Regulation (EU) 2019/1009 of the European Parliament and of the Council of 5 June... (32019R1009)
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)
- 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
- PFC 1(A)(I): SOLID ORGANIC FERTILISER
- PFC 1(A)(II): LIQUID ORGANIC FERTILISER
- PFC 1(B): ORGANO-MINERAL FERTILISER
- PFC 1(B)(I): SOLID ORGANO-MINERAL FERTILISER
- PFC 1(B)(II): LIQUID ORGANO-MINERAL FERTILISER
- PFC 1(C): INORGANIC FERTILISER
- 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
- PFC 1(C)(II)(a): STRAIGHT INORGANIC MICRONUTRIENT FERTILISER
- PFC 1(C)(II)(b): COMPOUND INORGANIC MICRONUTRIENT FERTILISER
- PFC 2: LIMING MATERIAL
- PFC 3: SOIL IMPROVER
- PFC 3(A): ORGANIC SOIL IMPROVER
- PFC 3(B): INORGANIC SOIL IMPROVER
- PFC 4: GROWING MEDIUM
- 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
- PFC 6(B): NON-MICROBIAL PLANT BIOSTIMULANT
- 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
- 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
- PFC 1(C): INORGANIC FERTILISER
- PFC 1(C)(I): INORGANIC MACRONUTRIENT FERTILISER
- PFC 1(C)(I)(a): SOLID INORGANIC MACRONUTRIENT FERTILISER
- PFC 1(C)(I)(b): LIQUID INORGANIC MACRONUTRIENT FERTILISER
- 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
- 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
- PFC 1(A): ORGANIC FERTILISER
- PFC 1(B): ORGANO-MINERAL FERTILISER
- PFC 1(C): INORGANIC FERTILISER
- PFC 2: LIMING MATERIAL
- PFC 3: SOIL IMPROVER
- PFC 4: GROWING MEDIUM
- PFC 5: INHIBITOR
- PFC 6(A): MICROBIAL PLANT BIOSTIMULANT
- PFC 7: FERTILISING PRODUCT BLEND
- 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
- 6. Surveillance under the responsibility of the notified body
- 7. CE marking and EU declaration of conformity
- 8. Availability of quality system documentation
- 9. Notified bodies’ information obligation
- 10. Authorised representative
- ANNEX V
- EU Declaration of conformity (No XXX)
- (1)
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