:

(1)Clearly identify 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 product 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 category ('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 Regulation. 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 least 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.

5.1.5The achievement 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 shall 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 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 quality 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 authorised 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 manner 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 auditing 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 manufacturer'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.

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 necessary.

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

6.1The purpose of surveillance 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, qualification reports on the personnel concerned.

6.3.1The 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.

6.3.2For 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 frequency:

(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).

6.4In 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.

7.2.1The 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. 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 5.6.15.6.3, paragraph 6.3 and paragraph 6.4.

9.Notified bodies' information obligation

9.1.Each notified body shall inform its notifying authorities 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 the 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, paragraph 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.

ANNEX V
EU Declaration 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 the 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 declaration 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):

(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 for 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).

(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 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.

(6) 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 1907/2006.

(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, 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.

(8) The exclusion of a material from CMC 1 does not prevent it from being an eligible component material by virtue of another CMC stipulating different requirements. See, for instance, CMC 11 on animal byproducts, CMCs 9 and 10 on polymers, and CMC 8 on agronomic additives.

(9) 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 1907/2006.

(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

(12) 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 1907/2006.

(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 1907/2006.

(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 benzo[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]anthracene and benzo[ghi]perylene

(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.

(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.

(19) It is optional for the manufacturer to assign a number to the EU declaration of conformity.

EUROPEAN COMMISSION

Brussels, 17.3.2016

COM(2016) 157 final

2016/0084(COD)

Circular Economy Package

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

(Text with EEA relevance)

{SWD(2016) 64 final}
{SWD(2016) 65 final}

EXPLANATORY MEMORANDUM

1.CONTEXT OF THE PROPOSAL

•Reasons for and objectives of the proposal

1.The proposal aims at addressing important problems currently present on the market, which were first identified in an ex-post evaluation of Regulation (EC) No 2003/2003 ('the existing Fertilisers Regulation') conducted in 2010. 1 It has also been identified as one of the key legislative proposals under the Circular Economy action plan. 2

The first reason and objective

2.First, innovative fertilising products, often containing nutrients or organic matter recycled from biowaste or other secondary raw materials in line with the circular economy model, have difficulties accessing the internal market due to the existence of diverging national rules and standards.

3.The existing Fertilisers Regulation ensures free movement on the internal market of a class of harmonised products belonging to one of the product-types included in Annex I to that Regulation. Such products are eligible to be labelled 'ECfertilisers'. Companies wishing to market products of other types as EC-fertilisers must first obtain a new type-approval through a Commission decision amending that Annex. Virtually all product-types currently included in the existing Fertilisers Regulation are conventional, inorganic fertilisers, typically extracted from mines or chemically produced in line with a linear economy model. Also, the chemical processes for producing for example nitrogen-based fertilisers are both energy consuming and CO2-intensive.

4.Around 50 % of the fertilisers currently on the market, however, are left out of the scope of the Regulation. This is true for a few inorganic fertilisers and for virtually all fertilisers produced from organic materials, such as animal or other agricultural by products, or recycled bio-waste from the food chain. Research, innovation and investment are currently developing rapidly, contributing to the circular economy by creating local jobs and by generating value from secondary, domestically sourced resources which would otherwise have been used directly on land or disposed as landfill waste, causing unnecessary eutrophication and greenhouse gas emissions. There is also a servitization trend in the business, with increasing product customisation based on analysis of the soil where the fertiliser will be used. SMEs and other enterprises throughout Europe are increasingly interested in contributing to this development. However, for customised products containing organic fertilisers, access to the internal market is currently depending on mutual recognition, and therefore often hindered.

5.The problem for innovative fertilisers with the existing regulatory construction is two-fold

6.The first angle of the problem is that inclusion in the existing Fertilisers Regulation of types of products sourced from organic or secondary raw material is challenging. Regulators hesitate because of the relatively variable composition and characteristics of such materials. The existing Fertilisers Regulation is clearly tailored for well characterised, inorganic fertilisers from primary raw materials, and lacks the robust control mechanisms and safeguards necessary for creating trust in products from inherently variable organic or secondary material sources. Furthermore, the links with existing legislation on control of animal by-products and waste are not clear.

7.As a result, fertilisers sourced in line with the circular economy remain non-harmonised. Many Member States have detailed, national rules and standards in place for such non-harmonised fertilisers, with environmental requirements (such as heavy metal contaminant limits) that do not apply to EC-fertilisers. Furthermore, free movement between Member States through mutual recognition has proven extremely difficult. As a result, a producer of fertilisers sourced from organic or secondary raw materials, established in one Member State and seeking to expand its market to the territory of another Member State, is often faced with administrative procedures making the market expansion prohibitively expensive. The resulting lack of critical mass hampers investment in this important sector of the circular economy. The problem is of particular importance for producers established in Member States with a small domestic market compared to the surplus of organic, secondary raw materials (typically manure) of which they dispose.

8.In summary, the playing field in the competition between those fertilisers sourced from domestic organic or secondary raw material in line with the circular economy model and those produced in line with a linear economy model is tilted in favour of the latter. This competition distortion hampers investment in the circular economy.

9.The problem is aggravated by the fact that one of the main fertiliser constituents is phosphate rock, which has been identified by the Commission as a critical raw material. For phosphate fertilisers, the EU is currently highly dependent on import of phosphate rock mined outside of the EU (more than 90% of the phosphate fertilisers used in the EU are imported, mainly from Morocco, Tunisia and Russia). This while domestic waste (in particular sewage sludge) contains large amounts of phosphorus, which – if recycled in line with a circular economy model – could potentially cover about 20-30% of EU's demand of phosphate fertilisers. The related investment potential remains, however, currently largely unexploited, which is partially due to the above-mentioned difficulties to access the internal market.

10.The second angle of the current Fertilisers Regulation's limitations for innovative fertilisers is that, even for new, inorganic fertilisers from primary raw materials, the type-approval procedure is lengthy, and cannot keep up with the innovation cycle of the fertilisers sector. It has therefore been deemed necessary to fundamentally reconsider and modernise the regulatory technique, in order to increase flexibility with regard to product requirements, while maintaining a high level of protection of human, animal, and plant health, safety and the environment. The considerations undertaken in this respect are detailed below in Section 3: Results of ex-post evaluations, stakeholder consultations and impact assessment.

11.The main policy objective of the initiative is therefore to incentivise large scale fertiliser production in the EU from domestic organic or secondary raw materials in line with the circular economy model, by transforming waste into nutrients for crops. The proposal will provide a regulatory framework radically easing access to the internal market for such fertilisers, thereby levelling their playing field with that of mined or chemical fertilisers produced in line with a linear economy model. This would contribute to the following circular economy objectives:

It would allow valorisation of secondary raw materials, hence enabling improved use of raw materials and turning eutrophication and waste management problems into economic opportunities for public and private operators.

It would increase resource efficiency and decrease import dependency for raw materials essential to European agriculture, in particular phosphorus.

It would boost investment and innovation in the circular economy, hence creating jobs in the EU.

It would contribute to relieving the fertilisers industry from its current pressure to reduce CO2-emissions under ETS, by allowing it to produce fertilisers from less carbon-intensive feedstock.

12.Increased production and trade in innovative fertilisers would also diversify the fertilisers offered to farmers, potentially contributing to making food production more cost- and resource-effective.

The second reason and objective

13.Second, the existing Fertilisers Regulation fails to address environmental concerns arising from contamination by EC-fertilisers of soil, inland waters, sea waters, and ultimately food. A well-recognised issue is the presence of cadmium in inorganic phosphate fertilisers. In the absence of EU limit values, some Member States have imposed unilateral cadmium limits for EC-fertilisers by virtue of Article 114 TFEU, hence creating a certain market fragmentation also in the harmonised field. The presence of contaminants in those fertilisers which are currently subject to national rules (e.g. nutrients recycled from sewage sludge) poses similar concerns.

14.A second policy objective is therefore to address this issue and introduce harmonised cadmium limits for phosphate fertilisers. The setting of such limit values, aiming at minimising the negative impact of fertiliser use on the environment and on human health, will contribute to a reduction of cadmium accumulation in soil and of cadmium contamination of food and water. It will also remove the market fragmentation to which the concern currently gives rise in the form of national cadmium limits in some Member States.

•Consistency with existing policy provisions in the policy area

15.The proposal will repeal the existing Fertilisers Regulation, but allow already harmonised fertilisers to remain on the market subject to compliance with the new safety and quality requirements. It will define the conditions under which fertilisers produced from waste and animal by-products can leave the controls provided for by Regulation (EC) No 1069/2009 of the European Parliament and of the Council of 21 October 2009 laying down health rules as regards animal by-products and derived products not intended for human consumption and repealing Regulation (EC) No 1774/2002 (Animal by-products Regulation) 3 and the Directive 2008/98/EC on waste and repealing certain Directives 4 and circulate freely as CE marked fertilisers. It will be complementary to Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) 5 , which will continue to apply to chemical substances incorporated into fertilising products.

