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Regulation (EU) 2019/1009 of the European Parliament and of the CouncilShow full title

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)

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  1. Introductory Text

  2. CHAPTER I GENERAL PROVISIONS

    1. Article 1.Scope

    2. Article 2.Definitions

    3. Article 3.Free movement

    4. Article 4.Product requirements

    5. Article 5.Making available on the market

  3. CHAPTER II OBLIGATIONS OF ECONOMIC OPERATORS

    1. Article 6.Obligations of manufacturers

    2. Article 7.Authorised representative

    3. Article 8.Obligations of importers

    4. Article 9.Obligations of distributors

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

    6. Article 11.Packaging and repackaging by importers and distributors

    7. Article 12.Identification of economic operators

  4. CHAPTER III CONFORMITY OF EU FERTILISING PRODUCTS

    1. Article 13.Presumption of conformity

    2. Article 14.Common specifications

    3. Article 15.Conformity assessment procedures

    4. Article 16.EU declaration of conformity

    5. Article 17.General principles of CE marking

    6. Article 18.Rules and conditions for affixing the CE marking

    7. Article 19.End-of-waste status

  5. CHAPTER IV NOTIFICATION OF CONFORMITY ASSESSMENT BODIES

    1. Article 20.Notification

    2. Article 21.Notifying authorities

    3. Article 22.Requirements relating to notifying authorities

    4. Article 23.Information obligation on notifying authorities

    5. Article 24.Requirements relating to notified bodies

    6. Article 25.Presumption of conformity of notified bodies

    7. Article 26.Subsidiaries of and subcontracting by notified bodies

    8. Article 27.Application for notification

    9. Article 28.Notification procedure

    10. Article 29.Identification numbers and lists of notified bodies

    11. Article 30.Changes to notifications

    12. Article 31.Challenge of the competence of notified bodies

    13. Article 32.Operational obligations of notified bodies

    14. Article 33.Appeal against decisions of notified bodies

    15. Article 34.Information obligation on notified bodies

    16. Article 35.Exchange of experience

    17. Article 36.Coordination of notified bodies

  6. CHAPTER V UNION MARKET SURVEILLANCE, CONTROL OF EU FERTILISING PRODUCTS ENTERING THE UNION MARKET AND UNION SAFEGUARD PROCEDURE

    1. Article 37.Union market surveillance and control of EU fertilising products entering the Union market

    2. Article 38.Procedure at national level for dealing with EU fertilising products presenting a risk

    3. Article 39.Union safeguard procedure

    4. Article 40.Compliant EU fertilising products which present a risk

    5. Article 41.Formal non-compliance

  7. CHAPTER VI DELEGATED POWERS AND COMMITTEE PROCEDURE

    1. Article 42.Amendments of Annexes

    2. Article 43.Separate delegated acts for separate component material categories

    3. Article 44.Exercise of the delegation

    4. Article 45.Committee procedure

  8. CHAPTER VII AMENDMENTS

    1. Article 46.Amendments to Regulation (EC) No 1069/2009

    2. Article 47.Amendments to Regulation (EC) No 1107/2009

  9. CHAPTER VIII TRANSITIONAL AND FINAL PROVISIONS

    1. Article 48.Penalties

    2. Article 49.Report

    3. Article 50.Biodegradability review

    4. Article 51.Repeal of Regulation (EC) No 2003/2003

    5. Article 52.Transitional provisions

    6. Article 53.Entry into force and application

  10. Signature

    1. ANNEX I

      Product Function Categories (PFCs) of EU fertilising products

      1. PART I DESIGNATION OF PFCS

        1. 1. Fertiliser

          1. A. Organic fertiliser

            1. I. Solid organic fertiliser

            2. II. Liquid organic fertiliser

          2. B. Organo-mineral fertiliser

            1. I. Solid organo-mineral fertiliser

            2. II. Liquid organo-mineral fertiliser

          3. C. Inorganic fertiliser

            1. I. Inorganic macronutrient fertiliser

            2. II. Inorganic micronutrient fertiliser

        2. 2. Liming material

        3. 3. Soil improver

          1. A. Organic soil improver

          2. B. Inorganic soil improver

        4. 4. Growing medium

        5. 5. Inhibitor

          1. A. Nitrification inhibitor

          2. B. Denitrification inhibitor

          3. C. Urease inhibitor

        6. 6. Plant biostimulant

          1. A. Microbial plant biostimulant

          2. B. Non-microbial plant biostimulant

        7. 7. Fertilising product blend

      2. PART II REQUIREMENTS RELATED TO PFCS

        1. 1. This Part sets out the requirements related to the PFCs...

        2. 2. The requirements laid down in this Annex for a given...

