ANNEX IIISupplementary provisions
ANNEX III In Part II of Annex IV to Regulation (EU) 2019/1009, Module D1 (Quality assurance of the production process) is amended as follows: (1) in point 2.2, sub-point (d) is replaced by the following: ‘(d) drawings, schemes, descriptions and explanations necessary for the understanding of the manufacturing process of the EU fertilising product, and, in relation to materials belonging to CMCs 3, 5, 12, 13, 14 or 15 as defined in Annex II, a written description and a diagram of the production or recovery process, where each treatment, storage vessel and area is clearly identified,’; (2) in point 5.1.1.1, the introductory wording is replaced by the following: ‘5.1.1.1. For materials belonging to CMCs 3, 5, 12, 13, 14 and 15, as defined in Annex II, senior management of the manufacturer’s organisation shall:’; (3) point 5.1.2.1 is replaced by the following: ‘5.1.2.1. For materials belonging to CMCs 3, 5, 12, 13, 14 and 15, as defined in Annex II, the quality system shall ensure compliance with the requirements specified in that Annex.’; (4) point 5.1.3.1 is amended as follows: (a) the introductory wording is replaced by the following: ‘5.1.3.1. For materials belonging to CMCs 3, 5, 12, 13, 14 and 15, as defined in Annex II, the examinations and tests shall comprise the following elements:’; (b) sub-points (b) and (c) are replaced by the following: ‘(b) Qualified staff shall carry out a visual inspection of each consignment of input materials and verify compatibility with the specifications of input materials laid down in CMCs 3, 5, 12, 13, 14 and 15 in Annex II [OR: as defined in Annex II]. (c) The manufacturer shall refuse any consignment of any given input material where visual inspection raises suspicion of any of the following: — the presence of hazardous or damaging substances for the process or for the quality of the final EU fertilising product, — incompatibility with the specifications laid down in CMCs 3, 5, 12, 13, 14 and 15 in Annex II [OR: as defined in Annex II], in particular by presence of plastics leading to exceedance of the limit value for macroscopic impurities.’; (c) sub-point (e) is replaced by the following: ‘(e) Samples shall be taken on output materials, to verify that they comply with the specifications laid down in CMCs 3, 5, 12, 13, 14 and 15, as defined in Annex II, and that the properties of the output material do not jeopardise the EU fertilising product’s compliance with the relevant requirements laid down in Annex I’; (d) in sub-point (fa), the introductory wording is replaced by the following: ‘(fa) For materials belonging to CMCs 12, 13, 14 and 15, the output material samples shall be taken with at least the following default frequency, or sooner than scheduled in the case of any significant change that may affect the quality of the EU fertilising product:’; (e) sub-point (fb) is replaced by the following: ‘(fb) For materials belonging to CMCs 12, 13, 14 and 15, each batch or portion of production shall be assigned a unique code for quality management purposes. At least one sample per 3 000 tonnes of these materials or one sample per two months, whichever occurs sooner, shall be stored in good condition for a period of at least two years.’; (f) sub-point (g)(iv) is replaced by the following: ‘(iv) for materials belonging to CMCs 12, 13, 14 and 15, measure retainer samples referred to in sub-point (fb) and take the necessary corrective actions to prevent possible further transport and use of that material.’; (5) in point 5.1.4.1, the introductory wording is replaced by the following: ‘5.1.4.1. For materials belonging to CMCs 3, 5, 12, 13, 14 and 15, as defined in Annex II, the quality records shall demonstrate effective control of input materials, production, storage and compliance of input- and output materials with the relevant requirements of this Regulation. Each document shall be legible and available at its relevant place(s) of use, and any obsolete version shall be promptly removed from all places where it is used, or at least identified as obsolete. The quality management documentation shall at least contain the following information:’; (6) in point 5.1.5.1, the introductory wording is replaced by the following: ‘5.1.5.1. For materials belonging to CMCs 3, 5, 12, 13, 14 and 15, as defined in Annex II, the manufacturer shall establish an annual internal audit program in order to verify the compliance of the quality system with the following components:’; (7) in point 6.3.2, the introductory wording is replaced by the following: ‘6.3.2. For materials belonging to CMCs 3, 5, 12, 13, 14 and 15, as defined in Annex II, the notified body shall take and analyse output material samples during each audit, and those audits shall be carried out with the following frequency:’.