European Compost Network Joint Meeting of TG 'Quality Assurance Scheme' & 'Fertilisers'
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European Compost Network
Joint Meeting of TG ‘Quality Assurance Scheme’
& ‘Fertilisers’
Day 1 TG QAS: 4 March 2020, 11:30 am – 5:30 pm
Day 2 TG FERT: 5 March 2020, 9:00 am – 5:00 pm
Chairs: Wim Vanden Auweele (TG QAS) & Irmgard Leifert (TG FERT)
info@compostnetwork.info
Agenda - TG QAS Meeting 4 March 2020
TOP 1 Welcome and Tour de Table 11:30-11:45 h
Chair: Wim Vanden Auweele (Vlaco) and Arjen Brinkmann (BVOR)
TOP 2 Benchmark of national quality assurance schemes 11:45-13:00 h
(Subjects: objective of the schemes, governance, stakeholders involved, etc.)
TOP 2.2 Benchmark of national quality assurance schemes (continued)13:45-15:15 h
(Subjects: organisation of sampling and analysis, role of auditors,
compost and digestate quality requirements of the schemes)
TOP 3 Benchmark of national quality assurance schemes (continued)15.15-17:00 h
(Subject: compost and digestate quality requirements of the schemes (contd.))
TOP 4 Conclusions of the day 17:00-17:30 h
10.03.2020 2/
Agenda - TG FERT Meeting 5 March 2020
TOP 1 Welcome and Tour de Table
Chair: Irmgard Leifert (Reterra), replaced by Stefanie Siebert (ECN)
TOP 2 Standardisation work on analytical methods for compost and digestate
Presentation provided by NEN (Secretariat of CEN/TC 223)
Arjen Brinkmann (BVOR); Stefanie Siebert (ECN)
TOP 3 ECN’s approach to the standardisation process
TOP 3.1 Identification of critical work items/analytical methods for compost &
digestate
TOP 3.2 ECN task group/project organisation for the standardisation process
(who does what, who is committed, etc.)
10.03.2020 3/Agenda - TG FERT Meeting 5 March 2020
TOP 4 In-depth discussion of critical work items/analytical methods for compost &
digestate
TOP 4.1 Stability (OUR/Self Heating Test/Residual Biogas Potential)
Wim Vanden Auweele (Vlaco)
TOP 4.2 Impurities
Maria Thelen-Jüngling (BGK)
TOP 4.3 Determination and monitoring of time temperature
NN (BVOR/DWMA)
TOP 4.4 Determination of organic nitrogen (Norg) PFC 1(A), (B); PFC3(A)
Stefanie Siebert (ECN)
TOP 4.5 Determination of the PAH16 content in composts and digestates
Stefanie Siebert (ECN)
TOP 4.6 Conformity Assessment procedure
Wim Vanden Auweele (Vlaco)
10.03.2020 4/Agenda - TG FERT Meeting 5 March 2020
TOP 5 Update on the state of the art on the EU Fertilising Product Regulation
TOP5.1 EU Guidance document for labelling
Irmgard Leifert (Reterra), replaced by Stefanie Siebert
TOP 5.2 Frequently Asked Questions (FAQs) on the EU Fertilising Product Regulation
Stefanie Siebert (ECN)
TOP 5.3 Further amendments on the EU Fertilising Product Regulation
Stefanie Siebert (ECN)
TOP 6 Conclusions and next steps
TOP 7 Any other business
10.03.2020 5/TOP 2 Standardisation work on analytical
▪ Standardisation request (M/564) sent to CEN on 10 February 2020
▪ Acceptance by CEN still open until 10 March 2020
Request to draft harmonised standards and European standardisation
deliverables in support of Regulation (EU) 2019/1009 for EU fertilising products
until 01 April 2022
Content of the standardisation request
▪ CEN shall prepare a work programme indicating all the standards and
standardisation deliverables listed in Annex I, the responsible technical
bodies and a timetable for the execution of the requested standardisation
activities in line with the deadlines set out in that Annex.
▪ CEN shall submit the draft work programme to the Commission by 15 May
2020. CEN shall inform the Commission of any amendments to the work
programme.
10.03.2020 6/NEN ASSISTS AND CONNECTS
Standards: always a tailor-made agreement
• A standard is a voluntary agreement between interested parties in
respect of a product, process, service or system
• Standardization is the process leading to the establishment of a
standard
• This process is open, transparent and focuses on achieving
consensus
• The standardization process results in:
o stable and reviewable
o broadly supported
o generally accepted
o coherent & non-conflicting
o reference documents with added value
• This makes standards and standardization powerful
instruments for self-regulation and deregulation
8Consensus: according to ISO Directives Consensus • general agreement, characterized by the absence of sustained opposition to substantial issues by any important part of the concerned interests and by a process that involves seeking to take into account the views of all parties concerned and to reconcile any conflicting arguments NOTE Consensus need not imply unanimity. Standards and Regulations 9
Standardization Requests
• Standardization requests (formerly named ‘Mandates’) are
requests from the European Commission to the European
Standardisation Organizations (ESOs) to draw up and adopt
European standards in support of European policies and
legislation.