        3. 3. The claim that an EU fertilising product complies with the function...

        4. 4. Where compliance with a given requirement (such as absence of...

        5. 5. Where the EU fertilising product contains a substance for which maximum...

        6. 6. Phosphonates shall not be intentionally added to any EU fertilising product....

        7. 7. The requirements in this Annex are expressed in oxidised form...

        8. 8. The requirements in this Annex are expressed by reference to...

        9. PFC 1: FERTILISER

        10. PFC 1(A): ORGANIC FERTILISER

          1. 1. An organic fertiliser shall contain:

          2. 2. Contaminants in an organic fertiliser must not exceed the following...

          3. 3. The copper (Cu) content in an organic fertiliser must not...

          4. 4. Pathogens in an organic fertiliser must not exceed the limits...

        11. PFC 1(A)(I): SOLID ORGANIC FERTILISER

          1. 1. A solid organic fertiliser shall be in solid form.

          2. 2. A solid organic fertiliser shall contain at least one of...

          3. 3. Organic carbon (Corg) content in a solid organic fertiliser shall...

        12. PFC 1(A)(II): LIQUID ORGANIC FERTILISER

          1. 1. A liquid organic fertiliser shall be in liquid form.

          2. 2. A liquid organic fertiliser shall contain at least one of...

          3. 3. Organic carbon (Corg) content in a liquid organic fertiliser shall...

        13. PFC 1(B): ORGANO-MINERAL FERTILISER

          1. 1. An organo-mineral fertiliser shall be a co-formulation of:

          2. 2. Where one or more of the inorganic fertilisers in the...

          3. 3. Contaminants in an organo-mineral fertiliser must not exceed the following...

          4. 4. The copper (Cu) content in an organo-mineral fertiliser must not...

          5. 5. Pathogens in an organo-mineral fertiliser must not exceed the limits...

        14. PFC 1(B)(I): SOLID ORGANO-MINERAL FERTILISER

          1. 1. A solid organo-mineral fertiliser shall be in solid form.

          2. 2. A solid organo-mineral fertiliser shall contain at least one of...

          3. 3. Organic carbon (Corg) content in a solid organo-mineral fertiliser shall...

          4. 4. In a solid organo-mineral fertiliser, each physical unit shall contain...

        15. PFC 1(B)(II): LIQUID ORGANO-MINERAL FERTILISER

          1. 1. A liquid organo-mineral fertiliser shall be in liquid form.

          2. 2. A liquid organo-mineral fertiliser shall contain at least one of...

          3. 3. Organic carbon (Corg) content in a liquid organo-mineral fertiliser shall...

        16. PFC 1(C): INORGANIC FERTILISER

          1. 1. An inorganic fertiliser shall be a fertiliser containing or releasing...

          2. 2. In addition to the requirements of either PFC 1(C)(I) or PFC 1(C)(II),...

        17. PFC 1(C)(I): INORGANIC MACRONUTRIENT FERTILISER

          1. 1. An inorganic macronutrient fertiliser shall be aimed at providing plants...

          2. 2. Contaminants in an inorganic macronutrient fertiliser must not exceed the...

          3. 3. The copper (Cu) content in an inorganic macronutrient fertiliser must...

        18. PFC 1(C)(I)(a): SOLID INORGANIC MACRONUTRIENT FERTILISER

        19. PFC 1(C)(I)(a)(i): STRAIGHT SOLID INORGANIC MACRONUTRIENT FERTILISER

          1. 1. A straight solid inorganic macronutrient fertiliser shall have a declared...

          2. 2. Where a straight solid inorganic macronutrient fertiliser contains only one...

        20. PFC 1(C)(I)(a)(ii): COMPOUND SOLID INORGANIC MACRONUTRIENT FERTILISER

          1. 1. A compound solid inorganic macronutrient fertiliser shall have a declared...

          2. 2. A compound solid inorganic macronutrient fertiliser shall contain more than...

        21. PFC 1(C)(I)(a)(i-ii)(A): STRAIGHT OR COMPOUND SOLID INORGANIC MACRONUTRIENT AMMONIUM NITRATE...

          1. 1. A straight or compound solid inorganic macronutrient ammonium nitrate fertiliser...

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

          3. 3. A straight or compound solid inorganic macronutrient ammonium nitrate fertiliser...

          4. 4. The oil retention of a straight or compound solid inorganic...

          5. 5. The detonation resistance of a straight or compound solid inorganic...

          6. 6. The % by mass of combustible material measured as carbon...

          7. 7. A solution of 10 g of a straight or compound solid...

          8. 8. Not more than 5 % by mass shall pass through a...

