EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
[…](2021) XXX  draft  
 
COMMISSION DELEGATED REGULATION (EU) …/...  
of XXX  
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  
(Text with EEA relevance)   EN 1  EN EXPLANATORY MEMORANDUM  
1. CONTEXT  OF THE  DELEGATED  ACT  
Regulation (EU) 2019/1009  (1) lays down rules on the making available on the market of EU 
fertilising products. EU fertilising products contain component materials of one or more of the 
categories listed in Annex II to that Regulation. In accordance with  Article 42(1) of 
Regulation  (EU) 2019/1009 , the Commission is empowered to adopt delegated acts in 
accordance with Article 44 adapting  Annex II to technical progress and facilitating internal 
market access and free movement for EU fertilising products, which have a potential to be the 
subject of significant trade on the internal market and for which there is scientific evidence 
that they do not present a risk to human, animal or plant health, to safety or to the 
environment and that they do ensure agronomic efficiency. Regulation (EU) N o 2019/1009 
repeals Regulation (EC) No 2003/2003 (2) and will apply as of 16 July 2022.  
When assessing the safety and agronomic criteria needed for the use of by -products belonging 
to Component Material Category  11 in accordance to Article 42(7), the Commi ssion’s Joint 
Research Centr e (‘JRC’)  has identified certain high purity materials  recovered from waste  
with a high agronomic value which could be used as component materials in EU fertilising 
products. The JRC assessme nt is included in the Report on  Techn ical proposals for by-
products and high purity materials as component materials for EU Fertilising Products . (link 
to the report when published to be added in a footnote ).  
The report includes technical proposals on eligible input materials and recovery operations  for 
such high purity materials , quality requirements and quality management systems.  
In accordance with Article 42(3) of Regulation (EU) No 2019/1009, the Commission may 
only adopt delegated acts pursuant to that Article to include materials in  Annex II to the 
Regulation that cease to be waste following a recovery operation, if recovery rules in that 
Annex, adopted no later than the inclusion, ensure that the materials comply with the 
conditions laid down in Art icle 6 of Directive 2008/98/EC (3). This delegated regulation 
establishes recovery rules  for high purity materials  ensuring that they comply with the 
conditions laid down in Directive  2008/98/EC . Consequently, the requirement set out in 
Article 42(3) of Regulation (EU) No 2019/1009  is fulfi lled.  
In this context, this delegate d Regulation amends Annex  II to Regulation (EU) No  2019/1009 
by adding recovered high purity materials  as a new Component Material Category, and Annex 
IV to the Regulation by setting up the legal framework for the relev ant conformity assessment 
for EU fertilising products containing such materials . 
This initiative feeds into the measures announced in the 2020 Circular Economy Action Plan 
(4), one of the main blocks of the European Green Deal (5), as it creates new opport unities for 
                                                 
