EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
[…](2021) XXX  draft  
ANNEXES 1 to 3  
 
ANNEXES  
to the  
COMMISSION DELEGATED REGULATION  
amending Annexes II, III and IV to Regulation (EU) 2019/1009 of the European 
Parliament and of the Council for the purpose of adding recovered high purity materials 
as a component material category in EU fertilising products        
  EN 1  EN ANNEX I 
Annex II to Regulation (EU) 2019/1009  is amended as follows:  
(1) In Part I, the following point is added:  
"CMC 1 5: Recovered  high purity materials ". 
(2) Part II is amended as follows:  
(a) In CMC 1 , point 1  is amended as follows :  
(i) at the end of  sub-point (j ),the word “or” is deleted;  
(ii) in sub-point ( k), “.” is replaced by “, or”; 
(iii) the following  sub-point (l ) is added:  
“(l) ammoni um salts, sulphate  salts, phosphate salts, elemental sulphur, calcium carbonate or 
[and?] calcium oxide , which are recovered from waste within the meaning of Article  3, 
point  1, of Directive 2008/98/EC .”. 
(b) In CMC 11 , point 1 is amended as follows : 
(i) at the end of sub-point (f ), the word “or” is deleted;  
(ii) in sub-point (g ), “.” is replaced by “, or”; 
(iii) the following  sub-point ( h) is added:  
“(h)  ammoni um salts, sulphate salts, phosphate salts, elemental sulphur, calcium car bonate 
or calcium oxide, which  are recovered from waste within the meaning of Article  3, point  1, of 
Directive 2008/98/EC. ”. 
(c) The following CMC  15 is added:  
“CMC 15: RECOVERED HIGH PURITY MATERIALS  
(1) An EU fertilising product may contain a recovered high purity material , which is  
ammonium salt, sulphate salt, phosphate salt, elemental sulphur, calcium carbonate 
or calcium oxide, or mixtures thereof, of a purity of at least 95  % dry matter of the 
material.  
(2) The high purity material  shall be  recovered  from waste generated  from : 
(a) a pro duction process that uses as input materials substances and mixtures other 
than animal by -products or derived products within the scope  of Regulation 
(EC) No 1069/2009  (*), or 
(b) a gas purification or emission control process designed to remove nutrients 
from  off-gases  derived from  one or more of the following input materials  and 
facilities : 
(i) substances and mixtures, other than:  
– waste within the meaning of Article  3, point  1, of Directive 
2008/98/EC , and 
– animal by -products or derived products within the scope of 
Regulation (EC) No 1069/2009 ; 
(ii) bio-waste within the meaning of Article 3, point 4, of Directive 
2008/98/EC, resulting from separate bio -waste collection at source , other than EN 2  EN animal by -products or derived products within the scope  of Regulation ( EC) 
No 1069/2009;  
(iii) urban  and domestic  waste waters within the meaning of Article  2, 
point s 1 and 2, respectively , of Directive 91/271/EEC  (**), other than animal 
by-products or derived products within the scope  of Regulation (EC) No 
1069/2009 ;  
(iv) sludge within the meaning of Article 2, point  (a), of Directive 
86/278/EEC  (***), which display s no hazardous properties listed in Annex III 
to Directive 2008/98/EC, and other than animal by -products or derived 
products within the scope  of Regulation (EC) No 1069/2009 ; 
(v) waste within the meaning of Article  3, point  1, of Directive 
2008/98/EC, being used as a (co)fuel for the production of energy or materials  
that are processed in a co -incineration plant in line with the conditions set out  
in Directive 2010/75/EU  of the European Parliament and of the Council 
(****), other than : 
– waste that display s the hazardous properties listed in Annex III to 
Directive 2008/98/EC and  
– animal by -products or derived products within the scope of 
Regulation ( EC) No 1069/2009;  
(vi)  manure within the meaning of Article 3, point  20, of Regulation (EC) 
No 1069/2009  or derived products thereof on condition th at the manure, the 
derived prod ucts thereof or the resulting high purity material has undergone  
hygienisat ion in accordance with  the standard transformation parameters laid 
down in Chapter  III, Section  1, of Annex  V to Regulation (EU) No 142/2011  
(***** ); or 
(vii)  livestock housing facilities , on condition that the resulting high purity 
material has undergone  hygienisation  in accordance with  the standard 
transformation parameters laid down in Chapter  III, Section  1, of Annex  V to 
Regulation (EU) No 142/2011.  
(3) The high purity material shall have a n organic carbon  (Corg) content of no more than 
0,5 % of dry matte r of the material.  
(4) The high purity material shall contain no more than 6 mg /kg dry matter of polycyclic 
aromatic hydrocarbons (PAH 16) (******) .  
(5) An EU fertilising product containing or consisting of high purity materials shall 
contain no more than:  
(a) 400 mg/kg dry matter  of total chromium (Cr); and 
(b) 2 mg /kg dry matter  of thallium (Tl).  
(6) Where for the product function category of an EU fertilising product containing or 
consisting of high purity materials no requirements regarding Salmonella  spp., 
Escherichia col i or Enterococcaceae  have been laid down  in Annex I, th ose 
pathogens shall not exceed the limits set out in the following table:  
Micro -organisms  
to be tested  Sampling  
plans  Limit  
n c m M EN 3  EN Salmonella  spp. 5 0 0 Absence in 25  g or 25  ml 
Escherichia coli   
or  
Enterococcaceae  5 5 0 1 000 in 1  g or 1  ml 
 
