6. References to the relevant harmonised standards used or references to the other technical specifications in relation to which conformity is declared:

5. The object of the declaration described above is in conformity with the relevant Union harmonisation legislation:

4. Object of the declaration (identification of product allowing traceability; it may, where necessary for the identification of the CE marked fertilising product, include an image):

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

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

The manufacturer's obligations set out in paragraph 3, paragraph 5.2, paragraphs 5.6.1-5.6.3, Heading 7 and Heading 8 may be fulfilled by his or her authorised representative, on his or her behalf and under his or her responsibility, provided that they are specified in the mandate.

9.2.Each notified body shall inform the other notified bodies of quality system approvals which it has refused, suspended or withdrawn, and, upon request, of quality system approvals which it has issued.

9.1.Each notified body shall inform its notifying authorities of quality system approvals issued or withdrawn, and shall, periodically or upon request, make available to its notifying authorities the list of quality system approvals refused, suspended or otherwise restricted.

- the decisions and reports of the notified body referred to in paragraph 5.6.15.6.3, paragraph 6.3 and paragraph 6.4.

8.The manufacturer shall, for a period ending at least 10 years after the product has been placed on the market, keep at the disposal of the national authorities:

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

7.2.1The manufacturer shall draw up a written EU declaration of conformity for each CE marked fertilising product lot and keep it at the disposal of the national authorities for 10 years after the CE marked fertilising product has been placed on the market. The EU declaration of conformity shall identify the product lot for which it has been drawn up.

7.1.The manufacturer shall affix the CE marking and, under the responsibility of the notified body referred to in paragraph 5.2, the latter's identification number to each individual product that satisfies the applicable requirements of this Regulation.

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.

(b)During the following years of surveillance: Half the sampling frequency indicated in the table included in paragraph 5.1.3.1(f).

(a)During the notified body's first year of surveillance of the plant in question: The same frequency as the sampling frequency indicated in the table included in paragraph 5.1.3.1(f); and

6.3.2For compost belonging to component material category ('CMC') 3 and digestate belonging to CMC 5, as defined in Annex II, the notified body shall take and analyse output material samples during each audit, and the audits shall be carried out with the following frequency:

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

6.2.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:

6.1The purpose of surveillance is to make sure that the manufacturer duly fulfils the obligations arising out of the approved quality system.

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

5.6.2.The notified body shall evaluate any proposed changes and decide whether the modified quality system will continue to satisfy the requirements referred to in point 5.2 or whether reassessment is necessary.

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

5.5.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

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

5.4.3.In addition to experience in quality management systems, the auditing team shall have at least one member with experience of evaluation in the relevant product field and product technology concerned, and knowledge of the applicable requirements of this Regulation. The audit shall include an assessment visit to the manufacturer's premises. The auditing team shall review the technical documentation referred to in point 2 in order to verify the manufacturer's ability to identify the relevant requirements of this Regulation and to carry out the necessary examinations with a view to ensuring compliance of the CE marked fertilising product with those requirements.

5.4.2.It shall presume conformity with those requirements in respect of the elements of the quality system that comply with the corresponding specifications of the relevant harmonised standard.

5.4.1.The notified body shall assess the quality system to determine whether it satisfies the requirements referred to in paragraph 5.1 and subparagraphs.

5.3.All the elements, requirements and provisions adopted by the manufacturer shall be documented in a systematic and orderly manner in the form of written policies, procedures and instructions. The quality system documentation shall permit a consistent interpretation of the quality programmes, plans, manuals and records. It shall, in particular, contain an adequate description of all the quality management elements mentioned above in paragraph 5.1 and subparagraphs.

- a written declaration that the same application has not been lodged with any other notified body,

- 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,

5.2.The manufacturer shall lodge an application for assessment of his or her quality system with the accredited notified body of his or her choice, for the products concerned. The application shall include:

(5)Internal audit realised in the frame of another quality management system can be taken into account provided that it is completed by an audit of the requirements to this quality system.

(4)The management responsible for the area audited shall ensure that the necessary corrective actions are taken without undue delay.

(1)A procedure that defines the responsibilities and requirements for planning and conducting internal audits, establishing records and reporting results shall be established and documented. A report identifying the non-conformities to the quality scheme shall be prepared and all corrective actions shall be reported. The records of the internal audit shall be annexed to the quality management documentation.

5.1.5.1.For compost belonging to component material category ('CMC') 3 and digestate belonging to CMC 5, as defined in Annex II, the manufacturer shall establish an annual internal audit program in order to verify the compliance to the quality system, with the following components:

5.1.5The achievement of the required product quality and the effective operation of the quality system shall be monitored.

(k)A record of the date, type and topic of training followed by the persons responsible for the quality of the product,

(j)Records of the complaints expressed by third parties and how they have been addressed,

(i)Reports on all accidents and incidents that occur to the site, their known or suspected causes and actions taken,

5.1.4.1.For compost belonging to component material category ('CMC') 3 and digestate belonging to CMC 5, as defined in Annex II, the quality records shall demonstrate effective control of input materials, production, storage and compliance of input- and output materials with the relevant requirements of this Regulation. Each document shall be legible and available at its relevant place(s) of use, and any obsolete version shall be promptly removed from all places where it is used, or at least identified as obsolete. The quality management documentation shall at least contain the following information:

5.1.4.The manufacturer shall maintain the quality records, such as inspection reports and test data, calibration data, qualification reports on the personnel concerned, etc.,

(3)Record in the quality records referred to in paragraph 5.1.4 if reprocessing takes place, or if the product is eliminated.

(2)Analyse the reasons of the non-conformity and take any necessary action to avoid its repetition,

(g)If any tested output material sample fails one or more of the applicable limits specified in the relevant sections of Annexes I and II to this Regulation, the person responsible for quality management referred to above in point 5.1.1.1(b) shall:

(f)The output material samples shall be taken with at least the following frequency:

(e)Samples shall be taken on output materials, to verify that they comply with the component material specifications for compost and digestate laid down in CMC 3 and CMC 5 in Annex II, and that the properties of the output material does not jeopardise the CE marked fertilising product's compliance with the relevant requirements in Annex I.

features that allow hazardous properties and the presence of plastics to be recognised.

incompatibility with the specifications of CMC 3 and CMC 5 in Annex II, in particular by presence of plastics leading to excedence of the limit value for macroscopic impurities.

the presence of hazardous or damageable substances for the composting or digestion process or for the quality of the final CE marked fertilising product, or of

(c)The manufacturer shall refuse any consignment of any given input material where visual inspection raises any suspicion of

(b)Qualified staff shall carry out a visual inspection of each consignment of input materials and verify compatibility with the specifications of input materials in CMC 3 and CMC 5 in Annex II.

(6)In case of refusal, the reasons for the rejection of the lot and where it was sent.

(5)Identification of each lot and delivery location on site. A unique identification code shall be assigned throughout the production process for quality management purposes; and

5.1.3.1.For compost belonging to CMC 3 and digestate belonging to CMC 5, as defined in Annex II, the examinations and tests shall comprise the following elements:

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

5.1.2.1.For compost belonging to component material category ('CMC') 3 and digestate belonging to CMC 5, as defined in Annex II, the system shall ensure compliance with the composting and digestion process criteria specified in that Annex.

(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.

(c)Conduct an internal audit every year, or sooner than scheduled if triggered by any significant change that may affect the quality of the CE marked fertilising product; and

Ensuring that each person whose duties affect the product quality is sufficiently trained and instructed; and

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;

Reporting to senior management of the manufacturer on the performance of the quality management and any need for improvement;

5.1.1.1.For compost belonging to component material category ('CMC') 3 and digestate belonging to CMC 5, as defined in Annex II, senior management of the manufacturer's organisation shall:

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

5.1.The manufacturer shall implement a quality system which shall ensure compliance of the CE marked fertilising product with the requirements of this Regulation that apply to them.

4.The manufacturer shall operate an approved quality system for production, final product inspection and testing of the products concerned as specified in point 5, and shall be subject to surveillance as specified in point 6.

3.The manufacturer shall keep the technical documentation at the disposal of the relevant national authorities for 10 years after the CE marked fertilising product has been placed on the market.

(g)where the product contains or consists of animal by-products within the meaning of Regulation (EC) No 1069/2009, the commercial documents or health certificates required pursuant to that Regulation, and evidence that the animal by-products have reached the end point in the manufacturing chain within the meaning of that Regulation.

(d)a list of the harmonised standards applied in full or in part the references of which have been published in the Official Journal of the European Union and, where those harmonised standards have not been applied, descriptions of the solutions adopted to meet the essential requirements of this Regulation, including a list of common specifications or other relevant technical specifications applied. In the event of partly applied harmonised standards, the technical documentation shall specify the parts which have been applied,

(c)descriptions and explanations necessary for the understanding of those drawings and schemes and of the use of the CE marked fertilising product,

(b)conceptual design and manufacturing drawings and schemes, including a written description and a diagram of the production process, where each treatment, storage vessel and area is clearly identified,

2.The manufacturer of the CE marked fertilising product shall establish the technical documentation. The documentation shall make it possible to assess the product's conformity with the relevant requirements, and shall include an adequate analysis and assessment of the risk(s). The technical documentation shall specify the applicable requirements and cover, as far as relevant for the assessment, the design, manufacture and use of the product. The technical documentation shall, wherever applicable, contain at least the following elements:

1.Quality assurance of the production process is the conformity assessment procedure whereby the manufacturer of the CE marked fertilising product fulfils the obligations laid down under Headings 2, 4, and 7, and ensures and declares on his or her sole responsibility that the CE marked fertilising products concerned satisfy the requirements of this Regulation that apply to them.

