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)

• 4.4.4.6.2.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.

• 4.4.4.7.Detonation velocity measurement can also be performed.

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

4.4.5.   Test report

Values for the following parameters are to be given in the test report for each of the detonation resistance tests:

• — the values actually measured 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.

4.4.6.   Evaluation of test results

If, in each firing, the crushing of at least one lead cylinder is less than 5 %, the test shall be considered conclusive and it shall be considered that the sample presented is resistant to detonation.

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

Figure 2

Image omitted; see official source

Booster charge with seven-point initiation

1	:	Steel tube
---	---	---
2	:	Wooden or plastic disc with seven holes
---	---	---
3	:	Plastic or cardboard cylinder
---	---	---
4	:	Detonating cords
---	---	---
5	:	Plastic explosive
---	---	---
6	:	Test sample
---	---	---
7	:	4 mm hole drilled to receive split pin
---	---	---
8	:	Split pin
---	---	---
9	:	Wooden or plastic rod surrounded by 4
---	---	---
10	:	Adhesive tape for securing 4 around 9

Figure 3

Image omitted; see official source

1	:	Steel tube
---	---	---
2	:	Wooden of plastic disc
---	---	---
3	:	Plastic or cardboard cylinder
---	---	---
4	:	Wooden of plastic rod
---	---	---
5	:	Plastic explosive
---	---	---
6	:	Compressed pellet
---	---	---
7	:	Test sample
---	---	---
8	:	4 mm hole drilled to receive split pin
---	---	---
9	:	Split pin
---	---	---
10	:	Wooden or plastic die for 5

Figure 4

Image omitted; see official source

Numbers in circles:

1	:	Steel tube
---	---	---
2	:	Lead cylinders
---	---	---
3	:	Steel block or stack of beams
---	---	---
4	:	Bottom plate
---	---	---
5	:	Booster charge

Numbers in squares:

Lead cylinders 1 to 6

5. CE marking and EU declaration of conformity

• 5.1.The manufacturer shall affix the CE marking and, under the responsibility of the notified body referred to in point 4, the latter’s identification number to each individual packaging of the EU fertilising product that satisfies the applicable requirements of this Regulation or, where it is supplied without packaging, in a document accompanying the EU fertilising product.

• 5.2.The manufacturer shall draw up a written EU declaration of conformity for an EU fertilising product type and keep it together with the technical documentation at the disposal of the national authorities for 5 years after the EU fertilising product has been placed on the market. The EU declaration of conformity shall identify the EU fertilising product type for which it has been drawn up.

• 5.3.A copy of the EU declaration of conformity shall be made available to the relevant authorities upon request.

6. Notified bodies’ information and operational obligations

• 6.1.Each notified body shall, without undue delay, inform its notifying authority and other bodies notified under this Regulation carrying out similar conformity assessment activities covering the same EU fertilising products of the following:

• (a) any case where the manufacturer has not complied with the 3-month period for performing the tests required under point 4;

• (b) any test results which demonstrate non-conformity with the detonation resistance requirement referred to in point 5 under PFC 1(C)(I)(a)(i-ii)(A) in Annex I.

• 6.2.In the case referred to in point 6.1(b) the notified body shall request the manufacturer to take the necessary measures in accordance with Article 6(8).

7. Authorised representative

The manufacturer’s obligations set out in points 4.4.7 and 5 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. Description of the module

• 1.1.EU-type examination is the part of a conformity assessment procedure in which a notified body examines the technical design of an EU fertilising product and verifies and attests that the technical design of the EU fertilising product meets the requirements of this Regulation.

• 1.2.Assessment of the adequacy of the technical design of the EU fertilising product is carried out through examination of the technical documentation and supporting evidence, plus examination of samples, representative of the production envisaged.

