REGULATION (EU) 2019/1009 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL
of 5 June 2019
laying down rules on the making available on the market of EU fertilising products and amending Regulations (EC) No 1069/2009 and (EC) No 1107/2009 and repealing Regulation (EC) No 2003/2003
(Text with EEA relevance)
CHAPTER I
GENERAL PROVISIONS
Article 1
Scope
Article 2
Definitions
Article 3
Free movement
Article 4
Product requirements
Article 5
Making available on the market
CHAPTER II
OBLIGATIONS OF ECONOMIC OPERATORS
Article 6
Obligations of manufacturers
Article 7
Authorised representative
Article 8
Obligations of importers
Article 9
Obligations of distributors
Article 10
Cases in which obligations of manufacturers apply to importers and distributors
Article 11
Packaging and repackaging by importers and distributors
Article 12
Identification of economic operators
CHAPTER III
CONFORMITY OF EU FERTILISING PRODUCTS
Article 13
Presumption of conformity
Article 14
Common specifications
Article 15
Conformity assessment procedures
Article 16
EU declaration of conformity
Article 17
General principles of CE marking
Article 18
Rules and conditions for affixing the CE marking
Article 19
End-of-waste status
CHAPTER IV
NOTIFICATION OF CONFORMITY ASSESSMENT BODIES
Article 20
Notification
Article 21
Notifying authorities
Article 22
Requirements relating to notifying authorities
Article 23
Information obligation on notifying authorities
Article 24
Requirements relating to notified bodies
Article 25
Presumption of conformity of notified bodies
Article 26
Subsidiaries of and subcontracting by notified bodies
Article 27
Application for notification
Article 28
Notification procedure
Article 29
Identification numbers and lists of notified bodies
Article 30
Changes to notifications
Article 31
Challenge of the competence of notified bodies
Article 32
Operational obligations of notified bodies
Article 33
Appeal against decisions of notified bodies
Article 34
Information obligation on notified bodies
Article 35
Exchange of experience
Article 36
Coordination of notified bodies
CHAPTER V
UNION MARKET SURVEILLANCE, CONTROL OF EU FERTILISING PRODUCTS ENTERING THE UNION MARKET AND UNION SAFEGUARD PROCEDURE
Article 37
Union market surveillance and control of EU fertilising products entering the Union market
Article 38
Procedure at national level for dealing with EU fertilising products presenting a risk
Article 39
Union safeguard procedure
Article 40
Compliant EU fertilising products which present a risk
Article 41
Formal non-compliance
CHAPTER VI
DELEGATED POWERS AND COMMITTEE PROCEDURE
Article 42
Amendments of Annexes
Article 43
Separate delegated acts for separate component material categories
Article 44
Exercise of the delegation
Article 45
Committee procedure
CHAPTER VII
AMENDMENTS
Article 46
Amendments to Regulation (EC) No 1069/2009
‘Article 51a
Exercise of the delegation
Article 47
Amendments to Regulation (EC) No 1107/2009
CHAPTER VIII
TRANSITIONAL AND FINAL PROVISIONS
Article 48
Penalties
Article 49
Report
Article 50
Biodegradability review
Article 51
Repeal of Regulation (EC) No 2003/2003
Article 52
Transitional provisions
Article 53
Entry into force and application
ANNEX I
Product Function Categories (PFCs) of EU fertilising products
PART I
DESIGNATION OF PFCS
1. Fertiliser
A. Organic fertiliser
B. Organo-mineral fertiliser
C. Inorganic fertiliser
2. Liming material
3. Soil improver
4. Growing medium
5. Inhibitor
6. Plant biostimulant
7. Fertilising product blend
PART II
REQUIREMENTS RELATED TO PFCS