4.The manufacturer's obligations set out in point 3 may be fulfilled by his or her authorised representative, on his or her behalf and under his or her responsibility, provided that they are specified in the mandate.

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

3.2The manufacturer shall draw up a written EU declaration of conformity for a CE marked fertilising product lot and keep it at the disposal of the national authorities for 10 years after the CE marked fertilising product has been placed on the market. The EU declaration of conformity shall identify the CE marked fertilising product lot for which it has been drawn up.

3.1The manufacturer shall affix the CE marking to each individual fertilising product that is in conformity with the type described in the EU-type examination certificate and satisfies the requirements of this Regulation.

2.The manufacturer shall take all measures necessary so that the manufacturing process and its monitoring ensure conformity of the manufactured CE marked fertilising products with the approved type described in the EU-type examination certificate and with the requirements of this Regulation that apply to them.

1.Conformity to type based on internal production control is the part of a conformity assessment procedure whereby the manufacturer fulfils the obligations laid down in points 2 and 3, and ensures and declares that the CE marked fertilising products concerned are in conformity with the type described in the EU-type examination certificate and satisfy the requirements of this Regulation that apply to them.

10.The manufacturer's authorised representative may lodge the application referred to in point 3 and fulfil the obligations set out in points 7 and 9, provided that they are specified in the mandate.

9.The manufacturer shall keep a copy of the EU-type examination certificate, its annexes and additions together with the technical documentation at the disposal of the national authorities for 10 years after the CE marked fertilising product has been placed on the market.

8.4.The notified body shall keep a copy of the EU-type examination certificate, its annexes and additions, as well as the technical file including the documentation submitted by the manufacturer, until the expiry of the validity of the certificate.

8.3.The Commission, the Member States and the other notified bodies may, on request, obtain a copy of the EU-type examination certificates and/or additions thereto. On request, the Commission and the Member States may obtain a copy of the technical documentation and the results of the examinations carried out by the notified body.

8.2.Each notified body shall inform the other notified bodies concerning the EU-type examination certificates and/or any additions thereto which it has refused, withdrawn, suspended or otherwise restricted, and, upon request, concerning the certificates and/or additions thereto which it has issued.

8.1.Each notified body shall inform its notifying authority concerning the EU-type examination certificates and/or any additions thereto which it has issued or withdrawn, and shall, periodically or upon request, make available to its notifying authorities the list of certificates and/or any additions thereto refused, suspended or otherwise restricted.

7.2.The manufacturer shall inform the notified body that holds the technical documentation relating to the EU-type examination certificate of all modifications to the approved type that may affect the conformity of the CE marked fertilising product with the requirements of this Regulation or the conditions for validity of the certificate. Such modifications shall require additional approval in the form of an addition to the original EU-type examination certificate.

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.

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.

6.2.The certificate and its annexes shall contain all relevant information to allow the conformity of manufactured CE marked fertilising products with the examined type to be evaluated and to allow for further in-service control.

6.1.Where the type meets the requirements of this Regulation that apply to the CE marked fertilising product concerned, the notified body shall issue an EU-type examination certificate to the manufacturer. The certificate shall contain the name and address of the manufacturer, the conclusions of the examination, the conditions (if any) for its validity and the necessary data for identification of the approved type. The certificate may have one or more annexes attached.

5.The notified body shall draw up an evaluation report that records the activities undertaken in accordance with point 4 and their outcomes. Without prejudice to its obligations vis-à-vis the notifying authorities, the notified body shall release the content of that report, in full or in part, only with the agreement of the manufacturer.

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

(4)carry out appropriate examinations and tests, or have them carried out, to check whether, where the solutions in the relevant harmonised standards and/or technical specifications have not been applied, the solutions adopted by the manufacturer meet the corresponding essential requirements of this Regulation;

(3)carry out appropriate examinations and tests, or have them carried out, to check whether, where the manufacturer has chosen to apply the solutions in the relevant harmonised standards and/or technical specifications, these have been applied correctly;

(2)verify that the specimen(s) have been manufactured in conformity with the technical documentation, and identify the elements which have been designed in accordance with the applicable provisions of the relevant harmonised standards and/or technical specifications, as well as the elements which have been designed in accordance with other relevant technical specifications;

(1)examine the technical documentation and supporting evidence to assess the adequacy of the technical design of the CE marked fertilising product;

(e)the supporting evidence for the adequacy of the technical design solution. This supporting evidence shall mention any documents that have been used, in particular where the relevant harmonised standards have not been applied in full. The supporting evidence shall include, where necessary, the results of tests carried out in accordance with other relevant technical specifications by the appropriate laboratory of the manufacturer, or by another testing laboratory on his or her behalf and under his or her responsibility.

(d)the specimens representative of the production envisaged. The notified body may request further specimens if needed for carrying out the test programme;

where the product contains or consists of animal by-products within the meaning of Regulation (EC) No 1069/2009, the commercial documents or health certificates required pursuant to that Regulation, and evidence that the animal by-products have reached the end point in the manufacturing chain within the meaning of that Regulation;

a list of the harmonised standards applied in full or in part the references of which have been published in the Official Journal of the European Union and, where those harmonised standards have not been applied, descriptions of the solutions adopted to meet the essential requirements of this Regulation, including a list of common specifications or other relevant technical specifications applied. In the event of partly applied harmonised standards, the technical documentation shall specify the parts which have been applied,

descriptions and explanations necessary for the understanding of those drawings and schemes and the use of the CE marked fertilising product,

(c)the technical documentation. The technical documentation shall make it possible to assess the CE marked fertilising product's conformity with the applicable requirements of this Regulation and shall include an adequate analysis and assessment of the risk(s). The technical documentation shall specify the applicable requirements and cover, as far as relevant for the assessment, the design, manufacture and use of the CE marked fertilising product. The technical documentation shall contain, wherever applicable, at least the following elements:

(b)a written declaration that the same application has not been lodged with any other notified body,

(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,

3.1.The manufacturer shall lodge an application for EU-type examination with a single notified body of his or her choice.

2.Assessment of the adequacy of the technical design of the CE marked fertilising product may be carried out through examination of the technical documentation and supporting evidence referred to in paragraph 3.2 below, plus examination of specimens, representative of the production envisaged, of one or more critical components of the product (combination of production type and design type).

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

6.The manufacturer's obligations set out under Heading 5 above may be fulfilled by his or her authorised representative, on his or her behalf and under his or her responsibility, provided that they are specified in the mandate.

5.2.The manufacturer shall draw up a written EU declaration of conformity for each CE marked fertilising product lot and keep it together with the technical documentation at the disposal of the national authorities for 10 years after the CE marked fertilising product has been placed on the market. The EU declaration of conformity shall identify such CE marked fertilising product for which it has been drawn up.

5.1.The manufacturer shall affix the CE mark to each individual fertilising product that satisfies the applicable requirements of this Regulation.

4.3.5.1.If, in each firing, the crushing of at least one lead cylinder is less than 5%, the test shall be considered conclusive.

the values actually measures for the outside diameter of the steel tube and for the wall thickness,

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

4.3.4.7.A probe for continuous measurement of the detonation velocity can be used; the probe should be inserted longitudinally to the axis of the tube or along its side wall.

4.3.4.6.2.Record for each of the marked lead cylinders, the degree of crushing expressed as a percentage of the original height of 100 mm. If the cylinders are crushed obliquely, record the highest and the lowest values and calculate the average.

4.3.4.6.1Allow sufficient time for the fumes (gaseous and sometimes toxic decomposition products such as nitrous gases) to disperse, then collect the lead cylinders and measure their heights with a Vernier caliper

4.3.4.5.3.Finally, remove the wooden rod and replace with the detonator. Do not carry out firing until the danger zone has been evacuated and the test personnel have taken cover.

4.3.4.5.2.If the booster charge with sevenpoint initiation is used, ensure that the detonation cords are stretched out as described in the footnote to paragraph 4.3.4.1.1.4 above and arranged as horizontally as possible.

Note: Should such firing sites not be available, the work can, if necessary, be done in a concretelined pit covered over with wooden beams. Detonation can cause steel fragments to be projected with high kinetic energy, therefore, firing shall be carried out at a suitable distance from dwellings or thoroughfares.

4.3.4.5.1.Set up the apparatus as described under Heading 4.3.4.4. in a bunker or suitably prepared underground site (e.g. mine or tunnel). Ensure that the temperature of the steel tube is kept at 20 ( 5)°C before detonation.