2. Technical documentation

• 2.1.The manufacturer shall establish the technical documentation. The documentation shall make it possible to assess the EU 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 intended use of the EU fertilising product. The technical documentation shall contain, where applicable, at least the following elements:

• (a) a general description of the EU fertilising product, the PFC corresponding to the claimed function of the EU fertilising product and description of the intended use,

• (b) a list of component materials used, the CMCs as referred to in Annex II to which they belong and information about their origin or manufacturing process,

• (c) the EU declarations of conformity for the component EU fertilising products of the fertilising product blend,

• (d) drawings, schemes, descriptions and explanations necessary for the understanding of the manufacturing process of the EU fertilising product,

• (e) a specimen of the label or the leaflet, or both, referred to in Article 6(7) containing the information required in accordance with Annex III,

• (f) a list of the harmonised standards referred to in Article 13, common specifications referred to in Article 14 and/or other relevant technical specifications applied. In the event of partly applied harmonised standards or common specifications, the technical documentation shall specify the parts which have been applied,

• (g) results of calculations made, examinations carried out, etc.,

• (h) test reports,

• (i) where the EU fertilising product contains or consists of derived 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 derived products have reached the end point in the manufacturing chain within the meaning of that Regulation,

• (j) where the EU fertilising product contains or consists of by-products within the meaning of Directive 2008/98/EC, technical and administrative evidence that the by-products comply with the criteria established by delegated act referred to in Article 42(7) of this Regulation, and with the national measures transposing Article 5(1) of Directive 2008/98/EC and, where applicable, implementing acts referred to in Article 5(2) or national measures adopted under Article 5(3) of that Directive, and

• (k) where the EU fertilising product contains total chromium (Cr) above 200 mg/kg dry matter, information about the maximum quantity and exact source of total chromium (Cr).

3. Application for EU-type examination

• 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 referred to in point 2,

• (d) the samples representative of the production envisaged. The notified body may request further samples 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 or common specifications 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. Assessment of the adequacy of the technical design

The notified body shall:

• (a) examine the technical documentation and supporting evidence to assess the adequacy of the technical design of the EU fertilising product;

• (b) verify that the sample(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 or common specifications, as well as the elements which have been designed in accordance with other relevant technical specifications;

• (c) carry out appropriate examinations and tests on the sample(s), or have them carried out, to check whether, where the manufacturer has chosen to apply the solutions in the relevant harmonised standards or common specifications, these have been applied correctly;

• (d) carry out appropriate examinations and tests on the sample(s), or have them carried out, to check whether, where the solutions in the relevant harmonised standards or common specifications have not been applied, or where relevant harmonised standards or common specifications do not exist, the solutions adopted by the manufacturer meet the corresponding requirements of this Regulation;

• (e) agree with the manufacturer on a location where the examinations and tests will be carried out.

5. Evaluation report

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 authority, the notified body shall release the content of that report, in full or in part, only with the agreement of the manufacturer.

6. EU-type examination certificate

• 6.1.Where the type meets the requirements of this Regulation that apply to the EU 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 EU-type examination certificate may have one or more annexes attached.

• 6.2.The EU-type examination certificate and its annexes shall contain all relevant information to allow the conformity of manufactured EU fertilising products with the examined type to be evaluated.

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

• 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 EU fertilising product with the requirements of this Regulation or the conditions for validity of the EU-type examination certificate. Such modifications shall require additional approval in the form of an addition to the original EU-type examination certificate.

8. Notified bodies’ information obligation

• 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 authority the list of EU-type examination 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 EU-type examination 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.

9. Availability of the EU-type examination certificate

• 9.1.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 EU-type examination certificate.

• 9.2.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 5 years after the EU fertilising product has been placed on the market.

10. Authorised representative

The manufacturer’s authorised representative may lodge the application referred to in point 3 and fulfil the obligations set out in points 7 and 9.2, provided that they are specified in the mandate.