• It is a “job description” that stipulates how the standardization
organization should implement the essential requirements
from a directive in a number of standards for the different types
of products.
• The standardization request is part of the political process, but
also the transition to a market-driven, technical process.
• To come into force, the standardization request is accepted by
the relevant standardization organization, which undertakes the
development of the standards in a given timeframe.
Standards and Regulations 10Standardization Request on fertilisers
• Regulation (EU) 2003/2003 replaced by Regulation (EU)
2019/1009 - Transition phase until 2022
• Standardization request in support of (EU) 2019/1009 covering
– CEN/TC 260 Fertilizers and liming materials
– CEN/TC 455 Plant Biostimulants
– CEN/TC 223 Soil improvers and growing media
• 68 harmonized standards consisting of required information and
standards of which a few also need to be developed
Standards and Regulations 11Structure
Sreq Fertilizers
CEN/TC 260 CEN/TC 223 CEN/TC 455
Fertilizers and liming Soil improvers and Plant Biostimulants
materials growing media
+ working groups + working groups
CEN/TC 223/WG 0 CEN/TC 223/WG 3 CEN/TC 223/WG 4 CEN/TC 223/WG 5
Chairman's Advisory Sampling Analytical methods Microbiology
Group
CEN/TC 223/WG 6 CEN/TC 223/WG 7 CEN/TC 223/WG 8
Harmonization Chemical contamination Physical contamination
12Work programme example
Title of harmonized standard Requirements and reference
information to be covered by the
standard
Determination of the PAH16 content in compost and digestate
European Standard: Compost and To use as basis standard: EN 16181
digestate properties when used in
fertilising products
Determination of the content of macroscopic impurities (glass,
metal, plastics) above 2mm in compost and digestate
To use as basis technical specification: CEN TS/16202
Determination of temperature and time profile during
composting and digestion
To be developed
Determination of the oxygen uptake rate in compost and
digestate
To use as basis standard: EN 16087-1
Determination of the self-heating factor in compost
To use as basis standard: EN 16087-2
Determination of the residual biogas potential in digestate
To use as basis British standard: OFW004-004
Standards and Regulations 13Next Steps
• Participation options
– A National Standardization Body provides access to CEN
> To join a CEN working group to develop standards,
> first become a member of a national committee
– National committees can vote and comment during
different stages of standards development
• Technical Specifications April 2022
– Non-validated methods
• Standards April 2024
– Methods need to be validated in approved labs
Standards and Regulations 14Developing a hEN (without TS stage) Standards and Regulations 15
Timeline for hEN (umbrella standard) Target dates Signature of the contract T0 Circulation of 1st draft (stage 20.60) T0 + 12 months Dispatch TS draft to CCMC (stage 30.99) T0 + 16 months Definitive TS text is available (stage 60.60) T0 + 24 months Dispatch Enquiry draft to CCMC (stage 30.99) T0 + 30 months Dispatch Formal Vote draft to CCMC (stage 45.99) T0 + 42 months Definitive EN text is available (stage 60.60) T0 + 48 months Standards and Regulations 16
Timeline for EN (+ collaborative study) Target dates Signature of the contract T0 Circulation of 1st draft (stage 20.60) T0 + 12 months Start collaborative study T0 + 16 months Collaborative study report is available T0 + 24 months Dispatch Enquiry draft to CCMC (stage 30.99) T0 + 30 months Dispatch Formal Vote draft to CCMC (stage 45.99) T0 + 42 months Definitive EN text is available (stage 60.60) T0 + 48 months Standards and Regulations 17
National standard body in the Netherlands
• NEN is an independent not-for-profit institute
• NEN has no direct interest in the content of standards
• Over more than 100 years, NEN provides a neutral platform where
different stakeholders can meet and reach agreement
• NEN-committees contribute to/develop clearly defined and usable
agreements which have a broad support
National standards bodies around the world (NEN and many others):
• can perform the role of secretariat for CEN- and/or ISO-technical
(sub)committees or working groups
• can assist (inter)national stakeholders with setting up a CEN-
and/or ISO-technical committee for a new topic
• may provide explanations regarding the development of standards
to (inter)national stakeholders
18Zarra de Laat, zarra.delaat@nen.nl Consultant AgroFood & Consument T +31 152 690 535 M +31 6 1145 5670 Hieke Reijnhoudt, hieke.reijnhoudt@nen.nl Consultant AgroFood & Consument T +31 152 690 224 M +31 6 3333 4655 NEN, www.nen.nl Vlinderweg 6, NL-2623 AX Delft P.O. Box 5059, NL-2600 GB Delft Standards and Regulations 19
TOP 3 ECN’s approach to the standardisation work
▪ All analytical methods for compost and digestate will worked out by CN/TC
223 soil improver and growing media
▪ CEN/TC 223 Secretariat: NEN – Standardisation body of the Netherlands
▪ ECN liaison with CEN/TC 223, no voting rights but can nominate experts for
the specific working groups under CEN/TC 223
▪ Involvement in national standardisation bodies
10.03.2020 20 /TOP 3 ECN’s approach to the standardisation work
Parameter Analytical method PFC/CMC
Organic Carbon EN 15936 PFC 1(A)/(B), PFC 3
Nitrogen (total EN 13654-2, EN 13645-1, PFC 1(A)/(B), PFC 3
EN 15561, NEN 7438
Ammonical, nitric and urea EN 15604, EN 16652, EN PFC1(A)/(B), PFC 3
nitrogen 13651
P2O5, K2O2, MgO, Na2O EN 13650, EN 16174, Det. PFC 1(A)/(B)
ISO 11885, TS 16170,
TS16171
Copper, Zink, inorganic EN 13650, Det. ISO 11885 PFC 1(A)/(B)
Arsenic
Cd, Ni, Hg, PB EN 13650 EN 1696 4; Det. PFC 1(A)/(B), PFC 3, PFC 4
EN 16319 or ISO 11885
(Cd/Ni/Pb); EN 16320 or
ISO 16772 for Hg ….
