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Fertilising Product Regulation
Implementation challenges
ManureSource 2019
Hasselt, 28 November 2019
Unit D2 - Chemicals
European Commission, DG Internal Market, Industry,
Entrepreneurship and SMEs
The Fertilising Products Regulation (FPR)
• Adopted on 5 June 2019
• The adoption of FPR is the
first deliverable 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
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 (PFCs)
EU fertilising product must comply
with requirements of at least one
product function category (PFC)
• Safety (contaminants , pathogens)
• Quality (content of nutrients)
• Labelling
EU fertilising product may claim
more than one functions (PFCs)
Blend (PFC 7) made of two or more
component EU fertilising products
An EU fertilising product belongs
to….
6
6
CMC 1: Virgin material substances
and mixtures
CMC 2: Plant, plant parts or plant
extracts
CMC 3: Compost
CMC 4: Fresh crop digestate
CMC 5: Digestate other than fresh
crop digestate
CMC 6: Food industry by-products
CMC 7: Micro-organisms
CMC 8: Nutrient polymers
CMC 9: Polymers other than
nutrient polymers
CMC 10: Derived Products from
animal by-products
CMC 11: By-products in the meaning
of Directive 2008/98/EC
• All component materials have to be covered by a
CMC
• Product composed of at least one CMC and comply
to its relevant requirements
- REACH (registration dossier including chemical
safety report for use as fertilising product)
- "End-of-waste criteria”
- Animal-By-Products Regulation
- additonal criteria for agronomic efficiency and safety
• One PFC may contain more than one CMC
• CMCs not expected to react intentionally
Component Material Categories (CMCs)
An EU fertilising product is
composed of….
7
FPR amends Regulation (EC) No 1069/2009
Period of transition
8
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
Implementation of FPR
• Commission expert group
• Conformity Assessment
• Market Surveillance
• Products derived from Animal By-Products (ABPs)
used as fertilising products (FP)
• Standardisation request
• Guidance document on labels
• Frequently Asked Questions document
9
Commission Expert Group
• Commission will need to consult a relevant
Commission expert group before adopting
delegated acts
• Expert group on fertilising products
 new mandate
 open call for observers
 new rules of procedure
10
Conformity assessment (1)
FPR follows the new legislative approach
• the conformity assessment to be done following
one of the modules set in Annex IV
• in some modules, notified bodies play a role
 need to create the corresponding infrastructure
• Timeline – April 2020
11
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*
12
Conformity assessment
13
Module B (EU-type examination)
a notified body examines technical design of EU fertilising product,
verifies that requirements are met and issues “EU-type examination
certificate”
Module C (Conformity to type based on internal production control)
manufacturer ensures that the EU fertilising products concerned are
in conformity with the type described in the “EU-type examination
certificate”
Option 1
CMC 10
Conformity assessment
14
Module D1 (Quality assurance of the production process)
manufacturer:
- ensures that EU fertilising product satisfy
requirements in FPR
- operates an approved quality system for
a) production, b) final product inspection and c) testing
a notified body:
- certifies the quality system
- performs periodic audits
Option 2
CMC 5
CMC 3
Conformity assessment
15
NANDO Information System
(New Approach Notified and Designated Organisations)
https://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=na.main
By 20 April 2020
• Notifying authorities in all Member States
• Procedures for the assessment and notification of
conformity assessment bodies and the monitoring of
notified bodies (established by national law)
As of April 2020
• List of Notified Bodies
Market surveillance
• New Market Surveillance Regulation (Regulation
(EU) 2019/1020) will be applicable by July 2022
• improves market surveillance
• seeks to boost Europe's track-and-trace capabilities
in the world of global supply chains
•
• Timeline – July 2022
• https://ec.europa.eu/growth/single-market/goods/building-blocks/market-surveillance_en
16
End points for products derived from ABPs
used in fertilising products
• Commission obligation to start the assessment of derived
products from ABPs used as fertilisers (article 46 of FPR)
• If assessment concludes
• “no risk to public or animal health”
• → Commission will adopt delegated acts to determine end
points in the manufacturing chain of specific derived
products from ABPs
17
Standardisation request
• Commission will request CEN to develop
technical specifications and
harmonised standards in support of FPR
• Presumption of conformity with the
requirements in FPR (Art 13 in FPR)
• – put for vote in written procedure in the
Committee on Standards
18
Guidance document on labels
• Commission has the obligation to publish a guidance
document with clear information and examples concerning
the visual appearance of the label of EU fertilising products
•
• Timeline – July 2020
19
EU fertilising product
PFC X, CMCs Y and Z,
N, P, K content……
20
‘Frequently asked Questions’ document
• A living document published in Commission’s website
to facilitate implementation of FPR
 aims in facilitating the implementation of FPR
 focus on issues that could raise difficulties in practice
and that are relevant to substantive requirements of
the regulation
• https://ec.europa.eu/docsroom/documents/36764
Thank you !