MODULE C – CONFORMITY TO TYPE BASED ON INTERNAL PRODUCTION CONTROL

1. Description of the module

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 on his or her sole responsibility that the EU 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

The manufacturer shall take all measures necessary so that the manufacturing process and its monitoring ensure conformity of the manufactured EU 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. CE marking and EU declaration of conformity

• 3.1The manufacturer shall affix the CE marking to each individual packaging of the EU fertilising product that is in conformity with the type described in the EU-type examination certificate and satisfies the applicable requirements of this Regulation or, where it is supplied without packaging, in a document accompanying the EU fertilising product.

• 3.2The manufacturer shall draw up a written EU declaration of conformity for an EU fertilising product type and keep it together with the technical documentation at the disposal of the national authorities for 5 years after the EU fertilising product has been placed on the market. The EU declaration of conformity shall identify the EU fertilising product type 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

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

Quality assurance of the production process is the conformity assessment procedure whereby the manufacturer fulfils the obligations laid down in points 2, 4, and 7, and ensures and declares on his or her sole responsibility that the EU 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 EU 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 intended use of the EU fertilising product. The technical documentation shall contain, where applicable, at least the following elements:

• (a) a general description of the EU fertilising product, the PFC corresponding to the claimed function of the EU fertilising product and description of the intended use,

• (b) a list of component materials used, the CMCs as referred to in Annex II, to which they belong and information about their origin or manufacturing process,

• (c) the EU declarations of conformity for the component EU fertilising products of the fertilising product blend,

• (d) drawings, schemes, descriptions and explanations necessary for the understanding of the manufacturing process of the EU fertilising product, and, in relation to materials belonging to CMCs 3, 5, 12, 13, 14 or 15 as defined in Annex II, a written description and a diagram of the production or recovery process, where each treatment, storage vessel and area is clearly identified,

• (e) a specimen of the label or the leaflet, or both, referred to in Article 6(7) containing the information required in accordance with Annex III,

• (f) a list of the harmonised standards referred to in Article 13, common specifications referred to in Article 14 and/or other relevant technical specifications applied. In the event of partly applied harmonised standards or common specifications, the technical documentation shall specify the parts which have been applied,

• (g) results of calculations made, examinations carried out, etc.,

• (ga) hazardous waste calculations for EU fertilising products containing or consisting of CMC 13; the testing referred to in point 6 in CMC 13 in Part II of Annex II shall be carried out at least every year, or sooner than scheduled in case of any significant change that may affect the safety or quality of the EU fertilising product (for example processing of input material batches of different composition, modification of process conditions). For a representative input material batch that is processed at the plant, the hazardous property identified (in accordance with point 5.1.3.1) and the total mass shall be measured on the different input materials (1, …, n) and on the output material that will be incorporated in the EU fertilising product. The incorporation rate of the hazardous property into the output material shall then be calculated as follows: Image omitted; see official source Where: HPC = the concentration of the hazardous property (mg/kg), M = the total mass (kg), and i (1-n) = the different input materials used in the production process. The removal of the hazardous property during the production process shall be such that the incorporation rate multiplied by the concentration of the hazardous property of each individual input material is below the limit values laid down in Annex III to Directive 2008/98/EC for that hazardous property,

• (h) test reports,

• (i) where the EU fertilising product contains or consists of derived 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 derived products have reached the end point in the manufacturing chain within the meaning of that Regulation,

• (j) where the EU fertilising product contains or consists of by-products within the meaning of Directive 2008/98/EC, technical and administrative evidence that the by-products comply with the criteria established by delegated act referred to in Article 42(7) of this Regulation, and with the national measures transposing Article 5(1) of Directive 2008/98/EC and, where applicable, implementing acts referred to in Article 5(2) or national measures adopted under Article 5(3) of that Directive, and

• (k) where the EU fertilising product contains total chromium (Cr) above 200 mg/kg dry matter, information about the maximum quantity and exact source of total chromium (Cr).

