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

MODULE D1 – QUALITY ASSURANCE OF THE PRODUCTION PROCESS U.K.

1. Description of the module U.K.

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

2. Technical documentation U.K.

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

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

(a)

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

(b)

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

(c)

the EU declarations of conformity for the component EU fertilising products of the fertilising product blend,

(d)

drawings, schemes, descriptions and explanations necessary for the understanding of the manufacturing process of the EU fertilising product, and, in relation to compost belonging to CMC 3 or digestate belonging to CMC 5, as defined in Annex II, a written description and a diagram of the production process, where each treatment, storage vessel and area is clearly identified,

(e)

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

(f)

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

(g)

results of calculations made, including the calculations to demonstrate conformity with point 5 of Part II of Annex I, examinations carried out, etc.,

(h)

test reports,

(i)

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

(j)

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

(k)

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

3. Availability of technical documentation U.K.

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

4. Manufacturing U.K.

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

5. Quality system U.K.

5.1. The manufacturer shall implement a quality system which shall ensure compliance of the EU fertilising products with the requirements of this Regulation that apply to them. U.K.

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

5.1.1.1. For compost belonging to CMC 3 and digestate belonging to CMC 5, as defined in Annex II, senior management of the manufacturer’s organisation shall: U.K.

(a)

ensure that sufficient resources (people, infrastructure, equipment) are available to create and implement the quality system;

(b)

appoint a member of the organisation’s management who shall be responsible for:

• ensuring that quality management processes are established, approved, implemented and maintained;

• reporting to senior management of the manufacturer on the performance of the quality management and any need for improvement;

• ensuring the promotion of awareness of customer needs and legal requirements throughout the manufacturer’s organisation, and for making the personnel aware of the relevance and importance of the quality management requirements to meet the legal requirements of this Regulation;

• ensuring that each person whose duties affect the product quality is sufficiently trained and instructed; and

• ensuring the classification of the quality management documents mentioned under point 5.1.4;

(c)

conduct an internal audit every year, or sooner than scheduled if triggered by any significant change that may affect the quality of the EU fertilising product; and

(d)

ensure that appropriate communication processes are established within and outside the organisation and that communication take place regarding the effectiveness of the quality management.

5.1.2. The quality system shall cover the manufacturing, quality control and quality assurance techniques, processes and systematic actions. U.K.

5.1.2.1. For compost belonging to CMC 3 and digestate belonging to CMC 5, as defined in Annex II, the quality system shall ensure compliance with the composting and digestion process criteria specified in that Annex. U.K.

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

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: U.K.

(a)

The following information shall be recorded for each batch of input materials:

(i)

date of delivery;

(ii)

amount by weight (or estimation based on the volume and density);

(iii)

identity of the input material supplier;

(iv)

input material type;

(v)

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

(vi)

in case of refusal, the reasons for the rejection of the batch and where it was sent.

(b)

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

(c)

The manufacturer shall refuse any consignment of any given input material where visual inspection raises any suspicion of:

• the presence of hazardous or damageable substances for the composting or digestion process or for the quality of the final EU fertilising product, or

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

(d)

The staff shall be trained on:

• potential hazardous properties that may be associated with input materials, and

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

(e)

Samples shall be taken on output materials, to verify that they comply with the 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 do not jeopardise the EU fertilising product’s compliance with the relevant requirements in Annex I.

(f)

The output material samples shall be taken on a regular basis with at least the following frequency:

Annual input(tonnes)	Samples / year
≤ 3 000	1
3 001 – 10 000	2
10 001 – 20 000	3
20 001 – 40 000	4
40 001 – 60 000	5
60 001 – 80 000	6
80 001 – 100 000	7
100 001 – 120 000	8
120 001 – 140 000	9
140 001 – 160 000	10
160 001 – 180 000	11
> 180 000	12

(g)

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

(i)

clearly identify the non-conforming output materials and their storage place,

(ii)

analyse the reasons of the non-conformity and take any necessary action to avoid its repetition,

(iii)

record in the quality records referred to in point 5.1.4 if reprocessing takes place, or if the output material is eliminated.

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

5.1.4.1. For compost belonging to 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: U.K.

(a)

a title,

(b)

a version number,

(c)

a date of issue,

(d)

the name of the person who issued it,

(e)

records about the effective control of input materials,

(f)

records about the effective control of the production process,

(g)

records about the effective control of the output materials,

(h)

records of non-conformities,

(i)

reports on all accidents and incidents that occur to the site, their known or suspected causes and actions taken,

(j)

records of the complaints expressed by third parties and how they have been addressed,

(k)

a record of the date, type and topic of training followed by the persons responsible for the quality of the product,

(l)

results of internal audit and actions taken, and

(m)

results of external audit review and actions taken.

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

5.1.5.1. For compost belonging to 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 of the quality system with the following components: U.K.

(a)

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

(b)

priority shall be given to non-conformities identified by external audits;

(c)

each auditor shall not audit his or her own work;

(d)

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

(e)

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

5.1.6. All the elements, requirements and provisions adopted by the manufacturer shall be documented in a systematic and orderly manner in the form of written policies, procedures and instructions. The quality system documentation shall permit a consistent interpretation of the quality programmes, plans, manuals and records. It shall, in particular, contain an adequate description of all the quality management elements set out in points 5.1.1 to 5.1.5. U.K.

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

• the name and address of the manufacturer and, if the application is lodged by the authorised representative, his or her name and address as well,

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

• all relevant information for the EU fertilising product category envisaged,

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

• the technical documentation referred to in point 2.

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

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

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

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

5.4. The manufacturer shall undertake to fulfil the obligations arising out of the quality system as approved and to maintain it so that it remains adequate and efficient. U.K.

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

5.5.2. The notified body shall evaluate any proposed changes and decide whether the modified quality system will continue to satisfy the requirements referred to in point 5.1 or whether reassessment is necessary. U.K.

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

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

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

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: U.K.

• the quality system documentation,

• the technical documentation referred to in point 2,

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

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

6.3.2. For compost belonging to 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: U.K.

(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 point 5.1.3.1(f); and

(b)

during the following years of surveillance: half the sampling frequency indicated in the table included in point 5.1.3.1(f).

6.4 In 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. U.K.

7. CE marking and EU declaration of conformity U.K.

7.1. The manufacturer shall affix the CE marking and, under the responsibility of the notified body referred to in point 5.2, the latter’s identification number to each individual packaging of the EU fertilising product that satisfies the applicable requirements of this Regulation or, where it is supplied without packaging, in a document accompanying the EU fertilising product. U.K.

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

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

8. Availability of quality system documentation U.K.

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

• the documentation referred to in point 5.1.6,

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

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

9. Notified bodies’ information obligation U.K.

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

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

10. Authorised representative U.K.

The manufacturer’s obligations set out in points 3, 5.2, 5.5.1, 7 and 8 may be fulfilled by his or her authorised representative, on his or her behalf and under his or her responsibility, provided that they are specified in the mandate.