SO3 content EN 15925, Det: EN 15749 PFC 1(A)/(B),
10.03.2020 21 /TOP 3 ECN’s approach to the standardisation work
Parameter Analytical method PFC/CMC
Chrom total EN 13650 PFC 1(A)/(B), PFC 3
Chrom VI EN 15192, EN 16318, EN PFC 1(A)/(B), PFC 3
ISO 17075-2
Biuret content ISO 18643 PFC1(A)/(B)
Chloride content EN 16195 PFC 1(A)/(B), PFC 3
Phosphonate content To be developed PFC 1(A)/(B), PFC 3
Dry matter EN 13040, ISO/Dis 19745 PFC 1(A)/(B), PFC 3, PFC 4
Salmonella spp EN ISO 6579 or CEN/TR PFC 1(A)/(B), PFC 3, PFC 4
15215
10.03.2020 22 /TOP 3 ECN’s approach to the standardisation work
Parameter Analytical method PFC/CMC
E.coli ISO 16649-2 or EN ISO PFC 1(A)/(B), PFC 3, PFC 4
9308-3 of CEN/TR 16193 PFC
Enterococcaceae EN 15788 or EN ISO 7899-1 PFC 1(A)/(B), PFC 3, PFC 4
PFC
Quantity (t.b.d.); EN 12580, EN (PFC 1(A)/(B)), PFC 3, PFC 4
15238
pH EN 13037 PFC 3, PFC 4
Electrical conductivity EN 13038 PFC 3 , PFC 4
PAH16 EN 16181 CMC 3, CMC 5
Impurities CEN/TS 16202 CMC 3, CMC 5
Time- temperature profiles To be developed CMC 3, CMC 5
10.03.2020 23 /TOP 3 ECN’s approach to the standardisation work
Parameter Analytical method PFC/CMC
Stability
Oxygen update Rate EN 16087-1 CMC 3, , CMC 4, CMC 5
Self-heating test EN 16087-2 CMC 3
Residual biogas potential OFW004-004 CMC 4, CMC 5
10.03.2020 24 /TOP 3.1 Identification of critical work items
Parameter Analytical method Remark
Stability
Oxygen update Rate EN 16087-1 Further discussion TOP 4.1
Self-heating test EN 16087-2
Residual biogas potential OFW004-004
Impurities EN/TS 16202 Further discussion TOP 4.2
Validation failed, important support of dry
sieving method against washing and
bleaching
Time-temperature profiles To be developed S. TOP 4.3 Engagement by ECN members
needed
Organic nitrogen To be developed s. TOP 4.4
PAH16 EN 16181 s. TOP 4.5
10.03.2020 25 /TOP 3.2 ECN Task group/project organisation for standardisation work
▪ ECN members are asked to nominate experts for the working groups under
CEN/TC 223
WG 4 WG 5 WG 6
WG 3 WG 7 Chemical WG 8 Physical
Working group: Analytical Micro- Harmoni-
Sampling contaminants contaminants
methods biology sation
Howard Andreas Laurent Dearbhail Ni Arjen
Convenor: ???
Burnett Baumgarten Largant Chualain ? Brinkmann
Country UK AT (UK?) FR IE NL
Sampling E.coli,
Corganic Heavy metals
Work item Time- Enteroc. Nutrients Impurities
Stability PAH
temperature Salmonella
Nominated SI (ECN)
10.03.2020 26 /TOP 4.1 Stability (OUR/Self Heating Test/Residual Biogas
Potential)
Requirements for stability in the EU Fertilising Products Regulation
Criteria CMC 3 CMC 5
compost digestate
Self heating test (Rottegrad) Class III – IV – V
Oxygen uptake rate ≤ 25 mmol O2/kg OM/h ≤ 25 mmol O2/kg OM/h
Residual biogas potential ≤ 25 l biogas/g VS
Rottegrad class Maximum
temperature (°C)
V 20-30
IV
III
II
30-40
40-50
50-60
? ?