•Consistency with other Union policies

16.The initiative supports the Commission's agenda for jobs, growth and investment, by providing the right regulatory environment for investment in the real economy.

17.In particular, the initiative will make an important and concrete contribution to the Commission's Circular Economy Package. It will create a level playing field for all fertilising products and facilitate recourse to domestic, secondary raw materials.

18.Furthermore, the initiative supports the aim to create a deeper and fairer internal market with a strengthened industrial base, by removing existing barriers to free movement of certain innovative fertilisers and facilitating the market surveillance by Member States.

19.The initiative is related to the following policy initiatives:

The Circular Economy Package: The Fertilisers Regulation revision aims at establishing a regulatory framework enabling production of fertilisers from recycled bio-wastes and other secondary raw materials, in line with the Bioeconomy strategy 6 , which encompasses the production of renewable biological resources and the conversion of these resources and waste streams into value added products. This would boost domestic sourcing of plant nutrients which are essential for a sustainable European agriculture, including the critical raw material phosphorus. It would also contribute to a better implementation of the waste hierarchy, by minimising landfilling or energy recovery of bio-wastes, and hence to solving related waste management problems.

The Single Market Strategy: As described above, a well-known barrier to free movement on the internal market constitutes of heavy and diverging national regulatory frameworks for those fertilisers currently not covered by harmonisation legislation. While economic operators often regard the diverging national rules as a prohibitive obstacle to entering new markets, Member States regard the rules as essential for protecting the food chain and the environment. Because of those concerns relating to health and the environment, mutual recognition has proven exceptionally difficult in the field of non-harmonised fertilisers, and economic operators have asked for the possibility to get access to the entire internal market by complying with harmonised rules addressing those concerns at EU level.

Horizon 2020: The proposal will have the potential to stimulate relevant research activities launched under Societal Challenges 2 (“Food security, sustainable agriculture and forestry, marine and maritime and inland water research, and the Bioeconomy”) and 5 (“Climate action, environment, resource efficiency and raw materials”), which aim, among other objectives, at providing innovative solutions for a more efficient and safer recovery of resources from waste, wastewater and bio-wastes, and at encouraging researchers to deliver innovative products in compliance with the market needs, the societal needs and the environmental protection policies. The Bio Based Industries Joint Undertaking has identified i.a. phosphorus recycling for production of fertilisers as an emerging and economically promising new value chain from (organic) waste. 7 Easy access to the internal market for such fertilizers would be a pre-condition for achieving these goals and bringing results from research to the market.

2.LEGAL BASIS, SUBSIDIARITY AND PROPORTIONALITY

•Legal basis

20.The aim of the proposal is to improve the functioning of the internal market for fertilising products, hence addressing the issues first identified in the ex-post evaluation of the existing Fertilisers Regulation conducted in 2010. The legal basis is therefore Article 114 of the Treaty on the Functioning of the European Union, which is also the legal basis for the existing Fertilisers Regulation.

•Subsidiarity (for non-exclusive competence)

21.The first objective of the proposed action is to boost investment in production and uptake of effective, safe, innovative fertilisers produced from organic or secondary raw materials in line with the circular economy model and the Bioeconomy strategy, by helping those products reach a critical mass through access to the entire internal market. More efficient recourse to such fertilisers can offer significant environmental benefits, reduced dependency on import of critical raw materials from outside of the EU, as well as an increased variety of high quality fertilising products to farmers. The existing barriers to the free movement of such products, in the form of diverging, national regulatory frameworks, cannot be removed through Member States' unilateral actions. In particular, mutual recognition in this field has proven exceptionally difficult, and becomes an increasingly important obstacle as the interest in producing and trading high-quality fertilisers from organic or secondary raw materials tends to increase. EU action, on the other hand, could ensure the free movement of such fertilisers by establishing harmonised high quality, safety and environmental criteria.

22.The second objective is to address cadmium contamination of soil and food through fertiliser use. Since most of the fertilisers from which the concern originates (i.e., inorganic phosphate fertilisers) are already harmonised, Member States cannot achieve this objective unilaterally. EU-wide maximum limits, on the other hand, can effectively reduce contaminants in harmonised fertilisers to safer levels.

•Proportionality

23.The first objective of the initiative is that of boosting investment in production of effective, safe, innovative fertilisers produced from organic or secondary raw materials in line with the circular economy model, with the related benefits for environmental impact, reduced import dependency, and increased variability of high-quality products on offer. The initiative aims at reaching a critical mass through internal market for such products. Mutual recognition of non-harmonised fertilisers has proven extremely difficult in the past, whereas product harmonisation legislation has been an effective way of securing internal market access for inorganic fertilisers. It is therefore concluded that product harmonisation legislation for fertilisers from organic or secondary raw materials does not go beyond what is necessary for providing the regulatory certainty required to incentivise large scale investment in the circular economy. The regulatory technique chosen in this proposal leaves economic operators a maximum of flexibility to put new products on the markets without compromising on safety and quality. Furthermore, it leaves Member States free to allow non-harmonised fertilisers to on the market, without depriving those economic operators seeking larger markets of the possibility to opt for the benefits of the harmonised regulatory framework.

24.The form of a Regulation is deemed the most appropriate for harmonisation of products in a field of such technical complexity and potential impact on the food chain and the environment as fertilisers. That conclusion is supported by the fact that the existing harmonisation legislation for fertilisers also has the form of a Regulation.

25.Regarding the second objective, i.e., addressing cadmium contamination of soil and food through use of fertilisers many of which are already harmonised, maximum levels in the product legislation is seen as an effective means of addressing the problem at source. The economic impacts are deemed proportionate to the objective of preventing irrevocable soil contamination affecting current and future generations of farmers and food consumers.

26.The proportionality is further developed in section 4.2.2 of the Impact Assessment.

•Choice of the instrument

27.The form of a Regulation is deemed the most appropriate for harmonisation of products in a field of such technical complexity and potential impact on the food chain and the environment as fertilisers. That conclusion is supported by the fact that the existing harmonisation legislation for fertilisers also has the form of a Regulation.

3.RESULTS OF EX-POST EVALUATIONS, STAKEHOLDER CONSULTATIONS AND IMPACT ASSESSMENTS

•Ex-post evaluations/fitness checks of existing legislation

28.The ex-post evaluation of the existing Fertilisers Regulation conducted in 2010 concluded 8 that the Regulation had been effective in meeting its objective of simplifying and harmonising the regulatory framework in relation to an important part of the fertiliser market.

29.However, the evaluation also concluded that the Regulation could be more effective in promoting innovative fertilisers, and that adjustments would also be needed to better protect the environment. Furthermore, regarding the organic fertilisers currently left out of the scope of the Regulation, the evaluation showed that neither economic operators, nor national authorities considered that mutual recognition was the most appropriate tool for ensuring free movement, since fertilisers are products for which legitimate product quality, environmental, and human health concerns can warrant stringent rules.

•Stakeholder consultations

30.Consultation of Member States and other stakeholders has been conducted extensively throughout the preparatory phase starting in 2011, in particular in the context of the Fertilisers Working Group. 9 The public consultation on Circular economy published in May 2015 included questions on this topic. 10 Stake holders were also invited to give feedback to the Roadmap for the revision of the Fertilisers Regulation published on 22 October 2015. 11

•Collection and use of expertise

31.The existing draft Impact Assessment report relies largely on the abovementioned ex-post evaluation of the Fertilisers Regulation of 2010 as well as on the study carried out in 2011 on options to fully harmonise the EU legislation on fertilising materials including technical feasibility, environmental, economic and social impacts 12 .

32.Phosphorus recycling has also been addressed by FP7 research projects, the results of which have been analysed during the workshop 'Circular approaches to phosphorus: from research to deployment', held in Berlin on 4 March 2015 13 . One of the identified priorities is to revise the EU Fertiliser Regulation to extend its scope to nutrients from secondary sources (e.g. recycled phosphates) and organic sources.

•Impact assessment

33.The proposal is supported by an impact assessment, the key documents of which can be found [Once the IAR is published, insert link to the summary sheet and to the positive opinion of the Regulatory Scrutiny Board]. The opinions of the Impact Assessment Board were taken into account by providing better evidence of the divergent national standards as a cause for market fragmentation, by clarifying the content of the various options assessed, and by better justifying the key impacts of the proposal.