3. Availability of technical documentation

The manufacturer shall keep the technical documentation at the disposal of the relevant national authorities for 5 years after the EU fertilising product has been placed on the market.

4. Manufacturing

The manufacturer shall operate an approved quality system for production, final product inspection and testing of the EU fertilising 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 EU fertilising products with the requirements of this Regulation that apply to them.

• 5.1.1.The quality system shall cover the quality objectives and the organisational structure with responsibilities and powers of the management with regard to product quality.

• 5.1.1.1.For materials belonging to CMCs 3, 5, 12, 13, 14 and 15, 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 point 5.1.4;

• (c) conduct an internal audit every year, or sooner than scheduled if triggered by any significant change that may affect the quality of the EU 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 cover the manufacturing, quality control and quality assurance techniques, processes and systematic actions.

• 5.1.2.1.For materials belonging to CMCs 3, 5, 12, 13, 14 and 15, as defined in Annex II, the quality system shall ensure compliance with the requirements specified in that Annex.

• 5.1.3.The quality system shall cover the examinations and tests to be carried out before, during and after manufacture with a specified frequency.

• 5.1.3.1.For materials belonging to CMCs 3, 5, 12, 13, 14 and 15, as defined in Annex II, the examinations and tests shall comprise the following elements:

• (a) The following information shall be recorded for each batch of input materials:
• (i) date of delivery;
• (ii) amount by weight (or estimation based on the volume and density);
• (iii) identity of the input material supplier;
• (iv) input material type;
• (v) identification of each batch and delivery location on site. A unique identification code shall be assigned throughout the production process for quality management purposes; and
• (vi) in case of refusal, the reasons for the rejection of the batch 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 laid down in CMCs 3, 5, 12, 13, 14 and 15 in Annex II [OR: as defined in Annex II].

• (c) The manufacturer shall refuse any consignment of any given input material where visual inspection raises suspicion of any of the following:
• — the presence of hazardous or damaging substances for the process or for the quality of the final EU fertilising product,
• — incompatibility with the specifications laid down in CMCs 3, 5, 12, 13, 14 and 15 in Annex II [OR: as defined in Annex II], in particular by presence of plastics leading to exceedance 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 specifications laid down in CMCs 3, 5, 12, 13, 14 and 15, as defined in Annex II, and that the properties of the output material do not jeopardise the EU fertilising product’s compliance with the relevant requirements laid down in Annex I.

• (f) For materials belonging to CMCs 3 and 5, the output material samples shall be taken on a regular basis with at least the following frequency: 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

• (fa) For materials belonging to CMCs 12, 13, 14 and 15, the output material samples shall be taken with at least the following default frequency, or sooner than scheduled in the case of any significant change that may affect the quality of the EU fertilising product: Annual output (tonnes) Samples/year ≤ 3 000 4 3 001 – 10 000 8 10 001 – 20 000 12 20 001 – 40 000 16 40 001 – 60 000 20 60 001 – 80 000 24 80 001 – 100 000 28 100 001 – 120 000 32 120 001 – 140 000 36 140 001 – 160 000 40 160 001 – 180 000 44

  180 000 48 Manufacturers may reduce the default frequency of testing for contaminants as indicated above by considering the distribution of historical samples. After a minimum monitoring period of one year and a minimum number of 10 samples showing compliance with the requirements in Annex I and II, the manufacturer may reduce the default sampling frequency for that parameter by a factor 2 in case the greatest contaminant level recorded from the last 10 samples is smaller than half of the limit value for that parameter laid down in Annexes I and II.

• (fb) For materials belonging to CMCs 12, 13, 14 and 15, each batch or portion of production shall be assigned a unique code for quality management purposes. At least one sample per 3 000 tonnes of these materials or one sample per two months, whichever occurs sooner, shall be stored in good condition for a period of at least two years.