Follow the work on the implementation of the FPR on CircABC space
Commission Expert Group on fertilising products
• https://circabc.europa.eu/ui/group/36ec94c7-575b-44dc-a6e9-
4ace02907f2f
21

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Presentation of the Fertiliser Product Regulation and the challenges of implementation

  • 1. Fertilising Product Regulation Implementation challenges ManureSource 2019 Hasselt, 28 November 2019 Unit D2 - Chemicals European Commission, DG Internal Market, Industry, Entrepreneurship and SMEs
  • 2. The Fertilising Products Regulation (FPR) • Adopted on 5 June 2019 • The adoption of FPR is the first deliverable 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 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 (PFCs) EU fertilising product must comply with requirements of at least one product function category (PFC) • Safety (contaminants , pathogens) • Quality (content of nutrients) • Labelling EU fertilising product may claim more than one functions (PFCs) Blend (PFC 7) made of two or more component EU fertilising products An EU fertilising product belongs to….
  • 6. 6 6 CMC 1: Virgin material substances and mixtures CMC 2: Plant, plant parts or plant extracts CMC 3: Compost CMC 4: Fresh crop digestate CMC 5: Digestate other than fresh crop digestate CMC 6: Food industry by-products CMC 7: Micro-organisms CMC 8: Nutrient polymers CMC 9: Polymers other than nutrient polymers CMC 10: Derived Products from animal by-products CMC 11: By-products in the meaning of Directive 2008/98/EC • All component materials have to be covered by a CMC • Product composed of at least one CMC and comply to its relevant requirements - REACH (registration dossier including chemical safety report for use as fertilising product) - "End-of-waste criteria” - Animal-By-Products Regulation - additonal criteria for agronomic efficiency and safety • One PFC may contain more than one CMC • CMCs not expected to react intentionally Component Material Categories (CMCs) An EU fertilising product is composed of….
  • 7. 7 FPR amends Regulation (EC) No 1069/2009
  • 8. Period of transition 8 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
  • 9. Implementation of FPR • Commission expert group • Conformity Assessment • Market Surveillance • Products derived from Animal By-Products (ABPs) used as fertilising products (FP) • Standardisation request • Guidance document on labels • Frequently Asked Questions document 9
  • 10. Commission Expert Group • Commission will need to consult a relevant Commission expert group before adopting delegated acts • Expert group on fertilising products  new mandate  open call for observers  new rules of procedure 10
  • 11. Conformity assessment (1) FPR follows the new legislative approach • the conformity assessment to be done following one of the modules set in Annex IV • in some modules, notified bodies play a role  need to create the corresponding infrastructure • Timeline – April 2020 11
  • 12. 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* 12
  • 13. Conformity assessment 13 Module B (EU-type examination) a notified body examines technical design of EU fertilising product, verifies that requirements are met and issues “EU-type examination certificate” Module C (Conformity to type based on internal production control) manufacturer ensures that the EU fertilising products concerned are in conformity with the type described in the “EU-type examination certificate” Option 1 CMC 10
  • 14. Conformity assessment 14 Module D1 (Quality assurance of the production process) manufacturer: - ensures that EU fertilising product satisfy requirements in FPR - operates an approved quality system for a) production, b) final product inspection and c) testing a notified body: - certifies the quality system - performs periodic audits Option 2 CMC 5 CMC 3
  • 15. Conformity assessment 15 NANDO Information System (New Approach Notified and Designated Organisations) https://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=na.main By 20 April 2020 • Notifying authorities in all Member States • Procedures for the assessment and notification of conformity assessment bodies and the monitoring of notified bodies (established by national law) As of April 2020 • List of Notified Bodies
  • 16. Market surveillance • New Market Surveillance Regulation (Regulation (EU) 2019/1020) will be applicable by July 2022 • improves market surveillance • seeks to boost Europe's track-and-trace capabilities in the world of global supply chains • • Timeline – July 2022 • https://ec.europa.eu/growth/single-market/goods/building-blocks/market-surveillance_en 16
  • 17. End points for products derived from ABPs used in fertilising products • Commission obligation to start the assessment of derived products from ABPs used as fertilisers (article 46 of FPR) • If assessment concludes • “no risk to public or animal health” • → Commission will adopt delegated acts to determine end points in the manufacturing chain of specific derived products from ABPs 17
  • 18. Standardisation request • Commission will request CEN to develop technical specifications and harmonised standards in support of FPR • Presumption of conformity with the requirements in FPR (Art 13 in FPR) • – put for vote in written procedure in the Committee on Standards 18
  • 19. Guidance document on labels • Commission has the obligation to publish a guidance document with clear information and examples concerning the visual appearance of the label of EU fertilising products • • Timeline – July 2020 19 EU fertilising product PFC X, CMCs Y and Z, N, P, K content……
  • 20. 20 ‘Frequently asked Questions’ document • A living document published in Commission’s website to facilitate implementation of FPR  aims in facilitating the implementation of FPR  focus on issues that could raise difficulties in practice and that are relevant to substantive requirements of the regulation • https://ec.europa.eu/docsroom/documents/36764
  • 21. Thank you ! Follow the work on the implementation of the FPR on CircABC space Commission Expert Group on fertilising products • https://circabc.europa.eu/ui/group/36ec94c7-575b-44dc-a6e9- 4ace02907f2f 21