          9. 9. The copper (Cu) content shall not be higher than 10 mg/kg,...

        22. PFC 1(C)(I)(b): LIQUID INORGANIC MACRONUTRIENT FERTILISER

        23. PFC 1(C)(I)(b)(i): STRAIGHT LIQUID INORGANIC MACRONUTRIENT FERTILISER

          1. 1. A straight liquid inorganic macronutrient fertiliser shall have a declared...

          2. 2. Where a straight liquid inorganic macronutrient fertiliser contains only one...

        24. PFC 1(C)(I)(b)(ii): COMPOUND LIQUID INORGANIC MACRONUTRIENT FERTILISER

          1. 1. A compound liquid inorganic macronutrient fertiliser shall have a declared...

          2. 2. A compound liquid inorganic macronutrient fertiliser shall contain more than...

        25. PFC 1(C)(II): INORGANIC MICRONUTRIENT FERTILISER

          1. 1. An inorganic micronutrient fertiliser shall be an inorganic fertiliser other...

          2. 2. Inorganic micronutrient fertilisers shall be made available to the end-user...

          3. 3. Contaminants in an inorganic micronutrient fertiliser must not exceed the...

        26. PFC 1(C)(II)(a): STRAIGHT INORGANIC MICRONUTRIENT FERTILISER

          1. 1. A straight inorganic micronutrient fertiliser shall have a declared content...

          2. 2. A straight inorganic micronutrient fertiliser shall belong to one of...

        27. PFC 1(C)(II)(b): COMPOUND INORGANIC MICRONUTRIENT FERTILISER

          1. 1. A compound inorganic micronutrient fertiliser shall have a declared content...

          2. 2. The sum of all declared micronutrient contents in a compound...

        28. PFC 2: LIMING MATERIAL

          1. 1. A liming material shall be an EU fertilising product the function...

          2. 2. Contaminants in a liming material must not exceed the following...

          3. 3. The copper (Cu) content in a liming material must not...

          4. 4. The following parameters determined on the basis of the mass...

        29. PFC 3: SOIL IMPROVER

        30. PFC 3(A): ORGANIC SOIL IMPROVER

          1. 1. An organic soil improver shall consist of material 95 % of...

          2. 2. Contaminants in an organic soil improver must not exceed the...

          3. 3. The copper (Cu) content in an organic soil improver must...

          4. 4. Pathogens in an organic soil improver must not exceed the...

          5. 5. An organic soil improver shall contain 20 % or more dry...

          6. 6. Organic carbon (Corg) content in an organic soil improver shall...

        31. PFC 3(B): INORGANIC SOIL IMPROVER

          1. 1. An inorganic soil improver shall be a soil improver other...

          2. 2. Contaminants in an inorganic soil improver must not exceed the...

          3. 3. The copper (Cu) content in an inorganic soil improver must...

        32. PFC 4: GROWING MEDIUM

          1. 1. A growing medium shall be an EU fertilising product other than...

          2. 2. Contaminants in a growing medium must not exceed the following...

          3. 3. The copper (Cu) content in a growing medium must not...

          4. 4. Pathogens in a growing medium must not exceed the limits...

        33. PFC 5: INHIBITOR

        34. PFC 5(A): NITRIFICATION INHIBITOR

          1. 1. A nitrification inhibitor shall inhibit the biological oxidation of ammoniacal...

          2. 2. The ammoniacal nitrogen (NH3-N) oxidation rate shall be measured by:...

        35. PFC 5(B): DENITRIFICATION INHIBITOR

          1. 1. A denitrification inhibitor shall inhibit the formation of nitrous oxide...

          2. 2. Compared to a control sample where the denitrification inhibitor has...

        36. PFC 5(C): UREASE INHIBITOR

          1. 1. A urease inhibitor shall inhibit hydrolytic action on urea (CH4N2O)...

          2. 2. Compared to a control sample where the urease inhibitor has...

        37. PFC 6: PLANT BIOSTIMULANT

          1. 1. A plant biostimulant shall be an EU fertilising product the function...

          2. 2. Contaminants in a plant biostimulant must not exceed the following...

          3. 3. The copper (Cu) content in a plant biostimulant must not...

          4. 4. The plant biostimulant shall have the effects that are claimed...

        38. PFC 6(A): MICROBIAL PLANT BIOSTIMULANT

          1. 1. A microbial plant biostimulant shall consist of a micro-organism or...

          2. 2. Pathogens in a microbial plant biostimulant must not exceed the...

          3. 3. When the microbial plant biostimulant is in liquid form, the...

        39. PFC 6(B): NON-MICROBIAL PLANT BIOSTIMULANT

          1. 1. A non-microbial plant biostimulant shall be a plant biostimulant other...

