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Regulation (EU) 2019/1009 of the European Parliament and of the Council of 5 June 2019 laying down rules on the making available on the market of EU fertilising products and amending Regulations (EC) No 1069/2009 and (EC) No 1107/2009 and repealing Regulation (EC) No 2003/2003 (Text with EEA relevance)
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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,
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,
the EU declarations of conformity for the component EU fertilising products of the fertilising product blend,
drawings, schemes, descriptions and explanations necessary for the understanding of the manufacturing process of the EU fertilising product,
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,
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,
results of calculations made, including the calculations to demonstrate conformity with point 5 of Part II of Annex I, examinations carried out, etc.,
test reports,
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,
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
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).
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,
the technical documentation referred to in point 2,
the samples representative of the production envisaged. The notified body may request further samples if needed for carrying out the test programme,
the supporting evidence for the adequacy of the technical design solution. This supporting evidence shall mention any documents that have been used, in particular where the relevant harmonised standards or common specifications have not been applied in full. The supporting evidence shall include, where necessary, the results of tests carried out in accordance with other relevant technical specifications by the appropriate laboratory of the manufacturer, or by another testing laboratory on his or her behalf and under his or her responsibility.
The notified body shall:
examine the technical documentation and supporting evidence to assess the adequacy of the technical design of the EU fertilising product;
verify that the sample(s) have been manufactured in conformity with the technical documentation, and identify the elements which have been designed in accordance with the applicable provisions of the relevant harmonised standards or common specifications, as well as the elements which have been designed in accordance with other relevant technical specifications;
carry out appropriate examinations and tests on the sample(s), or have them carried out, to check whether, where the manufacturer has chosen to apply the solutions in the relevant harmonised standards or common specifications, these have been applied correctly;
carry out appropriate examinations and tests on the sample(s), or have them carried out, to check whether, where the solutions in the relevant harmonised standards or common specifications have not been applied, or where relevant harmonised standards or common specifications do not exist, the solutions adopted by the manufacturer meet the corresponding requirements of this Regulation;
agree with the manufacturer on a location where the examinations and tests will be carried out.
The notified body shall draw up an evaluation report that records the activities undertaken in accordance with point 4 and their outcomes. Without prejudice to its obligations vis-à-vis the notifying authority, the notified body shall release the content of that report, in full or in part, only with the agreement of the manufacturer.
The manufacturer’s authorised representative may lodge the application referred to in point 3 and fulfil the obligations set out in points 7 and 9.2, provided that they are specified in the mandate.
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