Note: Make sure that the tube is in contact with all six lead cylinders; a slight curvature of the tube surface can be compensated for by rotating the tube about its longitudinal axis; if any of the lead cylinders is too tall, tap the cylinder in question carefully with a hammer until it is the required height.

4.3.4.4.2.Lay the steel tube prepared according to 4.3.4.3. horizontally on the lead cylinders so that the axis of the tube is parallel to the centre line of the steel block and the welded end of the tube extends 50 mm beyond lead cylinder No 6. To prevent the tube from rolling, insert small wooden wedges between the tops of the lead cylinders and the tube wall (one on each side) or place a cross of wood between the tube and the steel block.

4.3.4.4.1.Number the bases of the lead cylinders (point (f) under Heading 4.3.3. above) 1 to 6. Make six marks 150 mm apart on the centre line of a steel block (4.3.7) lying on a horizontal base, with the first mark at least 75 mm from the edge of the block. Place a lead cylinder upright on each of these marks, with the base of each cylinder centred on its mark.

4.3.4.3.3.Insert the booster charge into the tube so that it is in contact with the sample; the top surface of the wooden disc shall be 6 mm below the end of the tube. Ensure essential close contact between explosive and test sample by adding or removing small quantities of sample. As shown in Figures 2 and 3, split pins should be inserted through the holes near the open end of the tube and their legs opened flat against the tube.

4.3.4.3.2.3The filling height of the sample shall be adjusted in the steel tube so that the booster charge (referred to above under Heading 4.3.4.1.1. or 4.3.4.1.2.) to be inserted later will be in close contact with the sample over its entire surface.

4.3.4.3.2.2.Repeat this charging method with another portion of the test sample. Finally, a further addition shall be made such that, after compaction by raising and dropping the tube 10 times and a total of 20 intermittent hammer blows, the charge fills the tube to a distance of 70 mm from its orifice.

4.3.4.3.2.1Place the tube upright with its square bottom place resting on a firm, flat surface, preferably concrete. Fill the tube to about onethird of its height with the test sample and drop it 10 cm vertically onto the floor five times to compact the prills or granules as densely as possible in the tube. To accelerate compaction, vibrate the tube by striking the side wall with a 750 to 1 000gram hammer between drops for a total of 10 times.

4.3.4.3.1.The test sample, the steel tube and the booster charge shall be conditioned to temperatures of 20 ( 5)°C. 16 to 18 kg of the test sample are needed for two detonation tests.

4.3.4.2.At one end of the steel tube (point (d) under Heading 4.3.3. above), drill two diametrically opposed holes 4 mm in diameter perpendicularly through the side wall at a distance of 4 mm from the edge. Butt weld the bottom plate (point (e) under Heading 4.3.3. above) to the opposite end of the tube, completely filling the right angle between the bottom place and the wall of the tube with weld metal around the entire circumference of the tube.

4.3.4.1.2.2.Place the explosive (point (a) under Heading 4.3.3. above) into the cylinder (point (h) under Heading 4.3.3. above) standing upright on a level surface, then press it down with a wooden die to give the explosive a cylindrical shape with a central recess. Insert the compressed pellet into this recess. Cover the cylindrically shaped explosive containing the compressed pellet with a wooden disc (point (j) under Heading 4.3.3. above) having a central hole 7,0 to 7,3 mm in diameter for insertion of a detonator. Fix the wooden disc and the cylinder together with a cross of adhesive tape. Ensure that the hole drilled in the disc and the recess in the compressed pellet are coaxial by inserting the wooden rod (point (k) under Heading 4.3.3. above).

4.3.4.1.2.1.Taking the necessary safety precautions, place 10 grams of a secondary explosive (point (c) under Heading 4.3.3. above) in a mould with an inside diameter of 19 to 21 mm and compress to the correct shape and density. (The ratio of diameter: height should be roughly 1:1). In the centre of the bottom of the mould there is a peg, 12 mm in height and 7,0 to 7,3 mm in diameter (depending on the diameter of the detonator used), which forms a cylindrical recess in the compressed cartridge for subsequent insertion of the detonator.

4.3.4.1.1.4.Group the free ends of the seven lengths of detonating cord around the circumference of the wooden rod (point (k) under Heading 4.3.3. above) so that their ends are all level in a plane perpendicular to the rod. Secure them in a bundle around the rod by means of adhesive tape.

4.3.4.1.1.3.Shape the plastic explosive (point (a) under Heading 4.3.3. above) to form a cylinder 92 to 96 mm in diameter, depending on the diameter of the cylinder (point (h) under Heading 4.3.3. above). Stand this cylinder upright on a level surface and insert the shaped explosive. Then insert the wooden disc carrying the seven lengths of detonating cord into the top of the cylinder and press it down onto the explosive. Adjust the height of the cylinder (64 to 67 mm) so that its top edge does not extend beyond the level of the wood. Finally, fix the cylinder to the wooden disc for instance with staples or small nails, around its entire circumference.

4.3.4.1.1.2.Cut seven lengths of flexible detonating cord (point (b) under Heading 4.3.3. above) each 400 mm long, avoiding any loss of explosive at each end by making a clean cut and immediately sealing the end with adhesive. Push each of the seven lengths through each of the seven holes in the wooden disc (point (j) under Heading 4.3.3. above) until their ends project a few centimetres on the other side of the disc. Then insert a small dressmaking pin (point (l) under Heading 4.3.3. above) transversally into the textile sleeve of each length of cord 5 to 6 mm from the end and apply adhesive around the outside of the lengths of cord in a band 2 cm wide adjacent to the pin. Finally, pull the long piece of each cord to bring the pin into contact with the wooden disc.

4.3.4.1.1.1.Drill holes in the wooden disc (point (j) under Heading 4.3.3. above) parallel to the axis of the disc through the centre and through six points symmetrically distributed around a concentric circle 55 mm in diameter. The diameter of the holes shall be 6 to 7 mm (see Section AB in Figure 2), depending on the diameter of the detonating cord used (point (b) under Heading 4.3.3. above).

4.3.4.1.Depending on the availability of equipment, the explosive can be initiated in the booster charge either

Diameter: 92 to 96 mm. Diameter to be matched to the internal diameter of the plastic or cardboard cylinder (point (h) above)

Mass: at least 300 kg if there is no firm base for the steel block.

4.3.2.The test sample is confined in a steel tube and subjected to detonation shock from an explosive booster charge. Propagation of the detonation is determined from the degree of crushing of lead cylinders on which the tube rests horizontally during the test.

(h)placed at 150 mm intervals and supporting the tube horizontally. The test is to be carried out twice. The test is deemed conclusive if in both tests one or more of the supporting lead cylinders is crushed by less than 5%.

(e)Booster: the type and mass of the booster chosen shall be such as to maximise the detonation pressure applied to the sample in order to determine its susceptibility to the transmission of detonation,

4.3.1.2.The CE marked fertilising product shall be subjected to the test of resistance to detonation in a horizontal steel tube under the following conditions:

4.3.1.1The test shall be carried out on a representative sample of the CE marked fertilising product. Before being tested for resistance to detonation, the whole mass of the sample is to be thermally cycled five times complying with the provisions under heading 4.2 above.

4.2.3.Place a quantity of fertilisers sufficient for a single detonation into the box and close the cover. Place the box in the water bath. Heat the water to 51°C and measure the temperature in the centre of the fertiliser. One hour after the temperature at the centre has reached 50°C cool the water. One hour after the temperature at the centre has reached 25°C heat the water to start the second cycle. In the case of two water baths, transfer the box to the other bath after each heating/cooling period.

(b)A stainless steel box, watertight all around and provided with a thermocouple in the centre. The outside width of the box is 45 (± 2) mm and the wall thickness is 1,5 mm (see Figure 1). The height and length of the box can be chosen to suit the dimensions of the water bath, e.g. length 600 mm, height 400 mm.

(a)A water bath, thermostated in a temperature range of 20 to 51°C with a minimum heating and cooling rate of 10°C/h, or two water baths, one thermostated at a temperature of 20°C, the other at 51°C. The water in the bath(s) is continuously stirred; the volume of the bath shall be large enough to guarantee ample circulation of the water.

4.2.1.In a watertight box heat the sample from ambient temperature to 50°C and maintain at this temperature for a period of one hour (phase at 50°C). Thereupon cool the sample until a temperature of 25°C is achieved and maintain at that temperature for one hour (phase at 25°C). The combination of the successive phases at 50°C and 25°C forms one thermal cycle. After being subjected to the required number of thermal cycles, the test sample is held at a temperature of 20 (±3)°C pending the execution of the detonability test.

4.1.3.3.Maintain the water in each bath at constant temperature and keep in motion by rapid stirring to ensure the water level comes above the level of the sample. Protect the stopper from condensation by a foam rubber cap.

4.1.3.2.Move each flask every two hours from the 50°C bath to the 25°C bath and vice versa.

4.1.3.1.Put each test sample of 70 ( 5) grams into an Erlenmeyer flask which is then sealed with a stopper.

