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

MODULE A – INTERNAL PRODUCTION CONTROL

1. Description of the module

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

2. Technical documentation

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

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

(a)

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

(b)

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

(c)

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

(d)

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

(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 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,

(j)

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. Manufacturing

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

4. CE marking and EU declaration of conformity

4.1. The manufacturer shall affix the CE marking 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.

4.2. 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.

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

5. Authorised representative

The manufacturer’s obligations set out under point 4 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.