• (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, the person responsible for quality management referred to in point 5.1.1.1(b) shall:
• (i) clearly identify the non-conforming output materials and their storage place,
• (ii) analyse the reasons of the non-conformity and take any necessary action to avoid its repetition,
• (iii) record in the quality records referred to in point 5.1.4 if reprocessing takes place, or if the output material is eliminated  ,
• (iv) for materials belonging to CMCs 12, 13, 14 and 15, measure retainer samples referred to in sub-point (fb) and take the necessary corrective actions to prevent possible further transport and use of that material.

• 5.1.4.The quality system shall cover the manufacturer’s quality records, such as inspection reports and test data, calibration data, qualification reports on the personnel concerned, etc.

• 5.1.4.1.For materials belonging to CMCs 3, 5, 12, 13, 14 and 15, 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.

• 5.1.5.The quality system shall cover the means of monitoring the achievement of the required product quality and the effective operation of the quality system.

• 5.1.5.1.For materials belonging to CMCs 3, 5, 12, 13, 14 and 15, as defined in Annex II, the manufacturer shall establish an annual internal audit program in order to verify the compliance of the quality system with the following components:

• (a) 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;

• (b) priority shall be given to non-conformities identified by external audits;

• (c) each auditor shall not audit his or her own work;

• (d) the management responsible for the area audited shall ensure that the necessary corrective actions are taken without undue delay;

• (e) 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.

• 5.1.6.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 set out in points 5.1.1 to 5.1.5.

• 5.2.The manufacturer shall lodge an application for assessment of his or her quality system with the notified body of his or her choice, for the EU fertilising 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 EU fertilising product category envisaged,

• — the documentation concerning the quality system containing all the elements set out in point 5.1,

• — the technical documentation referred to in point 2.

• 5.3.1.The notified body shall assess the quality system to determine whether it satisfies the requirements referred to in point 5.1.

• 5.3.2.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.

• 5.3.3.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 EU fertilising product with those requirements.

• 5.3.4.The decision shall be notified to the manufacturer. The notification shall contain the conclusions of the audit and the reasoned assessment decision.

• 5.4.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.

• 5.5.1.The manufacturer shall keep the notified body that has approved the quality system informed of any intended change to the quality system.

• 5.5.2.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 5.1 or whether reassessment is necessary.

• 5.5.3.It shall notify the manufacturer of its decision. The notification shall contain the conclusions of the examination and the reasoned assessment decision.

6. Surveillance under the responsibility of the notified body

• 6.1.The purpose of 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 point 2,

• — the quality records, such as inspection reports and test data, calibration data, qualification reports on the personnel concerned.

• 6.3.1.The notified body shall carry out periodic audits to make sure that the manufacturer maintains and applies the quality system and shall provide the manufacturer with an audit report.

• 6.3.2.For materials belonging to CMCs 3, 5, 12, 13, 14 and 15, as defined in Annex II, the notified body shall carry out annual audits. In addition, the notified body shall take and analyse output material samples 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 tables included in points 5.1.3.1(f) and, respectively, 5.1.3.1(fa); and

• (b) during the following years of surveillance: half the sampling frequency indicated in the table included in point 5.1.3.1(f) and, respectively, 5.1.3.1(fa).

• 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. CE 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 point 5.2, the latter’s identification number to each individual packaging of the EU fertilising product that satisfies the applicable requirements of this Regulation or, where it is supplied without packaging, in a document accompanying the EU fertilising product.

• 7.2.The manufacturer shall draw up a written EU declaration of conformity for an EU fertilising product or type and keep it, together with the technical documentation at the disposal of the national authorities for 5 years after the EU fertilising product has been placed on the market. The EU declaration of conformity shall identify the EU fertilising product or type for which it has been drawn up.

• 7.3.A copy of the EU declaration of conformity shall be made available to the relevant authorities upon request.