          2. 2. Pathogens in a non-microbial plant biostimulant must not exceed the...

        40. PFC 7: FERTILISING PRODUCT BLEND

          1. 1. A fertilising product blend shall be an EU fertilising product composed...

          2. 2. The blending shall not change the nature of each component...

          3. 3. The manufacturer of the blend shall assess the conformity of...

          4. 4. Economic operators making fertilising product blends available on the market...

    2. ANNEX II

      Component Material Categories (CMCs)

      1. An EU fertilising product shall consist solely of component materials complying...

      2. The component materials, and the input materials used to produce...

      3. PART I DESIGNATION OF CMCS

      4. PART II REQUIREMENTS RELATED TO CMCS

        1. CMC 1: VIRGIN MATERIAL SUBSTANCES AND MIXTURES

          1. 1. An EU fertilising product may contain substances and mixtures, except:

          2. 2. All substances incorporated into the EU fertilising product, on their own...

          3. 3. Where the substance or one of the substances in the...

          4. 4. Where the substance or one of the substances in the...

        2. CMC 2: PLANTS, PLANT PARTS OR PLANT EXTRACTS

        3. CMC 3: COMPOST

          1. 1. An EU fertilising product may contain compost obtained through aerobic composting...

          2. 2. The composting shall take place in a plant:

          3. 3. The aerobic composting shall consist of controlled decomposition of biodegradable...

          4. 4. The compost shall contain:

          5. 5. The compost shall meet at least one of the following...

        4. CMC 4: FRESH CROP DIGESTATE

          1. 1. An EU fertilising product may contain digestate obtained through anaerobic digestion...

          2. 2. The anaerobic digestion shall take place in a plant:

          3. 3. The anaerobic digestion shall consist of controlled decomposition of biodegradable...

          4. 4. Both the solid and the liquid part of the digestate...

        5. CMC 5: DIGESTATE OTHER THAN FRESH CROP DIGESTATE

          1. 1. An EU fertilising product may contain digestate obtained through anaerobic digestion...

          2. 2. The anaerobic digestion shall take place in a plant:

          3. 3. The anaerobic digestion shall consist of controlled decomposition of biodegradable...

          4. 4. Neither the solid nor the liquid part of the digestate...

          5. 5. The digestate shall contain:

          6. 6. Both the solid and the liquid part of the digestate...

        6. CMC 6: FOOD INDUSTRY BY-PRODUCTS

          1. 1. An EU fertilising product may contain component material consisting of one...

          2. 2. All substances incorporated into the EU fertilising product, on their own...

        7. CMC 7: MICRO-ORGANISMS

        8. CMC 8: NUTRIENT POLYMERS

          1. 1. An EU fertilising product may contain polymers exclusively made up of...

          2. 2. At least 60 % of the polymers shall be soluble in a...

          3. 3. The final degradation products shall be only ammonia (NH3), water...

          4. 4. The polymers shall not contain more than 600 ppm of free...

        9. CMC 9: POLYMERS OTHER THAN NUTRIENT POLYMERS

          1. 1. An EU fertilising product may contain polymers other than nutrient polymers...

          2. 2. From 16 July 2026, the polymers referred to in point 1(a)...

          3. 3. For the polymers referred to in point 1(a) and (b), neither...

        10. CMC 10: DERIVED PRODUCTS WITHIN THE MEANING OF REGULATION (EC)...

        11. CMC 11: BY-PRODUCTS WITHIN THE MEANING OF DIRECTIVE 2008/98/EC

          1. 1. An EU fertilising product may contain by-products within the meaning of...

          2. 2. The by-products shall have been registered pursuant to Regulation (EC)...

          3. 3. From 16 July 2022, the by-products shall comply with the criteria...

    3. ANNEX III

      Labelling requirements

      1. This Annex sets out the labelling requirements for EU fertilising products....

      2. PART I GENERAL LABELLING REQUIREMENTS

        1. 1. The following information shall be provided:

        2. 2. Where the EU fertilising product has functions described in two or...

        3. 3. Where the EU fertilising product contains a substance for which maximum...

        4. 4. Where the EU fertilising product contains derived products within the meaning...

        5. 5. Where the EU fertilising product contains ricin, the following instruction shall...

        6. 6. Where the EU fertilising product contains unprocessed or processed cocoa shells,...

        7. 7. Where the EU fertilising product contains a polymer with the purpose...

        8. 8. Information other than the information required under points 1 to 6:...

        9. 9. The phrase ‘poor in chloride’ or similar may only be...

        10. 10. Where the nutrient content information requirements in this Annex are...

        11. 11. Where the information requirements in this Annex refer to organic...