34.The impact assessment compared status quo (referred to as option 1) with four other policy options (referred to as options 2-5). Under all of the options 2-5, the scope of harmonisation would be extended to fertilisers from organic raw materials and to other fertiliser-related products, and limit values would be introduced for contaminants. The options would build on different control mechanisms: Under option 2, the regulatory technique of the Fertilisers Regulation, i.e., type-approval, would remain un-changed. Under option 3, the type-approval would be replaced by a positive, exhaustive list of materials eligible for intentional incorporation into a fertiliser. Option 4 would achieve the necessary control through the 'New Legislative Framework' ('NLF'), with one conformity assessment procedure applicable across the board. Finally, option 5 would also build on the NLF, but the conformity assessment procedure would vary between material categories. For all four options 2-5, it was also examined whether the harmonisation should be mandatory for all products with a given function, or whether fertilisers could comply with the harmonised legislation on an optional basis, as an alternative to any applicable national legislation and mutual recognition, as is the case under status quo for inorganic fertilisers.

35.The final proposal corresponds with option 5, coupled with the variant of optional harmonisation. It was considered to be the best policy choice because it would lead to administrative simplification, in particular for fertilising products from well identified, primary raw materials, and ensure flexibility, while at the same time ensuring that the use of harmonised fertilising products does not pose unacceptable risks to health or the environment.

36.The proposal will mainly affect those producers of innovative fertilisers produced from organic or secondary raw materials in line with the circular economy model, who will be able to reach a critical mass through radically facilitated access to the internal market. Such producers will benefit from the initiative in particular in those Member States which are not providing a sufficiently large home market for new types of fertilisers.

37.It will also affect private and public recovery operators (such as operators of waste water treatment plants, or of waste management plants producing compost or digestate) who will be able to valorise their output, and thus facilitate investments in such infrastructure.

38.Many national authorities will see a decreased workload when national registration or authorisation systems for fertilisers are fully or partially replaced by EU-wide control mechanisms.

39.Finally, farmers and other fertiliser users are likely to see an increase in the product variety offered to them, while the general public will be better protected from contamination of soil, water and food.

•Regulatory fitness and simplification

40.The proposal will lead to simplification and reduction of the administrative burden for producers of fertilising products seeking access to more than one national territory on the internal market, since such access will no longer depend on mutual recognition. At the same time, it will avoid banning or restricting market access for producers that do not aim at compliance with EU-level rules, by keeping open the possibility to access national markets subject to any national rules and mutual recognition.

4.BUDGETARY IMPLICATIONS

41.The proposal will have no implications on the EU budget. Human and administrative resources within the European Commission will remain unchanged compared with the implementation and monitoring of the existing Fertilisers Regulation.

5.OTHER ELEMENTS

•Implementation plans and monitoring, evaluation and reporting arrangements

42.The European Commission will assist and monitor Member States' implementation of the Regulation. It will also analyse the need for guidance, standards or schemes proving sustainability of fertilising products, thus allowing sustainability-claims on the product labels.

43.The Commission furthermore intends to include additional component material categories in the Annexes, to keep up with technological progress allowing the production of safe and effective fertilisers from recovered, secondary raw materials, such as biochar, ashes and struvite. Finally, the Commission will keep the requirements in the Annexes under constant review, and revise them wherever necessary to provide an adequate protection of human, animal or plant health, safety or the environment.

•Detailed explanation of the specific provisions of the proposal

44.Chapter 1 of the proposed Regulation sets out the subject matter, scope and definitions, as well as the fundamental principles of free movement and marketability of CE marked fertilising products. The provision on product requirements refers to Annexes I and II, which contain the substantive requirements for the categories of end-products in accordance with their intended function (Annex I), as well as for the categories of component materials that can be contained in CE marked fertilising products (Annex II). It also refers to Annex III, which specifies the labelling requirements.

45.Chapter 2 lays down the obligations of economic operators involved in making CE marked fertilising products available on the market.

46.Chapter 3 sets out the general principle for conformity of CE marked fertilising products. It refers to Annex IV, which describes in detail the conformity assessment procedures applicable to CE marked fertilising products, depending on their component material categories and their product function categories. It also refers to Annex V, which sets out the model structure for the EU declaration of conformity.

47.Chapter 4 sets out the provisions on notified bodies, and Chapter 5 sets out the provisions on market surveillance. Chapter 6 sets out the conditions for the Commission's adoption of delegated and implementing acts, and Chapter 7 sets out final provisions.

2016/0084 (COD)

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

(Text with EEA relevance)

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty on the Functioning of the European Union, and in particular Article 114 thereof,

Having regard to the proposal from the European Commission,

After transmission of the draft legislative act to the national parliaments,

Having regard to the opinion of the European Economic and Social Committee 14 ,

Acting in accordance with the ordinary legislative procedure,

Whereas:

(1)The conditions for making fertilisers available on the internal market have been partially harmonised through Regulation (EC) No 2003/2003 of the European Parliament and of the Council 15 , which almost exclusively covers fertilisers from mined or chemically produced, inorganic materials. There is also a need to make use of recycled or organic materials for fertilising purposes. Harmonised conditions for making fertilisers made from such recycled or organic materials available on the entire internal market should be established in order to provide an important incentive for their further use. The scope of the harmonisation should therefore be extended in order to include recycled and organic materials.

(2)Certain products are being used in combination with fertilisers for the purpose of improving nutrition efficiency, with the beneficial effect of reducing the amount of fertilisers used and hence their environmental impact. In order to facilitate their free movement on the internal market, not only fertilisers, i.e. products intended to provide plants with nutrient, but also products intended to improve plants' nutrition efficiency, should be covered by the harmonisation.

(3)Regulation (EC) No 765/2008 of the European Parliament and of the Council 16 lays down rules on the accreditation of conformity assessment bodies, provides a framework for the market surveillance of products and for controls on products from third countries, and lays down the general principles of the CE marking. That Regulation should be applicable to products covered by the scope of this Regulation in order to ensure that products benefiting from the free movement of goods within the Union fulfil requirements providing a high level of protection of public interests such as health and safety in general, protection of consumers and protection of the environment.

(4)Decision No 768/2008/EC of the European Parliament and of the Council 17 lays down common principles and reference provisions intended to apply across sectoral legislation in order to provide a coherent basis for revision or recasts of that legislation. Regulation (EC) No 2003/2003 should therefore be replaced by a Regulation drafted to the extent possible in accordance with that Decision.

(5)Contrary to most other product harmonisation measures in Union legislation, Regulation (EC) No 2003/2003 does not prevent non-harmonised fertilisers from being made available on the internal market in accordance with national law and the general free movement rules of the Treaty. In view of the very local nature of certain product markets, this possibility should remain. Compliance with harmonised rules should therefore remain optional, and should be required only for products, intended to provide plants with nutrient or improve plants' nutrition efficiency, which are CE marked when made available on the market. This Regulation should therefore not apply to products which are not CE marked when made available on the market.

(6)Different product functions warrant different product safety and quality requirements adapted to their different intended uses. CE marked fertilising products should therefore be divided into different product function categories, which should each be subject to specific safety and quality requirements.

(7)Similarly, different component materials warrant different process requirements and control mechanisms adapted to their different potential hazardousness and variability. Component materials for CE marked fertilising products should therefore be divided into different categories, which should each be subject to specific process requirements and control mechanisms. It should be possible to make available on the market a CE marked fertilising product composed of several component materials from various component material categories, where each material complies with the requirements of the category to which the material belongs.

(8)Contaminants in CE marked fertilising products, such as cadmium, can potentially pose a risk to human and animal health and the environment as they accumulate in the environment and enter the food chain. Their content should therefore be limited in such products. Furthermore, impurities in CE marked fertilising products derived from bio-waste, in particular polymers but also metal and glass, should be either prevented or limited to the extent technically feasible by detection of such impurities in separately collected bio-waste before processing.

(9)Products complying with all the requirements of this Regulation should be allowed to move freely on the internal market. Where one or more of the component materials in a CE marked fertilising product falls within the scope of Regulation (EC) No 1069/2009 of the European Parliament and of the Council 18 , but reaches a point in the manufacturing chain beyond which it no longer poses any significant risk to public or animal health (the 'end point in the manufacturing chain'), it would represent an unnecessary administrative burden to continue subjecting the product to the provisions of that Regulation. Such fertilising products should therefore be excluded from the requirements of that Regulation. Regulation (EC) No 1069/2009 should therefore be amended accordingly.

(10)The end point in the manufacturing chain should be determined for each relevant component material containing animal by-products in accordance with the procedures laid down in Regulation (EC) No 1069/2009. Where a manufacturing process regulated under this Regulation starts already before that end point has been reached, the process requirements of both Regulation (EC) No 1069/2009 and this Regulation should apply cumulatively to CE marked fertilising products, which means application of the stricter requirement in case both Regulations regulate the same parameter.

(11)In the event of risks to public or animal health from CE marked fertilising products derived from animal by-products, recourse to safeguard measures in accordance with Regulation (EC) No 178/2002 of the European Parliament and of the Council 19 should be possible, as is the case for other categories of products derived from animal by-products.

