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Fertilising Product Regulation
implementation
1st Summit of the Organic and Organo-
mineral Fertiliser Industry in Europe
Brussels, 6 June 2019
Johanna Bernsel
DG GROW/D2
The Fertilising Products Regulation (FPR)
• Adopted on 5 June
• The adoption of FPR is part of
the Circular Economy Action
Plan.
• (for the most recent report on the
implementation of this Action Plan:
http://ec.europa.eu/environment/cir
cular-economy/index_en.htm)
2
Harmonised rules for Fertilising Products
• New Legislative Framework
• Harmonised rules apply on placing on the market of CE
marked Fertilising Product
• CE-marking → Free movement in the single market
• A product regulation; does not regulate use of products or
mode of application
• Replace the existing Fertilisers Regulation 2003/2003
3
Optional harmonisation
4
5
The main actors are:
The EP and Council decide all essential
elements
The Commission adopts delegated acts
CEN adopts voluntary harmonised standards
Economic operators ensure
conformity before placing
on the market, and
collaborate with market
surveillance authorities
Market surveillance authorities
check EU fertilising products
Notified bodies assist in conformity
assessment
Structure of the FPR - Operative Provisions
• Chapter 1- General provisions (art. 1-5)
• Chapter 2- Obligations of economic operators (art. 6-12)
• Chapter 3 – Conformity of EU Fertilising Products (art. 13-19)
• Chapter 4 – Notification of Conformity Assessment Bodies
(art. 20-36)
• Chapter 5 – Union market surveillance, control of EU
fertilising products entering the Union Market and
Union Safeguard Procedure (art. 37-41)
• Chapter 6 –Delegated powers and committee procedure (art.
42-45)
• Chapter 7 – Amendments (art. 46 – 47)
• Chapter 8 – Transitional and final provisions (art. 48 – 53)
6
Structure of the FPR - Annexes
• Annex I – Product Function Categories of EU fertilising products
(PFCs)
- Part 1- Designation of PFCs
- Part 2- Requirements related to each PFC
• Annex II – Component Material Categories (CMCs)
- Part 1 – Overview of CMCs
- Part 2 – Requirements related to each CMC
• Annex III – Labelling requirements
- Part 1- General labelling requirements
- Part 2 – Product-specific labelling requirements
- Part 3- Tolerance rules
• Annex IV – Conformity assessment procedures
- Part 1 – Applicability
- Part 2 – Description (modules)
• Annex V – EU declaration of conformity
7
PFC1 - Fertiliser
(A) Organic
(I) Solid
(II) Liquid
(B) Organo-
mineral
(C) Inorganic
PFC2 – Liming material
PFC3 – Soil Improver (A) Organic
(B) Inorganic
PFC4 – Growing medium
PFC5 – Inhibitor
PFC6 – Plant Biostimulant (A) Microbial
(B) Non-Microbial
PFC7 – Fertilising product blend
(I) Solid
(II) Liquid
(I) Macronutrient
(II) Micronutrient
Product Function Categories ('PFC')
CE-marked products comply with
requirements for at least one
product function category (PFC)
• Safety (contaminants , pathogens)
• Quality (content of nutrients)
• Labelling
CE marked product with
two or more functions (PFCs) →
may be considered as Blend (PFC 7)
A CE fertilising product
belongs to….
8
9
CMC 1: Substances and mixtures,
primary
CMC 2: Simple plant parts or
extracts
CMC 3: Compost
CMC 4: Energy crop digestate
CMC 5: Other digestate
CMC 6: Food industry by-products
CMC 7: Micro-organisms
CMC 8: Nutrient polymenr
CMC 9: Other polymers
CMC 10: Products derived from
animal by-products
CMC 11: By-products
• All component materials have to be
covered by a CMC
• Product composed of at least one
CMC and comply to its relevant
requirements
-REACH
-"End-of-waste criteria”
-Animal-by-products end points
• One PFC may contain more than
one CMC
• CMCs not expected to react
intentionally
• Precursors of a chemical need not
to be covered by a CMC if the
chemical is covered by CMC 1
Component Material Categories (CMCs)
A CE fertilising product is
composed of….