PFC 1: FERTILISER
PFC 1(A): ORGANIC FERTILISER
Micro-organisms to be tested |
Sampling plans |
Limit |
||
n |
c |
m |
M |
|
Salmonella spp. |
5 |
0 |
0 |
Absence in 25 g or 25 ml |
Escherichia coli or Enterococcaceae |
5 |
5 |
0 |
1 000 in 1 g or 1 ml |
PFC 1(A)(I): SOLID ORGANIC FERTILISER
PFC 1(A)(II): LIQUID ORGANIC FERTILISER
PFC 1(B): ORGANO-MINERAL FERTILISER
Micro-organisms to be tested |
Sampling plans |
Limit |
||
n |
c |
m |
M |
|
Salmonella spp. |
5 |
0 |
0 |
Absence in 25 g or 25 ml |
Escherichia coli or Enterococcaceae |
5 |
5 |
0 |
1 000 in 1 g or 1 ml |
PFC 1(B)(I): SOLID ORGANO-MINERAL FERTILISER
PFC 1(B)(II): LIQUID ORGANO-MINERAL FERTILISER
PFC 1(C): INORGANIC FERTILISER
Micro-organisms to be tested |
Sampling plans |
Limit |
||
n |
c |
m |
M |
|
Salmonella spp. |
5 |
0 |
0 |
Absence in 25 g or 25 ml |
Escherichia coli or Enterococcaceae |
5 |
5 |
0 |
1 000 in 1 g or 1 ml |
PFC 1(C)(I): INORGANIC MACRONUTRIENT FERTILISER
PFC 1(C)(I)(a): SOLID INORGANIC MACRONUTRIENT FERTILISER
PFC 1(C)(I)(a)(i): STRAIGHT SOLID INORGANIC MACRONUTRIENT FERTILISER
PFC 1(C)(I)(a)(ii): COMPOUND SOLID INORGANIC MACRONUTRIENT FERTILISER
PFC 1(C)(I)(a)(i-ii)(A): STRAIGHT OR COMPOUND SOLID INORGANIC MACRONUTRIENT AMMONIUM NITRATE FERTILISER OF HIGH NITROGEN CONTENT
PFC 1(C)(I)(b): LIQUID INORGANIC MACRONUTRIENT FERTILISER
PFC 1(C)(I)(b)(i): STRAIGHT LIQUID INORGANIC MACRONUTRIENT FERTILISER
PFC 1(C)(I)(b)(ii): COMPOUND LIQUID INORGANIC MACRONUTRIENT FERTILISER
PFC 1(C)(II): INORGANIC MICRONUTRIENT FERTILISER
Contaminant |
Limit values of contaminants expressed in mg, in relation to the total micronutrient content expressed in kg ( mg/kg of total micronutrient content, which means boron (B), cobalt (Co), copper (Cu), iron (Fe), manganese (Mn), molybdenum (Mo) and zinc (Zn)) |
Arsenic (As) |
1 000 |
Cadmium (Cd) |
200 |
Lead (Pb) |
600 |
Mercury (Hg) |
100 |
Nickel (Ni) |
2 000 |
PFC 1(C)(II)(a): STRAIGHT INORGANIC MICRONUTRIENT FERTILISER
Typology |
Description |
Minimum micronutrient content |
||||
Micronutrient salt fertiliser |
A chemically obtained straight solid inorganic micronutrient fertiliser containing a mineral ion salt as its essential ingredient |
10 % by mass of micronutrient salt fertiliser shall consist of a water-soluble micronutrient |
||||
Micronutrient oxide or hydroxide fertiliser |
A chemically obtained straight solid inorganic micronutrient fertiliser containing oxide or hydroxide as its essential ingredient |
10 % by mass of a micronutrient oxide or hydroxide fertiliser shall consist of a micronutrient |
||||
Micronutrient-based fertiliser |
A straight inorganic micronutrient fertiliser combining a micronutrient salt fertiliser with one or more other micronutrient salt fertilisers and/or with a single micronutrient chelate |
5 % by mass of a micronutrient-based fertiliser shall consist of a micronutrient |
||||
Micronutrient solution fertiliser |
An aqueous solution of different forms of a straight inorganic micronutrient fertiliser |
2 % by mass of a micronutrient solution fertiliser shall consist of a water-soluble micronutrient |
||||
Micronutrient suspension fertiliser |
A suspension of different forms of a straight inorganic micronutrient fertiliser |
2 % by mass of a micronutrient suspension fertiliser shall consist of a micronutrient |
||||
Micronutrient chelate fertiliser |
A water-soluble straight inorganic micronutrient fertiliser in which the declared micronutrient is chemically combined with chelating agent(s) fulfilling the requirements of CMC 1 in Part II of Annex II |