1 Regulation (EU) 2019/1009 of the European Parliament and of  the Council of 5 June 2019 laying down 
rules on the making available on the market of EU fertilising products and amending Regulations (EC) 
No 1069/2009 and (EC) No 1107/2009 and repealing Regulation (EC) No 2003/2003, OJ L 170, 
25.6.2019, p. 1 –114. 
2 Regulation (EC) No 2003/2003 of the European Parliament and of the Council  of 13 October 2003 
relating to fertilisers (OJ L 304, 21.11.2003, p. 1).  
3 Directive 2008/98/EC of the European Parliament and of the Council of 19 November 2008 on waste 
and repealing  certain Directives, OJ L 312, 22.11.2008, p. 3 –30. 
4 COMMUNICATION FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT, THE 
COUNCIL, THE EUROPEAN ECONOMIC AND SOCIAL COMMITTEE AND THE COMMITTEE 
OF THE REGIONS A new Circular Economy Action Plan For a cleaner and more competitive Europe, 
COM/2020/98 final.  EN 2  EN the use of by -products and of recovered waste, contributing to the well -functioning EU 
market for secondary raw materials .  
2. CONSULTATIONS  PRIOR  TO THE  ADOPTION  OF THE  ACT  
Pursuant to Article 44(4) of Regulation (EU) 2019/1009, experts designated by each Member 
State  were consulted in the Commission expert group on Fertilising Products (E01320) 
according to the rules of the Interinstitutional Agreement on Better Law -Making of 13 April 
20166. 
Details of these consultations can be found in  the minutes of the meeti ng held on 
… November 2021 , as well as in the various position papers of interested stakeholders 
publicly available on the CIRCABC page of the group, at the following link:  
https://circabc.europa.eu/ui/group/36ec94c7 -575b -44dc -a6e9 -4ace02907f2f/library/b8e01334 -
4d39 -445d -bf4e-589356d55b1f   
Member States and interested stakeholders were largely supporti ve of the adoption of this 
delegated Regulation.  
The draft delegated Regulation has been published for feedback on the Better Regulation 
portal  [to add details once the consultation is done] .  
The draft delegated Regulation has also been notified based on Article 2(9)(2) of the 
Agreement on Technical Barriers to Trade.  [to add details once the consultation is done ]  
 
3. LEGAL  ELEMENTS  OF THE  DELEGATED  ACT  
The legal act amends Regulation (EU) 2019/1009. The legal basis of this delegated act is 
Article 42(1) of Regulation (EU) 2019/1009.  
                                                                                                                                                         
5 COMMUNICATION FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT, THE 
EUROPEAN COUNCIL, THE COUNCIL, THE EUROPEAN ECONOMIC AND SOCIAL 
COMMITTEE AND THE COMMITTEE OF THE REGIONS The European Green Deal, 
COM/2019 /640 final.  
6 OJ L 123, 12.5.2016, p. 1 –14. EN 3  EN COMMISSION DELEGATED REGULATION (EU) …/...  
of XXX  
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  
(Text with EEA relevance)  
THE EUROPEAN COMMISSION,  
Havi ng regard to the Treaty on the Functioning of the European Union , 
Having regard to  Regulation (EU) 2019/1009 of the European Parliament and of the Council 
of 5 June 2019 laying down rules on the making available on the market of EU fertilising 
products and  amending Regulations (EC) No 1069/2009 and (EC) No 1107/2009 and 
repealing Regulation (EC) No 2003/20031, and in particular Article  42(1) thereof,  
Whereas:  
(1) Regulation (EU) 2019/1009 lays down rules on the making available on the market of 
EU fertilising p roducts. EU fertilising products contain component materials of one or 
more of the categories listed in Annex II to that Regulation.  
(2) In accordance with Article 42(1) of Regulation (EU) 2019/1009, the Commission is 
empowered to adopt delegated acts in acco rdance with Article 44 for the purpose of 
adapting Annex II to technical progress .. Pursuant to Article 42(3) of Regulation (EU) 
2019/1009 read in conjunction with Article 6 of Directive 2008/98/EC of the European 
Parliament and of the Council2, the  Commis sion may include in the component 
material categories  materials that cease to be waste following a recovery operation  if 
such materials  are to be used for specific purposes, have an exist ing market or demand 
and their use do not lead to overall adverse environmental or human health impacts.  
(3) The Commission’s Joint Research Centre (‘JRC’) has identified certain high purity 
materials which could be recovered from waste and used as component materials in 
EU fertilising products . [to add link when available ] 
(4) The high purity mat erials identified by the JRC are ammoni um salts, sulphate salts, 
phosphate salts, elemental sulphur, calcium carbonate and calcium oxide. All th ose 
materials are covered by Regulation (EC) No 2003/2003 of the European Parliament 
and of t he Council3, have a  significant market demand  and have proven their high 
agronomic value during a long history of use in the field.  
(5) As a first measure to ensure  both safety and agronomic efficiency, a minimum purity 
requirement of high purity materials should be laid down. According to the 
                                                 