      3. PART II PRODUCT-SPECIFIC LABELLING REQUIREMENTS

        1. PFC 1: FERTILISER

          1. 1. The content of nutrients may be declared only where they...

          2. 2. If nitrogen (N) or phosphorus (P) are not declared nutrients,...

          3. 3. The following rules apply to fertilisers containing inhibitors, as specified...

          4. 4. The term ‘mineral fertiliser’ may be used only if the...

          5. PFC 1(A): ORGANIC FERTILISER

          6. PFC 1(B): ORGANO-MINERAL FERTILISER

            1. 1. The following information shall be provided:

            2. 2. Where one or more of the micronutrients boron (B), cobalt...

            3. 3. Where one or both of the micronutrients copper (Cu) and...

            4. 4. Where copper (Cu) or zinc (Zn) is intentionally added to...

            5. 5. The micronutrients referred to in points 2, 3 and 4 shall...

            6. 6. Where an organo-mineral fertiliser has a cadmium (Cd) content equal...

          7. PFC 1(C): INORGANIC FERTILISER

            1. PFC 1(C)(I): INORGANIC MACRONUTRIENT FERTILISER

              1. 1. The following information shall be provided:

              2. 2. Where an inorganic macronutrient fertiliser has a cadmium (Cd) content...

              3. PFC 1(C)(I)(a): SOLID INORGANIC MACRONUTRIENT FERTILISER

                1. 1. A solid inorganic macronutrient fertiliser may be labelled ‘complex’ only...

                2. 2. The granulometry of a solid inorganic macronutrient fertiliser shall be...

                3. 3. The form of the physical unit of the product shall...

                4. 4. For coated solid inorganic macronutrient fertilisers, the name of the...

                5. 5. Where one or more of the micronutrients boron (B), cobalt...

                6. 6. Where one or both of the micronutrients copper (Cu) and...

                7. 7. Where copper (Cu) or zinc (Zn) is intentionally added to...

                8. 8. The micronutrients referred to in points 5, 6 and 7 shall be declared...

              4. PFC 1(C)(I)(b): LIQUID INORGANIC MACRONUTRIENT FERTILISER

                1. 1. The label shall indicate whether the liquid inorganic macronutrient fertiliser...

                2. 2. The nutrient content may be indicated as % by mass...

                3. 3. Where one or more of the micronutrients boron (B), cobalt...

                4. 4. Where one or both of the micronutrients copper (Cu) and...

                5. 5. Where copper (Cu) or zinc (Zn) is intentionally added to...

                6. 6. The micronutrients referred to in points 3, 4 and 5 shall be declared...

            2. PFC 1(C)(II): INORGANIC MICRONUTRIENT FERTILISER

              1. 1. The declared micronutrients in the inorganic micronutrient fertiliser shall be...

              2. 2. Where the declared micronutrients are chelated by chelating agents, and...

              3. 3. Where the declared micronutrients are complexed by complexing agents, the...

              4. 4. The following statement shall appear: ‘To be used only where...

              5. PFC 1(C)(II)(a): STRAIGHT INORGANIC MICRONUTRIENT FERTILISER

                1. 1. The label shall indicate the relevant typology, as referred to...

                2. 2. The total micronutrient content shall be expressed as % by...

              6. PFC 1(C)(II)(b): COMPOUND INORGANIC MICRONUTRIENT FERTILISER

                1. 1. Micronutrients may be declared only if they are present in...

                2. 2. If the compound inorganic micronutrient fertiliser is in suspension or...

                3. 3. The total micronutrient content shall be expressed as % by...

        2. PFC 2: LIMING MATERIAL

        3. PFC 3: SOIL IMPROVER

          1. 1. The dry matter content expressed as % by mass shall...

          2. 2. The following nutrients expressed as % by mass shall be...

          3. PFC 3(A): ORGANIC SOIL IMPROVER

        4. PFC 4: GROWING MEDIUM

        5. PFC 5: INHIBITOR

        6. PFC 6: PLANT BIOSTIMULANT

          1. PFC 6(A): MICROBIAL PLANT BIOSTIMULANT

        7. PFC 7: FERTILISING PRODUCT BLEND

      4. PART III TOLERANCE RULES

        1. 1. The declared nutrient content or physico-chemical characteristics of an EU fertilising...

        2. 2. The tolerances allowed in respect of the declared parameters indicated...

        3. 3. By derogation from point 1, the actual content of a component,...