|
||||
UVCB(5) iron chelates |
A water-soluble straight inorganic micronutrient fertiliser in which the declared iron is chemically combined with chelating agent(s) fulfilling the requirements of CMC 1 in Part II of Annex II |
|
||||
Micronutrient complex fertiliser |
A water-soluble straight inorganic micronutrient fertiliser in which the declared micronutrient is chemically combined with complexing agent(s) fulfilling the requirements of CMC 1 in Part II of Annex II |
|
PFC 1(C)(II)(b): COMPOUND INORGANIC MICRONUTRIENT FERTILISER
PFC 2: LIMING MATERIAL
PFC 3: SOIL IMPROVER
PFC 3(A): ORGANIC SOIL IMPROVER
Micro-organisms to be tested |
Sampling plans |
Limit |
||
n |
c |
m |
M |
|
Salmonella spp. |
5 |
0 |
0 |
Absence in 25 g or 25 ml |
Escherichia coli or Enterococcaceae |
5 |
5 |
0 |
1 000 in 1 g or 1 ml |
PFC 3(B): INORGANIC SOIL IMPROVER
PFC 4: GROWING MEDIUM
Micro-organisms to be tested |
Sampling plans |
Limit |
||
n |
c |
m |
M |
|
Salmonella spp. |
5 |
0 |
0 |
Absence in 25 g or 25 ml |
Escherichia coli or Enterococcaceae |
5 |
5 |
0 |
1 000 in 1 g or 1 ml |
PFC 5: INHIBITOR
PFC 5(A): NITRIFICATION INHIBITOR
PFC 5(B): DENITRIFICATION INHIBITOR
PFC 5(C): UREASE INHIBITOR
PFC 6: PLANT BIOSTIMULANT
PFC 6(A): MICROBIAL PLANT BIOSTIMULANT
Micro-organisms/their toxins, metabolites |
Sampling plans |
Limit |
|
n |
c |
||
Salmonella spp. |
5 |
0 |
Absence in 25 g or 25 ml |
Escherichia coli |
5 |
0 |
Absence in 1 g or 1 ml |
Listeria monocytogenes |
5 |
0 |
Absence in 25 g or 25 ml |
Vibrio spp. |
5 |
0 |
Absence in 25 g or 25 ml |
Shigella spp. |
5 |
0 |
Absence in 25 g or 25 ml |
Staphylococcus aureus |
5 |
0 |
Absence in 25 g or 25 ml |
Enterococcaceae |
5 |
2 |
10 CFU/g |
Anaerobic plate count unless the microbial plant biostimulant is an aerobic bacterium |
5 |
2 |
105 CFU/g or ml |
Yeast and mould count unless the microbial plant biostimulant is a fungus |
5 |
2 |
1 000 CFU/g or ml |
PFC 6(B): NON-MICROBIAL PLANT BIOSTIMULANT
Micro-organisms to be tested |
Sampling plans |
Limit |
||
n |
c |
m |
M |
|
Salmonella spp. |
5 |
0 |
0 |
Absence in 25 g or 25 ml |
Escherichia coli or Enterococcaceae |
5 |
5 |
0 |
1 000 in 1 g or 1 ml |
PFC 7: FERTILISING PRODUCT BLEND
ANNEX II
Component Material Categories (CMCs)
PART I
DESIGNATION OF CMCS
PART II
REQUIREMENTS RELATED TO CMCS
CMC 1: VIRGIN MATERIAL SUBSTANCES AND MIXTURES
CMC 2: PLANTS, PLANT PARTS OR PLANT EXTRACTS
CMC 3: COMPOST
CMC 4: FRESH CROP DIGESTATE
CMC 5: DIGESTATE OTHER THAN FRESH CROP DIGESTATE
CMC 6: FOOD INDUSTRY BY-PRODUCTS
CMC 7: MICRO-ORGANISMS
Azotobacter spp. |
Mycorrhizal fungi |
Rhizobium spp. |
Azospirillum spp. |
CMC 8: NUTRIENT POLYMERS
CMC 9: POLYMERS OTHER THAN NUTRIENT POLYMERS
CMC 10: DERIVED PRODUCTS WITHIN THE MEANING OF REGULATION (EC) NO 1069/2009
CMC 11: BY-PRODUCTS WITHIN THE MEANING OF DIRECTIVE 2008/98/EC
ANNEX III
Labelling requirements
PART I
GENERAL LABELLING REQUIREMENTS
PART II
PRODUCT-SPECIFIC LABELLING REQUIREMENTS
PFC 1: FERTILISER
PFC 1(A): ORGANIC FERTILISER
PFC 1(B): ORGANO-MINERAL FERTILISER
Micronutrient |
Content of micronutrient (% by mass) |
||
Solid organo-mineral fertiliser |
Liquid organo-mineral fertiliser |
||
Intended for use on crops or grassland |
Intended for horticultural use |
||
Boron (B) |
0,01 |
0,01 |
0,01 |
Cobalt (Co) |
0,002 |
n.a. |
0,002 |
Iron (Fe) |
0,5 |
0,02 |
0,02 |
Manganese (Mn) |
0,1 |
0,01 |
0,01 |
Molybdenum (Mo) |
0,001 |
0,001 |
0,001 |
Micronutrient |
Content of micronutrient (% by mass) |
||
Solid organo-mineral fertiliser |