(12)Where one or more of the component materials for a CE marked fertilising product fall within the scope of Regulation (EC) No 1069/2009 and has not reached the end point in the manufacturing chain, it would be misleading to provide for the product's CE marking under this Regulation, since the making available on the market of such a product is subject to the requirements of Regulation (EC) No 1069/2009. Therefore, such products should be excluded from the scope of this Regulation.

(13)For certain recovered wastes within the meaning of Directive 2008/98/EC of the European Parliament and of the Council 20 , a market demand for their use as fertilising products has been identified. Furthermore, certain requirements are necessary for the waste used as input in the recovery operation and for the treatment processes and techniques, as well as for fertilising products resulting from the recovery operation, in order to ensure that the use of those products does not lead to overall adverse environmental or human health impacts. For CE marked fertilising products, those requirements should be laid down in this Regulation. Therefore, as of the moment of compliance with all the requirements of this Regulation, such products should cease to be regarded as waste within the meaning of Directive 2008/98/EC.

(14)Certain substances and mixtures, commonly referred to as agronomic additives, improve the nutrient release pattern of a nutrient in a fertiliser. Substances and mixtures made available on the market with the intention of them being added to CE marked fertilising products for that purpose should fulfil certain efficacy criteria at the responsibility of the manufacturer of those substances or mixtures, and should therefore as such be considered as CE marked fertilising products under this Regulation. Furthermore, CE marked fertilising products containing such substances or mixtures should be subject to certain efficacy and safety criteria. Such substances and mixtures should therefore also be regulated as component materials for CE marked fertilising products.

(15)Certain substances, mixtures and micro-organisms, commonly referred to as plant biostimulants, are not as such nutrients, but nevertheless stimulate plants' nutrition processes. Where such products aim solely at improving the plants' nutrient use efficiency, tolerance to abiotic stress, or crop quality traits, they are by nature more similar to fertilising products than to most categories of plant protection products. Such products should therefore be eligible for CE marking under this Regulation and excluded from the scope of Regulation (EC) No 1107/2009 of the European Parliament and of the Council 21 . Regulation (EC) No 1107/2009 should therefore be amended accordingly.

(16)Products with one or more functions, one of which is covered by the scope of Regulation (EC) No 1107/2009, should remain under the control tailored for such products and provided for by that Regulation. Where such products also have the function of a fertilising product, it would be misleading to provide for their CE marking under this Regulation, since the making available on the market of a plant protection product is contingent on a product authorisation valid in the Member State in question. Therefore, such products should be excluded from the scope of this Regulation.

(17)This Regulation should not prevent the application of existing Union legislation relating to aspects of protection of health, safety and the environment not covered by this Regulation. This Regulation should therefore apply without prejudice to Council Directive 86/278/EEC 22 , Council Directive 89/391/EEC 23 , Regulation (EC) No 1907/2006 of the European Parliament and of the Council 24 , Regulation (EC) No 1272/2008 of the European Parliament and of the Council 25 , Commission Regulation (EC) No 1881/2006 26 , Council Directive 2000/29/EC 27 , Regulation (EU) No 98/2013 of the European Parliament and of the Council 28 , and Regulation (EU) No 1143/2014 of the European Parliament and of the Council 29 .

(18)Where a CE marked fertilising product contains a substance or mixture within the meaning of Regulation (EC) No 1907/2006, the safety of its constituent substances for the intended use should be established through registration pursuant to that Regulation. The information requirements should ensure that the safety of the intended use of the CE marked fertilising product is demonstrated in a manner comparable to that achieved through other regulatory regimes for products intended for use on arable soil or crops, notably Member States' national fertiliser legislation and Regulation (EC) No 1107/2009. Therefore, where the actual quantities placed on the market are lower than 10 tonnes per company per year, the information requirements determined by Regulation (EC) No 1907/2006 for the registration of substances in quantities of 10 to 100 tonnes should exceptionally apply as a condition for making available pursuant to this Regulation.

(19)Where the actual quantities of substances in CE marked fertilising products regulated by this Regulation are higher than 100 tonnes, the additional information requirements laid down in Regulation (EC) No 1907/2006 should apply directly by virtue of that Regulation. The application of the other provisions of Regulation (EC) No 1907/2006 should also remain unaffected by this Regulation.

(20)A blend of different CE marked fertilising products, each of which has been subject to a successful assessment of conformity with the applicable requirements for that material, can itself be expected to be suitable for use as a CE marked fertilising product, subject only to certain additional requirements warranted by the blending. Therefore, in order to avoid an unnecessary administrative burden, such blends should belong to a separate category, for which the conformity assessment should be limited to the additional requirements warranted by the blending.

(21)Economic operators should be responsible for the compliance of CE marked fertilising products with this Regulation, in relation to their respective roles in the supply chain, so as to ensure a high level of protection of the aspects of public interest covered by this Regulation, and also to guarantee fair competition on the internal market.

(22)It is necessary to provide for a clear and proportionate distribution of obligations which correspond to the role of each economic operator in the supply and distribution chain.

(23)The manufacturer, having detailed knowledge of the design and production process, is best placed to carry out the conformity assessment procedure. Conformity assessment of CE marked fertilising products should therefore remain solely the obligation of the manufacturer.

(24)It is necessary to ensure that CE marked fertilising products from third countries that enter the internal market comply with this Regulation, and in particular that the appropriate conformity assessment procedures have been carried out by manufacturers with regard to those fertilising products. Provision should therefore be made for importers to make sure that CE marked fertilising products which they place on the market comply with the requirements of this Regulation and that they do not place on the market CE marked fertilising products which do not comply with such requirements or present a risk to human, animal or plant health, safety or the environment. Provision should also be made for such importers to make sure that conformity assessment procedures have been carried out and that marking of CE marked fertilising products and documentation drawn up by manufacturers are available for inspection by the competent national authorities.

(25)When placing a CE marked fertilising product on the market, the importer should indicate on the packaging of the fertilising product his or her name, registered trade name or registered trade mark and the postal address at which he or she can be contacted, in order to enable market surveillance.

(26)Since the distributor makes a CE marked fertilising product available on the market after it has been placed on the market by the manufacturer or the importer, he or she should act with due care to ensure that his or her handling of the fertilising product does not adversely affect the compliance of that product with this Regulation.

(27)An economic operator who either places a CE marked fertilising product on the market under his or her own name or trade mark or modifies a CE marked fertilising product in such a way that compliance with the provisions of this Regulation may be affected should be considered to be the manufacturer and should assume the obligations of the manufacturer.

(28)Since distributors and importers are close to the market place, they should be involved in market surveillance tasks carried out by competent national authorities, and should be required to participate actively and provide those authorities with all necessary information relating to the CE marked fertilising product.

(29)Ensuring traceability of a CE marked fertilising product throughout the whole supply chain helps to make market surveillance simpler and more efficient. An efficient traceability system facilitates market surveillance authorities’ task of tracing economic operators who made non-compliant CE marked fertilising products available on the market. When keeping the information required for the identification of other economic operators, economic operators should not be required to update such information in respect of other economic operators who have either supplied them with a CE marked fertilising product or to whom they have supplied a CE marked fertilising product, since such updated information is normally not available to them.

(30)In order to facilitate the assessment of conformity with safety and quality requirements it is necessary to provide for a presumption of conformity for CE marked fertilising products which are in conformity with harmonised standards that are adopted in accordance with Regulation (EU) No 1025/2012 of the European Parliament and of the Council 30 .

(31)Where harmonised standards have not been adopted, or do not with sufficient detail cover all elements of the quality and safety requirements laid down in this Regulation, uniform conditions for implementing those requirements may be needed. The Commission should therefore be empowered to adopt implementing acts setting out those conditions in common specifications. For reasons of legal certainty, it should be clarified that CE marked fertilising products must comply with such specifications even if they are considered to be in conformity with harmonised standards.

(32)In order to enable the economic operators to demonstrate and the competent authorities to verify that CE marked fertilising products made available on the market comply with the requirements, it is necessary to provide for conformity assessment procedures. Decision No 768/2008/EC establishes modules for conformity assessment procedures, from the least to the most stringent, in proportion to the level of risk involved and the level of safety required. In order to ensure inter-sectoral coherence and to avoid ad-hoc variants, conformity assessment procedures should be chosen from among those modules. However, it is necessary to adapt those modules in order to reflect specific aspects of fertilising products. In particular, it is necessary to reinforce the quality systems and the involvement of notified bodies for the conformity assessment of certain CE marked fertilising products derived from recovered waste.

(33)In order to ensure that CE marked ammonium nitrate fertilisers of high nitrogen content do not endanger safety, and that such fertilisers are not used for purposes other than those for which they are intended, for example as explosives, such fertilisers should be subject to specific requirements relating to detonation resistance testing and to traceability.