I >60
10.03.2020 27 /TOP 4.1 Stability (OUR/Self Heating Test/Residual Biogas
Potential)
How easy/difficult is it to achieve the required criteria / limit values ?
green compost CMC 3
compost average median stdev 25pctile 75pctile 95pctile
self heating rate - III-IV-V V V - V V IV
Temperature °CTOP 4.1 Stability (OUR/Self Heating Test/Residual Biogas
Potential)
▪ Discussion on OUR during last meeting (sept 2019)
▪ Compost stability: EU FERT limit value OUR ≤ 25 mmol O2/kg OM/h
10.03.2020 29 /TOP 4.1 Stability (OUR/Self Heating Test/Residual Biogas
Potential)
▪ Is oxitop/OUR a suitable parameter for digestate products ?
▪ limit value OUR ≤ 25 mmol O2/kg OM/h => hard to achieve for digestate
▪ What with other organic fertilisers / soil improvers ?
OUR
product mmol O2/kg VS/h reference
incub: 20°C
cattle manure 29,1 ILVO
solid fraction cattle slurry 36,4 ILVO
composted cattle manure 8,3 ILVO
processed chicken manure 60 ILVO
biothermal dried chicken manure + biowaste 70-100 Vlaco
green compost 2-5 Vlaco
solid fraction digestate 12-25 Vlaco
dried digestate 15-35 Vlaco
post-composted solid fraction digestate +
substrate 2,4-7,1 Arbor, Biorefine
post-composted solid fraction digestate - substrate 13,1 Arbor, Biorefine
10.03.2020 30 /TOP 4.1 Stability (OUR/Self Heating Test/Residual Biogas
Potential)
▪ BE: CMA method: incubation at 20°C EN 16087-1: incubation at 30°C
▪ Research VITO: Q10-factor: influence on OUR when ΔT = +10°C
▪ Solid digestate products: Q10 = x1,8 (solid fraction), x1,6 (dried digestate)
10.03.2020 31 /TOP 4.1 Stability (OUR/Self Heating Test/Residual Biogas
Potential)
▪ With other CMC’s: no criteria for stability
▪ Examples:
▪ CMC 1: Virgin material substances and mixtures
▪ CMC 2: Plants, plant parts or plant extracts
▪ CMC 6: Food industry by-products
▪ CMC 10: Derived products within the meaning of Regulation (EC) No 1069/2009
An EU fertilising product may contain derived products within the meaning of Regulation (EC) No
1069/2009 having reached the end point in the manufacturing chain as determined in accordance with
that Regulation, and which are listed in the following table and as specified therein ( 12 ): …
=> What if compost or digestate are listed in the “following table” (not yet listed) ?
▪ CMC 11: By-products within the meaning of Directive 2008/98/EC
10.03.2020 32 /TOP 4.1 Stability (OUR/Self Heating Test/Residual Biogas
Potential)
▪ Is Residual Biogas Potential a suitable parameter for digestate products ?
▪ limit value RBP ≤ 0,25 liter biogas/g VS
▪ Limited analyses (not a common QA parameter)
▪ Some data: WRAP, 2010: Residual biogas potential test for digestates
(http://www.wrap.org.uk/sites/files/wrap/Residual%20Biogas%20Potential.pd
f)
▪ Method is described: OFW004-004
10.03.2020 33 /TOP 4.1 Stability (OUR/Self Heating Test/Residual Biogas
Potential)
Residual Biogas Potential (WRAP, 2010)
Dried digestate
Raw/whole digestate
10.03.2020 34 /TOP 4.1 Stability (OUR/Self Heating Test/Residual Biogas
Potential)
▪ Some recent results from Vlaco (intermediate results after 26 days)
RBP OUR OUR
product liter biogas/g VS mmol/kg VS/h mmol/kg VS/h
incub: 20°C incub: 30°C
dried digestate (without manure) 0,16 22,0 35,2
solid fraction digestate (without manure) 0,05 9,0 16,2
solid fraction digestate (with manure) 0,07 16,0 28,8
▪ Preliminary conclusions: RBP is a better parameter for compliance than OUR
▪ Cost: OUR = 70 €, RBP = 220 € (incl. VAT) per sample
10.03.2020 35 /TOP 4.6 Conformity Assessment procedure
▪ Notifying Authority (to be determined per member state) = competent
authority for fertilising products
▪ Conformity Assessment Bodies (CAB): independent bodies that
perform the assessments = audits
▪ The CAB needs accreditation (issued by national accreditation body)
▪ Standard for accreditation ISO/IEC 17065: Conformity assessment -
Requirements for bodies certifying products, processes and services
▪ For OFSI containing compost (CMC3) and digestate (CMC5), module D1
applies (Quality assurance of the production process)
▪ All analyses need to be done by accredited labs ISO/IEC 17025
10.03.2020 36 /TOP 4.3 Determination and monitoring of time temperature
Parameter Analytical method Remarks
Deadline
Time-Temperature BGK Method book Measurement once per day,
01/04/2024 Closed systems:
measurement of temperature in
exhaust air,
Open windrow systems:
measurement points basis,
core, boundaries
10.03.2020 37 /TOP 4.4 Determination of organic nitrogen (Norg)
Requested in Annex III Part II‚ Product Specific Labelling Requirements for
▪ PFC 1(A) Organic fertiliser (a),b),c))
▪ PFC 1 (B) Organo-mineral fertiliser (a),b),c),d),e))
▪ PFC3 (A) Organic soil improver (a)for C/N ratio, b))