Liquid organo-mineral fertiliser |
||
Intended for use on crops or grassland |
Intended for horticultural use |
||
Copper (Cu) |
0,01 |
0,002 |
0,002 |
Zinc (Zn) |
0,01 |
0,002 |
0,002 |
PFC 1(C): INORGANIC FERTILISER
PFC 1(C)(I): INORGANIC MACRONUTRIENT FERTILISER
PFC 1(C)(I)(a): SOLID INORGANIC MACRONUTRIENT FERTILISER
Micronutrient |
Content of micronutrients (% by mass) |
|
Intended for use on crops or grassland |
Intended for horticultural use |
|
Boron (B) |
0,01 |
0,01 |
Cobalt (Co) |
0,002 |
n.a. |
Iron (Fe) |
0,5 |
0,02 |
Manganese (Mn) |
0,1 |
0,01 |
Molybdenum (Mo) |
0,001 |
0,001 |
Micronutrient |
Content of micronutrients (% by mass) |
|
Intended for use on crops or grassland |
Intended for horticultural use |
|
Copper (Cu) |
0,01 |
0,002 |
Zinc (Zn) |
0,01 |
0,002 |
PFC 1(C)(I)(b): LIQUID INORGANIC MACRONUTRIENT FERTILISER
Micronutrient |
Content of micronutrient (% by mass) |
Boron (B) |
0,01 |
Cobalt (Co) |
0,002 |
Iron (Fe) |
0,02 |
Manganese (Mn) |
0,01 |
Molybdenum (Mo) |
0,001 |
PFC 1(C)(II): INORGANIC MICRONUTRIENT FERTILISER
PFC 1(C)(II)(a): STRAIGHT INORGANIC MICRONUTRIENT FERTILISER
PFC 1(C)(II)(b): COMPOUND INORGANIC MICRONUTRIENT FERTILISER
Micronutrient |
Content of micronutrient (% by mass) |
|
Non-chelated, non-complexed |
Chelated or complexed |
|
Boron (B) |
0,2 |
n.a. |
Cobalt (Co) |
0,02 |
0,02 |
Copper (Cu) |
0,5 |
0,1 |
Iron (Fe) |
2 |
0,3 |
Manganese (Mn) |
0,5 |
0,1 |
Molybdenum (Mo) |
0,02 |
n.a. |
Zinc (Zn) |
0,5 |
0,1 |
PFC 2: LIMING MATERIAL
PFC 3: SOIL IMPROVER
PFC 3(A): ORGANIC SOIL IMPROVER
PFC 4: GROWING MEDIUM
PFC 5: INHIBITOR
PFC 6: PLANT BIOSTIMULANT
PFC 6(A): MICROBIAL PLANT BIOSTIMULANT
PFC 7: FERTILISING PRODUCT BLEND
PART III
TOLERANCE RULES
PFC 1: FERTILISER
Inhibitors |
Permissible tolerance for the declared content of inhibitors |
Concentration below or equal to 2 % |
± 20 % of the declared value |
Concentration of more than 2 % |
± 0,3 percentage points in absolute terms |
PFC 1(A): ORGANIC FERTILISER
Forms of the declared nutrient and other declared parameters |
Permissible tolerance for the declared nutrient content and other declared parameters |
Organic carbon (Corg) |
± 20 % relative deviation of the declared value up to a maximum of 2,0 percentage points in absolute terms |
Dry matter content |
± 5,0 percentage points in absolute terms |
Total nitrogen (N) |
± 50 % relative deviation of the declared value up to a maximum of 1,0 percentage point in absolute terms |
Organic nitrogen (Norg) |
± 50 % relative deviation of the declared value up to a maximum of 1,0 percentage point in absolute terms |
Total phosphorus pentoxide (P2O5) |
± 50 % relative deviation of the declared value up to a maximum of 1,0 percentage point in absolute terms |
Total potassium oxide (K2O) |
± 50 % relative deviation of the declared value up to a maximum of 1,0 percentage point in absolute terms |
Total and water-soluble magnesium oxide (MgO), calcium oxide (CaO), sulphur trioxide(SO3) or sodium oxide (Na2O) |
± 25 % of the declared content of those nutrients up to a maximum of 1,5 percentage points in absolute terms |
Organic carbon (Corg)/total nitrogen (N) |
± 20 % relative deviation of the declared value up to a maximum of 2,0 percentage points in absolute terms |
Quantity |
± 1,5 % relative deviation of the declared value |
PFC 1(B): ORGANO-MINERAL FERTILISER
Forms of the declared nutrient and other declared parameters |
Permissible tolerance for the declared macronutrient content and other declared parameters |
Organic carbon (Corg) |