Where:  
n = number of samples to be tested,  
c = number of samples where the number of bacteria expressed in colony forming units (CFU) is between m and 
M, 
m = threshold value for the number of bacteria expressed in CFU that is considered satisfactory,  
M = maximum value of the number of bacteria expressed in CFU.  
 
(7) Where compliance with a given requirement laid down in points 3 to 6 (such as 
absence of a given contaminant)  follows certainly and uncontestab ly from the nature 
or the recovery process  of the high purity material  or the manufacturing process of 
the EU fertilising product , that compliance shall  be presumed in the conformity 
assessment procedure without verification (such as testing) , under  the re sponsibility 
of the manufacturer.  
(8) High purity materials  that are stored in a way that does not protect them against 
precipitation and direct sunlight may be added to an EU fertilising product only if 
they have  been  manufactured  maximum 36 months before sig ning the EU declaration 
of conformity for the res pective EU fertilising product.  
(9) The high purity material  shall have been registered pursuant to Regulation (EC) No 
1907/2006, with a dossier containing:  
(a) the information provided for by Annexes VI, VII and VIII to Regulation (EC) 
No 1907/2006, and  
(b) a chemical safety report pursuant to Article 14 of Regulation (EC) No 
1907/2006 covering the use as a fertilising product,  
unless explicitly covered by one of t he registration obligation exemptions provided for 
by Annex IV to Regulation (EC) No 1907/2006 or by points 6, 7, 8, or 9 of Annex V 
to that Regulation.  
(*) Regulation (EC) No 1069/2009 of the European Parliament and of the Council of 21 
October 2009 layin g down health rules as regards animal by -products and derived products 
not intended for human consumption and repealing Regulation (EC) No 1774/2002 (Animal 
by-products Regulation) (OJ L 300, 14.11.2009, p. 1).  
(**) Council Directive 91/271/EEC of 21 May 1 991 concerning urban waste -water treatment  
(OJ L 135, 30 .05.1991 , p. 40).  
(***) Council Directive 86/278/EEC of 12 June 1986 on the protection of the environment, 
and in particular of the soil, when sewage sludge is used in agriculture ( OJ L  181, 4.7.1986, 
p. 6). 
(****) Directive 2010/75/EU of the European Parliament and of the Council of 24 November 
2010 on industrial emissions (integrated pollution prevention and contro l) (OJ L 334, 
17.12.2010, p. 17).  EN 4  EN (*****) Commission Regulation (EU) No 142/2011 of 25 February 2011 implementing 
Regulation (EC) No 1069/2009 of the European Parliament and of the Council laying down 
health rules as regards animal by -products and derived  products not intended for human 
consumption and implementing Council Directive 97/78/EC as regards certain samples and 
items exempt from veterinary checks at the border under that Directive  (OJ L 54, 26.2.2011, 
p. 1). 
(****** ) Sum of naphthalene, acenapht hylene, acenaphthene, fluorene, phenanthrene, 
anthracene, fluoranthene, pyrene, benzo[a]anthracene, chrysene, benzo[b]fluoranthene, 
benzo[k]fluoranthene, benzo[a]pyrene, indeno[1,2,3 -cd]pyrene, dibenzo[a,h]anthracene and 
benzo[ghi]perylene. ”. EN 5  EN ANNEX II 
In Part I  of Annex III  to Regulation (EU) No 2019/1009, the following point 7b is inserte d: 
“7b. Where the EU fertilising product contains or consists of high purity materials referred to 
in Part II , CMC 15 , of Annex II and :  
(a) has a selenium (Se) content exceeding  10 mg/kg dry matter, the selenium  conten t 
shall be declared;  
(b) has a chloride  (Cl-) content exceeding  30 g/kg  dry matter , the chloride conten t shall 
be declared. ”.  EN 6  EN ANNEX  III 
In Part II  of Annex IV  to Regulation (EU) No 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 descriptio n 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, 1 4 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 requi rements 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-point s (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 manuf acturer shall refuse any consignment of any given input material where visual 
inspection raises suspicion of any of the following:  
– the presence of hazardous or damag ing 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 replac ed 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 (f a), 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) The following sub -point (fb) is inserted : EN 7  EN “(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 
3000 tonnes of these materials or one sample per two months, whichever o ccurs 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 (f b) and take the necessary corrective actions to prevent possible further tra nsport 
and use of that material .”. 
(5) In point 5.1.4.1, t he 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 Ann ex 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 rele vant 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: ”.