        4. PFC 1: FERTILISER

          1. PFC 1(A): ORGANIC FERTILISER

          2. PFC 1(B): ORGANO-MINERAL FERTILISER

          3. PFC 1(C): INORGANIC FERTILISER

        5. PFC 2: LIMING MATERIAL

        6. PFC 3: SOIL IMPROVER

        7. PFC 4: GROWING MEDIUM

        8. PFC 5: INHIBITOR

        9. PFC 6(A): MICROBIAL PLANT BIOSTIMULANT

        10. PFC 7: FERTILISING PRODUCT BLEND

    4. ANNEX IV

      Conformity assessment procedures

      1. PART I APPLICABILITY OF CONFORMITY ASSESSMENT PROCEDURES

        1. 1. APPLICABILITY OF INTERNAL PRODUCTION CONTROL (MODULE A)

          1. 1.1. Module A may be used for an EU fertilising product composed...

          2. 1.2. Module A may also be used for a fertilising product...

          3. 1.3. By derogation from points 1.1 and 1.2, Module A must not be used...

        2. 2. APPLICABILITY OF INTERNAL PRODUCTION CONTROL PLUS SUPERVISED PRODUCT TESTING (MODULE A1)...

        3. 3. APPLICABILITY OF EU-TYPE EXAMINATION (MODULE B) FOLLOWED BY CONFORMITY TO TYPE...

          1. 3.1. Module B followed by Module C may be used for an EU fertilising...

          2. 3.2. Module B followed by Module C may also be used for:...

          3. 3.3. By derogation from points 3.1 and 3.2, Module B followed by Module C...

        4. 4. APPLICABILITY OF QUALITY ASSURANCE OF THE PRODUCTION PROCESS (MODULE D1)

          1. 4.1. Module D1 may be used for any EU fertilising product.

          2. 4.2. By derogation from point 4.1, Module D1 must not be used for...

      2. PART II DESCRIPTION OF CONFORMITY ASSESSMENT PROCEDURES

        1. MODULE A – INTERNAL PRODUCTION CONTROL

          1. 1. Description of the module

          2. 2. Technical documentation

            1. 2.1. The manufacturer shall establish the technical documentation. The documentation shall...

            2. 2.2. The technical documentation shall specify the applicable requirements and cover,...

          3. 3. Manufacturing

          4. 4. CE marking and EU declaration of conformity

            1. 4.1. The manufacturer shall affix the CE marking to each individual...

            2. 4.2. The manufacturer shall draw up a written EU declaration of...

            3. 4.3. A copy of the EU declaration of conformity shall be...

          5. 5. Authorised representative

        2. MODULE A1 – INTERNAL PRODUCTION CONTROL PLUS SUPERVISED PRODUCT TESTING...

          1. 1. Description of the module

          2. 2. Technical documentation

            1. 2.1. The manufacturer shall establish the technical documentation. The documentation shall...

            2. 2.2. The technical documentation shall specify the applicable requirements and cover,...

          3. 3. Manufacturing

          4. 4. Product checks for oil retention and detonation resistance

            1. 4.1. Thermal cycles prior to a test for compliance with the...

              1. 4.1.1. Principle and definition

              2. 4.1.2. Apparatus

              3. 4.1.3. Procedure

                1. 4.1.3.1. Put each test sample of 70 ± 5 g into a suitable...

                2. 4.1.3.2. After attaining the temperature of 50 °C and maintain that temperature...

                3. 4.1.3.3. If using a water bath maintain the water of each...

            2. 4.2. Oil retention test referred to in point 4 under PFC 1(C)(I)(a)(i-ii)(A) in...

              1. 4.2.1. Description

              2. 4.2.2. Principle

              3. 4.2.3. Reagents

              4. 4.2.4. Apparatus

              5. 4.2.5. Procedure

                1. 4.2.5.1. Two individual determinations are carried out in quick succession on...

                2. 4.2.5.2. Remove particles smaller than 0,5 mm using the test sieve. Weigh...

                3. 4.2.5.3. Filter the entire contents of the beaker through the funnel...

                4. 4.2.5.4. Lay two sheets of filter paper (about 500 mm x 500 mm)...

                5. 4.2.5.5. Repeating the rolling procedure and reweighing

                6. 4.2.5.6. Two oil retention tests per sample are to be carried...

              6. 4.2.6. Test report

                1. 4.2.6.1. Expression of the results

                  1. 4.2.6.1.1. Method of calculation and formula

                  2. 4.2.6.1.2. Take as the result the arithmetic mean of the two...

                2. 4.2.6.2. The test report shall form part of the technical documentation....

            3. 4.3. Thermal cycles prior to the detonation resistance test referred to...

              1. 4.3.1. Principle and definition

              2. 4.3.2. Apparatus

                1. Method 1

                2. Method 2

              3. 4.3.3. Procedure

                1. Figure 1

            4. 4.4. Detonation resistance test referred to in point 5 under PFC 1(C)(I)(a)(i-ii)(A) in...