(34)To ensure effective access to information for market surveillance purposes, information regarding conformity with all Union acts applicable to CE marked fertilising products should be given in the form of a single EU declaration of conformity. In order to reduce the administrative burden on economic operators, that single EU declaration of conformity may be a dossier made up of relevant individual declarations of conformity.

(35)The CE marking, indicating the conformity of a fertilising product, is the visible consequence of a whole process comprising conformity assessment in a broad sense. General principles governing the CE marking and its relationship to other markings are set out in Regulation (EC) No 765/2008. Specific rules governing the affixing of the CE marking in the case of fertilising products should be laid down.

(36)Certain conformity assessment procedures set out in this Regulation require the intervention of conformity assessment bodies, which are notified by the Member States to the Commission.

(37)It is essential that all notified bodies perform their functions to the same level and under conditions of fair competition. That requires the setting of obligatory requirements for conformity assessment bodies wishing to be notified in order to provide conformity assessment services.

(38)If a conformity assessment body demonstrates conformity with the criteria laid down in harmonised standards it should be presumed to comply with the corresponding requirements set out in this Regulation.

(39)In order to ensure a consistent level of quality in the performance of conformity assessment of CE marked fertilising products, it is also necessary to set requirements for notifying authorities and other bodies involved in the assessment, notification and monitoring of notified bodies.

(40)The system set out in this Regulation should be complemented by the accreditation system provided for in Regulation (EC) No 765/2008. Since accreditation is an essential means of verifying the competence of conformity assessment bodies, it should also be used for the purposes of notification.

(41)Due to the variable nature of certain fertilising product component materials, and the potentially irreversible nature of some of the damages to which soil and crop exposure to impurities could lead, transparent accreditation as provided for in Regulation (EC) No 765/2008, ensuring the necessary level of confidence in certificates of conformity of CE marked fertilising products containing such components, should be the only means of demonstrating the technical competence of conformity assessment bodies.

(42)Conformity assessment bodies frequently subcontract parts of their activities linked to the assessment of conformity or have recourse to a subsidiary. In order to safeguard the level of protection required for CE marked fertilising products to be placed on the market, it is essential that conformity assessment subcontractors and subsidiaries fulfil the same requirements as notified bodies in relation to the performance of conformity assessment tasks. Therefore, it is important that the assessment of the competence and the performance of bodies to be notified and the monitoring of bodies already notified cover also activities carried out by subcontractors and subsidiaries.

(43)It is necessary to provide for an efficient and transparent notification procedure and, in particular, to adapt it to new technologies so as to enable online notification.

(44)Since the services offered by notified bodies may relate to CE marked fertilising products made available on the market throughout the Union, it is appropriate to give the other Member States and the Commission the opportunity to raise objections concerning a notified body. It is therefore important to provide for a period during which any doubts or concerns as to the competence of conformity assessment bodies can be clarified before they start operating as notified bodies.

(45)In the interest of easing market access, it is crucial that notified bodies apply the conformity assessment procedures without creating unnecessary burdens for economic operators. For the same reason, and to ensure equal treatment of economic operators, consistency in the technical application of the conformity assessment procedures needs to be ensured. That can best be achieved through appropriate coordination and cooperation between notified bodies.

(46)In order to ensure legal certainty, it is necessary to clarify that rules on internal market surveillance and control of products entering the internal market provided for in Regulation (EC) No 765/2008 apply to CE marked fertilising products covered by this Regulation. This Regulation should not prevent Member States from choosing the competent authorities to carry out those tasks.

(47)CE-marked fertilising products should be placed on the market only if they are sufficiently effective and do not present unacceptable risks to human, animal or plant health, to safety or to the environment when properly stored and used for their intended purpose, and under conditions of use which can be reasonably foreseen, that is when such use could result from lawful and readily predictable human behaviour. Therefore, requirements for safety and quality, as well as appropriate control mechanisms, should be established. Furthermore, the intended use of CE marked fertilising products should not lead to food or feed becoming unsafe.

(48)Regulation (EC) No 2003/2003 provides for a safeguard procedure allowing the Commission to examine the justification for a measure taken by a Member State against EC fertilisers considered to constitute a risk. In order to increase transparency and to reduce processing time, it is necessary to improve the existing safeguard procedure, with the view to making it more efficient and drawing on the expertise available in Member States.

(49)The existing system should be supplemented by a procedure under which interested parties are informed of measures intended to be taken with regard to CE marked fertilising products presenting an unacceptable risk to human, animal or plant health, to safety or to the environment. It should also allow market surveillance authorities, in cooperation with the relevant economic operators, to act at an early stage in respect of such fertilising products.

(50)Where the Member States and the Commission agree as to the justification of a measure taken by a Member State, further involvement of the Commission should be required only where non-compliance can be attributed to shortcomings of a harmonised standard, in which case the procedure of formal objection to harmonised standards laid down in Regulation (EU) No 1025/2012 should apply. 

(51)In order to ensure uniform conditions for the implementation of this Regulation, implementing powers should be conferred on the Commission. Those powers should be exercised in accordance with Regulation (EU) No 182/2011 of the European Parliament and of the Council 31 .

(52)The advisory procedure should be used for the adoption of implementing acts requiring the notifying Member State to take the necessary corrective measures in respect of notified bodies that do not meet or no longer meet the requirements for their notification, since such acts do not fall within the ambit of Article 2(2) of Regulation (EU) No 182/2011.

(53)The examination procedure should be used for the adoption of implementing acts with respect to compliant CE marked fertilising products which present an unacceptable risk to human, animal or plant health, to safety or to the environment, since such acts fall within the ambit of Article 2(2) of Regulation (EU) No 182/2011. For the same reason, it should also be used for the adoption, amendment or repeal of common specifications.

(54)The Commission should, by means of implementing acts, determine whether measures taken by Member States in respect of non-compliant CE marked fertilising products are justified or not. Since those acts will relate to the question whether national measures are justified, there is no need for the acts to be subject to control by the Member States.

(55)Promising technical progress is being made in the field of recycling of waste, such as phosphorus recycling from sewage sludge, and fertilising product production from animal by-products, such as biochar. It should be possible for products containing or consisting of such materials to access the internal market without unnecessary delay when the manufacturing processes have been scientifically analysed and process requirements have been established at Union level. For that purpose, the power to adopt acts in accordance with Article 290 of the Treaty on the Functioning of the European Union should be delegated to the Commission in respect of defining larger or additional categories of CE marked fertilising products or component materials eligible for use in the production of such products. For animal by-products, component material categories should be expanded or added only to the extent an end point in the manufacturing chain has been determined in accordance with the procedures laid down in Regulation (EC) No 1069/2009, since animal by-products for which no such end point has been determined are in any event excluded from the scope of this Regulation.

(56)Furthermore, it should be possible to react immediately to new findings regarding the conditions for CE marked fertilising products to be sufficiently effective and to new risk assessments regarding human, animal or plant health, safety or the environment. For that purpose, the power to adopt acts in accordance with Article 290 of the Treaty should be delegated to the Commission to amend the requirements applicable to various categories of CE marked fertilising products.

(57)In exercising those powers, it is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level. The Commission, when preparing and drawing up delegated acts, should ensure a simultaneous, timely and appropriate transmission of relevant documents to the European Parliament and to the Council.

(58)Member States should lay down rules on penalties applicable to infringements of this Regulation and ensure that those rules are enforced. The penalties provided for should be effective, proportionate and dissuasive.

(59)It is necessary to provide for transitional arrangements that allow the making available on the market of EC fertilisers that have been placed on the market in accordance with Regulation (EC) No 2003/2003 before the date of application of this Regulation without those products having to comply with further product requirements. Distributors should therefore be able to supply EC fertilisers that have been placed on the market, namely stock that is already in the distribution chain, before the date of application of this Regulation.

(60)It is necessary to provide for sufficient time for economic operators to comply with their obligations under this Regulation, and for Member States to set up the administrative infrastructure necessary for its application. The application should therefore be deferred to a date where those preparations can reasonably be finalised.

(61)Since the objective of this Regulation, namely to guarantee the functioning of the internal market while ensuring that CE marked fertilising products on the market fulfil the requirements providing for a high level of protection of human, animal, and plant health, safety and the environment, cannot be sufficiently achieved by the Member States but can rather, by reason of its scale and effects, be better achieved at Union level, the Union may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty on European Union. In accordance with the principle of proportionality, as set out in that Article, this Regulation does not go beyond what is necessary in order to achieve that objective,

HAVE ADOPTED THIS REGULATION:

Chapter 1
General provisions

Article 1
Scope

1.This Regulation shall apply to CE marked fertilising products.

However, this Regulation shall not apply to the following products:

(a)animal by-products which are subject to the requirements of Regulation (EC) No 1069/2009,

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

2.This Regulation shall not affect the application of the following acts :

(a)Directive 86/278/EEC;

(b)Directive 89/391/EEC;

(c)Regulation (EC) No 1907/2006;

(d)Regulation (EC) No 1272/2008;

(e)Regulation (EC) No 1881/2006;

(f)Directive 2000/29/EC;

(g)Regulation (EU) No 98/2013;

(h)Regulation (EU) No 1143/2014.