Declaration of nitrogen as % by mass:
a) Total nitrogen
b) Minimum amount of organic nitrogen (Norg), followed by a description of
the origin of the organic matter used
c) Nitrogen in form of ammonical nitrogen
d) Nitrogen in form of nitric nitrogen
e) Nitrogen in from of urea nitrogen
10.03.2020 38 /TOP 4.4 Determination of organic nitrogen (Norg)
Parameter Analytical method Proposal
Total Nitrogen (Ntotal)
EN 13654-2 or –EN 13654-
1, EN 15561, NEN 7438
Organic Nitrogen (Norg) To be developed Norg= Ntotal – (NH4-N + NO3-
N)
Ammonical Nitrogen (NH4-N) EN 15604, EN 16652, EN Determination of NH4-N,
13651 NO3-N
EN 38406 E5
Extraction with Ca2Cl
EN 13652
Extraction of waster soluble
nutrients
Nitric Nitrogen (NO2-N) EN 15604
Urea Nitrogen (CO(NH2)2 + 2 EN 15604
H2O
10.03.2020 39 /TOP 4.5 Determination of the PAH16 content in composts and digestates
Parameter Analytical method Proposal/ Remarks
PAH16 EN 16181
10.03.2020 40 /TOP 4.6 Conformity Assessment procedure
▪ Notifying Authority (to be determined per member state) = competent
authority for fertilising products
▪ Conformity Assessment Bodies (CAB): independent bodies that
perform the assessments = audits
▪ The CAB needs accreditation (issued by national accreditation body)
▪ Standard for accreditation ISO/IEC 17065: Conformity assessment -
Requirements for bodies certifying products, processes and services
▪ For OFSI containing compost (CMC3) and digestate (CMC5), module D1
applies (Quality assurance of the production process)
▪ All analyses need to be done by accredited labs ISO/IEC 17025
10.03.2020 41 /TOP 4.6 Conformity Assessment procedure
Investigation of the
notifying authority of
notification by the
member state
European Commission
Accreditation control
authorisation of a
conformity assessment
body (CAB)
conformity assessment
body (CAB)
Market surveillance
authority
Including:
testing, EU declaration of
inspection, conformity
certification
produced
materials
Conformity assessment Free EU market
42 /TOP 4.6 Conformity Assessment procedure
▪ European Commission: no initiative for a Technical Working Group on
Conformity Assessment (like TG Labelling)
▪ Will the initiative for CAB come from the market ? Existing bodies that
already perform certification for other products/processes/services ?
▪ Who will provide the CAB with the technical finesses of composting
and anaerobic digestion of biowaste ?
▪ Article 36: Coordination of notified bodies
The Commission shall ensure that appropriate coordination and cooperation between bodies
notified under this Regulation are put in place and properly operated in the form of a sectoral
group of notified bodies.
Notified bodies shall participate in the work of that group, directly or by means of designated
representatives.
▪ Input from ECN ?
10.03.2020 43 /TOP 4.6 Conformity Assessment procedure
Benchmark between ECN-QAS Conformity Assessed scheme and CE label
– some of the requirements
EU FERT – module D1 requirement
ECN-QAS requirement
Remarks
10.03.2020 44 /TOP 4.6 Conformity Assessment procedure
The manufacturer shall establish the technical documentation. The documentation shall make it
possible to assess the EU fertilising product’s conformity with the relevant requirements, and shall
include an adequate analysis and assessment of the risk(s).
3 Operation Quality
This chapter lays down the principle of quality management as applied by composting plants.
It would be best to set up a list of all required documentation for both composting and anaerobic
digestion. Many elements are already described in the ECN-QAS.
10.03.2020 45 /TOP 4.6 Conformity Assessment procedure
The technical documentation shall specify the applicable requirements and cover, as far as relevant for
the assessment, the design, manufacture and intended use of the EU fertilising product.
3.1 General data
General data constitute a summary of operational and plant data that shall be collected and stored in
a centralised place.
OK
10.03.2020 46 /TOP 4.6 Conformity Assessment procedure
The technical documentation shall contain, where applicable, at least the following elements:
(d) drawings, schemes, descriptions and explanations necessary for the understanding of the
manufacturing process of the EU fertilising product, and, in relation to compost belonging to CMC 3 or
digestate belonging to CMC 5, as defined in Annex II, a written description and a diagram of the
production process, where each treatment, storage vessel and area is clearly identified,
3.1.1 Plant description
The plant description shall include a process model (Annex C 1) identifying control points. Further
process control records for the assessment of the operational procedures should be kept.