8. Availability of quality system documentation

The manufacturer shall, for 5 years after the EU fertilising product has been placed on the market, keep at the disposal of the national authorities:

• — the documentation referred to in point 5.1.6,

• — the information on the changes referred to in points 5.5.1 and 5.5.2, as approved,

• — the decisions and reports of the notified body referred to in points 5.5.3, 6.3.1 and 6.4.

9. Notified bodies’ information obligation

• 9.1.Each notified body shall inform its notifying authority of quality system approvals issued or withdrawn, and shall, periodically or upon request, make available to its notifying authority 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, withdrawn, suspended or otherwise restricted, and, upon request, of quality system approvals which it has issued.

10. Authorised representative

The manufacturer’s obligations set out in points 3, 5.2, 5.5.1, 7 and 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)

([^E0043])

• 1.EU fertilising product (product-, batch-, or type- 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 the EU fertilising product allowing traceability; it may, where necessary for the identification of the EU fertilising product, include an image):

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

• — Regulation (EU) 2019/1009 ([^E0044]),

• — other Union harmonisation legislation where applicable:

• 6.References to the relevant harmonised standards or to the common specifications 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 or approval decision … (number):

• 8.Where applicable, annexed to this EU declaration of conformity are the EU declarations of conformity for the component EU fertilising products of the fertilising product blend.

• 9.Additional information:

• Signed for and on behalf of:

• (place and date of issue):

• (name, function) (signature):

[^E0001]: OJ L 123, 12.5.2016, p. 1.’

[^E0002]: 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).

[^E0003]: Commission Regulation (EU) No 37/2010 of 22 December 2009 on pharmacologically active substances and their classification regarding maximum residue limits in foodstuffs of animal origin (OJ L 15, 20.1.2010, p. 1).

[^E0004]: Commission Regulation (EU) 2019/1871 of 7 November 2019 on reference points for action for non-allowed pharmacologically active substances present in food of animal origin and repealing Decision 2005/34/EC (OJ L 289, 8.11.2019, p. 41).

[^E0006]: 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 3 on compost, CMCs 4 and 5 on digestate, CMCs 8 and 9 on polymers, CMC 10 on derived products within the meaning of Regulation (EC) No 1069/2009 or CMC 11 on by-products within the meaning of Directive 2008/98/EC.

[^E0007]: 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 point (d)(i) of Article 2(7) of Regulation (EC) No 1907/2006, as a substance registered with a dossier containing the information here indicated, and if information is available to the fertilising product manufacturer within the meaning of point (d)(ii) of Article 2(7) of Regulation (EC) No 1907/2006.

[^E0008]: 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.

[^E0009]: 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.

[^E0010]: Commission Regulation (EU) No 142/2011 of 25 February 2011 implementing Regulation (EC) No 1069/2009 of the European Parliament and of the Council laying down health rules as regards animal by-products and derived products not intended for human consumption and implementing Council Directive 97/78/EC as regards certain samples and items exempt from veterinary checks at the border under that Directive (OJ L 54, 26.2.2011, p. 1).

[^E0011]: 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.

[^E0012]: 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.

[^E0015]: The exclusion of a material from CMC 11 does not prevent it from being an eligible component material by virtue of another CMC stipulating different requirements. See, for instance, CMC 3 on compost, CMCs 4 and 5 on digestate, CMCs 8 and 9 on polymers or CMC 10 on derived products within the meaning of Regulation (EC) No 1069/2009.

[^E0016]: Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products (OJ L 167, 27.6.2012, p. 1).

[^E0017]: Directive 2009/28/EC of the European Parliament and of the Council of 23 April 2009 on the promotion of the use of energy from renewable sources and amending and subsequently repealing Directives 2001/77/EC and 2003/30/EC (OJ L 140 5.6.2009, p. 16).

[^E0018]: The exclusion of an input material from a sub-point does not prevent it from being an eligible input material by virtue of another sub-point.

[^E0019]: 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.

[^E0020]: The exclusion of an input material from a sub-point does not prevent it from being an eligible input material by virtue of another sub-point.

