Fertilising Products Regulation

02019R1009-20241120 → 02019R1009-20251230

ANNEX II Component Material Categories (CMCs) An EU fertilising product shall consist solely of component materials complying with the requirements for one or more of the CMCs listed in this Annex. The component materials, and the input materials used to produce them, shall … 11,408 unchanged words … (such as testing), under the responsibility of the manufacturer. (7) Where for the product function category of an EU fertilising product containing or consisting of high purity materials referred to in point 2(b) no requirements regarding Salmonella spp., Escherichia coli or enterococci Enterococci have been laid down in Annex I, those pathogens in the EU fertilising product shall not exceed the limits set out in the following table: Micro-organisms to be tested Sampling plans Limit n c m M Salmonella spp. 5 0 0 Absence in … 354 unchanged words … product only if they have been manufactured maximum 36 months before signing the EU declaration of conformity for the respective EU fertilising product. (10) The high purity material shall comply with the requirement set out in point 2 in CMC 1.

02019R1009-20241120 → 02019R1009-20251230

ANNEX III Labelling requirements This Annex sets out the labelling requirements for EU fertilising products. The requirements laid down in Part II and Part III of this Annex for a given PFC, as specified in Annex I, apply to EU fertilising products … 916 unchanged words … a polymer with the purpose of binding material in the product as referred to in Part II, section CMC 9, point 1(c) of Annex II, which does not meet any of the requirements in Part II, section CMC 1, point 1(f)(i), (ii), (iii) or (iv) 1(f) of that Annex. 7a. Where the EU fertilising product contains or consists of thermal oxidation materials and derivates as referred to in CMC 13 in Part II in Annex II or pyrolysis or gasification materials as referred to in CMC 14 … 6,336 unchanged words … deviation More than 25 up to 100 ± 10 % relative deviation More than 100 up to 250 ± 6 % relative deviation More than 250 up to 500 ± 5 % relative deviation More than 500 ± 25 g/kg or ± 25 g/l

02019R1009-20241120 → 02019R1009-20251230

ANNEX IV Conformity assessment procedures PART I APPLICABILITY OF CONFORMITY ASSESSMENT PROCEDURES This Part sets out the applicability of conformity assessment procedure modules, as specified in Part II of this Annex, to EU fertilising products depending on their CMCs as specified in Annex II, … 10,453 unchanged words … sure that the manufacturer maintains and applies the quality system and shall provide the manufacturer with an audit report. 6.3.2. For materials belonging to CMCs 3, 5, 12, 13, 14 and 15, as defined in Annex II, the notified body shall carry out annual audits. In addition, 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 … 368 unchanged words … 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.