Illustrative example :
how to obtain a CE Mark for organic fertiliser (PFC 1(A))
composed of compost (CMC 3)
Main product requirements:
Compliance with recovery rules for compost (material
purity + stability)
Limits for heavy metal contaminants/pathogens
Minimum content of nutrients and organic carbon
Label must include:
- Components above 5%
- Content of nutrients and organic carbon 10
Illustrative example:
how to obtain a CE Mark for organic fertiliser (PFC 1(A))
composed of compost (CMC 3)
Conformity assessment:
Module D1 is applicable
Manufacturer operates a quality system under
surveillance of notified body
CE marking indicates of the identification number of
the notified body
Quality system includes input material inspection
and output material sample testing
11
Waste Framework Directive
Animal By-products Regulation (ABPR)
Plant Protection Product Regulation
• CE-marked compliant fertilising products cease
being waste (Article 19 of FPR)
• ABPR allows fertilisers to reach the end-point in the
manufacturing chain (Article 46 of FPR)
• Plant biostimulants regulated under FPR (Article 47
of FPR; PFC 6)
12
Conformity assessment
• - Responsibility of the manufacturer following one
of the modules in Annex IV
• - in some of the modules, notified bodies play a
role  need to create the corresponding
infrastructure
13
Modules are defined in Annex IV depending on
component material category (CMC) or
product function category (PFC)
• *Module A1 shall be used for ammonium nitrate fertilisers of high
nitrogen content.
Module D1
PFCs 1*-6
containing
CMCs 3
and 5
Module B + C
• PFCs 1*-4
containing
CMCs 1(4),
2, 9 and 10
• PFCs 5 and 6
Module A
• PFCs 1*-4
containing
• CMC 1 except
1(4) and
• CMCs 4, 6, 7,
8 and 11
• PFC 7*
14
Dynamics/adaptability of FPR
• Annexes "limited" to PFCs/CMCs where realistic safety and
quality standards available
• Annexes will be more and more inclusive (Strubias, animal by-
products): mechanisms to adapt the annexes (delegated acts)
to technical progress
• If new safety concerns arise, reactivity to new risks (delegated
acts), safeguard mechanisms
15
Win for manufacturers:
16
More products covered by the FPR  new
opportunities
Less red-tape – much broader categories and
no need to amend the FPR for individual
products as it is the case now
Win for technology providers:
FPR opens the door to new technologies
such as decadmiation or phosphorus
recuperation
Win for farmers:
17
More choices for the fertilising products
they use
Produce raw materials for their own
fertilising products
• Mandatory limit values for the most
important contaminants and pathogens in
EU fertilising products
Win for EU citizens:
Period of transition
18
EU fertilising products FPR
EC fertilisers placed on the
market before the application of
FPR
National fertilising products
EC fertilisers R 2003/2003
National fertilisers
2019
2022
•Thank you !
• Follow the work on the implementation of the FPR on
CircABC – Fertilisers Working Group
• https://circabc.europa.eu/ui/group/36ec94c7-575b-
44dc-a6e9-4ace02907f2f
19

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Fertilising Product Regulation implementation - Johanna Bernsel - European Commission DG GROW

  • 1. Fertilising Product Regulation implementation 1st Summit of the Organic and Organo- mineral Fertiliser Industry in Europe Brussels, 6 June 2019 Johanna Bernsel DG GROW/D2
  • 2. The Fertilising Products Regulation (FPR) • Adopted on 5 June • The adoption of FPR is part of the Circular Economy Action Plan. • (for the most recent report on the implementation of this Action Plan: http://ec.europa.eu/environment/cir cular-economy/index_en.htm) 2
  • 3. Harmonised rules for Fertilising Products • New Legislative Framework • Harmonised rules apply on placing on the market of CE marked Fertilising Product • CE-marking → Free movement in the single market • A product regulation; does not regulate use of products or mode of application • Replace the existing Fertilisers Regulation 2003/2003 3
  • 5. 5 The main actors are: The EP and Council decide all essential elements The Commission adopts delegated acts CEN adopts voluntary harmonised standards Economic operators ensure conformity before placing on the market, and collaborate with market surveillance authorities Market surveillance authorities check EU fertilising products Notified bodies assist in conformity assessment
  • 6. Structure of the FPR - Operative Provisions • Chapter 1- General provisions (art. 1-5) • Chapter 2- Obligations of economic operators (art. 6-12) • Chapter 3 – Conformity of EU Fertilising Products (art. 13-19) • Chapter 4 – Notification of Conformity Assessment Bodies (art. 20-36) • Chapter 5 – Union market surveillance, control of EU fertilising products entering the Union Market and Union Safeguard Procedure (art. 37-41) • Chapter 6 –Delegated powers and committee procedure (art. 42-45) • Chapter 7 – Amendments (art. 46 – 47) • Chapter 8 – Transitional and final provisions (art. 48 – 53) 6