4.1.1.In an Erlenmeyer flask, heat the sample from ambient temperature to 50°C and maintain at this temperature for a period of two hours (phase at 50°C). Thereupon cool the sample until a temperature of 25°C is achieved and maintain at that temperature for two hours (phase at 25°C). The combination of the successive phases at 50°C and 25°C forms one thermal cycle. After being subjected to two thermal cycles, the test sample is held at a temperature of 20 (±3)°C for the determination of the oil retention value.

4.1.Thermal cycles prior to a test for compliance with the oil retention requirement referred to in paragraph 4 under PFC 1(C)(I)(a)(iii)(A) in Annex I

The tests shall be carried out under the responsibility of a notified body chosen by the manufacturer.

(a)the oil retention requirement referred to in paragraph 4 under PFC 1(C)(I)(a)(iii)(A) in Annex I to this Regulation, and

4.The cycles and test referred to under Headings 4.1-4.3 below shall be carried out on a representative sample of the product at least every 3 months on behalf of the manufacturer, in order to verify conformity with

3.The manufacturer shall take all measures necessary so that the manufacturing process and its monitoring ensure compliance of the manufactured CE marked fertilising products with the technical documentation referred to under Heading 2 above and with the requirements of this Regulation.

(e)a list of the harmonised standards applied in full or in part the references of which have been published in the Official Journal of the European Union and, where those harmonised standards have not been applied, descriptions of the solutions adopted to meet the essential requirements of this Regulation, including a list of common specifications or other relevant technical specifications applied. In the event of partly applied harmonised standards, the technical documentation shall specify the parts which have been applied,

(d)the names and addresses of the sites, and of the operators of the sites, at which the product and its principal components were manufactured,

(c)descriptions and explanations necessary for the understanding of those drawings and schemes and the use of the CE marked fertilising product,

2.2.The technical documentation shall specify the applicable requirements and cover, as far as relevant for the assessment, the design, manufacture and use of the CE marked fertilising product. The technical documentation shall contain, wherever applicable, at least the following elements:

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

1.Internal production control plus supervised product testing is the conformity assessment procedure whereby the manufacturer fulfils the obligations laid down under Headings 2, 3, 4, and 5 below, and ensures and declares on his or her sole responsibility that the CE marked fertilising products concerned satisfy the requirements of this Regulation that apply to them.

5.The manufacturer's obligations set out under Heading 4 above may be fulfilled by his or her authorised representative, on his or her behalf and under his or her responsibility, provided that they are specified in the mandate.

4.2.The manufacturer shall draw up a written EU declaration of conformity for each CE marked fertilising product lot and keep it together with the technical documentation at the disposal of the national authorities for 10 years after the CE marked fertilising product has been placed on the market. The EU declaration of conformity shall identify the CE marked fertilising product for which it has been drawn up.

4.1.The manufacturer shall affix the CE mark to each individual fertilising product that satisfies the applicable requirements of this Regulation.

3.The manufacturer shall take all measures necessary so that the manufacturing process and its monitoring ensure compliance of the manufactured CE marked fertilising products with the technical documentation referred to under Heading 2 above and with the requirements of this Regulation that apply to them.

(d)a list of the harmonised standards applied in full or in part the references of which have been published in the Official Journal of the European Union and, where those harmonised standards have not been applied, descriptions of the solutions adopted to meet the essential requirements of this Regulation, including a list of common specifications or other relevant technical specifications applied. In the event of partly applied harmonised standards, the technical documentation shall specify the parts which have been applied,

(c)descriptions and explanations necessary for the understanding of those drawings and schemes and the use of the CE marked fertilising product,

2.2The technical documentation shall specify the applicable requirements and cover, as far as relevant for the assessment, the design, manufacture and use of the CE marked fertilising product. The technical documentation shall contain at least the following elements:

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

1.Internal production control is the conformity assessment procedure whereby the manufacturer fulfils the obligations laid down under Headings 2, 3 and 4 below, and ensures and declares on his or her sole responsibility that the CE marked fertilising products concerned satisfy the requirements of this Regulation that apply to them.

2.By derogation from paragraph 1, Module D1 must not be used for a straight or compound solid inorganic macronutrient ammonium nitrate fertiliser of high nitrogen content, as specified in PFC 1(C)(I)(a)(iii)(A), or a fertilising product blend containing such a product.

3.By derogation from paragraphs 1 and 2, Module B and Module C must not be used for a straight or compound solid inorganic macronutrient ammonium nitrate fertiliser of high nitrogen content, as specified in PFC 1(C)(I)(a)(iii)(A), or a fertilising product blend containing such a product.

2.Module B and Module C may also be used for

1.Module B in combination with Module C may be used for a CE marked fertilising product composed solely of one or more

Module A1 shall be used for a straight or compound solid inorganic macronutrient ammonium nitrate fertiliser of high nitrogen content, as specified in PFC 1(C)(I)(a)(iii)(A), and for a fertilising product blend as specified in PFC 7 containing such a product.

(a)a straight or compound solid inorganic macronutrient ammonium nitrate fertiliser of high nitrogen content, as specified in PFC 1(C)(I)(a)(iii)(A), or a fertilising product blend containing such a product,

3.By derogation from paragraphs 1 and 2, Module A must not be used for

2.Module A may also be used for a fertilising product blend as specified in PFC 7.

1.Module A may be used for a CE marked fertilising product composed solely of one or more

This Part sets out the applicability of conformity assessment procedure modules, as specified in Part 2 of this Annex, to CE marked fertilising products depending on their Component Material Categories as specified in Annex II ('CMC'), and their Product Function Categories as specified in Annex I ('PFC').

± 20% relative deviation of the declared value up to a maximum of 2,0 percentage points in absolute terms

- 25% relative deviation of the declared value at any time in the distribution chain

± 10% relative deviation of the declared value up to a maximum of 1,0 percentage points in absolute terms

± 25% of the declared content of those nutrients up to a maximum of 1,5 percentage points in absolute terms.

± 25% of the declared content of the nutrient forms present up to a maximum of 2 percentage point in absolute terms

Total zinc (Zn) ± 50 % relative deviation of the declared value up to a maximum of 2,0 percentage points in absolute terms

Total copper (Cu) ± 50 % relative deviation of the declared value up to a maximum of 2,5 percentage points in absolute terms

Organic nitrogen: ± 50 % relative deviation of the declared value up to a maximum of 1,0 percentage point in absolute terms

Organic carbon: ± 20 % relative deviation of the declared value up to a maximum of 2,0 percentage point in absolute terms

± 25% of the declared content of those nutrients up to a maximum of 1,5 percentage points in absolute terms.

± 25% of the declared content of the nutrient forms present up to a maximum of 2 percentage point in absolute terms

± 50 % relative deviation of the declared value up to a maximum of 2,0 percentage points in absolute terms

± 50 % relative deviation of the declared value up to a maximum of 2,5 percentage points in absolute terms

± 25% of the declared content of those nutrients up to a maximum of 1,5 percentage points in absolute terms.

± 50 % relative deviation of the declared value up to a maximum of 1,0 percentage point in absolute terms

± 50 % relative deviation of the declared value up to a maximum of 1,0 percentage point in absolute terms

± 50 % relative deviation of the declared value up to a maximum of 1,0 percentage point in absolute terms

± 50 % relative deviation of the declared value up to a maximum of 1,0 percentage point in absolute terms

± 20 % relative deviation of the declared value up to a maximum of 2,0 percentage point in absolute terms

4.By derogation from paragraph 1, the actual content in a CE marked fertilising product of a component for which a minimum or a maximum content is specified in Annex I or Annex II may never be lower than the minimum content or exceed the maximum content.

2.The tolerances allowed in respect of the declared parameters indicated in this Part are negative and positive values in percentage by mass.

1.The declared nutrient content or physico-chemical characteristics of a CE marked fertilising product may deviate from the actual value only in accordance with the tolerances established in this Part for the relevant product function category. The tolerances are intended to allow for deviations in manufacture, sampling and analysis.

All the labelling requirements applicable to all component CE marked fertilising products apply to the CE marked fertilising product blend, and shall be expressed in relation to the final CE marked fertilising product blend.

The label shall contain the following phrase: 'Micro-organisms may have the potential to provoke sensitising reactions'.

For other pre-shaped growing media, expressed as size in at least two dimensions, and

The following parameters shall be declared in the following order, and expressed as a percentage of the CE marked fertilising product by mass:

The following parameters shall be declared in the following order:

–where the soluble content of the micronutrients is at least half of the total content of those nutrients, the total content and the content soluble in water; and

–where the micronutrients are totally soluble in water, only as the content soluble in water;

2.If the fertiliser is in suspension or in solution, the label shall indicate "in suspension" or "in solution", as relevant.

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

–where the soluble content of the micronutrient is at least a quarter of the total content of that nutrient, the total content and the content soluble in water; and

–where the micronutrient is totally soluble in water, only as the content soluble in water;

1.The label shall indicate the relevant typology, as referred to in the table under PFC 1(C)(II)(a) in Part II of Annex I.

4.The following statement shall appear: ‘To be used only where there is a recognised need. Do not exceed the appropriate rate’.

