BAKGRUNN (fra kommisjonsforordningen) 

(1) Regulation (EU) 2019/1009 lays down rules on the making available on the market of EU fertilising products. Following developments in the implementation of the Regulation and the relevant standardization work technical adaptations to Annexes I, II and III to Regulation (EU) 2019/1009 are needed to facilitate the free movement of safe and agronomically efficient EU fertilising products in the internal market. 

(2) Firstly, Annex I to Regulation (EU) 2019/1009 lays down maximum limit values for Enterococcaceae for various product function categories and Annex II to that Regulation sets out limit values for the same pathogen for EU fertilising products containing certain component materials. Enterococcaceae is a family of bacteria often present in environments rich in nutrients. Out of the various bacteria belonging to this family, enterococci are the most dangerous ones, from a health perspective, as they are often associated with human and animal infections. During the work performed by the European Committee for Standardization (CEN) to develop harmonised standards in support of those requirements in Regulation (EU) 2019/1009, CEN informed the Commission that there are no testing methods to determine the content of Enterococcaceae, given the wide variety of bacteria concerned. The existing testing methods determine the content of enterococci. Regulation (EU) 2019/1009 should therefore be amended to lay down requirements which can be tested in practice. That would facilitate the conformity assessment of the products and provide clarity both on the obligations of manufacturers and the way the market surveillance verifications should be performed. 

(3) Secondly, pursuant to Part II, point 4, of Annex I to Regulation (EU) 2019/1009, where compliance with a given requirement in Annex I (such as absence of a given contaminant) follows certainly and uncontestably from the nature or manufacturing process of an EU fertilising product, that compliance can be presumed in the conformity assessment procedure without verification (such as testing), at the responsibility of the manufacturer. A similar provision is laid down for the contaminant limit values in section CMC 15, point (6), for recovered high purity materials. For coherence reasons and to avoid unnecessary administrative burden, similar provisions should be introduced in Part II, sections CMC 3, CMC 5, CMC 12, CMC 13 and CMC 14 of Annex II to Regulation (EU) 2019/1009. Those provisions would facilitate the conformity assessment of EU fertilising products containing such materials and, ultimately, their free movement in the internal market. 

(4) Thirdly, Part III of Annex III to Regulation (EU) 2019/1009 sets out tolerance rules for various parameters to be included on the label of EU fertilising products. The declared value on the label may deviate from the actual value, only within the limit values set out by that Regulation. As regards the quantity of inorganic fertilisers, two tolerances are set out (1 % and 5 %). It is necessary to identify the situations in which each of the two values apply. Thus, the declared quantity of inorganic macronutrient fertilisers should deviate only with maximum 1 %, given that such products are normally sold in larger packages or bought in bigger quantities. Inorganic micronutrient fertilisers are usually sold in smaller packages and therefore a 5 % tolerance should be complied with. 

(5) Fourthly, Part III of Annex III to Regulation (EU) 2019/1009 sets out a tolerance of 0,3 percentage points in absolute terms for the content of inhibiting compounds exceeding 2 % concentration in inhibitors, the same as the one applicable to fertilisers with inhibiting compounds. According to the coordination group of notified bodies established under Article 36 of Regulation (EU) 2019/1009, that tolerance is very restrictive for inhibitors, as inhibiting compounds are usually present in big concentrations in such products, and not only in small concentrations as for fertilisers. In order to take into account manufacturing deviations and the accuracy of the available testing methods and thus to facilitate the conformity assessment of inhibitors, Regulation (EU) 2019/1009 should be amended to introduce a more permissive tolerance for the content of inhibiting compounds in inhibitors. 

(6) Regulation (EU) 2019/1009 should therefore be amended accordingly,