ANNEX IISupplementary provisions
ANNEX II In Annex IV, Part II, of 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 and 12 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,”. (2) The introductory wording in point 5.1.1.1 is replaced by the following: “5.1.1.1. For materials belonging to CMCs 3, 5 and 12, 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 and 12, 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 and 12, 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 in CMCs 3, 5 and 12 laid down in Annex II. (c) The manufacturer shall refuse any consignment of any given input material where visual inspection raises any suspicion of any of the following: — the presence of hazardous or damageable substances for the process or for the quality of the final EU fertilising product; — incompatibility with the specifications of CMCs 3, 5 and 12 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 and 12, 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 subpoint (f), the introductory wording is replaced by the following: “(f) For materials belonging to CMCs 3 and 5, the output material samples shall be taken on a regular basis with at least the following frequency:”. (e) The following sub-points are inserted: “(fa) For materials belonging to CMC 12, the output material samples shall be taken with at least the following default frequency, or sooner than scheduled if triggered by any significant change that may affect the quality of the EU fertilising product: Annual output (tonnes) Samples/year ≤ 3 000 4 3 001 – 10 000 8 10 001 – 20 000 12 20 001 – 40 000 16 40 001 – 60 000 20 60 001 – 80 000 24 80 001 – 100 000 28 100 001 – 120 000 32 120 001 – 140 000 36 140 001 – 160 000 40 160 001 – 180 000 44 > 180 000 48 Manufacturers may reduce the default frequency of testing for contaminants as indicated above by considering the distribution of historical samples. After a minimum monitoring period of one year and a minimum number of 10 samples showing compliance with the requirements in Annex I and II, the manufacturer may reduce the default sampling frequency for that parameter by a factor 2 in case the greatest contaminant level recorded from the last 10 samples is smaller than half of the limit value for that parameter laid down in Annexes I and II. (fb) For materials belonging to CMC 12, 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 soonest, shall be stored in good condition for a period of at least 2 years.”. (f) In sub-point (g) (iii), “.” is replaced by “,” and the following sub-point (iv) is added: “(iv) for materials belonging to CMC 12, 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 and 12, 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 contain at least 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 and 12, 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) Point 6.3.2 is replaced by the following: “6.3.2. For materials belonging to CMCs 3, 5 and 12, 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: (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 tables included in points 5.1.3.1(f) and, respectively, 5.1.3.1(fa); and (b) during the following years of surveillance: half the sampling frequency indicated in the table included in point 5.1.3.1(f) and, respectively, 5.1.3.1(fa).”.