–‘complexed by …', and the amount of complexed micronutrient as a percentage of the CE marked fertilising product by mass, and

3.Where the declared micronutrient(s) are complexed by complexing agent(s), the following qualifier shall be added after the name and the chemical identifier of the micronutrient:

–‘chelated by…’ name of the chelating agent or its abbreviation, and the amount of chelated micronutrient as a percentage of the CE marked fertilising product by mass.

2.Where the declared micronutrient(s) are chelated by chelating agent(s), and each chelating agent can be identified and quantified and chelates at least 1% water-soluble micronutrient, the following qualifier shall be added after the name and the chemical identifier of the micronutrient:

1.The declared micronutrients in the CE marked fertilising product shall be listed by their names and chemical symbols in the following order: boron (B), cobalt (Co), copper (Cu), iron (Fe), manganese (Mn), molybdenum (Mo) and zinc (Zn), followed by the name(s) of their counter-ion(s),

(e)The following statement: ‘To be used only where there is a recognised need. Do not exceed the appropriate rate’.

–the following qualifier after the name and the chemical identifier of the micronutrient: ‘complexed by …', and the amount of complexed micronutrient as a percentage of the CE marked fertilising product by mass; and

–‘chelated by…’ name of the chelating agent or its abbreviation, and the amount of chelated micronutrient as a percentage of the CE marked fertilising product by mass;

(c)Where the declared micronutrient(s) are chelated by chelating agent(s), the following qualifier after the name and the chemical identifier of the micronutrient:

–where the soluble content of those nutrients is at least a quarter of the total content of those nutrients, the total content and the content soluble in water; and

–where those nutrients are totally soluble in water, only as the content soluble in water;

(a)indication of the names and chemical symbols of the declared micronutrients, listed in the following order: boron (B), cobalt (Co), copper (Cu), iron (Fe), manganese (Mn), molybdenum (Mo) and zinc (Zn), followed by the name(s) of their counter-ion(s);

They shall be declared after the information on macronutrients. The following information elements shall be present:

shall be declared if they are intentionally added to the CE marked fertilising product, and

3.Where one or more of the micronutrients boron (B), cobalt (Co), copper (Cu), iron (Fe), manganese (Mn), molybdenum (Mo) and zinc (Zn), are present in the minimum content indicated below as a percentage by mass, they

2.The nutrient content shall be indicated as a percentage by mass or volume of the CE marked fertilising product.

a suspension means a two-phase dispersion in which solid particles are maintained in suspension in the liquid phase, and

1.The label shall indicate whether the fertiliser is in suspension or in solution, where

(e)The following statement: ‘To be used only where there is a recognised need. Do not exceed the appropriate rate’.

–the following qualifier after the name and the chemical identifier of the micronutrient: ‘complexed by …', and the amount of complexed micronutrient as a percentage of the CE marked fertilising product by mass; and

–‘chelated by…’ name of the chelating agent or its abbreviation, and the amount of chelated micronutrient as a percentage of the CE marked fertilising product by mass;

(c)Where the declared micronutrient(s) are chelated by chelating agent(s), the following qualifier after the name and the chemical identifier of the micronutrient:

–where the soluble content of those nutrients is at least a quarter of the total content of those nutrients, the total content and the content soluble in water; and

–where those nutrients are totally soluble in water, only as the content soluble in water;

(a)indication of the names and chemical symbols of the declared micronutrients, listed in the following order: boron (B), cobalt (Co), copper (Cu), iron (Fe), manganese (Mn), molybdenum (Mo) and zinc (Zn), followed by the name(s) of their counter-ion(s);

They shall be declared after the information on macronutrients. The following information elements shall be present:

shall be declared if they are intentionally added to the CE marked fertilising product, and

5.Where one or more of the micronutrients boron (B), cobalt (Co), copper (Cu), iron (Fe), manganese (Mn), molybdenum (Mo) and zinc (Zn), are present in the minimum content indicated below as a percentage by mass, they

(e)For sulphur (S) coated fertilisers and sulphur (S)/polymer coated fertilisers, the following marking: ‘The rate of nutrient release can vary according to the temperature of the substrate and the biological activity. An adjustment of fertilisation may be necessary”.

(d)For polymer coated fertilisers, the following marking: ‘The rate of nutrient releases can vary according to the temperature of the substrate. An adjustment of fertilisation may be necessary”; and

(b)The name of the medium (solvent or substrate) used in the test performed by the manufacturer for determining the release time;

(a)Release time defined in months of the coated fraction(s) followed by the percentage of nutrients released during this time for each fraction;

4.For coated fertilisers, the name of the coating agent(s) and the percentage of fertilisers coated by each coating agent(s) shall be indicated and followed by:

(c)powder, where at least 90% of the product can pass through a sieve with a mesh of 10 mm, or

3.The particle form of the product shall be indicated with one of the following mentions:

2.The granulometry of the fertiliser shall be indicated, expressed a percentage of product passing through a determined sieve.

(a)'complex', where each particle contains all the declared nutrients in their declared content, and

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

–where the soluble content of those nutrients is at least a quarter of the total content of those nutrients, the total content and the content soluble in water; and

–where those nutrients are totally soluble in water, only as the content soluble in water;

(d)the content of the following declared nutrients, in the following order and as a percentage of the fertiliser by mass,

(c)numbers indicating the total content of the declared nutrients nitrogen (N), phosphorus (P) or potassium (K), followed by numbers in brackets indicating the total content of magnesium (Mg), calcium (Ca), sulphur (S) or sodium (Na);

(e)The following statement: ‘To be used only where there is a recognised need. Do not exceed the appropriate rate’.

–the following qualifier after the name and the chemical identifier of the micronutrient: ‘complexed by …', and the amount of complexed micronutrient as a percentage of the CE marked fertilising product by mass; and

–‘chelated by…’ name of the chelating agent or its abbreviation, and the amount of chelated micronutrient as a percentage of the CE marked fertilising product by mass;

(c)Where the declared micronutrient(s) are chelated by chelating agent(s), the following qualifier after the name and the chemical identifier of the micronutrient:

–where the soluble content of those nutrients is at least a quarter of the total content of those nutrients, the total content and the content soluble in water; and

–where those nutrients are totally soluble in water, only as the content soluble in water;

(a)indication of the names and chemical symbols of the declared micronutrients, listed in the following order: boron (B), cobalt (Co), copper (Cu), iron (Fe), manganese (Mn), molybdenum (Mo) and zinc (Zn), followed by the name(s) of their counter-ion(s);

They shall be declared after the information on macronutrients. The following information elements shall be present:

shall be declared if they are intentionally added to the CE marked fertilising product, and

Where one or more of the micronutrients boron (B), cobalt (Co), copper (Cu), iron (Fe), manganese (Mn), molybdenum (Mo) and zinc (Zn), are present in the minimum content indicated as a percentage by mass in the table below, they

(e)The following statement: ‘To be used only where there is a recognised need. Do not exceed the appropriate rate’.

–the following qualifier after the name and the chemical identifier of the micronutrient: ‘complexed by …', and the amount of complexed micronutrient as a percentage of the CE marked fertilising product by mass; and

–‘chelated by…’ name of the chelating agent or its abbreviation, and the amount of chelated micronutrient as a percentage of the CE marked fertilising product by mass;

(c)Where the declared micronutrient(s) are chelated by chelating agent(s), the following qualifier after the name and the chemical identifier of the micronutrient:

–where the soluble content of those nutrients is at least a quarter of the total content of those nutrients, the total content and the content soluble in water; and

–where those nutrients are totally soluble in water, only as the content soluble in water;

(a)indication of the names and chemical symbols of the declared micronutrients, listed in the following order: boron (B), cobalt (Co), copper (Cu), iron (Fe), manganese (Mn), molybdenum (Mo) and zinc (Zn), followed by the name(s) of their counter-ion(s);

They shall be declared after the information on macronutrients. The following information elements shall be present:

shall be declared if they are intentionally added to the CE marked fertilising product, and

Where one or more of the micronutrients boron (B), cobalt (Co), copper (Cu), iron (Fe), manganese (Mn), molybdenum (Mo) and zinc (Zn), are present in the minimum content indicated as a percentage by mass in the table below, they

2.The following other elements shall be indicated as a percentage by mass of the CE marked fertilising product:

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

–where the soluble content of those nutrients is at least a quarter of the total content of those nutrients, the total content and the content soluble in water;

–where those nutrients are totally soluble in water, only as the content soluble in water;

–minimum amount of organic nitrogen (N), followed by a description of the origin of the organic matter used;

(d)the content of the following declared nutrients, in the following order and as a percentage of the fertiliser by mass:

(c)numbers indicating the total content of the declared nutrients nitrogen (N), phosphorus (P) or potassium (K), followed by numbers in brackets indicating the total content of magnesium (Mg), calcium (Ca), sulphur (S) or sodium (Na);

–where the soluble content of those nutrients is at least a quarter of the total content of those nutrients, the total content and the content soluble in water; and

–where those nutrients are totally soluble in water, only as the content soluble in water;

–minimum amount of organic nitrogen (N), followed by a description of the origin of the organic matter used;

(d)the content of the following declared nutrients and other parameters, in the following order and as a percentage of the fertiliser by mass,

(c)numbers indicating the total content of the declared nutrients nitrogen (N), phosphorus (P) or potassium (K), followed by numbers in brackets indicating the total content of magnesium (Mg), calcium (Ca), sulphur (S) or sodium (Na),

(d)Technical information shall be provided enabling the user to determine the rates and timing of application in relation to the crop being grown.