Plan with area for acceptance of waste, area for pre-treatment, area for composting, indicated area
for time/temperature monitoring, quarantine area, area for maturing, for posttreatment, for stock
and sale
10.03.2020 47 /TOP 4.6 Conformity Assessment procedure
The technical documentation shall contain, where applicable, at least the following elements:
e) a specimen of the label or the leaflet, or both, referred to in Article 6(7) containing the information
required in accordance with Annex III,
4.5 Compost declaration and labelling
The following information shall be provided with the compost product dispatched from the
composting facility (whether the product is packaged or unpackaged), either written on the packaging
or on accompanying fact sheets (see Annex C I 6)
See outcome of the TG Labelling: what info is required
10.03.2020 48 /TOP 4.6 Conformity Assessment procedure
The technical documentation shall contain, where applicable, at least the following elements:
(g) results of calculations made, including the calculations to demonstrate conformity with point 5 of
Part II of Annex I (MRL’s), examinations carried out, etc.,
no determination of MRL issues
Best is a global exclusion for MRL issues on the basis of acceptance protocol
10.03.2020 49 /TOP 4.6 Conformity Assessment procedure
The technical documentation shall contain, where applicable, at least the following elements:
(h) test reports,
4.3 Compost analysis
Harmonisation of standards and some new parameters involved
10.03.2020 50 /TOP 4.6 Conformity Assessment procedure
The technical documentation shall contain, where applicable, at least the following elements:
(i) where the EU fertilising product contains or consists of derived products within the meaning of
Regulation (EC) No 1069/2009, the commercial documents or health certificates required pursuant to
that Regulation, and evidence that the derived products have reached the end point in the
manufacturing chain within the meaning of that Regulation,
-
List of derived products (and requirements) that have reached the end-point in the manufacturing
chain: current situation ? If compost and digestate on the list, will this be CMC10 or remain CMC3/5 ?
10.03.2020 51 /TOP 4.6 Conformity Assessment procedure
The manufacturer shall operate an approved quality system for production, final product inspection and testing of the EU fertilising
products concerned as specified in point 5, and shall be subject to surveillance as specified in point 6.
5 Certification Process
5.1 Procedure of quality assurance
Quality assurance of operational processes shall be evidenced by:
• the recognition procedure (initial on-site inspection) performed by the QAO,
• continuous internal production control, and
• regular third-party inspection by the QAO.
5.1.4 External quality control
External quality control is the key process for compost production and product approval. It is the pre-requisite for the appropriate
marketing of compost in line with ECN-QAS.
5.1.6 Periodical third-party surveillance
The QAO shall perform an on-site inspection at minimum once every two years.
Special attention shall be given to the following aspects:
• Follow-up of the results of initial testing,
• Control of quality management according to ECN-QAS quality manual
do we need a procedure for time/temperature check by the CAB to check the monitoring made by the manufacturer ? This should be
part of the audit by the CAB.
10.03.2020 52 /TOP 4.6 Conformity Assessment procedure
The manufacturer shall implement a quality system which shall ensure compliance of the EU fertilising
products with the requirements of this Regulation that apply to them.
plants operate according to the ECN-QAS quality manual
Most of the requirements for EU FERT are listed in ECN-QAS, others are not and should be added, and
others are unclear, such as:
senior management of the manufacturer’s organisation shall ensure that appropriate communication
processes are established within and outside the organisation and that communication take place
regarding the effectiveness of the quality management
10.03.2020 53 /TOP 4.6 Conformity Assessment procedure
The quality system shall cover the examinations and tests to be carried out before, during and after
manufacture with a specified frequency.
5.1.6 Periodical third-party surveillance
The QAO shall perform an on-site inspection at minimum once every two years.
4.3 Compost analysis
The ECN-QAS includes regular sample taking and compost analysis of the relevant quality parameters
conducted by independent laboratories (see chapter 4.3.3).
Frequency of auditing and sampling/analysis is described in EU FERT
10.03.2020 54 /TOP 4.6 Conformity Assessment procedure
(f) The output material samples shall be taken on a regular basis with at least the following frequency: Annual input (tonnes)
Samples / year
≤ 3 000 1
3 001 – 10 000 2
10 001 – 20 000 3
20 001 – 40 000 4
40 001 – 60 000 5
60 001 – 80 000 6
80 001 – 100 000 7
100 001 – 120 000 8
120 001 – 140 000 9
140 001 – 160 000 10
160 001 – 180 000 11
> 180 000 12
In the following years – during the monitoring procedure – the frequency of compost analyses and sample taking should be calculated
on the basis of following equation as a minimum requirement:
Amount of input material / 10.000 [t] + 1 = Analyses per year, 12 per year at maximum.
A positive number behind the dot must be upgraded.
Not completely equal
10.03.2020 55 /TOP 4.6 Conformity Assessment procedure
(g) If any tested output material sample fails one or more of the applicable limits specified in the relevant sections of Annexes I and II,
the person responsible for quality management referred to in point 5.1.1.1(b) shall:
(i) clearly identify the non-conforming output materials and their storage place,
(ii) analyse the reasons of the non-conformity and take any necessary action to avoid its repetition,
(iii) record in the quality records referred to in point 5.1.4 if reprocessing takes place, or if the output material is eliminated.