1 OJ L 170, 25.6.2019, p. 1.  
2 Directive 2008/98/EC of the European Parliament and of the Council of 19 November 2008 on waste 
and repealing certain Directives (OJ L 312, 22.11.2008, p. 3 ). 
3 Regulation (EC) No 2003/2003 of the European Parliament and of the Council of 13 October 2003 
relating to fertilisers (OJ L 304, 21.11.2003, p. 1).  EN 4  EN information available in JRC ’s assessment  report, a 95  % purity , expressed in terms of 
(the) dry matter of the material , will ensure high agronomic efficiency  with low  risks  
to the environment, health and safety . While  this high level purity is for some 
materials  set at  more ambitious  levels than th ose required by  Regulation  (EC)  No 
2003/2003 , it is estimated that this higher purity is achievable based on existing 
practices.  
(6) In addition, it is appropriate to specify that high purity materials are recovered from 
waste following two  two types of processes: processes that isolate salts through (a 
combination of) advanced purification methods , such as  crystallisation, centrifugation  
or liquid -liquid extraction , often app lied in (petro -)chemical industries; and gas 
purification or emission control process es designed to remove nutrients from off -
gases .  
(7) Therefore, the c ontent of certain impurities , pathogens  or contaminants which are 
specific to th ose materials , or the cont ent of organic carbon  should be limited , based 
on the JRC assessment report . Such criteria should  apply in addition to the safety 
criteria laid down in Annex I to Regulation (EU) 2019/1009 for the corresponding 
product function category and without prejudi ce to Regulation (EU) 2019/1021 of the 
European Parliament and of the Council4.   
(8) Consequently , additional limit  values should be laid down for the contaminants total 
chromium and thallium. Some of the high purity materials may contain such 
contaminants as a result of the input materials and the processes they are obtained 
from . The proposed limit  values for those contaminants  should ensure that the use of 
EU fert ilising products containing high purity materials with such contaminants  does 
not lead to their accumulation in soil. In addition , requirements on the content of 
pathogens should be introduced for all EU fertilising products containing or consisting 
of hig h purity materials given the broad variety of processes  they could be obtained 
from and the waste streams allowed as input materials. The limit  values for both the 
contaminants and the pathogens should be determined as concentration in the final 
product, s imilar to the requirements set out in Annex I to Regulation (EU) 2019/1009. 
This is justified by the fact that the safety criteria introduced in reply to any particular 
risks identified concern, as a rule, the final product and not a component material. This 
should also facilitate the market surveillance of such products, as tests are to be carried 
out only on the final product.  
(9) Furthermore, additional safety criteria should be laid down to limit the content of 16 
polycyclic aromatic hydrocarbons (PAH 16) (5). Regulation (EU) 2019/1021 lays down  
release reductions for PAH 16 as unintentionally produced substances during 
manufacturing processes, but does not introduce a limit -value. Given the high risks 
generated by the presence of such pollutants  in fertilisi ng products , it is considered 
appropriate to introduce more stringent requirements than those laid down in that 
Regulation. Such  a limit  value should be laid down at component material level, and 
not as concentration in the final product to ensure maximum coherence with 
Regulation (EU) 2019/10 21.  
                                                 