              1. 4.4.1. Description

                1. 4.4.1.1. The test shall be carried out on a representative sample...

                2. 4.4.1.2. The EU fertilising product shall be subjected to the detonation resistance...

              2. 4.4.2. Principle

              3. 4.4.3. Materials

              4. 4.4.4. Procedure

                1. 4.4.4.1. Preparation of booster charge for insertion into steel tube

                  1. 4.4.4.1.1. Seven-point simultaneous initiation

                    1. 4.4.4.1.1.1. Drill holes in the wooden or plastic disc (point (j) under...

                    2. 4.4.4.1.1.2. Cut seven lengths of flexible detonating cord (point (b) under point 4.4.3)...

                    3. 4.4.4.1.1.3. Shape the plastic explosive (point (a) under point 4.4.3) to form a...

                    4. 4.4.4.1.1.4. Group the free ends of the seven lengths of detonating...

                  2. 4.4.4.1.2. Central initiation by a compressed pellet

                    1. 4.4.4.1.2.1. Preparing a compressed pellet

                    2. 4.4.4.1.2.2. Preparing the booster charge

                2. 4.4.4.2. Preparing steel tubes for the detonation tests

                3. 4.4.4.3. Filling and charging the steel tube

                  1. 4.4.4.3.1. The test sample, the steel tube and the booster charge...

                  2. 4.4.4.3.2.1 Place the tube upright with its square bottom plate resting...

                  3. 4.4.4.3.2.2. Repeat this charging method with another portion of the test...

                  4. 4.4.4.3.2.3 The filling height of the sample shall be adjusted in...

                  5. 4.4.4.3.3. Insert the booster charge into the tube so that it...

                4. 4.4.4.4. Positioning of the steel tube and lead cylinders (see Figure 4)...

                  1. 4.4.4.4.1. Number the bases of the lead cylinders (point (f) under point 4.4.3)...

                  2. 4.4.4.4.2. Lay the steel tube prepared according to point 4.4.4.3 horizontally on...

                5. 4.4.4.5. Preparation for detonation

                  1. 4.4.4.5.1. Set up the apparatus as described in point 4.4.4.4 in a...

                  2. 4.4.4.5.2. If the booster charge with seven-point initiation is used, ensure...

                  3. 4.4.4.5.3. Finally, remove the wooden or plastic rod and replace with...

                  4. 4.4.4.5.4. Detonate the explosive.

                  5. 4.4.4.6.1. Allow sufficient time for the fumes (gaseous and sometimes toxic...

                  6. 4.4.4.6.2. Record for each of the marked lead cylinders, the degree...

                  7. 4.4.4.7. Detonation velocity measurement can also be performed.

                  8. 4.4.4.8. Two detonation tests per sample are to be carried out....

              5. 4.4.5. Test report

              6. 4.4.6. Evaluation of test results

              7. 4.4.7. The test report shall form part of the technical documentation....

                1. Figure 2

                2. Figure 3

                3. Figure 4

          5. 5. CE marking and EU declaration of conformity

            1. 5.1. The manufacturer shall affix the CE marking and, under the...

            2. 5.2. The manufacturer shall draw up a written EU declaration of...

            3. 5.3. A copy of the EU declaration of conformity shall be...

          6. 6. Notified bodies’ information and operational obligations

            1. 6.1. Each notified body shall, without undue delay, inform its notifying...

            2. 6.2. In the case referred to in point 6.1(b) the notified body...

          7. 7. Authorised representative

        3. MODULE B – EU-TYPE EXAMINATION

          1. 1. Description of the module

            1. 1.1. EU-type examination is the part of a conformity assessment procedure...

            2. 1.2. Assessment of the adequacy of the technical design of the...

          2. 2. Technical documentation

            1. 2.1. The manufacturer shall establish the technical documentation. The documentation shall...

            2. 2.2. The technical documentation shall specify the applicable requirements and cover,...

          3. 3. Application for EU-type examination

            1. 3.1. The manufacturer shall lodge an application for EU-type examination with...

            2. 3.2. The application shall include:

          4. 4. Assessment of the adequacy of the technical design

          5. 5. Evaluation report

          6. 6. EU-type examination certificate

            1. 6.1. Where the type meets the requirements of this Regulation that...

            2. 6.2. The EU-type examination certificate and its annexes shall contain all...

            3. 6.3. Where the type does not satisfy the requirements of this...

          7. 7. Changes which may affect the conformity of the EU fertilising product...

            1. 7.1. The notified body shall keep itself apprised of any changes...

            2. 7.2. The manufacturer shall inform the notified body that holds the...