± 20 % relative deviation of the declared value up to a maximum of 2,0 percentage points in absolute terms |
Dry matter content |
± 5,0 percentage points in absolute terms |
Declared forms of inorganic nitrogen (N) |
± 25 % relative deviation of the declared value up to a maximum of 2,0 percentage points in absolute terms |
Organic nitrogen (Norg) |
± 50 % relative deviation of the declared value up to a maximum of 1,0 percentage point in absolute terms |
Declared forms of phosphorus pentoxide (P2O5) |
± 25 % relative deviation of the declared value up to a maximum of 1,5 percentage points in absolute terms |
Declared forms of potassium oxide (K2O) |
± 25 % relative deviation of the declared value up to a maximum of 1,5 percentage points in absolute terms |
Total and water-soluble magnesium oxide (MgO), calcium oxide (CaO), sulphur trioxide (SO3) |
± 25 % of the declared content of those nutrients up to a maximum of 1,0 percentage point in absolute terms |
Total and water-soluble sodium oxide (Na2O) |
± 25 % of the declared content up to a maximum of 0,9 percentage point in absolute terms |
Quantity |
± 1,5 % relative deviation of the declared value |
Micronutrient |
Permissible tolerance for the declared content of forms of micronutrient |
Concentration below or equal to 2 % |
± 20 % of the declared value |
Concentration of more than 2 % and below or equal to 10 % |
± 20 % of the declared value up to a maximum of 1,0 percentage point in absolute terms |
Concentration of more than 10 % |
± 1,0 percentage point in absolute terms |
PFC 1(C): INORGANIC FERTILISER
Forms of the declared nutrient and other declared parameters |
Permissible tolerance for the declared macronutrient content and other declared parameters |
Declared forms of nitrogen (N) |
± 20 % relative deviation of the declared value up to a maximum of 1,5 percentage points in absolute terms |
Declared forms of phosphorus pentoxide (P2O5) |
± 20 % relative deviation of the declared value up to a maximum of 1,5 percentage points in absolute terms |
Declared forms of potassium oxide (K2O) |
± 20 % relative deviation of the declared value up to a maximum of 1,5 percentage points in absolute terms |
Declared forms of nitrogen (N), phosphorus pentoxide (P2O5) or potassium oxide (K2O) in binary fertilisers |
± 1,5 percentage points in absolute terms |
Declared forms of nitrogen (N), phosphorus pentoxide (P2O5) or potassium oxide (K2O) in tertiary fertilisers |
± 1,9 percentage points in absolute terms |
Total and water-soluble magnesium oxide (MgO), calcium oxide (CaO), sulphur trioxide (SO3) |
± 25 % of the declared content of those nutrients up to a maximum of 1,0 percentage point in absolute terms |
Total and water soluble sodium oxide (Na2O) |
– 25 % of the declared content up to a maximum of 0,9 percentage point in absolute terms + 50 % of the declared content up to a maximum of 1,8 percentage points in absolute terms |
Granulometry |
± 10 % relative deviation of the declared percentage of material passing a specific sieve |
Quantity |
± 1 % relative deviation of the declared value |
Micronutrient |
Permissible tolerance for the declared content of forms of micronutrient |
Concentration below or equal to 2 % |
± 20 % of the declared value |
Concentration of more than 2 % and below or equal to 10 % |
± 20 % of the declared value up to a maximum of 1,0 percentage point in absolute terms |
Concentration of more than 10 % |
± 1,0 percentage point in absolute terms |
PFC 2: LIMING MATERIAL