-
This means, that if an exceedence appears, action needs to be taken. There is not a go/no go whenever 1 parameter is not in line with
the requirements. We will have to discuss the cases:
- lab deviation/doubtful result
- single non compliance
- repeatable non compliance
- margin for corrective measures
- tolerance with respect to the limit value
10.03.2020 56 /TOP 4.6 Conformity Assessment procedure
For compost belonging to CMC 3 and digestate belonging to CMC 5, as defined in Annex 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 relevant 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:
(a) a title, (b) a version number,
(c) a date of issue, (d) the name of the person who issued it,
(e) records about the effective control of input materials,
(f) records about the effective control of the production process,
(g) records about the effective control of the output materials,
(h) records of non-conformities,
(i) reports on all accidents and incidents that occur to the site, their known or suspected causes and actions taken,
(j) records of the complaints expressed by third parties and how they have been addressed,
(k) a record of the date, type and topic of training followed by the persons responsible for the quality of the product,
(l) results of internal audit and actions taken, and
(m) results of external audit review and actions taken.
-
(a) to (d): document management in a quality system
(e): a procedure: yes, recording of the control of input materials: through the input register/registration
(f): critical control points of the process and compost diary
(g): all analyses
(h) - (i): register
(j): complaints register
(k): training dates: HR
(l) and (m): quality manual of the plant
10.03.2020 57 /TOP 4.6 Conformity Assessment procedure
The notified body shall assess the quality system to determine whether it satisfies the requirements
referred to in point 5.1.
5.1 Procedure of quality assurance
Quality assurance of operational processes shall be evidenced by:
• the recognition procedure (initial on-site inspection) performed by the QAO,
• continuous internal production control, and
• regular third-party inspection by the QAO.
to determine: QAO becomes a notified CAB
10.03.2020 58 /TOP 4.6 Conformity Assessment procedure
For compost belonging to CMC 3 and digestate belonging to CMC 5, as defined in Annex II, the notified body shall take and analyse output material samples
during each audit, and the audits shall be carried out with the following frequency:
(a) during the notified body’s first year of surveillance of the plant in question: the same frequency as the sampling frequency indicated in the table
included in point 5.1.3.1(f); and
(b) during the following years of surveillance: half the sampling frequency indicated in the table included in point 5.1.3.1(f).
4.3 Compost analysis
The ECN-QAS includes regular sample taking and compost analysis of the relevant quality parameters conducted by independent laboratories (see chapter
4.3.3).
It is recommended on account of long years experiences to have 100 % external sampling. In agreement with the ECN-QAS it can be admitted that up to 50
% of the samples can be taken by the correspondingly educated plant manager.
At least four inspections for composting plants with a treatment capacity > 4000 t input material per year should be carried out during the first year of
operation - one for every season – to asses the essential quality characteristics over the course of the year. Generally one sample should be taken every
three months.
In the following years – during the monitoring procedure – the frequency of compost analyses and sample taking should be calculated on the basis of
following equation as a minimum requirement:
Amount of input material / 10.000 [t] + 1 = Analyses per year, 12 per year at maximum.
A positive number behind the dot must be upgraded.
the CAB that carries out the audits, also has to be the sample taker. This means that an accreditation according to ISO 17065 would also require sampling of
compost/digestate. This tasks could also be performed by a subcontractor, but this sample taker needs to be accredited as well.
If this is well understood, from year +1 half the sampling can be carried out by other persons than the auditor (auto-control allowed, or only independent
other sample takers ?)
10.03.2020 59 /TOP 4.6 Conformity Assessment procedure
In addition, the notified body may pay unexpected visits to the manufacturer. During such visits the notified body
may, if necessary, carry out product tests, or have them carried out, in order to verify that the quality system is
functioning correctly. The notified body shall provide the manufacturer with a visit report and, if tests have been
carried out, with a test report.
-
How can you organise this ? Who will claim that extra visits are necessary ? Who will be responsible ? Who will
assess that this is truely necessary ?
10.03.2020 60 /TOP 4.6 Conformity Assessment procedure
The manufacturer shall draw up a written EU declaration of conformity for an EU fertilising product or type and keep
it, together with the technical documentation at the disposal of the national authorities for 5 years after the EU
fertilising product has been placed on the market. The EU declaration of conformity shall identify the EU fertilising
product or type for which it has been drawn up.
-
Will the national authority carry out visits to treatment plants ? Will the work of the CAB be overlooked by the
competent authority ? With which frequency will this happen ? Only in the Member State of production, or also
market surveillance in the Member State of trade/application ?
10.03.2020 61 /TOP 5 Update on the EU Fertilising Product Regulation
TOP5.1 EU Guidance document for labelling
Irmgard Leifert (Reterra)
TOP 5.2 Frequently Asked Questions (FAQs) on the EU Fertilising Product Regulation
Stefanie Siebert (ECN)
TOP 5.3 Further amendments on the EU Fertilising Product Regulation
Stefanie Siebert (ECN)
10.03.2020 62 /TOP 5.1 EU Guidance document for labelling
Guidance document for labelling – last ‚working document‘ from 17 of February
(1)
• What does “ingredients” mean and how to label them?
• In the specific case of fertilising products containing composts
and/or digestate, it is recommended to complete the list of
ingredients with the raw materials used.