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

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

(a)The label shall state the words “nitrification inhibitor” or "urease inhibitor", as relevant, as well as the identification number of the notified body having examined the conformity assessment of the nitrification inhibitor or the urease inhibitor.

2.The following rules apply to fertilisers containing nitrification or urease inhibitors, as specified in paragraphs 3 and 4 of component material category ('CMC') 8 in Annex II:

1.The content of nitrogen (N), phosphorus (P) and potassium (K) shall be declared only where those nutrients are present in the CE marked fertilising product in the minimum quantity specified in Annex I for the relevant product function category (PFC).

8.The phrase 'poor in chloride' or similar may only be used if the chloride (Cl-) content is below 30 g/kg.

(c)shall not make claims such as 'sustainable' or 'environmentally friendly' unless such claims can be objectively verified against widely recognised guidance, standards or schemes.

(a)shall not mislead the user, for example by attributing to the product properties that it does not possess, or by suggesting that the product possesses unique characteristics which similar products also have;

6.The designation of a product function category ('PFC'), as indicated in Annex I, must not be indicated on a CE marked fertilising product which has not been subject of a successful conformity assessment in accordance with this Regulation for that PFC.

5.Where the CE marked fertilising product contains a substance for which maximum residue limits for food and feed have been established in accordance with Regulation (EEC) No 315/93, Regulation (EC) No 396/2005, Regulation (EC) No 470/2009 or Directive 2002/32/EC, the instructions referred to in paragraph 2(c) shall ensure that the intended use of the CE marked fertilising product does not lead to the exceedance of those limits in food or feed.

4.Where the CE marked fertilising product contains animal by-products within the meaning of Regulation (EC) No 1069/2009 other than manure, it shall carry the following user instruction: 'Farmed animals shall not be fed, either directly or by grazing, with herbage from land to which the product has been applied unless the cutting or grazing takes place after the expiry of a waiting period of at least 21 days.'

3.Where the conformity assessment procedure has involved a notified body, the identification number of the notified body shall be indicated.

(e)A description of all components above 5% by product weight in descending order of magnitude by dry weight, including an indication of the relevant component material categories ('CMC') as referred to in Annex II.

(d)Any relevant information on measures recommended to manage risks to human, animal or plant health, safety, or the environment; and

1.The information elements required by this Regulation shall be clearly separated from any other information elements.

This Annex sets out the labelling requirements for CE marked fertilising products. The requirements laid down in Part 2 and Part 3 of this Annex for a given Product Function Category ('PFC'), as specified in Annex I, apply to CE marked fertilising products in all subcategories of that PFC.

A CE marked fertilising product may contain animal by-products within the meaning of Regulation (EC) No 1069/2009 having reached the end point in the manufacturing chain as determined in accordance with that Regulation, which are listed in the table below and as specified therein:

(d)In the nitrification inhibition test with soil micro-organisms, the nitrite formation in soil exposed to the test material shall be more than 90 % of those from the corresponding blank soil not exposed to the test material. The results shall be considered to be valid, if the variation between replicate control samples (blank soil) and test samples is less than ± 20 %.

the average loss of biomass (mean weight) of the worms in the blank soil does not exceed 20 %.

(c)In the earthworm acute toxicity test, the observed mortality and the biomass of surviving earthworms in a soil exposed to the test material shall not differ by more than 10 % compared to those from the corresponding blank soil not exposed to the test material. The results shall be considered to be valid, if

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

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

the seedlings do not exhibit visible phytotoxic effects (e.g. chlorosis, necrosis, wilting, leaf and stem deformations) and the plants exhibit only normal variation in growth and morphology for that particular species;

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

3.Neither the polymer, nor its degradation by-products, shall show any overall adverse effect on animal or plant health, or on the environment, under reasonably foreseeable conditions of use in the CE marked fertilising product. The polymer shall pass a plant growth acute toxicity test, an earthworm acute toxicity test and a nitrification inhibition test with soil micro-organisms as follows:

(d)Prior to the test, the test material shall not be subject to conditions or procedures designed to accelerate the degradation of the film, such as exposure to heat or light.

(c)A micro-crystalline cellulose powder with the same dimension as the test material shall be used as a reference material in the test.

(b)The test shall be conducted in accordance with a method for determining the ultimate aerobic biodegradability of plastic materials in soils by measuring oxygen demand or the amount of carbon dioxide evolved.

2.As of [Publications office, please insert the date occurring three years after the date of application of this Regulation], the following criterion shall be complied with: The polymer shall be capable of undergoing physical, biological decomposition, such that most of it ultimately decomposes into carbon dioxide (CO2), biomass and water. It shall have at least 90 % of the organic carbon converted into CO2 in maximum 24 months, in a biodegradability test as specified points (a)-(c) below.

(a)controlling the water penetration into nutrient particles and thus the release of nutrients (in which case the polymer is commonly referred to as a 'coating agent'), or

1.A CE marked fertilising product may contain other polymers than nutrient polymers only in cases where the purpose of the polymer is that of

1.A CE marked fertilising product may contain polymers exclusively made up of monomer substances complying with the description in CMC 1, where the purpose of the polymerisation is to control the release of nutrients from one or more of the monomer substances.

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

(d)Article 8(8) (importers' obligation to keep a copy of the EU declaration of conformity at the disposal of the market surveillance authorities); and

(c)Article 8(2) (importers' obligation to ensure that the CE marked fertilising product is accompanied by the EU declaration of conformity);

6.Economic operators making the CE marked fertilising product available on the market shall respect the following provisions of this Regulation with regard to the EU declarations of conformity of both the CE marked fertilising product and the compliant agronomic additive:

5.The manufacturer of the CE marked fertilising product shall be in possession of the EU declaration of conformity of the compliant agronomic additive.

4.A CE marked fertilising product may contain a compliant urease inhibitor, as referred to in PFC 5(A)(II) of Annex I, only if at least 50% of the total nitrogen (N) content of the fertilising product consists of the nitrogen (N) form urea (CH4N2O).

3.A CE marked fertilising product may contain a compliant nitrification inhibitor, as referred to in PFC 5(A)(I) of Annex I, only if at least 50% of the total nitrogen (N) content of the fertilising product consists of the nitrogen (N) forms ammonium (NH4+) and urea (CH4N2O).

(b)not to cause an overall adverse effect on human, animal or plant health, on safety, or on the environment, under reasonably foreseeable conditions of storage or use of the CE marked fertilising product.

(a)to produce the effect claimed in the information provided to the user of the CE marked fertilising products, and

2.The quantity of the compliant agronomic additive in the CE marked fertilising product shall be such as

1.A CE marked fertilising product may contain a substance or a mixture intended to improve the fertilising product's nutrient release patterns, only if that substance's or mixture's compliance with the requirements of this Regulation for a product in PFC 5 of Annex I has been demonstrated in accordance with the conformity assessment procedure applicable to such an agronomic additive.

A CE marked fertilising product may contain micro-organisms, including dead or empty-cell micro-organisms and non-harmful residual elements of the media on which they were produced, which

unless explicitly covered by one of the registration obligation exemptions provided for by Annex IV to that Regulation or by points 6, 7, 8, or 9 of Annex V to that Regulation.

2.The substance shall have been registered pursuant to Regulation (EC) No 1907/2006, in a dossier containing

1.A CE marked fertilising product may contain component material consisting of one of the following substances:

Definition: an indicator of the gas released from a digestate in a 28 day period and measured against the volatile solids contained within the sample. The test is run in triplicate, and the average result is used to demonstrate compliance with the requirement. The volatile solids are those solids in a sample of material that are lost on ignition of the dry solids at 550°C.

Definition: an indicator of the extent to which biodegradable organic matter is being broken down within a specified time period. The method is not suitable for material with a content of particle sizes > 10 mm exceeding 20 %.

7.Both the solid and the liquid part of the digestate shall meet at least one of the following stability criteria:

6.As of [Publications office: Please insert the date occurring 5 years after the date of application of this Regulation], the digestate shall contain no more than 2,5 g/kg dry matter of macroscopic impurities in the form of plastics above 2 mm. By [Publications office: Please insert the date occurring 8 years after the date of application of this Regulation] the limit-value of 2,5 g/kg dry matter shall be re-assessed in order to take into account the progress made with regards to separate collection of bio-waste.

5.The digestate shall contain no more than 5 g/kg dry matter of macroscopic impurities in the form of glass, metal and plastics above 2 mm.

4.Neither the solid, nor the liquid part of the digestate shall contain more than 6 mg/kg dry matter of PAH16.