Forms of the declared nutrient and other declared parameters |
Permissible tolerances for the declared parameter |
Neutralising value |
± 3 |
Granulometry |
± 10 % relative deviation of the declared percentage of material passing a specific sieve. |
Total calcium oxide (CaO) |
± 3,0 percentage points in absolute terms |
Total magnesium oxide (MgO) |
|
Concentration below 8 % |
± 1,0 percentage point in absolute terms |
Concentration between 8 to 16 % |
± 2,0 percentage points in absolute terms |
Concentration above or equal to 16 % |
± 3,0 percentage points in absolute terms |
Reactivities (hydrochloric acid test and incubation test) |
± 5,0 percentage points in absolute terms |
Quantity |
± 1 % relative deviation of the declared value |
PFC 3: SOIL IMPROVER
Forms of the declared nutrient and other declared parameters |
Permissible tolerances for the declared parameter |
pH |
± 1,0 of the declared value |
Organic carbon (Corg) |
± 10 % relative deviation of the declared value up to a maximum of 1,0 percentage point in absolute terms |
Organic nitrogen (Norg) |
± 50 % relative deviation of the declared value up to a maximum of 1,0 percentage point in absolute terms |
Total nitrogen (N) |
± 20 % relative deviation up to a maximum of 1,0 percentage point in absolute terms |
Total phosphorus pentoxide (P2O5) |
± 20 % relative deviation up to a maximum of 1,0 percentage point in absolute terms |
Total potassium oxide (K2O) |
± 20 % relative deviation up to a maximum of 1,0 percentage point in absolute terms |
Dry matter content |
± 10 % relative deviation of the declared value |
Quantity |
± 5 % relative deviation of the declared value |
Electrical conductivity |
± 75 % relative deviation of the declared value |
PFC 4: GROWING MEDIUM
Forms for the declared nutrient and other declared parameters |
Permissible tolerances for the declared parameter |
Electrical conductivity |
± 75 % relative deviation of the declared value |
pH |
± 1,0 of the declared value |
Quantity by volume (litres or m3) |
± 5 % relative deviation of the declared value |
Quantity (volume) determination of materials with particle size greater than 60 mm |
± 5 % relative deviation of the declared value |
Quantity (volume) determination of pre-shaped growing medium |
± 5 % relative deviation of the declared value |
Nitrogen (N) extractable by CaCl2/DTPA (calcium chloride/ diethylenetriaminepentaacetic acid; ‘CAT-soluble’) |
± 75 % relative deviation of the declared value |
Phosphorus pentoxide (P2O5) extractable by CaCl2/DTPA (calcium chloride/ diethylenetriaminepentaacetic acid; ‘CAT-soluble’) |
± 75 % relative deviation of the declared value |
Potassium oxide (K2O) extractable by CaCl2/DTPA (calcium chloride/ diethylenetriaminepentaacetic acid; ‘CAT-soluble’) |
± 75 % relative deviation of the declared value |
PFC 5: INHIBITOR
Inhibiting compound |
Permissible tolerance for the declared content of inhibiting compound |
Concentration below or equal to 2 % |
± 20 % of the declared value |
Concentration of more than 2 % |
± 0,3 percentage point in absolute terms |
PFC 6(A): MICROBIAL PLANT BIOSTIMULANT
PFC 7: FERTILISING PRODUCT BLEND
Declared concentration in g/kg or g/l at 20 °C |
Permissible tolerance |
Up to 25 |
± 15 % relative deviation |
More than 25 up to 100 |
± 10 % relative deviation |
More than 100 up to 250 |
± 6 % relative deviation |
More than 250 up to 500 |
± 5 % relative deviation |
More than 500 |
± 25 g/kg or ± 25 g/l |
ANNEX IV
Conformity assessment procedures
PART I
APPLICABILITY OF CONFORMITY ASSESSMENT PROCEDURES