Article 2
Definitions

For the purposes of this Regulation, the following definitions shall apply:

(1)‘fertilising product’ means a substance, mixture, microorganism or any other material, applied or intended to be applied, either on its own or mixed with another material, on plants or their rhizosphere for the purpose of providing plants with nutrient or improving their nutrition efficiency;

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

(3)‘substance’ means a substance within the meaning of Article 3(1) of Regulation (EC) No 1907/2006;

(4)‘mixture’ means a mixture within the meaning of Article 3(2) of Regulation (EC) No 1907/2006;

(5)'micro-organism' means a micro-organism within the meaning of Article 3(15) of Regulation (EC) No 1107/2009;

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

(7)‘placing on the market’ means the first making available of a CE marked fertilising product on the Union market;

(8)‘manufacturer’ means a natural or legal person who manufactures a CE marked fertilising product or has a CE marked fertilising product designed or manufactured, and markets that fertilising product under his or her name or trademark;

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

(10)‘importer’ means any natural or legal person established within the Union who places a CE marked fertilising product from a third country on the Union market;

(11)‘distributor’ means any natural or legal person in the supply chain, other than the manufacturer or the importer, who makes a CE marked fertilising product available on the market;

(12)‘economic operators’ means manufacturers, authorised representatives, importers and distributors;

(13)'technical specification' means a document that prescribes technical requirements to be fulfilled by a CE marked fertilising product;

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

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

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

(17)‘conformity assessment’ means the process demonstrating whether the requirements provided in this Regulation relating to a CE marked fertilising product have been fulfilled;

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

(19)‘recall’ means any measure aimed at achieving the return of a CE marked fertilising product that has already been made available to the end-user;

(20)‘withdrawal’ means any measure aimed at preventing a CE marked fertilising product in the supply chain from being made available on the market;

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

(22)‘Union harmonisation legislation’ means any Union legislation harmonising the conditions for the marketing of products.

Article 3
Free movement

Member States shall not impede the making available on the market of CE marked fertilising products which comply with this Regulation.

Article 4
Product requirements

1.A CE marked fertilising product shall

(a)meet the requirements set out in Annex I for the relevant product function category;

(b)meet the requirements set out in Annex II for the relevant component material category or categories;

(c)be labelled in accordance with the labelling requirements set out in Annex III.

2.For any aspects not covered by Annex I or II, CE marked fertilising products shall meet the requirement that their use, as specified in the use instructions, does not lead to food or feed of plant origin becoming unsafe within the meaning of Articles 14 and 15 of Regulation (EC) No 178/2002, respectively.

Article 5
Making available on the market

CE marked fertilising products may be made available on the market only if they satisfy the requirements of the present Regulation.

Chapter 2
obligations of economic operators

Article 6
Obligations of manufacturers

1.When placing CE marked fertilising products on the market, manufacturers shall ensure that they have been designed and manufactured in accordance with the requirements set out in Annex I for the relevant product function category and the requirements set out in Annex II for the relevant component material category or categories.

2.Before placing CE marked fertilising products on the market, manufacturers shall draw up the technical documentation and carry out the relevant conformity assessment procedure referred to in Article 14, or have it carried out. Where compliance of such a fertilising product with the applicable requirements laid down in this Regulation has been demonstrated by that procedure, manufacturers shall affix the CE marking, draw up an EU declaration of conformity and ensure that the declaration accompanies the fertilising product when placed on the market.

3.Manufacturers shall keep the technical documentation and the EU declaration of conformity for 10 years after the CE marked fertilising product covered by those documents has been placed on the market.

4.Manufacturers shall ensure that procedures are in place for CE marked fertilising products that are part of a series production to remain in conformity with this Regulation. Changes in production method or characteristics of those fertilising products and changes in the harmonised standards, common specifications referred to in Article 13 or other technical specifications by reference to which conformity of a CE marked fertilising product is declared shall be adequately taken into account.

When deemed appropriate with regard to the performance of, or the risks presented by, a CE marked fertilising product, manufacturers shall carry out sample testing of such fertilising products made available on the market, investigate, and, if necessary, keep a register of complaints, of non-conforming CE marked fertilising products and recalls of such products, and shall keep distributors informed of any such monitoring.

5.Manufacturers shall ensure that the packaging of the CE marked fertilising products which they have placed on the market bears a type, batch or serial number or other element allowing their identification or, where the fertilising products are supplied without packaging, that the required information is provided in a document accompanying each fertilising product.

6.Manufacturers shall indicate their name, registered trade name or registered trade mark and the postal address at which they can be contacted on the packaging of the CE marked fertilising product or, where the fertilising product is supplied without packaging, in a document accompanying the fertilising product. The postal address shall indicate a single point at which the manufacturer can be contacted. The contact details shall be in a language easily understood by end-users and market surveillance authorities.

7.Manufacturers shall ensure that CE marked fertilising products are labelled in accordance with Annex III, or where the fertilising product is supplied without packaging, that the labelling statements are provided in a document accompanying the fertilising product and accessible for inspection purposes when the product is placed on the market. The labelling statement shall be in a language which can be easily understood by end-users, as determined by the Member State concerned, and shall be clear, understandable and intelligible.

8.Manufacturers who consider or have reason to believe that a CE marked fertilising product which they have placed on the market is not in conformity with this Regulation shall immediately take the corrective measures necessary to bring that fertilising product into conformity, to withdraw it or to recall it, if appropriate.

Furthermore, where manufacturers consider or have reason to believe that CE marked fertilising products which they have placed on the market present an unacceptable risk to human, animal or plant health, to safety or to the environment, they shall immediately inform the competent national authorities of the Member States in which they made the fertilising products available on the market to that effect, giving details, in particular, of any non-compliance and of any corrective measures taken.

9.Manufacturers shall, further to a reasoned request from a competent national authority, provide it with all the information and documentation, in paper or electronic form, necessary to demonstrate the conformity of the CE marked fertilising product with this Regulation, in a language which can be easily understood by that authority. They shall cooperate with that authority, at its request, on any action taken to eliminate the risks posed by CE marked fertilising products which they have placed on the market.

10.The manufacturer shall submit to the competent authority of the Member State of destination a report of the detonation resistance test prescribed in Annex IV for the following CE marked fertilising products:

(a)straight or compound solid inorganic macronutrient ammonium nitrate fertilisers of high nitrogen content, as specified in product function category 1(C)(I)(a)(iii)(A) in Annex I;

(b)fertilising product blends, as specified in product function category 7 in Annex I, containing a fertiliser referred to in point (a).

The report shall be submitted at least five days in advance of placing those products on the market.

Article 7
Authorised representative

1.A manufacturer may, by a written mandate, appoint an authorised representative.

The obligations laid down in Article 6(1) and the obligation to draw up technical documentation referred to in Article 6(2) shall not form part of the authorised representative's mandate.

2.An authorised representative shall perform the tasks specified in the mandate received from the manufacturer. The mandate shall allow the authorised representative to do at least the following:

(a)keep the EU declaration of conformity and the technical documentation at the disposal of national market surveillance authorities for 10 years after the CE marked fertilising product covered by those documents has been placed on the market;

(b)further to a reasoned request from a competent national authority, provide that authority with all the information and documentation necessary to demonstrate the conformity of a CE marked fertilising product;

(c)cooperate with the competent national authorities, at their request, on any action taken to eliminate the risks posed by CE marked fertilising products covered by the authorised representative's mandate.

Article 8
Obligations of importers

1.Importers shall place only compliant CE marked fertilising products on the market.

2.Before placing a CE marked fertilising product on the market importers shall ensure that the appropriate conformity assessment procedure referred to in Article 14 has been carried out by the manufacturer. They shall ensure that the manufacturer has drawn up the technical documentation, that the CE marked fertilising product is accompanied by the EU declaration of conformity and the required documents, and that the manufacturer has complied with the requirements set out in Article 6(5) and (6). Where an importer considers or has reason to believe that a CE marked fertilising product is not in conformity with the applicable requirements set out in Annex I, Annex II or Annex III, he or she shall not place the fertilising product on the market until it has been brought into conformity. Furthermore, where the CE marked fertilising product presents an unacceptable risk to human, animal or plant health, to safety or to the environment, the importer shall inform the manufacturer and the market surveillance authorities to that effect.

3.Importers shall indicate their name, registered trade name or registered trade mark and the postal address at which they can be contacted on the packaging of the CE marked fertilising product or, where the CE marked fertilising product is supplied without packaging, in a document accompanying the fertilising product. The contact details shall be in a language easily understood by end-users and market surveillance authorities.