[^E0021]: Council Directive 91/271/EEC of 21 May 1991 concerning urban waste-water treatment (OJ L 135, 30.5.1991, p. 40).

[^E0022]: 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.

[^E0023]: van den Berg M., L.S. Birnbaum, M. Denison, M. De Vito, W. Farland, et al. (2006) The 2005 World Health Organization Re-evaluation of Human and Mammalian Toxic Equivalency Factors for Dioxins and Dioxin-like Compounds. Toxicological sciences: an official journal of the Society of Toxicology 93:223-241. doi:10.1093/toxsci/kfl055.

[^E0024]: Polychlorinated dibenzo-p-dioxins and dibenzofurans.

[^E0025]: The exclusion of an input material from a sub-point does not prevent it from being an eligible input material by virtue of another sub-point.

[^E0026]: 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.

[^E0027]: van den Berg M., L.S. Birnbaum, M. Denison, M. De Vito, W. Farland, et al. (2006) The 2005 World Health Organization Re-evaluation of Human and Mammalian Toxic Equivalency Factors for Dioxins and Dioxin-like Compounds. Toxicological sciences: an official journal of the Society of Toxicology 93:223-241. doi:10.1093/toxsci/kfl055.

[^E0028]: Polychlorinated dibenzo-p-dioxins and dibenzofurans.

[^E0030]: 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) (OJ L 300, 14.11.2009, p. 1).

[^E0031]: Council Directive 91/271/EEC of 21 May 1991 concerning urban waste-water treatment (OJ L 135, 30.5.1991, p. 40).

[^E0032]: Council Directive 86/278/EEC of 12 June 1986 on the protection of the environment, and in particular of the soil, when sewage sludge is used in agriculture (OJ L 181, 4.7.1986, p. 6).

[^E0033]: Directive 2010/75/EU of the European Parliament and of the Council of 24 November 2010 on industrial emissions (integrated pollution prevention and control) (OJ L 334, 17.12.2010, p. 17).

[^E0034]: 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.

[^E0035]: van den Berg M., L.S. Birnbaum, M. Denison, M. De Vito, W. Farland, et al. (2006) The 2005 World Health Organization Re-evaluation of Human and Mammalian Toxic Equivalency Factors for Dioxins and Dioxin-like Compounds. Toxicological sciences: an official journal of the Society of Toxicology 93:223-241. doi:10.1093/toxsci/kfl055.

[^E0036]: Sum of 2,3,7,8-TCDD, 1,2,3,7,8-PeCDD; 1,2,3,4,7,8-HxCDD; 1,2,3,6,7,8-HxCDD; 1,2,3,7,8,9-HxCDD; 1,2,3,4,6,7,8-HpCDD; OCDD; 2,3,7,8-TCDF; 1,2,3,7,8-PeCDF; 2,3,4,7,8-PeCDF; 1,2,3,4,7,8-HxCDF; 1,2,3,6,7,8-HxCDF; 1,2,3,7,8,9-HxCDF; 2,3,4,6,7,8-HxCDF; 1,2,3,4,6,7,8-HpCDF; 1,2,3,4,7,8,9-HpCDF; and OCDF.

[^E0037]: Regulation (EC) No 1831/2003 of the European Parliament and of the Council of 22 September 2003 on additives for use in animal nutrition (OJ L 268, 18.10.2003, p. 29).

[^E0038]: 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).

[^E0039]: 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).

[^E0040]: 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).

[^E0041]: The diameter of the disc must always correspond to the inside diameter of the cylinder.

[^E0042]: NB: When the six peripheral lengths of cord are taut after assembly, the central cord must remain slightly slack.

[^E0043]: It is optional for the manufacturer to assign a number to the EU declaration of conformity.

[^E0044]: Regulation (EU) 2019/1009 of the European parliament and 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 (OJ L 170, 25.6.2019, p. 1).