  • 7. Structure of the FPR - Annexes • Annex I – Product Function Categories of EU fertilising products (PFCs) - Part 1- Designation of PFCs - Part 2- Requirements related to each PFC • Annex II – Component Material Categories (CMCs) - Part 1 – Overview of CMCs - Part 2 – Requirements related to each CMC • Annex III – Labelling requirements - Part 1- General labelling requirements - Part 2 – Product-specific labelling requirements - Part 3- Tolerance rules • Annex IV – Conformity assessment procedures - Part 1 – Applicability - Part 2 – Description (modules) • Annex V – EU declaration of conformity 7
  • 8. PFC1 - Fertiliser (A) Organic (I) Solid (II) Liquid (B) Organo- mineral (C) Inorganic PFC2 – Liming material PFC3 – Soil Improver (A) Organic (B) Inorganic PFC4 – Growing medium PFC5 – Inhibitor PFC6 – Plant Biostimulant (A) Microbial (B) Non-Microbial PFC7 – Fertilising product blend (I) Solid (II) Liquid (I) Macronutrient (II) Micronutrient Product Function Categories ('PFC') CE-marked products comply with requirements for at least one product function category (PFC) • Safety (contaminants , pathogens) • Quality (content of nutrients) • Labelling CE marked product with two or more functions (PFCs) → may be considered as Blend (PFC 7) A CE fertilising product belongs to…. 8
  • 9. 9 CMC 1: Substances and mixtures, primary CMC 2: Simple plant parts or extracts CMC 3: Compost CMC 4: Energy crop digestate CMC 5: Other digestate CMC 6: Food industry by-products CMC 7: Micro-organisms CMC 8: Nutrient polymenr CMC 9: Other polymers CMC 10: Products derived from animal by-products CMC 11: By-products • All component materials have to be covered by a CMC • Product composed of at least one CMC and comply to its relevant requirements -REACH -"End-of-waste criteria” -Animal-by-products end points • One PFC may contain more than one CMC • CMCs not expected to react intentionally • Precursors of a chemical need not to be covered by a CMC if the chemical is covered by CMC 1 Component Material Categories (CMCs) A CE fertilising product is composed of….
  • 10. Illustrative example : how to obtain a CE Mark for organic fertiliser (PFC 1(A)) composed of compost (CMC 3) Main product requirements: Compliance with recovery rules for compost (material purity + stability) Limits for heavy metal contaminants/pathogens Minimum content of nutrients and organic carbon Label must include: - Components above 5% - Content of nutrients and organic carbon 10
  • 11. Illustrative example: how to obtain a CE Mark for organic fertiliser (PFC 1(A)) composed of compost (CMC 3) Conformity assessment: Module D1 is applicable Manufacturer operates a quality system under surveillance of notified body CE marking indicates of the identification number of the notified body Quality system includes input material inspection and output material sample testing 11
  • 12. Waste Framework Directive Animal By-products Regulation (ABPR) Plant Protection Product Regulation • CE-marked compliant fertilising products cease being waste (Article 19 of FPR) • ABPR allows fertilisers to reach the end-point in the manufacturing chain (Article 46 of FPR) • Plant biostimulants regulated under FPR (Article 47 of FPR; PFC 6) 12
  • 13. Conformity assessment • - Responsibility of the manufacturer following one of the modules in Annex IV • - in some of the modules, notified bodies play a role  need to create the corresponding infrastructure 13
  • 14. Modules are defined in Annex IV depending on component material category (CMC) or product function category (PFC) • *Module A1 shall be used for ammonium nitrate fertilisers of high nitrogen content. Module D1 PFCs 1*-6 containing CMCs 3 and 5 Module B + C • PFCs 1*-4 containing CMCs 1(4), 2, 9 and 10 • PFCs 5 and 6 Module A • PFCs 1*-4 containing • CMC 1 except 1(4) and • CMCs 4, 6, 7, 8 and 11 • PFC 7* 14
  • 15. Dynamics/adaptability of FPR • Annexes "limited" to PFCs/CMCs where realistic safety and quality standards available • Annexes will be more and more inclusive (Strubias, animal by- products): mechanisms to adapt the annexes (delegated acts) to technical progress • If new safety concerns arise, reactivity to new risks (delegated acts), safeguard mechanisms 15
  • 16. Win for manufacturers: 16 More products covered by the FPR  new opportunities Less red-tape – much broader categories and no need to amend the FPR for individual products as it is the case now Win for technology providers: FPR opens the door to new technologies such as decadmiation or phosphorus recuperation
  • 17. Win for farmers: 17 More choices for the fertilising products they use Produce raw materials for their own fertilising products • Mandatory limit values for the most important contaminants and pathogens in EU fertilising products Win for EU citizens:
  • 18. Period of transition 18 EU fertilising products FPR EC fertilisers placed on the market before the application of FPR National fertilising products EC fertilisers R 2003/2003 National fertilisers 2019 2022
  • 19. •Thank you ! • Follow the work on the implementation of the FPR on CircABC – Fertilisers Working Group • https://circabc.europa.eu/ui/group/36ec94c7-575b- 44dc-a6e9-4ace02907f2f 19