(a)Thermophilic anaerobic digestion at 55°C during at least 24h and a hydraulic retention time of at least 20 days;

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

the total concentration of all additives does not exceed 5 % of the total input material weight; or

unless it is covered by the registration obligation exemption provided for by Annex IV to that Regulation or by points 6, 7, 8, or 9 of Annex V to that Regulation, and

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

(c)Living or dead organisms or parts thereof which are unprocessed or processed only by manual, mechanical or gravitational means, by dissolution in water, by flotation, by extraction with water, by steam distillation or by heating solely to remove water, or which are extracted from air by any means, except

1.A CE marked fertilising product may contain digestate obtained through anaerobic digestion of exclusively one or more of the following input materials:

Definition: an indicator of the gas released from a digestate in a 28 day period and measured against the volatile solids contained within the sample. The test is run in triplicate, and the average result is used to demonstrate compliance with the requirement. The volatile solids are those solids in a sample of material that are lost on ignition of the dry solids at 550°C.

Definition: an indicator of the extent to which biodegradable organic matter is being broken down within a specified time period. The method is not suitable for material with a content of particle sizes > 10 mm exceeding 20 %.

4.Both the solid and the liquid part of the digestate shall meet at least one of the following stability criteria:

(a)Thermophilic anaerobic digestion at 55°C during at least 24h and a hydraulic retention time of at least 20 days;

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

the total concentration of all additives does not exceed 5 % of the total input material weight; or

unless explicitly covered by one of the registration obligation exemptions provided for by Annex IV to that Regulation or by points 6, 7, 8, or 9 of Annex V to that Regulation, and

(b)Digestion additives which are needed to improve the process performance or the environmental performance of the digestion process provided that:

(a)Plants that have not been used for any other purpose. For the purpose of this paragraph, plants are understood to include algae and exclude blue-green algae;

1.A CE marked fertilising product may contain digestate obtained through anaerobic digestion of exclusively one or more of the following input materials:

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

Definition: an indicator of the extent to which biodegradable organic matter is being broken down within a specified time period. The method is not suitable for material with a content of particle sizes > 10 mm exceeding 20 %,

6.The compost shall meet at least one of the following stability criteria:

5.As of [Publications office: Please insert the date occurring 5 years after the date of application of this Regulation], the compost shall contain no more than 2,5 g/kg dry matter of macroscopic impurities in the form of plastics above 2 mm. By [Publications office: Please insert the date occurring 8 years after the date of application of this Regulation] the limit-value of 2,5 g/kg dry matter shall be re-assessed in order to take into account the progress made with regards to separate collection of bio-waste.

(b)no more than 5 g/kg dry matter of macroscopic impurities in the form of glass, metal and plastics above 2 mm.

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

the total concentration of all additives does not exceed 5 % of the total input material weight; or

unless explicitly covered by one of the registration obligation exemptions provided for by Annex IV to that Regulation or by points 6, 7, 8, or 9 of Annex V to that Regulation, and

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

(c)Living or dead organisms or parts thereof, which are unprocessed or processed only by manual, mechanical or gravitational means, by dissolution in water, by flotation, by extraction with water, by steam distillation or by heating solely to remove water, or which are extracted from air by any means, except

1.A CE marked fertilising product may contain compost obtained through aerobic composting of exclusively one or more of the following input materials:

1.A CE marked fertilising product may contain plants, plant parts or plant extracts having undergone no other processing than cutting, grinding, centrifugation, pressing, drying, freeze-drying or extraction with water.

unless explicitly covered by one of the registration obligation exemptions provided for by Annex IV to that Regulation or by points 6, 7, 8, or 9 of Annex V to that Regulation.

2.All the substances incorporated into the CE marked fertilising product, in their own or in a mixture, shall have been registered pursuant to Regulation (EC) No 1907/2006, in a dossier containing

(f)substances or mixtures intended to improve the nutrient release patterns of the CE marked fertilising product into which they are incorporated.

(c)materials formerly having constituted one of the materials mentioned in one of points a-b,

The component materials, or the input materials used to produce them, shall not contain one of the substances for which maximum limit values are indicated in Annex I of this Regulation in such quantities as to jeopardise the CE marked fertilising product's compliance with one of the applicable requirements of that Annex.

A CE marked fertilising product shall consist solely of component materials complying with the requirements for one or more of the Component Material Categories ('CMC') listed below.

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

Article 8(8) (importers' obligation to keep a copy of the EU declaration of conformity at the disposal of the market surveillance authorities); and

Article 8(2) (importers' obligation to ensure that the CE marked fertilising product is accompanied by the EU declaration of conformity);

5.Economic operators making CE marked fertilising product blends available on the market shall respect the following provisions of this Regulation with regard to the EU declaration of conformity of each component fertilising product as well as of the blend:

being in possession of the EU declaration of conformity of each of the component fertilising products.

drawing up an EU declaration of conformity for the CE marked fertilising product blend in accordance with Article 6(2) of this Regulation, and

4.The manufacturer of the blend shall assess the conformity of the blend with the requirements set out in paragraphs 1-3 above, ensure the blend's compliance with the labelling requirements laid down in Annex III, and assume responsibility pursuant to Article 15(4) of this Regulation for the compliance of the blend with the requirements of this Regulation by

in a manner having an adverse effect on human, animal or plant health, on safety, or on the environment, under reasonably foreseeable conditions of storage or use of the CE marked fertilising product blend, or

2.The compliance with the requirements of this Regulation of each component fertilising product in the blend shall have been demonstrated in accordance with the conformity assessment procedure applicable to that component fertilising product.

1.A fertilising product blend shall be a CE marked fertilising product composed of two or more CE marked fertilising products of category 1-6.

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

This shall be demonstrated by measuring the presence of at least one of those two types of bacteria.

4.None of the two following types of bacteria shall be present in the CE marked fertilising product by more than 1000 CFU/g fresh mass:

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

1.An organic non-microbial plant biostimulant shall consist of a substance or a mixture containing carbon (C) of solely animal or plant origin.

13.The shelf-life of the microbial plant biostimulant shall be at least 6 months under the storage conditions specified on the label.

a suspension means a two-phase dispersion in which solid particles are maintained in suspension in the liquid phase, and

11.Yeast and mould count shall not exceed 1000 CFU/g or ml sample of the CE marked fertilising product, unless the microbial biostimulant is a fungus.

10.Aerobic plate count shall not exceed 105 CFU/g or ml sample of the CE marked fertilising product, unless the microbial biostimulant is an aerobic bacterium.

5.Enterococcaceae must not be present in the CE marked fertilising product by more than 10 CFU/g fresh mass.

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

1.A microbial plant biostimulant shall consist solely of a micro-organism or a consortium of micro-organisms referred to in Component Material Category 7 of Annex II.

3.The plant biostimulant shall have the effects that are claimed on the label for the crops specified thereon.

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

1.A plant biostimulant shall be a CE marked fertilising product stimulating plant nutrition processes independently of the product's nutrient content with the sole aim of improving one or more of the following characteristics of the plant:

unless explicitly covered by one of the registration obligation exemptions provided for by Annex IV to that Regulation or by points 6, 7, 8, or 9 of Annex V to that Regulation.

2.The substance shall have been registered pursuant to Regulation (EC) No 1907/2006, in a dossier containing

1.A complexing agent shall be an organic substance intended to enhance nutrients' longterm availability to plants, which can form a flat or steric structure with one di or three valent transition metal cation.

unless explicitly covered by one of the registration obligation exemptions provided for by Annex IV to that Regulation or by points 6, 7, 8, or 9 of Annex V to that Regulation.

2.The substance shall have been registered pursuant to Regulation (EC) No 1907/2006, in a dossier containing

has two or more sites that donate electron pairs to a central transition metal cation (zinc (Zn), copper (Cu), iron (Fe), manganese (Mn), magnesium (Mg), calcium (Ca) or cobalt (Co)), and which

1.A chelating agent shall be an organic substance intended to enhance nutrients' longterm availability to plants consisting in a molecule which

2.An in-vitro measuring of the rate of hydrolysis of urea (CH4N2O) with respect to time in a soil sample where the urease inhibitor has been added shall show a statistical difference in hydrolysis rate when compared to a control sample where the urease inhibitor has not been added.

in a soil sample where the nitrification inhibitor has been added shall show a statistical difference in ammoniacal nitrogen (NH3-N) oxidation rate when compared to a control sample where the nitrification inhibitor has not been added.

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

unless explicitly covered by one of the registration obligation exemptions provided for by Annex IV to that Regulation or by points 6, 7, 8, or 9 of Annex V to that Regulation.

2.Each substance shall have been registered pursuant to Regulation (EC) No 1907/2006, in a dossier containing

1.An inhibitor shall be a substance or a mixture which delays or stops the activity of specific groups of micro-organisms or enzymes.

An agronomic additive shall be a CE marked fertilising product intended to be added to a product providing plants with nutrient, with the intention to improve that product's nutrient release patterns.

This shall be demonstrated by measuring the presence of at least one of those two types of bacteria.