1. APPLICABILITY OF INTERNAL PRODUCTION CONTROL (MODULE A)
2. APPLICABILITY OF INTERNAL PRODUCTION CONTROL PLUS SUPERVISED PRODUCT TESTING (MODULE A1)
3. APPLICABILITY OF EU-TYPE EXAMINATION (MODULE B) FOLLOWED BY CONFORMITY TO TYPE BASED ON INTERNAL PRODUCTION CONTROL (MODULE C)
4. APPLICABILITY OF QUALITY ASSURANCE OF THE PRODUCTION PROCESS (MODULE D1)
PART II
DESCRIPTION OF CONFORMITY ASSESSMENT PROCEDURES
MODULE A – INTERNAL PRODUCTION CONTROL
1. Description of the module
2. Technical documentation
3. Manufacturing
4. CE marking and EU declaration of conformity
5. Authorised representative
MODULE A1 – INTERNAL PRODUCTION CONTROL PLUS SUPERVISED PRODUCT TESTING
1. Description of the module
2. Technical documentation
3. Manufacturing
4. Product checks for oil retention and detonation resistance
4.1. Thermal cycles prior to a test for compliance with the oil retention requirement referred to in point 4 under PFC 1(C)(I)(a)(i-ii)(A) in Annex I
4.1.1. Principle and definition
4.1.2. Apparatus
4.1.3. Procedure
4.2. Oil retention test referred to in point 4 under PFC 1(C)(I)(a)(i-ii)(A) in Annex I
4.2.1. Description
4.2.2. Principle
4.2.3. Reagents
4.2.4. Apparatus
4.2.5. Procedure
4.2.6. Test report
4.2.6.1. Expression of the results
4.2.6.1.1. Method of calculation and formula
4.3. Thermal cycles prior to the detonation resistance test referred to in point 5 under PFC 1(C)(I)(a)(i-ii)(A) in Annex I
4.3.1. Principle and definition
4.3.2. Apparatus
Method 1
Method 2
4.3.3. Procedure
Figure 1
4.4. Detonation resistance test referred to in point 5 under PFC 1(C)(I)(a)(i-ii)(A) in Annex I
4.4.1. Description
4.4.2. Principle
4.4.3. Materials
4.4.4. Procedure
4.4.4.1. Preparation of booster charge for insertion into steel tube
4.4.4.1.1. Seven-point simultaneous initiation
4.4.4.1.2. Central initiation by a compressed pellet
4.4.4.1.2.1. Preparing a compressed pellet
4.4.4.1.2.2. Preparing the booster charge
4.4.4.2. Preparing steel tubes for the detonation tests
4.4.4.3. Filling and charging the steel tube
4.4.4.4. Positioning of the steel tube and lead cylinders (see Figure 4)
4.4.4.5. Preparation for detonation
4.4.5. Test report
4.4.6. Evaluation of test results
4.4.7. The test report shall form part of the technical documentation.
Figure 2
Figure 3
Figure 4
5. CE marking and EU declaration of conformity
6. Notified bodies’ information and operational obligations
7. Authorised representative
MODULE B – EU-TYPE EXAMINATION
1. Description of the module
2. Technical documentation
3. Application for EU-type examination
4. Assessment of the adequacy of the technical design
5. Evaluation report
6. EU-type examination certificate
7. Changes which may affect the conformity of the EU fertilising product
8. Notified bodies’ information obligation
9. Availability of the EU-type examination certificate
10. Authorised representative
MODULE C – CONFORMITY TO TYPE BASED ON INTERNAL PRODUCTION CONTROL
1. Description of the module
2. Manufacturing
3. CE marking and EU declaration of conformity
4. Authorised representative
MODULE D1 – QUALITY ASSURANCE OF THE PRODUCTION PROCESS
1. Description of the module
2. Technical documentation
3. Availability of technical documentation
4. Manufacturing
5. Quality system
Annual input (tonnes) |
Samples / year |
≤ 3 000 |
1 |
3 001 – 10 000 |
2 |
10 001 – 20 000 |
3 |
20 001 – 40 000 |
4 |
40 001 – 60 000 |
5 |
60 001 – 80 000 |
6 |
80 001 – 100 000 |
7 |
100 001 – 120 000 |
8 |
120 001 – 140 000 |
9 |
140 001 – 160 000 |
10 |
160 001 – 180 000 |
11 |
> 180 000 |
12 |