• Examples:
• Compost, CMC 3 (Bio-Compost) or Compost CMC 3 (Green-Compost)
• Digestate CMC5 (Dried digestate from manure, energy crops and bio-
waste) or Digestate CMC5 (Solid fraction digestate from energy crops and
bio-waste from plant origin)
10.03.2020 63 /TOP 5.1 EU Guidance document for labelling
Guidance document for labelling – last ‘working document’ from 17 of February
(2)
• How to provide information on the general application rates?
- Further discussion in Task Force meeting 19 Febr. – no results available
- Recommendation to distinguish between „end-user“ categories;
• Consumer use (i.e. private households, weekend gardeners),
• Detailed information application rate for crops
• Professional use (i.e. public domain, farmers),
• General application rate and reference sentence: “Contact Company XY
for more specific recommendations”
• “Farmers are encouraged to avoid over-fertilization and to take official
recommendations into account while drawing fertilization plan.”
• Industrial use (i.e. use of substances as such or in preparation at
industrial site, B-to-B
• “This product is for further processing to a finished fertilising product and
not available for direct application/use at moment.”
10.03.2020 64 /TOP 5.1 EU Guidance document for labelling
Guidance document for labelling – last ‘working document’ from 17 of February
(3)
How to provide the information of risk management?
• A generic sentence such as “To avoid risks to human health and the
environment, please comply with the recommended use instructions of this
fertilizing product” can be used.
• According to Annex III, part I points 4 to 7 of FPR, in the following specific
cases, add the sentences mentioned below:
• Where the EU fertilising product contains ricin,
• ‘Hazardous to animals in case of ingestion’.
• Where the EU fertilising product contains unprocessed or processed cocoa
shells,
‘Toxic to dogs and cats’.
10.03.2020 65 /TOP 5.1 EU Guidance document for labelling
Guidance document for labelling – last ‚working document‘ from 17 of February
(4)
How to describe the origin of organic matter when declaring Norg ?
• It is under the responsibility of the manufacturer to provide pertinent
information on the origin of the organic matter in organic soil improver.
However, the description of the origin of the organic matter should at
least mention:
• “From bio-waste origin” if the product contains only bio-waste as raw
material providing organic nitrogen.
• “From bio-waste from plant origin” if the product contains only bio-waste
from plant origin as raw material for providing organic nitrogen.
• ECN – An additional information for declaration of the origin of Norg
should be given according to the description of ingredients.
10.03.2020 66 /TOP 5.1 EU Guidance document for labelling
Guidance document for labelling – last „working „ document from 17 of
February (5)
Labelling document: Regulatory reference, explanation and voluntary additions
• The product fulfils the requirements of Regulation (EU) 2019/1009 of Annex I Part
II PFC 3(A) Organic Soil Improver and of Annex II Part II CMC 3 Compost.
• The product fulfils the requirements of Regulation (EU) 889/2008 (Organic
production and labelling of organic products with regard to organic production)
• The production process and the product has been externally controlled according
to Annex IV Part II Module D: Quality Assurance of the Production Process of
Regulation (EU) No 2019/1009.
• It should be considered that the requirements for the minimum guaranteed
contents of a product should apply at the timing of production to be assessed at
the conformity assessment.
•
10.03.2020 67 /TOP 5.1 EU Guidance document for labelling
Guidance document for labelling
– last ‚working document‘ from
17 of February
10.03.2020 68 /TOP 5.2 FAQs on the EU Fertilising Product Regulation
▪ ECN submitted FAQs on 4 December 2019
▪ No responses so far
10.03.2020 69 /TOP 5.3 Further amendments on the EU Fertilising Product Regulation
ECN has submitted comments on DOC10 of DG GROW and further amendments
on the EU Fertilising Product Regulation
▪ Ecoli/Entorococcaceae limits to be respected at the moment of the
production and up to the delivery from the production plant of PFC 1(A), 3, 4.
▪ Clarifying definition of CMC 2 (plants, plant parts or plant extracts) by
excluding bio-waste within the meaning of Directive 2008/98/EC (WFD) and
any plant materials from agriculture and forestry, which do not fall under WFD
and which are possibly infected with epidemiological relevant plant diseases
or traces of mycotoxins
10.03.2020 70 /TOP 5.3 Further amendments on the EU Fertilising Product Regulation
ECN has submitted comments on DOC10 of DG GROW and further amendments
on the EU Fertilising Product Regulation:
▪ Time-temperature profiles adding the sentence that the producer is allowed
to apply an alternative time temperature profile for which he can
demonstrate equivalent effectiveness for hygienisation as the indicated time
temperature profiles in the regulation.
▪ Adding food waste, food washing waste, sludges from food and feed
processing plants as input materials for composting and anaerobic digestion
10.03.2020 71 /TOP 6 Conclusion and next steps
Next step:
26-27 March meeting of Commission Expert Group on Fertilisers
• 3.3 The guidance document on the visual appearance of labels for EU
fertilising
products
For final discussion and endorsement
10.03.2020 72 /TOP 7 Any other business
Announcements
25 May 2020 ECN Annual meeting (2-6pm)
26 May 2020 EP breakfast debate on Soil organic matter and compost
hosted by MEP Bogovic and MEP Katainen (7:30-9:30 am)
10.03.2020 73 /You can also read