4.Importers shall ensure that the CE marked fertilising product is labelled in accordance with Annex III in a language which can be easily understood by end-users, as determined by the Member State concerned.

5.Importers shall ensure that, while a CE marked fertilising product is under their responsibility, its storage or transport conditions do not jeopardise its compliance with the safety and quality requirements set out in Annex I or with the labelling requirements set out in Annex III.

6.When deemed appropriate with regard to the performance of or the risks presented by a CE marked fertilising product, importers shall carry out sample testing of such fertilising products made available on the market, investigate, and, if necessary, keep a register of complaints, of non-conforming CE marked fertilising products and recalls of such products, and shall keep distributors informed of any such monitoring.

7.Importers who consider or have reason to believe that a CE marked fertilising product which they have placed on the market is not in conformity with this Regulation shall immediately take the corrective measures necessary to bring that fertilising product into conformity, to withdraw it or to recall it, if appropriate.

Furthermore, where importers consider or have reason to believe that CE marked fertilising products which they have placed on the market present an unacceptable risk to human, animal or plant health, to safety or to the environment, they shall immediately inform the competent national authorities of the Member States in which they made the fertilising product available on the market to that effect, giving details, in particular, of any non-compliance and of any corrective measures taken.

8.Importers shall, for 10 years after the CE marked fertilising product has been placed on the market, keep a copy of the EU declaration of conformity at the disposal of the market surveillance authorities and ensure that the technical documentation can be made available to those authorities, upon request.

9.Importers shall, further to a reasoned request from a competent national authority, provide it with all the information and documentation, in paper or electronic form, necessary to demonstrate the conformity of the CE marked fertilising product in a language which can be easily understood by that authority. They shall cooperate with that authority, at its request, on any action taken to eliminate the risks posed by CE marked fertilising products which they have placed on the market.

10.The importer shall submit to the competent authority of the Member State of destination a report of the detonation resistance test prescribed in Annex IV for the following CE marked fertilising products:

(a)straight or compound solid inorganic macronutrient ammonium nitrate fertilisers of high nitrogen content, as specified in product function category 1(C)(I)(a)(iii)(A) in Annex I;

(b)fertilising product blends, as specified in product function category 7 in Annex I, containing a fertiliser referred to in point (a).

The report shall be submitted at least five days in advance of placing those products on the market.

Article 9
Obligations of distributors

1.When making a CE marked fertilising product available on the market distributors shall act with due care in relation to the requirements of this Regulation.

2.Before making a CE marked fertilising product available on the market distributors shall verify that it is accompanied by the EU declaration of conformity and by the required documents, that it is labelled in accordance with Annex III in a language which can be easily understood by end-users in the Member State in which the CE marked fertilising product is to be made available on the market, and that the manufacturer and the importer have complied with the requirements set out in Article 6(5) and (6) and Article 8(3) respectively.

Where a distributor considers or has reason to believe that a CE marked fertilising product is not in conformity with the applicable requirements set out in Annex I, Annex II or Annex III, he or she shall not make the fertilising product available on the market until it has been brought into conformity. Furthermore, where the CE marked fertilising product presents an unacceptable risk to human, animal or plant health, to safety or to the environment, the distributor shall inform the manufacturer or the importer to that effect as well as the market surveillance authorities.

3.Distributors shall ensure that, while a CE marked fertilising product is under their responsibility, its storage or transport conditions do not jeopardise its compliance with the safety and quality requirements set out in Annex I or the labelling requirements set out in Annex III.

4.Distributors who consider or have reason to believe that a CE marked fertilising product which they have made available on the market is not in conformity with this Regulation shall make sure that the corrective measures necessary to bring that fertilising product into conformity, to withdraw it or to recall it, if appropriate, are taken.

Furthermore, where distributors consider or have reason to believe that CE marked fertilising products which they have made available on the market presents an unacceptable risk to human, animal or plant health, to safety or to the environment, they shall immediately inform the competent national authorities of the Member States in which they made the CE marked fertilising product available on the market to that effect, giving details, in particular, of any non-compliance and of any corrective measures taken.

5.Distributors shall, further to a reasoned request from a competent national authority, provide it with all the information and documentation, in paper or electronic form, necessary to demonstrate the conformity of the CE marked fertilising product. They shall cooperate with that authority, at its request, on any action taken to eliminate the risks posed by CE marked fertilising products which they have made available on the market.

Article 10
Cases in which obligations of manufacturers apply to importers and distributors

An importer or distributor shall be considered a manufacturer for the purposes of this Regulation, and shall be subject to the obligations of the manufacturer under Article 6, where he or she places a CE marked fertilising product on the market under his or her name or trademark or modifies a CE marked fertilising product already placed on the market in such a way that compliance with this Regulation may be affected.

Article 11
Identification of economic operators

1.Economic operators shall, on request, identify the following to the market surveillance authorities:

(a)any economic operator who has supplied them with a CE marked fertilising product;

(b)any economic operator to whom they have supplied a CE marked fertilising product.

2.The economic operators shall be able to present the information referred to in the first paragraph for 10 years after they have been supplied with the CE marked fertilising product and for 10 years after they have supplied the CE marked fertilising product.

Chapter 3
conformity of CE marked fertilising products

Article 12
Presumption of conformity

Without prejudice to the common specifications referred to in Article 13, CE marked fertilising products which are in conformity with harmonised standards or parts thereof the references of which have been published in the Official Journal of the European Union shall be presumed to be in conformity with the requirements set out in Annexes I, II and III covered by those standards or parts thereof.

Article 13
Common specifications

The Commission may adopt implementing acts laying down common specifications, the compliance with which shall ensure conformity with the requirements set out in Annexes I, II and III covered by those specifications or parts thereof. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 41(3).

Article 14
Conformity assessment procedures

1.Conformity assessment of a CE marked fertilising product with the requirements in this Regulation shall be carried out by applying the conformity assessment procedure specified in Annex IV.

2.Records and correspondence relating to conformity assessment procedures shall be drawn up in the official language(s) of the Member State where the notified body carrying out the conformity assessment procedures is established, or in a language accepted by that body.

Article 15
EU declaration of conformity

1.The EU declaration of conformity shall state that the fulfilment of the requirements set out in Annexes I, II and III has been demonstrated.

2.The EU declaration of conformity shall have the model structure set out in Annex V, shall contain the elements specified in the relevant modules set out in Annex IV and shall be continuously updated. It shall be translated into the language or languages required by the Member State in which the CE marked fertilising product is placed or made available on the market.

3.Where a CE marked fertilising product is subject to more than one Union act requiring an EU declaration of conformity, a single EU declaration of conformity shall be drawn up in respect of all such Union acts. That declaration shall state the Union acts concerned and their publication references. It may be a dossier made up of relevant individual declarations of conformity.

4.By drawing up the EU declaration of conformity, the manufacturer shall assume responsibility for the compliance of the CE marked fertilising product with the requirements laid down in this Regulation.

Article 16
General principles of CE marking

The CE marking shall be subject to the general principles set out in Article 30 of Regulation (EC) No 765/2008.

Article 17
Rules and conditions for affixing the CE marking

1.The CE marking shall be affixed visibly, legibly and indelibly to the accompanying documents and, where the CE marked fertilising product is supplied in a packaged form, to the packaging.

2.The CE marking shall be affixed before the CE marked fertilising product is placed on the market.

3.The CE marking shall be followed by the identification number of the notified body involved in the conformity assessment referred to in Annex IV, Module D1.

The identification number of the notified body shall be affixed by the body itself or, under its instructions, by the manufacturer or his or her authorised representative.

4.Member States shall build upon existing mechanisms to ensure correct application of the regime governing the CE marking and shall take appropriate action in the event of improper use of that marking.

Article 18
End-of-waste status

A CE marked fertilising product that has undergone a recovery operation and complies with the requirements laid down in this Regulation shall be considered to comply with the conditions laid down in Article 6(1) of Directive 2008/98/EC and shall, therefore, be considered as having ceased to be waste.

Chapter 4
notification of conformity assessment bodies

Article 19
Notification

Member States shall notify the Commission and the other Member States of bodies authorised to carry out third-party conformity assessment tasks under this Regulation.

Article 20
Notifying authorities

1.Member States shall designate a notifying authority that shall be responsible for setting up and carrying out the necessary procedures for the assessment and notification of conformity assessment bodies and the monitoring of notified bodies, including compliance with Article 25.

2.Member States may decide that the assessment and monitoring referred to in paragraph 1 shall be carried out by a national accreditation body within the meaning of and in accordance with Regulation (EC) No 765/2008.

3.Where the notifying authority delegates or otherwise entrusts the assessment, notification or monitoring referred to in paragraph 1 to a body which is not a governmental entity, that body shall be a legal entity and shall comply mutatis mutandis with the requirements laid down in Article 21. In addition it shall have arrangements to cover liabilities arising out of its activities.