4 Regulation (EU) 2019/1021 of the European Parliament and of the Council of 20 June 2019 on 
persistent organic pollutants (OJ L 169, 25.6.2019, p. 45).  
5 Sum of naphthalene, acenaphthylene, 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 (10) The limit values referred to in recitals (8) and (9)  may not be relevant for all high 
purity materials to be included as a new component material category. Therefore, 
manufacturers should have the possibility to p resume the conformity of the fertilising 
product with a given  requirement without verification , such as testing, whenever the 
compliance with the said  requirement follows certainly and uncontestably from the 
nature or the recovery process of  the respective  high purity material  or of the 
manufacturing process of the EU fertilising product . 
(11) As an additional safety measure, the high purity materials should be registered based 
on Regulation (EC) No 1907/2006 of the European Parliament and of the Council6, in 
the extensive conditions  already laid down in Regulation (EU) 2019/1009  for chemical  
substances in other component material categories . This should ensure that the 
manufacturers take into account the use as a fertilising product when performing the 
risk assessment under that Regulation  and that the registration is done also for low 
tonnage materials.   
(12) Furthermore , some of the high purity materials may be available on local market s in 
quantities that exceed demand . To ensure that market demand  for high purity materials 
exists and that their long-term storage does not lead to adverse environment al impacts 
, it is appropriate to limit the period of time during which they can be  used as 
component materials for EU fertilising products after they have been ge nerated , 
provided that the storing conditions are not adequate , Manufacturers should be  
require d to sign the EU declaration of conformity for the EU fertilising product 
containing the said material  within that period.  
(13) Based on the above, the Commission concludes that high purity materials if recovered  
following the recovery rules suggested  in JRC’s assessment report, ensure agronomic 
efficiency within the meaning of Article 42(1), first subparagraph,  point (b)(ii), of 
Regulation (EU) 2019/1009 . Furthermo re, they comply with the criteria laid down in 
Article 6 of Directive 2008/98/EC. Finally, if compliant with the other requirements in 
Regulation (EU) 2019/1009 in general and in Annex I to that Regulation in particular , 
they would not present a risk to hu man, animal or plant health, to safety or to the 
environment within the meaning of Article 42(1), first subparagraph, point (b)(i), of 
Regulation (EU) 2019/1009 . Such materials would also have a useful purpose as they 
would replace other raw materials used  in the production of EU fertilising products.  
Therefore, recovered high purity materials should be included in Annex II to 
Regulation (EU) 2019/1009.  
(14) Furthermore , given the fact that high purity materials  are recovered  waste within the 
meaning of Directi ve 2008/98/EC, they should be excluded from component material 
categories 1 and 11 of Annex  II to Regulation (EU) 2019/1009  pursuant to Article 
42(1), third subparagraph, of that Regulation.  
(15) Some of the high purity materials  may contain micronutrient sele nium  which  can be 
toxic  if present in high concentration . Some may also contain chloride, which raises 
concerns regarding the salinity in soil. Whenever those substances are present in 
                                                 
6 Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 
concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), 
establishing a Euro pean Chemicals Agency, amending Directive 1999/45/EC and repealing Council 
Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council 
Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 
2000/21/E C (OJ L 396, 30.12.2006, p. 1).  EN 6  EN concentrations exceeding a certain limit, their content should be declare d on the label 
so that the users of the fertilising product are properly informed.  Annex  III to 
Regulation (EU) 2019/1009 should be amended accordingly.  
(16) It is important to ensure that when fertilising products contain high purity materials , 
they ar e subject to an appropriate conformity assessment procedure including a quality 
system assessed and approved by a notified body. Therefore, it is necessary to amend 
Annex IV to Regulation (EU) 2019/1009 to provide for a conformity assessment 
appropriate fo r such fertilising products.  
(17) Given that the requirements set out in Annexes  II and III to Regulation (EU) 
2019/1009  and the conformity assessment procedures set out in Annex IV to that 
Regulation are to apply as of 16  July 2022, it is necessary to defer th e application of 
this Regulation to the same date ,  
HAS ADOPTED THIS REGULATION:  
Article 1  
Regulation ( EU) 2019/1009  is amended as follows:  
(1) Annex I I is am ended in accordance with Annex I  to this Regulation;  
(2) Annex III is am ended in accordance with Annex II  to this Regulation;  
(3) Annex IV is amended in accordance w ith Annex III  to this Regulation.  
Article  2 
This Regulation shall enter into force on the  twentieth day following that of its publication in 
the Official Journal of the European Union . 
It shall apply from  16 July  2022.  
This Regulation shall be binding in its entirety and directly applicable in all Member States.  
Done at Brussels,  
 For the Commission  
 The President  
 Ursula von der Leyen