          8. 8. Notified bodies’ information obligation

            1. 8.1. Each notified body shall inform its notifying authority concerning the...

            2. 8.2. Each notified body shall inform the other notified bodies concerning...

            3. 8.3. The Commission, the Member States and the other notified bodies...

          9. 9. Availability of the EU-type examination certificate

            1. 9.1. The notified body shall keep a copy of the EU-type...

            2. 9.2. The manufacturer shall keep a copy of the EU-type examination...

          10. 10. Authorised representative

        4. MODULE C – CONFORMITY TO TYPE BASED ON INTERNAL PRODUCTION...

          1. 1. Description of the module

          2. 2. Manufacturing

          3. 3. CE marking and EU declaration of conformity

            1. 3.1 The manufacturer shall affix the CE marking to each individual...

            2. 3.2 The manufacturer shall draw up a written EU declaration of...

            3. 3.3. A copy of the EU declaration of conformity shall be...

          4. 4. Authorised representative

        5. MODULE D1 – QUALITY ASSURANCE OF THE PRODUCTION PROCESS

          1. 1. Description of the module

          2. 2. Technical documentation

            1. 2.1. The manufacturer shall establish the technical documentation. The documentation shall...

            2. 2.2. The technical documentation shall specify the applicable requirements and cover,...

          3. 3. Availability of technical documentation

          4. 4. Manufacturing

          5. 5. Quality system

            1. 5.1. The manufacturer shall implement a quality system which shall ensure...

            2. 5.1.1. The quality system shall cover the quality objectives and the...

            3. 5.1.1.1. For compost belonging to CMC 3 and digestate belonging to...

            4. 5.1.2. The quality system shall cover the manufacturing, quality control and...

            5. 5.1.2.1. For compost belonging to CMC 3 and digestate belonging to...

            6. 5.1.3. The quality system shall cover the examinations and tests to...

            7. 5.1.3.1. For compost belonging to CMC 3 and digestate belonging to CMC 5,...

            8. 5.1.4. The quality system shall cover the manufacturer’s quality records, such...

            9. 5.1.4.1. For compost belonging to CMC 3 and digestate belonging to CMC 5,...

            10. 5.1.5. The quality system shall cover the means of monitoring the...

            11. 5.1.5.1. For compost belonging to CMC 3 and digestate belonging to CMC 5,...

            12. 5.1.6. All the elements, requirements and provisions adopted by the manufacturer...

            13. 5.2. The manufacturer shall lodge an application for assessment of his...

            14. 5.3.1. The notified body shall assess the quality system to determine...

            15. 5.3.2. It shall presume conformity with those requirements in respect of...

            16. 5.3.3. In addition to experience in quality management systems, the auditing...

            17. 5.3.4. The decision shall be notified to the manufacturer. The notification...

            18. 5.4. The manufacturer shall undertake to fulfil the obligations arising out...

            19. 5.5.1. The manufacturer shall keep the notified body that has approved...

            20. 5.5.2. The notified body shall evaluate any proposed changes and decide...

            21. 5.5.3. It shall notify the manufacturer of its decision. The notification...

          6. 6. Surveillance under the responsibility of the notified body

            1. 6.1. The purpose of surveillance is to make sure that the...

            2. 6.2. The manufacturer shall, for assessment purposes, allow the notified body...

            3. 6.3.1. The notified body shall carry out periodic audits to make...

            4. 6.3.2. For compost belonging to CMC 3 and digestate belonging to...

            5. 6.4 In addition, the notified body may pay unexpected visits to...

          7. 7. CE marking and EU declaration of conformity

            1. 7.1. The manufacturer shall affix the CE marking and, under the...

            2. 7.2. The manufacturer shall draw up a written EU declaration of...

            3. 7.3. A copy of the EU declaration of conformity shall be...

          8. 8. Availability of quality system documentation

          9. 9. Notified bodies’ information obligation

            1. 9.1. Each notified body shall inform its notifying authority of quality...

            2. 9.2. Each notified body shall inform the other notified bodies of...

          10. 10. Authorised representative

    5. ANNEX V

      EU Declaration of conformity (No XXX)

      1. 1. EU fertilising product (product-, batch-, or type- number):

      2. 2. Name and address of the manufacturer and, where applicable, its...

      3. 3. This EU declaration of conformity is issued under the sole...

      4. 4. Object of the declaration (identification of the EU fertilising product allowing...

      5. 5. The object of the declaration described above is in conformity...

      6. 6. References to the relevant harmonised standards or to the common...

      7. 7. Where applicable, the notified body … (name, number) performed … (description...

      8. 8. Where applicable, annexed to this EU declaration of conformity are...

      9. 9. Additional information:

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