4.The notifying authority shall take full responsibility for the tasks performed by the body referred to in paragraph 3.

Article 21
Requirements relating to notifying authorities

1.A notifying authority shall be established in such a way that no conflict of interest with conformity assessment bodies occurs.

2.A notifying authority shall be organised and operated so as to safeguard the objectivity and impartiality of its activities.

3.A notifying authority shall be organised in such a way that each decision relating to notification of a conformity assessment body is taken by competent persons different from those who carried out the assessment.

4.A notifying authority shall not offer or provide any activities that conformity assessment bodies or consultancy services perform on a commercial or competitive basis.

5.A notifying authority shall safeguard the confidentiality of the information it obtains.

6.A notifying authority shall have a sufficient number of competent personnel at its disposal for the proper performance of its tasks.

Article 22
Information obligation on notifying authorities

Member States shall inform the Commission of their procedures for the assessment and notification of conformity assessment bodies and the monitoring of notified bodies, and of any changes thereto.

The Commission shall make that information publicly available.

Article 23
Requirements relating to notified bodies

1.For the purposes of notification, a conformity assessment body shall meet the requirements laid down in paragraphs 2 to 11.

2.A conformity assessment body shall be established under the national law of a Member State and have legal personality.

3.A conformity assessment body shall be a third-party body independent of the organisation or the CE marked fertilising products it assesses.

A body belonging to a business association or professional federation representing undertakings involved in the design, manufacturing, provision, or use of CE marked fertilising products which it assesses, may, on condition that its independence and the absence of any conflict of interest are demonstrated, be considered such a body.

4.A conformity assessment body, its top level management and the personnel responsible for carrying out the conformity assessment tasks shall not be the designer, manufacturer, supplier, purchaser, owner, or user of fertilising products nor the representative of any of those parties. This shall not preclude the use of fertilising products that are necessary for the operations of the conformity assessment body or the use of fertilising products for personal purposes.

A conformity assessment body, its top level management and the personnel responsible for carrying out the conformity assessment tasks shall not be directly involved in the design, manufacture, marketing, or use of fertilising products or represent the parties engaged in those activities. They shall not engage in any activity that may conflict with their independence of judgement or integrity in relation to conformity assessment activities for which they are notified. This shall in particular apply to consultancy services.

Conformity assessment bodies shall ensure that the activities of their subsidiaries or subcontractors do not affect the confidentiality, objectivity or impartiality of their conformity assessment activities.

5.Conformity assessment bodies and their personnel shall carry out the conformity assessment activities with the highest degree of professional integrity and the requisite technical competence in the specific field and shall be free from all pressures and inducements, particularly financial, which might influence their judgement or the results of their conformity assessment activities, especially as regards persons or groups of persons with an interest in the results of those activities.

6.A conformity assessment body shall be capable of carrying out all the conformity assessment tasks assigned to it by Annex IV and in relation to which it has been notified, whether those tasks are carried out by the conformity assessment body itself or on its behalf and under its responsibility.

At all times and for each conformity assessment procedure and each kind or category of CE marked fertilising products in relation to which it has been notified, a conformity assessment body shall have at its disposal the necessary:

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

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

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

A conformity assessment body shall have the means necessary to perform the technical and administrative tasks connected with the conformity assessment activities in an appropriate manner and shall have access to all necessary equipment or facilities.

7.The personnel responsible for carrying out the conformity assessment tasks shall have the following:

(a)sound technical and vocational training covering all the conformity assessment activities in relation to which the conformity assessment body has been notified;

(b)satisfactory knowledge of the requirements of the assessments they carry out and adequate authority to carry out those assessments;

(c)appropriate knowledge and understanding of the requirements set out in Annex I, Annex II and Annex III, of the applicable harmonised standards and of the relevant provisions of Union harmonisation legislation and of national legislation;

(d)the ability to draw up certificates, records and reports demonstrating that assessments have been carried out.

8.The impartiality of the conformity assessment bodies, their top level management and of the personnel responsible for carrying out the conformity assessment tasks shall be guaranteed.

The remuneration of the top level management and personnel responsible for carrying out the conformity assessment tasks of a conformity assessment body shall not depend on the number of assessments carried out or on the results of those assessments.

9.Conformity assessment bodies shall take out liability insurance unless liability is assumed by the State in accordance with national law, or the Member State itself is directly responsible for the conformity assessment.

10.The personnel of a conformity assessment body shall observe professional secrecy with regard to all information obtained in carrying out their tasks under Annex IV, except in relation to the competent authorities of the Member State in which its activities are carried out. Proprietary rights shall be protected.

11.Conformity assessment bodies shall participate in, or ensure that their personnel responsible for carrying out the conformity assessment tasks are informed of, the relevant standardisation activities and the activities of the notified body coordination group established under Article 35 and shall apply as general guidance the administrative decisions and documents produced as a result of the work of that group.

Article 24
Presumption of conformity of notified bodies

Where a conformity assessment body demonstrates its conformity with the criteria laid down in the relevant harmonised standards or parts thereof the references of which have been published in the Official Journal of the European Union it shall be presumed to comply with the requirements set out in Article 23 in so far as the applicable harmonised standards cover those requirements.

Article 25
Subsidiaries of and subcontracting by notified bodies

1.Where a notified body subcontracts specific tasks connected with conformity assessment or has recourse to a subsidiary, it shall ensure that the subcontractor or the subsidiary meets the requirements set out in Article 23 and shall inform the notifying authority accordingly.

2.Notified bodies shall take full responsibility for the tasks performed by subcontractors or subsidiaries wherever these are established.

3.Activities may be subcontracted or carried out by a subsidiary only with the agreement of the client.

4.Notified bodies shall keep at the disposal of the notifying authority the relevant documents concerning the assessment of the qualifications of the subcontractor or the subsidiary and the work carried out by them under Annex IV.

Article 26
Application for notification

1.A conformity assessment body shall submit an application for notification to the notifying authority of the Member State in which it is established.

2.The application for notification shall be accompanied by a description of the conformity assessment activities, the conformity assessment module or modules and the CE marked fertilising product or products for which that body claims to be competent, as well as by an accreditation certificate issued by a national accreditation body attesting that the conformity assessment body fulfils the requirements laid down in Article 23.

Article 27
Notification procedure

1.Notifying authorities may notify only conformity assessment bodies which have satisfied the requirements laid down in Article 23.

2.They shall notify the Commission and the other Member States using the electronic notification tool developed and managed by the Commission.

3.The notification shall include full details of the conformity assessment activities, the conformity assessment module or modules and CE marked fertilising product or products concerned and the accreditation certificate referred to in Article 26(2).

4.The body concerned may perform the activities of a notified body only where no objections are raised by the Commission or the other Member States within two weeks of a notification.

Only such a body shall be considered a notified body for the purposes of this Regulation.

5.The notifying authority shall notify the Commission and the other Member States of any subsequent relevant changes to the notification.

Article 28
Identification numbers and lists of notified bodies

1.The Commission shall assign an identification number to a notified body.

It shall assign a single such number even where the body is notified under several Union acts.

2.The Commission shall make publicly available the list of the bodies notified under this Regulation, including the identification numbers that have been assigned to them and the activities for which they have been notified.

The Commission shall ensure that the list is kept up to date.

Article 29
Changes to notifications

1.Where a notifying authority has ascertained or has been informed that a notified body no longer meets the requirements laid down in Article 23 or that it is failing to fulfil its obligations, the notifying authority shall restrict, suspend or withdraw notification as appropriate, depending on the seriousness of the failure to meet those requirements or fulfil those obligations. It shall immediately inform the Commission and the other Member States accordingly.

2.In the event of restriction, suspension or withdrawal of notification, or where the notified body has ceased its activity, the notifying Member State shall take appropriate steps to ensure that the files of that body are either processed by another notified body or kept available for the responsible notifying and market surveillance authorities at their request.

Article 30
Challenge of the competence of notified bodies

1.The Commission shall investigate all cases where it doubts, or doubt is brought to its attention regarding, the competence of a notified body or the continued fulfilment by a notified body of the requirements and responsibilities to which it is subject.

2.The notifying Member State shall provide the Commission, on request, with all information relating to the basis for the notification or the maintenance of the competence of the notified body concerned.

3.The Commission shall ensure that all sensitive information obtained in the course of its investigations is treated confidentially.

4.Where the Commission ascertains that a notified body does not meet or no longer meets the requirements for its notification, it shall adopt an implementing act requiring the notifying Member State to take the necessary corrective measures, including withdrawal of notification if necessary.

That implementing act shall be adopted in accordance with the advisory procedure referred to in Article 41(2).

Article 31
Operational obligations of notified bodies

1.Notified bodies shall carry out conformity assessments in accordance with the conformity assessment procedures provided for in Annex IV.