4.None of the two following types of bacteria shall be present in the CE marked fertilising product in a concentration of more than 1000 CFU/g fresh mass:

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

1.A growing medium shall be a material other than soil intended for use as a substrate for root development.

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

5.Organic carbon (C) shall be present in the CE marked fertilising product by at least 7.5% by mass.

This shall be demonstrated by measuring the presence of at least one of those two types of bacteria.

(b)None of the two following types of bacteria shall be present in the CE marked fertilising product in a concentration of more than 1000 CFU/g fresh mass:

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

1.An organic soil improver shall consist exclusively of material of solely biological origin, excluding material which is fossilized or embedded in geological formations.

A soil improver shall be a CE marked fertilising product aimed at being added to the soil for the purpose of maintaining, improving or protecting the physical or chemical properties, the structure or the biological activity of soil.

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

1.A liming material shall be a CE marked fertilising product aimed at correcting soil acidity, and containing oxides, hydroxides, carbonates or silicates of the nutrients calcium (Ca) or magnesium (Mg).

a suspension means a two-phase dispersion in which solid particles are maintained in suspension in the liquid phase, and

2.The CE marked fertilising product shall contain declared nutrients in at least one of the following quantities:

at least 80% of the water-soluble micronutrient shall be complexed by a complexing agent fulfilling the requirements of PFC 5(C)

A water-soluble product in which the declared micronutrient is chemically combined with complexing agent(s) fulfilling the requirements of PFC 5(C)

at least 80% of the water-soluble micronutrient shall be chelated by a chelating agent fulfilling the requirements of PFC 5(B)

A water-soluble product in which the declared micronutrient is chemically combined with chelating agent(s) fulfilling the requirements of PFC 5(B)

2.The CE marked fertilising product shall comply with the one of the typologies, descriptions and corresponding minimum nutrient content requirements in the table below:

1.A straight inorganic micronutrient fertiliser shall have a declared content of not more than one nutrient.

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

2.Micronutrient fertilisers shall be made available to the end-user only in packaged form.

1.An inorganic micronutrient fertiliser shall be an inorganic fertiliser other than a macronutrient fertiliser aimed at providing one or more of the following nutrients: boron (B), cobalt (Co), copper (Cu), iron (Fe), manganese (Mn), molybdenum (Mo) or zinc (Zn).

2.The CE marked fertilising product shall contain more than one of the following declared nutrients in the minimum quantities stated:

2.The CE marked fertilising product shall contain one of the following declared nutrients in the minimum quantity stated:

1.A straight liquid inorganic macronutrient fertiliser shall have a declared content of not more than one nutrient.

a suspension means a two-phase dispersion in which solid particles are maintained in suspension in the liquid phase, and

A liquid inorganic macronutrient fertiliser shall be an inorganic macronutrient fertiliser in suspension or in solution, where

9.The copper (Cu) content shall not be higher than 10 mg/kg, and the chlorine (Cl) content shall not be higher than 200 mg/kg.

8.Not more than 5 % by mass of the CE marked fertilising product shall pass through a 1 mm mesh sieve, and not more than 3 % by mass shall pass through a 0,5 mm mesh sieve.

7.A solution of 10 g of the CE marked fertilising product in 100 ml of water must have a pH of at least 4,5.

0,4 % for CE marked fertilising products having a nitrogen (N) content of at least 28 % but less than 31,5 % by mass.

0,2 % for CE marked fertilising products having a nitrogen (N) content of at least 31,5 % by mass, and

one or more of the supporting lead cylinders is crushed by less than 5 %.

4.The oil retention of the CE marked fertilising product, following two thermal cycles as described under Heading 4.1 in Module A1 in Annex IV, must not exceed 4 % by mass.

3.The CE marked fertilising product shall be made available to the end-user only in packaged form. The package shall be closed in such a way or by such a device that, when it is opened, the fastening, the fastening seal or the package itself is irreparably damaged. Valve sacks may be used.

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

2.The CE marked fertilising product shall contain more than one of the following declared nutrients in the minimum quantities stated:

2.The CE marked fertilising product shall contain one of the following declared nutrients in the minimum quantity stated:

1.A straight solid inorganic macronutrient fertiliser shall have a declared content of not more than one nutrient.

A solid inorganic fertiliser shall be an inorganic macronutrient fertiliser, which is neither in suspension nor in solution within the meaning of PFC 1(C)(I)(b) in this Annex.

As of [Publications office, please insert the date occurring twelve years after the date of application of this Regulation]: 20 mg/kg phosphorus pentoxide (P2O5),

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

(1)Where the CE marked fertilising product has a total phosphorus (P) content of less than 5 % phosphorus pentoxide (P2O5)-equivalent by mass: 3 mg/kg dry matter, or

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

1.An inorganic macronutrient fertiliser shall be aimed at providing plants with one or more of the following macronutrients: nitrogen (N), phosphorus (P), potassium (K), magnesium (Mg), calcium (Ca), sulphur (S) or sodium (Na).

An inorganic fertiliser shall be a fertiliser other than an organic or organo-mineral fertiliser.

3.Organic carbon (C) shall be present in the CE marked fertilising product by at least 3 % by mass.

2 % by mass of total nitrogen (N), out of which 0,5 % by mass of the CE marked fertilising product shall be organic nitrogen (N), or

2.The CE marked fertilising product shall contain at least one of the following declared nutrients in the minimum quantities stated:

4.In the CE marked fertilising product, each unit shall contain the organic matter and the nutrients in their declared content.

3.Organic carbon (C) shall be present in the CE marked fertilising product by at least 7.5 % by mass.

2,5 % by mass of total nitrogen (N), out of which 1 % by mass of the CE marked fertilising product shall be organic nitrogen (N), or

2.The CE marked fertilising product shall contain at least one of the following declared nutrients in the minimum quantities stated:

This shall be demonstrated by measuring the presence of at least one of those two types of bacteria.

5.None of the two following types of bacteria shall be present in the CE marked fertilising product in a concentration of more than 1000 CFU/g fresh mass:

As of [Publications office, please insert the date occurring twelve years after the date of application of this Regulation]: 20 mg/kg phosphorus pentoxide (P2O5),

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

(1)Where the CE marked fertilising product has a total phosphorus (P) content of less than 5 % phosphorus pentoxide (P2O5)-equivalent by mass: 3 mg/kg dry matter, or

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

2.Where one or more of the inorganic fertilisers in the co-formulation is a straight or compound solid inorganic macronutrient ammonium nitrate fertiliser of high nitrogen content, as specified in PFC 1(C)(I)(a)(iii)(A), the CE marked fertilising product shall not contain 15,75 % or more by mass of nitrogen (N) as a result of ammonium nitrate (NH4NO3).

one or more inorganic fertilisers, as specified in PFC 1(C) below, and

3.Organic carbon (C) shall be present in the CE marked fertilising product by at least 5% by mass.

2.The CE marked fertilising product shall contain at least one of the following declared nutrients in the minimum quantities stated:

3.Organic carbon (C) shall be present in the CE marked fertilising product by at least 15% by mass.

2.The CE marked fertilising product shall contain at least one of the following declared nutrients in the minimum quantities stated:

This shall be demonstrated by measuring the presence of at least one of those two types of bacteria.

4.None of the two following types of bacteria shall be present in the CE marked fertilising product in a concentration of more than 1000 CFU/g fresh mass:

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

the use of the CE marked fertilising product as specified in the use instructions must not lead to the exceedance of those limits in food or feed.

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

4.Where the CE marked fertilising product contains a substance for which maximum residue limits for food and feed have been established in accordance with

3.Where compliance with a given requirement (such as absence of a given contaminant) follows certainly and uncontestably from the nature or manufacturing process of a CE marked fertilising product, that compliance can be presumed in the conformity assessment without verification (such as testing), at the responsibility of the manufacturer.

2.The requirements laid down in this Annex for a given PFC apply to CE marked fertilising products in all subcategories of that PFC.

1.This Part sets out the requirements related to the Product Function Categories ('PFC') to which CE marked fertilising products shall belong.

laying down rules on the making available on the market of CE marked fertilising products and amending Regulations (EC) No 1069/2009 and (EC) No 1107/2009

laying down rules on the making available on the market of CE marked fertilising products and amending Regulations (EC) No 1069/2009 and (EC) No 1107/2009

EUROPEAN COMMISSION Brussels, 17.3.2016 COM(2016) 157 final 2016/0084(COD) Circular Economy Package Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL laying down rules on the making available on the market of CE marked fertilising products and amending Regulations (EC) No 1069/2009 and (EC) No 1107/2009 (Text with EEA relevance) {SWD(2016) 64 final}

{SWD(2016) 65 final}



EXPLANATORY MEMORANDUM 1.CONTEXT OF THE PROPOSAL •Reasons for and objectives of the proposal 1.The proposal aims at addressing important problems currently present on the market, which were first identified in an ex-post evaluation of Regulation (EC) No 2003/2003 ('the existing Fertilisers Regulation') conducted in 2010. It has also been identified as one of the key legislative proposals under the Circular Economy action plan. The first reason and objective 2.First, innovative fertilising products, often containing nutrients or or